FDA does not have enough traceback information to identify the specific source of contamination or request a targeted recall from specific growers.

In its latest update on the continuing investigation of E. coli O157:H7 outbreak linked to romaine, FDA reiterated that epidemiologic, laboratory, and traceback evidence indicates that romaine lettuce from the Salinas, Calif., growing region is a likely source of this outbreak. However, the update stated that FDA does not currently have enough traceback information to identify the specific source of the contamination that would allow us to request a targeted recall from specific growers.

Because of this, FDA is continuing to recommend that consumers not eat romaine lettuce harvested from Salinas or any products identified in the November 21 USDA recall announcement; restaurants and retailers not serve or sell romaine harvested from Salinas or that for which the source is not known; suppliers, distributors and others in the supply chain not ship or sell romaine harvested in Salinas or from an unknown source. The Salinas region is defined as including the California counties of Santa Cruz, Santa Clara, San Benito, and Monterey.

FDA also requested that industry voluntarily withdraw romaine grown in Salinas from the market and withhold distribution of Salinas romaine for the remainder of the growing season in Salinas. “Without more specific traceback information, this was the most efficient way to ensure that contaminated romaine was off the market,” the update said.

According to CDC, there have been 102 cases reported in 23 states. The latest date that one of these patients reports becoming ill was on November 18, 2019. Due to

At this time, romaine lettuce that was harvested outside of the Salinas region has not been implicated, nor has hydroponically and greenhouse-grown romaine, which is voluntarily labeled as “indoor grown,” from any region. There is no recommendation for consumers to avoid using romaine harvested from these other sources.

The FDA and state partners are continuing to conduct a traceback investigation to determine whether a common supplier or source of contamination can be identified. This investigation involves collecting and analyzing potentially hundreds of distribution records to trace the romaine that may have been available at points of exposure reported by ill people to their source.

Read the full update at FDA.gov.

FDA publishes long-delayed rule detailing the use of laboratory oversight for food testing.

An unpublished provision of the Food Safety Modernization Act (FSMA) was addressed in early November with FDA’s publication of the proposed rule, Laboratory Accreditation for Analyses of Foods, which details the use of laboratory oversight for food testing.

“The proposed rule takes important strides to ensure that laboratories demonstrate their competency in testing food,” said Food Laboratory Alliance Director Robin Stombler. “Demonstrating appropriate validation methods, passing proficiency testing, and complying with the international standard ISO 17025:2017 are essential elements with which all food testing laboratories should adapt.”

Laboratories would be required to conduct proficiency testing at least once per year which LGC PT Operations for North America Director Heather Jordan said “will help improve the functioning of the laboratory and ensure the delivery of accurate results.”

Electronic or written comments on the proposed rule may be submitted through March 3, 2020. For more information, see the rule’s instructions, which follow the Summary, in the Federal Register.

SGS report compares pesticide monitoring in EU and U.S.

A new report from SGS compares pesticide monitoring in the United States and European Union. The analysis is based on the EU’s Rapid Alert System for Food and Feed (RASFF), and the US’s FDA Pesticide Residue Monitoring Program Report and Interagency Food Safety Analytics Collaboration (IFSAC) Annual Report on Foodborne Illness Source Attribution Estimates.

European Union. The RASFF reports that there 2018 there were 3,699 notifications, which resulted in 1,118 alerts in the EU in 2018. There were 979 notifications for pathogenic micro-organisms, 655 notifications for mycotoxins and 276 notifications for pesticide residues.

Other major notifications in order were composition (224), allergens (207), poor & insufficient controls (179), foreign bodies (168) and food additives & flavorings (142).

A few of these notifications came from governments of non-member countries, for example an alert from Chile of 112.63 ppb oxytetracycline in frozen Atlantic salmon fillets exported to Germany, which notified Denmark where the receipt of the consignment was located.

For pathogenic micro-organisms, Salmonella is still the most frequently reported pathogen, with poultry meat and poultry meat products being the top notification because of the food safety criteria for the absence of Salmonella Typhimurium and Enteritidis in fresh poultry meat. Sesame seeds are another product reported with major Salmonella issues. Listeria monocytogenes is the second most notified pathogenic source, which is primarily found on food of animal origin but a major outbreak involving frozen corn indicates that there are other sources that must be considered. In Europe norovirus was number three, with most of this from French oysters but some six notifications were for various berries. Shigatoxin-producing Escherichia coli (E. coli) is fourth with most of these notifications occurring in non-treated meat products and cheeses.

Mycotoxin compliance is primarily an issue of non-member countries. The major issue is Aflatoxin occurring in nuts, nut products, seeds and dried figs. Ochratoxin A is the next mycotoxin, with issues occurring in raisins and dried figs.

For pesticides, this is primarily an issue of non-member countries. Fruit and vegetables are still the primary concern for failed pesticide residue compliance, followed by cocoa and cocoa preparations, coffee and tea.

United States. The IFSAC report of 2017 analyzes the data of outbreaks from 1998 to 2017 to assess which categories of food were most responsible for four specific pathogens:

The US government estimates, annually, 9 million people become ill, 56,000 are hospitalized and 1,300 people die from foodborne diseases. For Salmonella, 75.3% of the illnesses can be attributed to seeded vegetables such as tomatoes, chicken, fruits, pork, eggs, other produce and beef. For E. coli 72.15% of the illnesses are from vegetable row crops such as leafy vegetables and beef. For Listeria monocytogenes 77.7% is from dairy products and fruits. For Campylobacter, when excluding unpasteurized milk, 78.9% of the illnesses are attributed to chicken, seafood, turkey and other meat and poultry.

The US FDA 2017 pesticide monitoring program report views pesticides as those products domestically produced and those products imported. There are six major categories grains, dairy/eggs, fish/shellfish (only imported), fruits, vegetables and others. Samples are recorded as with no residues, with residues, no violations and in violation.

Domestic results in violation are:

The ‘Other’ group is largely comprised of cashew nuts, seeds, condiments/dressings, olive oil, refined oil, honey, beverages, spices, multi-ingredient products, tea and dietary supplements.

Imported items that may require special attention per the 2016 and 2017 annual report are onions, leeks, scallions, shallots, papaya, peas, hot peppers, prickly pears, rice (excluding powder and snacks), spinach and snap (string) beans. Imported items that may require special attention criteria, in 2017 meant commodities with at least 20 samples analyzed or with a minimum of 4 violations and a violation rate of 10% or higher.

There was a special sampling of 119 samples of corn, soybean, milk and eggs for glyphosate for which 70.6% of the samples were without residues, no residue was found in milk and eggs. Also, no sample was found in violation.

Comparison of the Top Ten pesticide residues found in the EU versus US.

Chlorpyrifos, which was the top residue found in the EU testing and seventh residue found for the US, is in the process of being banned in the State of Hawaii, awaits the governor’s signature to be banned in New York state, will no longer be sold in California as of February 6, 2020, and growers there will no longer be permitted to possess or use this product after December 31, 2020. Additionally, the Natural Resources Defense Council has ongoing ligation against the current administration for refusal to ban this residue use on food crops. A similar situation is taking place in the EU as the European Food Safety Authority (EFSA) assessment that identifies human health effects and the approval period for chlorpyrifos expires January 2020.

Salmonella tops both the EU and US pathogenic organism list. In the US, about 4.3% of import refusals from January 2014 to September 2019 are related to Salmonella as fully or part of the refusal.

In Washington Post OpEd, Stephen Ostroff recommends task force recommendations be implemented.

In the last two years there have been five multistate outbreaks of E. coli O157:H7 linked to romaine lettuce. In an Op Ed in the Washington Post, former FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen M. Ostroff discusses the issue and poses some recommendations.  

Noting that the natural reservoir for E. coli is ruminant animals, especially cattle, he states that one particular strain is occurring in the growing regions of central coastal California, returning each fall near the end of the growing season. However, the source of the strain is unclear.  “What is clear is that additional steps must be taken to make romaine safer,” he wrote.

Ostroff then references the recommendations of the Romaine Task Force, which was established by the United Fresh Produce Association and the Produce Marketing Association at the request of FDA following the November 2018 E. coli O157:H7 outbreak involving romaine.  One of the recommendations in the report was that:

“the romaine industry needs to consider any open water source as potentially contaminated and therefore steps need to be taken to treat the water to prevent potential contaminants from contacting edible plant tissues. The working group also considered the 21-day window that the CA LGMA has adopted; i.e. if an open water source is used to irrigate romaine and contacts the edible tissues of the plant within 21-days of harvest, the water must be treated using a validated process to control any potential pathogens.”

With E. coli O157:H7 found in untreated surface water in both the Yuma and 2018 Thanksgiving outbreaks, Ostroff sees this as one of the most significant recommendations, stating, “The task force recommendations should be immediately adopted and implemented. But even more should be done. Surface water used for romaine irrigation should be treated throughout the growing cycle, not just in the three weeks before harvest. The FDA should also quickly issue agricultural water standards that have been postponed but are required by FSMA’s produce-safety rules.”

Also stated as a concern to be addressed was concentrated animal feeding operations, “where tens of thousands of cattle potentially carrying E. coli O157:H7 are housed, if they are located near leafy green growing areas. Buffers between the cattle operations and growing fields are required, but bigger ones may be needed.”

Read the full article in the Washington Post. Read the Task Force Report at unitedfresh.org.

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