Tag Archives: Fda

The foreign supplier verification rule is foreign to many importers

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My friend, Roy Costa from Florida, sent along this piece and I deemed it worthy.

The foreign supplier verification rule is foreign to many importers, October 20, 2018

The Foreign Supplier Verification Rule (FSVP), 21 CFR Part 1, Subpart L, is the part of the Food Safety Modernization Act that regulates the importation of food covered by FDA. While the Act when into effect in 2015, some importers have not yet fully implemented an FSVP program.

An FSVP program is a risk-based system that ensures that foreign suppliers meet the same US rules for food safety as domestic suppliers. This means that importers must verify that FDA’s rules, the Current GMP Hazard Analysis and Risk Based Preventive Controls for Human and Animal Foods, and the Produce Safety rules, have been implemented by suppliers.

Importers bare the responsibility for verification of the safety of foods imported into the US. The Customs filings now include a line item for the “FSVP Importer”. This entry utilizes the Dunn and Bradstreet’s unique facility identifier-the DUNS Number; no food maybe imported without this filing. Whoever is identified as the FSVP Importer must be qualified through education and experience to understand any document submitted for verification, and is subject to unannounced FDA inspection.

The FSVP rule allows third-party audits, microbial, physical and chemical testing and operational records to be used for verification purposes. The key documents an importer must verify are the Food Safety Plan of foreign manufacturers, and the records that show compliance with the Produce Safety rule.

In order to understand these complex verification documents, one must understand the Hazard Analysis and Critical Control Point (HACCP) concept. Education in the Preventive Controls and Produce Safety rules will be necessary for most importers. Without a scientific background, understanding how to successfully apply the five preliminary HACCP steps and the seven HACCP principles is impossible, and the Produce rule requires a deep understanding of Good Agricultural Practices.

Some importers will not be qualified to make decisions about supplier approval, or even understand what is required of them, without training.

An importer must prepare his own FSVP program for each commodity he obtains, based on a risk assessment similar to HACCP. He can only do this if he is a FSVP Qualified Individual, although he can hire or use another Qualified Individual, if he is not so qualified.

The barriers of entry are high. If a supplier does not meet the rules, or if the importer cannot verify the safety of foods, no such foods can be obtained. This could put some importers out of business, and restrict trade in foreign foods.

The impact is huge for the global economy. Currently, imported foods make up an estimated 15 percent of the U.S. food supply, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood.

The FSVP rule prohibits anyone with a financial interest in the outcome of verification to have a financial interest in an approval decision. The problems with conflicts of interest in this scheme are readily apparent, since many importers also own the operations of the foreign supplier, and virtually all importers have some kind of monetary incentive for bringing products into the US.

FDA has the authority to inspect the records of the FSVP Importer, and they typically do not notify in advance of a routine inspection. Once in the office, FDA has access to virtually all the records of the importing firm, and will expect that the firm has a Qualified Individual, policies and procedures, records, and a risk-based system to make decisions about supplier approval, with an approved supplier list. Without these vital documents, there will be no way an importer can demonstrate compliance.

At this time, FDA is making inspections to primarily educate the industry, but they will act if they find an importer violating US rules or obtaining unsafe foods.

With such dire consequences possible, one would expect that an importer would seek education in areas of legal compliance, but the industry has not shown overwhelming interest in taking the training needed to understand their responsibilities.

Eventually, the agency will take a focused approach to weeding out the non-compliant importing operations, but the job will be difficult. Policing these complex importer arrangements will not be an easy assignment; it is well known the importers sometimes flaunt the rules that have been in place, and engage in port shopping, ignoring Import Alerts, and outright deception. These new regulations should allow FDA to be more effective in detecting criminal activity, and I expect that penalties will be severe for importers who bring in contaminated foods that cause illness and death to US consumers.

I also expect that product liability will eventually stretch back to the importer in such cases, and that lawsuits will take into consideration the compliance history of the importer when perusing justice for victims of foodborne illness.

I strongly recommend that both foreign suppliers and importers take the Food Safety Preventive Controls Alliance FSVP course, and the other FSPCA relevant courses as needed, Preventive Controls for Human and Animal Foods, and Produce Safety Rules, and learn how to develop a compliant FSVP program.

Contact Environ Health Associates, Course Administration Manager; Katherine Jones 386-316-7266 for course registration.

If you’re not too busy farming read this: Draft Guidance for industry: Standards for the growing, harvesting, packing, and holding of product for human consumption,

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The purpose of this draft compliance and implementation guidance document is to help covered farms comply with the requirements of the Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce.  Entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” the rule is part of FDA’s implementation of the FDA Food Safety Modernization Act (FSMA). 

The draft guidance provides a broad range of recommendations on how to meet the requirements for most subparts of the rule. It also outlines how to determine whether produce or farms may be eligible for exemptions from certain requirements, or from the rule in its entirety.  

Specific regulatory or statutory requirements are cited, and in some cases, specified using the word must. The use of the word should indicates that something is recommended, but not required. The use of the word including means options that are not limited to the described items.

You are encouraged to submit comments on the draft guidance within 180 days of the publish date to ensure your comments are considered while FDA works on the final version of the guidance.

In addition to the draft guidance, there is an At-a-Glance overview of key points in each of the nine chapters described below, as well as a glossary of key terms. The overviews summarize important aspects of each chapter.  It is recommended that you review the draft guidance itself for complete information.

Frank Yiannas headed to FDA

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Bob Brackett, who was the U.S. Food and Drug Administration’s point man during the E. coli spinach outbreak of 2006 ( and did a great job), told me once it was always part of the plan to work in academia, government and industry, and he’s done it.

Much praise from this critic.

 

Frank Yiannas, the vice president of food safety for Walmart and an outspoken proponent of blockchain, is leaving retail to take a post at the Food and Drug Administration.We visited Frank when he was at Disney, Frank visited us when we were in Kansas, we went shopping together at Walmart, as food safety nerds do.

 

I have a lot of respect for Frank, and hope the bureaucratic screws don’t wear him down.

He always said, where can I get the most bang for my food safety buck (OK, those are my words) but I’m fairly sure Frank would go along with that encapsulation.

And the Susies in our lives.

44 sick from Salmonella Enteritidis linked to shell eggs from Gravel Ridge Farms

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Amy and I helped make breakfast for 120 grade 4 and 5 school kids this morning.

The kids had their annual sleepover Friday night at the school, in tents, with activities and endless gossip until late night or early morning (that’s Hubbell being busy in the background).

We arrived about 5:50 a.m., ready to make breakfast.

The menu was bacon and egg sandwiches on rolls, brown beans, and juice, along with vegan and halal alternatives, reflecting the multi-cultural nature of our neighbourhood and Sorenne’s school.

Amy worked in the kitchen, prepping rolls and keeping things rolling, while me and another dude worked the grill.

We cooked the bacon we had, then cleaned the grill thoroughly out of respect for others, and then the eggs.

There were no runny eggs.

There was no cross-contamination.

There wasn’t going to be some sorta Salmonella outbreak on my watch.

And Australia still has an egg problem.

What you do at home is your own business, but when cooking for 120 children, risk management is a little different.

For example, the U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated a multi-state outbreak of Salmonella Enteritidis illnesses linked to shell eggs.

As of October 25, 2018, there were 44 illnesses associated with shell eggs from Gravel Ridge Farms, in Cullman Alabama. The CDC has announced that this outbreak appears to be over.

The FDA advises consumers not to eat recalled shell eggs produced by Gravel Ridge Farms. Consumers who have purchased these products should discard the eggs or return them to the store for a refund. For a complete list of stores, visit the recall notice.

Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling raw eggs and raw egg-containing foods. Dishes containing eggs should be cooked to 160° F. For recipes that call for eggs that are raw or undercooked when the dish is use either eggs that have been treated to destroy Salmonella, by pasteurization or another approved method, or pasteurized egg products.

On September 5, 2018, the FDA and Alabama Department of Agriculture and Industry began an inspection at Gravel Ridge Farms and collected environmental and egg samples for laboratory testing. The results were used to confirm that Salmonella Enteritidis isolates collected from environmental and egg samples taken at the farm were genetically related to isolates obtained from ill persons.

As a result of the outbreak, Gravel Ridge Farms voluntarily recalled cage-free, large eggs and removed the eggs from the shelves at grocery stores, restaurants, and other retail locations.

Twenty-six of 32 (81%) people interviewed reported eating restaurant dishes made with eggs. These restaurants reported using shell eggs in the dishes eaten by ill people.

The whole restaurant dishes-made-with-raw-eggs-thing, such as mayo and aioli is problematic. My 9-year-old knows to ask how the aioli is made if she gets fish, and the server always comes back and says, chef makes it only with raw eggs, and she knows enough to say no.

But we are the poop family (it’s on the front door).

I had a couple of thermometers in my back pack but were not necessary.

2299 confirmed sick from Cyclospora in US from multiple outbreaks May 1-Aug. 30, 2018

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Shannon M. Casillas, Carolyne Bennett and Anne Straily of the U.S. Centers for Disease Control write in Morbidity and Mortality Weekly that cyclosporiasis is an intestinal illness caused by the parasite Cyclospora cayetanensis through ingestion of fecally contaminated food or water.

Symptoms of cyclosporiasis might include watery diarrhea (most common), loss of appetite, weight loss, cramping, bloating, increased gas, nausea, and fatigue. Typically, increased numbers of cases are reported in the United States during spring and summer; since the mid-1990s, outbreaks have been identified and investigated almost every year. Past outbreaks have been associated with various types of imported fresh produce (e.g., basil, cilantro, and raspberries) (1). There are currently no validated molecular typing tools* to facilitate linking cases to each other, to food vehicles, or their sources. Therefore, cyclosporiasis outbreak investigations rely primarily on epidemiologic data.

The 2018 outbreak season is noteworthy for multiple outbreaks associated with different fresh produce items and the large number of reported cases. Two multistate outbreaks resulted in 761 laboratory-confirmed illnesses. The first outbreak, identified in June, was associated with prepackaged vegetable trays (containing broccoli, cauliflower, and carrots) sold at a convenience store chain in the Midwest; 250 laboratory-confirmed cases were reported in persons with exposures in three states (illness onset mid-May–mid-June) (2). The supplier voluntarily recalled the vegetable trays (3).

The second multistate outbreak, identified in July, was associated with salads (containing carrots, romaine, and other leafy greens) sold at a fast food chain in the Midwest; 511 laboratory-confirmed cases during May–July occurred in persons with exposures in 11 states who reported consuming salads (4). The fast food chain voluntarily stopped selling salads at approximately 3,000 stores in 14 Midwest states that received the implicated salad mix from a common processing facility (5).

The traceback investigation conducted by the Food and Drug Administration (FDA) did not identify a single source or potential point of contamination for either outbreak.

In addition to the multistate outbreaks, state public health authorities, CDC, and FDA investigated cyclosporiasis clusters associated with other types of fresh produce, including basil and cilantro. Two basil-associated clusters (eight confirmed cases each) were identified among persons in two different states who became ill during June. Investigation of one cluster, for which the state health department conducted an ingredient-specific case-control study, found consumption of basil to be significantly associated with illness. A formal analytic study was not conducted for the other cluster, but all patients reported consuming basil. Three clusters associated with Mexican-style restaurants in the Midwest have resulted in reports of 53 confirmed cases in persons who became ill during May–August. Analytic studies were conducted for two clusters; consumption of cilantro was found to be significantly associated with illness in both. Although a formal analytic study was not possible for the third cluster, all 32 identified patients reported consuming cilantro at the restaurant. FDA traceback of the basil and cilantro from these clusters is ongoing. Additional clusters associated with Mexican-style restaurants were identified in multiple states; but investigations to determine a single vehicle of infection were unsuccessful because of small case counts, limited exposure information, or because fresh produce items (including cilantro) were served as components of other dishes (e.g., in salsa).

Many cases could not be directly linked to an outbreak, in part because of the lack of validated molecular typing tools for C. cayetanensis. As of October 1, 2018, a total of 2,299 laboratory-confirmed cyclosporiasis cases† have been reported by 33 states in persons who became ill during May 1–August 30 and did not have a history of international travel during the 14 days preceding illness onset. Approximately one third of these cases were associated with either the convenience store chain outbreak or the fast food chain outbreak.

The median patient age was 49 years (range = <1–103 years) and 56% were female (1,288 of 2,285). At least 160 patients were hospitalized; no deaths have been reported.

The 2,299 domestically acquired, laboratory-confirmed cases reported in persons who became ill during May–August 2018 are markedly higher than the numbers of cases reported for the same period in 2016 (174) and 2017 (623). This increase might be due, in part, to changes in diagnostic testing practices, including increased use of gastrointestinal molecular testing panels. CDC is working with state public health partners to determine whether and to what extent changes in testing practices might have contributed to increased case detection and reporting.

Consumers should continue to enjoy fresh produce as part of a well-balanced diet. To reduce risk from most causes of foodborne illness and other contaminants, CDC recommends washing fresh fruits and vegetables with clean running water; however, washing, including use of routine chemical disinfection or sanitizing methods, is unlikely to kill C. cayetanensis. Persons with diarrheal illness that lasts >3 days or who have any other concerning symptoms should see a health care provider if they think they might have become ill from eating contaminated food.

Acknowledgments

Contributing state and local public health department personnel; Food and Drug Administration

A heavenly match: Cilantro and cyclospora

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According to Food Safety Magazine, since 2014, the U.S. Food and Drug Administration (FDA) has been trying a new approach to produce sampling to assess microbial contamination in food commodities. The approach involves collecting a statistically-valid number of samples of targeted foods over a 12-18 month period, then identifying common microbial factors among them.

For fiscal year 2018, FDA had already been sampling fresh herbs, specifically basil, parsley, and cilantro, along with processed avocado and guacamole–all from both domestic and imported sources. The fresh herbs were chosen for sampling because they are eaten without having gone through any type of kill step (ie. cooking) to reduce or eliminate pathogens. Also, these items are grown low to the ground, which makes them susceptible to contamination. Initially, the sampling was to measure the prevalence of Salmonella and Shiga toxin-producing E. coli (STEC) in these herbs.

Recently, FDA added a new test to this sampling group: Cyclospora cayetanensis. The agency has a new analytical testing method for this parasite.

And my kid is really into this song; also no explanation.

Going public: FDA to disclose retailer information for certain food recalls to improve consumer safety

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Americans depend on the U.S. Food and Drug Administration to help ensure that the foods they buy and consume are safe.

No they don’t. Food safety is faith-based.

When we learn that potentially dangerous food products may be available in the U.S. marketplace, we must move quickly and efficiently to remove these food products from the market.

Our teams routinely work with food producers on voluntary recalls, and when necessary and where applicable, mandate recalls in order to keep people from getting sick or being harmed. We recognize that an important part of the recall process is also arming consumers with actionable information that they can use to avoid potentially contaminated food products. We’re committed to providing consumers with more information to take these actions. This is an area where we see more opportunity to improve the FDA’s role in protecting public health. To promote these goals, we’re advancing an important new policy.

When a food recall is initiated, the FDA typically works with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information. The aim is to enable consumers to identify whether they have the recalled product and take appropriate actions. That often includes discarding the product or returning it to the place of purchase.

The agency has not traditionally released lists of specific retailers where recalled foods may have been purchased. This is because certain supply chain information is confidential between the supplier and retailer. Moreover, in most cases, information publicized by the recalling company is sufficient to allow consumers to identify and avoid recalled product. But there are some cases where additional information about the retailers selling potentially harmful product may be key to protecting consumers such as when the food is not easily identified as being subject to a recall from its retail packaging and the food is likely to be available for consumption. It is particularly important in situations where the product has already been linked to foodborne illness. In these situations, providing retailer information can help consumers more quickly and accurately recognize recalled product and take action to avoid the product or seek assistance if they’ve already been exposed.

We recognize the importance of providing consumers with actionable information related to recalled food products. That’s why today the FDA issued new draft guidance that describes situations when disclosing retail information for products undergoing recalls is appropriate. The draft guidance outlines the circumstances when the FDA intends to make public the retail locations that may have sold or distributed a recalled human or animal food. These circumstances will particularly apply in situations associated with the most serious recalls, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Based on this new policy, moving forward the FDA intends to publicize retail consignee lists for food recalls when the food is not easily identified as being subject to a recall from its retail packaging, or lack thereof, and if the food is likely to be available for consumption. Some examples of this may include foods sold directly to consumers with no universal product code or UPC, or bar code. This might include deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually.

The new draft guidance also states that the FDA may disclose retail consignee lists in certain recall situations, including when a recalled food is related to a foodborne illness outbreak and where the information is most useful to consumers. For example, the FDA might release retailer information for a packaged food that was distributed in a particular geographic region or through a particular online retailer if providing that information could help consumers protect their health and wellbeing from a recalled food potentially purchased at one of these establishments.

In recent months, we’ve already begun taking actions that align with this approach.

For example, this summer the agency released detailed retail distribution information by state during a recall of pre-cut melon associated with an outbreak of Salmonella infections so consumers could better identify where the recalled food may have been purchased. The draft guidance released today, provides greater transparency on our intention to regularly use this approach in these and other scenarios.

We believe that providing retailer information for certain recalls will also improve the efficiency of recalls by helping the public to identify and focus on the foods that are recalled. It’s important to note that in sharing this information, the FDA may also not be able to fully verify the accuracy or completeness of the information it receives from recalling companies or distributors, and information may change over time.

Identifying retail locations can be complex. It can involve obtaining information from multiple parts of the supply chain, including the recalling company and intermediate distributors. But we also know this information can be very important to consumers. Knowing where a recalled product was sold during the most dangerous food recalls can be the difference between a consumer going to the hospital or not. While we can’t prevent every illness, we can make sure we provide information to consumers to prevent more people from becoming sick from a recalled or hazardous food product.

Chapman told USA Today that, “We can never become too vigilant when talking about food safety. We’re talking about 48 million cases of food-borne illnesses a year and that estimate being stable over the last 10 years. There are lots of ways for improvement.”

He said he personally shops at numerous grocery stores for his family, so he doesn’t always remember where he buys what, especially unmarked items, such as sweet potatoes and onions.

The FDA plan to cite specific retailers “can trigger that ‘Oh, I did shop at these places. Maybe I need to start looking,’ ” Chapman said.

Nice to see Chapman stepping up to fill the gap I left. But he still needs me to write it up.

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

Multistate outbreak of Vibrio parahaemolyticus infections linked to fresh crab meat imported from Venezuela

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The U.S. Centers for Disease Control (CDC), is getting in on the vibrio outbreak linked to crab meat imported from Venezuela – often posing as Maryland crab – along with state and local health officials, and the U.S. Food and Drug Administration.

CDC recommends that consumers not eat, restaurants not serve, and retailers not sell fresh crab meat imported from Venezuela at this time.

How would consumers know? Ask questions?

Consumers are not the critical control point of this food safety system.

Yet my 9-year-old knew enough to ask if the aioli that was served with her chips at a hockey tournament in Newcastle, Australia, this was weekend, contained raw egg.

I wasn’t around, but a shiver of pride went through my body.

This type of product may be labeled as fresh or precooked. It’s commonly found in plastic containers.

Food contaminated with Vibrio parahaemolyticus usually looks, smells, and tastes normal.

Steamed crab meat from blue crab (close up)

If you buy crab meat and do not know whether it is from Venezuela, do not eat, serve, or sell it. Throw it away.

CDC, state and local health officials, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Vibrio parahaemolyticus infections linked to eating fresh crab meat imported from Venezuela.

Epidemiologic evidence indicates that precooked fresh crab meat imported from Venezuela is the likely source of this outbreak.

Twelve people infected with Vibrio parahaemolyticus who ate fresh crab meat have been reported from Maryland, Louisiana, Pennsylvania, and the District of Columbia.

Four people (33%) have been hospitalized. No deaths have been reported.

Illnesses started on dates ranging from April 1, 2018 to July 3, 2018.

100 sick from Salmonella in 33 states: Kellogg’s Honey Smacks Cereal still suck and still being sold

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The U.S. Food and Drug Administration (FDA) has become aware that recalled Kellogg’s Honey Smacks cereal are still being offered for sale. All Honey Smacks cereal was recalled in June 2018.

Retailers cannot legally offer the cereal for sale and consumers should not purchase Kellogg’s Honey Smacks cereal.

The FDA has learned that some retailers are still selling this product. The FDA will continue to monitor this situation closely and follow up with retailers as we become aware of recalled products being offered for sale. Additionally, the public is urged to report any product being offered for sale to the FDA Consumer Complaint Coordinator in their region. More information about the recall can be found at FDA.gov.

The FDA, CDC, along with state and local officials are investigating a multi-state outbreak of Salmonella Mbandaka infections linked to Kellogg’s Honey Smacks sweetened puffed wheat cereal.

The CDC reports that 100 people in 33 states have become ill. There have been 30 hospitalizations and no deaths.

Following discussion with FDA, CDC, and state partners, the Kellogg Company voluntarily recalled Kellogg’s Honey Smacks cereal. The recalled products were distributed across the United States including Guam and Saipan and internationally. Consumers should not eat any Honey Smacks cereal.

As this is an ongoing investigation, the FDA will update this page as more information becomes available, such as product information, epidemiological results, and recalls.

The FDA provided a more detailed a list of foreign countries to which the Kellogg’s Honey Smacks cereal was distributed.. Here is the list of the foreign countries: Aruba/Curaçao/Saint Maarten (Netherlands Antilles), the Bahamas, Barbados, Tortola (British Virgin Islands), Costa Rica, Guatemala, Haiti, Mexico, Panama, and Tahiti (French Polynesia).

The FDA is advising consumers to not eat and to discard any Kellogg’s Honey Smacks cereal. This is regardless of size or “best if used by” dates. The recall notice accounts for all of the product that is on the market within the cereal’s estimated one year shelf-life. However, Honey Smacks products with earlier dates could also potentially be contaminated.  

The FDA quickly initiated an inspection at the contract facility where Kellogg’s Honey Smacks is manufactured. As part of the inspection, investigators collected environmental and product samples. Analysis of the environmental samples is now complete, and they were found to be a match to the outbreak strain. In addition, product samples collected and analyzed by state partners were positive for the outbreak strain of Salmonella Mbandaka. As of June 12, 2018, the manufacturing facility is no longer producing product. The FDA continues to work with the firm to address corrective actions.

When the Miami Herald filed a Freedom of Information Act request for the inspection of the facility, the FDA denied the request. The agency claimed two exemptions: “disclosure could reasonably be expected to interfere with enforcement proceedings” and possible disclosure of “trade secret and confidential commercial information.”

61 sick in 7 states from Cyclospora in new outbreak linked to McDonald’s; 3000 locations removing salads

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At least 61 people in seven Midwestern States have been sickened with Cyclospora possibly linked to salads served at McDonald’s restaurants.

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) report that two people have been hospitalized and to date, no deaths have been reported.

Ashley Nickle of The Packer reports that health authorities in Illinois and Iowa have reported 105 recent cases of cyclosporiasis and have linked some of them to McDonald’s salads.

“Out of an abundance of caution, we decided to voluntarily stop selling salads at impacted restaurants until we can switch to another lettuce blend supplier,” McDonald’s said in a statement. “We are in the process of removing existing salad blends from identified restaurants and distribution centers, which includes approximately 3,000 of our U.S. restaurants, primarily located in the Midwest.”

McDonald’s spokeswoman Terri Hickey said, “McDonald’s is committed to the highest standards of food safety and quality control. We are closely monitoring this situation and cooperating with state and federal public health authorities as they further investigate”

In June, federal agencies investigated cyclosporiasis cases that were linked to Del Monte vegetable trays. More than 225 illnesses have been reported in that outbreak. At this time, no link has been made by health authorities between the outbreak linked to McDonald’s salads and the outbreak linked to Del Monte vegetable trays, which included broccoli, cauliflower, carrots and dip.