Chicago sets a food safety standard, then ignores it

The Chicago Tribune reports that inspections are government stethoscopes. They detect leaky roofs, Cobb salads that can tear up our insides, faulty elevators and buildings that are firetraps.

restaurant-inspectionAbout those Cobb salads.

The Chicago Department of Public Health requires “high risk” food establishments, such as restaurants, school and hospital kitchens and day care centers to be inspected twice a year. In 2015, fewer than half of them got two inspections, city Inspector General Joseph Ferguson recently reported. Grocery stores are supposed to get an annual inspection, but nearly 1 in 5 were not visited by sanitarians last year. Bars and convenience stores are supposed to be inspected once every two years, but fewer than 1 in 4 got a visit from inspectors in 2014 and 2015.

The explanation is simple: not enough inspectors. The city has 38 full-time inspectors to handle a workload that the IG says would take 94.

Would you like ranch or Imodium on that Cobb salad?

Foodborne illness affects 48 million people every year in the U.S., according to the Centers for Disease Control and Prevention — hospitalizing at least 128,000, killing 3,000, and making countless others miserable.

Chicago’s food safety inspection rules follow state guidelines, which are based on recommendations from the U.S. Food and Drug Administration. But the city routinely falls short of those standards. For years, the city and state have agreed to “corrective action plans” that allow Chicago to continue to receive local health protection grants from the Illinois Department of Public Health. In 2015, that amounted to $2.5 million.

That raises some questions: Are twice-a-year restaurant inspections necessary to protect people from foodborne illness or not?

Why should consumers have confidence in food safety standards that state health officials consider negotiable?

Does Chicago need more inspectors, or more realistic rules?

If twice-a-year inspections are needed, then the city has an obligation to provide the staffing to conduct them. If they’re not needed, then there are better uses for scarce public dollars. The city needs to figure out which of those things is true, instead of leaving rules on the books and breaking them repeatedly. Taxpayers deserve to know their money is being used wisely, and diners deserve to know their local eateries are following safe food-handling procedures.

It’s not the first time the city has failed to carry out its own inspections regimen. In 2012, the Tribune reported that nearly two-thirds of the city’s elevators had not been inspected the previous year as required. Some of the buildings were downtown, where the city dealt with a backlog by allowing property owners to hire their own inspectors to check elevators. But many building managers didn’t get the inspections done, and the city largely let them off the hook, the Tribune found. Very few of the non-compliant building owners were fined, and the city failed to follow up with its own inspectors, an expense that could have been passed on to the owners.

The fees and fines paid by food service establishments don’t cover the cost of the required inspections — and in any case, that money goes into the city’s corporate fund, which pays for all sorts of programs and services. That money could be dedicated to the Department of Public Health to pay for inspections, though the city would have to find efficiencies in its operating budget to make up for the lost dollars. The city also could charge more for inspections and licenses, or raise the fines for violators, to help cover the costs.

But Ferguson makes an excellent point: The city first needs to determine whether it’s necessary to add 56 inspectors to its payroll. That means working with state health officials to craft an inspections regimen that ensures food safety and is cost-effective, and to codify those standards. The IG’s report recommends consulting with food safety experts — government agencies, NGOs and academic institutions — to come up with a science-based inspection schedule.

By keeping a rule on its books that it doesn’t enforce, the city is not being straight with Chicagoans. Meaningful food safety standards, adequately enforced, will give a hungry public the confidence to chow down.

 

Going public: FDA not liable for $15 million in damages sought by tomato grower for food safety warning error

I remember. I was in Quebec City with a pregnant Amy when all this went down. Doing hour-long iradio interviews where midnight callers asked about aliens and Salmonella.

tomato

Michael Booth of the National Law Journal reports the U.S. Food and Drug Administration cannot be held liable for financial damages suffered by farmers when it issues emergency, but erroneous, food safety warnings, the U.S. Court of Appeals for the Fourth Circuit has ruled.

In its Dec. 2 ruling, the Fourth Circuit refused to allow a South Carolina tomato farmer to seek more than $15 million in damages from the federal government under the Federal Tort Claims Act after the FDA issued a warning that an outbreak of Salmonella Saintpaul was caused by contaminated tomatoes, when it was later determined that the outbreak was caused by contaminated peppers imported from Mexico.

A South Carolina tomato farm, Seaside Farm on St. Helena Island, sued the federal government, claiming that the incorrect warnings issued by the FDA, beginning in May 2008 and later corrected, cost it $15,036,294 in revenue. The Fourth Circuit agreed with a trial court that the FDA was acting within its authority to issue emergency food safety warnings based on preliminary information in order to protect public health.

“We refuse to place FDA between a rock and a hard place,” wrote Judge J. Harvie Wilkinson for the panel, sitting in Richmond.

“One the one hand, if FDA issued a contamination warning that was even arguably overbroad, premature, or of anything less than perfect accuracy, injured companies would plague the agency with lawsuits,” he said.

“On the other hand, delay in issuing a contamination warning would lead to massive tort liability with respect to consumers who suffer serious or even fatal consequences that a timely warning might have averted,” Wilkinson said.

Judges Paul Niemeyer and Dennis Shedd joined in the Dec. 2 ruling.

The medical crisis arose on May 22, 2008, when the New Mexico Department of Health notified the Centers for Disease Control and Prevention (CDC) that a number of residents had been diagnosed as having Salmonella Saintpaul, a strain that causes fever, diarrhea, nausea and, if left untreated, death. Soon after, similar reports came in from Texas.

The CDC determined that a “strong statistical” analysis determined that the illnesses were caused by people eating raw tomatoes. By June 1 of that year, CDC was investigating 87 illnesses in nine states.

tomato-irradiationThe FDA then issued a warning to consumers in New Mexico and Texas. By June 6, 2008, however, reported cases grew to 145 incidents in 16 states. In New Jersey, three people were reported to have been diagnosed with the illness. On June 7, the FDA issued a blanket nationwide warning telling consumers that they should be wary of eating raw tomatoes. (New Jersey tomatoes were not implicated, since they do not ripen until later in the season.)

The warning listed a number of countries and states, including South Carolina, that were not included and were not implicated, but those states were not listed in media reports. Eventually, 1,220 people were diagnosed as having Salmonella Saintpaul.

Raw tomatoes were not the cause of the illnesses, however. The contamination was traced to imported jalapeño and serrano peppers imported from Mexico.

Seaside Farm, which had just harvested a large crop of tomatoes, sued in May 2011. The farm claimed the erroneous FDA warning about tomatoes cost it $15 million-plus damages in revenue. 

GAO: FDA sorta slow responding to produce industry

From the U.S. Government Accountability Office:

Although the United States has one of the safest food supplies in the world, foodborne illness is a common public health problem. Some of this illness can be linked to produce. In 2006, for example, an E. coli outbreak associated with baby spinach sickened 205 people and killed 3; in 2011, 147 people fell ill and 33 died as a result of eating melons contaminated with Listeria. Other produce-related outbreaks in recent years have involved cucumbers, alfalfa sprouts, bean sprouts, and packaged salads.

lettuce-skull-e-coli-o145The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has responsibility for ensuring the safety of produce, along with many other foods. Overall, FDA is responsible for ensuring the safety of more than 80 percent of the U.S. food supply.

Because produce is often consumed raw without processing to reduce or eliminate contaminants, preventing contamination is key to ensuring safe consumption. In January 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law, representing the largest expansion and overhaul of U.S. food safety law since the 1930s.1 FSMA, according to FDA, marked a historic turning point by focusing on preventing rather than reacting to foodborne illnesses. FSMA did so, in part, by requiring FDA to promulgate new rules that together provide a framework for industry to implement preventive measures and for FDA to oversee implementation. In response to FSMA, FDA developed seven foundational rules; among them was the rule entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption—widely referred to as the produce safety rule.2 This rule, which FDA promulgated in November 2015, established the first enforceable national standards for on-farm growing, harvesting, packing, and holding of domestic and imported produce.3 Among other things, the rule established standards related to agricultural water quality; the use of soil amendments, such as raw manure; the presence of domesticated and wild animals; worker training, health, and hygiene; and sanitation of equipment, tools, and buildings. The rule includes staggered compliance dates depending on average annual produce sales of a business and other factors. For example, compliance for some of the largest businesses comes due beginning in 2017 and 2018, while compliance for certain smaller businesses is not due until 2020. FDA has been developing guidance and training for those affected by the new standards under the produce rule; the agency has also set aside funding for states to help them support implementation of the rule. In addition, the agency is hiring experts with backgrounds in science and policy to work in different regions of the country assisting state officials with implementation of the rule, according to FDA officials.

Some in the produce industry have expressed concerns about the new produce rule standards, including concerns about the scientific basis for standards in such areas as water quality. Some have also expressed concerns about the costs associated with meeting the new standards, particularly for smaller businesses. The Agricultural Act of 2014, also referred to as the 2014 Farm Bill, required that FDA ensure the final produce rule include “a plan to systematically…develop an ongoing process to evaluate and respond to business concerns.”4

The act included a provision for GAO to report, 1 year after the promulgation of the final produce rule and again the next year, on the ongoing evaluation and response process. This first report examines (1) how FDA evaluates and responds to business concerns regarding the produce rule and (2) how FDA plans to assess the effectiveness of its efforts to evaluate and respond to business concerns regarding the rule.5

lettuceTo examine how FDA evaluates and responds to business concerns regarding the produce rule, we reviewed the final rule, including FDA’s responses to public comments on the rule; reviewed relevant information on FSMA and the produce rule on FDA’s website; interviewed FDA officials involved in implementation of the rule; and interviewed representatives from two organizations assisting FDA with implementation of the rule.6 We also interviewed representatives from six produce industry associations and one large retailer for their views on any FDA efforts to respond to business concerns.7 We selected industry associations with large memberships, those representing both large and small businesses, and those representing differing types of produce. These interviews provided a sampling of views and are not generalizable to all produce industry associations, businesses, or others affected by the produce rule. To determine how FDA plans to assess the effectiveness of its efforts to evaluate and respond to business concerns, we interviewed FDA officials to learn about any ongoing or planned efforts.

We conducted this performance audit from August 2016 to November 2016 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

FDA has developed an information clearinghouse to evaluate and respond to concerns from businesses and other stakeholders regarding any of the FSMA rules, including the produce rule. Operational since September 2015, this clearinghouse, called the Technical Assistance Network (TAN), serves as a central source of information to support understanding and implementation of the FSMA rules. Businesses and other stakeholders—such as industry associations, academia, and consumers—can submit questions online or by phone or traditional mail. Phase 1 of the TAN, which is currently operational, evaluates and responds to questions related to the publication of FSMA rules. Phase 2, which FDA expects to begin in 2017, will evaluate and respond to questions from FDA and state inspectors working to ensure industry compliance with FSMA rules. FDA officials we interviewed told us the agency intends to maintain the TAN as a mechanism to respond to stakeholder questions and concerns even after the produce rule and other FSMA rules are fully implemented.8

We examined FDA data on TAN questions received by the agency from early September 2015 through early September 2016.9 During that period, FDA received 2,626 TAN questions, most of which had been submitted online.10 About 14 percent of questions (363) pertained to the produce rule, and about 60 percent of questions (218) pertaining to the produce rule came from those who identified as belonging to “industry/business.”11 According to FDA, the agency tracks TAN questions to help inform FSMA policy, guidance, and training. For example, officials at FDA told us that many of the questions it received related to the produce safety rule sought clarification regarding uses of water that meet the definition of “agricultural water.” FDA also received many questions seeking clarification on the requirements for collecting samples of agricultural water. Because of the large number of questions on both of these topics, FDA considers them high-priority areas to address in developing guidance. Specifically, FDA identified these topics as those most important to include in the first phase of its general compliance and implementation guidance for the produce rule, whereas other topics will be addressed in the second phase of the guidance.

In addition to addressing business concerns through the TAN, FDA officials told us they will continue to reach out to industry during produce rule implementation, just as they did while developing the rule. For example, FDA officials plan to meet with industry as they develop guidance documents, which provide direction on complying with produce rule standards. According to these officials, the guidance development process will provide another opportunity to hear and respond to business concerns. FDA may incorporate industry suggestions into the final guidance, as appropriate. Representatives from industry associations we interviewed generally praised FDA’s level of collaboration during the rulemaking process, noting that FDA had been willing to engage with them and address their concerns.12

FDA Is Developing a Survey and Other Metrics to Assess Its Information Clearinghouse

FDA officials we interviewed said the agency is developing a stakeholder survey to assess the effectiveness of its information clearinghouse, the TAN. FDA will send a copy of the survey to businesses and other stakeholders when providing responses to TAN questions submitted online. Most TAN questions are submitted online. Officials told us surveys will be sent starting in fiscal year 2017, after the required Office of Management and Budget (OMB) review is complete.13 FDA plans to implement the survey in two parts, according to officials. The first part will begin in early fiscal year 2017 and will solicit feedback from stakeholders about the web page FDA provides for submitting questions online. In late fiscal year 2017, FDA will begin soliciting feedback about the quality of information the agency provided in its responses to TAN questions. In addition, officials said the agency is developing metrics to measure overall success in implementing the produce rule and plans to begin using these metrics in January 2018, when compliance with most of the produce rule standards comes due for most large businesses. These metrics will be used to examine how effective the TAN is in responding to questions and will ultimately be used to assess whether additional training and outreach to business are needed to help implement the produce rule.

We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN.

FDA officials told us that, as of early October 2016, the agency had responded to about 72 percent of all TAN questions received. Officials said FDA is currently studying how long it takes, on average, to respond to questions submitted to the TAN, and the agency is working to decrease its response time. Also, according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved.

Recall: Apples and goat milk may not mix

This is a little old, but I’m playing catch-up.

The U.S. Food and Drug Administration advises consumers not to eat goat cheese products manufactured by Apple Tree Goat Dairy of Richfield, Penn. (Apple Tree), because the products have the potential to be contaminated with Listeria monocytogenes.

apple-tree-goat-dairyApple Tree manufactures pasteurized and 60-day aged, semi-soft, and hard goat cheeses under the Apple Tree Goat Dairy brand. The products were sold in Pennsylvania, Washington, D.C., Maryland, Virginia, and New Jersey through Lancaster Farm Fresh Cooperative, West End Farmers Market in Alexandria, Va., Ambler (Penn.) Farmers Market, and Doylestown (Penn.) Farmers Market.

On September 12, 2016, FDA began its inspection of Apple Tree’s manufacturing facility in Richfield, PA. In addition to observing poor sanitation practices, FDA took environmental samples that identified Listeria monocytogenes in 18 environmental samples from Apple Tree’s processing, packaging, and storage areas, including food-contact surfaces such as a cheese slicer, cheese mold, tables, and plates used to hold cheese before packaging. FDA also tested Apple Tree’s goat cheese. Two of the finished goat cheeses and 18 of the environmental samples tested positive for Listeria monocytogenes.

On September 20, 2016, Apple Tree initiated a voluntary recall of the four lots of goat cheeses that PDA tested and found positive for Listeria monocytogenes. Later in September, Apple Tree expanded its recall to include all of its goat cheeses, but FDA is not aware of any public notification to consumers announcing the expanded recall. Accordingly, FDA is issuing this release and working with PDA to monitor this situation and take appropriate actions to protect consumers from Apple Tree goat cheeses that may have been exposed to or contaminated with Listeria monocytogenes.

Although no illnesses have been reported to date in association with Apple Tree’s goat cheeses, Listeria monocytogenes can cause a serious, potentially life-threatening infection called listeriosis.

Salmonella everywhere and i love science: Food regulators in Virginia seize adulterated milk products

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Virginia. The company is owned by the Maryland and Virginia Milk Producers Cooperative Association Inc. in Reston, Virginia. The seized products include dry nonfat milk powder and buttermilk powder packaged in 40- and 50-pound bags for further manufacturing and are worth nearly $4 million.

The U.S. Department of Justice filed the complaint, on behalf of the FDA, in the U.S. District Court for the Virginia Western District, alleging that the seized products are adulterated under the Federal Food, Drug, and Cosmetic Act.

During an FDA inspection of Valley Milk from July – September 2016, FDA investigators observed poor sanitary practices and reviewed the company’s records, which showed positive results for Salmonella in the plant’s internal environmental and finished product samples. FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized. Throughout the investigation, the FDA worked closely with the Virginia Department of Health and Virginia Department of Agriculture and Consumer Services.

“The FDA urged Valley Milk to conduct a voluntary recall of the implicated products,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The firm refused to recall and, as a result, we have had to intervene and seize this adulterated food to prevent it from reaching consumers who could be exposed to Salmonella from these products.”

The FDA used a bacterial typing tool called whole genome sequencing (WGS) to link the samples collected in the facility over time. WGS technology can show the relationship among isolates of bacterial pathogens found in the environment, a food source or a person who became ill from consuming contaminated food. The sampling results indicate that the Salmonella strains from 2016 are nearly identical to Salmonella strains found at the company in 2010, 2011 and 2013. These findings of Salmonella meleagridis at the company dating back several years demonstrate the existence of a persistent strain of Salmonella at this facility.

Salmonella is a pathogenic bacterium that can contaminate foods and which may result in gastroenteritis or other serious clinical conditions, including septicemia, arterial infections, endocarditis and septic arthritis. Most people recover from salmonellosis in four to seven days without treatment but about one person in every thousand with salmonellosis dies.

Valley Milk is currently not producing dry powdered milk products. No illnesses linked to Valley Milk products have been reported to date. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

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.

1 dead, 4 sick in 2014: Miami cheese producer jailed for 15 months

On August 4, 2014, Oasis Brands, Inc. voluntarily recalled quesito casero (fresh curd) due to possible Listeria monocytogenes contamination.

oasis-listeria-oct_-14On October 6, 2014, Oasis Brands, Inc. recalled cuajada en hoja (fresh curd) after the U.S. Food and Drug Administration isolated Listeria monocytogenes from environmental samples collected from the production facility.

Whole-genome sequences of the Listeria monocytogenes strains isolated from recalled quesito casero cheese produced by Oasis Brands, Inc. were found to be highly related to sequences of Listeria strains isolated from one person who became ill in September 2013 and four persons who became ill during June through October 2014.

These five ill persons were reported from four states: Georgia (1), New York (1), Tennessee (2), and Texas (1).

Four of the five ill persons were hospitalized. One death was reported in Tennessee. Three illnesses were related to a pregnancy – one of these was diagnosed in a newborn.

All ill persons were reported to be of Hispanic ethnicity and reported consuming Hispanic-style soft cheese. Two persons who were able to answer questions about specific varieties of Hispanic-style soft cheeses reported consuming quesito casero, though neither could remember the brand.

According to Andrea Torres of ABC Channel 10, after making promises to the feds, Christian Rivas knew he was distributing cheese with listeria and did so anyway.

Rivas was in federal prison Nov. 11, 2016 and faced 15 moths in prison after federal prosecutors armed with the results of CDC tests and FDA inspections were ready to show consumers were “fraudulently led to believe” the cheese was safe to eat when it wasn’t. 

Before the criminal case, authorities recalled 15 of their “Lacteos Santa Martha ” products targeting Central American migrants in Florida, Georgia, Tennessee, Virginia and North Carolina. The list included the “Queso Seco Olanchano,” the “Queso Seco Hondureno,” the  “Queso Cuzcatlan,” and the “Crema Guatemalteca.”

Rivas plead guilty to charges that he acted with an “intent to defraud and mislead, delivered cheese processed and packed at the Oasis facility into interstate commerce that was adulterated,” according to the U.S. Department of Justice. 

U.S. District Judge Robert N. Scola sentenced Rivas to 15 months in prison.  

Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, and Justin Green, Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office, announced the sentencing

“We will continue to pursue and bring to justice those who put the public’s health at risk by allowing contaminated foods to enter the U.S. marketplace,” Green said. 

Burning question for the US FDA: Is Nutella a spread or dessert topping?

Nutella, the nut spread kids seem to consume by the gallon – sorry, litre, in Australia – is under scrutiny by the U.S. Food and Drug Administration with the goal of answering this question: is Nutella a dessert or a spread?

nutellaCreated in 1946, Nutella was, according to Benedict Brook of news.com.au, created by Italian pastry chef Pietro Ferrero who combined chocolate with hazelnuts reportedly because, in post war Europe, a pure cocoa product would have been prohibitively expensive.

Today, enough jars of Nutella are produced annually to stretch 1.8 times around the world and Ferrero — who also make Kinder eggs — are the world’s fourth largest confectioner.

For those 70 years what it actually is has perplexed many a mind.

This matters because desserts are labelled differently to spreads in the US and that could affect sales.

According to U.S. authorities, Nutella is officially a ‘dessert topping’ alongside chocolate syrups and something called “marshmallow cream” which sounds utterly artificial but kind of great.

But for the last two years Ferrero has been desperately trying to persuade the FDA that should be reclassified as a spread in the same vein as honey and jam.

Ferrero says the FDA’s dessert theory is outdated and based on a survey of just 157 shoppers from 1991, reports US health and medicine website STAT.

In this survey, 27 per cent of people said they drizzled it on ice cream while 19 per cent dipped strawberries into the jar. Only eight per cent spread Nutella on bread, so a dessert toping it was.

But a 2012 survey by Ferrero, of almost 800 Americans, found that 60 per cent of people slathered it on their toast and sandwiches while only two per cent now dolloped it from a great height on their ice cream.

If it didn’t fit in the honey and jam category a whole new category called “nut cocoa-based spreads” should be created, Ferrero said — which would be a pretty lonely category consisting mostly of Nutella.

“Ferrero’s most recent advertising and promotion has advocated the consumption of a balanced breakfast with the inclusion of Nutella as a tasty, complementary spread to add on to nutrient-rich whole grain breads, fruit, and dairy products,” the company said in a letter to the FDA.

The spread stoush is because of the way sugar levels will soon have to be labelled on the jar’s nutrition table.

In the US, the average serving size of a dessert topping is labelled as two tablespoons. But a spread’s serving size is just one tablespoon.

Nothing was mentioned about the microorganisms that can make people barf, or labelling to enhance food-that-won’t-make-barf claims.

 

Perilous produce: FDA Import Alert 99-35

This import alert represents the Agency’s current guidance to the Food and Drug Administration (FDA) field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or any person, and does not operate to bind FDA or the public.

lettuce-skull-e-coli-o145Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, or manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce items that were likely contaminated as a result of insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove pathogenic microorganisms.

FDA may document insanitary conditions during an inspection of an establishment that grows, harvests, packs, holds, manufactures, processes, or transports produce. FDA may also use analytical evidence or epidemiological and traceback evidence to establish that a produce item was manufactured, processed, prepared, packed, or held under insanitary conditions.

Guidance:

Districts may detain, without physical examination, produce items from manufacturers, shippers, farms, packers and/or other entities (firms) identified on the Red List of this import alert.

Examples of evidence FDA may use to place a firm on the Red List include:

  1. Inspectional evidence.
  2. Epidemiological evidence and traceback evidence. This should include evidence implicating the particular produce item as a vehicle in a foodborne illness outbreak (including positive test results), traceback evidence demonstrating that the firm grows, harvests, packs, holds, manufactures, processes, or transports the implicated vehicle, and expert opinion that the outbreak was likely a result of insanitary conditions at the foreign firm (e.g., contamination likely resulted from insanitary conditions due to the typical modes of transmission of the pathogen implicated in the outbreak) or was related to a resident pathogen or systemic contamination at the foreign firm, or both.
  3. Analytical evidence. This should include evidence of a resident organism at the foreign firm and/or systemic contamination at the foreign firm, such as an expert opinion that the analytical evidence indicates insanitary conditions at the foreign firm or indicates a resident pathogen or systemic contamination at the foreign firm, or both. Examples include:

* A pathogen that matches an outbreak strain is isolated from an imported produce item;

* Microbial pathogens that are indistinguishable by one or more genetic tests are isolated from two or more lots of imported produce originating from the same foreign firm.

INFORMATION FOR FIRMS REQUESTING REMOVAL FROM THE RED LIST:

In order to be removed from the red list, the firm should submit documentation to FDA demonstrating that the firm has made all relevant corrections to overcome the appearance of adulteration, so that the agency will have confidence that future entries will be in compliance with the Act. Examples of such documentation may include:

  1. Documentation to show that inspectional observations or violations identified by FDA have been corrected. Firms whose produce items appear to be adulterated based on inspectional evidence should submit detailed descriptions of the specific steps taken to correct the violations along with documentation such as (as applicable) written plans, field records, packinghouse or facility records, training records, and photographs.
  2. Root cause analysis to identify potential sources and routes of contamination. Firms whose produce items appear to be adulterated based on analytical or epidemiological and traceback evidence should include a detailed root cause analysis to evaluate all aspects of their operations in order to identify potential sources and routes of contamination. The firm should also provide documentation to demonstrate that corrective actions to adequately control the sources and routes of contamination identified in the root cause analysis have been implemented.

cantaloupe-salmonellaFDA recommends that the firm’s submission be organized according to the following areas, as appropriate to the firm’s practices, processes, and procedures:

– Water adequacy for irrigation, agricultural sprays, cooling, and other uses;

– Soil amendment and biosolids;

– Animal management;

– Worker health and hygiene;

– Sanitary facilities, disposal of sewage and silage;

– Equipment cleaning and sanitation;

– Farm or facility sanitation;

– Transportation; and

– Programs to monitor produce safety practices, processes and procedures and to take corrective actions when measures fail or are not fully implemented.

The firm may wish to refer to FDA’s Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, or similar guidance, to assist them in their root cause analysis and corrective action. Additional guidance for produce, including commodity specific guidance, may be found the FDA website at www.FDA.gov.

I like pistachios: 11 sick with Salmonella so FDA get stern

Below are excerpts from a warning letter to Stewart Resnick, owner, The Wonderful Company based in Los Angeles, Calif., from the U.S. Food and Drug Administration.

salm-pistachiosDear Mr. Resnick:

From March 8th through April 7th, 2016, investigators from the United States Food and Drug Administration (FDA) conducted an inspection of your pistachio manufacturing process at your facility located at 13646 Highway 33, Lost Hills, CA 93249. The inspection was conducted in response to a multi-state outbreak of 11 human infections with Salmonella Montevideo (9 cases) and Salmonella Senftenberg (2 cases)) in nine states. Based on traceback and epidemiological evidence taken together with inspectional evidence, we have concluded that pistachio nuts produced by your firm are adulterated within the meaning of 21 U.S.C. 342(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain Salmonella, a deleterious substance which may render them injurious to health, and within the meaning of 21 U.S.C. 342(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, and held under insanitary conditions whereby they may have been rendered injurious to health.

Our investigators’ observations were noted on Form FDA-483, Inspectional Observations, which our investigators issued to you at the conclusion of the inspection. You may find a copy of the Act and the regulations promulgated under the Act by following links at www.fda.gov.

Based on collaborative epidemiological and investigational efforts between the FDA, CDC, and the California Department of Public Health, we conclude that pistachio nuts produced by Wonderful Pistachios & Almonds, LLC were linked to this outbreak of Salmonella infections. Ten of the eleven individuals infected with Salmonella were available for interview, and eight of the ten (80 percent) reported eating pistachios during the week before illnesses onset, five of whom reported eating Wonderful brand pistachios. By comparison, a review of data from the 2006-2007 FoodNet Population Survey, which provides information about food consumption among the general population, suggests that only 12% of consumers would have been expected to consume pistachios in a weeklong period. CDC evaluated the probability of case-patients reporting this exposure among a sample of 10 persons and found significance when four or more case-patients report the exposure. No other food specific food was identified as a suspect vehicle.

trader-joes_-pistachiosAfter reviewing the epidemiological evidence, we inspected your facility and collected three product samples at your firm, each consisting of 30 subsamples. Five of 30 subsamples of one sample of raw in-shell pistachios we collected from your silos yielded four positive tests for Salmonella Senftenberg and one for Salmonella Liverpool. Whole genome sequencing determined that the Salmonella Senftenberg isolates were nearly identical to isolates from case patients involved in the outbreak. The most probable number in these subsamples ranged from less than 3 to 23 Salmonella cells/gram.

We acknowledge that you recalled product in response to this outbreak.

We acknowledge your written response to the Form FDA-483, dated April 19, 2016. In your response you proposed to study the optimal level of chlorine in the (b)(4) tank and to install a (b)(4) system to remove foreign material prior to conveying the pistachios into storage. However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak.

This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the CGMP regulations for food. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including, without limitation, seizure and/or injunction.

You should respond in writing within 15 working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. In your response, include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, please state the reason for the delay and include a timetable for implementation of those corrections.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FFD&C Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.

When fairytales turn deadly: FDA says 10 children’s deaths may be linked to homeopathic teething tablets

Michelle Ewing of The Statesman reports the deaths of 10 children may be linked to homeopathic tablets that claim to relieve babies’ teething pain, according to the Food and Drug Administration.

homeopathic-teething-tabletsFDA is looking into the deaths and 400 “adverse events” reported to the agency.

“The relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” the FDA said in a statement, according to CNN.

The news comes less than two weeks after the FDA warned parents against using the products amid reports of infants and children having seizures, difficulty breathing, lethargy and other health issues after taking the tablets.

On Tuesday, Hyland’s announced it will no longer distribute its teething products in the U.S.