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Another FSMA Rule Takes Effect: Foreign Supplier Verification Program (FSVP)

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The FDA FSMA rule on Foreign Supplier Verification Program (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance date begins on May 30, 2017.
This rule imposes far reaching changes on food importers and requires review of the food safety practices of foreign suppliers and their compliance history.  Foreign suppliers must be approved in advance and must have a written program before they can be a supplier in the US.  The rule also requires new information to be submitted for customs entries: the FSVP importer must now be declared for each importation of FDA-regulated food (including dietary supplements) unless exempt.
The goal of the program is to protect US consumers from potentially contaminated or dangerous imported foods. This is carried out by requiring importers to ensure that imported foods are produced in a way that matches or equals the US FDA standards for food safety and preventative control.

Program Scope

FSVP is a program that must be put into place by importers of human and animal food,  to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as products produced domestically, and ensuring that the supplier’s food is not adulterated and not misbranded with respect to allergen labeling.
The importers are responsible for determining the hazard associated with each food, and evaluate the risk it poses. They need to conduct supplier identification activities, and take corrective action if needed. They must ensure that they import foods only from approved suppliers, based upon the risk posed by the imported food and the supplier’s performance. Each supplier requires to catty out a separate FSVP for each food.
 If the importer obtains a certain food from a few different suppliers, a separate FSVP will be required for each of those suppliers. Similarly, if the importer obtains many different foods from a single supplier, a separate FSVP will be required for each food.

Hazard Analysis

An importer is required to determine if there are any hazards that require control such as biological hazards from parasites and disease-causing bacteria; chemical hazards such as radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens; or Physical hazards, such as glass or metal. This analysis must evaluate the probability of their occurrence in absence of controls, and the severity of injury or illness that might result.
The analysis considers factors such as: Formulation of the food, establishment design, raw materials used, transportation methods, sanitation and employees’ hygiene, packaging and labeling activities, storage and distribution.

Food Risk and supplier Performance

An importer must evaluate, in addition to the hazard analysis, the suppliers’ procedures, processes, and practices related to food safety. He must also assess the suppliers’ adherence to FDA food safety regulations, and their food safety history including corrective action.

Supplier Verification

Written procedures must be established by the importer that the imported products are only from approved foreign suppliers and must establish supplier verification activities. This might include annual audits of the supplier’s facility, sampling and testing, and review of the supplier’s food safety records.

Corrective Action

Importers are required to take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required, or that the supplier produces food that is adulterated or misbranded with respect to allergen labeling.

Included Categories

Compliance is required by May 30 for the following foods/ supplier categories:

Exemptions

Some foods are exempt from these regulations. For example: meat, poultry and egg products subject to USDA regulations; alcoholic beverages; food imported for research or evaluation, provided it is not for retail sale, is properly labeled and is accompanied by an electronic declaration at entry; etc.

Unique Facility Identifier

A key to this regulation is the creation of Unique Facility Identifier (UFI). The Importer must provide its name, electronic mail address, and UFI recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States.
On March 31, 2017, The FDA issued guidance recognizing the DUNS number as an acceptable UFI for the FSVP regulation.
The FDA details the entry into the United States (U.S.), the U.S. Customs and Border Protection (CBP) Automated Commercial Environment (ACE) systems that are in place.
On May 11, the FDA  updated the regulations, by clarifying the categories of imports that must comply by May 30. The importers that must comply need to provide specific identification for each line entry of food product offered for importation into the United States.  The importer identification requirement includes the submission of the FSVP importer’s name, e-mail address, and UFI recognized as acceptable by FDA. Foreign persons cannot serve as the FSVP importer.
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Ten Hospitalized and One Death Linked to Botulism Outbreak due to Contaminated Cheese Sauce

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The Botulism Outbreak

According to California state and local officials 10 people were hospitalized after they had contracted botulism from eating nacho cheese sauce served at the Valley Oak Food and fuel gas station in Walnut Grove, California.
According to CNN the Sacramento County Department of Health and Human Services wrote in a statement that the cause of the illness “appears to be prepared food, particularly nacho cheese sauce” from a gas station in Walnut Grove.
On May 8, health officers from the state Department of Health impounded four bags of Gehl’s cheese sauce and reopened the store to sell prepackaged food items only. Gehl Foods is a Germantown, Wisconsin-based maker of ready-to-serve real dairy products. The company uses an advanced aseptic process to eliminate microorganisms.  Its products – cheese sauces, puddings, yogurt, and dairy-based beverages – are sold in restaurants and retail stores.
The Sacramento County Public Health Department, who has been part of the on-going investigation, said that the preliminary testing of the cheese found to be positive for botulism.  However, the California state officials have not yet determined the cause for the botulism outbreak, whether it originated from the manufacturing of the cheese or whether the outbreak originated within the gas station itself as an in-house contamination.

Victims

ABC 7 News reported on Friday(5/19/17) that Martin Galindo contracted botulism from nacho cheese bought at the gas station.  It is unclear whether Galindo’s case of botulism was related to the outbreak that has hospitalized 10 people. The state Department of Health will not release information on whether any counties other than Sacramento County have reported cases of botulism. The San Francisco County Coroner’s office stated that Galindo died on Thursday night (5/18/17).
CNN reports that one woman, Lavinia Kelly, a mother of 3, was reportedly hospitalized after putting the nacho cheese sauce on some Doritos chips on April 21. Kelly has spent more than three weeks in the intensive care unit according to the report.  Her family said that while she remains conscious, her motor skills are so far gone that she cannot even open her eyes. But the family said they still have hope. “Thank God that we know she can recover,” they said.
According to her attorney, Bruce Clark of the Seattle-based Marler Clark law firm, Kelly felt ill the same day she consumed the food, and went to Sutter Medical Center in Sacramento. She was discharged by doctors, but was back in the emergency room the next day as her symptoms became worse. By the next morning, she needed assistance from a ventilator to maintain breathing.
“The cruel thing about the toxin is it induces a slow, creeping paralysis starting at the head and moving down and includes the respiratory muscles,” Clark said. “They slowly lose the ability to breathe. If you can get on mechanical ventilation, your chances of survival are good. All will have some residual neurological damage.”
The law firm of Marler Clark has been retained by 6 individuals and has filed a lawsuit

Botulism

Clostridium botulinum grows on food that has not been properly canned or preserved and can be found in canned cheese sauce, according to the Centers for Disease Control and Prevention (CDC). Clostridium Botulinum grows under anaerobic conditions on food and produces toxins that, when ingested, causes paralysis.
Botulism neurotoxins prevent neurotransmitters from functioning properly, inhibiting motor control. As botulism progresses, the patient experiences paralysis from top to bottom, starting with the eyes and face and moving to the throat, chest, and extremities. When paralysis reaches the chest, death from inability to breathe results, unless the patient is ventilated. Symptoms of botulism generally appear 12 to 72 hours after eating contaminated food.  With treatment, illness lasts from 1 to 10 days.  Full recovery from botulism poisoning can take weeks to months.  Some people never fully recover.
Botulism poisoning is extremely rare, but so dangerous that each case is considered a public health emergency. Studies have shown that there is a 35 to 65 percent chance of death for patients who are not treated immediately and effectively with botulism antitoxin. If caught early, before the onset of paralysis, an antitoxin can be used to treat botulism. In the past 50 years, the percentage of patients with botulism who have died has dropped from 50 percent to 5 percent, according to the CDC.  There are about 145 cases of human botulism a year.  While botulism can be fatal, the CDC’s website states that only 3 to 5% of patients die.
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A New Method for the Detection of Salmonella in Powdered Dairy Products

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The Journal of Dairy Sciences reports that a team of researchers from China (Zhao et al. J. Dairy Sci. 100:3480–3496  May 2107) developed a new method for the detection of Salmonella in infant powdered milk.
The developed method is claimed to be rapid, specific, and sensitive. It is is based upon loop-mediated isothermal amplification technique combined with a lateral flow dipstick (LAMP-LFD) as the detection step.

Loop-Mediated Isothermal Amplification Technique (LAMP)

LAMP is a powerful new nucleic acid amplification method that detects very low levels of DNA. The method amplifies a few copies of target DNA with high specificity, efficiency and rapidity. The method uses a set of 4 specifically designed primers that recognize 6 distinct sequences of target DNA, and a DNA polymerase.
The cycling reaction can result in the accumulation of 109 fold of copies in less than 1 hour. The method is claimed to be more specific and less susceptible to interference than PCR, it is very fast, without the need of denaturing step.
 

Target Genes

The target gene invA encodes a Salmonella invasion protein and is thus considered a virulence gene located on Salmonella pathogenicity island (SPI), and is used frequently for the detection of Salmonella. The SPI4 region includes genes from siiA to siiF that are important for adhesion to polarized epithelial cells, and plays an important role in Salmonella pathogenicity.
The authors claim that this is the first attempt to use LAMP and the siiA gene to detect Salmonella.

 Lateral Flow Dipstick (LFD)

Lateral flow immunoassays dipsticks are used routinely to detect pathogens in food. Lateral flow dipstick use a sandwich type ELISA and the majority use polyclonal antibody as a capture antibody and a monoclonal antibody as the detection antibody. The antibodies are fixed on a hydrophobic membrane in immobilized in lines. Their role is to react with the analyte bound to the conjugated antibody. Recognition of the sample analyte results in an appropriate response on the test line, while a response on the control line indicates the proper liquid flow through the strip.
In the LAMP-LFD assay LFD strip is inserted into a tube that allows the strip to be immersed in the amplified sample. The sample migrates through the conjugate pad, which contains antibodies specific to the target analyte and are conjugated to colloidal gold and latex microspheres. The sample, together with the conjugated antibody bound to the target analyte, migrates along the strip into the detection zone
A number of researchers have combined LAMP with LFD. In this combination the LFD is soaked in LAMP amplified sample and the liquid travels by capillary action across the membrane to react with the antibodies and provide a color band.

Elimination of carryover Contamination

The high sensitivity of LAMP can become its largest potential disadvantage because trace left over material can be amplified and detected, causing false positive results, after several times of detection in the same place. Therefore, there is a need to eliminate any contamination from previous LAMP reactions.
To reduce incidence of LAMP contamination, the authors applied propidium monoazide (PMA) to eliminate carryover contamination of LAMP. The appropriate concentration of PMA diluted in water was applied to the working environment of any contaminated area and adequate light exposure conditions were used to complete the decontamination process.
 

Results

A very specific and conserved Salmonella target gene siiA was used to establish the LAMP-LFD detection method for Salmonella in powdered Infant formula.
In this study, the limit of detection of the LAMP-LFD for inoculated powdered infant formula, without enrichment was 2.2 cfu/g, which is 100x lower than the limit of detection for most PCR methods. A pure culture study of 21 Salmonella strains (with limited number of serotypes), and 60 inoculated samples of powdered infant formula yielded all positive results.  31 non-Salmonella strains (75% gram positive), including 20 non inoculated samples all yielded negative results.
 While more testing of this method is required, the reported method seems to be very rapid, specific, and sensitive for the detection of Salmonella in powdered infant formula.  PMA needs to be used to eliminate the LAMP carryover contamination.
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Aunt Jemima Frozen Products are Recalled due to Possible Listeria Contamination

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More environmental Listeria testing is being conducted due to the Food Safety Modernization Act (FSMA), resulting in more recalls due to Listeria monocytogenes found in the environment, not necessarily in the product.
The FDA announced that Pinnacle Foods Inc. is voluntarily recalling a variety of flavors of Aunt Jemima Frozen Pancakes, Frozen Waffles & Frozen French Toast Slices, distributed nationally in the United States and one product distributed into Mexico. The recall is due to the potential of the products being contaminated with Listeria monocytogenes, as Listeria monocytogenes was found in the production plant environment.
Two additional products (Aunt Jemima French Toast & Sausage, and Hungry Man Selects Chicken & Waffles) are being recalled in conjunction with the United State Department of Agriculture (USDA). These 2 products contain meat products.
Pinnacle Foods initiated the recall after testing detected the presence of Listeria monocytogenes in the plant environment. Pinnacle announcement stated that “the products are being recalled as a precautionary measure given the health and safety of our consumers is our top priority”. 
“No illnesses have been reported,” according to Pinnacle announcement. “All affected distributors and retail and food service customers are being notified and the affected products are being removed from store shelves.”
The announcement applies only to the Aunt Jemima frozen products listed in the announcement and does not include any Aunt Jemima dry mixes and syrups. All affected distributors and retail and food service customers are being notified and the affected products are being removed from store shelves.
In the CDC report for 2016 “Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food “ through the year there were only 127 confirmed cases of illness due to Listeria, with 123 hospitalizations, indicating that Listeriosis due to food consumption is rare. However the mortality rate of Listeriosis is high.
 
Since Listeria is ubiquitous in the environment in many cases it is difficult to attain zero tolerance, especially in the plant environment. Currently there is no international agreement on what numbers of Listeria monocytogenes in foods are acceptable  to protect the consumer. The FDA established a policy of zero tolerance for Listeria monocytogenes in RTE foods, and their production environment. In the EU, the rules state that Listeria monocytogenes cannot be present in a ready-to-eat product at levels above 100 cfu/g at the end of the shelf life, whereas in the US a ‘zero-tolerance’ policy does not permit any amount of Listeria to be present in ready-to-eat foods at any time. 
 
Time will tell if the zero tolerance of Listeria monocytogenes in the environment is justified.
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CDC Report on Incidence and Trends of Infections with Pathogens Transmitted Through Food for 2016

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The CDC report describes surveillance data for 2016 nine pathogens (Campylobacter, Cryptosporidium, Cyclospora, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia). The data of 2016 is compared with the data from 2013-2015.
FoodNet identified 24,029 infections, 5,512 hospitalizations, and 98 deaths caused by these pathogens. The data include both incidents confirmed by culturing the organisms and culture-independent diagnostic tests (CIDTs). CIDT can identify (by rapid diagnostic tests) the general type of bacteria causing illness within hours, without having to culture or grow the bacteria in a laboratory.
This is the first time that the CDC report also includes CIDTs (total number of infections from bacterial infections diagnosed only by rapid diagnostic tests). Previously, the report counted foodborne bacterial infections confirmed only by traditional culture-based methods of total numbers.
Without a bacterial isolate from the culturing process, public health scientists can’t perform tests that determine an organism’s strain or subtype (such as DNA fingerprints), resistance pattern, or other characteristics.
In this report confirmed bacterial infections are defined as isolation of the bacterium from a clinical specimen by culture. In a “CIDT positive–only” bacterial infection was positive only by CIDT result that was not confirmed by culturing.

Results and Comparison

Annual data from the CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) show that Campylobacter and Salmonella caused the most reported bacterial foodborne illnesses in 2016.
The largest number of confirmed or CIDT positive–infections in 2016 was reported for Campylobacter (8,547), followed closely by Salmonella (8,172). Shigella had 2,913 cases, and STEC 1,845. However, the largest number of confirmed positive infections was reported for Salmonella, followed by Campylobacter.
The proportion of infections that were CIDT positive without culture confirmation in 2016 was largest for Campylobacter (32%) and Yersinia (32%). There was a significant increase in CIDT in 2016 over 2013-2015.
Compared with 2013–2015, the 2016 incidence of Campylobacter infection was significantly lower (11% decrease) when only confirmed infections were included, yet it was not significantly different when including confirmed or CIDT positive–only infections. Incidence of STEC infection was significantly higher for confirmed infections (21% increase) and confirmed or CIDT positive–only infections (43% increase).
Among 7,554 confirmed Salmonella cases in 2016, serotype information was available for 6,583 (87%) of the cases. The most common serotypes were Enteritidis (17%), Newport (11%), and Typhimurium (9%). Salmonella Typhimurium infections decreased 18% in 2016 compared with the average for 2013-2015. This is perhaps due to the immunization of chicken flocks by producers.

Discussion Points

When including both culture confirmed with non culture confirmed, the incidence rates in 2016 were higher for each of the pathogens over previous years. This was mainly due to the increase in non- cultured CIDTs.
For example, the incidence of confirmed Campylobacter infections in 2016 was significantly lower than the 2013–2015 average. However, when including the non-cultured CIDT positive infections, a slight but not significant increase occurred. Similarly, the increase in STEC incidence is driven by the increase in STEC non-O157, which is not typically included in routine stool culture testing since it requires specialized methods. As a result, interpreting the incidence data is more complex due to the changing diagnostic landscape with unknown changes in frequency of testing, varying test performance, and decreasing availability of isolates for sub typing.
The new data reflect the increasing popularity of rapid tests known as culture-independent diagnostic tests, or CIDTs. According to the report, positive results from the rapid tests can be followed by culturing the organisms. However, often it is not done. The CIDT faster results have immediate benefit for treatment.  Nevertheless, it does not collect needed data on strains and their antibiotic resistance.
The change from culture methodology to CIDT creates new problem comparing data from this year to previous years.  Changes in the number of new infections could reflect changes in testing practices rather than a true increase in infections. Therefore, comparisons of the 2016 data with data from previous years may not accurately reflect trends.  Estimated infections in 2016 and in years past are accurate, but cannot be directly compared.