Darwin’s Natural Pet Products has recalled specific production lots of its Natural Selections brand Meals for Dogs after laboratory testing detected Salmonella and Listeria monocytogenes in samples of the products.
People who have handled the dog food are at risk of Salmonella infection and are advised to seek medical attention immediately if they develop symptoms of salmonellosis. Symptoms can include nausea, vomiting, abdominal cramps, diarrhea that is watery or bloody, fever and headache.
Countertops, utensils and pet food and water bowls should be throughly washed to prevent cross-contamination.
A search of the US Food and Drug Administration (FDA) Enforcement Report web page revealed the following products have been recalled by direct email communication with customers:
Natural Selections Duck Meals for Cats, frozen (2-lb. packages; Lot #38277; Mfg. Date: 06/01/17 ) – contaminated with Salmonella
Natural Selections Chicken with Organic Vegetables Meals for Dogs (2-lb. packages; Lot #40727; Mfg. Date: 09/26/17) – contaminated with Salmonella and Listeria monocytogenes
Natural Selections Duck With Organic Vegetables Meals for Dogs (2-lb. packages; Lot #40487; Mfg. Date: 09/29/17) – contaminated with Salmonella
Natural Selections Turkey With Organic Vegetables Meals for Dogs (2-lb. packages; Lot #39937 & #40507; Mfg. Dates 08/24/17 & 09/20/17) – contaminated with Salmonella.
Darwin sells and ships its products directly to customers. Its trademark is held by a Tukwila, WA, company, Arrow Reliance Inc. Darwin’s brand products are not available in stores, nor sold to distributors, according to the company. The recalled products were shipped to customers in September and early October.
Customers who were supplied with the affected products were notified of the recalls by email, with telephone follow-up where necessary, according to the company. No public recall notice was issued, although some information regarding the recall has been posted on Darwin’s Facebook page.
According to information posted on Darwin’s Facebook page, the company does not test “each and every batch of product” at present, but is re-evaluating its current processes in light of the current situation.
The Food and Drug Administration is aware of the recall, according to an agency spokesperson.
Between October 2010 and July 2012, FDA surveyed more than 1,000 samples of pet foods and pet treats for the presence of food-borne disease bacteria, including Salmonella. Of the 196 samples of raw pet food tested during the study, 15 were positive for Salmonella.
On July 16, 2013, FDA issued a “Compliance Policy Guide for Salmonella in Food for Animals,” affirming a zero-tolerance policy for Salmonella in pet food due to the risk to human health.
This report first appeared in Food Safety News and is reposted here with updates with permission.
Little appears to have changed since 2011 outbreak, despite efforts of U.S., Mexican governments
The CDC posted this photo with its outbreak notice, describing maradol papayas as large, oval fruits that weigh 3 or more pounds, with green skins that turn yellow when the fruit is ripe. The flesh inside the fruit is salmon-colored. Photo courtesy of CDC
Salmonella — the pathogen behind an ongoing foodborne illness outbreak that has sickened 173 people across 21 states, killing one — is a normal inhabitant of the intestinal tract of many birds, reptiles and mammals.
The possibility that an agricultural product such as papayas may be contaminated with Salmonella is impossible to eradicate; however, the risk of widespread contamination can be controlled through careful attention to current best sanitary practices in the cultivation, harvesting and packing of raw produce. Failure to do so can result in a vicious cycle of contamination in fields, packing houses and the distribution system.
Cultivation, harvesting and packing
The papaya is a fast-growing, tree-like herbaceous plant, which is at home in tropical and semi-tropical climates and is cultivated extensively across southeastern Mexico, according to a report issued by the University of Florida IFAS Extension Service. The most recent report from Mexico’s Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food) shows Mexico to be the fifth largest producer of papayas in the world.
Papaya trees are propagated from seeds. When seedlings are large enough, they are transplanted by hand into growing fields.
The papaya plant is propagated from seeds, with seedlings transplanted into fields when they are of sufficient size. The plant matures in six to nine months in warmer regions. Susceptible to a variety of plant diseases and pests, such as root rot, powdery mildew, papaya ringspot virus, fruit fly and white fly, papaya plants usually have an abbreviated commercial lifespan of two to three years, according to information from the University of Hawaii. It is not unusual for a papaya plant to only produce a single crop in its lifetime.
Once harvested and delivered to the packing house, each papaya is graded according to ripeness and size. Next, the fruit is sorted according to size a second time, as well as shape, and color. It is also examined for insect or mechanical damage.
The sorted fruit is generally washed in large vats of chlorinated tap water to remove dirt, debris and insect contamination. Depending upon the condition of the fruit and the expected final destination, it may be subjected to additional treatments, including a hot water bath or a fungicide dip. After air-drying, the fruit is packed for shipment.
2011 Salmonella Agona outbreak In 2011, the Centers for Disease Control and Prevention and the Food and Drug Administration investigated a Salmonella Agona outbreak that was traced to contaminated papayas imported from Mexico. The papayas were grown and packed by Agromod SA de CV of Chiapas, Mexico, and distributed by Agromod Produce Inc. of McAllen, Texas.
Photo illustration
The Agromod papaya plantation had an interconnected drainage ditch system, according to information presented in 2013 during the annual educational conference of the National Environmental Health Association (NEHA).
The marsh-like environment of the drainage ditches was a haven for waterfowl, frogs and other wildlife, and provided perfect growth conditions for pathogenic bacteria. During heavy rain and flooding, the ditches overflowed into the soil surrounding the trees, impregnating the soil with pathogens from the water.
During an on-site inspection of Agromod’s plantation and packing house, investigators from FDA recovered a full two dozen different types of Salmonella, including the Salmonella Agona outbreak strain. Salmonella-positive samples were drawn from fields where the papaya grew and from packing-house drains.
The crops at Agromod were harvested by two-person teams. One person worked at tree level, picking fruit and handing or tossing it to the other person below. The second person laid each papaya onto a piece of poly foam on the unprotected soil. The foam was wrapped around the fruit, which was loaded into foam-lined bins for transport to the packing house.
It was common practice at Agromod for the sheets of poly foam to be reused for up to 15 days before being discarded, helping to spread contamination from the fields to the fruit, packing house and back again.
Photo illustration
Once in the packing house, the fruit was washed in large vats of water. The level of chlorine in the wash water was not properly monitored or controlled, allowing Salmonella to spread throughout an entire batch of papayas.
The wash water was discharged into the drainage ditch system, returning Salmonella to the fields in a vicious cycle of contamination.
Import Alert In response to the extent of Salmonella contamination brought to light during the investigation of the 2011 outbreak, FDA instituted Import Alert #21-17, “Countrywide Detention Without Physical Examination Of Papaya From Mexico.” Firms that provided documentation of five consecutive Salmonella-negative commercial shipments qualified for an exemption from the automatic detention at the U.S. border.
Concurrent with FDA’s initiation of the Import Alert, Mexico’s Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (National Service for Health, Safety and Agrifood Quality) (SENASICA ) unveiled a plan to assist that country’s papaya growers, packers and shippers in addressing the issues of safe growing and handling of the fruit.
History repeats Notwithstanding the efforts of multiple agencies in both countries, the United States is once again in the throes of an outbreak of Salmonella that is associated with consumption of fresh, whole papayas imported from Mexico.
To view a larger version of the map on the CDC’s website, please click on the image.
As of Aug. 18 when the CDC posted it’s most recent outbreak update, 173 people had been confirmed sick across 21 states, with 58 hospitalizations, and one death on New York City. The CDC warns that the number of confirmed illnesses is likely to increase.
Thus far FDA has identified one farm in connection with the contaminated papaya. That farm, Carica de Campeche, has been supplying papayas to the U.S. market under an Import Alert exemption since 2015.
According to a spokesperson from FDA, at present there are no specific ongoing testing or inspection requirements that a producer must meet in order to maintain an exemption from automatic detention, although a firm is expected to “… continue to provide the commodity in a wholesome manner and follow all the regulatory requirements of FDA.”
The FDA revoked the exemption granted to Carica de Campeche under Import Alert 21-17 on Aug. 7.
This article first appeared in Food Safety News and is reposted here with permission.
The United States Food and Drug Administration (FDA) has vetoed a proposal by Evanger’s Dog and Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for pentobarbital.
The proposal was revealed in a June 29, 2017 Warning Letter issued by FDA, and released on its website Tuesday morning (July 4, 2017) under the agency’s standing policy to post recent Warning Letters on a weekly basis.
The letter addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “…serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.
In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “…sufficient assurance that the remaining units are not adulterated.”
After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all remaining recalled product.
The Warning Letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food that had been fed to all five of the animals, revealed the presence of a ‘large quantity’ of pentobarbital in both samples.
FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, Illinois on January 10, 2017.
On February 14, 2017, the inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:
• Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12 oz. can (Lot #1816E06HB13)
• Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12 oz. can (Lot #2415E01ATB12; BEST DEC 2019)
• Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat
• Pitted, cracked and damaged floors
• Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing
• Inadequate temperature controls
In addition to the two pentobarbital-positive samples cited in the February 14th Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:
• Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
• Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
• Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
• Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
• Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.
On March 3, 2017, Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.
In correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, 5/18/2017 and 5/23/2017, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the Warning Letter, are those FDA found to be inadequate or unacceptable.
Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat.
Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.
Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “…well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.”
FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.
Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated.
FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.
Evanger’s now requires new and current suppliers to provide letters of guarantee for their products.
FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.
As is customary, the Warning Letter concludes with a requirement that Evanger’s must furnish a written reply within fifteen working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.
Countertops, utensils and pet food and water bowls should be throughly washed to prevent cross-contamination.
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