FDA Warning Letter Issued to Pet Food Company for Inadequate Food Safety Plan

A pet food facility based in Tupelo MS (birthplace of Elvis) received a Warning Letter from FDA regarding making product with high Vitamin D levels.   In a nutshell, their Food Safety Plan did not sufficiently consider that their supplier could provide product with a different Vitamin D content than what their formulation called for, thus they ended up making product with excessive Vitamin D, which is harmful to pets.  In this case, they used an ingredient with over 60X the Vitamin D level

A few important points here: 1) When requiring COAs, one needs to be specific to the hazard they are looking for, and the level.  Too many people collect COAs just to collect them.  2) If one asks for a COA, then it must be reviewed, and in many cases verified.  3) All incoming materials should be checked for ingredient / raw material numbers to make sure they match.
Care must be taken when writing the Preventive Control Plan because it will be used to evaluate the facility.  Unfortunately, emphasis provided in the Animal Feed courses is not as good as in the Human Food courses in that it allows many ingredients to be lumped together.

Specifically, you identified vitamin and mineral toxicity and deficiency as a hazard requiring a preventive control in your food safety plan. However, as evidenced by the toxic levels of vitamin D found in some of your dog foods, you failed to implement adequate preventive controls to ensure your inclusion of vitamin D did not result in a nutrient toxicity or deficiency.

Your hazard analysis determined that a preventive control was not necessary at ingredient receiving for “wrong levels” of vitamins in ingredients due to your “internal programs.” .........

Your “internal programs” consist of SOP number (b)(4) and SOP number (b)(4).” With regard to micro ingredients, SOP (b)(4) states that “all bagged raw materials will provide a Certificate of Analysis (COA), which will be maintained in the ingredient purchasing office.” (b)(4) says that “it is the policy of Sunshine Mills that all incoming shipments of raw materials used in our products, including bulk grains, bulk protein and other meals, bulk fats and tallows, salt, packaged vitamin and mineral supplements, color additives, and other ingredients will be examined at the time of receipt to assure that they are of good quality and meet product specifications. This examination will consist of a visual inspection for identity and gross visible defects, a test for moisture content as may be indicated, and sampling for assay of protein, fiber, vitamin and mineral levels or other purchase specifications, and also to check for contaminants.” It is also your policy that “vendors, from time to time, provide a COA for such things as vitamin and mineral content when this is part of the puce-chase [sic] specifications.”

However, these SOPs did not ensure that vitamin D levels in incoming ingredients met established ingredient specifications. For example, the vitamin D levels were not analyzed at a laboratory facility on a routine basis to ensure that the vitamin D met your firm’s pre-set formulation. You did not question any difference in appearance of the packaging or the ingredient. In addition, your firm did not obtain Certificates of Analysis (COA) upon receipt of each shipment of vitamin D. Furthermore, there is no indication of who is responsible for performing these actions listed in the SOPs or verifying that they have been performed or what steps are to be taken if an incoming ingredient does not meet specifications.

Your “batching/mixing” preventive control includes no measures that would prevent the use of an ingredient that is the wrong concentration.

Consequently, you used five shipments of an ingredient that you were unaware contained a higher concentration of vitamin D (500,00 IU/g) instead of the vitamin D with a lower concentration (7,500 IU/g) consistent with your firm’s formulation.

2. ......Your firm failed to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed or held at your facility to determine whether there are any hazards requiring a preventive control, in accordance with 21 CFR 507.33(a)(1).

Specifically, your firm manufactures cat food that includes thermal processing (extrusion) as a manufacturing step. Your hazard analysis did not identify inadequate thiamine in extruded dry cat food as a known or reasonably foreseeable hazard.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunshine-mills-inc-576411-06252019
WARNING LETTER
Sunshine Mills Inc 
MARCS-CMS 576411 — Jun 25, 2019

Risks Associated with Metal Straws - Puncturing Your Face and Improper Sanitation

An English woman died when she fell and the metal straw she was carrying in her glass punctured her eye and entered her brain.

The face-puncture risk was not one that was on the radar, but probably should be, especially for little kids or for those consuming adult beverages such as in bars and restaurants.

The risk of contamination from improperly cleaned metal straws is another consideration.  Consider germs being passed from another person who used that straw or a mass of mold growing in a food-clogged straw.  As a reusable food utensil, the interior of the straw must be cleaned and sanitized since that is a food contact surface.  From the website of a metal straw manufacturer, they state cleaning procedures to be followed:

SOAKING & CLEANING: When Server Clears A Finished Drink, They Should Collect The Straw, And Place It In A Tub Of Hot Soapy Water To Soak. If The Straw Was Used For A Drink That Might Have Pulp Or Other Beverage Reside, Then It Should Be Scrubbed With A Cleaner Brush To Remove Any Such Debris. Rinse The Straws Thoroughly In Clean, Hot Water, To Remove All Soap.

This is followed by a sanitation step

SANITIZING: Soak Straws For At Least One Minute In Tube Filled With An Approved Restaurant Sanitizing Cleaning Formula. This Step Is Recommended For Commercial Establishments Cleaning Any Type Of Reusable Utensil — Including Spoons, Forks And Knifes — To Assure That Any Germs Are Destroyed.

Cleaning your own straw is not an issue, but in foodservice operations where hundreds of straws may need to be cleaned, then proper sanitation (cleaning and sanitizing) can be a major task.

Anyone who has had to clean glass pipettes knows that this is not an easy process and that the tubes can get easily blocked (and at least with glass, you were able to see which tubes were blocked).  For one, you won't know that a given metal straw is blocked unless you run a brush through each or at least, visually examine down each barrel.  Second, dropping the straws into a cleaner or a sanitizer solution will not guarantee that the cleaner sanitizer will come in contact with the entire surface due to air bubble blocks.  With pipet cleaning, the tubes are stacked vertically, not horizontally, in a cylindrical cleaner where waters is added and then flushed repeatedly. 

Metal straws and cleaning brushes

pipet cleaner

 (One other point to make - the potential loss of flavor with certain beverages like coffee in stainless steel.  Did you ever notice how coffee flavor is lost in a stainless steel cup vs a ceramic cup?)


https://www.foxnews.com/world/metal-straw-death-eye-impaled-brain
English woman died after falling on metal straw that went through her eye, impaled brain, inquest hears
By Travis Fedschun | Fox News
July 9, 2019

People Licking Ice Cream and Putting Back in the Display - Food Tampering is a Felony

A Texas youth has been identified for allegedly licking a tub of ice cream and then putting it back in the freezer.  The video of the young woman completing the act went viral.  Adulterating food, which this act is certainly that, is a felony offence that could result in an extensive stay in jail as well as hefty fines.  As a juvenile offender, she is not likely to face charges as an adult, so the penalty will be less severe.

A copycat incident occurred in LA when a 36 year old man also popped open a container of ice cream on the store shelf, licked it, and then placed it back.  The man claims to have then purchased the ice cream.

Time for manufacturers to review their packaging with an eye towards product security.

Insider.com
https://www.insider.com/police-identify-ice-cream-licking-culprit-from-viral-video-juvenile-2019-7
Local police have identified the suspected ice cream-licking culprit from viral video

June 8, 2019

Because of Health Concerns, FDA States CBD from Hemp Still Illegal as an Additive to Food

CBD from hemp has received an incredible amount of attention from those who would like to see it added to food.  However, "Other than one prescription drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body."  One of the biggest concerns is liver damage which has been shown by studies in mice.   Other issues are the impact on mental health.

"Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)."  While the "Farm Bill removed hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act", "CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance."

FDA Public Health News Release
https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
Content current as of:
06/19/2019

Death of Australian Man After Eating Gecko Likely Due to Parasite

An Australian man died a horrific death after eating a gecko on a dare.  Initially thought it was a massive Salmonella infection, it is now believed that it was a parasite that led to such dramatic symptoms as "vomiting green bile, his testicles each swelled to the size of a grapefruit with a strange fluid leaking from them — and his stomach was so badly bloated".  All of this within days after eating gecko.  From the article, a taxonomist and ecologist who is an expert in Asian house gecko parasites says a Spirometra tapeworm — which can group to about 4ft — could be what ravaged and ultimately killed the young dad."

Key - Ignore the dares and double dares when it comes to eating raw snails, reptiles, etc


The Sun
https://www.thesun.co.uk/news/9429635/dared-eat-gecko-australia-dead-tapeworm/
GRIM TWIST Man who died in agony after ‘gecko eating dare’ may have been killed by a parasitic Spirometra tapeworm, doctors say
Patrick Knox
3 Jul 2019, 16:19

Salmonella Outbreak May be Linked to Pig Ear Dog Treats

CDC identified pig ear dog treats as the likely source of an Salmonella outbreak.  To date, there have been 45 cases with 34 of 38 people interviewed having claimed contact with a dog with 17 of 24 claiming contact with pig ear treats or contact with a dog who had pig ear treats.

Testing done thus far has not identified the outbreak strain,  but they have found other strains of Salmonella.  Testing of the outbreak strain found that the organism is antibiotic resistant.

(Champ's snack of choice is Penn State Summer Sausage....luckily he is a little dude and doesn't eat mass quantities....plus his owner gets to enjoy some as well...all Salmonella free...can't put a price on that.)

https://www.cdc.gov/salmonella/pet-treats-07-19/index.html
Outbreak of Multidrug-Resistant Salmonella Infections Linked to Contact with Pig Ear Dog Treats
Published on July 3, 2019 at 2:45 PM ET

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDAexternal icon) are investigating a multistate outbreak of multidrug-resistant Salmonella I 4,[5],12:i:- infections linked to contact with pig ear dog treats.

At A Glance
Reported Cases: 45
States: 13
Hospitalizations: 12
Deaths: 0

A Distributor of Salmonella Contaminated Papayas Identified

FDA released an update regarding the ongoing Salmonella outbreak associated with papayas.  At this point, the FDA investigation "indicates that Agroson’s LLC of Bronx, New York, is the exclusive distributor of the imported papayas that likely made consumers from this outbreak sick. The papayas are sold under the brand name Cavi. To date, there have been no positive product samples."

With this, FDA lifts the hold on Mexican papayas.  There was no indication in the notice where the NY distributor sourced the papayas.

To date, there have been 71 cases with 27 hospitalizations,  All cases originated in the northeastern section of the US.

https://www.fda.gov/food/outbreaks-foodborne-illness/salmonella-uganda-likely-linked-whole-fresh-papayas-june-2019
Salmonella Uganda Likely Linked to Whole, Fresh Papayas, June 2019
Consumers in all states warned to avoid Cavi brand whole, fresh papayas distributed by Agroson’s LLC
Case Counts
Total Illnesses: 71
Hospitalizations: 27
Deaths: 0
Last illness onset: June 16, 2019
States with Cases: CT (14), FL (1), MA (5), NJ (18), NY (27), PA (4), RI (1), TX (1)

July 5, 2019

Growers Express Recalls Fresh Processed Vegetable Products After Positive Listieria Finding

Growers Express production facility in Biddeford, Maine is recalling  select fresh vegetable products  including packaged varieties of butternut squash, cauliflower, zucchini and a butternut squashed based veggie bowl due to the potential for contamination with Listeria monocytogenes.  According to the report, the recall was issued after being notified of a single positive sample by the Massachusetts Department of Health

"Most of the affected products are labeled with a “Best If Used By” Date of June 26 – June 29, 2019"...so a three day production window....and it should be noted that product has already its expiration date.  The company has stopped production and is "deep sanitizing the entire facility and our line equipment, as well as conducting continued testing on top of our usual battery of sanitation and quality and safety tests before resuming production."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/growers-express-issues-voluntary-recall-multiple-fresh-vegetable-products-due-potential
Growers Express Issues Voluntary Recall of Multiple Fresh Vegetable Products Due to Potential Contamination of Listeria monocytogenes
Summary
Company Announcement Date: June 30, 2019
FDA Publish Date: July 01, 2019.
Product Type:Food & Beverages
Produce Reason for Announcement:  Listeria monocytogenes
Company Name: Growers Express
Brand Name:  Green Giant Fresh, Growers Express, Signature Farms, Trader Joe’s
Product Description:  Butternut squash, cauliflower, zucchini, and butternut squash based veggie bowl products

Are You Using A Thermometer for Cooking Your Burger on the 4th? Why You Are Probably Not

Thermometers are the most effective way to determine if food is safe.  That is, to determine if specific temperatures have been reached to ensure leathality for pathogens of concern.  A recently published study looked at 85 studies from the past 21 years to see why thermometers are used or not used.  For those using thermometers, the motivators for thermometer use were to protect
those for whom the food is prepared and to improve food quality.

However, the majority of people do not use thermometers with the barriers being categorized into two major groups: “the belief that a thermometer is not necessary” and “the difficulty of selecting and using a thermometer.”

Barrier type 1 - Belief that a thermometer is not necessary -

1. Preference for alternative techniques. 

"Many consumers (47 to 51%) responded that it is unnecessary to use a cooking thermometer to check the doneness of an egg or meat dish. The most frequently reported alternative to food thermometer use was use of color to determine the doneness of the meat. Consumers also determined the doneness of egg or meat dishes by touch, taste, recipe cooking time, inserted a knife to examine the internal texture, inserting a toothpick or other utensil to see whether it came out clean, or other indications of texture, such as shaking an egg dish and considering it done when the item was firm.

2. Mainstream media and food professionals seldom serve as role models and often negate the need for food thermometers. 

Food workers indicated they were less likely to use a food thermometer when the managers were perceived as not caring about or monitoring this activity; some workers reported that their managers were bad examples when using thermometers. Food workers who were less likely to use a thermometer also believed that their boss, coworkers, customers, and the health inspector would not support thermometer use. Some culinary preparations seldom incorporate temperature measurement. Young Asian consumers reported not seeing a food thermometer used in their daily lives.

3.  Limited awareness of potential health issues associated with current practices.

4. Limited knowledge and awareness related to thermometer use for specific food groups.

Barrier type 2 - Difficulty of selecting and using a thermometer.

1. Difficulty in selecting the type of food thermometer.
2. Availability of food thermometers.
3. Lack of skills related to use of food thermometers.
4. Limited knowledge related to endpoint temperatures.
5. Inability to calibrate food thermometers.
6. Lack of knowledge of food thermometer cleaning and sanitation.

Are you making excuses or are you going to control your process?


Journal of Food Protection, Vol. 82, No. 1, 2019, Pages 128–150
doi:10.4315/0362-028X.JFP-18-245
Copyright , International Association for Food Protection

ABSTRACT

Motivators and Barriers to Cooking and Refrigerator Thermometer Use among Consumers and Food Workers: A Review