FDA on Steps for the Safety of Imported Goods from China Considering Coronavirus

The US imports a lot of goods from China and of course, people are concerned about this fact regarding Coronavirus.  FDA released a statement indicating that there is no perceived issue at this time.

"Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed. "

 "We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law."

As an enveloped virus, it will not last as long as a non-enveloped virus such as Norovirus.

https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-steps-ensure-quality-foreign-products
Coronavirus Update: FDA steps to ensure quality of foreign products
For Immediate Release:
February 24, 2020

Is it Worth Wearing Masks to Prevent Coronavirus?

There has been a rush to purchase surgical masks to prevent Coronavirus.  In short, it is not going to do much and thus not worth the effort.  Surgical masks prevent the wearer from spewing out droplets, but are not overly efficient at the reverse.    So it would be recommended for someone who may have been exposed, but not for someone who is just trying to prevent illness, especially in places like the US where it is a low risk.

Healthcare workers working with potentially ill person from Coronavirus are advised to wear a heavy-duty mask called an N95 respirator.   "These respirators are designed to fit tightly around the nose and mouth, and, when worn correctly, block out at least 95% of small airborne particles, according to the CDC."  But these are not something recommended for the general public.

https://www.businessinsider.com/wuhan-coronavirus-face-masks-not-entirely-effective-2020-1
People are racing to buy face masks amid the coronavirus outbreak, but they probably won't protect you from illness
Holly Secon Feb 26, 2020, 2:45 PM

This Week in Mislabeled Product for Week Ending February 29, 2020

Wrong Formulation Adds Milk Chocolate Chips - Choice Products USA, LLC of Eau Claire, WI, is recalling 275 - 3lb tubs of Peanut Butter Cookie Dough, because it may contain undeclared milk from milk chocolate chips. Some containers of the 3lb. Peanut Butter Cookie Dough have been found to contain milk chocolate chips which were mistakenly included in the mixing process of the Peanut Butter Cookie Dough. The recall was initiated after it was discovered that product containing milk chocolate chips was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by an inadvertent adherence to the company's “production and packaging procedures."

Pasta Contains Gluten and Cannot Be Called Gluten Free- Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of "Pasta e Fagioli" because the soup mix contains an individually wrapped package of pasta, which contains gluten. However outer packaging states the product is Gluten Free.   The recall was initiated after it was discovered that the gluten-containing product was distributed in packaging that did not clearly reveal the presence of gluten. Subsequent investigation indicates the problem was caused by a breakdown in the company's packaging processes.

Milk Missing from Label - Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, because it may contain undeclared milk.   The recall was initiated after it was discovered that product containing milk was distributed in packaging that did not list the presence of milk.

Peanut and Almond Mix-up? Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen and they are recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen

FDA Issues Warning Letters To Two Importers for No FSVP

FDA issued Warning Letters to two importers for not having Foreign Supplier Verification Programs in place for their international suppliers.

• Banjaras Inc of Texas did not have a FSVP in place for suppliers of coriander and garlic, Rasam powders, Kesar mango pulp and Suji rusk.
• Hindy Import Inc. of Cajon, CA did not have a FSVP for suppliers of red lentils, bulgur coarse with vermicelli noodles, and vermicelli noodles, and white quinoa.

Whether a company is directly importing product or if they are using importers to bring in product, someone must be responsible for evaluating the safety of that product. While manufacturers who directly import food or ingredients can do that as part of their Preventive Controls plan, if they are using an importer, then it is critical to understand who has a program in place to evaluate and ensure the safety of that product. For food manufacturers, they often assume the broker is covering the regulatory requirements, but without delineating that on a contractual basis, one does not know for certain.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banjaras-inc-589115-09252019
FDA WARNING LETTER
Banjaras Inc
MARCS-CMS 589115 — September 25, 2019

Allergen Related Recall Triggers FDA Inspection that Results in Warning Letter

FDA issued a Warning Letter to a Wisconsin ice cream facility for an inspection that was initiated  after a company-issued recall when the company packed Bourbon Honey Pecan Ice Cream into Gluten Free Cookies N Cream ice cream containers (gluten and tree nut allergens into a package with a gluten-free label and no nuts listed).

The firm was cited for not having adequate allergen controls to prevent a recall, specifically actions to prevent improper packaging with allergen declarations.  They were also cited for not implementing their sanitation controls systems including corrective action and verification.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sassy-cow-creamery-llc-587954-12042019
WARNING LETTER
Sassy Cow Creamery, LLC 
MARCS-CMS 587954 — December 04, 2019

FDA Issues Warning Letter to Sandwich Chain for Series of Outbreaks and Sprouter for Issues Leading to Outbreak

FDA issued Warning Letters to both Jimmy John's and a sprout distributor in light of a series of outbreaks associated with the chain.  The investigation "lays out evidence from five outbreaks, including the most recent outbreak in the state of Iowa during November and December 2019, of human infections with Escherichia coli O103, a Shiga toxin producing Escherichia coli (STEC)."

A bit of this announcement seems to be grandstanding for FDA's new movement, the "New Era of Smarter Food Safety".  In this news release for the action against Jimmy Johns, it goes on to state "The FDA is currently developing a Strategic Blueprint that will outline how the agency plans to leverage technology and other tools, to create a more digital, traceable and safer food system. This work will build on the advances that have been and are being made in the FDA’s implementation of the Food Safety Modernization Act to further strengthen prevention of foodborne illnesses."

So while the letter against Jimmy John's is based on outbreaks linked to the restaurant chain, the letter against the Iowa sprouter is after an invetigation associated with the an "outbreak of human infections with Shiga toxin-producing Escherichia coli O103 (E. coli O103) that sickened 22 people between November 21 and December 14, 2019."

1.  Did not test spent sprout irrigation water (SSIW) from each production batch of sprouts for E. coli O157:H7 and Salmonella, as required by 21 CFR 112.144(b). 
2.  Did not take steps to hold all product from entering commerce before receiving results from the spent sprout irrigation water tests, as required by 21 CFR 112.147(
3. Did not take corrective actions when environmental samples of your growing, harvesting, pack

FDA In Brief: FDA Issues Warning Letters to Jimmy John’s and a Sprout Distributor for Food Safety Violations
February 25, 2020

New Consumer Product for Sanitizing Surfaces Released

P&G introduced a new surface sanitizer, Microban 24, a Quaternary Ammonium based sanitizing solution.  It is important to note that this is not designed for food contact surfaces, at least not without rewashing the surface after application and before use.

So, how important is it to have the residual sanitizing affect on a non-food contact surface?  Do you want to have chemicals left on the surface or is having clean surface enough?

While it comes at a time when Coronavirus, Covid-19, is on everyone's mind, the product has not been tested against that specific virus, so it can't make that specific claim.

Asked about Microban 24’s use as a guard against the 2019 novel coronavirus (Covid-19), the spokeswoman responded carefully, noting that because it’s a new strain, “there is not yet an acceptable EPA method for claims against it.” 

But it is claimed that it has been found effective against similar viruses.

Microban 24 Product Description
Microban 24-Hour Disinfectant Sanitizing Spray, Citrus, 15 oz - Microban provides 24-hour sanitization against bacteria even after multiple touches. Kills 99.9% of bacteria in 5 minutes, and keeps killing for 24 hours. Cleans and sanitizes in one step. Suitable for everyday use. Aerosol Sanitizing Spray suitable for use on hard surfaces and non-washable soft surfaces like upholstery, backpacks, luggage, curtains and cushions.

• Provides 24-hour sanitization against bacteria even after multiple touches.
• Kills 99.9% of bacteria in 5 minutes, and keeps killing for 24 hours.
• Cleans and sanitizes in one step.
• Suitable for everyday use on hard surfaces and non-washable soft surfaces like upholstery, backpacks, luggage, curtains and cushions.

This Week in Mislabeled Products for Week Ending February 22, 2020

Cheddar Chips in Wrong Labeled Bag Results in Milk Allergen Miss -  Saratoga Potato Chips, llc of Fort Wayne, Indiana is recalling 140 cases of Kroger Sweet & Mesquite BBQ Potato Chips 17 oz (UPC 0111100320101) with the specific lot code because it may contain undeclared milk.  The issue was discovered when some consumers reported finding cheddar cheese flavored chips in the Bag of Sweet & Mesquite BBQ Potato Chips

Product With Peanut Gets Wrong Labeled Sleeve -  Containing Peanuts Mislabeled - CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. The voluntary recall was initiated because the company discovered some bowls that were packaged in outer sleeves indicating Teriyaki Noodle Bowls contain Pad Thai noodle, which contains peanuts that are not listed on the ingredient list or allergen information.

Study - Growth and Survival of Vegetative Pathogens in Beef and Plant (Fake Beef) Burgers

Not that we would expect to have high levels of vegetative pathogens (STEC, E. coli, Listeria, and Salmonella) in plant-based burgers, but we would consider the risk of them being there should be low, with the possible exception of Listeria.  However, the plant-based burgers are a TCS food (they have the necessary nutrients, Aw and pH) and thus will support the growth of organisms during storage. 

Storage at refrigeration and slight temperature abuse situations - At slight temperature abuse temperatures (10C), the levels of all three pathogens increased by ca. 1.0 to ca. 2.5 log CFU/g in plant-based burgers (beef burgers showed a slight decrease).
Cooking - all pathogens were reduced equally well in plant-based burgers and regular burgers.

Key - need to treat plant based burgers like regular burgers, especially regarding storage temperatures.

Viability of Shiga Toxin–Producing Escherichia coli, Salmonella, and Listeria monocytogenes within Plant versus Beef Burgers during Cold Storage and following Pan Frying 
JOHN B. LUCHANSKY ;  BRADLEY A. SHOYER  ;  YANGJIN JUNG  ;  LAURA E. SHANE  ;  MANUELA OSORIA  ;  ANNA C. S. PORTO-FETT
J Food Prot (2020) 83 (3): 434–442.
https://doi.org/10.4315/0362-028X.JFP-19-449

ABSTRACT

The viability of Shiga toxin–producing Escherichia coli (STEC), Salmonella, and Listeria monocytogenes within plant- and beef-based burgers was monitored during storage and cooking. When inoculated (ca. 3.5 log CFU/g) into 15-g portions of plant- or beef-based burgers, levels of STEC and Salmonella decreased slightly (≤0.5-log decrease) in both types of burgers when stored at 4°C, but increased ca. 2.4 and 0.8 log CFU/g, respectively, in plant-based burgers but not beef-based burgers (≤1.2-log decrease), after 21 days at 10°C. For L. monocytogenes, levels increased by ca. 1.3 and 2.6 log CFU/g in plant burgers after 21 days at 4 and 10°C, respectively, whereas pathogen levels decreased slightly (≤0.9-log decrease) in beef burgers during storage at 4 and 10°C. Regarding cooking, burgers (ca. 114 g each) were inoculated with ca. 7.0 log CFU/g STEC, Salmonella, or L. monocytogenes and cooked in a sauté pan. Cooking plant- or beef-based burgers to 62.8°C (145°F), 68.3°C (155°F), or 73.9°C (165°F) delivered reductions ranging from ca. 4.7 to 6.8 log CFU/g for STEC, ca. 4.4 to 7.0 log CFU/g for L. monocytogenes, and ca. 3.5 to 6.7 log CFU/g for Salmonella. In summary, the observation that levels of all three pathogens increased by ca. 1.0 to ca. 2.5 log CFU/g in plant-based burgers when stored at an abusive temperature (10°C) highlights the importance of proper storage (4°C) to lessen risk. However, because all three pathogens responded similarly to heat in plant-based as in beef-based burgers, well-established cooking parameters required to eliminate STEC, Salmonella, or L. monocytogenes from ground beef should be as effective for controlling cells of these same pathogens in a burger made with plant-sourced protein.