Imported Foods and the FSMA Foreign Verification Program Rule (FSVP)

The Food Safety Modernization Act (FSMA), signed into law in 2011, was designed to improve public health by strengthening the food safety system. The law provided authority to the U.S. Food and Drug Administration (FDA) to write and enforce regulations that focus on preventing food safety issues. The law also directs FDA to enforce food safety standards for foods imported from other countries, with the intent that these foods meet the same safety standards as those grown or processed in the U.S. FDA regulated foods that are grown, manufactured, or processed outside the U.S. are therefore covered under several FSMA regulations including the Produce Safety Rule, the Preventive Controls for Human Foods Rule, and the Preventive Controls for Animal Foods Rule. The Foreign Verification Program Rule (FSVP) requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

One of the first challenges for food importers is determining if a particular food falls under FSMA or is excluded. There are many foods imported into the U.S. that may be excluded from FSMA coverage because pre-existing regulation are already in place. These include foods regulated under previously enacted FDA regulations for seafood and juice products. Foods that fall under USDA jurisdiction, specifically meat and poultry products, are excluded because USDA has established its own import regulations. There are also exclusions for imported foods that will not be consumed in the U.S., as well as foods imported solely for test purposes. A general rule to remember is that if a food that is not excluded, it will fall under one or more of the FSMA rules.

A key point for importers to understand is that all foods that are brought into the U.S., and then consumed in the US, must meet U.S. food safety standards. This means that fresh fruits and vegetables grown in another country for export to the U.S. must be grown, harvested, packed, and held under the standards established in the Produce Safety Rule. Foods (human or animal) or food ingredients imported into the U.S. for further processing by U.S. manufacturers will fall under the food safety requirements written in the Preventive Controls Rule for Human Foods or the similar rule for animals food. Imported foods that will not be processed by the importer such as those directly sold through retail entities must assume responsibility, in conjunction with their foreign supplier for the safety the product by developing a plan by to ensure that the safety of the product is properly controlled by the foreign supplier. It is the importer’s responsibility to understand the requirements of this rule and implement necessary measures to ensure that their foreign supplier has adequate food safety controls in place.

In some cases, the determination of who the importer is is not easy. Imported foods may by touched by a number of different entities as they make their way into the U.S. The key part of the regulation is to make sure that the importer is identified before the food enters the U.S. FDA requires this in order to assign responsibility for the imported product to that entity. This responsible entity must have a U.S. address where the proper documentation will be kept.

The designated FSVP importer is required, through development of a hazard analysis, to determine what potential hazards, if any, represent a potential risk for the given imported food. For those identified hazards having significant potential risk, the importer must ensure, or verify, that the foreign supplier has adequate controls to prevent or eliminate that risk. As a means of verification, importers can use one or more ways, including implementing testing requirements, conducting food safety audits, and collecting pertinent documentation. Verification must take place beforehand as part of a supplier approval process, and then monitored on an ongoing basis.

Individuals tasked with writing and implementing an a Foreign Supplier Verification Program must be qualified through training to do the task. This can be accomplished through attending a FSVP training course developed by the Food Safety and Preventive Control Alliance (FSPCA) and which is offered by Penn State. This training is not just necessary for those who import foods and therefore must write a FSVP plan. It is also important for U.S. food processors, retailers, and other food businesses who buy food from foreign sources; because in the end, they will also pay a price for a foreign supplier’s inadequate food safety program.

As you can see, the FSVP is complex and requires training to understand how the rule could affect your food operation. Visit the Penn State Extension FSMA website at extension.psu.edu/fsma for more information on the FSVP Rule and when and where Penn State will be offering training.

Links.
Registration site for the Penn State Foreign Supplier Verification Workshop
https://extension.psu.edu/foreign-supplier-verification-workshop

FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm

People Have Gene to Produce Chitin Digesting Enzyme - Please Pass the Stinkbugs

A study in Molecular Biology and Evolution shows that people do have the enzyme that can break down insect casings.  Primates, including humans do have the gene that breaks down chitin, the substance that forms the exoskeleton of bugs.  Most of us were taught that chitin would not be broken down in our digestive systems.  Not so.

An article in National Geographic from 2013,  U.N. Urges Eating Insects; 8 Popular Bugs to Try, suggests these bug species:
1. Beetles
2. Butterflies and Moths
3. Bees and wasps
4. Ants
5. Grasshoppers, crickets, and locusts
6. Flies and mosquitos
7. Water boatmen and backswimmers
8. Stinkbugs

Yes, Stinkbugs....from the article  "If you can get past the funky smell, these insects apparently add an apple flavor to sauces and are a valuable source of iodine. They're also known to have anesthetic and analgesic properties. Who would have thought?"  Not me, that is for sure.

So what wine should we pair with our bowl of crunchy crickets.....a nice grassy sauvignon blanc perhaps?  An article on the subject in Food and Wine magazine suggests pairing a Riesling with honey mustard crickets. 


IFT Weekly Newsletter
http://www.ift.org/Food-Technology/Newsletters/IFT-Weekly-Newsletter/2018/February/021418.aspx
Study finds most primates, including humans, can digest insects

Iowa Retailer Recalls Chicken Salad After Reported Cases of Salmonella Infection

An Iowa retailer is recalling chicken salad after the product was linked to several cases of Salmonella infection.  The chicken salad was produced by a third party establishment.

Iowa Department of Public Health News Release

https://idph.iowa.gov/News/ArtMID/646/ArticleID/158205/Consumer-Advisory-Issued-for-Chicken-Salad-Purchased-at-Fareway-21318

Consumer Advisory Issued for Chicken Salad Purchased at Fareway (2/13/18)

Author: Polly Carver-Kimm/

Tuesday, February 13, 2018/

Categories: Infectious Disease Prevention

FDA Issues Alert for Raw Pet Food Brands About Potential Pathogens

FDA issued an alert for raw pet food products under the Darwin’s Natural and ZooLogics brand labels.  "The FDA is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products."

There have been a number of complaints of illness and deaths associated with the product.     "As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA has confirmed that new samples of Darwin’s Natural Pet Products raw pet foods have tested positive for Salmonella."   In addition to illness, there have also been injuries associated with bone shards.

As FDA states on this Alert, "Raw pet food is more likely than other types of pet food to contain Salmonella and Listeria monocytogenes. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products."  But it further states, "The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any pet food found to be contaminated with the harmful bacteria."

So why aren't these processors using High Pressure Processing to eliminate pathogens?  Why do we recall it knowing that pathogens can be present?  Why do people buy this knowing that the harm to the dog can far outweigh any benefit?  Really, if people want to feed raw meat to dogs, buy whole cuts of meat, surface sanitize and cut it yourself.  While this will not eliminate the risk completely, it is less risky than buying commercially made product.

FDA Alert
https://www.fda.gov/Safety/Recalls/ucm596594.htm
FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food
For Immediate Release
February 13, 2018

Online Consumer Complaint Portals - Too Much Transparency?

An interesting article in the NY Times titled Too Much Power to the People? A Food Safety Site Tests the Limits discusses the online complaint site IWasPoisoned.com and the impact it has on food companies.  According the article, the site has collected about 89,000 reports since starting in 2009.   The site provides an outlet for consumers to voice their issues, in this case, the blame for their illness.

While it has proved a key for pointing out linkages to foodborne illness associated with less-than-good operators such as Chipolte, there are some major drawbacks of having too much transparency.

"Restaurant executives have criticized IWasPoisoned for allowing anonymous and unverified submissions, which they say leads to false reports and irresponsible fear-mongering. Some public health officials have objected on the grounds that food poisoning victims can’t be trusted to correctly identify what made them sick."  

So for one, people can publicly bash a restaurant with out substantiating the restaurants involvement.  Depending on the type of agent involved in foodborne illness, the food may have been consumed hours before or days before the symptoms show up.  Unfortunately, people are apt to blame the food they last ate.

People may just want to pile on without actually being sick.  In some cases, people may do it because they don't like a given food establishment, or perhaps they favor a competitor.

The website does review complain submissions and they do provide an opportunity for those establishments which have been blamed for an illness to appeal any complaints.

However, the high level of transparency makes this information readily available for all, including news media outlets who are always hungry to report an outbreak of foodborne illness.

One fact is interesting in how a website like this makes money - they provide an early warning to investor and others willing to pay for leads on a given restaurant that may be involved in an outbreak scenario.

NY Times
https://www.nytimes.com/2018/02/13/business/too-much-power-to-the-people-a-food-safety-site-tests-the-limits.html
Business Day
Too Much Power to the People? A Food Safety Site Tests the Limits
The Shift
By KEVIN ROOSE FEB. 13, 2018

Dog Treats Recalled After Positive Laboratory Test

A CA pet products company is recalling a single product, bully stick dog chews, after the Colorado Department of Agriculture found that a single sample collected from a retail location detected positive for Salmonella.  According to the owner, every product lot before it tested before it leaves the manufacturing plant. This lot code in question was tested both at the company lab as well as by a third-party testing facility.

Hopefully the positive was analyzed to determine that it was not from the laboratory.  But conducting further analysis, specifically DNA testing, will help in determining the source and whether this organism was transient or established within the facility.

Is it possible for a facility to do finished product testing and still have a positive sampling?  Absolutely.  Small levels of contamination may not be found by limited finished product testing.  More important is having a comprehensive monitoring system that focuses on the environment.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm596190.htm
Redbarn Pet Products Issues Voluntary Recall of Dog Chews
For Immediate Release
February 9, 2018

Study Assesses Exposure to PAA for Food Processing Employee Safety

With peracetic acid (PAA) being used more in food processing operations, a study reported in Meatingplace looked at exposure levels to employees who work in poultry facilities.  In summary, the level of exposure to employees was below proposed threshold limits for health and safety, but the researchers recommended additional work is needed.

Meatingplace - Industry News - AM

http://www.meatingplace.com/Industry/News/Details/78054
Study assesses poultry workers’ exposure to peracetic acid
By Tom Johnston on 2/13/2018

FDA Releases 2017 Food Code - What's New in the Regulation

FDA released the 2017 version of the Food Code.  The Food Code is a model for ensuring safe food that is provided for adoption by local, state, and federal governmental jurisdictions for administration to food service, retail food stores, or food vending operations.  Every 4 years, a new version is issued with updates.   According to the release, there are 4 significant changes.   

Item #1 - Revised requirement for the Person in Charge (PIC) to be a Certified Food Protection Manager (CFPM) (Section 2-102.12)

What’s changed – in the 2013 version, section 2-102.12 specifies that one person within the operation be a certified person. The update removes the 'one person'  but puts in that the person in charge is teh certified person.  The change makes the regulation less prescriptive, so instead of saying at least one person, now it says whoever has the duties of the person in change (2-103.11), that person has to be certified.   This may make it easier for small multi-unit operations to comply.

Item #2 - Added a new section that addresses the use of bandages, finger cots or finger stalls (Section 2-401.13)

What’s new – This section was added into the code. While covered in the ServSafe training, covering a wound on the hand is now detailed in the regulation - the wound is covered by bandage or cot (or stall) and then covered by a glove. (A finger cot and stall are essentially the same, but a stall generally refers to a finger covering that has a support back to the wrist).

Item #3  Harmonized cooking time/temperature parameters for intact and non-intact meat and poultry in accordance with guidance from the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) (Section 3-401.11) 

What's changed - There are two significant changes here - the first is the dwell time for ground meat, injected meat, mechanically tenderized meat - it is 155ºF for 17 seconds, instead of 15 seconds.  The second is for poultry and stuffed meat - the temperature is 165ºF is an instantaneous time, instead of of what is listed in the earlier versions as 15 seconds.

Item #4  Updated procedures for retail food establishment operations to continue during an extended water or electrical outage if a written emergency operation plan has been pre-approved by the Regulatory Authority, immediate corrective action taken and the Regulatory Authority has been notified upon implementation of the plan (Section 8-404.11) 

What's changed  - More detail was added to the regulation about continuing operation when an outage of electrical or water service is encountered.  It gives the regulatory authority and the operator means of writing and approving a plan provided there is no risk.

LINK to 2017 Food Code

The specific sections are covered below showing impacted sections of the regulation.


FDA Constituent Update
LINK To Announcement
FDA Releases 2017 Food Code

Recall Data from Past Five Years - What is Changing?

Each quarter, Stericycle Expert Solutions releases their Recall Index which analyzes the frequency, volume, and causes of U.S. product recalls.   This week they issued a 5 year summary of making these reports. From this article,  Reflections on Recalls: Five Years of the Stericycle Expert Solutions Recall Index

"The food and beverage industry experienced the most dramatic spike in units recalled over the past five years. Food products recalled by the U.S. Food and Drug Administration (FDA) skyrocketed 92.7 percent since 2012, and recalled pounds regulated by the U.S. Department of Agriculture (USDA), which largely oversees meat production, jumped 83.4 percent in the same period.  Technological improvements in food testing, combined with factory farming and growing automation in food production were major drivers of the increases. "

Many have interpreted this report to make it seem like things are out of control.  Not really.  Increased testing, improved testing, and a risk-averse public have more to do with the number of recalls.  Our systems of supply have not changed as much as our testing requirements and capabilities and with that, our threshold for the issues that are found.  Because of this, our food supply is becoming more safe, not less safe.

https://www.prnewswire.com/news-releases/reflections-on-recalls-five-years-of-the-stericycle-expert-solutions-recall-index-300594063.html
Reflections on Recalls: Five Years of the Stericycle Expert Solutions Recall Index 
Q4 2017 Recall Index Reveals Zero Fines for Consumer Products, Continued Decreases in Medical Device Recalls, and Severity of Drug Recalls Continuing to Rise, Among Other Findings