FoodHACCP Newsletter



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09/21. QualitySupervisor/FS Supervisor - Lebanon, PA
09/21. QAManager - Hastings, NE
09/21. FSQA Supervisor - Fredericksburg, PA
09/19. FoodSafety QA Manager - Hazlehurst, MS
09/19. QualityAssurance, Food Safety - Vallejo, CA
09/19. QA/ Food Safety Manager - Chenoa, KY
09/17. FoodSafety Specialist- Retail - Dallas, TX
09/17. FoodSafety Manager - Minot, ND
09/17. Food Safety andQuality Specialist - Manteno, IL

 

09/24  2018 ISSUE:827

 

USDA Releases Distribution List in Cargill E. coli O26 Ground Beef Outbreak
Source : https://foodpoisoningbulletin.com/2018/distribution-list-cargill-e-coli-ground-beef-outbreak/
By News Desk (Sep 24, 2018)
The USDA has released the distribution list of where the ground beef in the deadly Cargill E. coli O26 outbreak was sold. That Cargill E. coli outbreak sickened 18 people in four states and killed one person in Florida. Six people were hospitalized, and one person developed hemolytic uremic syndrome (HUS), a type of kidney failure.
UPDATED 8/27/18: The grocery stores and chain stores that probably sold the ground beef nationwide include Aldi stores in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, Oklahoma, and Wisconsin; FoodMaxx in California, Pak N Save in California, Meijer nationwide; Safeway/Albertson’s in California, Colorado, and Hawaii; Sam’s Club in North Carolina, Ohio, and Virginia; Target stores nationwide; and Vons in California.  In addition, in California, Central Meat & Provision Co at 1603 National Avenue in San Diego, and Save Mart on 9999 Niblick Drive in Roseville may have sold the meat.
In Georgia, Foothills IGA Market in Marble Hill may have sold the meat. In Colorado, Graystone in Eckert may have carried it. In Kentucky, Sam’s Club in Nicholasville, Lexington, and Florence may have sold the ground beef. In Michigan, Aldi in Escanaba, Martin’s Supermarket in St. Joseph and Stevensville, and Village Market in Allegan and Decatur might have carried it. In Missouri, Food 4 Less in Jolin and Springfield are included. In New Mexico, Camicderia La Paloma in Las Cruces may have sold the beef.
In Ohio, Canal Fulton Provision at 2014 Locust Street in Canal Fulton may have carried the ground beef. In South Carolina, Sam’s Club in Myrtle Beach, Florence, and Rock Hill could have carried the recalled ground beef. In Tennessee, Sam’s Club in Johnson City is on the list. In Virginia, Jeb’s Market in Carrollton and Piggly Wiggly in Newport News could have sold the beef. And finally, in West Virginia, the Piggly Wiggly in Charleston, and the Sam’s Club in Vienna, Beckley, Clarksburg, and South Charleston may have sold the ground beef.
The original recall notice was for Publix ground chuck sold in Florida. The Cargill E. coli O26 outbreak was originally announced in that recall notice.
The USDA states that they have reason to believe those facilities received ground beef products recalled by Cargill Meat Solutions, but the list may not include all retail locations. In addition, these stores may have not received the product. Consumers should use the product specific information on the recall notice to identify the ground beef.
The Centers for Disease Control and Prevention has stated that this Cargill E. coli O26 outbreak is over. But it’s important for consumers to handle ground beef with care. There have been many food poisoning outbreaks linked to undercooked and raw ground beef over the last few years.
The symptoms of an E. coli infection include severe and painful stomach cramps, nausea, and diarrhea that is usually bloody or watery. The symptoms of hemolytic uremic syndrome (HUS) included little or no urine output, easy bruising, pallor, and lethargy. Anyone experiencing those symptoms needs to see a doctor.

Keep Food Safe at Fall Football Cookouts With Tips From Experts
Source : https://foodpoisoningbulletin.com/2018/keep-food-safe-fall-football-cookouts/
By Linda Larsen (Sep 19, 2018)
It’s football time, and that means tailgating. Keep your food safe at fall football cookouts with food safety tips from Auburn University.
Tailgate parties usually take place in parking lots and areas around football stadiums around the country. Most people grill at these gatherings, which present some unique food safety issues. But if you follow these tips at each step, from purchasing the food to grilling and cleanup, you can stay safe and avoid foodborne illness.
First, when you shop, purchase meats such as ground hamburger, hot dogs, and chicken last. Get them home quickly and into the refrigerator and freezer.
When you are packing and preparing food for your fall football cookouts, make sure you put them in an insulated cooler and use ice or frozen gel packs to keep them at a safe temperature. Put the meat into a sealed container and place it at the bottom of the cooler to prevent leaks. Pack a separate cooler for drinks, so the cooler that holds the perishable food is opened as little as possible.
Bring separate utensils and plates for preparing, serving, and eating the food. Also bring a food thermometer so you can make sure the meat you are grilling is cooked to a safe final internal temperature. Cook poultry to 165°F, and ground beef and pork to 160°F. Remember that even if meat looks done, it may not be. So use the food thermometer on every piece of meat every time.
Then mark the time when you start eating. It’s not safe to leave grilled meat and other perishable foods that have been at room temperature for more than two hours. That time shrinks to one hour when the ambient air temperature is above 90°F. When in doubt, throw it out.
After guests have served themselves, you can put dips and perishable side dishes back into the cooler to keep them cool. But remember that coolers won’t cool food to a safe temperature quickly enough. Follow these tips and you’ll enjoy safe fall football cookouts.

Food Safety: Are You on Top of It?
Source : https://cstoredecisions.com/2018/09/19/food-safety-are-you-on-top-of-it/
By Ryan Yost, CSD Staff (Sep 19, 2018)
Each year, more than 48 million Americans are sickened from food poisoning. The culprits? Listeria, E. coli, salmonella and, more recently, cyclosporiasis, which this summer made more than 500 quick-service restaurant (QSR) customers sick after they ate pre-packaged salads at locations across the U.S.
Grocery chains and convenience stores are just as vulnerable, particularly when selling grab-and-go items like sandwiches, salads, wraps and desserts.
It not only hurts your brand and location (tremendously!) but you lose the trust of your customers, and often potential customers, when word spreads. We haven’t even mentioned the loss of inventory. After all, if you get a report of food contamination, you’ll often end up purging more than the offending item once you realize you have food safety issues. On average, refrigerated inventory at any time is valued at up to $10,000 in restaurants and retail stores.
How can you protect yourself? Here are a few things to check—and double check.
• Equipment: How cool are your coolers? Don’t know? You need to know at all times the temperature in your coolers. Invest in a temperature tracking system with wireless sensors—most are easy to install—that track temperatures and report to a “gateway” that’s plugged into a centrally located outlet.
The gateway pushes the data to the cloud where employees can access it through various devices. Stand-alone systems are available that don’t involve Wi-Fi networks. Employees know right away if temperatures are fluctuating out of normal ranges; they’ll receive alerts through Apple, Android and Windows smart devices as well as through Windows PCs.

Depending on what you’re cooling—or keeping warm—certain thresholds will need to be maintained in your systems. If those are breached, your system should push out alerts via text and email to designated users, allowing for quick response so employees and operators are ahead of food safety issues before they make people sick.
•Labeling: Still hand-labeling your grab-and-go items? Industry studies have shown not only is hand-labeling time-consuming for your employees—taking them away from other responsibilities like cleaning and helping customers—but handwritten labels often cause confusion that compromises food safety. Maybe that “1” looks like a “7” or that “3” looks like an “8.” When that happens it’s possible an expiration date goes unnoticed, and food stays in the cooler past its expiration date, increasing your chances a customer will purchase the item and get sick.
Better to invest in an automated system that prints easy-to-read labels. As an added bonus, these systems print for each grab-and-go item a list of ingredients, fat and calorie counts and all of the other information mandated as of May 2018 by the U.S. Food and Drug Administration.
•Communication: Invest in a tablet system—some come with portable printers, to allow staff to participate in these processes and track information as they go, including noting food that’s been donated or thrown away. At the start of a new shift, employees can get a printout to see what’s been done and review notes of what’s still left to do. It’s a great way for different shifts to “talk” to each other when they’re not face-to-face.
Know what you’re donating and throwing away will also help you control inventory costs as you’ll start to recognize how much you sell on average during certain seasons and times of day.
Utilize today’s technology and equipment to streamline your perishable food items, remain in compliance and maintain food safety.
Ryan Yost is a general manager for the Printer Solutions Division (PSD) for  Avery Dennison Corp. For more information visit www.averydennison.com/food.

 

 


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FDA’s Ongoing Efforts to Prevent Foodborne Outbreaks of Cyclospora
Source : https://www.foodsafetymagazine.com/news/fdae28099s-ongoing-efforts-to-prevent-foodborne-outbreaks-of-cyclospora/
By FDA (Sep 19, 2018)
FDA’s Ongoing Efforts to Prevent Foodborne Outbreaks of Cyclospora
The following is a statement issued on September 18 by FDA Commissioner Scott Gottlieb:
The safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.
As part of these efforts, we conduct surveys that involve collecting a robust sample of certain food commodities available in the U.S. marketplace to monitor for the presence of foodborne pathogens. Over time, the FDA has increased its surveillance sampling efforts. We’ve also advanced new technology for pursuing these efforts and expanded the list of foodborne pathogens that the FDA monitors. Owing to these efforts, including a new FDA laboratory testing method, we’ve recently been able to add screening for Cyclospora – a parasite that causes intestinal infection after people ingest something, such as fresh or uncooked produce, or water that was contaminated with human waste – to the list of foodborne pathogens that we can routinely test for in appropriate commodities.
The availability of new testing methods for Cyclospora played an important role in helping the FDA identify a number of positive samples this summer. We detected Cyclospora in domestically grown cilantro that was tested as part of an ongoing sampling assignment of herbs. This cilantro sample has not been linked to any illnesses, but it was the first time we identified Cyclospora in any domestically grown produce item.  Our domestic oversight efforts will evolve to confront this new risk.
This year has been notable for the number of cyclosporiasis cases reported by state and local health departments. Our partners at the Centers for Disease Control and Prevention (CDC) today announced that 2,173 cases of domestically acquired cyclosporiasis have been recorded this spring and summer as of Sept. 12. Although this case count represents a significant increase from our previous experience with this parasite over the last several years, some of this increase is likely the result of improved public health monitoring for human illness, including better diagnostic tests.
Many of this year’s illnesses with Cyclospora are linked to two very large produce-associated outbreaks that we announced over the last several months. One of these outbreaks occurred in the spring. It resulted in 250 illnesses in four states and was linked to Del Monte vegetable trays containing broccoli, cauliflower, and carrots that were sold mostly in convenience stores in the Upper Midwest. Our traceback efforts to determine the source of the contamination indicate that the ingredients could have come from either domestic or imported sources. While our findings were not conclusive regarding the source, we were able to work with Del Monte to voluntarily recall the vegetable trays to limit the extent of illness and on Sept. 6, the FDA and CDC declared this outbreak over.
The second outbreak occurred this summer when 511 Cyclospora illnesses were reported by 16 states. Most of these illnesses occurred in the Midwest. This outbreak was linked to McDonald’s salads sold in 14 states in the Midwest that contained a romaine lettuce and carrot mix supplied by Fresh Express. The FDA worked with McDonald’s to quickly remove implicated salad from the stores. Testing conducted by the FDA identified the parasite in an unopened package of the bagged salad mix, supporting epidemiologic evidence that the salad mix is the source of the outbreak. Fresh Express took the additional precautionary step of recalling lots of romaine lettuce outside the positive lot contained in the salad mix. On Sept. 12, the FDA and CDC announced that this outbreak had ended.
Our experts worked with both McDonald’s and Fresh Express to trace the bagged salad mix ingredients back to where they were grown. We found that the products came from primarily domestic growers. During our investigation, two samples of domestically grown romaine lettuce were also found to be positive for Cyclosporaeven though they were not sourced from locations associated with the lettuce that was linked to this outbreak. None of the romaine lettuce associated with these positive test results for Cyclospora went into the marketplace and all of the produce suspected of being contaminated was destroyed, preventing additional Cyclosporaillnesses from occurring. However, these findings are important as they represent the second time that Cyclospora has been identified in produce grown in the U.S.
Although these two outbreaks are large, together they account for less than half of all domestically acquired Cyclospora cases reported to CDC in 2018.  As noted by CDC, smaller clusters of illness have also been identified and investigations to date have found them to be epidemiologically linked to consumption of basil and cilantro in Mexican-style restaurants. These clusters are similar to clusters of Cyclosporaseen in previous years that were traced to imported herbs although our investigation into the source of the current illnesses is ongoing. That said, our market survey of fresh herbs did identify Cyclospora earlier this summer in cilantro offered for import from two producers in Mexico. In response to that finding, the FDA refused entry for these shipments and took action to prevent contaminated cilantro from those firms from entering the U.S. market.
The discovery of Cyclospora in both domestic and imported produce raise both old and new concerns. They underscore the importance of the FDA’s surveillance activities to better define risks, like investigating why different product types like vegetable trays are being linked to Cyclospora outbreaks, and how widespread Cyclospora may be in the U.S. They also stress the need to broaden the tools, like import alerts, that we have up to this point used to prevent Cyclospora illnesses in the U.S. to also include actions that are more appropriate for addressing domestic contamination events.
The findings also highlight the significance of continuing to implement the provisions of the Produce Safety Rule at home and abroad. We must continue to put in place science-based measures to prevent microbial contamination from occurring, and work with our state and foreign partners to implement the Produce Safety Rule. We’ve been working closely with the National Association of State Departments of Agriculture and our state partners to, among other things, train federal and state regulators who will conduct inspections slated to begin next spring, develop inventories of farms that are covered by the rule, put in place the Produce Safety Network to support the states and their farming communities regionally, conduct On Farm Readiness Reviews to help farmers assess their preparedness to implement the Produce Safety Rule, and continue training opportunities for the farming community. All of these efforts are part of our commitment to working every day to assure the American public of the safety of the foods you and your family purchase and consume.
The U.S. has one of the safest food supplies in the world. But we also recognize that there is more that we can do when we have new findings like we’ve seen with Cyclospora. New risks will continue to emerge. Our system needs to be rigorous, nimble, and proactive in order to confront new challenges.
I want to reinforce to consumers that it’s our goal to figure out how these outbreaks happened. We take this obligation very seriously. That’s, in part, why we are intervening early. And it’s why we’ll be communicating regularly with the public to provide information and updates on all of the outbreaks we work on.
I remain committed to strengthening our work on outbreak investigations -- and to applying the FDA's food safety expertise to protect American families and keep them safe both now and in the future. We’ll provide more updates as our investigations continue, especially when we have actionable information for consumers.
The FDA encourages consumers with questions about food safety to Submit An Inquiry [disclaimer icon] to the agency, or to visit www.fda.gov/fcic for additional information.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FSMA Complexities: Have You Made One of Seven Deadly Assumptions?
Source : https://www.foodsafetymagazine.com/enewsletter/fsma-complexities-have-you-made-one-of-seven-deadly-assumptions/
By Rachel Montgomery (Sep 18,2 018)
FSMA Complexities: Have You Made One of Seven Deadly Assumptions?
The U.S. Food and Drug Administration (FDA) has used a modern approach under the Food Safety Modernization Act (FSMA), because after all, FSMA stands for the Food Safety Modernization Act. FDA has provided help to industry in the form of curricula for courses, had their personnel trained in the same training courses as industry, listened to industry’s concerns about deadlines and other specific compliance challenges, and included flexibility. FDA has emphasized they are “educating while they regulate.” But the final FSMA rules have been in place for almost 3 years now, and FDA has said they will not be in the ‘educate while regulating’ mode forever. FDA inspections under FSMA will become more and more commonplace, and enforcement will follow.
Importing and manufacturing companies are still discovering the intricacies and complexities of the rules and exemptions, especially as FDA issues policies and guidance documents, with extended deadlines and enforcement discretion related to the FSMA regulations.
There are seven implementing regulations, “rules,” under FSMA. FDA issued the final rule for “Current Good Manufacturing Practices and Risk-Based Preventive Controls for Human Food” and the rule for animal foods (the PC rules) in September 2015, and the first compliance date was September 2016. FDA issued the Foreign Supplier Verification Programs (FSVP) rule in November 2015, and the first compliance date was May 2017. The other four ‘foundational’ rules under FSMA are the Produce Safety rule, the Sanitary Transportation rule, the Intentional Adulteration rule, and Accredited Third-Party Certification.
The following italicized sentences are examples of only seven of the numerous erroneous assumptions one might hear in discussions with industry and importers about FSMA. Although these seven examples of assumptions may not be ‘deadly,’ they are certainly problematic. Assumptions like those below illustrate why adequate training is essential for your understanding of the rules so that you can ensure compliance for your particular business situation. Test your knowledge as you read each statement and consider why it is not true. Also consider these questions in view of your suppliers: In other words, you will want to ask yourself, “Have all my foreign and domestic suppliers under the FSMA definition (farms or facilities, not brokers), properly evaluated their status and taken appropriate compliance action under FSMA?”
1. Customer assurance and disclosure: “I am assuming that since FDA has indicated ‘enforcement discretion’ for 2 years after the customer assurance provisions compliance dates, a manufacturing facility for human food with less than 500 employees and a manufacturing facility for animal food with more than 500 employees can wait until September 2019 to begin their disclosure of hazards not being controlled.”
No, FDA did realize that supply chains are usually more complex than the typical supplier, processing facility, and customer. In many cases, there are multiple processors and other intermediaries within a typical supply chain. Thus, FDA announced extensions of dates for obtaining customer assurance of control of hazards, under 117.36. However, entities must disclose hazards that are not controlled, and in documents of trade accompanying the food. FDA did not extend the timeline for the disclosure requirement. FDA stated that entities seeking additional detail on its policy regarding its intent not to enforce the regulatory provisions discussed in the August 2016 final rule should consult the January 2018 final guidance “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry.”[1] Keep in mind that together these three provisions—disclosure, obtaining customer assurance, and ensuring that the entity acts consistently with the assurance—are intended to provide assurance that food for further processing will be processed to control the identified hazard before it reaches consumers, and “customer” means a commercial customer, not a consumer.
2. Exemption and LACF: “I assume that I don’t need a food safety plan under the PC rule for the low acid canned food (LACF) that I manufacture because LACFs are exempt from FSMA.”
No, but someone might make that assumption; the exemption can be confusing. The list of exemptions for compliance with preventive controls (subpart C) and supply chain (subpart G) listed in 21 C.F.R. part 117.5 does include activities subject to part 113, when the facility is required to comply with and is in compliance with part 113.
But you must read further: The paragraph goes on to include a statement that the exemption is applicable only with respect to the microbiological hazards under part 113. A Hazard Analysis must be conducted, all other hazards must be considered, and a food safety plan must be developed and documented.
3. Impact of subsidiary and affiliate companies: “My facility is an older manufacturing facility for juice and sports beverages recently purchased by another manufacturer who is expanding my facility to include additional lines. I am preparing my attestation as a qualified facility under the PC rules since my sales of sports beverages, excluding juice, over the last 3 years have averaged just under 1 million dollars and I am assuming I need comply only with Current Good Manufacturing Practices.”
Why is this assumption wrong? If you have a parent, subsidiary, or other affiliated company, the sales of those companies must be included also in determining qualification. Another aspect of the above assumption is that you must consider all human food manufactured, sold, and held. The small manufacturer must add in sales of juice in calculating that facility’s total sales; it would not be a qualified facility even if it were stand-alone without affiliates.
4. Impact of being a co-manufacturer with private label brand owners: “As a co-manufacturer, I am not going to have to take any action under the PC rule since the brand owner specifies which suppliers I must use. Also, the contract with our brand owner does not allow us to obtain information they consider confidential, for example, audits of suppliers. Therefore, I am assuming I can rely completely on the brand owner to conduct the Hazard Analysis, and for hazards requiring a supply chain control, to handle all supplier approval and verification activities, and I need do nothing, even if there is a hazard requiring a supply chain preventive control in an ingredient for which the brand owner specifies the supplier.”
This is another example of an incorrect assumption: Remember that the supply chain provisions in 21 C.F.R. part 117 subpart G, part 507 subpart E, and FSVP include evaluating and approving suppliers and determining and conducting appropriate supplier verification activities. These provisions do allow the flexibility of conducting of activities by an entity other than the supplier, as long as the receiving facility reviews and assesses documentation of that activity. Also, FDA has provided additional flexibility to industry to allow time for contracts to be changed to allow this sharing, with an intent not to take enforcement action until November 6, 2019. See the November 2017 “Supply Chain Program requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry.”[2]
However, there are still a number of actions a co-manufacturer must take. In this above cited guidance, FDA (Center for Veterinary Medicine in the Center for Food Safety and Applied Nutrition) also stated that the co-manufacturer must not only follow “written procedures for receiving raw materials and other ingredients and documenting use of the procedures,” but that the co-manufacturer must conduct a Hazard Analysis of the food, include in its food safety plan a description that the brand owner is considering supplier performance, and conduct any needed activities not conducted by the brand owner such as sampling and testing. The following example is given by FDA of when it does not intend to take enforcement action until November 2019: “…when an audit is determined to be the appropriate supplier verification activity but a co-manufacturer does not independently obtain a supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand owner, the co-manufacturer’s food safety plan states that the brand owner will obtain and review audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification activities (e.g., sampling and testing of the raw material or other ingredient).”
5. Import exemption for some countries: “Since the only foods I import are final products from Canada with no additional processing in the U.S., I am under the assumption I have no actions required.”
Unfortunately, this another incorrect assumption. Canada, as well as New Zealand and Australia, are exempt from FSMA’s FSVP because they are under a Systems Recognition Agreement, and no Hazard Analysis of the food and no supplier evaluation for approval and verification must be conducted. However, there are still certain actions required for certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the U.S. system. These foods are subject to modified requirements under FSVP, namely, before importing, there must be determination and documentation that the foreign supplier is in good compliance standing with the appropriate foreign food safety authority, and, after importing, you must continue to monitor whether the foreign supplier is in good compliance standing with that foreign food safety authority. Further, if should you become aware of any information indicating that the hazards associated with the food you import are not being significantly minimized or prevented, you are required to promptly take corrective action. For all of these actions, you must maintain records.
Remember that you cannot import unless you are identified with your data universal numbering system number as the FSVP importer on the Customs and Border Protection entry filing, FDA will see you as being responsible for all FSVP activities and will visit or otherwise request your FSVP records to review for compliance.
6. Exempt foods and qualified facility determination: “I have imported an average of under $1 million in Asian condiments for seafood for the last 3 years. These condiments supplement my sales of seafood that I also import in large quantities, well over $1 million per year. The seafood is exempt from FSVP, so I am under the assumption that I don’t need to include seafood sales in my attestation as a very small business; I have very limited actions under FSVP since I am a very small business.”
This assumption is for imported food under FSVP but is similar to assumption #3 above, which is related to the PC rule. All human food, even exempt food like that under Seafood HACCP, must be considered in the calculation of value of imported human food. The importer making the assumption above will fall under full FSVP unless there is another reason it would qualify for modified requirements, such as if importing from certain small suppliers.
7. Food contact substances and requirements: “Even though food contact substances meet the FDA definition of food, as a manufacturing facility, I don’t need a supply chain applied control for food contact substances under the PC rule. But as an importer under the FSVP rule, FDA extended my compliance date for food contact substances by 2 years compared to other foods.
Why is this a wrong assumption? This is an example of an assumption that can actually make you work harder than you need to. Here the assumption is wrong. Initially there was a 2-year extension, but actually there is even better news: Take a look at the policy issued January 2018. FDA has indicated they “intend to exercise enforcement discretion for food contact substances in regard to the FSVP requirements.”
There are many other examples of misinterpretation. For example, assumptions can be made about the applicability of the modified requirements under part 117.206 related to a facility solely engaged in the storage of unexposed packaged food. FDA has issued guidance on the “solely engaged” requirements related to Current Good Manufacturing Practices and preventive controls under parts 117 and 507. Essentially all activities must be exempt for the establishment to be exempt, and there are requirements that apply in certain situations, for example, time/temperature control. Consult the guidance for more information.
Confusion can also exist between rules, for example, on what is exempt. Dietary supplements are exempt from the PC rules, so an assumption might be that “I don’t need to worry about FSVP since I import only dietary supplements and they are exempt from the PC rules.” Dietary supplements, however, are within the scope of applicability of the FSVP rule.
As you can see, the FSMA rules are quite complex. You may want to reconsider your actions needed, including checking with your suppliers to ensure they are not making erroneous assumptions, since FDA is already checking the compliance of FSVP importers and domestic and foreign manufacturers and processors to FSMA.
Rachel Montgomery is a Food Safety Preventive Controls Alliance Lead Instructor (Human Foods Certificate # 32c592bd, Animal Foods Certificate # 1bd2c691, Foreign Supplier Certification Programs, FSVP, Certificate # f3830814), with over 30 years of experience as a food safety executive in large-scale manufacturing in the fermentation industry. She is the principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists). She can be contacted at RMontgomerySCS@gmail.com or www.FSMAComplianceTraining.com for more information.

References
1. www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm590646.htm.
2. www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM583490.pdf.

Where Do We Stand on the Bioengineered Food Disclosure Standard?
Source : https://www.foodsafetymagazine.com/enewsletter/where-do-we-stand-on-the-bioengineered-food-disclosure-standard/
By August Horvath, Esq. (Sep 18, 2018)
Where Do We Stand on the Bioengineered Food Disclosure Standard?
It was an interesting summer for followers of the regulation of genetically modified organisms (GMOs), genetic engineering, bioengineering, or whatever we want to call it, in food labeling. In May, the U.S. Department of Agriculture (USDA)’s Agricultural Marketing Service put out a proposed rule for the labeling of bioengineered foods as directed by the Federal Bioengineered Food Disclosure Standards Act of 2016, amending the Agricultural Marketing Act, and accepted public comments until July 3. Where are we now with respect to the proposed new National Bioengineered Food Disclosure Standard?
Issues Raised in the Public Comments
USDA received 14,016 comments by everyone from major food trade associations to foreign governments to individual consumers. The following were the issues raised in the proposed rulemaking that were most frequently cited by commenters:
Use of “Bioengineered” Instead of “GMO”
The proposed rule adopted “bioengineered” rather than “genetically modified” or “genetically engineered” as a descriptor for the food or ingredients to be disclosed. Some comments discussed whether this descriptor is technically broader or narrower than “GMO,” but the overwhelming concern among commenters was that the term “bioengineered” may be meaningless to consumers. Some organic food interest groups even submitted the results of consumer perception surveys indicating that “bioengineered” is far less recognized, and far less often searched on internet search engines, than “genetically modified,” “GMO,” or “genetically engineered.” The abbreviation of “BE” proffered by USDA for use on symbol-based disclosures was even less understood and recognized, although not much less than the abbreviation “GE” for genetically engineered.
Proposed Disclosure Alternatives
A related issue, aside from the adoption of “bioengineered,” was the forms of disclosure permitted by the proposed rule. Two aspects of the disclosure came in for special criticism. One was the set of possible symbols suggested by USDA as a possible alternative to a straightforward text disclosure. Most of these symbols incorporated the abbreviation BE without explanation, and contained graphic elements suggestive of green fields, leaves, the sun, and even “smiley faces.” Many commentators opined that the symbols were not only difficult to interpret, but communicated a positive bias in favor of whatever is being disclosed. The other issue was the option not to disclose directly the presence of bioengineered food, but to provide a web link, scannable QR code, or other such device, and inviting consumers, allegedly cryptically, to follow these links to the internet for more information on the food ingredients. Commenters were concerned that neither of these measures would provide clear and immediate information to consumers about the presence of bioengineered ingredients, and that they would discriminate against rural, elderly, and low-income consumers in terms of their likelihood of having a smart phone and wireless coverage to be able to access the internet at the point of sale.
Whether Refined Products Require Disclosure
The proposed regulations proposed, as an open question, whether highly refined foods such as oils or sugars, which may be extracted from bioengineered foods but which, once extracted, contain no genetic material, need to be disclosed in some form. On this point there was sharp disagreement. Some food companies and trade associations, especially producers of such refined products, opposed disclosure on the basis that these products do not contain, in the terms of the statute, bioengineered material. Individual consumers and public interest groups, and several mainstream food companies, strongly supported some form of disclosure, contending that consumers wish to know whether genetically engineered material was involved in any away in the origin of the food, even if it is no longer present.
Definitions of Bioengineered Food
Some commenters were dissatisfied with the proposed rule’s definition of its subject matter, insisting that various new modification techniques be included and that the definition of bioengineered food be flexible enough to encompass any future form of genome manipulation.
Small Company Exemption
The proposed USDA rule suggested an exemption from disclosure for small companies on grounds of burden and put forth various candidate company sizes. Not surprisingly, commenters lined up on both sides of this question based on the nature of the constituents they represented.
“No GMO” or “No BE” Labeling
USDA’s proposed rule is solely concerned with affirmative disclosure of the presence of bioengineered foods. It contains no provision or requirement for a labeling or marketing claim that a food has no genetically engineered content. Several comments, however, addressed this issue. Especially vocal was the organic food industry, which seems to be united in the view that 1) foods that comply with the national organic certifications standard should be allowed be marketed as “no BE” without further review and 2) other foods, even if not required to disclose bioengineered ingredients, should not necessarily be allowed to claim “no BE.” Other food companies commented that while certified organic foods may be able to make the “no BE” claim, other foods satisfying some yet-to-be-determined criteria should be able to do the same, even if they do not satisfy all requirements to be organic.
What Is Next for USDA?
The Bioengineered Foods Disclosure Standards Act set an ambitious deadline of July 29, 2018, for USDA to issue its final rule. Advocacy groups have already sued the USDA for missing this deadline, hoping to force quick action.
USDA must now be reviewing the comments and taking possible revisions to its proposed rule, and choices among some of the alternatives presented, as it formulates its final rule. It may again offer its final rule for renewed public comment after it considers comments to the key issues described above, and others. USDA is likely reconsidering the use of symbols and wording that use the terms “genetically engineered” or “GMO,” at least as an optional means of disclosure. Other issues, such as the question of whether disclosure should be required for refined products containing no DNA, but derived from genetically engineered sources, clearly have created a major split among industry players and experts, and USDA will be hard pressed to resolve these to everyone’s satisfaction.
August Horvath, Esq., partner at Foley Hoag, is an expert in advertising and marketing law related to the food and beverage industry.

Food Fraud: How Chemical Fingerprinting Adds Science to the Supply Chain
Source : https://foodsafetytech.com/feature_article/food-fraud-how-chemical-fingerprinting-adds-science-to-the-supply-chain/
By Sam Lind, Ph.D. (Sep 17, 2018)
You would be forgiven for thinking that food fraud is a sporadic issue but, with an estimated annual industry cost of $50 billion dollars, it is one currently plaguing the food and drink sector. In the UK alone, the food and drink industry could be losing up to £12 billion annually to fraud.
As the scale of food fraud becomes more and more apparent, a heightened sensitivity and awareness of the problem is leading to an increasing number of cases being uncovered.
Recently: Nine people contracted dangerous Vibrio infections in Maryland due to mislabeled crabmeat from Venezuela; food fraud raids have been conducted in Spain over fears of expired jamon re-entering the market; and authorities seize 1 ton of adulterated tea dust in India.
Spurred by the complexity of today’s global supply chains, food fraud continues to flourish; attractive commercial incentives, ineffective regulation and comparatively small penal repercussions all positively skew the risk-reward ratio in favor of those looking to make an extra dollar or two.
The 2013 horsemeat scandal in Europe was one such example, garnering significant media attention and public scrutiny. And, with consumers growing more astute, there is now more onus on brands to verify the origin of their products and ensure the integrity of their supply chains.
Forensic science is a key tool in this quest for certainty, with tests on the product itself proving the only truly reliable way of confirming its origin and rooting out malpractice.
Current traceability measures—additives, packaging, certification, user input—can fall short of this: Trace elements and isotopes are naturally occurring within the product and offer a reliable alternative.
Chemical Fingerprinting for Food Provenance
Like measuring the attributes of ridgelines on the skin of our fingertips as a unique personal identifier, chemical fingerprinting relies on differences in the geochemistry of the environment to determine the geographic origin of a product—most commonly measured in light-stable isotopes (carbon, nitrogen, sulphur, oxygen, hydrogen) and trace elements.
Which parameters to use (either isotopes, TEs or both) depends very much on the product and the resolution of provenance required (i.e. country, farm, factory): Isotope values vary more so across larger geographies (i.e., between continents), compared to smaller scales with TEs, and are less susceptible to change from processing further down the supply chain (i.e., minced beef).
The degree of uptake of both TEs and light isotopes in a particular produce depends on the environment, but to differing extents:
TEs are related to the underlying geochemistry of the local soil and water sources. The exact biological update of particular elements differs between agricultural commodities; some are present with a lot of elements that are quantifiable (“data rich” products) while others do not. We measure the presence and ratio of these elements with Inductively Coupled Plasma—Mass Spectrometry (ICP-MS) instrumentation.
Light Isotopes are measured as an abundance ratio between two different isotopes of the same element—again, impacted by environmental conditions.
Carbon (C) and nitrogen (N) elements are generally related to the inputs to a given product. For example, grass-fed versus grain-fed beef will have a differing C ratio based on the sugar input from either grass or grain, whereas conventionally farmed horticulture products will have an N ratio related to the synthetic fertilisers used compared to organically grown produce.
Oxygen (O) and hydrogen (H) are strongly tied to climatic conditions and follow patterns relating to prevailing weather systems and latitude. For ocean evaporation to form clouds, the O/H isotopes in water are partitioned so that droplets are “lighter” than the parent water source (the ocean). As this partitioning occurs, some droplets are invariably “lighter” than others. Then, when rainfall occurs, the “heavier” water will condense and fall to the ground first and so, as a weather front moves across a landmass, the rainfall coming from it will be progressively “lighter”. The O/H ratio is then reflected in rainfall-grown horticultural products and tap water, etc. Irrigated crops (particularly those fed from irrigation storage ponds) display different results due to the evaporation, which may occur over a water storage period.
Sulphur (S) has several sources (including anthropogenic) but is often related to distance from the sea (“the sea spray effect”).
Analysis of light isotopes is undertaken with specialist equipment (Isotope Ratio Mass Spectrometry, IRMS), with a variety of methods, depending on product and fraction of complex mixtures.
Regardless of the chemical parameter used, a fingerprinting test-and-audit approach requires a suitable reference database and a set of decision limits in order to determine the provenance of a product. The generation of sample libraries large enough to reference against is generally considered too cost prohibitive and so climatic models have been developed to establish a correlation between observed weather and predicted O/H values. However, this approach has two major limitations:
1.The chemical parameters related to climate are restricted (to O and H) limiting resolving power
2.Any model correlation brings error into further testing, as there is almost never 100% correlation between measured and observed values.
 As such, there is often still a heavy reliance on building suitable physical libraries to create a database that is statistically robust and comprehensive in available data.
To be able to read this data and establish decision limits that relate to origin (i.e., is this sample a pass or fail?), the parameters that are most heavily linked to origin need to be interpreted, using the statistics that provide the highest level of certainty.
One set of QC/diagnostic algorithms that use a number of statistical models have been developed to check and evaluate data. A tested sample will have its chemical fingerprint checked against the specific origin it is claimed to be (e.g, a country, region or farm), with a result provided as either “consistent” or “inconsistent” with this claim.
Auditing with Chemical Fingerprints
Chemical fingerprinting methods do not replace traditional traceability systems, which track a product’s journey throughout the supply chain: They are used alongside them to confirm the authenticity of products and ensure the product has not been adulterated, substituted or blended during that journey.
A product can be taken at any point in the supply chain or in-market and compared, using chemical fingerprinting, to the reference database. This enables brands to check the integrity of their supply chain, reducing the risk of counterfeit and fraud, and, in turn, reducing the chance of brand damage and forced product recalls.
Reducing Risk and Adding Value
All businesses and brands in the food supply chain are susceptible to fraud, and evidence shows the likelihood of it occurring increases day by day. It’s the businesses that are proactive in accepting the risk and who take steps to manage it that are the ones who will win.
The purpose of auditing and protecting the integrity of the supply chain is to provide all stakeholders with peace of mind that what they are dealing with is authentic. The impact of having your supply chain compromised is too great to ignore.
With origin fingerprinting, from product creation through to distribution to the end consumer, each supplier can be assured that they are part of a process that aims to keep transparency and consumer interests at the core of the process.
This auditing process can:
•Reduce risk exposure for directors and demonstrate good governance
•Deter fraud within the supply chain
•Mitigate the risk for supply chain partners
•Help exonerate innocent parties in a food fraud event
•Signal to consumers that the supply chain is robust
•Send the message that the brand and its products are worth protecting
Businesses in the agricultural and food services industry have never faced greater pressures than they do today. Rapid technological development, volatile economic landscapes and changes in the earth’s climate that effect—and sometimes destroy—agricultural yields all force the continual evolution of supply chains. As agribusiness continues to globalize, traversing countries and continents across the world, supply chains become more complex.
While globalization brings people together and fuels economic growth, it is also the reason that today’s businesses have never faced greater risk. The pressure to lower prices coincides with the need to protect the value of premium products, with products such as milk, olive oil, honey, fish, coffee and cocoa being the most vulnerable to food fraud. Consumers are concerned with the provenance of their food and demand proof of origin and truth to labelling from the brands they love. When the trust of consumers is broken, brands suffer irreparable blows to their reputation.
Such fraudulence inevitably has much broader implications for brands, tarnishing the reputation of the producers at the source who are responsible for the product, whether or not they are responsible for the adulteration of it.
That is why taking the steps to guarantee the integrity of their products is more important than ever for food services and supply companies, and why adding science to the supply chain is the way forward.

How safe are the foods your children are eating?
Source : https://www.washingtonpost.com/amphtml/national/health-science/how-safe-are-the-foods-your-children-are-eating/2018/09/17/7398985c-9688-11e8-810c-5fa705927d54_story.html?noredirect=on
By Consumer Reports (Sep 17, 2018)
Certain chemicals added to food and used in food packaging have been linked to negative health effects, and children may be most at risk. That’s according to a report from the American Academy of Pediatrics (AAP) published in July in the journal Pediatrics.
“Parents are right to worry about what they feed their kids, especially when it’s prepackaged,” says James E. Rogers, director of food-safety research and testing at Consumer Reports. “But learning more about what to look out for can help you make the right choices when you feed your family.”
The AAP report and an accompanying statement highlighted five chemical groups of concern: bisphenols (such as BPA), which line metal cans and are mixed into plastics; phthalates (which make plastic soft); perfluoroalkyl chemicals (or PFCs, which are found in grease-proof wrappers and packaging); perchlorate (found in food packaging); and nitrates/nitrites (curing agents found in some meats).
A number of studies performed in the past two decades have linked these and other chemicals to a variety of health problems, including developmental and reproductive harms and obesity (bisphenols, phthalates, and PFCs), thyroid hormone disruption (perchlorate, nitrates/nitrites) and cancer (nitrates/nitrites).
Open questions remain, including exactly how harmful some of these chemicals are for children and whether the amount that most are exposed to is risky. What’s clear is that there’s not enough evidence to prove such chemicals are harmless for everyone. And that’s especially true for children, whose developing organ systems may be particularly vulnerable.
“There are lots of chemicals that are put into foods without the evidence base to show that they’re safe,” says the report’s senior author, Sheela Sathyanarayana, an associate professor of pediatrics at the University of Washington. “They may very well be safe, but we don’t know. And that’s the point.”
It's not just food additives
This new report is only the latest in a flurry of recent findings that suggest that the food we feed children sometimes contains additives that may be risky or toxic contaminants that should never be there.
For example, experts (including those from Consumer Reports) have recently questioned the safety of rice and rice-based products for infants and young children, as recent research has found these products can harbor a growing list of heavy metals.
One study published in October 2017 found that among a sampling of 119 popular cereal brands, rice cereals had, on average, three times as much methylmercury, the most concerning type of mercury, as multigrain cereals had; and 19 times as much as in cereals made with grains other than rice. Another study published one month later found infant rice cereals to contain about six times more arsenic than other grain cereals.
“One of the most important things we can do is raise awareness about this issue among the general population,” says Tunde Akinleye, a food-safety expert at Consumer Reports. “Consumers should also continue to demand changes to the way the Food and Drug Administration regulates and oversees the safety of the food we feed ourselves and our children.”
In a statement provided to Consumer Reports, the American Chemical Council, an industry group, said that “all plastics intended for contact with food are reviewed for safety and must meet stringent FDA safety requirements before they can be used in food packaging.”
According to Sathyanarayana, it’s important to remember that your child is not going to be harmed by a one-time exposure to any of these chemicals. “Don’t panic if you’re feeding your kid a hot dog once a week,” says Sathyanarayana, “but you should really be trying not to do that every single day.”
5 ways to minimize exposure
Many of the chemicals that are potentially concerning are practically everywhere (even in dust), so it’s impossible to avoid them completely, says Akinleye.
But there are some easy ways you can lower the risk to yourself and to your kids:
Focus on whole fruits and vege­tables. Buying fruit either whole or frozen — as opposed to canned, packaged or processed — can greatly minimize exposure to BPA (from cans) and phthalates (from packaged or processed food).
Wash hands and produce. Consumer Reports' experts recommend rinsing, rubbing or scrubbing fruit and vegetables to help remove pesticide residue, and washing your hands after handling food products and packaging. Soaking apples in a solution of baking soda and water can remove more pesticides than rinsing in tap water or a bleach solution. Seeking out organic produce can also reduce your exposure to pesticides.
Be cautious with plastic. Some of the most concerning chemicals are mixed into plastic containers, food wraps and packaging. And when they're heated or exposed to hot liquids, the chemicals can leach into your food or drink. The AAP suggests using glass or stainless-steel alternatives to plastic when possible, and avoiding putting plastic containers in the microwave or dishwasher.
The AAP also recommends using the recycling number to identify plastics that carry the highest risk: recycling codes 3, 6 and 7 contain phthalates, styrene and bisphenols, respectively. “Biobased” or “greenware” plastics are fine, because they’re made from corn and not bisphenols.
Avoid processed meats, especially if you're pregnant. Previous studies have linked the consumption of "ultra-processed" foods, such as hot dogs, chicken nuggets, sodas and sweets, to obesity, high blood pressure and high cholesterol. Additionally, many processed meats contain nitrates and nitrites, preservatives that may form cancer-causing compounds called nitrosamines in the body.
Double-check the label. Read the fine print on package labels to ensure you're getting a product that doesn't contain nitrates or nitrites, says Charlotte Vallaeys, Consumer Reports' senior policy analyst and top food labels expert.
Some processed meats labeled “no nitrates or nitrites added” may still contain them from nonsynthetic sources, such as celery juice or powder, says Vallaeys, and these can be just as harmful. Watch out for phrasing that says “except for those occurring naturally in . . . .” That means it’s not completely nitrate- or nitrite-free.

 

 

 

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