In the spring of 2019, FDA began routine Produce Safety Rule (PSR) inspections of larger farms and orchards, with small farm inspections to begin in the spring of 2020. To determine what these food producers should expect when FDA comes knocking on the farmstead door, what the agency is seeing thus far, and how it all impacts the downstream food chain, including food processors and manufacturers, QA asked FDA Commissioner of Food Policy & Response Frank Yiannas about his farm-visit experiences and impressions. Following are his responses:

1. This spring, you began Produce Safety Rule inspections of larger farms and orchards. In general, what are you finding — both positive practices and continuing opportunities?

FDA and our state partners began routine inspections this year at large farms. Routine inspections for sprout operations began prior to that time. FDA has started conducting routine inspections of foreign farms while the vast majority of domestic Produce Safety Rule (PSR) inspections are conducted by our state partners under the State Cooperative Agreement Program (CAPs). Some routine state and FDA inspections are only just beginning because the produce harvest season for those farms only just started. While it’s too soon to provide trends because of the limited pool of inspectional data that FDA and state partners have collected so far, we’re off to a good start doing work that has never been done before.

2. FDA has said its initial goal in PSR inspections is to be educational and collaborative, while still ensuring compliance and food safety. What does this mean?

At FDA, we’re committed to prevention. Our inspection teams are trained to help farmers understand the PSR requirements and provide them with reference materials to facilitate that understanding. The collaborative mindset also means that our inspection teams will engage with the farmers to understand the farm operations and will evaluate the overall food safety impacts of the farm practices, taking a big-picture approach that considers how different parts of the operation intersect and impact each other. While collaboration and education are important, when we see a condition or practice that could introduce hazards into produce, we will take appropriate action to help ensure the condition or practice is addressed.

We delayed the start of routine large-farm inspections until this spring in part because more time was needed to help ensure that produce farmers have the training and information they needed to comply with the Produce Safety Rule. During that time, we worked to help provide access to training; we published a draft guidance; and we collaborated with the National Association of State Departments of Agriculture on the development of On-Farm Readiness Reviews. These voluntary reviews help farmers assess how ready they are to comply with the rule.

Just as with the first round of routine inspections for other rules established by the FDA Food Safety Modernization Act, such as the Preventive Controls for Human Food, the Preventive Controls for Animal Food, and the Foreign Supplier Verification Program, we understand that this may be new territory for food producers. That is why we continue to focus on education and technical assistance during these initial inspections.

3. You have noted that treatment of surface water used for irrigation is catching on. Can you discuss what you’ve seen?

On a recent trip to California, we had an opportunity to observe treatment of agricultural water used for overhead sprinkler irrigation of leafy greens to meet a new requirement of the California Leafy Greens Marketing Agreement (LGMA). On this visit to an organic farm we watched agricultural water being treated in accordance with LGMA requirements for overhead sprinkler irrigation for leafy greens seed germination. We also observed the irrigation crews carefully verifying treatment parameters at the terminus of the irrigation system, to help ensure that the treatment is delivered in an effective manner throughout the overhead sprinkler irrigation system. In addition, we saw similar water treatment equipment on other fields and farms.

4. Following those observations, you stated, “If more firms take measures like this, we will make surface water even safer.” Please explain.

Observing firsthand how growers are using a risk-based approach to evaluate, monitor, and control for contamination in agricultural water to prevent contamination of their fruit and vegetable crops is a game-changer. We have observed a variety of different approaches on farms, and FDA has long said that growers have a range of viable options to consider when addressing agricultural water safety issues, based on the practices and conditions specific to their farms. In some circumstances other options, such as changing the timing or manner of water application, may be more feasible than the option to treat water.

Whatever option they choose, farmers are increasingly taking proactive measures like these to help further strengthen food safety culture on their farms, which is ultimately a win for consumers.

5. How are your on-farm and industry group visits being used in FDA’s continuing look at the microbial water quality and testing standards of the rule? Any updates on this?

During the period of the agricultural water compliance date extension for covered produce other than sprouts, FDA has been pursuing a rigorous stakeholder engagement plan. One aspect of that plan has been more than 200 educational farm visits since 2017, which have helped to further refine our understanding of the myriad of variations in agricultural water sources and uses. The farm tours have included representatives from government agencies, academia, and the produce industry, along with farmers whose farms are covered by the PSR. We also have engaged with technical experts from both the public and private sectors on matters such as water microbiology and water systems. These experiences help to inform our work on the produce rule’s agricultural water provisions as we diligently pursue solutions to further reduce the regulatory burden or increase flexibility while continuing to protect public health.

6. How does all this impact food processors and manufacturers; i.e., what should be required of their produce suppliers, and what will FDA be looking for in produce supplies when inspecting these facilities?

Under the FSMA preventive controls and foreign supplier verification rules, processors and importers have the responsibility to assess their supply chain, unless a future step in the manufacturing process will apply necessary controls. When evaluating processors and importers, FDA will review the supply chain controls to determine that the processors and importers are meeting their requirements and have the necessary programs in place. Since produce is often processed without a cook step, having supply chain or importer controls in place is very important to ensure the safety of processed or imported produce.

7. What else is important for the food industry to understand in this area?

It’s important for the food industry to understand that FDA is committed to the partnership that has grown and evolved since FSMA was first signed into law. FDA leaders have visited farms and facilities all over the country, and we have all been impressed with the dedication we’ve seen among farmers to the nation’s rich tradition of farming and to the health and well-being of the customers who trust them to provide safe foods.

In the speeches I’ve given since joining FDA, I always close with this thought: “I’ve learned from working with FDA from the other side of the fence that there’s a lot industry can do to advance food safety. And there’s a lot government can do to advance food safety. But what is crystal clear to me, having now been on both sides of that fence with some influential organizations, is that there’s so much more we can do together.

“Whether you’re in the private or public sector, whether you’re at the state or Federal level, we’re all working for the same boss — consumers — so let’s work together to keep their food safe. They’re counting on us to do so.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.

A new synthetic material that creates a linked sensory network similar to a biological nervous system would enable robots to sense how they interact with their environment and adjust their actions accordingly. Robots fitted with the material, developed by Cornell University Ph.D. student Patricia Xu through the Organic Robotics Lab, would be well suited for manufacturing and the health care industry.

“We want to have a way to measure stresses and strains for highly deformable objects, and we want to do it using the hardware itself, not vision,” said lab director Rob Shepherd, associate professor of mechanical and aerospace engineering and the senior author of the lab’s paper, “Optical Lace for Synthetic Afferent Neural Networks,” (Science Robotics, September 11, 2019). “A good way to think about it is from a biological perspective. A person can still feel their environment with their eyes closed, because they have sensors in their fingers that deform when their finger deforms. Robots can’t do that right now.”

Shepherd’s lab previously created sensory foams that used optical fibers to detect such deformations. For the optical lace project, Xu used a flexible, porous lattice structure manufactured from 3D-printed polyurethane; she threaded its core with stretchable optical fibers containing more than a dozen mechanosensors, then attached an LED light to illuminate the fiber.

When she pressed the lattice structure at various points, the sensors were able to pinpoint changes in the photon flow. “When the structure deforms, you have contact between the input line and the output lines, and the light jumps into these output loops in the structure, so you can tell where the contact is happening,” Xu said. “The intensity of this determines the intensity of the deformation itself.”

The optical lace, which also is washable, would not be used as a skin coating for robots, Shepherd said, it would be more like the flesh itself. A robot would need to know its own shape in order to touch and hold and assist in manufacturing without damaging parts or product. “If they can feel what they’re touching, then that will improve their accuracy,” Shepherd said.

While the optical lace does not have as much sensitivity as, say, a human fingertip that is jam-packed with nerve receptors, the material is more sensitive to touch than is the human back.

The researchers also plan to explore the potential of incorporating machine learning to detect more complex deformations, like bending and twisting. “I make models to calculate where the structure is being touched, and how much is being touched,” Xu said. “But in the future, when you have 30 times more sensors and they’re spread randomly throughout, that will be a lot harder to do. Machine learning will do it much faster.”

Even as robots become more aware of how they interact with the environment, humans still have a distinct advantage. “We don’t know our own bodies as well as some robots know parts of their limbs and joints and fingers,” Shepherd said. “But we can still perform better than robots generally because we can deal with uncertainty through mechanical design, as well as neural architecture.”

The paper was co-authored by postdoctoral researcher Anand Kumar Mishra; students Lillia Bai and Cameron Aubin; and Letizia Zullo from the Center for Synaptic Neuroscience and Technology, Istituto Italiano di Tecnologia. The research was supported by grants from the Air Force Office of Scientific Research and the National Institutes of Health.

Source: Cornell University

Chocolate Clouds THC Testing

Chocolate components may interfere with cannabis potency testing, causing inaccurate results.

Manufacturers add cannabis to a wide variety of foods, and the composition of these products, (the matrix) can affect potency testing results. In an investigation focused on potency testing for cannabis-infused chocolates, David Dawson, the project’s principal investigator, and his colleagues at CW Analytical Laboratories noticed some “weird potency variations” depending on how the chocolate samples were prepared for testing.

So the team decided to study the effects of altering sample prep conditions, such as the amounts of chocolate and solvent, pH, and type of chocolate, on the concentration of ?9-tetrahydrocannabinol (?9-THC), the major psychoactive constituent of cannabis, measured by high-performance liquid chromatography (HPLC).

“When we had less cannabis-infused chocolate in the sample vial, say one gram, we got higher THC potencies and more precise values than when we had two grams of the same infused chocolate in the vial,” Dawson said.

Not only does this go against what he would consider to be basic statistical representation of samples, where one would assume that the more sample you have, the more representative it is of the whole, but, he said, “Simply changing how much sample is in the vial could determine whether a sample passes or fails, which could have a huge impact on the producer of the chocolate bars, as well as the customer who might be under- or overdosing because of this weird quirk of matrix effects.”

It also has critical regulatory implications. “If an edible cannabis product tests 10% below the amount on the label, California law states that is must be relabeled, with considerable time and expense,” Dawson said. “But it’s even worse if a product tests 10% or more above the labeled amount — then the entire batch must be destroyed.”

The results suggested that some other component of the chocolate — a matrix effect — was suppressing the signal for ?9-THC. So Dawson is trying to figure out which ingredient of chocolate is responsible for the matrix effects. He has tried spiking a standard solution of ?9-THC with varying amounts of chocolate bar, cocoa powder, baker’s chocolate, and white chocolate, all of which have different components, and observing how the HPLC signal changes. “Our best lead right now is that it has something to do with the fats, which makes sense considering that ?9-THC is fat-soluble,” Dawson says.

The team would like to extend their analyses to other cannabinoids, such as CBD, and they plan to investigate other food matrices, such as chocolate chip cookies. Dawson said he hopes the research will contribute toward developing standard methods for cannabis potency testing in a variety of edibles.

The research was presented at the American Chemical Society (ACS) Fall 2019 National Meeting & Exposition.

Source: American Chemical Society (ACS)

From Plastic to 3D Ink

A Russian University student develops a way to turn plastic waste into 3D ink.

Gokma Sahat Tua, a bachelor’s student at Tomsk State University (TSU) in Siberia, Russia, has developed a way to recycle plastic waste into ink for 3D printing. The student from Indonesia developed his project as part of the curriculum of TSU and the University of Maastricht in The Netherlands.

The TSU Tomsk International Science Program (TISP) is an international bachelor’s degree program in the natural sciences, physics, and mathematics areas presented in English, developed jointly with the University of Maastricht. The program is problem-practice oriented, that is, it involves students in solving real problems. One of these was undertaken by Tua.

“We have developed an extruder for recycling plastic waste into 3D printing ink,” Tua explained. “The machine is assembled in parts, which can be ordered online. The total cost will not exceed 10,000 rubles ($155 U.S.). That is, this is very cheap equipment that a group of students can afford.”

The extruder utilizes raw plastic material that is not accepted even for standard processing. “If you don’t go into technical specifications, the extruder transforms polyethylene and other types of plastic into 3D printing materials,” he said. “You load the resulting thread into a printer and can print anything — watches, chairs, or any designer items and models.”

Currently, the project team has developed a website with information on waste recycling, its standards, and the possibilities for the second life of plastic. A mobile application also is planned. “From an environmental point of view, plastic is a dangerous, toxic, and useless material with a specific odor,” Tua said. “But for design, it is a supermaterial that can be used everywhere and saves money.”

It was early fall of 1999 and my husband, Paul, and I were eagerly anticipating the birth of our twins. Despite some low-iron issues that had put me on bed rest, it should have been a fairly easy, typical delivery. But, without warning, the birth of Luke and Chloe became everything but that when the twins were born with Apgar scores so low, no one knew if they would live.

Apgar scores measure a newborn’s breathing effort, heart rate, muscle tone, reflexes, and skin color; 10 is best. With Luke scoring a 1 — with a slight temperature being the only sign of life — and Chloe, a little better at 4 but having a high level of infection, the two were immediately rushed to the neonatal intensive care unit (NICU). Suffering with a temperature that dropped so low my organs were shutting down, I, too, was taken to ICU where I was alert and aware that my children were dying, but was unable to see them for the first days of their lives. It was at this point, my husband later said, “I realized everybody in my family was extremely sick.” So sick, in fact, that we asked a priest to give Luke last rites.

Because none of us presented with normal foodborne-illness symptoms, numerous tests were run and medications attempted. So many that Chloe’s feet were bruised from all the injections and Luke underwent central line heart surgery to receive medications straight to his heart — as they could no longer find veins in which to inject medications.

At one point, while I was still in ICU, my husband brought me a photo of Luke, in which his tiny arm was raised above his head, “See, he’s waving hi to us!” Paul said. It was a comforting thought, until we learned that it was because he was having a seizure.

Not being able to be with my babies when they were so ill — with silent cries and voices hoarse from intubation, projectile vomiting, diarrhea, trying to keep medications down when everything wanted to come up — was pure hell. When I did finally get to see them, Luke had two IV needles coming out of his forehead.

It wasn’t until one of the nurses who had seen victims of a previous outbreak suspected Listeria poisoning. When the tests came back positive, Chloe and I were put on antibiotics, but Luke, who had ingested the Listeria-infected meconium while in the womb, faced more complications and had to be intubated.

It didn’t help my frame of mind to know that it was a meat product that I had eaten the month before that caused such suffering for us all. Having been put on bed rest due to low iron counts, the meat product my sister brought me was supposed to have been a help. But it became the vector that nearly cost my husband his entire family.

Altogether, I spent three days in ICU and five more in the maternity ward; Chloe spent 10 days in NICU; and Luke was in NICU for three weeks. It took several months — of diarrhea, severe acid reflux, and projectile vomiting for the twins; diarrhea, inability to breastfeed and excessive weight loss for me; and a slow, precarious process of weaning Luke off the phenobarbital that had helped mitigate his seizures — before we could even begin to say we were on the road to health.

Today, we are extremely careful with everything we eat. We heat supposedly ready-to-eat meat (which was the initial cause of the infection); we cook all meat to well done; we receive email alerts on food recalls; we go above and beyond to keep everything clean and sanitized.

We wonder why it still happens two decades later; we wonder if we will ever forget. But, most of all, we wonder how — but are so thankful that — we all three survived when the Listeria strain that affected us kills 30% of those stricken with it. We continue to advocate for food safety and tell our story wherever we can — asking that you, who process and prepare consumers’ food, think about the people in your family and others you love, and how food contaminated with Listeria could affect them. Then do everything you can to prevent it.

In one way or another, nearly my entire career has been focused on keeping food safe – whether writing about insect and rodent control; Salmonella, Listeria, and E. coli; the Big 8 allergens; or other potential and actual food contaminants and adulterants. Having majored in Journalism in college with minors in European History and German, food safety was not something I ever expected to write about beyond the random food-related local or news story — or even really thought much about.

Then I happened into a communications position in the commercial pest control industry, where pest contamination was a key focus. This led to a few articles in QA’s sister publication, Pest Control Technology (PCT), which then led to question from the publisher, “You have experience with the food processing industry, right? We’ve started a new magazine ... Could you write an article about biofilm?”

And thus, my career with QA was born. It is a career that has evolved through the years to become not just a job, but a calling; a passion; a way to contribute to consumer safety in ways I never considered when deciding my life path was writing.

As you likely can relate, however, it is a contribution that is rarely recognized because consumers do not see food safety as having any add-on value; rather it is, as it should be, an expectation. That is, it is an expectation for those whom food contamination has not personally impacted. For those who have faced life-altering foodborne illness, it is no longer an expectation. For them, food contamination is a daily dread, a heavy burden, a literal food fight.

Thus, it is the unspoken, even unaware, gratitude by those who have been affected in the past — and those who, thankfully, have not — that gives our food safety contributions purpose. And it is precisely that generally unspoken praise that caused a recent acknowledgment of our value to strike my heart (and tear ducts).

“Thanks for writing about food safety and how lives are impacted,” wrote the author of this issue’s My Story (page 10). “Stop Foodborne Illness has been a wonderful organization for my family, and I’m glad you found us through them.”

My response: “Thank you so much for sharing your story with QA. My hope is that by sharing these stories with food industry workers, we strike their emotions and increase their understanding of the real-world reasons of ‘Why’ everything they do in their daily jobs working with food impacts real people.”

That is exactly why we are partnering with Stop (https://stopfoodborneillness.org) to run a personal impact story in every issue of QA. And in each story, you will re-read the words of Stop CEO Mitzi Baum, “Behind every foodborne illness outbreak are people who suffer horrible consequences due to food contamination. Everyone is susceptible to foodborne illness, everyone. “It is up to all of us to handle food safely to save lives.”

Is your team handling food safely to save lives?