Tag Archives: The FDA

New Zealand salmon company enters US retail market 2020-07-29 | Instant News


NEW YORK – New Zealand Salmon Co. introduced the retail line of products under the Regal Wood Roasted King Salmon brand for sale in the United States. The firewood filet is available in four flavors, including New Zealand beech, double manuka, pepper and spices, and sweet chili and lime.

The channel is currently available on Amazon and certain retailers in the Northeast. Salmon comes in a 3.5 ounce package, is sold in a supermarket fridge and has a suggested retail price of $ 9.99.

The Regal Wood Roasted King Salmon brand was launched in New Zealand in 2012. US expansion is a natural step, said Michael Fabbro, vice president of North America.

“With almost all Americans cooking at home now, our Salmon Roasted Wood produces extraordinary taste and quality with little effort,” he said

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A New Era of Smarter Food Safety | Instant News


When Frank Yiannas was tapped to become Deputy Commissioner for Food Policy and Response at the FDA, it was clear that innovation and new technology would be a core aspect of his vision for the agency’s approach to food safety. Yiannas is known for her book, Food Safety Culture, Creating Behavior Based Food Safety Management Systems, and the use of blockchain technology while VP for Food Safety at Walmart

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So when, earlier this week, he launched the Food and Drug Administration blueprint for “A New Era of Smarter Food Security” it is taken into account in how the food industry, regulators and technology companies can work collaboratively to implement technology-supported food systems with strong human components.

Speaking at the Institute of Food Technologists’ Virtual event SHIFT20 the day after the blueprint was released, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas stressed, “We are in the midst of a food revolution. Many believe there will be more changes in the food system over the next ten years than in the last twenty or thirty years. I believe it. I have seen it. ”

A New Era of Smarter Food Safety marks a new approach to addressing the challenges and ongoing opportunities to improve our food system. “To succeed in this modern era, we believe we need more modern approaches to food security,” Yiannas said.


“Put simply, smarter food security is people-led, based on FSMA and made possible by technology,” Yiannas said.


The blueprint is structured in four core elements, the basic pillars for the FDA approach to combating foodborne diseases: Technology Traceability, Smarter Tools and Approaches for Epidemic Prevention and Management, New Business Models and Retail Modernization, and Food Safety Culture. As Yiannas explained, “What must we do differently to win the fight against foodborne diseases and ensure that consumers have access to a safer and more trusted food system? Data science and technology will be the key to that answer. ”

Food System Digitalization

Food traceability, the ability to systematically track and track food ingredients and products throughout the course of their supply chain, is the primary means of being able to respond to foodborne disease outbreaks. After laboratory and epidemiological methods find pathogens and vehicles (ie which food products), traceback and traceforward investigations find out where the product originates and where it is distributed, respectively. Yiannas explained this digitalization path, “If you capture food safety information on paper, [you] start the journey to digitize it. Because food safety data on a piece of paper is a dead end. But food safety data in digital form is the beginning of meaningful prevention. ”

Previous regulatory policies do require tracking records, but do not have to be digitized, which prevents epidemiologists and traceback specialists from investigating outbreaks where every hour is counted to prevent consumption of contaminated products.

In addition, technology-supported food supply chain systems will allow a number of analytical tools and methods to be used in areas where the food industry previously had only limited insight. Yiannas stated, “Data systems that are data driven, digital, and traceable are important because when there is fear of food, our inability to track and track food to the source has caused problems. This has involved the livelihoods of farmers who were not involved in the outbreak. And that of course has prevented us from getting resources quickly, determining the root causes and lessons that can be learned to inform prevention in the future. ”

Smart Era as Policy

In a time when new regulations and guidelines from the federal government were sparse, the Smart Era blueprint matched the law stipulated in the 2011 Food Safety Modernization Act, a law that was enacted with the intention of using modern technology and science to transfer our food. the administration of safety from a reactive mindset to prevention. “People, scientists, people like you and me, must be the ones who lead this task about how we can increasingly bend the foodborne illness curve. For us, it will continue to be FSMA-based …. an extraordinary regulatory framework will remain the foundation on which we build our work. “Yiannas said.

Where to start?

Considering the breadth and scope of the Smarter Era, where would the FDA put its first brick from the blueprint? In his speech, Yiannas clearly said that “For next year we will focus on food traceability and the broader goal is transparency.” With the recent major outbreak among romaine lettuce over the past 2 years highlighting the challenges in traceback, and Yiannas’s experience with blockchain and other digital search systems, this is only logical. In addition, a more transparent supply chain will increase industry accountability and trigger other blueprint elements. The human dimension to food security is not forgotten, however, with Yiannas stating, “Often, we think of this new era approach, we are so fixated on technology that we forget that it must be high-tech and high-touch. . And there are changes that we must make in terms of increasing our workforce, changing processes, and changing soft skills. ”

US Food and Drug AdministrationA New Era of Smarter Food Safety

Both food safety, technology and soft skills must grow to meet a smarter era of food security. As Yiannas said, “Think about both – think of high technology and think of high touch.”

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The Future of Maine Food Sovereignty Movement | Instant News


The increasing popularity of municipal regulations on food production in Maine can attract federal preemption challenges.

For nearly a decade, in response to the growing food sovereignty movement by small-scale farmers, Maine has done so experimenting in a radical self-government over food production. During this time state efforts had clashed with the federal food safety regulatory regime that was overseen by US Department of Agriculture (USDA) and US Food and Drug Administration (FDA). Despite the movement for food sovereignty growth and success, the potential for federal preemption that always exists threatens its long-term survival.

The Maine food sovereignty movement secured its first major policy victory in 2011, when, in response to grassroots pressure on the state to protect its small-scale farmers, the Legislature of Maine passed joint resolution “to oppose any federal law, law or regulation that seeks to threaten our human rights to save seeds and grow, process, consume and exchange food and agricultural products” within the state. Joint resolution is not a law but more than that express “Special recognition or opinion” —in this case, vocal differences of opinion with the federal government.

That same year, the municipality began to adopt food sovereignty regulations (FSO). FSO model stated that his authority derives from “inherent, irrevocable, and fundamental rights of the citizens of the city for self-government,” as well Maine Constitution and house rules Constitution. Some FSO go furthermore, adding that “it is against the law for any law or regulation adopted by the state or federal government to interfere with the rights recognized by this regulation.”

Legal commentators in general is assumed that this procedure will be preceded by state and federal law but will still provide a strong expressive function. Four months later, Maine suing Farmer Brown, a small dairy farmer for selling raw milk without a license, testing legality of the FSO. Maine Supreme Court avoided determine whether the state law precedes the FSO and decides against farmers for other reasons.

Despite a joint resolution, without state authorization, the specter of state preemption remains – that is, until 2017 when grassroots pressure makes the governor sign the law. Maine Food Sovereignty Act (MFSA). Action allowed municipalities to adopt FSO which will replace state and federal regulations, are subject to certain conditions which are not heavy.

But the state is not the highest authority in regulating food. Although states adopt their own food regulations in accordance with and in accordance with federal regulations, federal law requires states to ensure that state and local requirements are at least as stringent as federal requirements. Country can, too operate their own meat and poultry inspection program if they meet and enforce “at least the same” requirements imposed by the federal government. Maine is one of 27 states that have USDA make it possible to inspect smaller meat processing facilities.

Because of the federal supervisory regime’s expansive authority over food, the MFSA surprisingly ruffled the USDA’s fur. A few weeks before the country’s laws take effect, the USDA shipped letter to the governor threatening to transfer meat and poultry control from the state to federal inspectors. USDA debate that Maine cannot ensure that its state and local requirements will be as stringent as federal regulations, bearing in mind that Maine, by applying the MFSA, has declared municipal sovereignty over food regulations. If the USDA is followed up with the threat, only the USDA facility will be legal, which is this farmer debate, will prohibit the sale of processed meat at current state-licensed facilities, force state facilities to close, and paralyze many state family farms.

To avoid such results, state legislatures was called in emergency session to change MFSA. The amended version substantially eroded the power of cities by stipulating that the state would continue to request state inspections and licenses in accordance with federal laws for meat and poultry. MFSA now limit local control over products to situations that involve face-to-face interactions at actual food production – agricultural sites, not farmers’ markets.

This year, 73 cities in Maine have adopted FSO, affecting about 187,260 people. Twenty-six of these cities passed such procedures in 2019 alone, and many others is expected follow. The USDA and FDA have so far remained silent, despite legal scholars to debate that the specter of federal preemption still appears in the background.

However, federal silence provides an opportunity for the movement for food sovereignty grow across Maine and even expand to another state – at least for now. The amended MFSA no longer clashes with the USDA authority, and only the FDA had been authority over products entering trade between countries. However, if the movement for food sovereignty continues to grow, it will probably reach the point where intrastate trade is effective Becomes trade between countries. Decree of the US Supreme Court in 1942 in Wickard v. Philburn, followed by a 2005 decision in Jakarta Gonzales v. Raich, both support the FDA’s authority over intrastate activities that substantially affect trade between countries. If enough parents buy their food from farmers covered by the FSO, they can have such an effect.

Consistent federal court decisions was found that interstate trade requirements pose “no obstacles” to FDA regulations regarding even “activities that appear to be fully intrastate.” The question then becomes: at what point will the FDA object to the Maine self-regulation project?

Given the FDA for a long time the opposite for raw milk (one of the main products distributed on local farms under MFSA), the FDA may be more willing to challenge the food sovereignty movement. For example, in response to a failed 2010 lawsuit against the FDA that sought to reverse the state’s ban on raw milk, the government respond that “there is no historical tradition ‘rooted in’ about unlimited access to all types of food.” His argument rejects the right to choose food to be bought and consumed. The FDA is also explicit be warned towards raw milk consumption but noted that it tolerates intrastate distribution.

The Maine food sovereignty movement could eventually become a victim of its own success – if it grows enough to affect interstate commerce and if the FDA decides to challenge it. To date, however, the most obvious threat to food sovereignty is the FDA authority which is widely interpreted and its dislike of raw milk.

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Will an immune passport let people travel again? | Instant News



Remember all the hype about the so-called “passport of immunity” to get the world back on track? The government is still exploring whether certificates, bracelets or mobile applications can make those who have recovered from Covid-19 work and travel again. But the idea that passport holders of immunity will be able to travel to the world, free of masks on planes and tour empty museums and amusement parks without fear of infection, is short-lived. Personal passports might seem basically a good plan, but experts are now sounding their alarms. Body testing is surprisingly inaccurate. Much ado was made when the Emirates airline began testing an antibody prick test on a small group of passengers in March. But when the accuracy rate was found to be around 30%, the Dubai Health Authority, which had carried out the test, banned the test altogether. Think 30% low? It is getting worse. A report by more than 50 scientists found that of the 14 antibody tests on the market, only three gave consistently reliable results (and even all three had problems). The Foundation for Innovative New Diagnostics (FIND), a global non-profit diagnostic organization, estimates that more than 250 antibody tests have been commercialized to date, with more than 30 under development. Nurses in Rome show a fast Covid-19 antibody test kit .TIZIANA FABI / AFPM Following criticism that allowed dubious antibody testing to flood the market, the US Food and Drug Administration announced in early May that antibody test makers had 10 days to provide accurate results or eliminate face of the market. On May 21, the FDA issued about 31 antibody tests from the agency’s official “notification list”, a decision praised by FDA Commissioner Stephen M. Hahn as “an important step taken by the agency to ensure that Americans have access to tests that can trusted. ” Even with a reputable test kit, one might not be enough. The FDA states that a single antibody test may not be accurate enough to know whether members of the general population have Covid-19 antibodies. This recommends a second test – ideally which evaluates antibodies to different viral proteins – to improve the accuracy of the results. If the test becomes more reliable, an immune passport might become a reality. But most likely we have to wait until we have the vaccine. Sharona Hoffman Lecturer in ethics at Case Western Reserve University Not surprisingly, erroneous results can have profound consequences. An article published by Johns Hopkins Bloomberg School of Public Health on April 22 states: “A false negative can prevent a person from returning to work; false positives can cause an epidemic chain.” Noting these inaccuracies, eight contributors to the article concluded that the certificate of immunity “is not a justifiable step at this time.” The presence of antibodies does not mean much. The assumption of testing accuracy increases, passport immunity has another big hurdle to overcome, and that is understanding what the actual results mean. While some antibodies provide immunity to the virus for decades (measles and chicken pox, for example), this is not the case for coronaviruses, in part because of its ability to mutate over time. The World Health Organization (WHO) issued a brief report at the end of April stating there was no evidence that those infected with Covid-19 were protected against a second infection. However, two days later, it was clarified in the tweet that they expected the antibodies to provide “some level of protection.” WHO also warns that antibody tests must be able to distinguish between past infections from SARS-CoV-2, the virus that causes Covid-19, and a set of six other human corona viruses, two of which are MERS and SARS (among which antibodies) convey average immunity average for one and two years, respectively). The other four cause the common cold; those who recover from a lighter coronavirus can expect less immunity against subsequent infections. In the end, Covid-19 antibodies may provide protection against re-infection, but to what extent and for how long is still unknown. This makes the prospect of widespread use of an immunity passport “very unlikely,” said Dr. Sharona Hoffman, a professor of bioethics at the Case Western Reserve University of Medicine. “If the test becomes more reliable, an immunity passport can become a reality,” Dr. Hoffman “But it looks like we have to wait until we have the vaccine.” Peter Gulick, an infectious disease expert at the University of Michigan State University’s Osteopathic Medicine, agrees. “At this point, we don’t know how long these antibodies last, whether a few months or a year,” he said. “Once we have the vaccine, requiring evidence of vaccination, as well as evidence of protective antibodies, it will be far more meaningful and safer for travel.” The travel industry is moving forward. While medical studies continue, the travel industry does not stand still on the sidelines. Eager to get planes in the air and hotels opened, the travel industry is formulating new ways to attract tourists back, walking the line between ensuring customer safety and not needing to disrupt their travels. Better than persuading those who have positive antibody test results, some opt for more accurate nasal swab molecular tests, also known as PCR tests, which detect active Covid-19 infection. The Telegraph reported last week that the Maldives plans to reopen tourists in July with plans to make the Covid-19 molecular test mandatory for all tourists. Sha Wellness Clinic, a medical and hotel clinic in southeastern Spain, requires all guests to give two negative tests – one taken several days before arriving and another at check-in. Travelers who are far socially awaiting the results of saliva samples at the corona virus testing facility at the AsiaWorld-Expo in Hong Kong on Thursday, May 14, 2020.Laurel Chor / Bloomberg Most countries and companies that reopen for summer travel choose the option that is lacking invasive, such as health checks, cleaning improvements, and social distance guidelines. In particular, the journey continues, and the absence of an immunity passport does not seem to hold airlines, shipping companies or hotels back. Official, legal and public policy concerns. Passport law appeals to anyone who longs for life as usual (ie all of us), but consider the consequences of certain sectors of society to be able to move, gather, travel and work freely – while others cannot. This is the subject of an article in the well-known medical journal “The Lancet.” Vulnerable populations, such as those who cannot afford long periods of time without work, may be motivated to look for infections, which can exacerbate existing racial and gender inequality, not to mention the level infection. Evidence of immunity can be a requirement for recruitment, and a black market for fake immunity documents can develop. In addition to the issue of discrimination, author Alexandra L. Phelan distinguishes between the WHO Carte Jaune, or the Yellow Card (which shows evidence of vaccination), and immunity passports by stating: “Vaccination certificates give individuals incentives to get vaccinated against viruses, which are social goods. Instead , a passport of immunity provides an incentive for infection. ” . Thomas Trutschel / Photothek A similar situation developed during the yellow fever outbreak in the US during the 19th century, which resulted in people who were not exposed to the disease being denied employment and housing. “City dwellers of that time tried to prove they had yellow fever to get a job,” Hoffman said. “People are looking for exposure and hope to live through it will be considered as acclimatization and have job opportunities. But many of them died after being exposed.” The United Kingdom is driving a passport program that uses testing and facial biometrics to identify those who use Covid-19. antibodies (despite the emphasis on work, not traveling), while Germany decided to seek advice from the national ethics council before using millions of antibody tests purchased from the Swiss pharmaceutical company Roche. If an immune passport is issued, there may be a population that does not have access to antibody tests or ways to pay for it, Hoffman said. “Hopefully, we will have a program that will make antibody tests very accessible, maybe even free for people who don’t have health insurance.” potential passport holders yet. For an immunity passport to work, there must be enough people who have them to make a significant effect on the travel industry. While countries with the highest Covid-1 infection rate – that is, the United States, Brazil, Russia, Peru, India and parts of Western Europe – may have the best reasons for making an immune passport, the number of those who have recovered in these countries maybe not enough to make the development of a valuable program. More than 6.3 million people have been infected with Covid-19 worldwide, a number far smaller than the estimated 1.4 billion international tourist arrivals in 2018.d3sign. Although this varies by region, it is estimated that no more than 5% of this amount. the population has antibodies (conversely, about 70% of the population needs to have antibodies, either through recovered infection or vaccination for herd immunity). Countries that have succeeded in “leveling the curve” – ​​such as Australia, New Zealand, Vietnam, Hong Kong and Taiwan – have fewer cases, and thus fewer incentives to create an immunity passport program. What is a good antibody test for the moment? Although they might not be the golden ticket to travel the world, antibody tests are very important for other reasons. It can track the level of pandemics in a particular region, improve modeling data and (finally) determine which frontline workers can work with an infected person. Singapore has effectively used antibody tests to track the Covid-19 group. People with antibodies can donate plasma to help those currently fighting the disease and prioritize later vaccinations if it is determined they already have some level of immunity. If an immune passport won’t work, what will happen? Rather than an immune passport, a “digital” health passport – which can contain positive antibody test results, recent negative Covid-19 test results and finally, proof of vaccination – may be a more useful type of travel document to carry in the future. health can reduce some, but not all, of the problems inherent in passport immunity, although considerations of privacy and international cooperation must be addressed to make the health passport program work.



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Trucks Used for Corpses Can Now Carry Food, the FDA said | Instant News


IMPORTANT POINT

  • Refrigerated trucks used to store COVID-19 can now return to transport food
  • The FDA has guidance on disinfectants and ensures these trucks are virus free
  • The trucks will be the defining symbols of this era, said a New York doctor

Refrigerated trucks that were temporarily used to store corpses from New York hospitals, mortuaries and funeral homes, when COVID-19 cases flooded the United States health system, can now return to transport and store food, the Food and Drug Administration (FDA) said.

The FDA released guidance on what to do with these refrigerated food transport vehicles and refrigerated storage units, which have blood and body fluids from COVID-19 patients who die, after receiving requests from the public.

“When additional refrigerated storage is no longer needed, the industry may want to return trailers and storage units to be used for food transportation and storage,” the guide stated.

The FDA also said the storage truck was easily cleaned and disinfected using EPA-registered disinfectants.

“Some surfaces may require repeated applications to ensure treatment for the required contact time,” the FDA guidelines underline. “Also, because some disinfectants might not be effective at cooling temperatures (check labels), the interior might need to be brought to the appropriate temperature before disinfection.”

Coronavirus novels spread through respiratory droplets and may not be transmitted through food. According to the Centers for Disease Control and Prevention (CDC), the risk of contracting the virus from touching surfaces, objects and boxes may be very low.

“In general, because of the poor survival of the corona virus on the surface, there is a very low risk of possible spread of food products or packaging,” the CDC said.

However, trucks with traces of blood and body fluid that cannot be cleaned should no longer be used for the original purpose of transporting food. If an unpleasant odor still permeates the storage unit, despite repeated disinfection, the truck should not be used to transport food again.

If the surface of the truck is damaged, cracked and porous, it will not be disinfected properly. As such, it should not be used for food delivery as well.

Lance Corporal Matthew Aquino, a rifleman with Five Companies, Battalion 3, 2nd Marine Regiment, New York Task Force, and police officers with the Critical Response Command at the New York City Police Department Counterterrorism Bureau posted security for the USNS Comfort hospital ship (T -AH 20) in New York City, April 23, 2020. Photo: Creative Commons

Meanwhile, Dr. Jeremy Rose of the Mount Sinai Beth Israel Hospital in Manhattan wrote his article The Washington Post refrigerated trucks will be the defining symbol of this era.

“Every disaster has a picture, a symbol,” Rose wrote. “For COVID-19, maybe it’s just a refrigerator truck. This is our overflowing mortuary, housing patients we can’t save.”

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