Tag Archives: FDA

Melanie J Neumann is Vice President and Chief Financial Officer for The Acheson Group

By Melanie Neumann, JD, MS

Although FDA immediately gained increased authority for records access upon the signing of FSMA in January 2011, some companies haven’t gotten the memo yet.

The following best practices will help food and beverage manufacturing facilities get inspection ready and offer guidance on how to push back if overreaching occurs.

Keep a paper trail. Documentation and recordkeeping is crucial. Disclosure is relevant only to the documents that FDA is allowed to have, such as production documentation. This does not apply to proprietary/trade secret information (i.e., financials and recipes).
Appoint a designated person to guide FDA during the inspection. This person should be the sole contact for all requests of documents, information, samples, etc., and accommodate requests for information from the inspector, as long as they are reasonable and in scope. This point person must have adequate training and experience in regulatory requirements and recent changes to have an awareness of what records inspectors are and are not technically authorized to review or access. If you are unsure of what the inspector is asking for at any point, we have a word of advice: Never speculate; always ask for clarification.
Duplicate everything. If the inspector takes swabs or photos, shadow him/her and take duplicate swabs and/or photos so you have a record of what was taken by the agency. It’s another question whether to take the swabs to test or not—but at least have a replica of what the agency has so you have the same or very similar information.
Engage legal if you feel that lines are being crossed. When you think inspectors have crossed the line into records to which they should not have access, it’s okay to respectfully state that you would like to speak with your legal counsel prior to disclosing the record. Make it clear you are not outright refusing to produce the document; rather that you are unsure what the company policy and/or regulation is on disclosure of that particular document/piece of information; and, as such, you wish to seek legal counsel prior to disclosing.
If you do refuse outright to produce requested information, do so wisely. Inspectors are given clear guidance on what actions to take if met with refusals. Criminal provisions of the Act may be invoked but this is in the most egregious of cases. Some of the guidance relevant to inspectors that food companies should be aware of are stated in the FDA Inspector Inspection Manual and are included below to give you an idea of the response you may receive to an outright inspection refusal or refusal to allow copying of records:
- 2.6 – INSPECTION WARRANT. A refusal to permit inspection or a refusal to permit access to or copying of records may invoke criminal provisions of sections 301(e) and 301(f) of the FD&C Act [21 U.S.C. 331(e), (f)].
- However, as stated in 5.2.5, the request still needs to be fair and reasonable:
- 2.5 – INSPECTION REFUSAL. Refusal as used in your IOM means refusing to permit an inspection or prohibiting you from obtaining information to which FDA is entitled under the law. In the case of a refusal you must show your conduct was reasonable, fair, and you exercised reasonable precaution to avoid refusal. You must have shown your credentials and given the responsible individual a properly prepared and signed Notice of Inspection, FDA 482.
- 2.5.2 – Refusal to Permit Access to or Copying of Records. If management objects to the manner of the inspection or coverage of specific areas or processes, do not argue the matter but proceed with the inspection. However, if management refuses to permit access to or copying of any record to which you are entitled under law, call attention to Section 301(e) of the FD&C Act[21 U.S.C. 331] or applicable sections of the PHS Act. If management still refuses, proceed with the inspection until finished.

Mark documents confidential/proprietary. Mark all documents and materials disclosed to the inspector as Confidential/Proprietary or Company Confidential Information if you wish to even attempt to maintain confidentiality and keep the information from being disclosed in a Freedom of Information Act (FOIA) release. If not marked as such, 483 information is generally discoverable through FOIA requests.
Request your own FOIA. After the inspection, the FDA inspector will write a report called the Establishment Inspection Report (EIR). Best practice is for the company to submit a FOIA request for both a redacted (confidential information removed) and an unredacted copy of the EIR to ensure the information in the report matches the one that the inspector provided to the company. This is requested through the FDA Freedom of Information Office in Rockville, Maryland.
If you don’t agree with a 483 item, it can be disputed/appealed. This is done in the standard 483 response in which a firm provides information on corrective actions it will take on issues that do need correcting. As stated in the FDA Field Directive No. 120, “The firm may request clarification, criticize FDA 483 items, disagree with the FDA 483, or raise other questions or issues. In these cases, the District will evaluate the firm’s information and send the District’s conclusion to the firm. A copy shall also be sent to the official establishment file.”

For more details on the topic, see Neumann’s blog, “How Do you Graciously Push Back in an FDA Inspection?”

Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group

June 18, 2015

Beltway Beat

Market Withdrawal Vs. Recall: What’s the Difference?

By Peyman Fatemi, Melanie J. Neumann

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Determining whether to initiate a market withdrawal or recall procedure depends on the situation and unfortunately, is not always a clear-cut decision. Whether due to a lack of insights into the intricacies of recall management nuances o r because you simply cannot please everyone all the time, even using the best judgment can still cause upset. Take, for example, the 2013 Chobani yogurt incident: Let’s look at some of the facts surrounding the case.

The Chobani Market Withdrawal

On August 31, 2013, Chobani initiated a market withdrawal of yogurt due to “quality concerns surrounding certain products, which were experiencing swelling or bloating.” On September 3, the company stated that the issue was caused by a type of mold “commonly found in the dairy environment”.

Although the mold (Mucor circ inelloides) was not considered to be a disease-causing foodborne microorganism and “should not pose a health risk to most consumers” (according to Chobani’s blog), the company moved from a voluntary market withd rawal of the product to a voluntary recall on September 5.

Chobani seemed to be following protocol on withdrawals and recalls, and it was providing daily updates to consumers on its blog, but it did not escape negative publicity. In fact, foodborne illness lawyer Bill Marler, who dedicated nine of his own blogs to the incident, stated, “This probably ranks near the top in a mismanaged recall/market withdraw/PR disaster that I have seen in 20 years.” And directed questions to Chobani, including: “Why did you at first try to quietly ‘withdraw’ the product instead of issuing a ‘recall?’”

Market Withdrawals vs. Recalls

So, when should you initiate a market withdrawal and when might does it need to be elevated it to a voluntary recall (and if so, at what recall class)? In addition, at what point does FDA escalate it to a mandatory recall? Or, when should you voluntarily inform FDA yourself?

Chobani’s issue was not an isolated case. There are several theories about why its recall received so much negative publicity. Was the company slow to initially respond? Could it have stayed on top of social media monitoring more proactively? Did it take too long to determine the need to elevate from a market withdrawal to a recall? Some would say yes. Others would say the company made the best decision it could with the facts it had at the time it had to make the decision. Whatever the reason—understanding the nuances between market withdrawals and recalls will help.

Since each case will be unique, there isn’t a hard-and-fast answer without discussing the particulars of each situation, but we can provide you with more information about withdrawals and recalls – so that your first reaction and call are, if nothing else, at least a bit less frantic.
FDA’s definitions:

• Market withdrawal: When a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation.
• Recalls: Actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
Class I: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II: Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Class III: Use of or exposure to a violative product is not likely to cause adverse health consequences.

In the Chobani case, an initial assessment showed that “common mold” was a quality issue that did not violate food safety regulations or require a recall, so the company initiated a market withdrawal. However, as more people who consumed the yogurt allegedly became ill, the incident was escalated (although no confirmed link was established) and was eventually classified by FDA as a Class II recall.

Your company needs to ask this type of question when a product is found to be defective in any way. Not only which of the above definitions does it fit at this time, but also whether it is likely that the consequences could be more severe. Using Chobani as the example, perhaps the fact that containers were bulging and exploding would indicate that there was a component in the product that could potentially make people sick? You need to constantly reassess the situation and consider if a status or actions must change.

Additionally, you need to consider your brand reputation. No one really wants to go to the regulators and fess up to a mistake that may not become an issue. But, it’s kind of like telling Mom you accidentally spilled your red Kool-Aid on the carpet before she sees it. If immediately targeted, that stain just may come out – and she may even consider your scrubbing of the carpet and promise to NEVER again take red Kool-Aid into the living room as “corrective action” enough. But if it sits for a day and she finds it herself while you remain quiet, it could be permanent, her trust in you soiled, and the punishment more severe than if you would have just told her in the first place.

When in doubt, if you address the potential “stain” on your product and brand head on, admit to your error, be upfront about the cause – and what you are doing to correct it – to both FDA and your customers, FDA is likely to work with you on your situation, and your customers will forgive you and continue to buy your product once they know the issue has been corrected. Understanding the differences between market withdrawals and recalls will be key to possibly avoiding a “spill” in the first place.

Does your product contain PHOs? FDA says they're not GRAS.

June 16, 2015

Partially Hydrogenated Oils Not GRAS, Says FDA

By Maria Fontanazza

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FDA has made it official. The main source of artificial trans fat in processed foods, partially hydrogenated oils (PHOs), are not generally recognized as safe (GRAS) for use in human food. The agency is giving food manufacturers three years to comply. Companies can either reformulate products without PHOs and/or petition FDA to allow specific uses.

FDA is defining PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than four”.

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in an FDA press release. Manufacturers have been required to indicate the presence of trans fats on product labeling since 2006. The agency estimates that between 2003 and 2012, consumption of trans fat decreased by nearly 78%, and attributes this drop to labeling requirements and consumer awareness. For the past decade, the Institute of Medicine has recommended limiting trans fat consumption.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” stated Stephen Ostroff, M.D, acting commissioner of FDA. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

After issuing its notice in November 2013 that PHOs were not GRAS, FDA received more than 6000 comments in response to this tentative determination. According to the Federal Register notice, the majority of comments from industry, trade associations, advocacy groups, health professionals, and government stakeholders were in favor of FDA’s tentative determination. Those who expressed dissent cited the agency’s scientific analysis as well as its potential effect on trade, taxes, and the potential that it could lead to bans on other substances; some provided alternatives to dealing with the issue of trans fat in food.

Lab technicians use the Hunter device during a test process. InstantLabs manufactures the Hunter system as well as test kits for food pathogens and species identification such as the catfish testing commercialization agreement outlined with the FDA.

June 11, 2015

New Catfish Test Catches Mislabeling Faster

By Maria Fontanazza

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As Americans seek to make healthier choices, seafood is becoming more popular than ever before. In fact, U.S. consumers eat 50% more seafood now than they did 50 years ago and spend $80 billion annually on creatures from the sea, according to Oceana. Coupled with the increasing popularity is the growing problem of seafood fraud and mislabeled imports. Oceana’s study in 2013 performed DNA testing on seafood samples taken around the United States and found that nearly 33% of those samples were mislabeled.

FDA has made a significant investment in DNA sequencing to improve its ability to detect misrepresented seafood species in interstate commerce and from other countries. “The Agency has trained and equipped eight field laboratories across the country to perform DNA testing as a matter of course for suspected cases of misbranding and for illness outbreaks due to finfish seafood, where the product’s identity needs to be confirmed,” stated Steven M. Solomon, deputy associate commissioner for regulatory affairs at FDA, before the U.S. Senate’s Committee on Small Business and Entrepreneurship in May. “FDA also trained analysts from the U.S. Customs and Border Protection (CBP) and the National Marine Fisheries Service in its new DNA-based species identification methodology.”

With some of the most common seafood choices including white fish varieties like tilapia and catfish, DNA-based testing plays a critical role in detecting mislabeling of species. If you’re a knowledge seafood person and you get a whole fish, there’s a high likelihood you can identify it correctly,” says Steven Guterman, CEO of InstantLabs. “However, once that fish has been filleted—let’s call it a white fish—it’s almost impossible for anyone to visually correctly identify that fish. That’s where the DNA testing comes into play.”

InstantLabs offers a series of DNA-based seafood tests for species identification. Last week the company announced a partnership with FDA to co-develop and commercialize a new Ictalurid catfish species identification test that enables much faster sequencing of samples and at a lower cost. “I think everyone is recognizing that the current method industry uses for validation, which is to take a sample and send it out to a lab for sequencing, just takes too long,” says Guterman. There is a typical time lag of about one to two weeks from taking a sample to getting a result.

The Hunter System is a real-time PCR instrument that delivers results in a much shorter period of time. “Switching from a sequencing test to a PCR test where you’re looking for a specific target DNA and getting results on site in two hours, or in a laboratory within a day, changes the way the industry operates,” says Guterman. “It enables better enforcement, and government regulators and suppliers can do validation in a way that’s not disruptive to their normal course of business.”

FDA and InstantLabs began talking about the technology about a year ago, as both have worked closely with the University of Guelph, according to Guterman. FDA was looking for a company that would be able to commercialize a test kit for U.S. catfish, and the new partnership is part of a Cooperative Research and Development Agreement (CRADA) with the agency. U.S. Farm Bill legislation states that only members of the Ictaluridae family can be legally marketed as catfish within the United States.

The FDA-InstantLabs CRADA collaboration will help ensure the integrity of labeling related to U.S. catfish. The Pangasiidae species, which hails from Southeast Asia, has been increasingly mislabeled as U.S. catfish. This is not only a concern from a cost standpoint but also a safety perspective, as FDA has detected toxins in catfish that come from Asia.

April 6, 2015

Food Safety is Key Initiative as FDA Develops Lab Testing Standards

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When President Barack Obama in 2011 signed the Food Safety Modernization Act, the most sweeping reform of American food safety laws in more than 70 years, the Food and Drug Administration’s job got a lot tougher.

As the FDA’s Palmer Orlandi explained at Pittcon [on March 9], they might need your help to get that job done. Orlandi, who spoke as part of the two-day Food Safety Tech Food Labs Conference at Pittcon, is the agency’s acting chief science officer in the office of food and veterinary medicine. The FDA traditionally has been very good at reacting to safety issues in our food supply as they arise and finding the source of the problem, Orlandi said. But, now the agency is charged with more of a preventive role, which means identifying the biggest risks before they become a threat to the public. That’s a big job, and the FDA can’t do it alone. “We’re looking for burden-sharing,” Orlandi said.

Partnerships with other federal agencies such as the Department of Agriculture and the Department of Homeland Security are part of the solution. They’re also working with state-level laboratories and even the private sector, he said. As an example, he cites the Food Emergency Response Network, which includes food-testing laboratories at the local, state, and federal levels. Initially formed to deal with bioterrorism threats, Orlandi said it has become a useful food safety network as well. FERN-affiliated labs recently tested 1,600 samples of avocados for salmonella and listeria, he said.

Much of the burden of this new preventive approach will fall on food producers. Orlandi said FDA is willing to work with private labs to develop standards. This can be tricky, however, because the agency doesn’t want to create the impression that it is somehow favoring one private sector entity over another. Meanwhile, private companies have their own trade secrets to protect. “Where is the middle ground where we can cooperate?” Orlandi asked rhetorically.

FDA has developed validation standards that field labs can use, he said. But, he concedes, the agency hasn’t done a good job compiling and publishing those standards into an accessible document or reaching out to stakeholders to make sure they’re up to speed. “That’s another thing on our to-do list,” he said.

Funding for these efforts is scarce. Joe Konschnik, a market research manager for Restek Chromatography Products who attended Orlandi’s presentation, helps to supply scientists working in College Park, MD to develop new procedures to analyze pesticides. Traditionally, once the research is published, the researchers’ jobs are over. Konschnik says now they’re trying to send the information out to other labs in the U.S. and overseas. That way, everyone can work from the same page to validate the work and create consistent standards.

One of the problems is that, for example, aerating seeds to run multilevel validation studies can cost $35,000, he said. But the FDA only has about $75,000 to fund such studies, which obviously would run out very quickly. “There’s no money to fund the back-end stuff,” Konschnik said. He said he works with the American Council of Independent Laboratories, which is willing to do the testing for free. But it still costs money for the FDA to make samples, send them to the labs, gather the data, and validate the data.

In short, the partnerships FDA is building remain a work in progress. But it has a new tool: the America Competes Act, which gives federal agencies the authority to award prizes for solving significant problems. The FDA has issued a “food safety challenge,” Orlandi said, looking for ways to reduce turnaround times on food safety tests, checking for salmonella, for example, from a few weeks to a day or two. The agency has a $500,000 prize pool, with $400,000 potentially going to the winner.

This article originally appeared in CEN media group’s Pittcon Today on Tuesday, March 10 and has been republished with permission.

March 31, 2015

FDA Advises Egg Safety for Easter

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FDA estimates that 142,000 illnesses each year are caused by consuming eggs contaminated with Salmonella. While there are regulations in place to help prevent contamination of eggs on the farm and during shipping and storage, the most effective way to prevent egg-related illness is by knowing how to buy, store, handle and cook eggs safely.

Fresh eggs must be handled carefully to avoid the possibility of foodborne illness, often called “food poisoning.” Even eggs with clean, uncracked shells may occasionally contain bacteria called Salmonella that can cause an intestinal infection.

The U.S. Food and Drug Administration (FDA) estimates that 142,000 illnesses each year are caused by consuming eggs contaminated with Salmonella. FDA has put regulations in place to help prevent contamination of eggs on the farm and during shipping and storage. But consumers play a key role in preventing illness associated with eggs. In fact, the most effective way to prevent egg-related illness is by knowing how to buy, store, handle and cook eggs — or foods that contain them — safely. Follow these safe handling tips to help protect yourself and your family.

What is Salmonella?

Salmonella, the name of a group of bacteria, is the most common cause of food poisoning in the United States. Salmonella germs have been known to cause illness for over 100 years. They were discovered by an American scientist named Salmon, for whom they are named.

Most people infected with Salmonella develop diarrhea, fever, abdominal cramps, and vomiting 12 to 72 hours after infection. Symptoms usually last 4 to 7 days and most people get better without treatment. However, in some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated quickly with antibiotics. Certain people are at greater risk for severe illness and include pregnant women, young children, older adults and people with weakened immune systems.

Safe Handling Instructions

To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly. Eggs that have been treated to destroy Salmonella — by in-shell pasteurization, for example — are not required to carry safe handling instructions.

Buy Right

You can help keep eggs safe by making wise buying decisions at the grocery store. Buy eggs only if sold from a refrigerator or refrigerated case. Open the carton and make sure that the eggs are clean and the shells are not cracked. Refrigerate promptly. Store eggs in their original carton and use them within 3 weeks for best quality.

Keep Everything Clean

Cleaning counter before preparing any food, remember that cleanliness is key! Wash hands, utensils, equipment, and work surfaces with hot, soapy water before and after they come in contact with eggs and egg-containing foods.

Cook Thoroughly

Thorough cooking is perhaps the most important step in making sure eggs are safe. Cook eggs until both the yolk and the white are firm. Scrambled eggs should not be runny. Casseroles and other dishes containing eggs should be cooked to 160°F (72°C). Use a food thermometer to be sure. For recipes that call for eggs that are raw or undercooked when the dish is served — Caesar salad dressing and homemade ice cream are two examples — use either shell eggs that have been treated to destroy Salmonella, by pasteurization or another approved method, or pasteurized egg products. Treated shell eggs are available from a growing number of retailers and are clearly labeled, while pasteurized egg products are widely available.

Serve Safely

Bacteria can multiply in temperatures from 40°F (5°C) to 140°F (60°C), so it’s very important to serve foods safely. Serve cooked eggs and egg-containing foods immediately after cooking. For buffet-style serving, hot egg dishes should be kept hot, and cold egg dishes kept cold. Eggs and egg dishes, such as quiches or soufflés, may be refrigerated for serving later but should be thoroughly reheated to 165°F (74°C) before serving. Cooked eggs, including hard-boiled eggs, and egg-containing foods, should not sit out for more than 2 hours. Within 2 hours either reheat or refrigerate.

Store Properly

Use hard-cooked eggs (in the shell or peeled) within 1 week after cooking. Use frozen eggs within 1 year. Eggs should not be frozen in their shells. To freeze whole eggs, beat yolks and whites together. Egg whites can also be frozen by themselves. Refrigerate leftover cooked egg dishes and use within 3 to 4 days. When refrigerating a large amount of a hot eggcontaining leftover, divide it into several shallow containers so it will cool quickly.

On The Road

Cooked eggs for a picnic should be packed in an insulated cooler with enough ice or frozen gel packs to keep them cold. Don’t put the cooler in the trunk — carry it in the air-conditioned passenger compartment of the car. If taking cooked eggs to work or school, pack them with a small frozen gel pack or a frozen juice box.

Source: FDA.gov

March 30, 2015

Standards for Animal Food Ingredients

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The U.S. Food and Drug Administration has announced a strategy to establish ingredient definitions and standards for animal food in order to increase transparency and affirm the safety of the animal food supply, as required by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

As part of the strategy, FDA will review the list of animal food ingredient definitions used by industry and state regulators, which is contained in Association of American Feed Control Officials’ (AAFCO) Official Publication. AAFCO is a voluntary membership organization that includes regulatory officials of U.S. state and federal government agencies. AAFCO provides a forum for these regulatory officials to provide guidance and recommendations to ensure that the regulation of animal feeds is as uniform as possible from state to state.

The Official Publication includes FDA-approved food additives and ingredients that are generally recognized as safe (GRAS), as well as AAFCO-established definitions for other ingredients. The FDA intends to align AAFCO ingredient listings with the agency’s regulatory process and requirements.

The agency has identified the following steps for animal food ingredients:

FDA intends to publish a proposed rule establishing as the agency’s standards and definitions for animal food ingredients the AAFCO definitions for those ingredients that are recognized as GRAS or approved by the agency as food additives. This proposed rule will be open for public comment, and the agency will consider those comments before issuing a final rule.
FDA scientists will evaluate the remaining animal food ingredients listed in the AAFCO Official Publication that are currently not FDA-approved food additives or regcognized as GRAS.
- In cases where the scientific literature supports a GRAS determination, the FDA will publish the supporting information in the Federal Register for public comment before affirming the ingredient as GRAS.
- In cases where the data and information support a finding that the ingredient meets the food additive approval standard, the FDA intends to approve the ingredient as a food additive.
- In cases where the FDA does not currently have data to make a GRAS determination or to approve the ingredient as a food additive, the agency will require manufacturers of these ingredients to submit a food additive petition in order to allow continued legal use of the product in animal food.

Although animal food ingredient definitions and standards generally do not vary widely across the industry, and consumers can be confident in their accuracy, FDA’s strategy will formalize definitions and standards to meet federal laws and regulations.

The agency intends to work closely with industry during this transition to minimize disruption to animal food production and ensure transparency and clarity for both manufacturers and the public.

March 25, 2015

InstantLabs Launches DNA-based Atlantic and Coho Salmon SpeciesID Test Kits to Combat Seafood Mislabeling

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The company has broadened species identification product line created in partnership with University of Guelph and plans to release additional test kits during the year.

InstantLabs announced today the expansion of its SpeciesID product line by offering DNA-based tests for Atlantic and Coho salmon. InstantLabs SpeciesID™ tests provide accurate DNA verification in under two hours.

The launch of the salmon test kits highlights InstantLabs’ efforts to meet market demand by expanding the affordable, simple-to-use InstantID™ product line. The company already offers kits to identify Atlantic Blue Crab, pork and horse meat. The InstantLabs’ system gives food wholesalers, processors and inspectors a fast and reliable option for product tests.

The two new products were created in partnership with the University of Guelph, an international leader in agricultural and food science. The InstantID test kits for Atlantic (Salmo salar) and Coho salmon (Oncorhynchus kisutch) are the first of four salmon assays planned for release during 2015. InstantLabs will launch InstantID™ for Chinook (Oncorhynchus tshawytscha) and Sockeye (Oncorhynchus nerka) salmon later this year.

Expanding its presence in the high-demand seafood market, the Baltimore-based manufacturer of the Hunter® system expects to also release InstantID™ kits for snapper, catfish, grouper, and tilapia.

“Producers, wholesalers and government entities needs robust tools to combat seafood fraud,” said Steven Guterman, chief executive officer of InstantLabs. “InstantLabs’ real-time PCR testing systems and reagent kits can become an integral part in a testing program to verify labeling accuracy.”

InstantLabs’ Hunter^® Real-Time PCR instrument combines accuracy, speed, and ease-of-operation into a compact portable system. The Hunter system is designed for use at points-of-need to detect and analyze a wide variety of food samples by targeting DNA. Results delivered quickly allow seamless integration into food industry firms’ processes and facilities.

Dr. Robert Hanner, Ph. D., has directed the University of Guelph’s research in conjunction with InstantLabs. “This collaboration has been essential in commercializing DNA-based food authentication tests for the seafood industry,” said Dr. Hanner, associate professor at the Center of Biodiversity Genomics. “This technology will help safeguard against existing supply chain vulnerabilities, protecting both businesses and consumers from food fraud.”

InstantLabs identification tests are designed for use on the Hunter, a real-time PCR system developed by the company, and are also available for use with other PCR instruments.

Seafood industry reports continue to highlight concerns about fraud, species substitution and consumer preferences to use sustainable fish stocks. Approximately one-third of all fish sold in the U.S. was mislabeled, reported a recent survey from Oceana. The U.S. Food and Drug Administration identifies a range of lower valued fish regularly substituted for 20 higher-priced species. InstantLabs will provide critical tool sets needed by the industry to ensure the integrity of the supply chain.

ABOUT INSTANTLABS:

InstantLabs, a molecular diagnostic device company, developed and markets the Hunter® Accelerated-PCR system, a fully-integrated, easy-to-use, portable and affordable real-time polymerase chain reaction (RT-PCR) platform for rapid, accurate pathogen detection. InstantLabs Medical Diagnostics Corp., the legal entity, offers the Hunter® system for use with several food-borne pathogen test kits for the global food industry. The Hunter® system is especially well suited for use at points-of-care and points-of-need to detect and analyze a wide variety of common and problematic pathogens. InstantLabs’ growing worldwide customer base includes some of the world’s leading food companies. InstantLabs is also developing products for additional markets, including medical diagnostics where gold-standard accuracy, combined with Ease-of-use and rapid results, are critical. Founded in 2008, InstantLabs is located in Baltimore, MD. For more information please visit www.instantlabs.com.

ABOUT THE UNIVERSITY OF GUELPH:

Acknowledged as one of the leading public research universities, the University has 39 Canada Research chairs in natural sciences, energy, health services and social sciences. With a commitment to student learning and innovative research, University leaders are dedicated to cultivating the essentials for our quality of life – water, food, environment, animal and human health, community, commerce, culture and learning. The University community also shares a profound sense of social responsibility, an obligation to address global issues and a concern for international development. Learn more at www.uoguelph.ca.

Additional resources on seafood fraud:

March 24, 2015

GM Apples and Potatoes are ‘Safe’: FDA

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Arctic Apples have ‘silenced’ genes that prevent them from turning brown when bruised, while genetic modification of Innate potatoes reduces the activity of genes that cause tubers to turn brown.

The U.S. Food and Drug Administration has completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are “as safe and nutritious as their conventional counterparts.”

Okanagan’s Granny Smith and Golden Delicious varieties of apples, known collectively by the trade name “Arctic Apples,” are genetically engineered to resist browning associated with cuts and bruises by reducing levels of enzymes that can cause browning.

Simplot’s varieties of Ranger Russet, Russet Burbank and Atlantic potatoes are collectively known by the trade name “Innate” and are genetically engineered to reduce the formation of black spot bruises by lowering the levels of certain enzymes in the potatoes. In addition, they are engineered to produce less acrylamide by lowering the levels of an amino acid called asparagine and by lowering the levels of reducing-sugars. Acrylamide is a chemical that can form in some foods during high-temperature cooking, such as frying, and has been found to be carcinogenic in rodents.

Foods derived from genetically engineered plants must meet the same legal standards, including safety standards, as foods derived from traditional plant breeding methods. Though producers of genetically engineered foods are not compelled to submit their products for FDA approval, both Okanagan, of British Columbia, Canada, and Simplot, of Boise, Idaho, submitted to FDA a summary of their safety and nutritional assessments.

“The consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties,” said Dennis Keefe, Ph.D., director of the FDA’s Office of Food Additive Safety. “This case-by-case safety evaluation ensures that food safety issues are resolved prior to commercial distribution.”

The changes are expected to make the produce healthier, more palatable and easier to transport and sell without spoilage, and hence result in less food waste. But the approval is expected to spark controversy among critics who argue that genetically modified foods will introduce potentially dangerous unknowns into the American food supply. Okanagan and Simplot may label their products as GMO, something that many consumer groups have advocated for.

Source: FDA.gov

March 17, 2015

CAPA and Root Cause Analysis for the Food Industry

By Dr. Bob Strong

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A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.

Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.

Who should perform the RCA?

Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan

CAPA: The process unpacked

A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:

Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
Investigate: Make a plan to research the problem.
Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
The Action Plan: Narrow the list of possible causes.
Implement: Execute the action plan
Review: Verify and assess effectiveness

CAPA benefits

A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.

This article is an excerpt from a white paper prepared by SAI Global Assurance Services, and has been published in Food Safety Tech with permission. Click here to download the white paper in its entirety.

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