Tag Archives: FDA

enokie mushrooms

Bulb Onions and Imported Mushrooms Focus of New FDA Food Safety Prevention Strategies

By Food Safety Tech Staff
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enokie mushrooms

The FDA has announced two new food safety prevention strategies. The first is for imported enoki and wood ear mushrooms. The second is focused on bulb onions. Both food groups were identified in foodborne illness outbreaks in 2020.

In 2020, a multistate outbreak of Listeria monocytogenes (L. monocytogenes) infections that sicked 26 people was linked to the consumption of imported enoki mushrooms. Testing conducted by the California Department of Public Health (CDPH) identified a matching strain of L. monocytogenes in enoki mushrooms from the Republic of Korea.

Also in 2020, CORE, in collaboration with the CDC and state and local partners, investigated a multistate outbreak of Salmonella Stanley infections linked to the consumption of imported wood ear mushrooms. A total of 55 salmonellosis illnesses were reported in 12 states. Testing conducted by CDPH identified a matching strain in a sample of imported wood ear mushrooms from China. These were the first outbreaks reported to FDA in 20 years related to these products.

As a result of the outbreak findings, the FDA will conduct research to better understand how L. monocytogenes contaminates enoki mushrooms and to better understand the survival of L. monocytogenes and Salmonella on enoki mushrooms and wood ear mushrooms.

The agency will also increase strategic and targeted FDA sampling of imported specialty mushrooms at U.S. ports of entry and at U.S.-based retail sites on the state level. When specific producers are linked to the contaminated shipment, FDA may also detain future shipments until the producer can assure the FDA that the conditions that gave rise to the appearance of the violation have been resolved.

The FDA will also be working with industry to ensure international specialty mushroom producers have access to training intended to help them meet requirements for ensuring the safe production of mushrooms for import into the U.S.

Bulb Onions

In 2020 and 2021, Salmonella outbreaks associated with the consumption of bulb onions produced in the U.S. and Mexico caused more than 2,100 confirmed cases of foodborne illness in the United States.

As a result of the outbreak investigation, the FDA will engage domestic and foreign industry and government partners to promote a broad understanding of the outbreak investigation findings, applicable Produce Safety Rule requirements and the importance of root cause analysis after outbreaks.

Additional actions under the new safety prevention strategy include:

  • Prioritizing inspections of bulb onion farms in the U.S. and Mexico that are covered by the FDA’s Produce Safety Rule.
  • Identifying and assessing practices and conditions associated with onion curing.
  • Supporting research efforts to better understand bulb onion production practices, including the impact of different soil conditions and curing practices on the safety of bulb onions.
  • Supporting industry-led efforts to develop and implement best practices for bulb onion production.
  • Prioritizing Foreign Supplier Verification Program inspections of bulb onion importers to ensure that onion importers are verifying that foreign suppliers follow processes and procedures that provide the same level of public health protection as U.S. food safety requirements.
  • Increasing strategic and targeted sample collection and testing of imported bulb onions from the State of Chihuahua, Mexico.
  • Continuing to collaborate with Mexican competent authorities through the established Food Safety Partnership to help ensure the safe production of bulb onions in the State of Chihuahua, Mexico.

 

Hand washing

Norovirus: Handwashing and Exclusion of Ill Employees Most Effective Mitigation Measures

By Food Safety Tech Staff
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Hand washing

FDA has completed a research study entitled, Evaluation of the Impact of Compliance with Mitigation Strategies and Frequency of Restaurants Surface Cleaning and Sanitizing on Control of Norovirus Transmission from Ill Food Employees Using and Existing Quantitative Risk Assessment Model,” which focused on identifying strategies to reduce the risk of norovirus (NoV) from consumption of foods prepared in food establishments.

The study, which was published in the Journal of Food Protection, evaluated more than 60 scenarios examining the impact of implementation of and compliance with recommendations contained in the FDA Food Code.

The objectives of the risk assessment were to:

  • Evaluate the dynamics of norovirus transmission from ill or infected food employees to ready-to-eat food and consumers.
  • Evaluate the impact of prevention strategies and their level of compliance on the prevalence of contaminated food servings and the number resulting infected consumers.
  • Provide a basis for evaluation of potential changes regarding Employee Health for the 2017 FDA Food Code.

The study found that:

  • Compliance with Food Code exclusion of ill food employees and hand hygiene rules had the most impact on consumer illnesses.
  • Washing hands before donning and changing gloves efficiently reduces NoV transfer.
  • Restriction of food employees needs additional provisions to be effective.
  • Eliminating hand-contact from restroom surfaces and prioritizing cleaning and sanitizing of restroom surfaces in restaurants helps to control the transmission of norovirus to food and consumers.
  • Surface cleaning and sanitizing has the least impact on consumer illnesses.

 

Lettuce

FDA Announces New Efforts to Enhance the Safety of Leafy Greens

By Food Safety Tech Staff
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Lettuce

In light of the recent E. coli outbreak that has been linked to romaine lettuce, the FDA announced that it will begin targeted sampling of leafy greens grown on farms and ranches during the fall 2022 harvest season in the Salinas Valley region of California. In addition, the agency is releasing results from a 2021 sampling assignment and providing an update on other work happening under the Leafy Greens STEC Action Plan (LGAP).

The LGAP sampling efforts seek to detect and prevent contaminated product from reaching consumers and help leafy greens growers and processors identify practices or conditions that may present microbial risks so they can strengthen the microbiological safety of their operations.

During the fall 2022 harvest season the FDA plans to collect about 240 lettuce samples at farms/ranches in the Salinas Valley that were identified by traceback investigations in recent years as being potentially associated with a foodborne illness outbreak in which lettuce or leafy greens were the likely or suspect food vehicle.

The FDA notes that it also may collect environmental samples such as water, soil and scat, as appropriate, based on observations made at the time of sampling and a farm/ranch’s past inspection history. All samples will be tested for Salmonella spp. and E. coli O157:H7. The sampling will begin in mid-September 2022 and run through October 2022.

In 2021, the FDA conducted a leafy greens sampling assignment and has released a summary report of the results. As part of this assignment, the agency collected lettuce from commercial coolers in the Salinas Valley growing area and tested samples for E. coli O157:H7 and Salmonella spp. between May and November 2021. The agency detected Salmonella enterica in one green leaf sample and STEC in two other samples. The potentially contaminated products were destroyed and follow-up inspections were conducted.

As a result of continued outbreaks and ongoing concerns about leafy green contamination, multi-disciplinary food safety experts from across the FDA also will be visiting with leafy greens producers in California over the next two months to learn more about leafy greens operations. The FDA shared that recent outbreaks have raised concerns about the sanitary design of harvest equipment and how field production and processing practices may be contributing to contamination events, which spurred the creation of this working group.

PFAS

Phasing Out PFAS

By Food Safety Tech Staff
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PFAS

Efforts to regulate and remediate per- and polyfluoroalkyl substances (PFAS) are picking up a steam. Earlier this month, researchers from Northwestern University published a study verifying a low-cost process that breaks the chemical bonds of two major classes of PFAS compounds—perfluoroalkyl carboxylic acids (PFCAs) and perfluoroalkyl ether carboxylic acids (PFECAs)—leaving behind only benign end products.

Last week, the EPA proposed designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), two of the most widely used PFAS, as hazardous substances. If finalized, the rule will trigger industry reporting of PFOA and PFOS releases and allow the agency to require cleanups and recover cleanup costs.

For the food and beverage industry, most current regulations involve food contact packaging, with states outpacing the FDA in implementing thresholds and working toward outright bans.

“Maine has a declaration requirement for PFAS in food packaging, and eight states are in motion to completely ban PFAS in food packaging products,” says Sally Powell Price, regulatory expert for food and beverage safety, MilliporeSigma.

California, Connecticut, Maine, Minnesota, New York, Vermont and Washington are among the states that have already passed legislation limiting the use of PFAS in food packaging. Outside the U.S., the Eurpean Commissions’ Restrictions Roadmap outlines a plan to outlaw the use of PFAS in packaging by 2030.

The good news for the food and beverage industry is that non-PFAS packaging alternatives are affordable. “The alternatives are fairly priced, so if manufacturers are converting from PFAS to non-PFAS materials, it may require changing some processes, but the price will not change very much,” says Yanqi Qu, food & beverage safety and quality technology specialist, MilliporeSigma.

The area that poses a greater challenge and requires more significant investment from the public and potentially industry groups lies in the testing of actual food commodities. This is also an area of increased regulatory scrutiny.

Regulating and Detecting PFAS in Food

In July, the FDA released the results of its Total Diet Study, which included outcomes of its retail seafood products PFAS testing. “This testing actually catalyzed a recall of clam products from China,” says Price. “The FDA tested foods imported from all regions for the study, so this is something that the FDA is monitoring. I can see this recent recall driving them to do more testing at the border for products coming in to the U.S., especially seafood.”

The state of Maine has dairy testing mandates already in place. “PFAS are bio-accumulators, so it’s not just fish. Cattle and other livestock could also be an issue,” says Price. “The testing program in Maine is a regulatory model that I would use to extrapolate and look at where our future could lie.”

One of the key challenges in detecting PFAS levels in food commodities lies in the variety of matrices to be tested and the huge numbers of PFAS currently in the environment. In December 2021, the FDA published its methodology for PFAS analysis in food and beverage, which focused on fruits, vegetables and beverage samples.

“They are using an extraction method. They used a solvent to extract materials from the surface of the food and beverage samples, and then analyzed them using a liquid chromatoghraphy and mass spectrometry (LC-MS) system,” says Qu. “This method was just posted last year, and the public is not satisfied with it. There are more than 600 different types of PFAS compounds, and for this method they only focused on 16 of them. The FDA is saying, we need more time to test for all 600.”

LC-MS used to test for PFAS in food and beverages is very similar to the PFAS testing in the environment. However, testing food products is more complex than testing water or soil. “Different foods have different interferences and complications, and it is extremely difficult to account for all of the potential interferences and or complications that might arise as you move from one matrix to another,” says Taylor Reynolds, marketing manager for environmental testing and industrial chemical manufacturing, MilliporeSigma. “The science is struggling to keep up. You get into issues where you might have overlapping peaks on your chromatogram, which makes it hard to distinguish the readings. Calibration standards are not all readily available. So, even if a lab wanted to test for 600 compounds, I’m not sure they could easily get their hands on 600 compounds as a reference standard to do their calibration groups.”

What Food Manufacturers Can Do

Price encourages food manufacturers to keep an eye on their state legislatures for proposed and upcoming regulations and be aware of known concerns specific to their areas. “The FDA looks to best fit for purpose,” she says. “So if there is a known concern, for example local data shows that you have PFAS infiltration in the ground water near your livestock or your crops, having a testing plan in place or a mitigation strategy is a good idea, where possible.”

Local FDA and EPA departments can often provide mitigation support as well as guidance to ensure you are aligned with local regulations.

In the coming years, we are likely to see not only more stringent regulations, but also a better understanding of the most hazardous PFAS compounds to help target mitigation and replacement strategies. This data combined with continued efforts to neutralize PFAS, as seen in the Northwestern study, could signal a promising future.

“Our work addressed one of the largest classes of PFAS, including many we are most concerned about,” said William Dichtel, Robert L. Letsinger Professor of Chemistry in Northwestern’s Weinberg College of Arts and Sciences, and lead author of the Northwesten study. “There are other classes that don’t have the same Achilles’ heel, but each one will have its own weakness. If we can identify it, then we know how to activate it to destroy it.”

“PFAS compounds have been so incredibly useful, yet weaning ourselves off of them is not going to be terribly difficult,” says Reynolds. “As long as organizations keep their heads up and are paying at least a marginal amount of attention, it shouldn’t be a terribly difficult to transition away from them, particularly on the packaging side of things. I personally am optimistic about the ultimate resolution of this issue, because people are taking it seriously and the science is showing that we can find solutions.”

 

Image: PFAS Molecule, courtesy of NIST

Romaine Lettuce

Wendy’s Pulls Romaine Lettuce Over E. Coli Concerns

By Food Safety Tech Staff
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Romaine Lettuce

A multi-state outbreak of E. coli led Wendy’s to take the precautionary measure of removing romaine lettuce being used in sandwiches from restaurants in the region of the outbreak.

The CDC reports that as of August 18, 2022, a total of 37 people infected with the outbreak strain of E. coli O157:H7 have been reported from Michigan, Indiana, Ohio and Pennsylvania. The illnesses started on dates ranging from July 26, 2022, to August 8, 2022.

A specific food has not yet been confirmed as the source of this outbreak, but among 26 people who have been interviewed, 22 (86%) reported eating sandwiches with romaine lettuce at Wendy’s restaurants in Michigan, Ohio or Pennsylvania in the week before their illness started. Based on this information, Wendy’s removed the romaine lettuce being used in sandwiches from restaurants in those regions.

A spokesperson for Wendy’s released the following statement: “We are fully cooperating with public health authorities on their ongoing investigation of the regional E. coli outbreak reported in certain midwestern states. While the CDC has not yet confirmed a specific food as the source of that outbreak, we have taken the precaution of discarding and replacing the sandwich lettuce at some restaurants in that region. The lettuce that we use in our salads is different, and is not affected by this action. As a company, we are committed to upholding our high standards of food safety and quality.”

The CDC emphasized that it is not advising that people avoid eating at Wendy’s restaurants or that people stop eating romaine lettuce.

The CDC, public health and regulatory officials in several states, the FDA and the USDA-FSIS are collecting and analyzing data at the ingredient level to identify the food source of the outbreak, confirm whether romaine lettuce is the source and determine if there are any other possible foods that could be the source of the outbreak.

 

Cooked shrimp

FDA Launches Phase Three of AI Imported Seafood Pilot Program

By Food Safety Tech Staff
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Cooked shrimp

The FDA has launched the third phase of its Artificial Intelligence (AI) Imported Seafood Pilot program, which uses AI and machine learning (ML) to strengthen import screening to ensure that foods entering the U.S are safe.

The FDA chose to focus on seafood for the pilot program as more than 90% of the U.S. seafood supply comes from other countries, and the agency has seen food safety concerns for various imported seafood products along different points in the supply chain.

The program was implemented under the New Era of Smarter Food Safety Blueprint, a program that was developed to reduce the number of foodborne illnesses by leveraging technology to create a safer, more digital, traceable food system.

The third phase is designed to improve the agency’s ability to quickly identify imported seafood products that may be contaminated by illness-causing pathogens, decomposition, the presence of unapproved antibiotic residues or other hazards.

The first phase of the pilot, launched in 2019, was an analytical proof of concept. The analysis demonstrated potential for an ML-driven approach to expedite the review of lower-risk seafood shipments, while identifying those of higher risk for violations or refusals. The second phase, conducted in the field, was designed to integrate ML into existing import data systems to inform decisions about sampling by entry reviewers while gaining more experience with training of the ML model. It was launched at all 328 U.S. ports of entry from February 2021 through July 2021. The real-time model was able to analyze an import entry and return a sample recommendation within seconds.

The third phase will help determine the feasibility of deploying in-house AI/ML models using the intelligence that FDA extracts from the data collected while reviewing millions of import entries per year.

The agency notes that ML has the ability to analyze data from various sources to help inform FDA decisions and target resources at the borders. In a related shrimp pilot, the FDA was able to focus on areas of increased risk, such as shrimp contaminated by aquaculture drugs, for foreign inspections. “This includes increased importer inspections, higher rates of sampling and examination, and use of non-traditional tools, such as third-party audits, specific to this commodity. We incorporated the data from this project into the Third Phase of AI Imported Seafood Pilot Program, allowing for a more robust and larger targeted sampling,” said the FDA in a statement to constituents.

 

FDA logo

FDA Announces Two Virtual Events for Food Safety Professionals

By Food Safety Tech Staff
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FDA logo

Registration is now open for the 2022 FDA Retail Food Protection Seminar. Registration for the September 19-22, 2022, event is free and open to all professionals interested in retail food safety, including all state, local, territorial and tribal regulators, standardized officers, industry and academia.

The event provides an opportunity for the FDA and state, local, tribal and territorial regulators to discuss current and emerging issues related to retail food safety. This year’s seminar will have a focus on norovirus, including assessing employee health, investigating norovirus related foodborne illnesses and implementing successful employee health intervention strategies.

A Risk Factor Study Workshop, planned for Thursday, September 22, 2022, will focus on how to design and conduct a Risk Factor Study and cover requirements for Standard 9 of the Voluntary National Retail Food Regulatory Program Standards. The aim of the workshop is to help participants understand different study designs as well as the FDA’s data collection approach, and get an overview on how to conduct a data collection. There will also be a demonstration on the use of FDA’s Risk Factor Study Database.

Attendees can register here.

On August 11 at 1:00 pm ET, the FDA is hosting a webinar to discuss the biennial food facility registration renewal period, the requirement for facilities to have a unique facility identifier (UFI) and general information and guidance on how to register with the FDA.

U.S. and foreign human and animal food facilities that are required to register with FDA must renew their registration this year between October 1 and December 31, 2022.

Nicole Shokatz and Robert Spear from the FDA’s Center for Food Safety and Applied Nutrition, Office of Compliance, will lead the webinar and answer questions submitted during registration.

The agenda includes:

  1. Who needs to register or renew
  2. How to obtain a UFI
  3. How and where to register
  4. The benefits of registering
  5. Questions and Answers

Registration is open until August 10.

Strawberries

FDA Is Focusing on Safety of Frozen Berries

By Food Safety Tech Staff
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Strawberries

On July 22, the FDA announced that it is developing a food safety prevention strategy to enhance the safety of fresh and frozen berries. The move comes in response to multiple hepatitis A (HAV) and norovirus (NoV) outbreaks linked to the consumption of both fresh and frozen berries.

The FDA reports that there have been four HAV outbreaks and three NoV outbreaks linked to frozen berries from 1990 to 2016 in the U.S., and since 2011, there have been three HAV outbreaks linked to fresh berries, including a current outbreak linked to fresh organic strawberries.

In addition, from 1983 to 2018, there were 50 outbreaks globally that were attributed to frozen berries: 36 caused by NoV and 14 by HAV. The FDA noted that although freezing preserves berries it generally does not inactivate viruses that may be introduced at various points in the supply chain, such as by infected workers, contaminated water or contaminated food contact surfaces. In addition, fresh berries are generally eaten raw without a kill-step that could eliminate pathogens.

In August, the FDA plans to resume an assignment to collect and test frozen berries that it paused at the start of the COVID-19 pandemic. The assignment seeks to estimate the prevalence of HAV and NoV in frozen strawberries, raspberries and blackberries and help the FDA identify sites where practices or conditions may exist that constitute safety vulnerabilities.

The FDA also plans to work collaboratively with industry, academia and regulatory partners in the development of a food safety prevention strategy to identify measures that can be taken to limit or prevent contamination from occurring throughout the berry supply chain, approaches to re-enforce control measures and their application as well as areas where additional research is needed.

 

STOP Foodborne Illness
Food Safety Think Tank

Food Safety Culture Webinar To Broadcast Live from IAFP

STOP Foodborne Illness

The FDA and the Alliance to STOP Foodborne Illness have announced that the fourth installment of the “Collaborating on Culture in the New Era of Smarter Food Safety” webinar series will take place on August 3 from 12:15pm – 1:15pm ET.

The webinar, entitled “What More Do You Want to Know About Food Safety Culture?” will be broadcast live from the International Association for Food Protection 2022 Annual Meeting. Speakers and attendees will have the opportunity to engage in a question-and-answer session. Registration is available for both in-person and virtual attendance.

The webinar series was designed to bring together experts from the public and private sectors for a collaborative exchange of ideas and experiences related to the importance of food safety culture in ensuring safe food production.

 

Woman shopping

FDA Seeks Information on Fluorinated Polyethylene Food Contact Packaging

Woman shopping

The FDA is seeking scientific data and input from industry on current food contact uses of fluorinated polyethylene, as well as consumer dietary exposure that may result from those uses. On July 19, the agency issued a request for information due to concerns that fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS).

The FDA authorized fluorinated polyethylene for general use in contact with food in 1983 (21 CFR 177.1615). However, the regulation requires specific manufacturing conditions that must be in place during the fluorination process. In 2021, testing by the Environmental Protection Agency (EPA) noted the migration of perfluorooctanoic acid (PFOA), a type of PFAS, from fluorinated polyethylene containers used to hold pesticides. In response, the FDA issued a letter to food manufacturers, reminding industry that only certain fluorinated polyethylene containers are authorized for food contact use.

The July 19 call for input and data is part of the FDA’s efforts to monitor new scientific information on food contact surfaces (FCS) as it becomes available. “This includes reviewing scientific literature and studies from other regulatory and health agencies in the U. S. and in other countries. Considering recent developments, the FDA is seeking additional information on current practices to ensure the safe use of fluorinated polyethylene in contact with food,” said the FDA in its letter to industry.

Those interested in providing information can submit comments electronically on Regulations.gov to docket number FDA-2022-N-1526.

Submit written/paper submissions with Docket No. FDA-2022-N-1526 for “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information” to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852