Tag Archives: FDA

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

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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

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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

 

 

Accreditation

FDA Recognizes JANAAC as an Accreditation Body Under FSMA

By Food Safety Tech Staff
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Accreditation

The U.S. Food and Drug Administration (FDA) has recognized Jamaica National Agency for Accreditation (JANAAC), as an accreditation body under the Accredited Third-Party Certification Program for a period of five years.

Accreditation bodies recognized by FDA have the authority to accredit third-party certification bodies. These certification bodies, once accredited, can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods—both human and animal—that they produce. Those certifications are required to be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program. In addition, those certifications may be used in certain circumstances where the FDA can require that imported products be certified before entering the United States.

JANAAC is being recognized as having the authority to accredit certification bodies with the ability to conduct food safety audits under the following scopes of accreditation:

  • Acidified Foods (AF)
  • Dietary Supplements
  • Juice Hazard Analysis and Critical Control Points (Juice HACCP)
  • Low-Acid Canned Foods (LACF)
  • Medicated Feed Current Good Manufacturing Practices (Medicated Feed CGMPs)
  • Preventive Controls for Animal Food (PCAF)
  • Preventive Controls for Human Food (PCHF)
  • Produce Safety
  • Seafood Hazard Analysis and Critical Control Points (Seafood HACCP)
  • Shell Eggs

For more information on the eligibility criteria for recognition, see Key Facts about the Accredited Third-Party Certification Program.

Gary Nowacki
FST Soapbox

It’s Time To Embrace Ingredient Agility

By Gary Nowacki
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Gary Nowacki

In a recent Politico report, critics blasted the U.S. Food and Drug Administration (FDA) for chronic failures, including instances of contaminated baby formula, outbreaks of contaminated produce and the agency’s institutional reticence to implement changes.[1] Compounding the situation is the most fragmented global supply chain in history, making it a particularly challenging time for food and beverage companies.

Ingredients are the building blocks of the supply chain, so when circumstances threaten their integrity and availability, the ripple effect can linger for weeks, months or even years. As the FDA’s limitations become more apparent and supply chain challenges persist, brands must take responsibility for foundational change that addresses and mitigates risks related to food-, beverage- and supplement-borne illness.

Food Safety and Supply Chain Issues Challenge CPGs

As the Politico coverage pointed out, high turnover at the top of FDA has contributed to the agency’s challenges: five different commissioners have led the FDA over the last three years. In addition to concerns with federal oversight, brands are still navigating a broken supply chain, which has taken a beating over the last few years. And while the damage has come from war, trade tariffs and shipping congestion, food safety also emerged as a culprit when the FDA announced a recall of some of the country’s most popular infant formula brands. In February, the agency announced it was investigating consumer complaints of bacterial infections in four infants who were hospitalized. This bacterial infection might have contributed to death in two cases.[2]

While the recall emerged as a catalyst for the U.S. formula shortage, it wasn’t the only factor. Import restraints and market concentration (four companies produce 90% of the formula sold [3]) contributed to this perfect storm that rocked an already strained supply chain. National out-of-stock rates peaked at 70% near the end of May, and regulators announced that they did not expect relief until July. [4]

In scenarios such as this, the best defense brands can employ is to build a diverse supplier base and agile ingredient supply chain. Relying on a limited number of ingredient suppliers is a risky strategy even under the best of market conditions. But when disaster strikes, it can cripple a manufacturer and grind production to a halt. For the sake of consumers, creating agility and resilience around ingredients and sourcing is critical.

Equally important to cultivating relationships with alternate suppliers is the ability to have quick access to critical data. A robust digital document management system that offers manufacturers a unified view of products, data and processes across the business and the supply chain can help brands ensure they have a resilient ingredients network able to withstand supply chain or ingredient-sourcing issues. CPGs can benefit from instant access to millions of supplier documents to help fast-track sourcing, formulation and recipe development as well as protect themselves from potential disaster.

Pandemic Uncertainty and New Legislation

As the pandemic ramped up in March 2020, the FDA announced it would pause most foreign food inspections.[5] Additionally, regulators moved to virtual audits to keep their inspectors safe from COVID. Recalls fell. The FDA reported 495 recalls in the fiscal year 2020 and 427 in 2021. By comparison, the agency reported 526 recalls in the fiscal year 2019.[6]

The drop in recalls could be attributed to the ongoing rollout of the Food Safety Modernization Act (FSMA), which strengthened food production safeguards. In addition, a proposed rule change to FSMA, Section 204, would enforce better recordkeeping and quicker recall responses. The introduction of the Formula Shortage Reporting Act of 2022, requiring immediate action from manufacturers when future disruptions to production occur, is another step toward stricter food standards.

If passed, Section 204 would require companies who process, pack or hold items on the food traceability list (FTL) to capture and store ingredient data for two years, and submit it within 24 hours of a recall.[7] Without a formal system of record in place to manage food production, tracing ingredients—where, when and from whom they came—is a difficult and complex challenge to solve. Human error, overseas suppliers, recalls and other constantly changing variables all must be tracked and monitored constantly. This diligence demands automation and collaboration at scale.

Collaboration via holistic networked platforms can facilitate that diligence by enabling global ingredients suppliers, CPG brands, co-manufacturers and packing companies to build safer, stronger and more modern supply chain networks. Today, the stakes of not having a modern supply chain and access to real-time ingredient data have grown exponentially beyond profit and competitive advantage to a whole new level of costing lives.

Nimble Access to Ingredient Data is Crucial

On May 27, U.S. Sen. Edward J. Markey, D-Massachusetts, introduced the “Ensuring Safe and Toxic Free Foods Act.” The bill, co-sponsored by Sens. Richard Blumenthal, D-Connecticut, and Elizabeth Warren, D-Massachusetts, would—among other things—strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which allows companies to avoid pre-market approval for food chemicals.[8]

The bill would direct the FDA to revise the GRAS Rule to include provisions that:

  • Prohibit manufacturers from designating substances as safe without supplying proper notice and supporting information to the Secretary of Health and Human Services
  • Require safety information to be publicly available on the FDA website and subject to a 90-day public review period
  • Prohibit carcinogenic substances from receiving GRAS designation
  • Prohibit substances that show reproductive or developmental toxicity from receiving GRAS designation
  • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data regarding GRAS designations

Brands must have easy access to ingredient data to ensure compliance with the GRAS revisions as well as be proactive about food safety. Software that monitors threats and regulatory risks throughout the supply chain in real-time is essential to prevent both food safety issues and supply chain disruptions. These systems transform massive amounts of data into user-friendly, actionable insights for fast and effective risk management.

Food safety remains one of the gravest public health threats to consumers worldwide. The U.S. Centers for Disease Control and Prevention (CDC) insists that foodborne diseases cause 76 million illnesses in the U.S. annually, leading to 325,000 hospitalizations and 5,000 fatalities.[9]

With the FDA still struggling to regain the agency’s pre-pandemic diligence, it’s incumbent on manufacturers to double down on food safety. Digitization—evolving from paper to relevant, real-time data—is a critical component of the path forward to improve safety and increase ingredient agility.

Technology and automation help manufacturers and suppliers work better together, collaborate on ingredient data, move more quickly and problem solve together. In today’s modern supply chain, more CPGs are investing in partnerships to increase agility and gain more resilience over the shocks we’ve seen the past few years. More flexible and collaborative tools for engaging with global ingredient supplier networks can increase safety while improving bottom line efficiency.

References:

[1] Bottemiller Evich, H. (2022, April 8). The FDA’s Food Failure. Politico.

[2] U.S. Food & Drug Administration. (2022, May 12). Powdered Infant Formula Recall: What to Know.

[3] Muller, M. & Nyler, L. (2022, May 20). How US Baby Formula Monopolies Have Failed Families. Bloomberg.

[4] KHN. (2022, May 27). FDA Chief Suggests Stockpile Of Baby Formula Once Crisis Ends In July. Kaiser Health News.

[5] U.S. Food & Drug Administration. (2021, May). Resiliency Roadmap for FDA Inspectional Oversight.

[6] U.S. PIRG Education Fund. (2022, January 31). Food Recalls Decline in 2021, but That Doesn’t Mean Food is Safer.

[7] Govinfo.gov. (2022, June 13). Formula Shortage Reporting Act of 2022.

[8] Ensuring Safe and Toxic-Free Foods Act of 2022. (2022, May 27). Ensuring Safe and Toxic Free Foods Act.

[9] Centers for Disease Control and Prevention. (2018). Estimates of Foodborne Illness in the United States.

 

Peanut Butter

Candies, Protein Snacks and Ice Cream Among Latest Jif Peanut Butter-Related Recalls

By Food Safety Tech Staff
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Peanut Butter

The FDA has posted an updated list of additional recalls related to the multistate outbreak of Salmonella Senftenberg infections linked to certain Jif brand peanut butter products produced at the J.M. Smucker Company facility in Lexington, Kentucky.

The recalls are being conducted by companies that have used the peanut butter as an ingredient in the manufacturing of a new product or in repackaging the product. The recalls include:

Deskins Candies of Bluefield, West Virginia, is recalling the following 16 oz. products: Deskins Candies Peanut Butter Fudge, Deskins Candies Peanut Butter No-Bake, Deskins Candies Peanut Butter Pinwheel, and Deskins Candies Chocolate No-Bake

F&S Produce Co. of Vineland, New Jersey is recalling a limited quantity of Fresh Garden Highway Protein Power Snacks

Taharka Brothers Ice Cream of Baltimore, Maryland is recalling its Peanut Butter Cup ice cream

J.M. Smucker Company has voluntarily recalled Jif brand peanut butter products that have the lot code numbers between 1274425 – 2140425, only if the first seven digits end with 425 (manufactured in Lexington, KY).

Additional information including advice for consumers, restaurants and retailers is available on the FDA Outbreak Investigation of Salmonella: Peanut Butter page.