Tag Archives: FDA

CDC, FDA, USDA logos

IFSAC to Continue Focus on Finding Sources of Foodborne Illnesses

By Food Safety Tech Staff
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CDC, FDA, USDA logos

The Interagency Food Safety Analytics Collaboration (IFSAC) has published its 2022–2023 Interim Strategic Plan, placing continued emphasis on foodborne illness source attribution for Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. Over the next year, IFSAC will address several short-term goals surrounding improvement of methods to evaluate and identify foodborne illness source attribution through the use of outbreak and non-outbreak-associated disease data, and continued collaboration with external partners in an effort to boost data access and capabilities. The group will be targeting several efforts in the coming year, including:

  • Analysis of trends related to foodborne disease outbreak-associated illnesses over the past two decades, with a subsequent peer-reviewed journal article that reveals results.
  • Development and improvement of machine-learning methods used to predict food sources of illnesses that have an unknown source. WGS will be used to compare Salmonella isolates of known and unknown sources.
  • Collaboration with FoodNet when assessing key food sources for sporadic Salmonella Enteritidis and Campylobacter illnesses. The group will develop case-control studies using specific FoodNet data.

Formed in 2011, IFSAC is a partnership between FDA, FSIS and the CDC that seeks to strengthen federal interagency efforts and maximize use of food safety data collection, analysis and use. During 2022–2023, IFSAC will publish its yearly reports on foodborne illness source attribution for the previously mentioned priority pathogens.

Recall

FDA Continues Investigation of Listeria Outbreak in Packaged Salad

By Food Safety Tech Staff
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Recall

— UPDATE — January 12, 2022

Dole Fresh Vegetables, Inc. has now issued a voluntary recall of Dole-branded and private label packaged salads processed at its Springfield, OH (product ID lot code “W” and “Best if Used By” date December 22, 2021–January 9, 2022) and Soledad, CA production facilities containing iceberg lettuce.

–END UPDATE —

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes illnesses linked to Fresh Express Packaged Salad and Dole Packaged Salad.

Last month Dole Fresh Vegetables issued a voluntary recall for salads processed at its facilities in Bessemer City, NC and Yuma, AZ due to the health risk. The company also temporarily suspended operations at both facilities. The brand names in which the salads were sold under include Dole, Kroger, Lidl, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise and Simply Nature. The products have “Best if Used By” dates between November 30, 2021 and January 8, 2022.

The agencies’ investigation of Fresh Express Packaged Salad resulted in the company stopping production at its Streamwood, IL facility. It also initiated a recall of certain varieties of its branded and private-label salads that were produced at this facility.

The FDA’s investigation into the Listeria monocytogenes outbreak linked to both Dole and Fresh Express is ongoing. Thus far, no deaths linked to the outbreak have been reported.

Jonathan Sharp, Environmental Litigation Group
In the Food Lab

How Baby Food Companies Can Minimize the Concentration of Heavy Metals in Products

By Jonathan Sharp
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Jonathan Sharp, Environmental Litigation Group

On February 4, 2021, the U.S. House of Representatives made public a report concerning the existence of heavy metals in baby food. The heavy metals of concern were cadmium, arsenic, lead and mercury, which pose a tremendous hazard to developing children’s health. After reviewing internal documents and test results from seven of the largest baby food manufacturers in the country, the Subcommittee on Economic and Consumer Policy found each company’s products to contain dangerously high concentrations of heavy metals.

Four of the companies, Nurture, Beech-Nut, Hain and Gerber, responded to the request. They provided internal testing policies, test results for ingredients and finished products, and documentation about how they handled finished products and ingredients that exceeded their internal testing limits.

On the other hand, Walmart, Campbell and Sprout Organic Foods refused to partake in the investigation. The Subcommittee on Economic and Consumer Policy members are very concerned that the lack of cooperation of these manufacturers could obstruct the presence of even higher levels of heavy metals in their products than their competitors.

Practical Measures Baby Food Companies Can Take to Ensure Products Are Safe for Children

Baby food manufacturers may not intentionally add heavy metals to their products, but their lack of testing and a lack of regulation in this sense is a cause for great concern. The main ingredients in baby foods such as rice, sweet potatoes, wheat, and carrots absorb heavy metals from the soil and water and metal-containing pesticides and industrial pollution.

Therefore, the companies that manufacture baby food should tackle the issue of heavy metals at the root of the problem and abide by strict safety measures and protocols to ensure low concentrations of heavy metals, particularly arsenic. Some of the steps that they could take to minimize this issue are the following:

  • Sourcing cereals, fruits, and vegetables from fields with lower arsenic concentrations in the earth
  • Growing crops with natural soil additives that reduce heavy metal uptake
  • Using strains of food that are less prone to absorb heavy metals
  • Altering irrigation practices
  • Preparing the food with excess water that is afterward poured off
  • Blending it with lower arsenic grains in multi-grain products

Subsequently, when the end product is finished, manufacturers should collect a sample from the finite product and test it for cadmium, arsenic, lead and mercury. Fortunately, nowadays, testing baby food for heavy metals is easier than ever and cost-efficient. Every food facility that must comply with FSMA must implement HACCP and establish preventive controls. HACCP, which is recognized internationally, ensures the health and safety of consumers by avoiding hazardous toxins in food. When it comes to baby food companies, they should focus on chemistry testing, as it addresses chemical and physical hazards, including heavy metals.

Alternatively, baby food companies can test their products by using the guidelines of the Environmental Defense Fund. The non-profit advocacy group advises manufacturers to prohibit arsenic, cadmium explicitly, and lead in any packaging or food handling equipment and strictly avoid brass and bronze unless they are confident that no heavy metal was added. Manufacturers of baby food should test the products per se, the ingredients, and the packaging for arsenic, cadmium, and lead. More specifically, companies should:

  • Consistently test baby food and their main ingredients that may be contaminated with arsenic, cadmium, or lead by using the method approved by the FDA and examine potential sources of heavy metals where measurable concentrations are found
  • Periodically test the packaging that comes in contact with food anywhere along the supply chain for arsenic, cadmium, or lead through a CPSC-accepted, third-party certified lab that evaluates baby food for heavy metals

In December of 2019, the cost of heavy metal testing was between $50 and $100 per sample. Nevertheless, companies that produce baby food should invest in heavy metal testing, no matter how small or large. This is the only way of making sure they put exclusively clean and safe products of high quality on the market.

To make sure baby food companies keep following the guidelines concerning heavy metals and do not fail to test their products for these neurotoxins regularly, the authority of the FDA should be expanded. Accordingly, the agency should be able to request a recall of adulterated or misbranded baby food whose concentration of heavy metals exceeds the safe limit. Moreover, the FDA should establish health-protective standards for each heavy metal and implement a testing program for neurotoxins in foods eaten by infants and toddlers that could be similar to the agenda of the Consumer Product Safety Commission for children’s toys.

The Ethical Measures Baby Food Companies Should Take to Avoid Selling Tainted Products

Baby food companies should exercise their social and moral capacity at all times. Nonetheless, while few people achieve the extent of influence necessary to change society itself, the food industry can drastically change societies. Moreover, it can also act in morally beneficial or detrimental ways, which inevitably affects people, the environment, and, ultimately, the planet itself.

To prevent your baby food company from developing unethical conducts, such as allowing dangerous concentrations of heavy metals in the products that end up on the market, there are a series of measures you and the other people who are in charge of the business can take, the paramount being the following:

  • Hiring accredited, trustworthy and competent people is perhaps the most important, as well as the first, step you can take to ensure no foul play will occur, as they will be unlikely to cover up essential information from you and the other higher-ups
  • Sourcing your ingredients from ethical suppliers, that are, preferably, local farmers, as they usually employ transparent business practices
  • Make sure that your facilities are maintained clean 24/7 by hiring the right people to take care of this not-so-easy job as if you neglect the condition of your facilities. Other contaminants may end up in the food you sell
  • Systematically testing your baby food for cadmium, arsenic, lead and mercury to ensure the products you allow to go on the market do not contain dangerous levels of heavy metals
  • Partnering with experienced laboratories to have your baby food regularly tested for heavy metals, which may help you save money if it is going to be a win-win situation
  • Having clear labels, even if you add ingredients that are not so healthy in your products, which will result in the consumers you target trusting you as a company
  • Voluntarily recalling a line of baby food products as soon as you receive the positive test results for one or multiple heavy metals, which will spare you some liability if you willingly take your food off the market

The Changes the Baby Food Safety Act May Bring About if the Bill Becomes Effective

On March 26, 2021, Representative Raja Krishnamoorthi introduced the Baby Food Safety Act, a bill to set maximum limits for each heavy metal in infant and toddler food, which is defined as food manufactured for children younger than 36 months. The initiative was taken because the concentration of neurotoxins in baby food is poorly regulated in our country. There is only a maximum limit for arsenic set by the FDA, which is considered dangerous by multiple other health agencies. It applies solely to infant rice cereals. The other three harmful heavy metals are not regulated at all.

If the Baby Food Act of 2021 becomes effective, companies that manufacture, process, pack or hold baby food need to ensure that their food complies with the limits on heavy metals set by the bill. Furthermore, baby food companies would also have to provide public information, such as test results for neurotoxins in their infant and toddler.

FDA

FDA’s Foodborne Outbreak Response Improvement Plan Seeks to Expedite Investigations

By Food Safety Tech Staff
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FDA

Today FDA released a plan to help the agency and its partners improve the “speed, effectiveness, coordination and communication” of investigations surrounding foodborne illness outbreaks.

“We know that the 21st century has brought new challenges in identifying, investigating and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges,” stated Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network in an agency news release. “We also recognize that today’s U.S. food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products. That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future.”

The Foodborne Outbreak Response Improvement Plan targets four areas that, if improved, will have the greatest effect on foodborne illness outbreaks:

  • Tech-enabled product traceback: Being smarter about using digital technology, regularly, to streamline traceback investigations
  • Root-cause investigations: Adapting and strengthening procedures for conducting root-cause investigations
  • Working with the CDC, USDA’s FSIS and other partners to improve the analysis and distribution of outbreak data (including identifying recurring, emerging and persistent strains of pathogens)
  • Enhancing performance measures across the agency’s food programs to enable better evaluation of the timeless and effectiveness of outbreak and regulatory investigation activities

In addition to this improvement plan, the agency also released “An Independent Review of FDA’s Foodborne Outbreak Response Processes”, which was contracted with the University of Minnesota’s School of Public Health. The independent report played an important role in the development of FDA’s improvement plan.

FDA

FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule

By Food Safety Tech Staff
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FDA

After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.

With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.

The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.

FDA

FDA Publishes Long-Awaited Final Rule on Lab Accreditation

By Food Safety Tech Staff
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FDA

At long last FDA has issued its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). The FSMA rule establishes a lab accreditation program for testing food in certain situations and applies only to accredited bodies and food testing labs that opt to participate in the program; these ABs and labs must fulfill certain eligibility requirements.

“The establishment of the LAAF program will improve the FDA’s capacity to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories,” CFSAN states in a news release.

According to CFSAN, the LAAF will apply to testing that is:

  • “to support removal of a food from an import alert through successful consecutive testing requirements;
  • to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
  • required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
  • required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
  • conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.”

The final rule will be published on the Federal Register on December 3.

Recall

Q3 Food Recalls Drop More than 10%, 2021 Could See Lowest Recall Levels in a Decade

By Maria Fontanazza
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Recall

FDA food recalls fell more than 11% and USDA recalls increased by just one recall in Q3. If this decreased activity continues, 2021 food recalls could fall to their lowest levels in more than a decade.

The drop in recalls is good news, but food companies remain challenged in maintaining and implementing effective employee training. “Health and safety risks related to the coronavirus, combined with labor shortages, mean that companies must double down on training, communication, and accountability, particularly in cases where employees have never worked in food manufacturing,” according to Sedgwick’s Q3 update on U.S. recalls. “All the right protocols and procedures can be in place, but without a skilled workforce and commitment to continuous improvement, no number of written policies and procedures will prove effective. Companies and their quality and safety teams must be ready, willing, and able to embrace new technologies and evolve with new regulatory guidance as the industry innovates.”

FDA Recalls: Notable Numbers (Q3 2021)

  • Recall activity dropped from 106 recalls in Q2 to 94 recalls (11.3% decline)
  • Prepared foods and produce were top categories for recalls, with 13 events each
  • Recalls affected 2.4 million units, a nearly 70% drop from Q2 (7.9 million units)
  • 33% of recalls were Class I
  • Undeclared allergens was leading cause of recall, with milk being the main cause
  • Bacterial contamination came in second for amount of recalls at 25, followed by quality concerns at 11 recalls

USDA Recalls: Notable Numbers (Q3 2021)

  • Recalls increased from 12 to 13 events (quarter-over-quarter)
  • Number of pounds increased from 207,000 pounds to 10.7 million pounds (due to a single recall of ready-to-eat poultry products that affected almost 9 million pounds)
  • Bacterial contamination was the top cause of recalls—Listeria, Salmonella, and E.coli were the named pathogens of concern
  • Eight recalls were due to undeclared allergens
  • Poultry products the most impacted product category

In November alone, there were nine recalls as a result of foreign matter contamination. Learn more about the strategies companies should implement to prevent and detect foreign materials during Food Safety Tech’s upcoming virtual event, “Food Safety Hazards: Physical Hazards”. | Thursday, December 16 at 12 pm ET.

Robert Califf, FDA

President Biden to Make Nomination for FDA Commissioner and USDA Food Safety Head

By Food Safety Tech Staff
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Robert Califf, FDA

President Biden plans to nominate former FDA Commissioner Robert Califf, M.D. to lead the agency once again—in an announcement mainly focused on clinical trials, vaccine approvals, and ending the coronavirus pandemic. Califf briefly served as FDA commissioner in 2016. His tenure was less than a year.

Perhaps more significant news for the food industry is the President’s intent to nominate Jose Emilio Esteban, Ph.D. to the post of undersecretary for food safety at the USDA. Esteban is currently the chief scientist for FSIS and has been in this role since 2018; he has served in the USDA’s FSIS since 2006. Before his time at the agency, he worked for the CDC.

The Senate must confirm both positions.

FDA

Online Food Shopping Becomes New Normal for Consumers, FDA to Ramp Up Food Safety Efforts

By Food Safety Tech Staff
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FDA

Online grocery shopping became essential during the early months of the COVID-19 pandemic. While many consumers have returned to the brick and mortar stores, many others have completely changed how they shop for food, opting for online shopping, whether out of convenience or for safety. The FDA has seen and recognizes this shift and even held a three-day virtual summit last month, “The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers”, to discuss and gain insights into the world of business to consumer e-commerce involving food.

“It is now clear that this is not a trend that will be completely reversed in time but one likely to lead to a new normal in how consumers shop for food, whether it’s from restaurants, grocery stores, or companies providing meal kits and other products,” state Frank Yiannas, deputy commissioner for food policy and response at FDA and Andreas Keller, director, multi-commodity foods, Office of Food Safety at CFSAN on the FDA Voices blog. “Thus, the U.S. Food and Drug Administration is actively working with partners in federal, state, and local government and industry in the U.S. and other nations, as well as with consumer advocates, to help ensure that consumers aren’t ever unwittingly trading food safety for convenience.”

During last month’s meeting, many challenges and questions came up, from how to further prevent food tampering to labeling issues, especially related to allergens, to ensuring that food safety values are shared across all parties involved in producing, transporting and selling food in the e-commerce setting.

FDA announced that it will be reviewing and assessing the information it received during the meeting and is inviting industry to submit public comments now through November 20, 2021 (Docket FDA-2021-N-0929). From there, the agency will determine the critical issues that need to be addressed first.

The daily recordings of the virtual summit are available on FDA’s website.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

It’s Official: FDA Designates New Webpage to Food Fraud

By Susanne Kuehne
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Susanne Kuehne, Decernis
FDA, Food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image Credit: Susanne Kuehne

Food fraud has become such an important issue that many governments are monitoring it much more closely. To keep producers and consumers informed on the latest developments, the FDA has generated a new web page on economically motivated adulteration (EMA). The page includes links on how to report food fraud (including a list of consumer complaint coordinators), important examples of adulteration (i.e., honey, olive oil and seafood), how food fraud is detected and monitored, enforcement and legal consequences such as recalls, seizures and import refusals, guidance documents to assist manufacturers and importers, and a list of import alerts.

Resource

  1. FDA. (November 4, 2021). “Economically Motivated Adulteration (Food Fraud)”.