Food and Drug Administration

What You Need to Know About the FSMA 204 Delay

Mon, 11 Aug 2025 20:06:56 GMT

Last week the Food and Drug Administration announced an official extension to the enforcement date to the Food Traceability Rule of the Food Safety Modernization Act (FSMA). This follows a March notice about its intent to delay.

Angela Fernandez, senior vice president of market development at GS1 US, sat down with The Packer to discuss what was new in this latest announcement and what the produce industry needs to understand about this 30-month delay.

First, the FDA set a new compliance date for enforcement of July 20, 2028. Secondly, Fernandez says this announcement was as much about formality as it was an update to the industry.

Fernandez says any changes, including the extension of the compliance date, needed to go through the Office of Management and Budget (OMB); once the office signed off on the change, a 30-day comment period opened.

“Any changes to the rule require OMB approval as well as public comment periods,” she says.

While the FSMA 204 rule is open for comments, Fernandez says the FDA has signaled that it does not intend to change any of the requirements.

“Organizations have the opportunity over the next 30 days to comment on the rule,” she says. “As much as the FDA is trying to focus on the additional time needed, is 30 months the right time? Are we looking at this the right way, taking into account the implementation challenges that they have heard from industry and from associations? That’s where they’re looking for comments.”

The FDA made available several resources with this announcement. Fernandez says these include examples for specific items to help an organization understand its responsibility with the Food Traceability Rule. The FDA also updated its FAQs around traceability lot code source.

“The FAQs did call out that the global location number, which is a part of our standard that identifies entities or locations, as being acceptable to be able to support this requirement of the rule,” she says. “They noted that the challenges industry is looking at overcoming with this role is around, of course, the data that has to be shared and the extent of that data and recognizing that everybody runs on different systems and different technologies. There was a call out that common data standards are probably going to have to be embraced.”

Fernandez says, in the FAQs, the agency acknowledged the need for some new standards or agreed upon standards for the industry to be able to use as part of the requirements of FSMA 204.

Fernandez says it’s important that organizations understand the data-sharing components of FSMA 204.

“When they’re calling for digital record-keeping and organizations that have certain requirements depending on their role in the supply chain, it could be a lot of data that they have to store and share, and being able to understand that is absolutely critical,” she says. “So, the fact that they’re recognizing that common data standards are going to have to be used, I think it’s just one step towards helping the food supply chain understand how they might be able to achieve those requirements that are laid out.”

And, as always, Fernandez encourages businesses and organizations impacted by FSMA 204 to not delay the process of preparing for enforcement. While 2028 might seem like a long time, she says it’s important that organizations work toward compliance during these 30 so months.

“This additional time just gives them an opportunity to not de-prioritize items and to sit back and wait,” she says. “I think it is a real mistake, because there’s a lot of changes, that happen with people process technology, irrespective of where you fall today in the food supply chain, and the faster you’re able to identify the enhancements you need to make and test that with your trading partners, then you really have assurance that the extension has served your firm well and making sure that you can meet those requirements.”

And she says many trading partners have expectations of traceability information being shared sooner.

“When you look at the largest retailers that really service our food supply chain, and the guidance they put out to their suppliers, their dates are still there,” she says. “They’re testing or going from pilots into implementation with their trading partners. And would encourage folks to just lean into that and be a part of that. Start those conversations with your trading partners if you haven’t yet.”

Having those conversations within an operation’s own supply chain is also a good use of these 30 months, Fernandez says.

“Now is the time to talk to transform your supply chains and lean into the requirements that are coming of extending and sharing that data that a lot of firms are doing internally today,” she says. “But how do we make that acceptable and translatable to the next trading partner, which is also going to give them visibility into where their product is going and how it’s being how it’s being sold or ingested into food items? If we’re truly sharing information back up the supply chain, this unlocks a potential amount of business benefits for organizations.”

FDA Officially Announces FSMA 204 Delay

Wed, 06 Aug 2025 18:13:53 GMT

In a news release , the U.S. Food and Drug Administration said it will propose to extend the compliance date for the Food Traceability Rule, known as FSMA 204, by 30 months.

FSMA 204 establishes additional traceability record-keeping requirements for entities that grow, process, pack or hold foods on this list. FDA says this requires a higher degree of coordination between members of the fresh produce and food industry.

The extension gives covered entitles — which include cucumbers, fresh-cut leafy greens, fresh leafy greens, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, ready-to-eat salads and more — more time to ensure complete coordination across the supply chain.

The agency had announced its intentions to delay compliance back in March .

And in its latest announcement, the agency reiterated this compliance date does not change the requirements of this final rule.

“The proposed compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule, which will improve food safety and protect public health,” the agency said in its update. “The proposal is designed to afford covered entities the additional time necessary to ensure coordination between supply chain partners in order to fully implement the final rule’s requirements.”

The agency cited challenges to meeting the original January 2026 timeline for growers as the need to delay this compliance date.

“The FDA is aware that even among those few entities who are well positioned to meet the final rule’s requirements by January 2026, there are challenges to meeting this timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who might not be similarly situated,” the agency said.

On the agency’s Food Traceability Rule webpage , the following is now available:

New FAQs
New examples of traceability plans for food processors, distribution centers and aquaculture farms and facilities
New supply chain examples for produce, dual jurisdiction facilities and more
An at-a-glance document on the rule
Translations of the above documents into six additional languages (Spanish, French, Chinese, Thai, Vietnamese, Indonesian)

Public comment period open for new nutrition label

Mon, 02 Jun 2025 15:28:24 GMT

The U.S. Food and Drug Administration recently proposed a new front-of-package nutrition label. The proposed label would give consumers of packaged foods a quick-glance shorthand for how a product compares nutritionally. The proposal is open for public comment through the Federal Register through July 15.

The new label would list the serving size — the daily value percentage of saturated fats, sodium and added sugars — and rank those three elements as low, medium or high.

“The proposed rule would provide consumers, including those who have lower nutrition knowledge, with interpretive nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet,” the FDA wrote in its call for comments.

The proposed new label would apply to foods that must currently carry the full nutrition facts label. It would also make slight changes to the wording of certain phrases on the full nutrition facts label.

Public comments can be submitted in the following ways:

Online at Regulations.gov or the Federal Register
Hard copy by mail, addressed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852

Comments will be accepted through July 15 at 11:59 pm EDT. All comments will be published in the final docket as submitted and be publicly available unless commenters follow the instructions for submitting confidential comments, available at the online comment opportunities.

FDA to delay FSMA 204 compliance date by 30 months

Fri, 21 Mar 2025 17:36:23 GMT

The Food and Drug Administration says it will delay the compliance date for the Food Traceability Rule, known as FSMA 204, by 30 months . The agency said it will use appropriate procedures at a later time to extend this compliance date and will publish a proposed rule in the Federal Register.

The FDA says it is committed to a successful implementation of the full requirements of this rule, which will allow for faster identification and removal of potentially contaminated food from the market.

“The compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule, which will improve food safety and protect public health,” the agency said in a news release.

The extension gives covered entitles — which includes cucumbers, fresh-cut leafy greens, fresh leafy greens, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, ready-to-eat salads and more — more time to ensure complete coordination across the supply chain.

FSMA 204 establishes additional traceability record-keeping requirements for entities that grow, process, pack or hold foods on this list. The FDA says this requires a higher degree of coordination between members of the fresh produce and food industry.

To achieve the full public health benefits of the final rule, all covered entities must be in compliance, the agency says.

“Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated,” the FDA said in the release. “Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.”

The agency said it will continue to work with stakeholders to identify solutions to implementation challenges during this 30-month delay.

Enoki mushrooms recalled for possible health risk

Mon, 21 Nov 2022 21:05:12 GMT

Vernon, Calif.-based wholesaler Green Day Produce recently recalled packages of enoki mushrooms for possible listeria contamination, and suspended distribution.

The recalled mushrooms were sold nationally to distributors and retailers from September 2022 to October 2022, according to a Nov. 17 announcement.

The potential for contamination was discovered by a sample analysis from the Michigan Department of Agriculture and Rural Development. Testing determined the presence of listeria in a 200-gram/7.05-ounce package of Enoki mushrooms. The recalled enoki mushrooms were a product of Korea.

No illness has been reported to date in connection with the recalled product.

Enoki mushrooms are white, leggy mushrooms, often sold in bunches, sealed in clear, plastic packaging. These mild, slightly crunchy mushrooms are popular in Japanese, Chinese and Korean food, where they are often enjoyed cooked in soups, hot pots and stir-fried dishes. Enoki mushrooms are also called enokitake, golden needle, futu or lily mushrooms.

Related news: One (or two) more mushroom purchases a year could mean tens of millions

Enoki and wood ear mushrooms have recently gained attention by the Centers for Disease Control and Prevention in recent years. The CDC posted a warning after a 2020 outbreak, urging consumers and restaurants to cook enoki mushrooms to thoroughly kill any foodborne germs.

What is listeria?

Listeria is an organism that can cause serious and even fatal infections in children, frail, elderly or pregnant people or others with weakened immune systems, according to the Food and Drug Administration. Common symptoms include high fever, headache, stiffness, nausea, abdominal pain and diarrhea.

According to the CDC, symptoms of severe listeria typically start two weeks after eating contaminated food but can start as early as the next day.

What you can do

If you have purchased any 200-gram/7.05-ounce packages of Enoki mushrooms from Green Day Produce with a UPC reading 16430-69080 on the back side of the package, return the product for a full refund.

Questions about the product or recall can be directed to Green Day Produce Inc. at (323) 587-4688 or william@greendayinc.com .

FDA unveils Food Traceability Final Rule

Wed, 16 Nov 2022 19:01:27 GMT

The Food and Drug Administration released its 600-plus page Food Traceability Final Rule on Nov. 15, 2022. The weighty tome outlines the FDA’s additional record-keeping requirements for manufacturers, processors, packers and shippers of foods on the FDA’s Food Traceability List, which includes fresh produce staples. Foods subject to the final rule requirements were determined based on factors Congress identified in Section 204 of the FDA Food Safety Modernization Act.

“To help ensure the safety of food and its ingredients through all steps in its journey, we must get better at following its movement. It’s just that simple,” Frank Yiannas, FDA deputy commissioner for food policy and response, said in a stakeholder call following the announcement.

At the heart of the final rule is the expectation that individuals contacting food will record critical facts associated with key milestones in the food supply chain journey, such as harvesting or cooling. Specifically, the FDA expects persons contacting food on the Food Traceability List to record “key data elements” at “critical tracking events” and provide this information to the FDA within 24 hours or a pre-arranged timeframe.

“Having this information is going to let us alert the public more rapidly to avoid certain food in the event of a food outbreak,” Yiannas said. “It’s going to allow us to remove contaminated food quicker from the marketplace as a secondary prevention, and it’s going to help us become more effective at rapidly evaluating why the outbreak happened in the first place. We’ll be able to conduct root cause analysis so that we can prevent these outbreaks from happening again.”

This rule will cover domestic production throughout the entire food supply chain, as well as foreign companies producing food for consumption in the U.S.

What is the Food Traceability List?

The Food Traceability List is the FDA’s roundup of specific foods that require additional record-keeping requirements under the FDA’s Food Safety Modernization Act Section 204 and includes the many fresh produce commodities.

According to the FDA’s Katie Vierk, director of the division of public health informatics and analytics, the foods on the list were determined using a risk ranking model that considered factors such as frequency of outbreaks and occurrences of illnesses, as well as criteria such as the likelihood of contamination and potential for pathogen growth.

Key dates to know

Jan. 20, 2023: Estimated date that the Final Rule goes into effect, following a 60-day waiting period after publication.
Jan. 20, 2026: Enforcement date. Compliance and record-keeping requirements go into effect.

What this means for fresh produce

“Rule 204 will go a long way toward enabling faster response to recalls and outbreak investigations, ultimately protecting public health and fostering consumer confidence,” Alyson Sharron, vice president of marketing at iFoodDS, told The Packer. “While the compliance date of Jan. 20, 2026, is seemingly light-years away, Rule 204 is complex — especially for grocers, foodservice operators, processors and independent distribution centers.”

Jason Varni, senior director of solutions at iTradeNetwork, noted that many companies already collect the data they need for compliance with Section 204. Further, he’s encouraged by the concerted effort from groups like GS1, International Fresh Produce Association and Canadian Produce Marketing Association to provide guidance on data sharing across the supply chain.

“The FDA was very measured in taking into account the feedback and concerns it received over the past two years from those subject to the FSMA 204 rule. It has been reorganized in several ways to make compliance less complicated and more approachable,” Varni told The Packer. “It will allow companies to find manageable ways to capture, store and share the required Key Data Elements with their trading partners.”

The final rule was informed by over 1,100 stakeholder comments, according to the FDA. The agency took the feedback into consideration when drafting requirements, timelines and exceptions. The FDA says its aim is to create a universal traceability language through FSMA rulemaking. This vision, leveraged with greater tech-enabled traceability capabilities and compliance expectations, will “connect the dots and allow traceability to scale a little bit easier,” Yiannas said.

How to prepare for compliance

“IFPA is committed to working with the FDA to help our members understand and comply with the requirements of the final rule,” Ed Treacy, vice president of supply chain and sustainability at the International Fresh Produce Association, said in a news release. “We appreciate that the major concerns we had about the draft rule have been addressed. We encourage our members to participate in upcoming opportunities to learn more about how this rule impacts their business.”

According to Sharron at iFoodDS, businesses that begin the process of implementing record-keeping plans now will gain a competitive advantage. “iFoodDS welcomes the opportunity to work with customers on solutions that work seamlessly with their workflows and enable supply chain collaboration, visibility and insight,” Sharron said.

Varni sees this moment as an opportunity to improve end-to-end traceability. “At iTradeNetwork, we have been working for over 20 years to connect companies upstream and downstream within the supply chain. We are very excited to partner with our member companies to not only achieve compliance for FSMA 204 rules and protect consumer health, but also realize the many ways these efforts will actually provide real ROI in terms of operational benefits and increased efficiencies,” he said.

The first step is to determine applicable food items included on the FDA Food Traceability List . Second, the FDA offers a tool to determine what, if any, compliance exemptions apply to specific operations.

The FDA will host a webinar on Dec. 7, 2022, providing an overview of the Final Rule.

On Dec. 14 at 12 p.m. EST, IFPA will host a virtual town hall, “FSMA 204 Traceability Final Rule,” moderated by Ed Treacy, IFPA traceability expert.

Wegmans voluntarily recalls microgreens, sweet pea leaves, cat grass

Wed, 28 Dec 2022 22:22:04 GMT

Rochester, N.Y.-based Wegmans Food Markets issued a voluntarily recall on its products containing microgreens, sweet pea leaves and cat grass because of potential salmonella contamination, according to the U.S. Food and Drug Administration .

Wegmans is voluntarily recalling these products because some of the soil they were grown in, supplied to Wegmans Organic Farm by bio365 of Ithaca, N.Y., tested positive for salmonella by the supplier, according to a news release. This is out of an abundance of caution. No illnesses have been associated with this recall.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

The affected products were sold at various Wegmans stores in New York, Pennsylvania, Massachussetts, New Jersey, Virginia, Maryland and North Carolina.

Suspected products include:

Wegmans Organic Farm & Orchard Micro Greens, a 1.75-ounce package with a universal product code of 77890-25036 and use-by dates of Dec. 17, 2022 and Dec. 24, 2022.
Wegmans Organic Baby Kale & Baby Spinach with Sweet Pea Leaves, a 5-ounce package with a universal product code of UPC 77890-52377 and a use-by date of Dec. 20, 2022.
Wegmans Organic Farm & Orchard Cat Grass, one each with a universal product code of 77890-50938, sold since: Oct. 25, 2022.

Wegmans is placing automated phone calls to alert customers who purchased these products using Shoppers Club cards.

Customers should return these products to the service desk for a full refund. Those with questions may contact Wegmans Food Markets at 1-855-934-3663 8 a.m. to 7 p.m. weekdays and 8 a.m. to 5 p.m. weekends.

Wegmans Food Markets, Inc. is a regional supermarket chain with 109 stores along the East Coast. The family company celebrated its 100th anniversary in 2016.

Wegmans has been named one of the “100 Best Companies to Work For” by Fortune magazine for 25 consecutive years, ranking No. 3 in 2022. The company also ranked No. 5 for corporate reputation among the 100 most visible companies, according to the 2022 Axios Harris Poll 100 Reputation Quotient study.

Industry responds to how FDA redefines 'healthy' labeling

Mon, 06 Mar 2023 22:33:02 GMT

Grocery shoppers rely on food packaging information to make informed decisions about their purchases and health, so when a box of granola bars says “healthy” and a bag of carrots doesn’t, the message can be misleading — even when it seems like common sense.

The word “healthy” may soon be redefined , and our industry has some thoughts about it.

After all, the rules on this marketing claim were last updated in 1994.

The Food and Drug Administration has proposed that food products bearing “healthy” claims will need to contain certain amounts of food from recommended food groups, or food group equivalents (FGE). For example, a half-cup equivalent of vegetable equals one FGE of vegetable.

The FDA’s proposed new rule on the voluntary marketing claim of “healthy” on food packaging is based on modern nutrition science, federal dietary guidance — especially the Dietary Guidelines for Americans, 2020-2025 — and the updated Nutrition Facts label.

Read: The FDA’s proposed rule on the Federal Register

The International Fresh Produce Association included this kind of labeling policy among its eight recommendations at the White House Conference on Hunger, Nutrition and Health . IFPA also sent comments to the FDA on its proposed new rule.

“Big picture: Beyond produce, the percentage of products on the market that meet the old and new healthy definition is low, so a voluntary healthy claim does not go far enough to promote transparency and empower consumers to help meet dietary guidelines,” said Mollie Van Lieu, IFPA’s vice president of nutrition and health.

Similarly, the Center for Science in the Public Interest generally supports the adoption of these food group requirements, but it also says the proposed requirements for fruits and vegetables are insufficient.

“The proposal could be improved in several ways, including by strengthening the whole grain, fruit and vegetable requirements and ensuring that terms like ‘wholesome,’ ‘nutritious’ and ‘heart healthy’ are considered implied ‘healthy’ claims,” the center wrote in its Feb. 16 comments to the FDA.

A core component of IFPA’s work has been increasing fruit and vegetable consumption through federal policy and programs, including effective and transparent labeling, according to the Feb. 16 comments.

IFPA pointed out in these comments several other opportunities the FDA has to address deceptive and misleading labeling, particularly around fruits and vegetables.

Why this labeling matters

The Centers for Disease Control and Prevention reports that only 1 in 10 Americans are meeting recommended consumption rates.

“Food and nutrition labeling touches every consumer regardless of socio-economic status. While we must focus on those who are most nutrition insecure, almost all Americans under-consume fruits and vegetables,” IFPA’s comments to the FDA said. “Every time a consumer seeks nutritious food and is sold a food or beverage that undermines their health, it is a missed opportunity to reduce diet-related disease.”

About 45% of adults have diabetes or prediabetes, according to a 2017 report from the National Center for Chronic Disease Prevention and Health Promotion.

Consumers pay attention to labels, IFPA said.

More than half of consumers look at the Nutrition Facts Panel or ingredient list “often” or “always” when making a purchasing decision, and about 40% say they consider other labeling statements about health or nutrition benefits, according to the 2018 Food and Health Survey from the International Food Information Council Foundation.

“Labeling transparency is a valuable tool for assisting consumers in making healthful choices and following dietary guidance” IFPA’s letter said.

Go further

IFPA supports the agency’s proposed decision to include all raw, whole fruits and vegetables as meeting the “healthy” definition without any additional requirements for food group equivalents or nutrients to limit.

But, as the Dietary Guidelines for Americans (DGA) includes cut, sliced, diced or cubed produce in its definition of “whole” produce, IFPA encouraged the agency to ensure that individual servings of whole fresh produce that are cut, sliced, diced and cubed for convenience, and have no added nutrients to limit, are not excluded in this new rule.
The FDA needs to finalize the requirement-exclusion decision about raw fruits and vegetables. Because raw produce is often sold in bulk with no packaging, a requirement that this type of produce meet the half-cup equivalent requirement would be unrealistic, disincentivize retailers or marketers from using “healthy,” and runs counter to the intent of the rule to increase consumption of foods consistent with DGA healthy eating patterns.
As the agency considers concentrated purees, pastes, powders and dried products, IFPA encouraged FDA to consider how much of these products people actually eat so it’s consistent with the DGA recommendations. Even when these products don’t meet the “healthy” definition, they often imply more meaningful amounts through depictions of fruits and vegetables or including the names of the produce in product descriptions, which can be confusing and misleading. That marketing tactic needs to be considered.
The FDA’s proposed rule indicates that a half-cup equivalent of fruit or vegetable juice would qualify for “healthy,” when the DGA recommends no fruit or vegetable juice for children younger than 12 months and no more than 4 ounces of fruit juice, if absolutely necessary, for people more than 2 years old. There needs to be mechanism to communicate to the consumer at point of purchase that juices should be limited — especially considering the sizes of juice bottles. Also, proposed changes to the WIC food package recommend limited or no juice in the food package, which can be confusing when one set of dietary guidelines conflicts with a “healthy” claim on fruit and vegetable juice products.

“Given the DGA recommendations to consume mostly whole fruits and vegetables, the agency must be mindful of whether a healthy claim could drive consumers to select juices over whole or cut fruit and vegetables,” IFPA’s comments said.

Also, IFPA wrote, “the agency must consider that nearly half of Americans currently live with diabetes or prediabetes, and that juice is generally suggested to be limited for this population. FDA should consider the implications of allowing a healthy claim or logo to apply to fruit and vegetable juices.”

IFPA included considerations for food marketed toward caregivers of babies and children younger than 2.

Related news: CDC: Small children aren’t eating vegetables (Me: No kidding!)

The association also warned about depictions of fruits and vegetables and deceptive labeling.

Consider requiring foods making fruit and vegetable claims (through words or depictions) to disclose the quantity of fruits and vegetables per serving in household measures. For example, “contains 1/8 teaspoon of strawberries per 1-cup serving.” The declaration should be specific to the type of fruit or vegetable depicted or mentioned in claims, to avoid creating a lack of transparency that unfairly depicts that more desirable or expensive ingredients, such as spinach or strawberries, predominate in a food when they do not.
Foods that contain fruit or vegetables that are not in their whole or cut form (without added sugar or sodium) should not be counted toward the amount of fruit in the declaration (for example, powders, concentrated fruit juice or purees). A required disclosure should also indicate that the “The Dietary Guidelines for Americans recommends that at least half of your daily amount of fruit intake should be from whole fruits.”
If a food is lacking in fruits and vegetables and contains only fruit or vegetable flavoring, it should bear a disclosure: “Contains no real fruits/vegetables.”

Consumer Reports applauds approval of FDA’s human foods program reorganization

Thu, 30 May 2024 20:22:37 GMT

Consumer Reports is praising the approval of the Food and Drug Administration’s reorganization of its human foods program .

The reorganization aims to more effectively protect public health from foodborne illness outbreaks and other food safety risks, according to a news release. Implementation of the plan is set to begin on Oct. 1.

“Consumers depend on the FDA to be effectively organized and governed to ensure our food is safe,” Brian Ronholm, director of food policy at Consumer Reports, said in the release. “Today’s announcement is a major step forward and much credit goes to [FDA] Commissioner [Robert] Califf for facilitating the process to get to this point.

“We recognize that a significant amount of work remains to be done because a meaningful change in culture does not happen overnight,” Ronholm continued. “We look forward to working with the FDA to ensure this plan is effectively implemented so that it can carry out its critical mission to protect the public from food safety risks.”

In 2022, Califf ordered an external review of the agency’s office of food safety following widespread criticism of its handling of the infant formula crisis, the release said. Later that year, the Reagan Udall Foundation issued a report that concluded that the FDA’s culture, organizational structure and governance model have undermined its effectiveness. The report validated many of the concerns about the FDA raised by Consumer Reports and a diverse coalition of consumer groups, industry leaders, and state and local regulators, the release said.

FDA extends comment period for draft introduction of food safety guidance

Thu, 30 May 2024 14:57:10 GMT

The Food and Drug Administration is extending the comment period for the introduction, and Appendix 1, of the draft guidance on Preventive Controls for Human Food by an additional 60 days.

The revised sections of the draft guidance were published on Feb. 2 and were initially open for comment until June 3, 2024. The new deadline for comments is August 2, the FDA said.

The agency said it is extending the comment period in response to stakeholder requests to allow additional time for interested persons to develop and submit comments.

Electronic comments can be submitted through the Federal eRulemaking Portal at regulations.gov . Written comments should be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions received must include the docket No. FDA-2016-D-2343 .

New Era of Smarter Food Safety is upon us

Fri, 13 Nov 2020 06:40:40 GMT

The Food and Drug Administration’s New Era of Smarter Food Safety and corresponding “blueprint” that guides the process are not a quick fix to outbreaks that led regulators to seek new answers.

The FDA, which released the New Era details and blueprint on July 13, said it’s a 10-year plan. As expected, it leans heavily on technology, particularly in traceability and outbreak responses.

Former FDA Commissioner Scott Gottlieb, whose tenure included several E. coli outbreaks linked to romaine lettuce, voiced concerns about the lack of technology hampering investigations, and said it would be a priority for the FDA.

In introducting the New Era plan, FDA Commissioner Stephen Hahn on July 13 said it’s important the technology is used “to build and put in place more effective approaches and processes.”

The blueprint plan has four core elements:

Tech-enabled traceability;
Smarter tools and approaches for prevention and outbreak response;
New business models (such as e-commerce) and retail food modernization; and
Food safety culture.

Hahn said the blueprint to implement the New Era builds on the work the FDA has taken with the Food Safety Modernization Act, and is the next stage in the process.

Each of the core elements are assigned leaders from the FDA’s foods program .

“We want to explore ways to encourage companies to adopt tracing technologies and also to harmonize efforts to follow food from farm to table,” Hahn said in his statement.

“We should strive to speak the same language, by espousing similar data standards across government and industry for tracking and tracing a food product.”

‘No surprises’

Jennifer McEntire, the United Fresh Produce Association’s vice present of food safety and technology, said the blueprint doesn’t include any surprises, and is a “solid outline of where food safety should be headed.”

Questions, McEntire said, include:

Will early adopters be rewarded by customers/consumers for embracing some of these initiatives?
What will incentivize those who lag behind?
And who is going to measure progress over these next 10 years?

“The blueprint covers a lot of ground and I’m curious to see the areas that move quickly and the ones we’re still talking about a decade from now,” she said.

Trevor Suslow, vice president of produce safety at the Produce Marketing Association , said the blueprint has few unanticipated, but all generally welcomed framework elements to advance food safety. Trade associations will continue to be involved in the process, he said.

“One key opportunity for the produce industry is to respond to the oversight management incentives described by FDA by moving beyond mere baseline compliance with investment in broad advancements in food safety systems, including end-to-end traceability and verifiable food safety culture,” Suslow said.

Preventing outbreaks

Inside the FDA, plans include strengthening procedures and protocols for conducting root cause analyses to understand how food becomes contaminated in the hopes of preventing it in the first place.

“Another example of the kinds of new tools we’re developing for prevention can be seen in a pilot program we’re conducting that will leverage artificial intelligence and machine learning to strengthen the agency’s review of imported foods at ports of entry to help ensure that they meet U.S. food safety standards,” Hahn said in the statement.

Hahn said the FDA was days away from announcing the blueprint details in March when the pandemic delayed it and work turned to address COVID-19.
“In the months that have followed, it has become even clearer — from our experiences with the pandemic and the lessons we have been learning as part of the FDA’s response to it — just how essential the actions outlined in this blueprint are and, if anything, that they are more important now than ever,” Hahn said in his statement.

According to the blueprint, the FDA plans to engage members of the industry, academics, trade associations, consumer groups and regulators agencies and groups it traditionally has not worked with before, including technology companies.

“We recognize that building on our food safety approach in a rapidly evolving and interconnected world will require resources and innovation,” according to the blueprint.

“Continued investments throughout FDA and the food safety system will be critical to improving public health and reducing supply chain disruption.”

The FDA has a FAQ list on its New Era for Smarter Food Safety website .

A 10-year plan

In a July 13 media call, Frank Yiannas, deputy commissioner for food policy and response for the FDA, said some of the document’s aspects will be addressed by the end of the year, but the FDA sees the blueprint as a decade-long pursuit with evolving activities.

One of the issues the agency is working on right now is Section 204 of the FSMA: Enhancing Tracking and Tracing of Food and Recordkeeping, a component of which requires the FDA to designate high-risk food that would require additional recordkeeping.

During the media call, Yiannas said the “one step forward, one step back” model of traceability is no longer the goal, and although Section 204 doesn’t address technology or set an end-to-end traceability standard, that’s the desired goal.

“We are approaching that rule with what we call a 21st-century mindset,” he said.

“We are limited by what we can say about rulemaking, but what I can say to you is that we are being thoughtful and thinking about what our key elements for traceability purposes are.”

The blueprint doesn’t ban paper records, but it is becoming increasingly difficult to meet expectations, and retail partners are becoming more aware of supplier’s methods and exerting more pressure on growers to modernize.

He said the concept of a linear “supply chain” doesn’t apply to the food supply, and he prefers “food system.”

“The idea or notion that everybody can get into a central database and track foods easily is just too simplistic, so what we’re trying to do is to be very intentional and strategic,” Yiannas said.

Many outbreaks are linked to foods bought at retail and not foodservice, he said, and the FDA is interested in a retail food safety summit to address the issue.

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Year in Produce No. 2 — Food Safety

FDA official promises new era of food safety

FDA calls for ‘New Era of Food Safety’

Moorman outlines plan for new era of smarter food safety

Fri, 13 Nov 2020 06:44:24 GMT

Food and Drug Administration official Mark Moorman acknowledges that the “smarter” era of food safety has not yet arrived.

Moorman, director of FDA’s Office of Food Safety, spoke about the agency’s food safety goals on Aug. 20 at the U.S. Apple Association’s online 125th Annual Crop and Outlook Marketing Conference.

Recall of onions from Thomson International Inc., Bakersfield, Calif., were still occurring as of Aug. 20, Moorman said.

“We’re sitting here three weeks later and the companies that received those onions are just now recognizing these onions are bad and they’re having to pull back,” he said. “For three weeks my family and yours have been exposed to bad onions, and you know what? That’s not OK.”

He reviewed the four pillars of the New Era of Smarter Food Safety :

Tech-enabled traceability;
Smarter tools and approaches for prevention and outbreak rsponse;
New business models and retail modernization; and
Food safety culture.

He said the vision for the future is for a much more responsive food safety system, with end-to-end traceability.

“What if you were scanning a bag of lettuce at the grocery store, and (the cashier) immediately knew where it came from?” Moorman said. “And you knew that it was tagged as linked to an outbreak of foodborne illness? Or better yet, what if you scan that bag of lettuce and the register didn’t let you take it home?”

The FDA and the public health infrastructure use technologies that identify tainted more quickly, and traceability can help track those foods through the supply chain.
By direction of Congress and a court order, FDA must issue a list of high-risk foods in September that will carry enhanced traceability requirements.

He said the FDA is “technology agnostic.”

“I don’t care what the technology is that enables this to happen, we’re trying to find ways to incentivize (traceability), to pull together the various partners to make this happen,” he said.
Genetic sequencing is allow health officials identify contaminated food more quickly.

One of the “New Era” goals is more consistent investigations.

“What we really want to get to point of where there is some standardization of investigations at the federal, state, local, tribal and territorial level, and we all have a standardized investigation approach of root cause analysis, and that we share those results,” he said.

Analyzing big data can also be valuable, he said. The rise of online grocery food deliveries will draw increasing food safety scrutiny at the FDA, he said.

“There are lots of questions that need to be asked in this space,” Moorman said. “Just because there (are) new exciting business models doesn’t mean it’s safe.”

The FDA plans to work with the U.S. Department of Agriculture to improve the way recalls are communicated. The agency also is doing research in behavioral sciences to understand how food safety culture can be changed within an organization or company.

“I want to be very clear with this group looking very hard and in our own culture and we are asking ourselves how do we influence consumer behavior,” he said.

Asked whether apples are low risk because they don’t come in contact with the ground, Moorman noted the current recall of peaches, which are linked to an outbreak of salmonella.
“I would agree in general that apples are a lower-risk (food), but all of us should remain humble, and recognize that the world of microbiology is causing us to rethink assumptions,” he said.

The Packer’s Food Safety Coverage

The Packer’s FDA Coverage

The Packer’s Apple Coverage

LGMAs adopt numerous changes on water, sanitation

Fri, 13 Nov 2020 06:44:34 GMT

The California Leafy Greens Marketing Agreement has made more than 50 changes to rules as the group continues a review of its practices following E. coli outbreaks in recent years.

The Arizona LGMA has made similar changes, according to a news release.

The LGMA established subcommittees this year to address specific parts of the food safety process, and the ones for farm water use and field/equipment sanitation have met numerous times in recent months, according to CEO Scott Horsfall. They focused on new research, examine outbreak findings and gather input from food safety experts, he said in the release.

Many of the changes approved by the LGMA board recently strengthen existing rules, several substantive changes have been made, according to the release.

Those changes include:

Requirements to ensure the safety of water used during overhead application of pesticides and crop protection materials, similar to rules added last year that require open water sources — such as a canal or reservoir — applied via overhead application must be treated to eliminate pathogens during the previous 21 days before harvest;
Added regular water quality tests and sample collecting requirements throughout irrigation systems;
Addressed the risk of water applied via furrow irrigation from coming into contact with any edible portion of leafy greens;
Updated practices for cleaning harvest equipment, containers, tools and bathroom facilities in and near leafy greens fields; and
Preventing the cut end of leafy greens from coming into contact with the ground during harvest.

“The LGMA is committed to strengthening required food safety practices throughout our processes,” Dan Sutton, California LGMA chairman and general manager of Pismo-Oceano Vegetable Exchange in San Luis Obispo County. “We are doing everything possible on our farms to prevent future foodborne illness outbreaks.”

The LGMA will be educating members on how to comply with the new standards.

Subcommittees on soils amendments/inputs and adjacent lands are working on more changes to LGMA standards. The group is interested in adjacent lands that have livestock, and how to ensure E. coli isn’t transferred to crops via water or other means.

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LGMA considers water standard updates, soil amendments next

Seminar covers what companies should be doing in pandemic

Fri, 23 Sep 2022 21:28:08 GMT

Three federal agencies are hosting a web seminar to update food companies on COVID-19 pandemic operating guidelines.

The Food and Drug Administration, Centers for Disease Control and Prevention, and the Occupational Safety and Health Administration have scheduled the seminar from 2:30-3:30 p.m. Eastern Sept. 1.

The event, according to a news release, will:

Highlight the Employee Health and Food Safety Checklist for Human Food Operations During the COVID-19 Pandemic ;
Discuss CDC testing strategy; and
Provide an update on FDA inspections.

The web seminar will be recorded and posted on the FDA’s website.
Registration will close at 5 p.m. Eastern on Aug. 28 . Space is limited, according to the FDA.

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California LGMA survey looks at members’ traceability plans

Fri, 13 Nov 2020 06:46:34 GMT

Members of the California Leafy Greens Marketing Agreement, who grow an overwhelming majority of the lettuce and other leafy greens in the state, and 80% of the U.S. lettuce, say they’re capable of quickly tracking recalled products.

The LGMA conducted a survey of members , who are required by the group’s bylaws to have a system to trace back to the field from which it originated to the customer who bought it from the grower, a one-step forward, one-step back traceability model.

“Verification that a traceback system is in place happens every time an LGMA member is audited by the government, which occurs about five times per year under our program,” Scott Horsfall, CEO of the California LGMA, said in a news release. “We can say with confidence that 100% of our members have a traceback system in place.”

The survey was designed to help the group better understand how growers’ traceback systems are helping health and regulatory agencies in outbreak investigations, according to the release — and if additional requirements could improve the speed/accuracy in tracking product in future outbreak.

Even before the Food and Drug Administration made updating tracking technology in the industry a priority of its New Era of Smarter Food Safety, former FDA Commissioner Scott Gottlieb noted that investigations into the source of romaine lettuce tainted with E. coli would benefit from increased technology in the grower-shipper community.

Gottlieb noted that investigators were handed printed records for traceability verification, and even hand-written notes, which prolonged the investigation.
Fifty-two of the 93 LGMA growers responded to the survey, representing a cross-section of processors, growers and shippers of varying sizes.

According to the LGMA survey, 15% of LGMA member still use paper-based tracking systems.

“We’ve heard reports from government investigators that too many traceback systems involve antiquated paper-based systems,” Horsfall said in the release. “We did find that some (15%) of our members use paper-based systems, but the majority are using electronic systems.”

Horsfall said it’s important to note that all respondents reported being able to trace back to a field within two hours, regardless of systems they use.
Sixty-three percent of respondents use the voluntary Produce Traceability Initiative for labeling and traceback, he said.

“What we can conclude from this survey is that LGMA members are collecting detailed information through their traceback systems.” Horsfall said in the release. “But, in practice, traceback systems within the supply chain are not working as quickly as needed.”

The LGMA and industry needs to work with the FDA to determine how traceback systems at the grower-shipper level can better assist in investigations, he said.

Horsfall said the LGMA supports an ongoing project coordinated by several food industry associations including United Fresh Produce Association and the Produce Marketing Association to examine and test traceback capabilities throughout the supply chain.

The Leafy Greens Traceability Pilot involves the United Fresh Produce Association , Produce Marketing Association and others is looking at traceback capabilities in the supply chain.

Jennifer McEntire, senior vice president of food safety and technology at United Fresh, said in the release the pilot will help find what information can be quickly shared in a format that allows it to connect the supply chain.

“The insights from the pilots will aid in more quickly and effectively locating the source of contamination during an actual outbreak,” she said in the release.

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FDA calls for ‘New Era of Food Safety’

FDA proposes heightened traceability rules for certain produce

Fri, 13 Nov 2020 06:46:49 GMT

The Food and Drug Administration has proposed new traceability rules that seek elevated record-keeping for many fresh produce items, from all fresh-cut products to leafy greens and tomatoes.

Starting Sept. 23, there will be a 120-day public comment period on the new rule through the Federal Register. A draft is available for viewing until then. The rule is a key component of the FDA’s New Era of Smarter Food Safety and implements the long-awaited Section 204 of Food Safety Modernization Act.

Frank Yiannas, FDA deputy commissioner for food policy and response, said the agency seeks to harmonize and standardize record-keeping process to ease investigations. The FDA will still allow paper records, but all companies in the supply chain should be able to submit an electronic spreadsheet containing traceability information within 24 hours.

“More generally, the FDA encourages all food businesses to maintain their traceability records electronically whenever possible, to expedite the identification of traceability information when needed to address threats to public health,” according to an FDA news release.

Yiannas acknowledged that many in the produce industry have adopted voluntary traceability standards, whether through the Produce Traceability Initiative or the California/Arizona Leafy Greens Marketing Agreement.

But the current one-step forward, one step back requirement, is lacking, according to the FDA.

“These requirements form a baseline for traceability recordkeeping, but they provide limited information to effectively and rapidly link shipments of food through each point in the supply chain,” according to the FDA release. “This — and the fact that recordkeeping systems can be largely paper-based and lack a universal lexicon throughout industry — can make it difficult to trace a product to its original source when necessary.

Formerly referred to as “high-risk foods,” the Food Traceability List includes these items — and any items made with them:

Cucumbers, all varieties;
Fresh herbs, all varieties;
Leafy greens, including all lettuces and kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive;
All melons, including watermelon, honeydew and cantaloupe
Peppers, all varieties;
Sprouts; all varieties;
Tomatoes; all varieties;
Tropical tree fruits, including mangoes, papayas, lychees, starfruit and guavas; and
Fresh-cut fruits and vegetables.

The FDA is highlighting what it calls Critical Tracking Events (CTEs), which includes growing, receiving, transforming (fresh-cut), and shipping. For each CTE, the FDA wants entities to maintain records (known as Key Data Elements/KDEs) including:

Traceability lot code;
Date the product was received;
When it was shipped; and
A description of the product.

“In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program, which would help regulators better understand a firm’s recordkeeping practices and traceability operations,” according to the release.

The industry will become familiar with the new terminology (CTE, KDE); Yiannas said a big step to standardization is a common language shared by all in the supply chain.

According to a statement from the California LGMA, it and its sister organization in Arizona appear to be in compliance with the proposed FDA rules.

“We want to assure our customers and consumers that members of the Leafy Greens Marketing Agreement are already required to have traceback systems in place,” according to the statement. “This has been part of the LGMA requirements since the organization was formed in 2007.

“As with any other aspect of our program, the LGMA is committed to making any necessary improvements to protect consumers,” according to the LGMA’s statement.

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New Era of Smarter Food Safety is upon us

California LGMA survey looks at members’ traceability plans

Groups urge FDA to require better traceability for leafy greens

“Food traceability list” is high-risk foods by another name

Fri, 13 Nov 2020 06:46:54 GMT

The Food and Drug Administration’s proposed rule is called “Requirements for Additional Traceability Records for Certain Foods.”

In June last year, the Food and Drug Administration agreed in a consent decree to act by September this year to designate a list of high-risk foods and a proposed record-keeping rule for those same foods. The consent decree was an outcome of a lawsuit filed in 2018 against the FDA by consumer groups Center for Food Safety and the Center for Environmental Health. Those groups said the FDA was in clear violation of complying with the Food Safety Modernization Act mandates in publishing the list of high-risk foods.

The list is here at long last, but there is no mention of “high-risk foods” in the title of the proposed rule. The summary of the 199-page document tries to distill the agency’s efforts.

From the summary:

“The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).”

The proposed rule will have about a four-month comment period according to the FDA.

So what commodities are on the FDA;s Food Traceability List?

In what the FDA calls a “Tentative Food Traceability List,” the agency lists these items:

Cheeses, other than hard cheeses: Iincludes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk;
Shell eggs: Shell egg means the egg of the domesticated chicken;
Nut butter: Includes all types of tree nut and peanut butters; does not include soy or seed butters;
Cucumbers: Includes all varieties of cucumbers;
Herbs (fresh): Includes all types of herbs, such as parsley, cilantro, basil;
Leafy greens: Including fresh-cut leafy greens, includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive;
Melons: Includes all types of melons, such as cantaloupe, honeydew, and watermelon:
Peppers: Includes all varieties of peppers;
Sprouts: Includes all varieties of sprouts;
Tomatoes: Includes all varieties of tomatoes;
Tropical tree fruits Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit
Fruits and Vegetables (fresh-cut): Includes all types of fresh-cut fruits and vegetables;
Finfish: Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish;
Crustaceans: Includes all crustacean species, such as shrimp, crab, lobster, and crayfish;
Mollusks, bivalves: Includes all species of bivalve mollusks, such as oysters, clams, and mussels; does not include scallop adductor muscle; and
Ready-to-eat deli salads Includes all types of ready-to-eat deli salads, such as egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads.

Do readers see any surprises with the list? The FDA doesn’t necessarily want to put all the onus on the above commodities. Here is one excerpt from the proposed rule that illustrates their mindset:

“To realize the full benefits of end-to-end traceability, although the proposed rule applies only to foods on the Food Traceability List, we encourage all firms involved in food production, distribution, and sale to consumers to adopt the recordkeeping practices set forth in the proposed rule for all the foods they manufacture, process, pack, and hold. Consistent with FDA’s “New Era of Smarter Food Safety” initiative (Ref. 21), we will pursue ways to help all supply chain entities adopt practices and technologies that will promote rapid and effective tracking and tracing of foods to prevent or mitigate foodborne illness outbreak..”

The industry has been waiting on this shoe to drop for years. Back in May 23, 2014, I wrote the following in a column for The Packer:

“Is there any way to overcome the distinction of being tabbed by the Food and Drug Administration (FDA) as a “high-risk” food?

Perhaps one fanciful marketing tack to consumers would go something like this: “Sure, our much-loved commodity X is called ‘high risk’ by FDA.

But, it should be pointed out, it is also ‘high reward’ as well. Big-time phytonutrients and vitamins are on board, along with the risk of Salmonella and E. coli bacteria.” I kid, of course.

Having your star-performing fruit or veggie tabbed a “high risk” food is absolutely the worst designation possible for a commodity group or shipper. In that context, I was visiting with one industry leader this week, and he mentioned that the comment period closed May 22 on FDA’s request for industry input on the agency’s methodology for its designation of high-risk foods. In its request for comments, FDA pointed out that the Food Safety Modernization Act (FSMA) requires the designation of high-risk foods.

“Specifically, … FSMA requires FDA to designate high-risk foods for which additional record-keeping requirements are appropriate and necessary to protect the public health,” according to the request for comments.

The law also requires FDA to publish the list of such foods on the agency’s website at the time when FDA issues final rules to establish the additional record-keeping requirements for high-risk foods. So it is a double whammy. Yes, you are a high-risk food! And, yes, you have extra record-keeping requirements!

Former FDA official David Acheson, president and chief executive officer of Frankfort, IL-based The Acheson Group LLC, said in February that the biggest challenge FDA may face is the question of whether a high-risk food can ever be classified as a low-risk food. “Can you get fresh produce, or certain aspects of fresh produce, from a high-risk (list) to a lower risk?” he asked. “That’s part of the challenge.”

No one in the food industry, including fresh produce, wants their commodity to be on the list of high-risk foods. FDA plans to publish the list either before or at the same time it issues a proposed rule establishing record-keeping requirements for designated high-risk foods. FDA’s draft approach to identifying high-risk foods uses several criteria to determine a total risk score, according to the notice. However, no commodities were identified as high-risk in FDA’s initial document.

Some of the factors that FDA will weigh as it determines which foods are high-risk include outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns and the probability of contamination and steps taken during manufacturing to reduce contamination. FDA also will look at health and economic factors, cost of illness and disabilities expected, according to the notice.”

TK: If the other shoe has dropped, it is only a soft thud. I think the industry is motivated and can handle all this proposed rule will throw at them. More on what the proposed rule’s traceability requirements are found in Chris Koger’s coverage in The Packer .

Sprout Safety Alliance training program set

Fri, 13 Nov 2020 06:46:39 GMT

The Sprout Safety Alliance has scheduled its next training course for growers.

The course is the second part of its Sprout Grower Training Blended Course and contains two four-sessions, on Nov. 5-6. The first part of the course is self-led and can be completed before the second part, which is online and features live instruction. The class is limited to 12, according to the organization.

Registration and information on both parts of the course is on the Sprout Safety Alliance’s website .

Sprout-growing operations are subject to the Produce Safety Rule, including requirements specifically for growing sprouts. The Sprout Safety Alliance’s course is the “standardized curriculum” recognized by the FDA, according to the organization.

“Successfully completing this course will be helpful in understanding and implementing the Produce Safety Rule requirements and best practices for enhancing sprout safety,” according to the alliance’s website.

Carmen Wakeling, owner and manager of Eatmore Sprouts, Courtenay, British Columbia, and president of the International Sprout Growers Association, said the Sprout Safety Alliance in 2016 initiated a two-day training program for growers. To date 104 growers have participated in the training.

“We look forward to continuing to build a healthy and safe sprouting industry,” Wakeling said in an e-mail.

The Sprout Safety Task Force, which started in 2009, is a collaboration of growers, regulators and scientists that has been involved in numerous projects to support and educate growers and seed suppliers, Wakeling said.

Yiannas explores lessons learned from COVID-19

Fri, 23 Sep 2022 18:06:15 GMT

Frank Yiannas said the COVID-19 pandemic reinforced the necessity of public-private partnerships and confirmed the value of creating more digital-based record-keeping for the food system.

Yiannas, deputy commissioner for food policy and response for the Food and Drug Administration, spoke Sept. 25 at the United Fresh Produce Association ’s Washington Conference about COVID-19 lessons learned and silver linings.

With the coronavirus, he said the food system in America passed the biggest test in the past 100 years. While there were rocky times and some shortages, he said the majority of SKUS are still on grocery store shelves.

“We passed the test,” he said.

Passing the test

Yiannas said the federal rules were adjusted to allow food normally sent to foodservice establishments to be sold at retail grocery stores.

That type of regulatory flexibility will be needed going forward to develop even more supply chain resilience, he said.

Another lesson learned, Yiannas said, is the value of using technology to solve business challenges.

“The reality, I think, is the pandemic shows that business sectors, including the food sector, have (become) a little bit more digitized. Digitalization has equated to speed and flexibility, and so I think it’s a reminder that we have to double down ... (so) we can make faster decisions and more intelligent decisions to be more flexible,” he said.

In addition, Yiannas said the pandemic illustrates the importance of ongoing public-private partnerships, which served the food industry well during the crisis.

“When we work together better and faster than we have in the past, that’s actually good for American consumers.”

The FDA, Yiannas said, had many conversations with industry leaders during the spring and summer and they were all built on complete transparency and trust.

“We were in the fog of the battle, if you will, we were in the foxhole together, and we had to trust each other,” he said.

“I think we all want to continue this and let this become the new normal.”

The pandemic provided an unprecedented time for interaction between industry associations and government, said Jennifer McEntire, senior vice president of food safety and technology for United Fresh.

McEntire interviewed Yiannas during the Washington Conference virtual presentation.

She said the FDA played an important role in communicating to consumers that food did not play a role in spreading the virus.

Yiannas also praised the efforts by the Texas International Produce Association, United Fresh and other industry food safety leaders who worked with the FDA and Mexican food safety inspectors to help create new food safety protocols for Mexican papayas.

“It was a wonderful model and it needs to be replicated in clones,” he said, noting that FDA penned a letter to the papaya industry last year asking for action after eight years of outbreaks.

“I think it’s a model that we should use for reoccurring problems in the supply chain.”

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FDA: Red onion salmonella outbreak over; investigation isn’t

Fri, 23 Sep 2022 20:24:31 GMT

The Food and Drug Administration has declared the Salmonella Newport outbreak that was likely caused by red onions from Thomson International Inc. is over.

In the U.S., 1,127 people became ill from eating the onions, according to the FDA/Centers for Disease Control and prevention. The Canadian investigation into the 515 cases of Salmonella Newport in that country was closed Oct. 2.

The FDA worked with the California Department of Food and Agriculture and California Department of Public Health conducted field-level investigations at multiple Thomson International locations within days of its onions being linked to the illnesses, according to the FDA’s Oct. 8 update.

By that time, however, most of the onions had been shipped by then.

“Thus far, FDA has completed over 2,000 product and environmental analyses from multiple Thomson International Inc. locations and surrounding areas, including water, soil, and scat samples,” according to the FDA release. “Although a variety of genetic strains of Salmonella Newport have been detected, as well as multiple other Salmonella serotypes, a genetic match to the outbreak strain has yet to be identified in any of the samples collected.”

The FDA is continuing a root cause investigation and additional analysis of samples is underway, according to the update.

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Arizona LGMA adopts new water metrics

Fri, 13 Nov 2020 06:13:40 GMT

The Arizona Leafy Greens Marketing Agreement has adopted more stringent water quality metrics in preparation for the coming season.

The metrics, adopted in late August, are similar to those approved by the California LGMA in April, but with changes to “better address the practicality of using surface water, setting the highest produce industry standards for water,” according to a news release from the Arizona group.

“These new water metrics are expected to be particularly helpful in facilitating data collection for growers to better identify potential risks,” according to the release. “Having these answers will allow for faster response and execution of mitigation efforts.”

California’s water quality testing changes requires growers to:

Review water system, sources, storage and irrigation methods;
Conduct water testing and routinely monitor sources and systems; and
Treat water if necessary (surface water for overhead irrigation 21 days before harvest must be sanitized).

“We have spent countless hours going over and reviewing every aspect of our industry,” Vicki-Lynne Scott, technical assistant, said in the release. “It’s an ongoing effort, but we are continuing a proud heritage of growing and distributing quality leafy greens to customers throughout the U.S.”

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Arizona LGMA revises metrics in wake of E. coli outbreak

FDA, state ag departments sign produce safety plan

Fri, 13 Nov 2020 06:13:30 GMT

The Food and Drug Administration has signed an agreement that will help state departments of agriculture as they take on roles in ensuring the Produce Safety Rule is implemented.

The five-year cooperative agreement with the National Association of State Departments of Agriculture provides “critical information and resources” to implement the rule, part of the Food Safety Modernization Act, according to an FDA release. The agreement provides $1.3 million to the association allowing it to help state and territorial produce safety programs to develop programs, educate about the rule and compliance to it.

The agreement also calls for an annual National Consortium of the state and territorial agencies to give program updates, share best practices and provide the FDA with feedback.

In the first and second year of the agreement, the National Association of State Departments of Agriculture will work with the FDA the On-Farm Readiness Review system, according to the release. The next three years will be assisting the FDA in developing a national program “to establish and promote a uniform foundation of produce safety, including research on existing programs and how they can be leveraged to develop a national produce safety regulatory program.”

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FDA approves company for 3rd-party certification program

Fri, 13 Nov 2020 06:14:06 GMT

The Food and Drug Administration has added Global Standards S.C. as an approved certifier for companies seeking Food Safety Modernization Act requirements.

The FDA accreditation gives Mexico-based Global Standards S.C. the authority to conduct food safety audits and issue certifications under the FDA’s Accredited Third-Party Certification Program, according to an FDA news release.

The company has been approved by the American National Standards Institute to certify for the Produce Safety Rule, Preventive Controls for Human Food, Juice Hazard Analysis and Hazard Analysis and Critical Control Point, according to the release.

Certifications issued by Global Standards S.C. can be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program, which offers expedited review for food entering the U.S., according to the release.

There are seven other certification bodies approved under the third-party certification program.

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FDA sets meeting on New Era of Smarter Food Safety

Fri, 13 Nov 2020 06:14:06 GMT

The Food and Drug Administration will have a public meeting to discuss its New Era of Smarter Food Safety .

The all-day meeting will be Oct. 21 at the Hilton Washington DC/Rockville Hotel in Rockville, Md. Topics of breakout sessions will include traceability, smarter tools for prevention, evolving business models and retail food safety, according to a news release.

The FDA is seeking a “blueprint” for the New Era program.

“We intend for the strategic plan to outline how this new approach will address public health challenges, including being able to trace sources of contaminated foods and using new predictive analytics tools like artificial intelligence to assess risks and prioritize the agency’s work and resources,” according to the FDA release.

Comments from the meeting, and submissions to the Federal Register , will help shape the blueprint.

In an interview on the New Era program on the FDA’s website, the agency’s Frank Yiannas, deputy commissioner for Food Policy and Response, said there is new technology that can help trace items through the food supply chain.

“These include blockchain, sensor technology, the internet of things, and artificial intelligence to create a more digital, traceable, and safer food system,” he said in the online interview. “This new approach creates shared value for all stakeholders — farmers, food producers, regulators, consumers and the planet.”

The FDA announced plans for its food safety campaign in late April following E. coli outbreaks traced to California and Arizona leafy greens. During investigations, traceability became problematic due to lack of digital records or no record-keeping at all.

“The emergence of blockchain technology, because of its distributed and decentralized nature that aligns more closely with a decentralized and distributed food system, has enabled food system stakeholders to imagine being able to have full end-to-end traceability,” Yiannas said in the interview. “An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.”

The public meeting registration is online .

More information, including deadlines for submitting requests to comments at the meeting are on the FDA website .

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FDA: food pesticide residue levels “not concerning”

Fri, 13 Nov 2020 06:13:58 GMT

The Food and Drug Administration has released its annual Pesticide Residue Monitoring Program report for fiscal year 2017.

Available for download at the FDA website , the report delivers results of the testing for 761 pesticides and industrial chemicals across 6,504 total samples, according to a news release.

For the pesticides that were tested for in FY 2017, th release said 96.2% of the 1,799 domestic and 89.6% of the 4,270 imported human food samples were in compliance with federal pesticide residue standards. No pesticide residues were found in 52.5% of domestic and 50% of imported human food
samples analyzed.

Domestic and import fruit and vegetable results

The FDA said that in the domestic fruits commodity group, 387 samples were analyzed; 14.2% contained no residues and 7 samples (1.8%) contained violative residues. For the domestic vegetables commodity group, no residues were found in 37.5% of the 563 samples analyzed and 53 (9.4%) contained violative residues.

For the import fruit commodity group, no residues were detected in 478 (39.8%) of 1,198 samples analyzed and 95 (7.9%) had violative residues. Of the 1,819 import vegetable commodity group samples analyzed, 763 (41.9%) had no residues detected and 227 (12.5%) had violative residues.

“The findings in this report demonstrate that generally levels of pesticide chemical residues measured by the FDA are below EPA’s tolerances, and therefore at levels that are not concerning for public health,” the agency said.

CDC: Papaya salmonella outbreak over, investigation continues

Fri, 13 Nov 2020 06:13:53 GMT

Federal health officials report that the multistate outbreak of Salmonella Uganda illnesses linked to Cavi Brand whole, fresh papayas appears to be over.

The Food and Drug Administration said that while the outbreak is over, the agency is continuing its investigation.

The release said the epidemiological and traceback information collected in the investigation confirmed that Agroson’s LLC of Bronx, N.Y., was the exclusive distributor of the imported papayas that made consumers from this outbreak sick.

On Aug. 26, the FDA issued a statement calling on the papaya industry to improve practices and better protect consumers, according to the release. Additionally, the FDA issued a Warning Letter to Agroson’s LLC, the distributor of Cavi brand papayas implicated in this outbreak.

In the release, the FDA said consumers and distributors no longer need to avoid or withhold Cavi brand whole, fresh papayas imported from Mexico. The FDA also said that the papayas that were linked to the illnesses in this outbreak are no longer on the market.

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UPDATED: FDA links Mexican papaya to outbreak, asks for halt to sales

Urban Remedy recalls salads, wraps

Fri, 13 Nov 2020 06:13:58 GMT

Urban Remedy , a California-based producer and retailer of ultra-fresh, organic meals, is voluntarily recalling 76 salads and wraps that contain spinach that may be contaminated with E. coli.

No juices or any other products are being recalled, according to a news release.

“In an abundance of caution, we are voluntarily recalling a limited number of our products that contain potentially contaminated spinach,” Paul Coletta, the company’s CEO, said in the release. “We’re taking preventative action to keep our customers safe, although no illness has been reported to date.”

The release said spinach from a supplier tested positive for a small amount of E. coli) bacteria. Coletta said in the release that Urban Remedy will no longer buy spinach from the supplier.

The products were sold in Urban Remedy’s retail stores, at Whole Foods Markets, online, and at other California retailers, according to the release. All remaining affected products have been removed from store shelves and the Urban Remedy website. No illnesses have been reported, according to the release.