Tag Archives: produce safety

Produce Traceability: 4 Steps to Get Started

By Samantha Humphrey
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With the effective date for updated traceability recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

On November 21, 2022, the Food and Drug Administration (FDA) published the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). With the effective date for updated recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

Most produce companies are no strangers to the importance of traceability. In fact, the Produce Traceability Initiative (PTI) was created over 15 years ago as a voluntary, industry-wide effort designed to help the industry maximize the effectiveness of current track and trace procedures, while developing a standardized industry approach to enhance the speed and efficiency of traceability systems for the future. The PTI has set dozens of companies throughout North America—ranging from small farms to international retailers—on the path to enhanced traceability and compliance with the FDA’s Food Traceability Rule.[i]

The following steps can help any produce company, whether it currently follows the PTI or not, prepare to meet FDA’s traceability requirements:

  1. Understand the Food Traceability Rule.

While the FDA has had traceability requirements in the past, the FSMA Food Traceability Rule is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one step forward, one step back” traceback approach. The objective of the Rule is to help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.[ii]

In comparing the FSMA Rule to the PTI, a recent PTI press release states that the requirements of the PTI for case-level traceability are aligned with the Final Rule and cover approximately 90-95% of the requirements, with major differences stemming from the Traceability Lot Code Source and Traceability Lot Code Source Reference.[iii]

The key elements of the FDA Rule are built into several acronyms:

  • FTL (Food Traceability List): This list identifies the categories of high-risk foods that require additional traceability records under the Food Traceability Rule. The FTL currently comprises the following produce commodities: cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, and fresh cut fruits and vegetables. Other non-produce foods on the FTL include cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads.
  • TLC (Traceability Lot Code): This descriptor, often containing a combination of letters and numbers, is used as a unique identifier for product as it moves through the supply chain. The TLC is to be established by entities that originate, transform, or create food on the FTL. Once a food has been assigned a TLC, the TLC must be included in traceability program records collected at each Critical Tracking Event (CTE) and as a part of all Key Data Elements (KDEs) (see below). The TLC remains the same throughout the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
  • CTE (Critical Tracking Event): CTEs are the events in the food supply chain that require additional recordkeeping. These include harvesting, cooling before initial packing, packing, transforming, shipping, and receiving. At each CTE, the responsible entity must record the TLC.
  • KDE (Key Data Element): KDEs comprise the information associated with a CTE for which a record, including a TLC, must be maintained. Examples of KDEs include location description of the food being harvested; name of the field or growing area where the produce was harvested; date of harvest; quantity and unit of measure of the produce; date when the produce went from harvest, to cooling, to packing, to shipping, etc.
  1. Interpret the Rule and Determine its Applicability.

To determine the Rule’s applicability, it is important to first take an inventory of your operations and products:

  • Do you grow cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, or tropical tree fruits?
  • Do you process fresh cut fruits, leafy greens, or vegetables other than leafy greens?
  • Do you manufacture a product that contains any of the foods listed above?

If the Rule applies (i.e., you answered yes to any of the three questions above), you must:

  • Maintain specific data records (i.e., KDEs) for at least two years.
  • Keep records of all CTEs.
  • Maintain an approved, updated Traceability Plan.
  • Ensure all data is easily accessible so it can be provided to the FDA within 24 hours of a request.

Note that there are a few nuanced exemptions that apply to farms, as noted on this FDA flow chart.[iv]

  1. Perform a Gap Assessment.

Most produce companies are likely capturing at least some of the information needed to comply with the Food Traceability Rule, particularly if they already implement the PTI requirements. Conducting a gap assessment will help identify missing elements that may be required for compliance with FDA’s Rule. The following questions can help guide this assessment:

  • Does your organization already capture data that may be considered a KDE? For example, do you apply lot codes to your products? Do you collect location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information or data points you are missing and how you can gather that data.
  • Do you have a sufficient Traceability Plan? Does it cover all the elements required in the Food Traceability Rule?
  • Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Having a good document/records management system is essential for maintaining and sharing the data required by the Food Traceability Rule.
  • What collaborative activities can you and your suppliers/buyers perform to ensure that data is shared efficiently and encourage compliance?
  1. Create a Plan of Implementation.

The gap assessment will identify elements that you need to implement to help ensure compliance. Use that information to create a game plan, working backwards from the Rule’s January 20, 2026 effective date. Doing so now affords time to test solutions, see how they work in practice, problem solve, and find the right solutions for your organization.

At a minimum the implementation plan must include two key elements that will be vital for compliance:

  • Traceability Plan. Every organization must develop a new (or update an existing) Traceability Plan for collecting the KDEs that are required by the Rule, as outlined in the CFR[v] (see also the FDA example of a Traceability Plan for Farms[vi]). The Traceability Plan must be updated annually, and old plans must be maintained for at least two years. The Traceability Plan must include:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how TLCs are assigned.
    • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
    • Map identifying the farms where FTL produce is grown.
  • Document/Records Management System. Produce companies who manufacture, process, pack, or hold foods on the FTL will need to implement a document/records management system to fulfill the Food Traceability Rule’s recordkeeping requirements. While hard copies in binders can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data.

As produce companies work through this process, it is important to remember the objective of the Food Traceability Rule. Ultimately, the Rule will allow the food industry to quickly remove potentially harmful foods from the supply chain and make the entire recall process more efficient. Even if the FTL list does not apply to all your products, your customers may still require that all produce they purchase meet the same requirements as foods listed on the FTL. Creating this end-to-end traceability will save time, money, and most importantly, human lives.

[i] Produce Traceability Initiative. The Produce Traceability Initiative: Working to achieve standardized, electronic (computerized) traceability across the supply chain. September 2011. https://producetraceability.org/wp-content/uploads/2022/03/PTI-Flyer_FNL_v2-2011-10-20.pdf.

[ii] Food and Drug Administration. What you need to know about the Food Traceability Rule: Recordkeeping Information for Produce Farms. June 2023. https://www.fda.gov/media/169510/download.

[iii] The Produce Traceability Initiative. Produce Traceability Initiative (PTI) Releases FSMA 204 Implementation Guidance. February 13, 2024. https://producetraceability.org/produce-traceability-initiative-pti-releases-fsma-204-implementation-guidance/.

[iv] Food and Drug Administration. Exemptions to the Food Traceability Rule. https://collaboration.fda.gov/tefcv13/.

[v] National Archives and Records Administration. CFR Title 21, Chapter I, Subchapter A, Part 1, Subpart S, Traceability Plan. May 21, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S/subject-group-ECFRe6c9096adb572d4.

[vi] Food and Drug Administration. Traceability Plan Example for Farms (§1.1315). November 2023. https://www.fda.gov/media/174057/download?attachment.

FDA Logo

FDA Publishes Final Rule on Agricultural Water To Enhance Produce Safety

By Food Safety Tech Staff
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FDA Logo

On May 2, the FDA published a final rule on agricultural water developed to enhance the safety of produce. The revised requirements are intended to enhance public health by improving the safety of water used in produce cultivation. The revisions are also designed to be practical across various agricultural water systems, uses, and practices, while remaining adaptable to future advancements in agricultural water quality science.

The final rule replaces certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in the 2015 Produce Safety Rule with requirements for systems-based agricultural water assessments to minimize potential risks associated with pre-harvest agricultural water. Specifically, this rule:

  • Establishes requirements for agricultural water assessments that evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water. This includes an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors.
  • Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances.
  • Requires farms to implement effective mitigation measures within specific timeframes based on findings from their assessments. Hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation.
  • Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

Farms are required to conduct assessments of their pre-harvest agricultural water annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

These revised requirements reflect findings from investigations of several produce-related outbreaks as well as feedback from a variety of stakeholders on the agricultural water requirements in the 2015 Produce Safety Rule. Dates for compliance with the new pre-harvest agricultural water requirements for non-sprout covered produce are as follows:

  • Very small farms: 2 years, 9 months after the effective date of the final rule
  • Small farms: 1 year, 9 months after the effective date of the final rule
  • All other farms: 9 months after the effective date of the final rule

The rule does not alter existing requirements for agricultural water for sprouts, for which compliance dates have passed. It also does not alter existing requirements for harvest and post-harvest agricultural water activities. Additional information about compliance dates can be found on the FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements webpage.

The FDA will work with its state partners to implement these changes. The agency plans to work closely with state regulators, National Association of State Departments of Agriculture (NASDA), educators, and others, including the Produce Safety Alliance, to provide training to implement these changes to the agricultural water requirements.



Romaine Lettuce

Study Identifies Listeria Contamination Patterns in Produce Processing Facilities

By Food Safety Tech Staff
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Romaine Lettuce

A two-year study on Listeria monocytogenes (Lm) contamination patterns and related sanitation programs in produce processing facilities is already uncovering valuable insights. Ana Allende, Ph.D., and her team from the CEBAS-CSIC research institute in Spain, are hoping that their research, funded by the Center for Produce Safety, will yield practical data about produce facilities’ environmental monitoring plans as well as the efficacy of sanitation programs.

The researchers worked with three processing plants: one with a cut iceberg lettuce line, one with a cut fruit line, and one with a salad bowl line. Their first objective was to understand how different factors such as zoning, sanitary design, and connectivity affected the probability of contamination in different fresh produce processing facilities. In the case of salad bowls, the ingredients included not only leafy greens and other vegetables but also proteins from meat, fish and cheese, or pastas from different sources.

The researchers divided the processing areas into three zones based on their proximity to contact with the produce. Zone 1 involved areas with direct contact, such as knives and conveyor belts. Zone 2 included surfaces that did not contact food but were in close proximity, and zone 3 included more remote non-contact surfaces, such as drains, floors, and ceilings that could potentially lead to contaminating zones 1 and 2.

They conducted systematic sampling of the facilities at the end of the day before cleaning and sanitizing. They also resampled the three processing lines after the cleaning and disinfection activities. In addition to the more than 600 total samples from the three zones, the researchers collected 45 samples from raw ingredients and end products.

“By sampling the processing plants before and after cleaning and disinfection, we could understand which might be the entry points of the contamination,” said Allende.

Regardless of the facility, they had the highest number of positive Lm samples from zone 3. “One of the hypotheses we had was the raw material was introducing much of the Listeria,” said Allende. “This was before we did sampling and the whole genome sequencing to understand the isolates and that they were not all coming from the raw material. Some of the contamination was probably coming from zone 3 in the different processing facilities.”

The researchers also conducted whole genome sequencing on 100 samples to better understand whether the Lm was transient or persistent. What surprised them was that the same two serotypes of L. monocytogenes were found on the three processing lines after the two samplings, before and after cleaning. “This makes us understand that these serotypes are inherent and are moving from zone 3 to zone 1,” said Allende.

As part of the project, the researchers also evaluated the efficacy of biocides against resident Lm isolates. “We found, indeed, all of the isolates obtained from the environment after cleaning were sensitive to the biocides,” said Allende. This allayed concerns that the pathogens were becoming resistant to the sanitizers.

While the research aimed to provide relevant results for the three cooperating produce processors, it also has broader implications for the produce industry about how they should conduct environmental monitoring including sampling after processing just before cleaning. In addition, it should help processors better understand the main contamination points in zone 1 and how they relate to identical or similar Lm sequence types in zones 2 and 3.

Red Apple

Nano-encapsulated Wax Coatings Protect Produce from Pathogens

By Food Safety Tech Staff
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Red Apple

Researchers from Texas A&M have developed a wax coating with nano-encapsulated essential oils for use on produce that provides both immediate and delayed antibacterial effects. Mustafa Akbulut, professor of chemical engineering, worked with horticultural science professor Luis Cisneros-Zevallos to engineer a nano-encapsulated cinnamon-bark essential oil that was then imbibed into a food-grade wax commonly applied on produce surfaces.

They tested the coating on red apples and compared it to traditional wax coatings. Results, published in Current Research in Food Science (vol. 8, 2024), showed that the wax coating with the encapsulated essential oil produced a significant reduction in viable bacterial counts compared to controls coated with paraffin wax after 24 hours of exposure, with reductions of 1.8 ± 0.4 log10 CFU/mL (PBS) and 3.5 ± 0.3 log10 CFU/mL (TSB) for S. aureus, and 1.2 ± 0.2 log10 CFU/mL (PBS) and 1.4 ± 0.4 log10 CFU/mL (TSB) for E. coli.

The nano-encapsulated essential oil made it harder for bacteria to attach and survive on fruits or vegetables. The delayed release of the essential oil increased the half-life of active ingredients and produce compared to its unencapsulated counterparts, according to the study.

The antibacterial effect persisted even after 72-hour immersion in water followed by bacterial exposure. “Furthermore, our novel coatings exhibited significantly reduced bacterial attachment compared to pristine wax-coated substrates. The coatings also showed a great aversion toward A. flavus with the initial zone of inhibition measuring 13.5 ± 0.15 mm and no hyphae and conidiophores growth on the substrates (with coatings) even after 10 days,” the authors wrote.

“This coating was also inhibiting the fungal attachment,” said doctoral student Yashwanth Arcot who ran experiments to support the research. “We have tested this system against Aspergillus, a fungus responsible for the spoilage of food commodities and the onset of lung infections in humans. We were successful in preventing its growth on the hybrid coatings, and these hybrid wax coatings are easily scalable and can be implemented in food processing industries.”



FDA Releases Results of Sampling Assignment of Romaine Lettuce from Yuma, Arizona

By Food Safety Tech Staff
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As part of its efforts to prioritize the safety of leafy greens, the FDA released the results of a sampling assignment involving testing romaine lettuce from commercial coolers in Yuma County, Arizona. Earlier this year the agency announced that it would be collecting samples of romaine lettuce as part of ongoing surveillance following the spring 2018 multistate outbreak of E.coli O157:H7.

The lettuce was tested for Shiga toxin-producing Escherichia coli (STEC), specifically enterohemorrhagic Escherichia coli (EHEC), and Salmonella spp. The FDA collected 504 romaine samples, and an independent lab conducted the testing.

E.coli O130:H11 was found in one sample, and as a result, the FDA conducted an investigation at the farm to find potential sources and routes of contamination—samples of soil, water, sediment and animal fecal material were taken, and the agency also looked at farm equipment and other surfaces. Out of 24 samples, just one came back positive for STEC, and this sample was taken from the outer leaves of the lettuce. It was determined that the strain was low risk to human health, and FDA did not find that this strain was linked to any past known foodborne illness outbreaks.

“The agency’s goal in conducting this assignment was to determine whether the target pathogens and specific strains may be present in romaine lettuce from the Yuma agricultural region, to help prevent foodborne illness when possible,” FDA stated in a constituent update. “If product that tested positive for EHEC or Salmonella was found, the Agency planned to work with industry and state regulatory partners to identify the cause (e.g., farm follow-up investigation) to inform future regulatory and/or research efforts and to develop strategies that could help preventive additional outbreaks.”


FDA and NASDA Collaborate on $1.3 Million Produce Safety Program

By Food Safety Tech Staff
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Yesterday FDA announced a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to enable more support of developing, implementing and improving programs related to the Produce Safety rule. The agreement will provide funding to help NASDA work with state and territorial produce safety regulatory programs to facilitate the safe production of fresh fruits and vegetables, along with better understanding of the Produce Safety Rule and its requirements.

“This advances the agency’s efforts to develop a nationally integrated food safety system by helping to ensure consistency of state and territorial produce safety regulatory programs with the Produce Safety Rule,” FDA stated in a release.

The current program has $1.3 million in funding. During the first two years of the cooperative agreement, NASDA will work with FDA on implementing and updating the On-Farm Readiness Review system with the agency and its partners in state and territorial produce safety programs. During the third through fifth years of the program, NASDA will help FDA in establishing and promoting a “uniform foundation of produce safety” to help create a national produce safety regulatory program.

Tim Birmingham, Almond Board of California
In the Food Lab

10 Years, 0 Salmonella Outbreaks

By Tim Birmingham
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Tim Birmingham, Almond Board of California

Almond Board of California (ABC) tackled food safety head-on in the wake of emerging Salmonella concerns in the early 2000s. Conventional wisdom of the time suggested that low-moisture foods like almonds presented a minimal threat, but rather than simply accepting this, ABC engaged in research to better understand the risks. The resulting best practices and groundbreaking mandatory pasteurization program developed by ABC remain the gold standard for other sectors—and drive continued food safety and quality efforts for California Almonds.

In 2017, ABC marked the 10-year anniversary of its mandatory almond pasteurization program – and, most importantly, 10 years free of Salmonella recalls and outbreaks attributed to California Almonds. The almond industry is proud of its unified efforts over the last decade, as well as the food safety record we’ve been able to achieve. However, the work to protect and improve food safety and quality continues. Looking back at our initiatives and successes reminds us of how important this work is and drives our exploration of what’s next.

Understanding and Addressing the Risk

Outbreaks of Salmonella in 2001 and 2004 raised questions and concerns about food safety and quality across industries. For California Almonds, one of the biggest challenges was determining the true level of risk. The easy answer seemed to be that risk should be low, that, based on accepted conventions of the time, pathogens should not be able to grow in almonds and other low-moisture foods. However, ABC investigated further and quickly realized that the pathogen could present a problem. The organization decided to take action and tackle Salmonella and other potential threats.

In collaboration with food safety experts and research partners, ABC began research in 2001 to better understand the prevalence and concentration of contamination in almonds, conducted in tandem with efforts to develop strategies for contamination control. ABC was able to gather enough survey data over the course of several years to show that Salmonella was indeed present in about 1% of the almonds tested at very low concentrations. This data was fed into ABC’s risk assessment work, which enabled identification of appropriate performance criteria for ensuring consumer safety (>4-log reduction).

At the same time, ABC also worked to identify effective processing technologies and the best means of validating them. A technical expert review panel was assembled to help ABC develop a plan, assess research needs, establish standards and create guidelines for the industry. Extensive work went into determining how to validate equipment, including the determination of an appropriate surrogate (non-pathogenic microorganisms) that could be used in lieu of Salmonella in the plant. Concurrently, researchers worked to determine the specific time and temperature combinations needed for a >4-log (and 5-log) reduction for a range of pasteurization processes, including oil roasting, blanching and dry roasting, some steam processes and PPO processing. ABC and partners invested significant time and effort into this research, which culminated in the development of the groundbreaking mandatory pasteurization program for Salmonella reduction, and validation guidelines.

Process Implementation and Ongoing Education

Voluntary compliance with the pasteurization program began in 2004, well in advance of September 2007, when it became mandatory. By that time, pasteurization was established as the industry norm and laying the groundwork for ongoing food quality and safety efforts. Today, ABC has more than 1 billion pounds of validated pasteurization capacity for processes that maintain the raw characteristics of almonds, including steam, moist heat and propylene oxide (PPO). It also has close to 1 billion pounds of validated capacity for processes such as dry roasting, oil roasting and blanching. All reduce the level of potential contamination in almonds without diminishing the product’s quality, nutritional value or sensory qualities (taste and crunch).

ABC also developed a comprehensive round of updates to recommended food safety practices, creating a powerful program with tools that help growers and processors achieve their desired results. These tools include Good Agricultural Practices, Good Manufacturing Practices, HACCP guidelines and Pathogen Environmental Monitoring resources.

In total, ABC has made a $5 million investment in food quality and safety research and validated more than 200 treatment processes, to date. It remains committed to this mission, maintaining close connections with the scientific and regulatory communities to stay current on food safety in the broader context as well as issues specific to California Almonds. All relevant insights and information are disseminated to growers and processors in the form of clear, practical resources, including print publications and digital communications, and workshops and one-on-one field trainings.

What’s Next: Research, Tech and Regulatory Practices

The mandatory pasteurization program is now well established, but it isn’t static – ABC continues to stay on top of the latest methods, regulations and needs impacting California Almonds. Industry investment continues to increase, particularly in processes that maintain the raw characteristics of the product. And, while much information regarding processes and technologies are company-specific and confidential, equipment manufacturers continue evolving and growing their offerings, with a particular focus on maximizing almond quality and throughput.

On the regulatory side, FSMA continues to roll out for growers and processors. ABC helps growers and other stakeholders understand which rules apply, what actions to take to ensure compliance and when specific requirements come into effect for different operations, with FSMA-related resources, Preventative Controls and Produce Safety trainings and timely information available online. Many processors and non-farm huller/shellers started 2018 already meeting FSMA Preventive Control requirements, but the number of impacted orchards and huller/shellers expanded in January as the Produce Safety rule came into effect. At this point, the almond industry and the larger community of food and beverage industries have had time to assess the impact on their stakeholders and take action to ensure FSMA compliance.

FSMA reflects the evolving role of FDA in ensuring food safety. Traditionally, FDA has taken a reactive approach to food safety. The agency now has the authority to investigate farms and facilities regularly to ensure food safety regulations are followed. For the first time, growers and huller/shellers falling under the farm definition may be audited by FDA or FDA-designated agencies. While some growers may choose the exemption option, ABC encourages almond growers to understand the rule’s requirements and develop food safety plans appropriate to their farms. It will be new and uncertain territory for some, but with the FDA’s proactive approach, staying ahead of the curve on food safety and quality will be beneficial.

Currently, almonds are the only tree nut with a mandatory pasteurization program and defined performance criteria accepted by FDA. They have paved the way for validation of other tree nuts, and those industries should also consider implementing appropriate preventive controls for Salmonella. ABC’s work can be considered a road map for other nuts and low-moisture foods, but what works for almonds will not always work for other foods. Research specific to each type of nut needs to be conducted to uncover pathogen prevalence and concentration, as well as pathogen/surrogate resistance to various processes. We will continue to be proactive, as well, evaluating current practices and engaging in research to improve how we understand and control microbial contamination in almonds.

Even with a track record to take pride in, the responsibility and work of food quality and safety never end. We will continue to update and evolve programs, not only as a function of compliance, but to protect the almond customers who support us every day.

Jim Gorny, CFSAN

CFSAN Announces New Senior Science Advisor for Produce Safety

By Food Safety Tech Staff
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Jim Gorny, CFSAN

FDA has created a new position for former FDA member Jim Gorny to serve as the senior science advisor for produce safety at CFSAN. Gorny worked at FDA from 2009 to 2013 as the senior advisor in the agency’s Office of Food Safety at which time he was involved in the development of FSMA. He was previously the vice president of food safety and technology at the Produce Marketing Association.

In his position at CFSAN Gorny will work with a team of produce safety professionals on implementing new science and risk-based requirements that aim to prevent illnesses from contaminated produce. He will serve as the chief advisor to CFSAN Director Susan Mayne on policies and programs associated with produce safety. His responsibilities include stakeholder outreach and engagement, investigations and recalls, research and training.

“I will be working with state regulatory partners and other government agencies at home and abroad to build support for implementation of the produce rule, as well as with industry to help further compliance… I’ll be working to make sure that the people in senior-level management and the field staff, including those conducting foreign inspections, are speaking the same language. – Jim Gorny, FDA

In an interview published on FDA’s website, Gorny discusses his role at FDA, the produce safety rule and how he will be working with industry and key stakeholders, including the farming community.


Need Help with Produce Safety and FSMA? FDA Launches New Page

By Food Safety Tech Staff
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FDA has launched a FSMA landing page on its website in an effort to provide more information about FSMA and assist in compliance. Links include information about the rules, guidance documents, training and technical assistance, compliance and implementation tools and general background about FSMA.

As the first major compliance date for large farms recently went into effect, the agency also recently updated the Produce Safety page. In an agency news update, it noted that in September 2017, FDA announced that routine inspections would be postponed until Spring 2019 to provide more time for education, outreach and training in 2018.


FDA Releases Five FSMA Guidance Documents

By Food Safety Tech Staff
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Today the FDA issued five guidance documents related to FSMA with the goal of assisting food importers and producers meet provisions in the regulation.

The first two documents are related to the Foreign Supplier Verification Program (FSVP) regulation. The FDA issued the draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, along with a small entity compliance guide. The third draft guidance is related to whether a measure provides the same level of public health protection as the corresponding requirement in 21 CFR part 112 or the PC requirements in part 117 or 507 . “This draft guidance aims to provide a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food,” according to FDA.

The FDA also released a final chapter in the draft guidance related to FSMA requirements for hazard analysis and risk-based PCs for human food. The chapter is intended to assist food facilities in complying with the supply chain program requirements.

The fifth guidance is an announcement of the FDA’s policy to exercise enforcement discretion related to the FSVP rule regarding certain grain importers that bring the product into the United States as raw agricultural commodities. “This enforcement discretion is meant to better align the FSVP rule with the exemption for non-produce RACs under the PC rules,” stated FDA.