Tag Archives: FSMA

EMAlert, Economically motivated adulteration

Food Fraud: Perps Two Steps Ahead, Innovation Needed to Keep Up

By Maria Fontanazza
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EMAlert, Economically motivated adulteration

Economically motivated adulteration (EMA) has considerable economic ramifications, impacting businesses from a financial and liability perspective, posing dangers to consumers, and eroding product confidence. One of the biggest issues with monitoring the volume and type of adulterated products is the fact that the landscape of food fraud is ever changing. “The perpetrators are always two steps ahead, so innovation is needed to keep up,” said Jeff Moore, Ph.D., director of science, food program at U.S. Pharmacopeial Convention (USP), at the GMA Science Forum last week.

GMA and Battelle have teamed up to launch EMAlert, a tool that companies can use to quantitatively assess the vulnerability of their supply chains to EMA. The secure, cloud-based platform comes with 50 commodities off the shelf (including spices, grains, dairy, seafood, meat, oils, fruits, veggies, and food ingredients). It was developed fairly rapidly (Battelle, which serves as the technology provider, started development at the beginning of this year) and still needs to be validated; full validation will be presented at the IAFP meeting this summer. And if EMAlert lives up to its potential, it could help companies be more nimble in monitoring and acting on threats in their supply chain.

The purpose of the tool is to generate quantitative vulnerability results that allow people to make actionable decisions based on numeric values. As such, it has been designed to be dynamic and customizable, since every company has its own risk tolerance. In addition, it looks at real-time environmental changes, because you can’t have a static tool to monitor vulnerability when it’s always changing, said Joseph A. Scimeca, Ph.D., vice president, global regulatory & scientific affairs at Cargill, Inc.

EMAlert, Economically motivated adulteration
A screenshot of EMAlert

“The EMA threat is changing,” said Ashley Kubatko, principal research scientist at the Battelle Memorial Institute. “A static assessment is only a snapshot in time.” EMAlert pulls live, automated data that takes into account economic drivers (value, volume, and scarcity of product), historical drivers (how often has product adulteration occurred in the past, geopolitical stability), and ease drivers (how frequently the commodity is tested; whether there are government regulations around the commodity group; how often the product changes hands or is repackaged). Data is pulled from several databases, including FDA, UN Comtrade, USP, Quandi, and Transparency International.

When creating the tool Battelle borrowed from its approach in working with the U.S. Department of Homeland Security to develop models that predict terrorist decision making and used the same mathematical methodology, providing a predictive model of fraudster behavior. Keeping in mind that perpetrators are also constantly monitoring how law enforcement and industry is keeping track of their strategies, EMAlert not only requires a subscription, but Kubatko says that Battelle will also be monitoring its users to ensure there is no suspicious activity within EMAlert.

In the Food Lab

New Dynamics in Environmental Testing

By Erin Dreyling, Ph.D
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Recent recalls and outbreaks associated with Listeria coupled with FDA’s finalization of the FSMA preventive controls rule have heightened the industry’s need to focus on environmental testing programs. The need for a preventive control program with higher resolution is especially highlighted by the government’s increasing use of whole genome sequencing data to more rapidly link human illness to food processing establishments. I work with many customers who simply do not recognize all of the factors that influence their ability to detect Listeria in environmental samples. For many, an environmental sample is collected, shipped to a third-party lab, results are received within two to four days, and few questions asked. Most companies have not invested the time and resources needed to truly understand how each component of an environmental sample impacts their ability to detect Listeria. So what factors should be considered to maximize Listeria detection in the plant environment?

Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREListeria is a True Survivor

Listeria is inherently a hearty organism that can withstand highly adverse conditions in the plant environment. It is able to survive and grow across a wide range of temperatures, including refrigeration, and it is more tolerant to heat than Salmonella and E. coli. Additionally, the organism survives across a wide pH range, including extended periods in highly acidic conditions, and can survive food processing and preservation with up to 25.5% salt. These traits may result in highly injured Listeria being collected in environmental samples, and requires optimization of the sample collection and analysis process in order for detection and culture confirmation to occur.

Sanitation Programs May Not Destroy Listeria

Sanitation practices are intended to destroy Listeria in the plant environment, but not all sanitizers will be 100% effective. In some cases, sanitizers may not fully kill Listeria, leaving highly injured Listeria that may require an extended lag phase in order for growth and detection during testing. Sub-lethally injured Listeria remains a food safety concern, as the bacteria maintain the ability to recover and flourish in a nutritive environment. Additionally, Listeria readily forms biofilms in the plant environment, which many traditional sanitizers do not effectively remove. Biofilms in the plant environment may maintain low levels of Listeria that may be challenging to detect without the use of a sensitive detection method.

Sample Collection: Choose the Right Tool for the Job

The neutralizing and nutritive capacity of the collection media used with the collection device can have a significant impact on the ability to resuscitate, detect and culture stressed Listeria. When selecting a collection media, it is important to ensure that the media will effectively neutralize the sanitizers used in the plant environment. For instance, peroxyacetic acid and quaterinary ammonia-based sanitizers will not be neutralized well by commonly used collection media such as Neutralizing Buffer or Letheen Broth. Neutralization of the sanitizer in environmental samples is important in order for resuscitation and growth of any Listeria present within the sample. Additionally, use of a collection media that contains nutrients to begin the resuscitation process for Listeria immediately upon collection is also important for detection and culture confirmation of Listeria in samples. Collection media such as Neutralizing Buffer contains monopatassium phosphate, sodium thiosulfate, and aryl sulfonate complex intended only to neutralize sanitizers. Conversely, D/E Broth and HiCap Broth have components to nourish Listeria and facilitate resuscitation in addition to neutralizing sanitizers.

Enrichment Media Determines Recovery & Growth

Enrichment media plays a major role in the speed of recovery and growth of Listeria in environmental samples. Medias that facilitate faster recovery of injured Listeria allow for shortened lag phases facilitating more rapid growth. Enrichment media that facilitate faster recovery and growth allow Listeria to reach the limit of detection for screening tools more quickly. When paired with a highly sensitive method, enrichment media, which foster greater Listeria growth and recovery, can allow for significant reductions in time to results for screening methods. Additionally, faster recovery and growth of Listeria due to enrichment media can increase the likelihood of culturally confirming Listeria found at low levels pre-enrichment.

Not All Detection Methods are the Same

The ability of a detection method to find Listeria in an environmental sample is impacted by two factors: 1) method sensitivity and 2) method robustness in the presence of sanitizers. The more sensitive a rapid test method, the greater the chance of finding low levels of Listeria in an environmental sample. Low levels of Listeria in environmental samples are likely due to the injured state of Listeria in the plant environment post sanitization. Immuno-based rapid methods have a sensitivity of 105–106, DNA-based methods have a sensitivity of 104–105 and RNA based methods have a sensitivity of 102–103. Using an RNA-based method offers 1 to 2 logs greater sensitivity and greatly increases the chance of finding low-level Listeria.1 This can be particularly true when sampling conditions such as collection media or enrichment media are less than optimal for the neutralization of sanitizers and growth and recovery of Listeria.

Another important factor that influences a test method’s ability to detect Listeria in an environmental sample is the method’s ability to amplify and detect the organism in the presence of sanitizers. Most molecular-based methods do not include a sample clean up step resulting in sanitizer being present during the amplification step. For some methods, sanitizers may inhibit amplification, resulting in indeterminate or false negative results.

Confirmation Requires Optimization of the Sampling Process

The ability to culturally confirm a Listeria sample that screens positive is influenced by the entire environmental sampling process. In order to culture confirm samples with highly injured, low-level Listeria, it is necessary to optimize the sample collection media, enrichment media, and confirmation process to provide the greatest likelihood of culture recovery. If Listeria is not adequately resuscitated and able to achieve sufficient growth, the level of Listeria present in the sample post-enrichment may be below the limit of detection for culture. The likelihood of culture confirmation can be increased by incorporating steps such as a secondary enrichment or concentration via IMS capture. Culture confirmation for samples that screen positive on a rapid method can be especially challenging if a highly sensitive test method is used for screening that may detect Listeria at lower levels than culture. Thus, optimizing the environmental sample program is especially important if confirmation of screening results for highly sensitive methods is desired.

Method Sensitivity and Increased Positivity

Employing a highly sensitive screening tool for environmental samples provides a better lens to view risk within the food safety processing environment. Many companies fear that a more sensitive method will result in significant increases in positivity and cost for increased sanitation. In working with customers who have moved from immune-based methods to a highly sensitivity molecular method, I’ve observed an initial increase in positivity followed by a leveling off of low-level positivity after enhanced interventions are taken in the plant. Companies that proactively seek out and destroy Listeria in their plants are then able to maintain low level rates of positivity with routine cleaning measures, while also maintaining the confidence that they are using the best tool available for Listeria monitoring.

Understand Your Risk & Establish a Culture of Food Safety

It is important for food safety professionals to fully consider the hidden risks that may exist in their plant environment due to the environmental sample process masking the true presence of Listeria. Each component of the environmental monitoring process, sanitizer, collection media, enrichment media, detection method and culture process plays an important role in a company’s ability to be able to detect and culture confirm Listeria in the plant environment. Optimizing each step within the environmental sample process allows a company to be proactive instead of reactive. This approach creates a company culture of food safety that can seek out, detect and destroy Listeria in the plant environment, can significantly mitigate risk. The good news is that by incorporating the right food safety culture and making data-driven choices, today’s manufacturer can achieve both short-term dividends of risk reduction as well as a long-term elevation of control of its process.

Reference

  1. Culture Shift: The New Dynamics of Listeria Environmental Control and Testing. Roka Bioscience, Webinar.
magnifying glass

How to Survive an FDA Foreign Facility Inspection

By Maria Fontanazza
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magnifying glass

Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.

First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International.  Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.

Prepare for the Inspection

  • Develop an internal policy for foreign inspections
  • To ensure readiness at all times, implement a proactive program that involves the following activities
    • Annual review of registered facilities
    • Review of any products or materials made for U.S. markets (including R&D samples)
    • Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
    • Employee training on FDA requirements
    • Create a site-specific FDA inspection manual for all necessary documentation

Survive the Inspection

  • Align expectations with the inspector at the start of the inspection
  • Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
  • Consider having a U.S. regulatory support colleague available for questions during the inspection

Post-inspection

  • Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
  • If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions

At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.

FST Soapbox

Intelligent Algorithms Shape Food Safety

By Steven Burton
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The North American food safety testing market is projected to reach $16 billion by 2020, according to a recent study by Markets and Markets. In just a few short years, it’s safe to say that purchasing a software solution to create and manage food safety programs will become ubiquitous, equivalent to that of employing any other software tool such as Microsoft Excel.

However, there is a broad range of capabilities for food safety software, and some solutions are much more complex than others. Many types of HACCP software operate as part of an ERP system, merely managing documents online under IT administration. But the technological capabilities of a food safety management system are endless in terms of value-driven innovation. Any competitive software on the market should go further, and be flexible and agile enough to meet and contain the challenges of a changing regulatory landscape and aggressive market space.

One of the ways food safety management can take things further is through the use of intelligent algorithms that can help food safety professionals get the most out of their software—and their HACCP plan. For example, instead of manually searching for all the physical, chemical and biological hazards (as well as radiological hazards under HARPC), intelligent algorithms can use data from other HACCP plans to suggest hazards. By comparing facility types, process flows, ingredients and more, a sophisticated algorithm can make smart suggestions that give food safety professionals a significant leg up, cutting down research time and providing a context of learning since it’s much easier to learn by example than starting from scratch. As such, suggestions can equip food safety professionals with the right mindset to discover potential hazards.

There are core benefits to searching for software technologies that have intelligent algorithms in place to analyze and retrieve data for those food businesses looking to get the most long-term value out of their vendor purchase.

Facilities with High-Risk Products and Complex Process Steps

High-risk foods are defined by the FDA as foods that “may contain pathogenic microorganisms and will normally support formation of toxins or growth of pathogenic microorganisms.” High-risk foods include raw meat, poultry, fish, dairy, fresh fruit, and vegetables, and processors working with these products handle more hazards and process steps in general than processors making low-risk foods. Instead of sorting through hundreds of hazards, facilities with high-risk products and complex process steps are able to skip much of the manual grunt work and simply select automatically generated hazards and process steps suggested to them at their fingertips.

Small Business Owners or Basic Food Safety Professionals

It’s common for small food businesses to put the bulk of their food safety duties on the shoulders of the owner. For many who have no previous background in food safety, there can be an unexpected and frustrating learning curve to overcome before you can pay the sweat equity required to develop a HACCP plan, and not for lack of trying. Similarly, junior food safety employees in new facilities can find established food safety practices challenging to navigate. Through intelligent algorithms, a software system can reinforce food safety hazards and process steps that might have been missed or forgotten by making them instantly available for retrieval and selection.

Giving Back Time

Recordkeeping is an essential component to an excellent food safety culture. In the grand scheme of things, managing resources to allocate time to high-level tasks that require human expertise on the production floor is a critical activity that most food safety professionals prioritize. Having more time to correct potential risk actions is crucial to ensuring the lowest possible likelihood of a recall. Smart software systems facilitate better employee time management practices so they can maximize their hours for meaningful, rather than menial, work. By taking back the time that would have been spent researching hazards, smart suggestions provide food safety professionals with a starting point that allows them to choose from a curated selection without delay.

Experimental Facilities with Changing Product Portfolio

Facilities that have a tendency to experiment with product development (i.e., food startups) are prone to using a significant amount of ingredients and formulas. When it comes time to present the right information for inspections and audits, this translates into a substantial amount of additional work in maintaining a HACCP plan. Intelligent algorithms enable a clear and organized focus, eliminating the minutiae surrounding information management of experimental product development.

New Regulations and International Compliance

Around the world new regulations surrounding acceptable food safety documentation are coming into effect; notably, FSMA even adds to the traditional hazards included under HACCP. For foreign exporters as well as American businesses, regulatory expectations for a more comprehensive approach to hazards and critical control points are higher than in the past. In the face of new regulatory demands, smart algorithms help food businesses lay out a common framework so that they can build internationally compliant programs

Extra Safeguard Check

Human error is inevitable. The beauty of technology is that it acts as a safeguard to ensure there are no glaring omissions that may have an impact on food safety duties. As a final once-over before sending in the HACCP plan, it makes good sense to have smart suggestions to cover all the bases.

Intelligent algorithms allow food safety professionals to do more with their time. By selecting from suggestions related to ingredients, materials, packing and process steps, a considerable amount of time is restored to the work day compared to the time-consuming exercise of manually assembling lists. The main benefit to a food safety software solution with intelligent algorithms is to reinforce the right mindset for listing physical, chemical and biological hazards for ingredients, material, processes and beyond. While smart suggestions should always be verified by a food safety professional familiar with the internal operations of a facility, for companies that aim to work smarter but not harder, smart algorithms are a key feature to keep in mind when researching software vendors.

Survey: Not All Food Companies Sure if FSMA Applies, More Help Needed

By Maria Fontanazza
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How ready is your company for FSMA compliance?
How ready is your company for FSMA compliance? 69% are somewhat ready, 25% are ready, and 6% are not ready at all, according to a recent survey. (Click to enlarge)

Many companies need to prepare for FSMA compliance by September, yet three out of four only consider themselves “somewhat ready”, according to a recent survey of about 400 food companies. However, the findings generally indicate that companies are taking action now to be FSMA ready—they just might need some help along the way.

Sponsored by SafetyChain Software and The Acheson Group, “2016 FSMA Readiness & Compliance Strategy” surveyed mainly U.S. companies (88% with more than $1 million in revenue) that produce and manufacture food for human consumption.

An effective food safety plan is a fundamental part of FSMA compliance. The majority of participants (80%) are either currently updating their food safety plans or plan on doing so this year. Conducting a gap analysis is a common way to assess the effectiveness of a food safety plan: 84% of respondents plan to conduct a gap analysis, have one in progress, or have already completed the exercise. More than half of these companies are tackling it using internal resources, and 29% are seeking expertise outside their organization.

85% of companies surveyed know which rules apply to their company. Survey sponsored by Safety Chain and The Acheson Group
85% of companies surveyed know which rules apply to their company. Survey sponsored by SafetyChain and The Acheson Group

Documentation plays a large role in meeting FSMA requirements, and in the event of an audit, companies must be able to produce records within 24 hours. The good news is that 76% of companies say they can retrieve records required by FDA within this time span, but 22% are still unsure. Half of the organizations anticipate being audit ready on day one of FSMA enactment. And despite a push to migrate to electronic documentation, most of the companies surveyed (84%) still keep both paper and electronic records; only 3% keep strictly electronic documents.

FSMA compliance, technology
Companies indicate that they’re using technology to aid in FSMA compliance.

The survey authors concluded that companies still need more information on how they can meet FSMA requirements, what resources are available, and how certain systems can help. In addition, they indicated that corporate executives must play a larger role in implementing compliance.

FSMA, Food Safety Tech, FDA

FSMA Rule on Sanitary Transportation Finalized

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

FDA has finalized the FSMA rule Sanitary Transportation of Human and Animal Food. The rule establishes sanitary requirements for shippers, loaders, motor and rail vehicle carriers, and receivers involved in transporting human and animal food. The rule does not apply to exporters that ship food through the United States.

“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine in an agency press release.

The sanitary transportation rule puts forth requirements for the following:

  • Vehicles and transportation equipment, including design and maintenance
  • Transportation operations, including temperature control, preventing contamination between ready-to-eat food and raw food
  • Training of carrier personnel
  • Record maintenance, including written procedures, agreements and training

Those exempt from the rule include:

  • Food transportation shippers, receivers and carriers with less than $500,000 in annual revenue
  • Farms that perform transportation
  • Transport of compressed food gases and food contact substances
  • Transport of live food animals
  • Transport of human food byproducts for use as animal food without additional processing

Businesses must comply with the regulation one year following publication; smaller businesses (those with fewer than 500 employees and motor carriers with less than $27.5 million in annual receipts) have two years to comply.

Additional information is available on FDA’s website.

Counting Food Laboratories

By Robin Stombler
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What We Think We Know

Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.

More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”  In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.

There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.

To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:

  • The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
  • Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
  • It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
  • There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
  • In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.

With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.

Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:

But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…

Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.

Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.

To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?”  The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.

A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?”  Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.

ISO 17025

What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.

What We Need Now

FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.

FSMA, Food Safety Tech, FDA

FDA Submits Sanitary Transportation Final Rule

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA
Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall
How are FDA investigators taking a new approach with FSMA? WATCH THE VIDEO

FDA announced today that it has submitted the final FSMA rule, Sanitary Transportation of Human and Animal Food, to the Federal Register for publication. It can take a few days for the documents to be available, so stay tuned for updates from Food Safety Tech once the final rule is available.

In the meantime, find out how the sanitary transportation rule affects employee training: Specific Training Required Under FSMA: A Look at Each Rule

 

Palmer Orlandi, FDA, Food Labs conference

FDA Pushing Proactive, Real-Time Analysis

By Maria Fontanazza
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Palmer Orlandi, FDA, Food Labs conference

Over the past year, FDA has been emphasizing the level of collaboration necessary with industry to drive a more preventive culture of food safety.  Much of these efforts surround closely integrated partnerships between federal, state and local stakeholders, including a larger role that laboratories will play in FSMA implementation.

Palmer Orlandi, FDA, Food Labs conference
“We can’t test our way to food safety. It’s just not possible,” said Orlandi. He added that industry can work together to develop a testing program that leads to safer foods.

There will be greater reliance on the responsibilities and capabilities of laboratories as a result of the proactive movement in finding points of contamination, before they invade the home of the consumer, in real time. With the convergence of more laboratory analysis and the responsibilities that the FSMA regulations warrant, industry will be relying on the establishment of uniform and standardized lab-related processes and policies in order to bring uniformity and trust to the quality of data being generated and shared, according to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine. Orlandi, speaking at the Food Labs Conference last week, said that FDA is moving in this direction. “The oversights we’re mandating moving forward for data sharing, data reporting and data acceptance are completely equivalent across the board,” he said. FDA is working toward providing more transparency in terms of laboratory oversight and how it intends on working with industry.

Within the five published final FSMA rules there is at least some component of lab support that is necessary. The rule that deals the most with lab involvement, especially laboratory accreditation, is the foreign supplier verification program, because the responsibility falls on the importer to assure and verify safety of the commodity, and this requires the submission of laboratory analysis, said Orlandi.

Palmer Orlandi, FDA, Food Safety Consortium
Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium. WATCH NOW

Currently the majority of FDA’s work effort in the laboratory category falls under compliance program driven sampling, with domestic activities (i.e., inspections) and import activities coming in second and third respectively. Moving forward, environmental driven sampling will play a much larger role, as FSMA places greater emphasis on a risk-based approach and finding issues in real time, directly in the environment.

“We don’t want to be the agency that is just is responding to foodborne outbreaks or responding to problems with industry or farms or any of the commodities,” said Orlandi. “We want to work and become less of an enforcement agency and one of a partner so we can stop problems where they may occur. That involves making partners and leveraging our resources.”

FDA is expanding its responsibility for testing and sampling in the area of surveillance, verification (i.e., preventive controls and import controls), and compliance (i.e., removing adulterated products from the market, enforcement actions, and environmental assessment). The agency is taking a risk-based approach to deploying its resources, and where it does not have the capacity it will be relying on partners for assistance. It is also investing more resources in import testing and the criteria that go into accepting data for import testing, and will be preparing guidance for submission of data.

FDA Vs. USDA: Who Regulates What?
FDA Responsibilities USDA Responsibilities
Manufacturers, processers, packers, holders, distributors, food transporters

Growers of fresh fruits and vegetables, tree nuts and sprouts

Dairy products

Plant products and spices

Grain-based products

Seafood (except catfish)

Beverages and bottled water

Food and color additives

Dietary supplements

Meat

Poultry

Frozen, dried and liquid eggs (FDA regulates whole eggs)

Catfish

FDA tests foods for the presence of pesticides, toxic elements, mycotoxins, chemotherapeutics in seafood, and microbial hazards (bacterial, parasitic, viral)
FDA

No FDA Mandatory Recall Activity in 2015

By Food Safety Tech Staff
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FDA

On Friday FDA released its 2015 Annual Report to Congress on the Use of Mandatory Recall Authority and there was not much news to report.  According to the agency: “In FY 2015, FDA had no mandatory recall activity to report under section 423 of the FD&C Act. As a result, FDA did not issue any public health advisories as described in section 206(f) of FSMA.”

This is the third report of its kind since FSMA was enacted. It is worthy to not that it only deals with recalls themselves, not other agency communication efforts such as public health advisories, which include consumer advisories, warning letters and reports of outbreak investigations.