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.
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.
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 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.
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.
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.
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.
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.
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.
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.
“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 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.
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)
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.
With the passage of FSMA, any location that handles food for public consumption must implement Hazard Analysis and Critical Control Points (HACCP) plans to reduce food safety risks across the food chain. Many businesses with multiple locations in the restaurant and retail industries are finding that traditional paper-based methods of record keeping are no longer adequate to comply with the FSMA. By abandoning paper-based systems and adopting cloud-based technology, restaurant and retail locations can embrace and enforce stronger food safety cultures and help eliminate human error.
Why? The process of purchasing, transporting, preparing and serving food heavily revolves around individual human behaviors related to cooking, cleaning, handling and refrigerating food. When employees do not follow the correct processes and procedures, it can lead to accidental food safety issues.
FSMA & HACCP Plans
In an effort to shift from responding to food contamination incidents after the fact to proactively preventing them, the FDA introduced FSMA in 2011. To allow businesses time to adjust to new rules and regulations, the FSMA requirements are implemented in phases, which began in September 2015 and will continue through May 2016.
As part of a larger food safety initiative, FSMA requires any business that handles food for public consumption to implement a HACCP plan. The purpose of the plan and its procedures is to identify potential hazards in any food-related processes where a lapse in attention or failure to complete a task could turn a potential hazard into an actual one.
The three main components of an HACCP plan that are required to be documented are:
Hazards: Evaluate potential hazards that exist in the enterprise. For example, how, when and why Salmonella or Listeria could migrate into a finished product
Critical Control Points: Identify critical control points where failures could occur, such as when products are moved from preparation to the sales floor
Preventative Steps: Establish the preventative steps that must be followed at each critical control point to reduce hazards, for example, interval checks to make sure correct temperatures, whether hot or cold, are consistently maintained
FSMA also mandates a record of food safety compliance to ensure a company follows its HACCP plan. Every location must document all actions, including ongoing monitoring of when a problem was spotted and corrective actions taken. These records, which have traditionally been created and maintained with pen or pencil and paper logs, must be kept for a minimum of two years.
Deli worker checks cold food temperatures using a handheld probe and wireless device. Maintaining proper food temperatures and recording checks for consistency is an important part of HACCP guidelines.
Compliance Challenges
With multiple locations and an ever-changing labor force, it is difficult for companies to be confident that the food they sell is safe and that every employee is acting diligently when it comes to food safety across the entire enterprise.
In a busy restaurant or retail environment with ever-changing customer demands for a variety of different products and services, a food safety culture and plan can unintentionally become compromised.
With local farmers to international food manufacturers supplying fresh, frozen and prepared foods and a variety of workers in contact with each for different reasons, it can be difficult to track food safety procedures.
Add an inefficient, manual, paper-based food safety record-keeping system that does not proactively remind employees to complete tasks or prompt corrective actions when needed, and you are opening the door to potential problems.
It’s Time to Break the Pencil
Companies must implement the highest standards of food safety processes at all levels and locations. Once a food safety culture is defined, it needs to be enforced every day. Employees should be well trained on policies, feel empowered and mandated to behave consistently.
A major part of the solution is abandoning traditional pen or pencil and paper-based record-keeping systems. By adopting technology, restaurants and retail locations can embrace and enforce stronger a food safety culture and help eliminate human error.
Electronic and intelligent checklists and digital record keeping on mobile, handheld solutions that are integrated into the Internet of Things (IoT) represent a major technological advancement over what was previously possible, and can manage and dynamically influence food safety processes. Through connectivity to the cloud, mobile, digital solutions can be deployed anywhere throughout a business, from warehouses to sales floors, to prompt the desired behaviors and provide a detailed, accurate audit trail of completion. Devices can also keep track of relevant safety alerts and recalls to improve efficiencies and initiate steps that may not be part of a typical routine.
Daily employee work schedules can be preloaded and custom electronic-based checklists and templates can be built specifically around potential hazards to manage employee tasks and processes. Any missed steps or violations are flagged for easy correction.
As tasks are completed, data is electronically gathered and transmitted directly to the cloud where it can be stored, analyzed and reported for compliance.
In addition, through the cloud and IoT, employees at various levels of an organization, from corporate headquarters to store managers, can view and access real-time data from each location. New information can be uploaded from any location and automatically distributed to a particular store, region or all locations across an enterprise. Enterprise-wide access helps ensure all locations are practicing the most up-to-date HACCP plan and procedures.
Digital food safety solutions have many benefits for a business:
Overall Food Safety: Ensures critical control points are monitored and proper corrective actions are taken when necessary
Higher Performance: Employees are reminded to complete assigned tasks, so more tasks are completed on time with fewer misses
Audit Trail: Detailed, automated audit trail of who completed the action, what time it was completed and the data retrieved from the action
Process Improvement: A single database of comprehensive information detailing timing, missed checklists, commonly missed items and top violations to help improve overall processes
Cost Savings: Fewer resources are needed to complete food safety inspections, a 60% reduction in time compared to pen or pencil and paper-based systems1
Quality Improvement: In addition to HACCP compliance, the information gathered can be used for quality control. For example identifying where there has been over- or under-cooking in the food preparation process
Handheld, wireless and cloud-based technologies can serve as more accurate, reliable and efficient systems. Electronic systems are part of the solution for businesses to comply with new FSMA regulations and improve food safety procedures. When implemented properly, these technologies can help turn food safety in a positive direction and potentially avoid the next foodborne illness outbreak.
In light of the FSMA Produce Safety rule, FDA is asking industry for feedback on the use of raw manure (which has been seen as an effective method to enrich soil quality) and its potential to contain disease-causing bacteria. In a Federal Register notice just released, FDA is requesting “scientific data, information, and comments that would assist the agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure).” The risk assessment will evaluate and quantify any risk of human illness related to consuming produce grown in fields or other areas that contain such untreated soil for pathogens including E. coli O157:H7 and Salmonella.
The agency is asking industry for more information about how farms use raw manure, along with strategies that should be taken into account in order to reduce the health risk to the public.
The Federal Register notice will be published March 4. There is a 60-day period to submit comments and scientific data.
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