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The US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) is considered the most sweeping reform of US food safety laws in more than 70 years. The FSMA focuses on preventing, rather than reacting to contamination. Therefore, it requires organizations within the food industry to ensure that their supply chains are secure.
The FDA Food Safety Modernization Act (FSMA) Produce Safety rule is now final, and the earliest compliance dates for some farms begin one year after the effective date of the final rule (see “Compliance Dates” below). The rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.
The final rule is a combination of the original proposal and revisions outlined in the supplemental proposal, with additional changes as appropriate. The definition of “farm” and related terms were revised in the final Preventive Controls for Human Food rule, and the same definitions of those terms are used in this rule to establish produce safety standards. Operations whose only activities are within the farm definition are not required to register with FDA as food facilities and thus are not subject to the preventive controls regulations.
For operations that meet the farm definition, exemptions and modified requirements for the Produce Safety are explained in “Exemptions and Variances” and in the Coverage and Exemptions/Exclusions flowchart
A GUIDE TO FSMA COMPLIANCE FOR FOOD AND BEVERAGE COMPANIES
The FDA’s Food Safety Modernization Act (FSMA) has been called the most sweeping reform of U.S. food safety laws in seven decades. Its main purpose is to protect public health using a proactive, instead of reactive, approach to food safety. FSMA also granted the FDA new enforcement authorities to improve compliance with prevention- and risk-based food safety practices. Because it encompasses such a robust overhaul of food safety regulation, efforts to finalize laws and put legislation into effect have been ongoing since FSMA was signed into law in 2011. By now, however, many compliance dates have passed, and food and beverage companies under FSMA are responsible for the development and implementation of a FSMA-compliant food safety program.
What is FSMA?
For Food & Beverage companies, FSMA is a critical pillar of compliance which calls for a compressive food safety program. Here, we’ll review critical information to help your facility achieve and maintain FSMA compliance, including FSMA requirements and regulations.
The following guide will review key need-to-know components of FSMA, including:
The Background & History of FSMA
What Prompted the FDA to Develop FSMA?
Beginning in 2009, a host of high-profile food recalls took place, spurring the FDA to update the nation’s food safety system. Among the most noteworthy of these recalls was the multi state outbreak of salmonella found in peanut butter from 2008 to 2009. The CDC reports 714 people fell ill as a result of exposure and the infection reached people in 46 different states, as well as one resident of Canada. It is also suspected that the infection contributed to nine deaths. As a result of the outbreak, a jury in Georgia convicted a former peanut company owner guilty of fraud, conspiracy, and other federal charges in 2014. It marked the first federal felony conviction of an executive in a food safety case. Many other recalls have gained national attention since, stemming from pathogens such as E. coli and listeria found within spinach, ice cream, cantaloupe, and more popular food products.
In addition to these isolated incidents, the overall statistics of foodborne illnesses in the U.S. have been startling: every year, one in six Americans – or 48 million people – becomes sick from a foodborne disease, while 128,000 people are hospitalized and 3,000 deaths occur.
A Brief History of FSMA
The September 11th terrorist attack in 2001 influenced the government to enhance U.S. security across all realms. In 2002, President Bush signed the Bioterrorism Act into law, which granted the FDA administrative detention authority over food items presenting a threat of serious health issues to people or animals. FSMA was then created in 2009, broadening the FDA’s authority and allowing for administrative attention based on any reason to believe a food item has been adulterated.
The Food Safety Enhancement Act was passed by the House in 2009, but following negotiation with the Senate, it transformed into the Food Safety and Modernization Act. The Senate passed the final bill in 2010, and the House approved it shortly thereafter. President Barack Obama signed it into law in January of 2011.
The FDA’s key dates for FSMA Final Rules span the greater part of a decade, with the Preventive Controls for Human Food Final Rule having been published in September 2015, and the proposed compliance dates for very small farms under the Produce Safety Regulation extending all the way to January 2024. Each facility’s ability to understand the ways in which FSMA impacts its operations is central to ensuring compliance by the appropriate deadlines.
Who Does FSMA Apply To?
Under FSMA, all food producers, including manufacturers, processors, packers, and distributors, must comply with general FSMA requirements unless otherwise exempted, with the exception of USDA regulated meat, poultry, and egg producers. These requirements include biannual registration with the FDA, development and implementation of a food safety plan with preventive controls based on a hazard analysis, and development and implementation of a food defense plan with mitigation strategies based on a vulnerability assessment. Companies that fall under FSMA must also promptly report to the FDA’s Reportable Food Registry upon the discovery of any foods that could lead to adverse health effects. Dairy farms, with the exception of exempted very small dairy farms, are also included in the Intentional Adulteration Rule of FSMA.
What Are the FSMA Regulations?
The FDA has determined compliance dates for rules that form the foundation and implementation of FSMA based on company size and characterizes enterprises on a rule-by-rule basis as follows:
The Preventive Controls for Human Food Rule
The Preventive Controls for Human Food Rule is the crux of FSMA requirements. It focuses on the prevention of problems which could cause foodborne illnesses through the implementation of risk-based preventive controls to prevent or minimize identified hazards. FSMA compliance dates were staggered as follows:
Very Small Businesses - Businesses that average less than $1 million per year. Compliance date: September 17, 2018
Small Businesses- Businesses with fewer than 500 full-time employees. Compliance date: September 18, 2017
Other Businesses - Businesses that average equal to or more than $1 million per year. Compliance date: September 19, 2016
While compliance dates for the Preventive Controls for Animal Food Rule are the same as listed above, FDA defines very small and other businesses differently for this rule, with very small businesses earning less than $2.5 million, and others earning that figure or more.
Foreign Supplier Verification Program (FSVP) Rule
The Foreign Supplier Verification Programs (FSVP) Rule applies to importers of human and animal foods. It requires importers to perform risk-based activities to ensure that food imported into the U.S. meets FDA safety standards.
FSMA compliance dates are based on a number of factors, including the size of the foreign supplier, nature of the importer, and whether the foreign supplier meets FSMA’s Preventive Controls rule. Compliance dates began in May 2017 and will continue into 2021, so any importers that have not yet done so should review dates on the FDA’s official website.
Rule International Adulteration (IA) Rule
The Intentional Adulteration (IA) Rule aims to prevent purposeful acts intended to cause wide-scale harm to public health. Compliance dates are as follows:
Very Small Businesses - Businesses averaging less than $10 million per year are exempt but must provide documentation to show qualification for exemption by July 26, 2021.
Small Businesses- Businesses employing fewer than 500 full-time employees. Compliance date: July 27, 2020.
Other Businesses - Businesses averaging equal to or more than $10 million per year. Compliance date: July 26, 2019.
Farms earning more than $25,000 annually are also subject to the various components of the Produce Safety Rule, which has compliance dates ranging from 2016 to 2024.
What Are the FSMA Compliance Requirements?
FSMA requirements encompass six key components: a product and facility plan, risk assessment, preventive controls, monitoring, CAPAs and reanalysis, and documentation. Each element is covered in greater depth below.
1. Product & Facility Plan
Food companies under FSMA governance must develop a written food safety plan for each product or group of similar products as well as the facility itself. This could require thousands or even tens of thousands of plan components, incorporating elements such as PRPs, CCPs, specifications, and more. There must also be demonstrable proof that product and facility plans are being implemented and monitored continuously.
2. Risk Assessment
The development of a FSMA compliant food safety plan requires a robust risk assessment. To analyze potential hazards throughout the supply chain, companies must identify and assess all risks that are reasonably likely to occur. Thereafter, they must determine which are most significant. While the FDA does not provide a standard definition of significance, FSMA does indicate that if someone knowledgeable in food safety would see the risk as a hazard that they would want to control in order to protect the public, it should be considered significant.
Potential hazards can include biological, chemical, and physical risks. To identify risks, food safety professionals may consider previous experiences with the product, its past history, or the history of similar products.
3. Preventive Controls
Once risks have been identified, the next step is to establish controls which can be put in place to mitigate them. The preventive controls within a company’s food safety plan should be designed to do all that is possible to prevent potential risks from occurring. It is also important to note that the controls for a FSMA food safety plan can extend beyond hazard analysis critical control points (HACCP), and must also encompass factors such as process controls, allergen controls, sanitation controls, training, and recall plans.
4. Monitoring & Verification
The only way to confirm that a FSMA food safety plan is working effectively is to actively monitor, verify, and validate preventive controls. The FDA requires continuous monitoring, so not only will plans themselves need to be presented upon audits, but also proof of ongoing tracking. The primary purpose of FSMA is, after all, to prevent food safety outbreaks instead of responding to issues after they arise.
Tracking FSMA plan performance is ultimately up to the discretion of each company. With that said, tracking controls on an ongoing basis and documenting results are two critical aspects of a successful plan. To ensure effectiveness, companies can measure specific parameters such as temperature, monitor an aspect of the environment, test products routinely, or find a similar means of tracking data.
5. CAPA & Reanalysis
Under FSMA, Corrective/Preventive Actions (CAPAs) must be in place when preventive controls fail. Plans and controls must also be revisited periodically to ascertain whether any areas of improvement can be addressed. In general, plans should be readdressed at least every three years, or if a food safety incident occurs and was caused by a failure in preventive controls. The objective of a FSMA food safety plan is to identify CAPAs before they are needed so prompt remedial action can take place in the event it is needed.
With FSMA, it is often said that “if it isn’t documented, you might as well not have done it.” Indeed, every component of a FSMA food safety plan must be documented: the programs that make up the plan, proof of completion and validation, all test results and supplier documents, and CAPAs. The objective is for each facility to be able to tell a narrative about its FSMA food safety plan. This can be simplified through a single, unified system of records. Modern food safety solutions allow users to record, store, track, and retrieve all of the pieces of data for a FSMA food safety plan with ease and convenience.
The level of enforcement on the FDA’s part changes significantly based on industry events. While in past years they have been able to focus on building programs for FSMA, recent outbreaks have demanded the agency’s attention.
The food industry still has yet to see how FDA enforcement of FSMA will take shape. While the FDA originally began with what may have been an approach that was 95% education and 5% regulation, there is now a heavier focus on regulation. There also appears to be variability from one jurisdiction to the next, with some large facilities having yet to experience FDA inspections, while some smaller enterprises have had multiple audits. Additionally, although the use of swabathons is not FSMA-derived, the FDA will likely continue leveraging lab testing and genetic capabilities more and more if they are able to acquire the necessary resources.
Although most FSMA compliance dates have passed, staying up-to-date on evolving regulations will remain critical for Food & Beverage companies. FSMA regulations continue to evolve, with new traceability rules on the horizon from the FDA. As such, implementing a scalable and flexible food safety program will be integral to navigating regulations as they develop.
FSMA compliance for fresh produce processing. Less waste, more traceability.
Farmsoft delivers opportunities to reduce waste during the packing, processing, storage, and distribution phases. By enforcing best practices, FIFO (when practical), inventory expiry monitoring, and easy stock takes - your company has every opportunity to minimize waste and maximise profit. From bar code managed inventory, inventory labeling, to 3D pallet storage, farmsoft delivers on reduced waste.
TRACEABILITY MADE EASY
Perform recalls in seconds, with the full confidence of accuracy and reliability. Minimize risk by ensuring accurate traceability is automatically captured. Pass audits with ease & reduce compliance costs using farmsofts traceability guidelines. Trace fresh produce up and down the supply chain, over multiple traceability hops. Instantly produce spray records, residue analysis, soil analysis, and any other farm traceability records if you use our farm solution.
REDUCE ADMINISTRATION COSTS
Minimize your administration costs with automatic paperwork generation. Ensure accuracy of paperwork by having necessary documentation (invoice formats, export documents, transport documents etc) presented to employees based on the needs of the specific customer - ensuring timely and accurate documentation. No more rejected orders because of bad documentation accompanying a shipment. Food traceability software made easy!
CONSISTENT QUALITY CONTROL
Guarantee consistent, accurate, and efficient quality control is performed at any part of the fresh produce handling life-cycle; including during delivery, pre processing, post processing, and dispatch. Create quality control tests based on each customers requirements, and even create a daily factory hygiene test, employee performance tests and more. Accurate quality control helps to improve customer confidence and quality perception. Easily follow fresh produce quality control & fresh produce inventory guidelines.
BETTER PRODUCTION PLANNING & DISPATCH
Monitor orders, assign orders to specific packhouses (you can have unlimited processing sites in farmsoft), and allow micro monitoring of each production lines output requirements using dashboards. The dashboards ensure the correct products are produced at the correct time to fill orders. Dispatch teams are given details on their mobile device (or PC/Mac) and scan pallets onto orders. Administration teams can see orders are picked and ready for dispatch, and are presented with the correct documents for printing. All of these features result in improved accuracy of both production and dispatch processes.
OPTIONAL FARM SOFTWARE INTEGRATION FOR FARM TO PLATE MANAGEMENT SOLUTIONS
Optionally use farmsoft Farm Management software with our Post Harvest solution. Using both solutions provides an end to end solution from field to plate. Farm Management by farmsoft delivers full farm record keeping, farm inventory, cost monitoring, budgeting, best practice enforcement, and adherence to international farming standards. Use Farm Management by farmsoft to manage your own farms, or even hundreds of external farms that supply your fresh produce company.
'Training helps with food safety and FSMA compliance'
The Food Safety Modernization Act (FSMA) identifies water as one of the largest contributors to foodborne illness outbreaks. SmartWash Solutions®, founded two years before the FSMA became law in 2011, was created to mitigate bacterial cross-contamination in fresh-cut produce wash water environments. The SmartWash Solutions system combines proprietary wash enhancers for both conventional and organic products, an industry-leading wash-water process controller and regular operator training.
"We believe operator training is a critical component to enhancing food safety and ensuring FSMA compliance," said Angela Nunez, VP of Technical Support for SmartWash Solutions. "This hands-on training gives our customer partners an understanding of the science behind wash water cross-contamination and how our products combat these problems, so they can consistently operate their systems to enhance food safety while reducing chemical usage and lessening demands for water, electricity and labor."
Partners who complete their annual SmartWash Solutions training experience interactive sessions presented in English and Spanish. The SmartWash training addresses the importance of wash water chemistry in any food safety program as well as the significance of SmartWash equipment and its proper use in fresh cut produce wash lines. This annual training offers a more in-depth view into how the system works, allowing them to use real-world data to ensure best practices. In addition, the training gives participants an opportunity to learn from other SmartWash Solutions partners, while keeping abreast of any regulatory changes and how those affect their existing process controls.
Reflecting on his recent training experience, Mike O’Sullivan, SmartWash Technician with Taylor Farms Tennessee, said, "This year’s training was very informative. The hands-on technical part and the reference sheets will be very helpful moving forward. I have been a SmartWash champ for several years and still learned a lot this time!"
For more information:
US: Estimated costs to comply with Food Safety Modernization Act
In an effort to improve food safety by reducing foodborne illnesses, the Food Safety Modernization Act of 2011 (FSMA) empowered the U.S. Food and Drug Administration (FDA) to impose new regulatory requirements on food producers and handlers, to expand requirements for and inspections of food imports, and to issue mandatory recalls of food. As a result, FDA gained expanded authority to regulate fresh-produce production practices at the farm level. The FSMA Produce Rule will be implemented in phases beginning in 2018 and will affect farms supplying almost all fresh produce sold in the United States.
by John Bovay, Peyton Ferrier, and Chen Zhen
As part of the rule-making process, FDA estimated the cost of compliance with the Produce Rule for a few broad categories of farms distinguished by annual produce sales value and exemption status. In its analysis, FDA estimated the total costs of compliance to be $368 million for domestic farms (annualized over 10 years, using a 7-percent discount rate) but did not estimate the costs by commodities or regions. Using those original FDA estimates, this study provides estimates of the cost of compliance with the Produce Rule by commodity, State, and farm size (based on sales). The findings of the study have implications for understanding future competitiveness of smaller farms and markets for locally grown fruits and vegetables and enable researchers to characterize effects of FSMA on retail prices, by commodity.
What did the study find?
The many fixed costs associated with the administrative and personnel components and the food safety process components of complying with the Produce Rule cause compliance costs to be higher as a share of revenue for smaller farms. For this reason, fruit and vegetables produced on larger farms are estimated to have smaller compliance costs than those produced primarily on small farms. Findings on the annual costs of compliance with the Produce Rule upon full implementation of the rule in 2022 include the following:
- Farms with annual produce sales over $3,450,000 account for 58.6 percent of U.S. farm produce sales and are estimated to incur annual costs of compliance of about 0.3 percent of the value of their produce sales. Farms with annual produce sales between $500,000 and $700,000 are estimated to incur annual costs of compliance of about 4.2 percent. Small farms (annual sales between $250,000 and $500,000) and very small farms (annual sales between $25,000 and $250,000) are estimated to incur annual costs of 6.0 percent and 6.8 percent, respectively.
- Very small farms that qualify for a partial exemption from the rule are estimated to incur annual costs of around 2.4 percent of the value of their produce sales, compared with 6.8 percent for nonexempt farms of the same size.
- The annual costs of compliance with the Produce Rule are estimated to add about 0.3 percent to the farm cost of producing romaine lettuce (lowest among vegetables considered in this study) and 3.0 percent to the farm cost of producing snap beans (highest among vegetables).
- The annual costs of compliance with the Produce Rule are estimated to add about 0.7 percent to the farm cost of honeydew (lowest among fruits considered in this study). Among fruits primarily grown domestically for U.S. consumption, the highest farm cost is estimated at 3.0 percent for pears. These differences in cost of compliance across commodities reflect differences in farm sizes; fully regulated farms that grow honeydew tend to have much larger value of sales than fully regulated farms that grow pears.
- Differences in estimated cost of compliance, by State and county, depend on the average value of sales for farms subject to the FSMA Produce Rule in each locality. Fully regulated farms in Arizona tend to be quite large; on average, farms in Arizona that are subject to the FSMA Produce Rule are estimated to have the lowest annual cost of compliance among all States, at 0.6 percent of produce sales revenue. Farms in nine States with smaller produce-growing farms (Vermont, Arkansas, Minnesota, Kentucky, Mississippi, Iowa, Alabama, South Dakota, and Alaska) are estimated to have average compliance costs of 3.0 percent or higher.
- Our estimates of compliance costs assume that no farms are already in compliance prior to the enactment of the Produce Rule, thereby representing upper bounds on actual compliance costs. If large shares of farms were already in compliance prior to implementation of the rule, then actual compliance costs will be below our estimates.
How was the study conducted?
This study drew on the FDA’s published estimates of the 10-year cost of complying with the Produce Rule to develop a function that relates each farm’s produce sales to its cost of complying with the rule. Using data from the 2012 Census of Agriculture, researchers first computed estimates of the cost of compliance for regulated farms falling within different farm size categories, with varying implementation timelines and possible exemptions over the 2016 to 2022 period. They then calculated the average estimated cost of compliance by county and State for different farm sales categories and by fresh-produce commodity.
GlobalG.A.P. releases new FSMA guide
GlobalG.A.P. has published a new guide for compliance with the Food Safety Modernization Act (FSMA).
The GlogbalG.A.P. User’s Guide and Self Assessment for FSMA Produce Safety Rule Compliance supports Integrated Farm Assurance (IFA) users in efficiently meeting Produce Safety Rule (Produce Rule) requirements. IFA is one of the the most widely utilized good agricultural practice scheme for fresh produce in the world.
Where differences in approach and requirements were identified, GLOBALG.A.P. developed an explanation in the form of this Guide. It includes a Self Assessment, highlighting specific differences between GlobalG.A.P. IFA coverage and the Produce Rule. The Self Assessment allows the IFA user to make the necessary adjustments to comply with the Produce Rule. The Guide provides an extra table that details exactly how IFA requirements address those in the Produce Rule.
The Self Assessment is not audited as part of the GlobalG.A.P. IFA certification process at this time by GlobalG.A.P.’s independently accredited and licensed certification bodies. Producers can receive help with the Guide and Self Assessment from GlobalG.A.P.’s USA-based and international technical support staff.
Dr. Kristian Moeller, CEO of GlobalG.A.P., expressed his gratitude to the many individuals who contributed to this Guide’s development: “At GlobalG.A.P., we are committed to an inclusive process for developing our standards and guidelines. We wish to thank the technical staff, National Technical Working Group members, producers, retailers and other stakeholders who contributed to the development of this Guide over the past year. Your contributions of time and knowledge ensure that GlobalG.A.P. reflects your needs, making IFA your standard.”
"GlobalG.A.P. has created a practical management tool for GlobalG.A.P. IFA users all over the world to help ensure FSMA Produce Rule compliance with the publication of this guidance document,” said Walter Ram, VP of Food Safety at the Giumarra Companies and Chairman of the GlobalG.A.P. USA Crops National Technical Working Group.
Mr. Ram added: “As a supplier of fresh produce from the USA and many other countries, we want to maximize the efficiency of our food safety and regulatory controls and this tool helps our growers to use GlobalG.A.P. IFA to ensure Produce Rule compliance. It addresses the unique requirements in the Produce Rule without compromising IFA’s global identity and recognition.”
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PMA comments FDA's proposed FSMA implementation work plans
In written comments submitted today to the U.S. Food and Drug Administration’s (FDA) proposed Food Safety Modernization Act (FSMA) implementation work plans (Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards), Produce Marketing Association (PMA) again supported the need for increased funding for FDA’s food safety budget, including the appropriation of an additional $109.5 million in new budget authority. However, PMA clearly outlined its opposition to funding FSMA implementation through the imposition of user fees, inspection fees or registration fees by Federal or State governments.
“PMA and its members absolutely understand that FDA needs sufficient budgetary resources for food safety tools, infrastructure, and personnel to appropriately implement FSMA,” said Dr. Jim Gorny, PMA’s vice president of food safety and technology. “However, we believe these financial resources should come from the Federal budget rather than unfairly and disproportionally falling on the food industry sector.”
The comments also highlighted three areas of most concern to members:
- Education & Technical Assistance for Industry: Gorny outlined that the Administration’s Federal Budget appropriations request of $11.5M for industry education and technical assistance is, “[…] woefully inadequate given the sheer number of regulated business that will be affected by the FSMA regulations.” The association suggested greater federal government resources need to be authorized and appropriated for FSMA education and technical assistance to industry particularly for Land Grant University Cooperative Extension Services. “It is imperative that sufficient resources be allocated to educate industry about FSMA implementation and compliance before FDA regulates,” said Gorny.
- Guidance Development at FDA: The comments expressed a strong desire to engage early, often and repeatedly with FDA on the development of guidance documents for produce industry operations. Gorny requested that, “[…] FDA consider routinely convening a group composed of industry, academia and government subject matter experts to draft and update model compliance guidance for each of the FDA FSMA implementing regulations […].” The comments suggest that group would make recommendations to the agency as to what preventive controls, policies, procedures or practices would address “hazards” appropriately and deem a business to be “in-compliance” with applicable regulations.
- National Integrated Food Safety System: In the Administration’s FY’ 2016 Federal Budget, the President proposed the possibility of a single Federal Food Safety Regulatory Agency. “While the concept has some merit it would simply be too much, too fast with the impending implementation of FSMA. What’s really needed is a truly national integrated food safety system involving federal, state, local and tribal food safety agencies,” said Gorny. PMA expressed support for the role of state governments assisting with education outreach to produce growers and to perform routine FSMA compliance inspections, “[…] because state governments are best positioned to have in-depth working knowledge about produce growers’ and packers’ procedures, policies and practices in their state.” Additionally, the comments requested that FDA provide sufficient time and resources to train produce industry businesses so that they can comply with final rules, as well as training FDA and state regulatory officials regarding agricultural practices. Gorny encouraged FDA to work with stakeholders to harmonize independent third party produce safety market access audit requirements, and to strongly consider the results of those safety audits to reduce redundant inspections by FDA or states that are verifying compliance with the FSMA produce rule.
To read PMA’s comments, visit www.pma.com/topics/food-safety/fsma
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