With First Wave of New FDA Food Safety Regulations, Farmers and Food Producers Set Their Sights on Compliance

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According to the United States Food and Drug Administration (FDA), each year roughly 48 million get sick, 128,000 require hospitalization, and 3,000 lose their lives as a result of a foodborne illness. Unsurprisngly, an increasing number of consumers are listing food safety among their top concerns as a result of these figures. Food safety encompasses a variety of issues, including animal disease, perishable foods, food handling and preparation, and bacterial contamination.


In an attempt to curtail these figures, the Federal Government has adopted one of the most drastic and broad-sweeping set of food safety reforms that the nation has ever seen: the Food Safety Modernization Act (FSMA). FSMA represents the first substantive overhaul of the United States food safety law system, which has gone relatively untouched since 1938. Now, food safety regulations will encompass a broader range of food producers, like farms that grow fresh fruits and vegetables, and require food manufacturers to perform more due diligence regarding food input products and suppliers.


Compared to pre-FSMA food safety standards, things are about to get a lot more serious.


Signed into law on January 4, 2011, FSMA provides the FDA with broader authority to issue rules and regulations governing food safety with an emphasis placed on preventing food safety problems rather than relying on a reactionary system to address issues after illnesses occur. More specifically, the law provides the FDA with a new set of enforcement authorities that are designed to accomplish higher rates of compliance with prevention-and-risk-based food safety standards.


One aspect of FSMA directs the FDA to establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. In developing the so-called Produce Rule, the FDA must consider a variety of potential hazards, including naturally occurring hazards and those that may be introduced unintentionally or intentionally. Some examples of potential food illness hazards include soil additives like compost, employee hygiene, packaging, temperature controls, animals in the growing area, and water.


According to proposed versions of the Produce Rule, farmers will likely need to ensure that any water that comes into contact with produce or food-contact surfaces is of adequate sanitary quality, subject to periodic inception and testing requirements. When it comes to domestic animals, the law may soon require minimum waiting periods between crop harvest and grazing if there is a reasonable probability of contamination.


The law also establishes a mandated inspection frequency based on risk for food facilities, imbues the FDA with access to records and industry food safety plans, imposes various water  quality requirements, and requires certain types of food testing to be performed by accredited laboratories.


The first of FSMA’s broad-sweeping rule changes is coming up on August 30, 2015 (Preventative Controls for Human Food & Preventative Controls for Animal Food), with additional taking effect on October 31, 2015, including the Produce Rule.


“FSMA is coming. There are a lot of farmers and other individuals that will be required to be compliant at some point,” says Ramkrishnan Balasubramanian, Director at Quality Certification ServicesQuality Certification Services (QCS). “We certainly feel based on the interactions we’ve had that some farmers and operations may not be ready yet.” With more than 25 years of industry experience, QCS is a USDA and ISO Guide 65 accredited certification program offering a wide variety of certification options for farming, livestock packing, handling, processing, and wild harvest operations.


For Backyard Farms, New England’s largest producer of tomatoes, getting certified was a top priority. On June 17, 2015, the company announced that it has become the first grower to obtain a GLOBALG.A.P. Harmonized Produce Safety Standards (HPSS) certification. GLOBALG.A.P. is an initiative started by a group of retailers who became increasingly aware of consumers’ growing concerns regarding food safety, health, and welfare. The organization is a Global Food Safety Initiative recognized standard that assures customers of a company’s good agricultural practices for food safety and environmental management practices. It is one of the world’s leading farm assurance programs, translating consumer requirements into Good Agriculture Practice in a rapidly growing list of countries – currently more than 110 worldwide.


As GLOBALG.A.P.’s newest food safety certification, HPSS covers food safety and food traceability essentials for fruits and vegetables in tune with FSMA and many of its current and impending requirements. “GLOBALG.A.P. and HPSS are very important for operations for a number of reasons. First, making sure the food that is being consumed is safe. Second, minimizing the risk associated with the business, including liability for illnesses and recalls,” says Balasubramanian.


With a number of food safety schemes on the market it can be hard for farmers—and investors evaluating a potential play—to know which certification packs the most punch. “What sets GLOBALG.A.P. apart is that it encompasses everything from the seed all the way up to the farm gate,” says Balasubramanian. “This is incredibly important.” Nearly every major retailer throughout the United States and Europe has accepted the program’s food safety certifications.


HPSS is a subset of GLOBALG.A.P.’s Integrated Farm Assurance (IFA) certification, which is a globally harmonized scheme for Good Agricultural Practices including food safety and environmental components. The core of the IFA certification consists of four control points and compliance criteria: food safety, food traceability, environmental sustainability, and worker operational health and safety. Both the HPSS and IFA evaluate several key food safety components, including crop management, pesticide control, quality management systems, and hazard analysis and critical control points.


According to Balasubramanian, there are plenty of opportunities for AgTech to innovate in the food safety realm, particularly as the clock keeps ticking toward various compliance deadlines. “There is an opportunity for AgTech folks to come up with solutions so that farmers can get up to speed quickly, if and when they must become compliant.” According to Balasubramanian, more and more farmers will be searching for information and tools to help them become compliant—and fast.


A number of tech companies have answered that call, creating software programs that streamline the FSMA compliance process. Intelex, for example, has set up a complete set of software solutions for managing FSMA compliance as the new regulations take effect. “From farm to fork, whether you’re a processor, ingredients provider, manufacturer, packager, restaurant chain, or retailer, Intelex has the software solutions that will empower you to achieve your business objectives,” reads the company’s website. SafetyChain offers a similar service featuring real-time data analysis along every point of the supply chain, including in the field and around the farm.


Big data and tech companies may have another part to play when it comes to helping farmers and food producers stay on track with the new record keeping and document adherence requirements mandated by FSMA. For many food producers, detailed records regarding everything form training, agricultural water, soil amendments of animal origin, and sprouts must be kept for a specified period of time.


FSMA’s requirements create many specific opportunities for innovation, particularly when it comes to using big data to help farmers and food producers learn about their suppliers. With many companies sourcing ingredients and supplies through brokers and distributors who keep their source lists private, knowing where each ingredient or input came from can be a bit of a challenge. Once FSMA takes effect, however, overcoming this hurdle will be necessary for some producers. Under FSMA, a product that has a historically low food-safety risk sourced from a supplier with a strong track record will typically require less safety verification oversight than riskier products from supplier’s with rocky backgrounds.


The FDA is still in the process of developing and finalizing many of the regulations that it will need in order to carry out FSMA’s mandates. When it comes to compliance, the timeline varies based on the size of each business:


  • Very small businesses, those with more than $25,000 but no more than $250,000 in annual produce sales, would have four years after the rule’s effective date to comply with most provisions.
  • Small businesses, those with more than $250,000 but no more than $500,000 in produce sales, would have three years after the rule’s effective date to comply with most provisions.
  • All other farms would have two years after the effective date to comply with most provisions.
  • The compliance dates for water quality standards, and related testing and recordkeeping provisions would be an additional two years beyond the compliance dates for the rest of the final rule.


For more information on FSMA, visit


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