FSMA: The Food Safety Modernization Act

One of the key food related laws signed into legislation in the USA has been the Food Safety Modernization Act (FSMA). It is possibly one of the most sweeping reform acts in US regulatory life since the introduction of the Food, Drug & Cosmetic Act of 1938. For over 70 years there has not been a significant piece of food legislation in the USA  since the introduction of this new law reform which started in 2011.  

The FSMA was introduced by President Obama on 4th January 2011. The Food & Drug Administration (FDA) has been developing the framework ever since so that rules can be in place for the act to be properly implemented. The whole act concerns better and more effective prevention of a variety of food safety issues which have dogged the US food supply chain for many years.

Why Does The FSMA Exist ?

There is an oft quoted statistic from the Center for Disease Control and prevention (CDC) which estimated in 2011 that each year 48 million people in the USA were being made sick from food borne disease. In some cases this was so serious that 3,000 dies from such diseases whilst 128,000 were hospitalized.

Food Safety In The Supply Chain

The FSMA concerns the need to ensure food safety throughout the supply chain. There are two critical measures which are:-

  • An intervention plan to eliminate or reduce pathogen load in food products
  • Th detection and identification of any food borne organisms.

For many food producers it means especially preventing microbial contamination rather than dealing with the issue once it has occurred. The consequence is that the law affects growers, producers, people who harvest food, the processors both in the USA and anybody bringing food in from outside the country.

The law has seven main rules each of which has staggered implementation dates so that the industry is not overburdened by regulation at once. To ensure there is some fairness in the rules being proposed, these rules were published in the Federal Register (January 4th, 2013). Then a public comment period was made lasting 120 days but subject to extension. These rules were then published as final rules about a year after all the comments closed.

The implementation dates began in 2015.

The main rules are:-

  1. Produce safety (October 31, 2015)
  2. Prevention controls for human food (August 30, 2015)
  3. Prevention controls for animal food (August 30, 2015)
  4. Foreign supplier verification programs (October 31, 2015)
  5. Accreditation of third-party auditors (October 31, 2015)
  6. Focused mitigation strategies to protect food from intentional adulteration (May 31, 2016)
  7. Sanitary transportation of human and animal food (March 31, 2016)

Produce Safety (The Produce Safety Rule [PSR])

The Produce Safety Rule (PSR) 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. It is 547 pages with the last 66 pages covering the actual rule.

The PSR has the biggest impact on fruit and vegetable growers. It applies to raw agricultural commodities including fruits and vegetables, mushrooms, tree nuts, sprouts and any mixes of these including intact fruits and vegetables. The PSR applies to farms whose operations are not less than $25,000 total sales over a 3 year average.

There are 5 areas covered:- the workers, agricultural water, animals, animal-derived soil amendments, facilities and food contact surfaces

Introduction of the PSR has been less frenetic than with other introductions of parts of the FSMA because the industry has needed to understand how to manage it. It is much more complex and there are many ramifications.

For example, growers of produce have had to examine their water sources for susceptibility to contamination by back flow. Many food safety issues relate to contaminated water of salad crops for example. That means back-flow prevention devices must be in place between the valves and irrigation water sources. It also means that the hardware must be suitable for production.

Corroded, broken equipment must be repaired or scrapped and replaced.

All produce contact surfaces need to be identified. Harvest bin interiors are classic food contact surfaces and all of these must be cleaned. Special consideration has to be given to contamination by external surfaces when bins are stacked.

Pre-harvest inspections are to be carried out. The individuals responsible for food safety have to inspect fields looking for obvious signs of contamination such as animal intrusion.

Fruits & Vegetables Covered

  • almonds, apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other melons (such as canary, crenshaw and persian), mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers (such as bell and hot), pineapple, plums, plumcot, radish, raspberries, red currant, scallions, snow peas, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, watercress, and watermelon.
  • Mixes of intact fruits and vegetables including fruit baskets

The produce That Is Exempt:-

arrowhead, arrowroot, artichokes, asparagus, beets, black-eyed peas, bok choy, Brussels sprouts, chickpeas, collard greens, crab apples, cranberries, eggplant,  figs, ginger root, kale, kidney beans, lentils, lima beans, okra, parsnips, peanuts, pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga, sugar beet, sweet corn, sweet potatoes, taro, turnips, water chestnuts, winter squash (acorn and butternut squash), and yams.

Staff & Personnel

Food processors are meant to meet an FSMA requirement of having  “preventive controls qualified individuals”.

It is requirement that people responsible for implementing the PSR on their farms for example must attend a recognised training event. The only one recognised to date is the Produce Safety Alliance Grower Training.


The FDA has the authority with this bill to issue a mandatory recall when a company fails to voluntarily recall any unsafe food when requested to do so by the FDA.


Firms must comply with implementing preventive controls and adhering to the produce safety regulations. If a business fails to meet the requirements which are described under section 419, there is a scale of punitive measures which depend on the severity of the violation. The types of action possible include the following:-

  • the issuance of advisory letters;
  • court actions, such as seizure or injunction; and
  • administrative actions, such as administrative detention to gain control of adulterated or misbranded products, mandatory recall of violative food, or suspension of a facility’s food registration to prevent the shipment of food.

When it comes to imported foods, the FDA is allowed to refuse entry of the food into the country and hold onto it. They can also ask FDA field staff to refuse future shipment of the food without needing further physical examination.

Food exporting companies and regulators must also comply. This has meant an overhaul of their own infrastructure so as to keep their competiveness.

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