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FSMA Rules on Produce Safety

In January of 2011, President Obama signed the FSMA (Food Safety Modernization Act) into law.  The Act is designed to shift government focus away from merely responding to outbreaks of food borne illness.  The Act proposes a more proactive approach by enacting preventative measures designed to protect America’s food supply.  The FSMA contains seven regulations intended to have far reaching effects on food production, supply and distribution systems.  One of the seven regulations under the FSMA is the Produce Safety Rule. 

The Produce Safety Rule is the U.S. Government’s first attempt to set science-based rules and standards for safe growing, harvesting, packing and distributing fruits, vegetables, mushrooms and sprouts for human consumption.  We don’t need to look far to see the impetus for the new Rule.  Every year, there are multiple news reports of e-coli or salmonella outbreaks associated with produce.  The latest was the romaine lettuce recall.   On December 13, 2018, Adam Brothers Farming, Inc. of Santa of Barbara, California recalled leaf lettuce and cauliflower contaminated by e-coli found in water from a local reservoir.  As is typical, the testing and recall happened only after the lettuce and cauliflower had been distributed over the U.S. and Mexico and multiple reports of illness from eating the produce.  Recent outbreaks raise questions.  Why isn’t the new Rule in place yet?  How will it help the situation?  What does the Rule require?  Hopefully, this article will answer some of those questions for you.

What Producers and Products Do the Rules Cover?

The Produce Safety Rule encompasses all phases of produce production.  There are standards for water quality, employee hygiene, animal and human waste in soil, and equipment and tools used in farming and processing.  Annual sales and level of risk for particular foods to cause illness were used as the basis for the new standards.

Covered and Exempt Products

Fruits, vegetables, mushrooms and sprouts that are likely to be eaten raw are covered under the Rule.  That means items like leafy green vegetables, onions, cucumbers, tomatoes, zucchini, mushrooms and most fruits are regulated by the Rule. Because cooking destroys most harmful bacteria, raw produce needs more careful scrutiny.  Sprouts are especially prone to contamination and have often been the focus of food borne illnesses.  Sprouts are definitely covered by the Rule.

Produce that is rarely eaten raw is not subject to the new Rule.  That includes items like potatoes, winter squash, pumpkins, sweet potatoes, and yams.  The FDA has an exhaustive list of which products are covered by the regulations.

Which Producers are Covered and Which are Exempt

Only commercial produce farms are covered by the Rule. Home gardens, retail stores, restaurants, farmers’ markets and roadside farm stands are not subject to the Rule.  Commercial farms with annual produce sales of a minimum of $25,000 in 2011, are subject to the regulation.  That figure has been adjusted upward for inflation for each year since 2011.  Commercial farms selling less than the designated amount are not subject to the Rule.  Basically, if you own a commercial farm that sells more than the $25,000 + inflation in fruit, tomatoes, and other produce that is eaten raw, you are subject to the new Rule.  If you sell less, you are not.  If you own a commercial potato farm that sells $25,000 + inflation of potatoes each year but none of the regulated vegetables, you are not subject to the Produce Safety Rule.

Key Requirements Under the Produce Safety Rule

1.  Worker health, hygiene and training.  All workers who harvest or handle fresh produce along with their supervisors must receive food safety training.   They must be trained on health and personal hygiene, including good handwashing practices.  Other required areas of instruction include symptoms of contagious illness, proper cleaning of tools and surfaces that come in contact with food, and in recognizing foods that may be contaminated with molds or bacteria.  Supervisors must also be trained to pull workers with suspected contaminating illnesses away from contact with food or equipment.  Workers must receive training in a language they can readily understand.

2.  Agricultural water for planting, growing and harvesting.  Growers are required to test the quality of the water they use for agricultural cultivation.  Agricultural water is defined as water that is intended or likely to come in contact with harvestable portions of the crop.  The big concern with water quality is the possible presence of animal or human feces that may contain the e-coli bacillus.  The frequency and degree of required testing depends on the source of the water.  Surface water is the most likely to be contaminated.  Groundwater is generally safer than surface water, and municipal water is considered the safest source.

3.  Biologic Soil Amendments.   These portions of the Rule regulate the use of animal and human waste in farming.  Animal manure has long been used in agriculture because it is a rich source of soil nutrients.  However, raw animal manure poses significant dangers for bacterial contamination.  Human waste is never permitted to come into contact with harvestable portions of crops because the danger of contamination with pathogens is even higher than with animal waste.  The Produce Safety Rule also provides scientific standards for composting to prevent contamination.

4.  Domestic and wild animal contamination.  During crop harvesting, farmers are expected under the Rule to take all necessary precautions to prevent farm animals and wild animals like deer from getting into the fields and contaminating the crops with animal feces.

5.  Equipment, tools and buildings.  The Produce Safety Rule contains standards for equipment and tools that are likely to come in contact with harvestable portions of the crop.  Tools and equipment must be constructed to allow for easy cleaning.  They must be kept clean and stored in such a way to prevent mice and other pests from contaminating them.  

Delays in Implementation

When the FDA published the Produce Safety Rule, it was surprised by the negative reaction from growers and commodity groups who complained that the Rule was burdensome, and the required testing was too complicated for growers.  They also complained about the documentation and records keeping requirements being burdensome.  In response, the FDA agreed to simplify the agricultural water testing requirements and to allow an additional two years beyond the original deadline for compliance. 

Compliance deadlines are based on three-year sales averages.  The deadline for large growers with sales over $500,000 was January 26, 2018.  Smaller growers have later deadlines.  However, in 2017, the FDA proposed additional extensions for compliance with agricultural water standards.  That means the Produce Safety Rule requirements have not yet been met by most growers and packers.  You can stay abreast of compliance deadlines and implementation of the Rule by monitoring the FDA website: www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm

Resources

www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm

www.fda.gov/Food/GuidanceRegulation/FSMA/ucm472503.htm

www.extension.psu.edu/understanding-fsma-the-produce-safety-rule

www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm626330.htm

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This website has been prepared for general information purposes only. The information on this website is not legal advice. Legal advice is dependent upon the specific circumstances of each situation. Also, the law may vary from state-to-state or county-to-county, so that some information in this website may not be correct for your situation. Finally, the information contained on this website is not guaranteed to be up to date. Therefore, the information contained in this website cannot replace the advice of competent legal counsel licensed in your jurisdiction.

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