Produce Safety

 
The Food Safety Modernization Act Produce Safety Rule

What is the FSMA PSR rule?
To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) has established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce raw agricultural commodities grown for human consumption. FDA established these standards in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, referred to as the Produce Safety Rule under 21 CFR Part 112, as part of the implementation of the FDA Food Safety Modernization Act (FSMA).

The goal of the FDA Food Safety Modernization Act Produce Safety Rule (FSMA PSR) is not to just contain food-borne outbreaks, but prevent them from occurring in the first place. FSMA PSR went into effect January 26, 2016.

Sell With Confidence

With the Nebraska Produce Safety Program, you can build more trust with every potential buyer that comes your way. Just fill out our Produce Farm Survey to register, and complete optional trainings, reviews or inspections to help us reduce the risk of food contamination. No matter how far you go, you’ll be able to display a Nebraska Produce Safety label that gives customers confidence in every purchase.

 

Already Registered?
Be sure to log in to your online profile to make sure all of your information is up to date! Online profiles help market your produce on the Nebraska Farmers Market Online Database.

Not a grower, but looking for local produce?
The Nebraska Farmers Market Online Database provides a list of farmers markets as well as local produce growers selling fresh, local produce close to you!

 

FSMA Produce Safety Alliance Grower training is being offered online on various dates. For more information, click here.
*Participants will only be eligible for the PSA/AFDO Certificate of Course Completion if they are present for all modules of the course.*

To determine where your farm falls under the Produce Safety Rule, use FDA's decision tree, a step-by-step guide on coverages/exemptions to the PSR.

Follow FDA's decision tree to determine where your farm falls under the Produce Safety Rule.

psr decision tree
Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro).

psr decision tree
Produce does not include food grains meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are primarily grown and processed for use as meal, flour, baked goods, cereals and oils rather than for direct consumption as small, hard fruits or seeds (including cereal grains, pseudo cereals, oilseeds, and other plants used in the same fashion). Examples of food grains include barley, dent – or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed).

If you do not sell the listed amount of produce, your farm is not covered by the PSR.

psr decision tree
Produce that is rarely consumed raw, specifically the produce on the following list: Asparagus; beans, black beans; great Northern beans; kidney beans, lima beans, navy beans, pinto beans; beets, garden (roots and tops); sugar beets, cashews; sour cherries, chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash, sweet potatoes; and water chestnuts

If you grow produce not listed above, it is safe to assume it is covered produce and the Produce Safety Rule may apply to your farm.

psr decision tree
Are you and your family the only ones who eat your produce? If so, you are not covered by this rule.

psr decision tree
The PSR provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions. (i.e. fermenting, canning, cooking, etc.)

For example, if you are a grower who only sells strawberries to a processor to be made into jelly, you would be exempt from this rule. However, you would need to provide documentation from the processor that explains to the grower how your strawberries will be processed in a way that adequately reduces the presence of microorganisms.

psr decision tree
Qualified Exempt Explained

To be qualified exempt, the Decision Tree asks if your farm has less than $500,000 in FOOD sales and a majority of the food is sold directly to a qualified end user.

  1. “Food” here includes, but is not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.
  2. So when it asks about food sales in this situation, it would include your food grains and produce as well as any other food you sell (not just produce).
  3. Qualified end user is
    1. The consumer of the food OR
    2. A restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm that produced the food OR
    3. Not more than 275 miles from such farm (“consumer” does not include a business).
  4. Selling products at a farmers market in the same state or within 275 miles of your farm would be considered selling to a qualified end user.
  5. A majority of sales means more than 50%.

Farms with a qualified exemption must still meet certain requirements:

Labeling: Disclosing the name and address of the farm where the produce was grown either on the label of the produce or at the point of purchase.

Records: Keep adequate records showing that the farm is below the sales threshold, selling more to qualified end users than not, and purchaser is a qualified end user.

psr decision tree

Since NDA is required to have all growers listed in the inventory, we are requesting that all produce growers complete the Nebraska Produce Farm Survey.

By registering, the NDA will be able to assist you with understanding the new Produce Safety Rule. Learn more about when the rule will affect your farm.


Download: Produce Safety Rule Decision Tree

The PSR has specific record keeping requirements for produce growers.

The FDA has updated Subpart E – Agricultural Water, of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule
The FDA has announced dates for implementation for harvest, and post-harvest water usage. FDA recognizes that there was not previously clarity on whether the FDA would propose to change the harvest or post-harvest requirements related to agricultural water. The FDA states that they understand that adequate training and technical assistance will be needed to fully understand the requirements of the harvest and post-harvest agricultural water rule. The FDA will continue enforcement discretion for the harvest and post-harvest agricultural water requirements for the Produce Safety regulation until:

  • January 26, 2023, for large operations
  • January 26, 2024, for small operations
  • January 26, 2023, for very small operations

The FDA plans to take an “educate before and while we regulate” stance, as the agricultural water rules are implemented for the harvest and post-harvest requirements. The FDA states that it plans to work closely with state, other regulatory, and industry partners to advance training, technical assistance, educational visits, and on-farm readiness reviews to prepare growers and state regulators for implementing these provisions prior to initiating routine inspections verifying compliance. The FDA will provide further communications as additional resources become available. The Nebraska Department of Agriculture is working in conjunction with the North Central Region Center for FSMA Training, Extension, and Technical Assistance to provide resources as well. Check our website for updates.

Additionally, The FDA is proposing a revision to Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule that would change the pre-harvest agricultural water requirements for covered produce (other than sprouts). The requirements in this proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule with requirements for systems-based pre-harvest agricultural water assessments. These assessments would be used to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces, and to determine whether corrective or mitigation measures are needed to minimize the risks associated with pre-harvest agricultural water.

To read or comment on the proposed changes, or sign up for the public meetings FDA will be holding to discuss this proposal, please visit the FDA's page.

Tory Heisner, Produce Safety Program Specialist
Tory Heisner Hello, I’m Tory Heisner, the Produce Safety Program Specialist for the Nebraska Department of Agriculture. I earned my B.A. in Biology from the University of Nebraska at Omaha, and I’m passionate about ensuring public safety while supporting the agricultural community across Nebraska. I work closely with producers to help them understand and comply with the Produce Safety Rule (PSR) and other relevant regulations.

With a nurse for a mom and a farmer for a dad, I’ve always been drawn to the intersections of health and agriculture, which fuels my commitment to this work. Outside of work, I enjoy going to the gym, hunting, fishing, reading, learning American Sign Language (ASL), exploring nutrition, and reading. I also have a keen interest in self-sufficiency and sustainable living practices. I’m always eager to meet new people and learn more about the nuances of health and nutrition, both in my professional and personal life.

I focus on conducting inspections, offering tailored guidance, and fostering a strong food safety culture within the community. My goal is to bridge the gap between regulatory compliance and day-to-day farming operations, making it easier for producers to succeed while maintaining high safety standards.

Jennifer Loeffler, Inspector
Jennifer Loeffler Hello! I was born and raised in Norfolk, NE. After earning a B.A. in Biology at the University of NE in Omaha, I later returned to my hometown and began my career in public health.

I have been an inspector with NDA since 2015. Mostly my days are spent visiting retail establishments (restaurants, grocery and convenience stores, food trucks and bars), as well as warehouses and processing facilities.

My interests and hobbies include yoga, gardening, practicing other languages, and learning about philosophy, nutrition, and holistic medicine.

I love meeting people and getting to know all kinds of local businesses. Every day is a new adventure! I am fortunate to have the opportunity to learn from Nebraska growers, too -- and to support them in their important role of providing excellent food.

If you have questions, you can contact us by email, agr.produce.safety@nebraska.gov, or by phone, 402-471-3422.

We can help you complete the inventory questionnaire. We can also help you with the decision tree to determine if you will be covered by the rule or exempt from the rule.

How is the Produce Safety Rule implemented in the state of Nebraska?
The FDA and the State of Nebraska have a cooperative agreement to meet objectives. The state of Nebraska will conduct produce safety inspections under the FDA’s authority and will complete other applicable program objectives. For additional information please visit: FDA-State Produce Safety Implementation Cooperative Agreement Program.

What is FSMA PSR's goal?
The goal of FSMA PSR is to prevent and minimize the risk of serious adverse health consequences or death from consumption of contaminated produce.

How does the state of Nebraska apply the FSMA PSR?
The state of Nebraska applies FSMA PSR through the following steps:

  1. Educate - The state of Nebraska is committed to educating produce growers on how to comply with the FSMA Produce Safety Rule. Participation in Produce Safety Alliance Trainings, On Farm Readiness Reviews, and Farm Technical Assistance are a great way we can help set you up for success.
  2. Implement - Ensure that proper practices are in place and records are being maintained. To ensure successful implementation of the program, staff should be adequately trained to understand regulatory requirements, preventative controls, and food safety practices.
  3. Regulate - FSMA PSR is mandatory. Compliance to the program will be ensured through regulatory inspections.

How does the Produce Safety Rule fit in with the State of Nebraska's priorities?

  • The PSR promotes consumer safety, through ensuring risks associated with consumption of contaminated produce are minimized.
  • The PSR promotes customer service through offering education, and communication with produce growers and consumers.
  • The PSR promotes efficiency and effectiveness by maintaining a cooperative agreement with the FDA to meet objectives.
  • The PSR promotes growth supporting produce growers who are developing economic opportunities in the state.
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