University of Vermont

Cultivating Healthy Communities

Food Safety & Modernization Act Proposed Rules

The Food Safety Modernization Act (FSMA), called the most sweeping reform of the food safety laws of the United States in more than 70 years, was signed into law in January 2011. Since then, the Food and Drug Administration (FDA) has been developing the specific rules designed to keep the American food supply safe through preventative measures.

On November 27, 2015, the FDA posted the final version of the FSMA Produce Safety Rule to the Federal Register. The focus of the Produce Rule is on prevention of microbial contamination of fresh, whole produce that may be eaten raw.

Greens

The other FSMA rule that may apply to Vermont growers who process food is the Preventive Controls Rule (otherwise known as Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food). More information on the Preventive Controls Rule can be found here .

Below are links to resources to help you understand what the Produce Safety and Preventive Controls rules might mean for your business.

The Vermont Agency of Agriculture, Food and Markets also maintains a webpage with FSMA-related information that can be found here.

The Produce Rule Categories: What You Need to Know Now (January 2016)

You can download a .pdf file with the below information here.

For most standards, farmers will have 2 to 4 years to come into compliance with the Produce Safety Rule, However, there is one thing that all farms need to do now, and that is to pull together records that will document whether your farm is covered* by FSMA or not, and if it is covered,* whether you are eligible for the modified exemption.
Starting now
:

  • Figure out your annual gross sales for all food sold from your farm (averaged over a three year period, starting in 2011). All food includes: dairy, eggs, meat, processed foods and livestock feed as well as produce.
  • This figure will tell you whether you are covered* by the Produce Rule or not, and if you are covered*, if you are eligible for the qualified exemption. Check out the FDA Produce Rule Flowchart to determine where you fall.
  • If you are eligible for a Qualified Exemption, you must keep your financial records for three years (starting from 2011) to document your eligibility. You can use tax returns, Quickbooks or other financial software to document your gross sales for all food.
  • If you are covered* by FSMA, you have 2-4 years to come into compliance, depending on your gross sales (see table below). You have an additional two years to come into compliance on water quality.
  • FSMA does NOT require growers to have a food safety plan.

Where does your operation fall?

Click on the statement below that describes your farm to see a list of actions you can take now.

I. My average annual gross sales of all food are under $25,000

Your farm is not covered* by FSMA, and there is nothing special that you need to do to be in compliance with the law other than keeping records to document that your annual gross sales are under $25,000.

Remember: being covered* by FSMA does not take the place of a third party audit if your buyer requires an audit. Even if you are not covered* by the law, some buyers may want to know that you are following good produce safety practices.

Action Items

  • Learn more about produce safety practices through UVM Extension's Center for Sustainable Agriculture's Practical Produce Safety Program here.
  • Convene a "Kitchen Table Worksession" to write your Produce Safety Plan- join with one to four other farms in your area to work with Ginger Nickerson on writing Produce Safety Plans for your farms. For more information contact Ginger at gnickers@uvm.edu or 802-505-8189.
  • Get VT-CAPS certified. The Vermont Vegetable and Berry Growers Association has a certification program: Vermont CAPS (Community Accredited Produce Safety) for farms that do not need to be GAPs certified. For more information contact Hans Estrin at hestrin@uvm.edu
  • .
II. My average annual gross sales of all foods sold are between $25,000 and $500,000 AND over 50% of those sales (by value) are to "Qualified End Users**".

You are eligible for a Qualified Exemption from FSMA.

Action Items:

  • Start now to pull together records since 2011 that will document that your average gross annual sales for the last three years are under $500,000 to demonstrate eligibility for the Qualified Exemption
  • Going forward from January 2016, you will need to document that over 50% of the value of your gross sales are to Qualified End Users. You can do this through invoices/receipts, Quickbooks or other financial software that tracks sales by customer type.
  • If you are eligible for a Qualified Exemption, you must keep your financial records for three years (starting from 2011) to document your eligibility. You can use tax returns, Quickbooks or other financial software to document your gross sales for all food.
  • By January 2020, you must start labeling shipping cartons with your farm name and business address. When labels are not required, you must prominently display farm name and complete business address at point of purchase (such as through a farmstand, farmer's market, or CSA pick-up location).
  • Learn more about Qualified Exemptions at the FDA's FSMA Produce Rule webpage.

**Qualified end users are customers who are going to consume the food, and/or restaurants or retail food establishments that are located in the same state as your farm or not more than 275 miles from your farm.

III. My average annual gross sales of all foods are between $25,000 and $500,000 AND over 50% of those sales (by value) are NOT to Qualified End Users (i.e. they are to distributors or other middlemen)
OR
My average annual gross sales of all foods are over $500,000
  • You are covered* by FSMA and will be required to comply. You will have to follow certain standards.
  • See the table below to see how much time you have to come into compliance.
  • Learn more about the rules at the FDA's FSMA Produce Rule webpage.
  • Watch the Wes Kline Farm Credit East Webinar on How to Prepare Your Farm for FSMA.

Action Steps:

  • If you irrigate using surface water, you may want to begin to sample your surface water sources to understand how the quality of your water fluctuates under different circumstances and if/when you need to take corrective actions.
  • Determine if you will need to make any infrastructure improvements and start to plan for them.
  • Each farm must have at least one person who has successfully completed a food safety training that is recognized as equivalent to FDA training. Trainings for growers will start in September, 2016. To sign up to be notified of the dates and locations of trainings, go to the Produce Safety Alliance Grower listserv sign-up page.
  • IV. I grow sprouts.

    Because sprouts require warm, moist and nutrient-rich conditions favored by microbes, they have been frequently associated with food borne illness outbreaks. Depending on the size of the operation, farms that grow sprouts will have only one to three years to comply with subpart M of the rule, with no additional time to meet the water requirements. Farms that do less than or equal to $250,000 in annual gross sales of produce will have three (3) years to comply with the sprout standards; farms that do less than or equal to $500,000 in annual gross sales of produce will have two (2) years to comply; and farms that do over $500,000 in gross sales of produce will have one (1) year to comply. The sprout rule does not apply to sprouts grown in soil and harvested without their roots.

    For more information on the Sprouts standards under FSMA, see the FDA's Produce Safety Rule website and the Sprout Safety Alliance website.

    V. I only sell produce that is rarely consumed raw and/or produce that is going to be commercially processed and go through a "kill" step.

    If you only sell produce that is usually cooked, such as sweet corn, potatoes, pumpkins or winter squash, your farm may still be covered,* but those crops are not covered by FSMA. This means that you should still keep records to demonstrate what your gross sales are, but you will not need to follow the rules if you are not growing crops covered* by the law. See below for a complete list of crops that are not covered* by FSMA.

    Foods that are Rarely Consumed Raw

    • Produce that is rarely consumed raw: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
    • Food grains, including 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).
    • Processed products


    Timeline for Compliance

    Size Definition Compliance date for activities involving covered* produce (except sprouts) Compliance date for water quality standards, testing and recordkeeping
    Very small farm Average annual value of produce sold is greater than $25,000, but not more than $250,000 January, 2019: 4 years from effective date 2021: 6 years
    Small farm Average annual value of produce sold is greater than $250,000, but not more than $500,000 January, 2018: 3 years from effective date 2020: 5 years
    Other covered* farms Average annual value of produce sold $500,000 January, 2017: 2 years 2019: 4 years



    Review of Who is Covered*

    Average annual gross sales of all food for your farm is: Covered* by FSMA? What you must do
    Under $25,000 Not covered* by FSMA Keep financial records to document you fall in this category
    Between $25,000 and $500,000 AND over half the value of your sales is to Qualified End Users (direct consumers or retail establishments within 275 miles of farm) Covered* by FSMA, but possibly eligible for Qualified Exemption
    • Keep financial records to document you fall in this category.
    • By January 2020: Use labels and signage
    • Must have name of farm and complete business address on labels (ex: shipping cartons)
    • When labels not required, must prominently display name and complete business address at point of purchase (ex: farmstands, farmer's markets, CSA pickup location)
    Other covered* farms Average annual value of produce sold $500,000 January, 2017: 2 years

    Want more information?

    The Preventive Controls Rule

    For additional resources and assistance if the Preventive Controls rules apply to you, contact UVM Extension's Food Safety Faculty:

    Omar Oyarzabal , Food Safety Specialist
    Email: omar.oyarzabal@uvm.edu
    Phone: (802) 524-6501 ext. 452
    Food Safety for Producers and Processors website

    * 'Covered' means you are required to comply with the Produce Rule regulations.

    Last modified February 04 2016 11:28 AM