What is the Food Safety Modernization Act?
This 28-minute video covers the basics of the Food Safety Modernization Act (FSMA), and provides in-depth information on the Produce Safety and Preventive Controls for Human Foods Rules. Watch and learn how FSMA affects you.
The following flow charts are used in the video, and are available to view or print for reference:
- [Narrator] The following is for informational purposes only and is not intended as legal advice.
- [Instructor] Is my farm or food business regulated under the Food Safety Modernization Act?
The food and agriculture industry is represented by thousands of farms, packing houses, and food processing facilities that offer a diverse array of raw agricultural commodities and processed food products.
Many of these businesses are going to be affected by the Food Safety Modernization Act.
Everything from smaller family run fruit and vegetable farms to larger produce farms and packing houses that ship products to other states.
Those effected also include big food companies that sell products all over the world but also many smaller value added food processors that distribute their products to local and regional markets.
This video will help you to understand what the Food Safety Modernization Act is and know whether or not it applies to your operation.
We'll also look at which rule covers your crops or food products, whether you are eligible for exemptions, and what the deadlines are for compliance.
Let's get started with just a little background on the Food Safety Modernization Act.
What is it and what do we need to know about it?
The Food Safety Modernization Act, commonly shortened to FSMA and pronounced Fyz-ma is a federal law.
The US Congress passes laws and the president signs them into law.
FSMA was passed by Congress in 2010 and President Obama signed it into law on January fourth, 2011.
Congress has signed the Food and Drug Administration or FDA for short, responsibility for enforcing FSMA.
In 2015, the FDA finalized the FSMA regulations we will discuss in this video.
It's important to know that FSMA regulations only apply to commercially grown, packed, and processed food or feed.
Home gardeners or home food preservers are not covered under the law.
Some types of produce crops and food products are also not covered and so they do not fall under the regulations.
First, direct-to-consumer sales at restaurants and retail food establishments.
This includes grocery stores, farmers markets, farm stands, and internet food sales.
However, these may be covered under other state or local regulations.
Also, FSMA regulations only apply to FDA regulated foods, not USDA regulated meat and poultry products.
If your operation is already covered under other FDA food safety rules like juice HACCP or seafood HACCP, your products are not covered under all aspects of the law.
You will need to check to make sure which parts of the law you fall under so although this list excludes some businesses most of the food produced in the US is FDA regulated and most businesses including farms and food processors are going to be affected.
We'll come back to who is affected by FSMA in just a moment but first let's take a brief look at the seven FSMA regulations or rules as they are also called.
Each of these rules has a long official name which you can find at the FDA's website and a shorter name by which most refer to it.
We'll use the short names here.
The seven rules are produce safety, preventive controls for human food, preventive controls for animal feed, food defense, transportation, imported food auditors, and import verification.
The first two rules are the ones that will affect many produce growers and food processors in Pennsylvania and other states.
We'll focus on these two.
The produce safety rule pertains to most produce growers.
All but the smallest operations.
The preventive controls for human food rule regulates all food processing facilities and some produce packing operations.
Finally, some farms that process foods will be regulated by the preventive controls rule.
So, to put this another way we've got three main types of businesses affected by these two rules, farms, packing operations, and food processing facilities.
Now let's find out which rule covers your crops or food products.
We'll be looking at two rules, the produce safety rule and the preventive controls for human food rule but first what does it mean to be covered by a rule?
Covered means that A, your produce or product falls under one of the regulations issued under the Food Safety Modernization Act and B, you need to make sure you are in compliance with each of the specific requirements in that regulation.
In some cases, those covered under the regulations are eligible for exemptions to the rules which we'll go over later.
We'll use a series of flow charts to help you figure out which rule you are covered under.
We'll present you with some statements and then depending on which statement you agree with you will move to the next set of statements until your determine your FSMA status.
We'll start with a series of questions related to what type of food business you operate according to the FDA, a farm, packing operation, or processing facility.
First, do you grow, harvest, and pack produce on your farm?
According to the FDA, a farm is an operation devoted to growing, harvesting, and packing produce in one general location and under one general management.
Second, do you conduct off-farm packing activities?
The FDA defines a packing operation as a location where harvested produce is placed into containers and shipped for further distribution and finally the last question, do you operate a food processing facility?
That's a place where food or ingredients are transformed into new food products by physical or chemical means.
Think about each of these questions and decide which category you fall under.
If you said you grow, harvest and pack produce you fall into this box.
Your business is a farm.
The first decision to make is related to whether or not you grow any produce that is likely to be eaten raw.
Let's stop for a minute and discuss what exactly the FDA means when they say produce likely to be eaten raw.
The FDA established a list of familiar items that falls into this category.
These include most fruits and vegetables, greens, nuts and herbs.
In some situations, some of these items might also be sold as canned or frozen products or could be cooked by the consumer.
Things like tomatoes or onions but if there is a strong possibility that some people would eat them raw it's on this list.
Here is the full list.
You can pause the video now if you like to review it in detail.
Note that this list is not exhaustive meaning that there are potentially others that FDA has not thought of yet but FDA has another list.
These are produce crops that they have decided are rarely consumed raw.
These are things that are almost always cooked or processed in some way such as dry beans, root crops and baking fruit.
Here's the full list.
It is an exhaustive list meaning unlike the previous list it is complete according to the FDA.
Go ahead and pause the video now if you'd like to review it.
Okay, let's get back to the flow chart.
If you selected I only grow produce that is rarely eaten raw then none of the produce you grow is covered under the produce safety rule.
It's that simple.
This rule only covers produce that is likely to be eaten raw but if you said yes, at least some produce I grow is on the FDA's list of produce likely to be eaten raw then those produce crops could be covered under the produce safety rule but to find out you need to go to the next set of statements and choose which one is true about your farm.
My average annual produce sales are less than 25,000 dollars or my average annual produce sales are at least 25,000 dollars.
The amount of your annual produce sales is the average value of your produce sales taken over the last three years and the dollar limit will be raised each year based on the rate of inflation.
That means the limit will go up a bit each year.
If your average annual produce sales are less than 25,000 dollars then none of your produce is covered under the produce safety rule.
Congress wrote this 25,000 dollar limit on produce sales into the Food Safety Modernization Act to protect very small farming operations from burdensome regulations.
So what if your average annual produce sales are at least 25,000 dollars?
If that's the case then at least some of the produce you grow is covered under the produce safety rule.
Later, we'll check to see if any exemptions to the rule apply to your operation.
Before we move on to the next category of business activities, let's retrace our road back to the top of the flow chart.
If your business is a farm, you have one more possibility to follow and that is I also process food on my farm.
That means that some type of value added commercial food processing activities occur on your farm.
Again, processing food for personal use only doesn't count.
So what is the specific definition of food processing?
According to the FDA, it is when you transform food or ingredients into new food products by physical or chemical means.
For instance, do you slice or peel your apples or carrots before you sell them?
Do you can or freeze any of your products for sale?
Cooking, baking, drying, and fermenting are also examples of food processing methods.
If you do any of these activities on your farm any processed food products that you then sell are covered under the preventive controls for human food rule.
So that means you could be covered under both rules.
Now, let's go back up and over to the next box on the flow chart where it says I process food.
That is, your business is a food processing facility.
If you process foods, no matter if it's on a farm or as a standalone business, then you are covered under the preventive controls for human food rule.
You may qualify for some exemptions but we'll return to this to see later if you are eligible for any of these.
Also note that a few years ago, all food processing facilities were required under federal law to register with the FDA.
If you did this you are covered under the preventive controls for human foods rule.
If you have not registered your food processing facility yet you should call the FDA or visit their website to do so immediately.
Okay, we're almost done with our coverage decisions but there is one more set of decisions to go over.
Let's go back up and over to the box that says I pack fresh produce at a location that is not on a farm.
Before you proceed here it's important to understand that if you pack produce on your farm you fall into this first category and you're only covered by the produce safety rule but if you conduct packing activities at a location that is not on your farm you need to move down to the next set of choices.
Again, you have two statements to choose from.
The first statement is more than 50% of the produce I pack is grown on a farm or farms under a different ownership than my packing house.
If this is true, then your packing activities are covered under the preventive controls for human food rule but what if only 50% or less of the produce you pack off-farm is grown on a farm or farms under a different ownership than your packing house?
In other words, more than half of the produce you pack was grown on your farm.
If this is true then FDA says your packing activities are covered under the produce safety rule.
Later we'll help you figure out whether you are eligible for any exemptions for each of these rules.
You see by now that this is pretty complex.
If you're unsure of anything go back to the beginning and go through it again but here is something to keep in mind.
Even if you determine your produce or products are not covered, if you sell them to commercial buyers, the buyer may require that you provide evidence of good food safety practices and that could mean meeting the food safety standards in the produce safety rule or the preventive controls for human food rule.
So be sure to ask your buyers.
Based on three types of business activities we determined if any of your produce crops or food products are covered.
If you still are not sure of where you stand go to the Penn State FSMA website to find an expert who can help you.
Now let's find out if you are eligible for any of the exemptions that are available under the FSMA produce safety rule and the preventive controls for human food rule.
If you determined that your produce or food products are not covered under either of these rules, this part of the video does not apply to you.
First, what is an exemption?
An exemption means you do not have to comply with all parts of the rule.
You only have to comply with certain parts of the rule called modified requirements.
Exemptions are generally based on the size of your operation, your intended buyer, or how the product will be used once it gets into the market place.
You will need to find out what the modified requirements are.
Okay, let's begin again with the produce safety rule.
If you have determined that at least some of your produce crops are covered under this rule, now you can find out whether you qualify for any exemptions.
We'll walk you through each step in the flow chart to see what exemptions might be available.
If you are unsure at any point as we move through this video, stop and go back to review it.
The first determination to make is whether or not your produce is intended for further processing that destroys pathogens.
For instance, blanching vegetables in hot water before freezing or thermal processing in cans or jars are processing methods that can reduce the number of harmful microorganisms to safe levels.
So for example, although tomatoes or carrots that you grow may be covered under the produce safety rule, if you sell them to a commercial freezing or canning operation you are eligible for a processing exemption under the produce safety rule for these specific crops.
If your produce will not go through further processing to destroy pathogens, that is you know that it will be sold to consumers in its fresh form, then you won't be eligible for the processing exemption but you may still be eligible for what the FDA calls a qualified exemption.
Now you need to determine whether your average annual total food sales are either less than 500,000 dollars or at least 500,000 dollars.
Here, total food sales includes the value of all the food your business produces, not just your produce sales.
So produce plus any other food crops like grains intended for making bread, milk from your dairy herd, or even the value of animals raised on your farm that are intended for human food.
If your total annual food sales are 500,000 dollars or more than you are not eligible for a qualified exemption and you must comply with all requirements in the produce safety rule.
However, if you chose my average annual total food sales are less than 500,000 dollars, you still have a chance to get this exemption.
The decisions that follow are related to who you sell your produce to.
First, you need to decide how much of your food sales are direct to consumers.
Examples of direct sales to consumers are when you sell your produce at your farm stand, a farmers market, through a CSA program or over the internet.
Are more than 50% of your average annual food sales directly to consumers?
If so, then your farm business is eligible for the qualified exemption.
If this isn't the case and 50% or less of your food sales are direct to consumer keep going.
There are a few more decisions you need to go over.
If 50% or less of your food sales are made directly to individual restaurants or grocery stores who prepare or sell it to consumers at that site that would mean that the majority of your sales are to grocery chain warehouses, brokers, distributors, fresh processing facilities, or other types of businesses where your produce will be resold to other businesses.
If this is the case, you are not eligible for a qualified exemption and you must meet the full requirements of the produce safety rule but if more than half your food sales are made directly to restaurants or retail food establishments and not to a distributor who resells to another business there is another way you might be eligible for a qualified exemption.
If you fall into this category there is one more requirement you need to meet to get the qualified exemption.
The restaurants or retail food establishments you sold the food to must be in the same state as your farm or no more than 275 miles away.
This was written in the law by congress with the goal of giving local foods a break.
If that is your situation then you are eligible for a qualified exemption.
If your food sales are to out of state buyers that are more than 275 miles from your farm then you are not eligible for the qualified exemption and you must comply with all requirements within the produce safety rule.
Now we switch to directions to the preventive controls rule.
If you decided earlier that you are covered under the preventive controls for human food rule we can move on to find possible exemptions.
If your business is a farm where commercial food processing activities also occur then start on this side of the chart and go through the decisions.
We'll go over possible exemptions for non-farm processing activities a little bit later.
If you process foods on your farm you need to decide whether all of your processed food products are on the FDA's list of low risk products.
Those considered low risk are the only farm processing activities you can do and still be eligible for what the FDA calls a mixed type facility exemption.
What does the FDA consider to be low risk?
Low risk processing activities include making jams and jellies, syrups and honeys, grains, oils, vinegars, baked goods, and other products that do not require refrigeration to keep them safe to eat.
Many small scale processors add vinegar or other acids to foods to pickle them.
However, pickled products are not on the low risk list.
If from this list of activities you decide that you process at least some items that are not considered to be low risk on your farm then you are not eligible for the mixed type facility exemption but you may still qualify for the qualified facility exemption.
To find out if you qualify for the qualified facility exemption you will need to go through the decisions on the other side of this chart.
We'll come back to that in just a bit.
If you decided that all of my processed food products are low risk then you may be eligible for the mixed type facility exemption but only if you meet certain business size requirements.
If you have less than 500 full time employees on your farm or your average annual food sales plus the value of your inventory is less than one million dollars than you are eligible for the mixed type facility exemption.
Recall that to get your annual total food sales you want to take the average of all your food sales over the previous three years including things like produce, grains, dairy, and meats and don't forget to add the value of your inventory but what if you have at least 500 full time employees and your annual food sales plus the value of your inventory are at least one million dollars?
Then you are not eligible for the mixed type facility exemption under the preventive controls rule.
So if you either manufacture processed foods on property that is not a farm or you do your processing activities on your farm but were not eligible for the mixed type exemption, now we can check to see if you are eligible for a qualified facility exemption.
We only need to answer one question to find out.
Are your average annual food sales plus the value of your inventory at least one million dollars?
If this is true, then you are not eligible for a qualified facility exemption but if your average annual food sales plus inventory are less than one million dollars then you are eligible for a qualified facility exemption.
It's that simple.
That was a lot of information.
Again, go back and review it now if you need to.
Proving eligibility for qualified exemptions under either rule requires three years of sales records to support your claim for the exemption.
You should begin collecting sales records now to prepare you for your claim once your compliant date occurs.
Keep in mind that the FDA can remove your exemption if they find you are growing produce or making processed food products under unsafe conditions.
Finally, let's talk about the deadlines for when you need to be in compliance with the Food Safety Modernization Act regulations as well as some resources for learning more about what compliance means for you.
When the FDA wrote the final regulations they decided that smaller businesses would need more time than larger ones to get ready to comply with the rules.
Therefore compliance dates differ by size categories based on annual sales.
Compliance dates for the produce safety rule are based on January 2016 start date.
Your annual produce sales will be based on a rolling three year average.
Farms grossing from 25,000 dollars up to 250,000 dollars in annual produce sales are considered very small businesses and the general compliance date for them is four years from the effective date of the rule.
Farms grossing more than 250,000 but less than 500,000 annually are classified as small businesses and the general compliance date for them is three years.
Larger farms with over 500,000 dollars in sales have two years to comply.
Within each business category farms get an additional two years to comply with the requirements related to agricultural water standards.
The compliance timeline for the preventive control for human food rule is a bit shorter ranging from one to three years.
Compliance dates are based on a September 2015 start date.
Very small food businesses with annual food sales averaging less than one million dollars have three years from the effective starting date to comply.
Small businesses with fewer than 500 employees have two years to comply and larger food businesses that meet either of these criteria have only one year.
Compliance dates for all farm produce packing operations covered under the preventive controls for human food rule have been adjusted so that they are aligned with the compliance dates for farms conducting similar activities that are regulated under the produce safety rule.
Visit the Penn State FSMA website to obtain clarification on any of these compliance dates.
But what's next you ask.
Where do I learn what I actually need to do to comply?
Am I required to complete any training?
The actual requirements of the regulations are beyond the scope of this presentation and we will not delve into them here.
If you are covered under any of the regulations discussed and are not eligible for any exemptions you should take a one to three day training course to learn the details of what you will actually have to do.
Non-exempt growers of produce covered under the produce safety rule are required to take an FDA approved course on farm food safety created by the Produce Safety Alliance.
At least one supervisor level person on your farm must complete the training.
For those who are covered under the preventive controls for human regulation and not eligible for any exemptions, training courses are currently being offered.
Visit the Preventive Controls Alliance website for more information.
Finally, visit Extension's FSMA website to learn more details about what you need to do if you are covered under FSMA regulations and about modified requirements for those with exemptions.
Be sure to keep up to date on new developments under the law and any changes you'll need to make in your operations to remain in compliance with the rules.
In this video, we covered a lot of material.
We learned about the Food Safety Modernization Act and the two rules that will effect a lot of produce growers and food processors.
You learned whether your crops or produce are covered under the produce safety rule or the preventive controls for human foods rule and if so, whether you're eligible for any exemptions and you know how much time you have to be in compliance with the rules and where you can go to learn more about trainings.
If you have more questions you can always rely on the Penn State FSMA website for more information or to find an expert who can help you.