FSMA's Preventive Controls for Animal Foods Rule
The Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Rule is discussed in this video. Learn if your operation is affected and what you need to do to comply.
- [Speaker] The following is for informational purposes only and is not intended as legal advice.
- [Speaker] Is my animal feed business regulated under the food safety modernization act?
The animal feed and pet food industry is represented by thousands of farms, feed mills, and animal food processing facilities that offer a diverse array of raw agricultural commodities and processed animal food products.
Many of these businesses are going to be affected by the food safety modernization act.
Feed mills, animal feed, and pet food processors and manufacturers as well as holding facilities that sell products all over the world will be affected.
But, so will many smaller mills and pet food makers that distribute their products to local and regional markets.
This video will help you to understand what the food safety modernization act is all about.
And know whether it applies to your operation.
Then, we'll see if any of your animal feed or pet food products are covered under the preventive controls for animal food rule.
If your products are covered under the rule, we'll see if you are eligible for exemptions.
And finally, what the deadlines are for complying with the regulations.
So now, let's get started with a little background information to help you to understand what the food safety modernization act is.
The food safety modernization act, commonly shortened to FSMA, and pronounced fyz-ma, is a federal law.
In the U.S. congress passes laws and the president signs them into law.
FSMA was passed in congress in 2010.
And President Obama signed it into law on January fourth 2011.
Congress assigned the food and drug administration, or FDA for short, responsibility for enforcing FSMA.
In 2015 and 16, the FDA finalized the FSMA regulations that we'll discuss in this video.
FSMA regulations only apply to commercially packed and processed animal feed or pet food.
Before we continue, let's take a quick look at what types of operations are not covered by this law.
First, home based businesses where processing and manufacturing take place within a personal residence are not covered.
Also, retail establishments that sell animal feed or pet food directly to consumers are not covered.
But, be sure you check with your state department of agriculture to see if any local regulations apply.
Information on Pennsylvania state regulations that apply to home based feed and pet food businesses are available on the PennState FSMA website.
Now, 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 the produce safety rule.
The preventive controls for human food rule.
Preventive controls for animal food.
The imported food auditors rule.
And the import verification rule.
The regulation that will affect commercial animal feed processors and mills in the U.S. is the preventive controls for animal food rule.
The full name is current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals.
And we'll focus on this rule.
You can see from this longer title that the regulation has two basic components.
Good manufacturing practices and preventive controls.
Good manufacturing practices or GMPs, are the basic, foundational sanitation standards all animal feed and pet food operations must follow to prevent product contamination.
Every operation covered under the rule must comply with the GMPs.
More information on the GMPs can be found at the PennState FSMA website.
Preventive controls are procedures in place based on the specific product and process of an operation.
These are established in a hazard analysis developed by the company.
Not every operation covered under the rule will need to implement preventive controls.
Now, let's see if any of your animal or pet food products are covered under the preventive controls for animal food rule.
First of all, what does it mean to be covered by a rule?
Covered means that your business or product falls under the regulation.
Some animal feed products are not covered under the rule.
And so they do not fall under the regulation.
However, if your feed products are covered, you need to make sure you are in compliance with each of the specific requirements in the regulation.
In some cases, businesses producing covered products are eligible for certain exemptions to the rules.
We'll use a series of flow charts to help you figure out whether or not your animal feed or pet food products are covered under the rule.
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 you determine your FSMA status.
We'll start with two situations where animal feed or pet food is either produced on a farm or at a location other than a farm.
Let's start with a farm where animal food processing or manufacturing occurs.
According the the FDA a farm is an operation devoted to raising animals and/or growing, harvesting, packing or holding crops.
A farm establishment that conducts both farming and processing activities is called a mixed-type facility.
So, if your farm also conducts processing activities, then your operation is a mixed-type facility.
And you may or may not be covered under the animal food rule.
To figure this out, you need to consider two questions.
First, is your farm and feed business 100 percent vertically integrated?
That means that the farm, the feed processing operation and all of the animals that consume all of the feed are the same location and under the same ownership or management?
If so, then the animal feed or pet food processed or manufactured on your farm is not covered under the animal food rule.
But, if your business is not 100 percent vertically integrated, meaning that at least some of your farm processed feed products are sold to other businesses under different ownership or management than your farm, then all of your products are covered under the animal food rule.
Now let's consider the second case of an all farm animal feed or pet food processing or manufacturing operation.
All animal feed products produced at a location other than a farm are covered under the preventive controls for animal food rule.
It's just that simple.
Now, let's find out what exemptions might be available for businesses that produce feed products covered under the preventive controls for animal food rule.
First, what is an exemption?
An exemption means you do not have to comply with all parts of the rule.
Only certain parts of the rule called modified requirements.
Exemptions are generally based on the size of your operation, your average sales and inventory, the risk associated with the animal feed that you are manufacturing, or whether you are only storing raw agricultural commodities.
Exemptions are not automatically given.
You will need to have records on hand to prove that you are eligible for an exemption.
Let's continue with our discussion of the preventive controls for animal food rule.
If you have determined that your animal feed or pet food products are covered under this rule, now you can find out whether you qualify for any exemptions.
There are three types of exemptions possible under this regulation.
One, the mixed-type facility exemption.
Two, the qualified facility exemption.
And three, the holding facility exemption.
We'll walk you through each step in the flow chart to see what exemptions might be available for your covered operation.
If you are unsure at any point as we move through this video, stop and go back to review it.
A mixed-type facility is an establishment that conducts both farming and processing activities.
A mixed-type facility that sells some of its animal feed to other businesses may or may not be eligible for a mixed-type facility exemption.
Depending on whether its products and processes are among those that the FDA has defined as low-risk.
Are all of your products and processes low-risk?
Or, are some of them not low-risk?
Let's talk about what that means.
Here are some examples of low-risk products.
If you need to review this list in detail, pause the video now.
Another consideration is the process used to make the animal feed product.
Again, here are some examples.
If you want to review this list in detail, go ahead and pause the video here.
On the other hand, higher-risk products and processes might include those that have been historically linked with outbreaks or instances of microbial or chemical contamination.
Higher-risk products would also include those that have physical characteristics that support the growth of harmful micro organisms.
Such as high moisture or higher pH.
Or those that require consistently accurate procedures for formulation in order to assure animal and consumer safety.
After reviewing these lists, if you still aren't sure about the risk level of the animal food products you process or manufacture on your farm, visit the PennState FSMA website to find an expert who can help you.
So, even if some of your products or processes are not low-risk, then you are not eligible for a mixed-type facility exemption.
However, if all of your products and processes are considered low-risk, then you should go on to the next set of decisions.
Do you have less than 500 full time employees on the farm?
If so, you are eligible for a mixed-type facility exemption.
If you have 500 or more full time employees, then you have one final question to ask.
Are your average annual feed sales plus the value of your inventory less or more than two million 500 thousand dollars?
To get your average annual feed sales, simply average the value of all your feed sales over the previous three years.
Then, don't forget to add in the value of your inventory.
If your average sales plus inventory are less than two million 500 thousand dollars, then you are eligible for the mixed-type facility exemption.
If your average sales plus inventory are two million 500 thousand dollars or more, then you are not eligible for this exemption.
But, you may still be eligible for the second type.
The qualified facility exemption.
Which we'll talk about now.
So, if your facility was not eligible for the mixed-type facility exemption, or if you process or manufacture animal feed at a non-farm location, you could be eligible for a qualified facility exemption.
Determining your eligibility for a qualified facility exemption is quite simple.
Your average annual feed sales taken over the last three years plus the value of your inventory must total less than two million 500 thousand dollars.
If this is the case, then you are eligible for a qualified facility exemption.
And you only have to meet certain modified requirements.
On the other hand, if that dollar amount is two and a half million or more, you are not eligible for the qualified facility exemption and have to comply with all parts of the rule.
Proving eligibility for both mixed-type facility and qualified exemptions under the preventive controls rule requires three years of sales records to support your claim.
So begin collecting your sales records now.
Keep in mind that the FDA can remove your exemption if they find you are processing animal feed products under unsafe conditions.
And finally, there is one more type of exemption.
The holding facility exemption.
Holding facilities are farm or non-farm animal feed operations that only store raw agricultural commodities other than produce that are intended for animal feed.
For example, unprocessed grains.
If you fall into this category, then you are eligible for a holding facility exemption.
Modified requirements are in place for these kinds of operations.
As you can see, the requirements for obtaining an exemption are complex.
If you are still not sure where you stand, go to the PennState FSMA website at extension.psu.edu/fsma to learn details about modified requirements for each type of exemption.
And how to find an expert who can help you.
Finally, let's talk about when you need to be in compliance with the preventive controls for animal food rule.
We'll also point you to some additional resources so you can learn more about what you'll need to do to comply with the rules.
When the FDA wrote the final regulation, they decided that smaller businesses would need more time than larger ones to get ready to comply with the rules.
Therefore, compliance dates vary for different size businesses.
And are based on the number of employees and average annual sales over the last three years.
Compliance dates are phased in after the date the regulation was issued, which was September 2015.
For the preventive controls regulation, very small businesses with sales less than two and a half million dollars have four years to comply.
Small businesses with less than 500 full time employees have three years to comply.
All other businesses that have both more than two and a half million dollars in sales, and have more than 500 employees are considered to be larger businesses and have up to two years after the issue date to comply.
The animal food rule also contains a good manufacturing practices component.
Deadlines for implementing the GMPs are one year before preventive control dates for each business size category.
Visit the PennState FSMA website to obtain clarification on any of these compliance dates.
But what next you ask?
Where do I learn what I actually need to do to comply?
Am I required to complete any training?
The details of the requirements within the preventive controls for animal food regulation are beyond the scope of this presentation.
If your animal feed or pet food products are covered under the regulation, and your business is not eligible for any exemptions, you should take an FDA approved training course developed by the preventive controls alliance so that you will understand what exactly you will have to do.
Finally, visit extension's FSMA website to learn more details about the regulation, 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 rule.
Now you understand more about the food safety modernization act, and whether your products are covered under the preventive controls for animal food rule.
You should also understand whether you are eligible for any exemptions under the rule.
Finally, you now know how much time you have to comply with the animal food rule, and where you can go to learn more about trainings.
And as always, you can rely on PennState extension for more detailed information.