How do I Start an Animal Food Business?

If you are thinking about starting an animal food business, you may have questions about what
regulatory requirements would apply to your business. In addition to the Food and Drug
Administration's (FDA's) requirements, your food business may have to comply with other
federal, state, and local requirements. Some requirements apply to all animal food businesses,
and some are specific to the type of animal food you are handling or making (for example,
whether you are making medicated feed or have to register with FDA as a food facility).

If you are planning to start an animal food business, there are several steps you need to take
before marketing your product in the United States, such as:

Submitting the appropriate registration, licensing, and notification information to the

FDA;

Complying with all FDA food safety regulations for the type of activities you are
conducting and the type of animal food you are marketing;
Ensuring any ingredients and additives are safe and suitable for their use, and have the
appropriate regulatory status or approvals needed to legally market the animal food;
Complying with labeling and marketing requirements; and

Complying with applicable state and local animal food regulatory requirements.

In addition to operating in the United States, some businesses may be interested in importing or
exporting animal food products.

The chart, below, gives you a snapshot of the requirements based on the three most common
animal food business scenarios: in-home businesses, on-farm businesses, and commercial
businesses. The chart is divided into three sections:

Requirements that apply to all animal food businesses,

Requirements that apply to animal food businesses that must register with FDA, and

Requirements that apply to specific animal food business activities, such as importing or
exporting animal food or ingredients.

Each requirement is hyperlinked to its corresponding section on this page, so you can easily find
the information you need as you start your business. If you need more information, you can find
the FDA’s Center for Veterinary Medicine (CVM) email and phone contact information at the
bottom of the page.
Which requirements apply to my animal food business?
Requirements that Apply to All Food In-home On-Farm Other
Businesses Business Business Businesses/Industry

Adulteration yes yes yes

Ingredients and Additives yes yes yes

Labeling and Marketing yes yes yes

State Regulations yes yes yes

Food Facility Registration Requirement no no yes

Requirements that Apply if

You’re Required to Register as a
Food Facility Description

Qualified Facility Attestation If you are a very small business you must submit a qualified facility attestation to be
exempt from certain requirements of the Preventive Controls for Animal Food during
your initial food facility registration and subsequent biennial renewal.

Preventative Controls for Animal Requirements for manufacturing, processing, packing, and holding animal food
Food under current good manufacturing practice (CGMP) and a food safety plan for all
businesses that must register as a food facility.

Reportable Food Registry Requirements for when registered food facilities must notify FDA that a food
(including animal food) may cause serious adverse health consequences (e.g.,
illness, injury), or death to humans or animals.

Certain Activities with

Additional Requirements Activity applies to:

Medicated Feed Mill Businesses and farms manufacturing, processing, packing, or holding medicated feed.
Licensing and CGMPs

Veterinary Feed Directives Veterinarians, clients (animal caretakers), manufacturers, and distributors authorizing,
manufacturing, distributing, or using medicated feed with a veterinary feed directive
(VFD) marketing status.

Low Acid Canned Food Businesses manufacturing shelf stable low-acid foods in hermetically sealed container,
Regulations such as pet food in a can or an airtight pouch.

Sanitary Transportation of Businesses involved in the transportation of animal food, such as shippers, receivers,
Animal Food loaders, and carriers who transport food in the United States by motor or rail vehicle.
 Certain Activities with
Additional Requirements Activity applies to:

Bovine Spongiform Businesses that are handling animal food for ruminants, such as cows, sheep, and
Encephalopathy goats, or handling brain and spinal cord tissue from cattle 30 months of age or over
intended for food for any species.

Import/Export of Animal Businesses importing animal food into the United States or exporting animal food from
Food the United States.

Requirements that Apply to All Food Businesses

Adulteration
All animal food must meet the requirements in the Federal Food, Drug, and Cosmetic Act
(FD&C Act), which prohibits the adulteration of animal food. Common reasons an animal food
may be considered adulterated include:

If it contains a contaminant, such as bacteria, toxins, or physical objects (e.g., glass or

metal) which may harm human or animal health;

If is not suitable for animal food, for example because it has gone bad (e.g., rotted);

If it is something that is not safe for animals to eat, for example because it has been labeled
“not for animal food use,” or because it contains an unsafe ingredient; and

If it was not handled in a way to keep it safe for animals to eat.

You can find the full legal definition of adulterated food (https://uscode.house.gov/view.xhtml?
req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) in the U.S. Code (21
U.S.C. 342 codifies the adulteration provisions in section 402 of the FD&C Act) and information
about contaminants in animal food (/animal-veterinary/animal-food-feeds/biological-chemical-
and-physical-contaminants-animal-food) on the FDA website.

What is the difference between the FD&C Act and the United States Code
(U.S.C.)?

When Congress passes and the President signs a law, they publish it as an “Act.” The
Federal Food, Drug, and Cosmetic (FD&C) Act is the foundational law that establishes FDA
regulation of certain products and businesses. Congress makes changes to the law by
amending it. For example, the Food Safety Modernization Act (FSMA) amends the FD&C
Act by adding in new requirements.
 The Office of the Law Revision Counsel compiles these Acts and amendments to the law,
organizing them by subject, into something called the United States Code (U.S.C.). The
U.S.C. contains only the current enacted law. As a result, you may see a reference to Section
402 of the FD&C Act, which is the section on food adulteration, or you might see a reference
21 U.S.C. 342, which is the same information as compiled into the U.S.C. FDA has a helpful
explanation about the FD&C Act and U.S.C. at: Federal Food, Drug, and Cosmetic Act
(FD&C Act) (/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-
act-fdc-act).

Ingredients and Additives

Under the FD&C Act, anything that’s added to or becomes part of an animal food, directly or
indirectly, must either be approved as a food additive or it must be considered Generally
Recognized as Safe (GRAS) for that use (/animal-veterinary/animal-food-feeds/generally-
recognized-safe-gras-notification-program). Approved food additives and ingredients that are
GRAS are limited to specific uses. Some ingredients may be safe when used one way, but not
safe when used in other ways. For example, xylitol is an artificial sweetener that is an approved
food additive for use in human foods, but can be extremely toxic to dogs, and therefore not
acceptable for use in dog food (/animal-veterinary/animal-health-literacy/paws-xylitol-toxic-
dogs).

In addition to federal regulations, the Official Publication of the Association of American Feed
Control Officials (AAFCO) contains a list of animal food ingredients and their definitions, a list
of approved animal food additives, and a list of ingredients that are considered GRAS for
specific uses. Many of the ingredients in the AAFCO Official Publication, however, are not
approved food additives and may not meet the criteria needed to be recognized as GRAS for
those uses. FDA accepts the list of ingredients in the Official Publication for their marketing and
sale in the U.S. if there are no safety concerns with the listed ingredients.

You can find more information about animal food ingredients and additives and how FDA
regulates them on the Ingredients and Additives webpage (/animal-veterinary/animal-food-
feeds/ingredients-additives).

Labeling and Marketing

Labeling for animal foods marketed in the United States must comply with current federal
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-501?toc=1) and state
regulations. The FD&C Act defines "labeling" as all labels and other written, printed, or graphic
matter upon any article or any of its containers or wrappers, or accompanying such articles.
Labeling can include promotional websites, promotional brochures, promotional pamphlets,
testimonials, product information sheets, books, etc.
Labels must comply with animal food labeling requirements listed in 21 CFR part 501
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-501), which requires the
label to include:

A statement of identity (the name of the food) and, when needed, what the product is used
for;
An ingredient statement listing ingredients by their common or usual name, in descending
order of predominance by weight, meaning that the ingredient that weighs the most is
listed first and the ingredient that weighs the least is listed last;
The name and address of manufacturer, packer, or distributor;

A net quantity statement, which provides the amount of food in the container or package.
It must be expressed in weight, measure, or numeric count. Generally, if the food is solid,
semisolid or viscous, it should be expressed in terms of weight (pounds and ounces). If the
food is a liquid, it should be expressed in fluid measure (e.g., fl oz);

The label must be in English. If the label is in a foreign language, it must include an
English translation; and
Warning and/or caution statements, when applicable.

Medicated feed (/animal-veterinary/animal-food-feeds/medicated-feeds) has additional federal

labeling requirements. When a Type A medicated article is approved by FDA, the company that
makes the article is required to create a model “Blue Bird Label” to guide manufacturers of
medicated animal feeds when preparing final printed feed labels. Information from that Blue
Bird Label must appear on any medicated feeds made with that Type A medicated article. You
can find more information about medicated feed labels on our Blue Bird Labels webpage
(/animal-veterinary/medicated-feeds/blue-bird-labels).

Labeling must also comply with the Federal Food, Drug, and Cosmetic Act's misbranding
provisions (https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-
section343&num=0&edition=prelim). In general, a product is misbranded if it does not have
required information on the labeling or if it is false or misleading. A label is false or misleading
if it contains information that is not true or could confuse consumers, such as implying that an
animal food has more of a beneficial ingredient than what is actually included in the animal
food.

For state labeling requirements, the best source of information is AAFCO

(https://www.aafco.org/)  (http://www.fda.gov/about-fda/website-policies/website-
disclaimer). To promote uniform labeling requirements across all U.S. states and territories,
AAFCO developed a set of “Model Regulations for Pet Food and Specialty Pet Food,” which can
be found in AAFCO’s Official Publication (https://www.aafco.org/Publications) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer). Since the AAFCO “Model
Regulations” are consistent with Federal requirements, they are a useful resource for
information on the regulation of pet food.

You can find more information about animal food regulation (/animal-veterinary/animal-food-
feeds/product-regulation) (including pet food (/animal-veterinary/animal-health-literacy/fdas-
regulation-pet-food)), marketing (/animal-veterinary/animal-health-literacy/information-
marketing-pet-food-product), and labeling on FDA’s website.

State Regulations
In addition to meeting federal requirements, your animal food business may also have to follow
certain state regulatory requirements. The AAFCO webpage (https://www.aafco.org/) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) has detailed information
about your state’s regulatory requirements (https://www.aafco.org/regulatory) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) for animal food. You can
find other useful resources for animal food businesses on their Industry webpage
(https://www.aafco.org/Industry)  (http://www.fda.gov/about-fda/website-policies/website-
disclaimer). Additional information about starting a pet food business and state requirements
can be found on AAFCO’s The Business of Pet Food (https://petfood.aafco.org/) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) site.

Food Facility Registration Requirement & Qualified Facility Attestation

If your company manufactures, processes, packs, or stores an animal food in the United States,
you must register as a food facility, unless an exemption applies to your business. The below
webpages will help you determine if you must register as a food facility and if so, how to
complete a food facility registration and get your unique facility identifier.

Animal Food Facility Registration and Qualified Facility Attestation Frequently Asked
Questions (/animal-veterinary/animal-food-feeds/animal-food-facility-registration-and-
qualified-facility-attestation-frequently-asked-questions)
Guidance for Industry: Questions and Answers Regarding Food Facility Registration
(Seventh Edition) (/regulatory-information/search-fda-guidance-documents/guidance-
industry-questions-and-answers-regarding-food-facility-registration-seventh-edition)

Registration of Food Facilities and Other Submissions (/food/guidance-regulation-food-

and-dietary-supplements/registration-food-facilities-and-other-submissions)
Registration of Food Facilities—electronic Code of Federal Regulations
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H)
Some animal food businesses meet the definition of a “qualified facility
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507),” typically because
they are very small businesses. A qualified facility is generally a business that, because of its very
small size, is required to meet only modified requirements under the FDA Food Safety
Modernization Act (FSMA) Preventive Controls for Animal Food (PCAF) regulation. These
businesses must “attest,” or affirm, to FDA that they are qualified facilities on their food facility
registrations.

CVM’s website has more information about how to determine whether your business is a
qualified facility (/regulatory-information/search-fda-guidance-documents/guidance-industry-
determination-status-qualified-facility), current inflation adjusted cut offs for qualified facilities
(/food/food-safety-modernization-act-fsma/fsma-inflation-adjusted-cut-offs), and answers to
frequently asked questions (/animal-veterinary/animal-food-feeds/animal-food-facility-
registration-and-qualified-facility-attestation-frequently-asked-questions).

Requirements that Apply if You’re Required to Register as a

Food Facility
Preventative Controls for Animal Food (PCAF)
The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive
Controls for Food for Animals regulation in 21 CFR part 507 (/regulatory-information/search-
fda-guidance-documents/cvm-gfi-241-small-entity-compliance-guide-what-you-need-know-
about-fda-regulation-current-good) is commonly referred to as the PCAF regulation or part 507.
The PCAF regulation has two primary parts, the current good manufacturing practice (CGMP)
requirements and the hazard analysis and risk-based preventive controls (PC) requirements.
The PCAF regulation also addresses related personnel, training, and recordkeeping
requirements (See 21 CFR part 507, subparts A and F (https://www.ecfr.gov/current/title-
21/chapter-I/subchapter-E/part-507/subpart-A/section-507.10)). The PCAF requirements
apply to all facilities that must register with the FDA unless they fall under an exemption
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507/subpart-A/section-
507.5). There are also exemptions (https://www.ecfr.gov/current/title-21/chapter-
I/subchapter-E/part-507/subpart-A/section-507.10), or modified requirements
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507/subpart-C/section-
507.51) for warehouses or other businesses that only store packaged animal food that is not
exposed to the environment.

Current Good Manufacturing Practice (CGMP) Requirements (/regulatory-

information/search-fda-guidance-documents/cvm-gfi-235-current-good-manufacturing-
practice-requirements-food-animals)
The CGMP requirements provide baseline safety and sanitation standards for the
manufacturing, processing, packaging, and storing of animal food (See 21 CFR part 507,
subpart B (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-
507/subpart-B).)
Hazard Analysis and Risk-Based Preventive Controls (PC) Requirements (/regulatory-
information/search-fda-guidance-documents/cvm-gfi-245-hazard-analysis-and-risk-
based-preventive-controls-food-animals)
The PC requirements provide a framework to help you assess the food safety hazards
associated with your animal food and animal food facility. When needed, you must
establish risk-based preventive controls for your facility to prevent or minimize the
hazards you identify. Preventive controls include management components such as
monitoring, corrective actions, and verification, to ensure you are using the correct
methods for preventing potential hazards in the animal food you make (See 21 CFR part
507, subpart C (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-
507/subpart-c)). In some situations, you may decide in your hazard analysis that you have
a hazard requiring a preventive control, but your supplier needs to control the hazard
before you receive the ingredient for use in your manufacturing process. In that situation,
you would also need to follow the supply-chain requirements (see 21 CFR part 507,
subpart E).

Qualified Facility Attestation and Modified Requirements (/regulatory-

information/search-fda-guidance-documents/guidance-industry-determination-status-
qualified-facility)
Some animal food businesses meet the definition of a “qualified facility
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507/subpart-
A/section-507.3),” typically because they meet the definition of a very small business.
These businesses must “attest,” or affirm, to FDA that they are qualified facilities when
completing their food facility registrations. If your business is a qualified facility, you must
follow CGMP requirements (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-
E/part-507/subpart-B) and the modified requirements for qualified facilities
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507/subpart-
A/section-507.7), but you are exempt from the PC requirements (See 21 CFR 507.7
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507/subpart-
A/section-507.7)).

CVM’s website has more information about how to determine whether your business is a
qualified facility (/regulatory-information/search-fda-guidance-documents/guidance-
industry-determination-status-qualified-facility), current inflation adjusted cut offs for
qualified facilities (/food/food-safety-modernization-act-fsma/fsma-inflation-adjusted-
cut-offs), and answers to frequently asked questions (/animal-veterinary/animal-food-
feeds/animal-food-facility-registration-and-qualified-facility-attestation-frequently-
asked-questions).
Food Facilities with Both Human and Animal Food
Some human food facilities also manufacture, process, package, or hold animal food. For
example, some ingredient manufacturers make ingredients, such as salt, used in human
and animal food. Some human food manufacturers send human food by-products, such as
vegetable peels, or human food that does not meet their quality standards, such as bakery
products, to facilities that make animal food. Some facilities may hold human and animal
food, such as warehouses that hold prepackaged human food and pet food. If you are a
human food facility that also handles animal food you must follow the PCAF regulation;
however, the requirements you have to follow will vary depending on the animal food
activities you are performing.

Facilities that do not perform further manufacturing/processing

If your facility does not further manufacture or process the human food by-products
intended for use as animal food, and your facility meets certain conditions
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-507/subpart-
A/section-507.12), you only have to follow the limited holding and distribution
activities listed in in the CGMPs. These requirements are co-listed in 21 CFR 507.28
of the animal food (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-
E/part-507/subpart-B/section-507.28) CGMPs and 21 CFR 117.95 of the human
food (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-
117/subpart-B/section-117.95) CGMPs. For more detailed information, see section V
of CVM’s draft Guidance for Industry #239: Human Food By-Products for Use as
Animal Food (/media/97467/download).
Facilities that only perform certain manufacturing/processing activities to
facilitate storage and distribution
If your facility only performs certain limited manufacturing/processing activities on
your human food by-products for use as animal food you must follow CGMP
requirements. However, you do not need to follow the hazard analysis and risk-based
preventive controls requirements if you only perform certain activities under certain
circumstances. The limited activities and circumstances include:

drying/dehydrating, evaporating, pressing, chopping, and similar activities to

reduce weight, bulk, or volume;
mixing (e.g., combining different vegetable culls and trimmings, combining
juice and dairy by-products, stirring), centrifuging, and similar activities to
combine ingredients or separate components (e.g., water and solids); and
activities that are not performed to prevent or significantly minimize animal
food hazards and do not create new animal food hazards.
 You can find more information about these activities and circumstances in section D
of FDA’s Policy Regarding Certain Entities Subject to the Current Good
Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign
Supplier Verification Programs: Guidance for Industry (/media/110023/download).
Facilities that perform manufacturing/processing activities
If your facility makes human and animal food, part 507 allows you the option in 21
CFR 507.1(d) (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-
507/subpart-A/section-507.1) to either follow the human food requirements in part
117 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117) or the
animal food requirements in part 507 (https://www.ecfr.gov/current/title-
21/chapter-I/subchapter-E/part-507) for the production of your animal food at the
same facility.

For example, when implementing CGMPs, your facility may follow either the
requirements in part 117, subpart B, or the requirements in part 507, subpart B for
the animal food at your facility.

Likewise, if your facility is required to follow the hazard analysis and risk-based
preventive controls requirements, you may choose to follow the requirements in part
117, subparts C and G, or part 507, subparts C and E. Regardless of the option you
choose, in your food safety plan and hazard analysis you must consider any hazards
that are associated with the animal food (e.g., you would not have to consider
allergens for your animal food, but you would need to consider nutrient toxicities
and deficiencies). If you want, you may choose to have two separate food safety
plans, one for animal and one for human food, or one food safety plan that covers
both types of food.

For more detailed information, see section VI of CVM’s draft Guidance for Industry
#239: Human Food By-Products for Use as Animal Food (/media/97467/download).

Reportable Food Registry (RFR) Requirements

If your animal food business is required to register as a food facility, you are required to file a
report with FDA’s Reportable Food Registry (RFR) whenever you have an instance of a
“reportable food.” A “reportable food” is a food for which there is a reasonable probability that
the use of, or exposure to, an article of food will cause serious adverse health consequences or
death to humans or animals. For example, this could be an animal food that is contaminated
with something that would cause the animal eating it to get sick, such as disease-causing
bacteria, or the food could contain something that would harm the animal, like pieces of plastic
that could pose a choking hazard. Reportable food also includes animal food that could cause
people to get sick, either from handling the animal food or from consuming milk, meat, eggs, or
other animal products from the animal that ate the animal food. If you have a reportable food,
you must file a report as soon as possible, but no later than 24 hours after you have identified
that the animal food is a “reportable food.”

The Reportable Food Registry webpage (/food/compliance-enforcement-food/reportable-food-

registry-industry) has detailed information about these requirements.

Certain Activities with Additional Requirements

Medicated Feed Mill Licensing and CGMPs
Medicated Feed Mill Licensing and Drug Establishment Registration

If you are an animal food business that manufactures or processes medicated feeds, you may
need an FDA-approved medicated feed mill license and drug establishment registration if you
make the following types of feed (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-
E/part-558):

medicated feed using Category II, Type A medicated articles (21 CFR 558.4(a)
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-558/subpart-
A/section-558.4#p-558.4(a)));
all free-choice medicated feeds that contain a Category II drug (21 CFR 510.455(f)
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-510/subpart-
E/section-510.455#p-510.455(f)));
free-choice medicated feeds that contain a Category I drug and use a proprietary formula
and/or specifications (21 CFR 510.455(f) (https://www.ecfr.gov/current/title-21/chapter-
I/subchapter-E/part-510/subpart-E/section-510.455#p-510.455(f)));
all liquid medicated feeds that contain a Category II drug (21 CFR 558.5(g)(1)
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-558/subpart-
A/section-558.5#p-558.5(g))); and

liquid medicated feeds that contain a Category I drug and use a proprietary formula
and/or specifications (21 CFR 558.5(g)(2) (https://www.ecfr.gov/current/title-
21/chapter-I/subchapter-E/part-558/subpart-A/section-558.5#p-558.5(g))).

If you use drugs from Categories I and II (https://www.ecfr.gov/current/title-21/chapter-

I/subchapter-E/part-558/subpart-A/section-558.4) in a combination drug product, the
Category II requirements apply to the entire combination drug product (21 CFR 558.4(e)). You
need a medicated feed mill license and drug establishment registration to make the combination
drug product from a Type A medicated article.

Whether or not you are required to have a feed mill license and drug establishment registration
determines what Medicated Feed Mill Current Good Manufacturing Practice
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-225) requirements in 21
CFR part 225 apply at your facility.

CVM’s Medicated Feeds webpage (/animal-veterinary/animal-food-feeds/medicated-feeds) has

more information and resources on medicated feed mill licensing and drug establishment
registration, including the forms and instructions for submitting a medicated feed mill
application and a link to drug establishment registration information.

Veterinary Feed Directive Feeds (VFDs)

If you are a distributor of medicated feeds containing veterinary feed directive (VFD) (/animal-
veterinary/development-approval-process/veterinary-feed-directive-vfd) drugs, you must send
a one-time notification to FDA (21 CFR 558.6(c)(5)) (https://www.ecfr.gov/current/title-
21/chapter-I/subchapter-E/part-558/subpart-A/section-558.6). A VFD drug is intended for use
in animal feeds. VFD drugs can only be used under the professional supervision of a licensed
veterinarian. CVM’s website (/animal-veterinary/development-approval-process/veterinary-
feed-directive-vfd) has information about what you must include in the notification and how
and where to submit it.

To view the current VFD Distributor Notification List, which lists the names and addresses of
businesses that distribute VFD medicated feeds, visit the Medicated Feeds section of the Animal
Drugs @ FDA (https://animaldrugsatfda.fda.gov/adafda/views/#/search) home page. You can
view the list as a PDF or as an Excel spreadsheet. You can sort the Excel spreadsheet by
distributor name or state. FDA updates the lists when new notifications are processed.

In addition to the notification, you must also follow the VFD requirements. These requirements
cover authorizations from veterinarians to use VFD feed, manufacturers and distributors who
manufacture and distribute VFD feed, and clients or animal producers who use VFD feed. The
regulation includes general requirements in 21 CFR 558.6(a) that apply to all three roles, as well
as more specific requirements for authorizing veterinarians in 21 CFR 558.6(b) and for VFD
distributors in 21 CFR 558.6(c). You can find more information about these requirements on
CVM’s webpage:

Veterinary Feed Directive Requirements for Distributors (Who Manufacture VFD Feed)
(/animal-veterinary/development-approval-process/veterinary-feed-directive-
requirements-distributors-who-manufacture-vfd-feed)
 Veterinary Feed Directive Requirements for Distributors (Who Do Not Manufacture VFD
Feed) (/animal-veterinary/development-approval-process/veterinary-feed-directive-
requirements-distributors-who-do-not-manufacture-vfd-feed)
Guidance for Industry #120 Veterinary Feed Directive Regulation Questions and Answers
(/regulatory-information/search-fda-guidance-documents/cvm-gfi-120-veterinary-feed-
directive-regulation-questions-and-answers)

Low Acid Canned Food (LACF)

If your animal food business thermally processes low-acid foods packaged in hermetically sealed
(airtight) containers, commonly called low-acid canned foods (LACF), you must follow the LACF
requirements (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-113).
Although some airtight containers (like pouches or trays) used to thermally process low-acid
foods are not considered cans, we continue to use the term “low-acid canned foods” and its
abbreviation (LACF) as a shorthand description. If your business makes these types of products,
you must register your business as a Food Canning Establishment and file scheduled processes
with FDA for each product you make. A scheduled process is the process you select as adequate
under the conditions of manufacture for a given product to achieve commercial sterility. This
process may be in excess of that necessary to ensure destruction of microorganisms of public
health significance, and shall be at least equivalent to the process established by a competent
processing authority to achieve commercial sterility (21 CFR 113.3(r)).

FDA’s website contains more information about LACF requirements (/food/guidance-

documents-regulatory-information-topic-food-and-dietary-supplements/acidified-low-acid-
canned-foods-guidance-documents-regulatory-information) and acidified requirements. Note
that the information on this page covers both LACF requirements and acidified food
requirements. LACF requirements apply to both human and animal food, but acidified
requirements apply only to human food.

Sanitary Transportation of Animal Food

The Sanitary Transportation of Human and Animal Food (ST) regulation
(https://www.ecfr.gov/current/title-21/part-1/subpart-O) in 21 CFR part 1, subpart O, explains
the steps that shippers, loaders, motor or railroad carriers, and receivers must take to ensure the
safety of food during transport. Ways that food can become unsafe during transport include:

not properly refrigerating food,

inadequately cleaning vehicles between loads, and
not protecting food from contamination by non-food items in the same load or previous
load.
The regulation is broken down into sections including General Provisions, Vehicles and
Transportation Equipment, Transportation Operations, Training, Records, and Waivers. The
Sanitary & Transportation Guidance Documents & Regulatory Information webpage
(/food/guidance-documents-regulatory-information-topic-food-and-dietary-
supplements/sanitation-transportation-guidance-documents-regulatory-information) has links
to the different regulations and guidance documents you need.

Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”)

If your animal food business handles “prohibited materials,” which are materials that could
cause the spread of BSE disease through animal food, then you must follow the BSE
requirements for handling these materials as part of your business.

Prohibited materials include, but are not limited to, ruminant (e.g., cattle, sheep, and goat) meat
and bone meal, organs, and offal. The most common prohibited material found in animal food is
meat and bone meal that comes from cattle. You can find more information about prohibited
materials on CVM’s Bovine Spongiform Encephalopathy (BSE) webpage (/animal-
veterinary/compliance-enforcement/bovine-spongiform-encephalopathy).

Prohibited materials are commonly handled at businesses such as renderers, protein blenders,
commercial animal feed manufacturers, distributors (including retailers), transporters of animal
feed and animal food ingredients, and on-farm animal feed mixers. Although ruminant feeders
are unlikely to handle prohibited materials, it is important they are aware of the requirements
and know what to avoid. The regulations (21 CFR 589.2000) define several of these business
types.

There are two FDA regulations that focus on preventing the spread of BSE through animal food.

The “Animal Proteins Prohibited from Use in Animal Feeds” regulation in 21 CFR 589.2000
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-589/subpart-B/section-
589.2000) was created to prevent BSE from spreading through animal food. This regulation
prohibits using certain tissues from mammals in animal food for ruminants (e.g., cattle, sheep,
goats). You can find more information about this regulation on CVM’s ruminant feed
inspections (/animal-veterinary/bovine-spongiform-encephalopathy/ruminant-feed-
inspections) webpage.

The “Cattle Materials Prohibited in Animal Food/Feed (CMPAF)” regulation in 21 CFR

589.2001 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-589/subpart-
B/section-589.2001) prohibits using the brains and spinal cords from cattle 30 months of age
and older in any animal food, including all types of livestock and poultry feed and pet food. The
regulation is age-specific because cattle in this age range are at the highest risk for BSE. In BSE-
infected cattle, the brain and spinal cord contain most (about 85%) of the infectious materials
that could cause the spread of BSE. This regulation is intended to remove these tissues from the
animal food chain entirely, thus greatly reducing the potential for inadvertent cross-
contamination. Removing these tissues from the animal food chain prevents cross-
contamination or accidental or intentional misfeeding. The regulation mainly applies to
renderers and slaughter facilities because it focuses on removing the brains and spinal cords
from animal carcasses, which is an activity typically performed at these facilities.

You can find CVM BSE Guidances (/animal-veterinary/guidance-industry/bovine-spongiform-

encephalopathy-bse-guidances), the Feed Ban Enhancement (/animal-veterinary/bovine-
spongiform-encephalopathy/feed-ban-enhancement-implementation-questions-and-answers),
and other requirements for BSE on the CVM BSE webpage (/animal-veterinary/compliance-
enforcement/bovine-spongiform-encephalopathy).

Import/Export of Animal Food

Importing Animal Food
General FDA Imports Information

Imported animal food, including medicated feed products, must meet the requirements of The
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(https://www.cbp.gov/trade/priority-issues/import-safety/bioterrorism) (the Bioterrorism
Act). This law requires animal food producing facilities to register with FDA and to file "prior
notice" for each shipment of imported food before it arrives at a U.S. port of entry. The FDA
website has more detailed information about facility registration (/food/guidance-regulation-
food-and-dietary-supplements/registration-food-facilities-and-other-submissions) and prior
notice (/food/importing-food-products-united-states/prior-notice-imported-foods)
requirements.

If you have questions, or you need help with registering your facility or with filing prior notice,
please contact the FDA’s Industry Systems Help Desk experts Monday to Friday from 7:30 am
to 11:00 pm EST

By phone: 1-800-216-7331
By email: furls@fda.gov (mailto:furls@fda.gov)

In addition to FDA requirements, you may need to satisfy U.S. Customs and Border Protection
(CBP) requirements. You can find CBP’s requirements on the U.S. Customs and Border
Protection website (https://www.cbp.gov/trade/basic-import-export).

FDA can examine shipments of regulated products whenever they are offered for entry at a U.S.
Port of Entry (https://www.cbp.gov/contact/ports). FDA will detain products that violate FDA
law and regulations. Products that cannot be brought into compliance with the law will be
refused. Refused products must be exported or destroyed under CBP supervision. Even if FDA
did not examine a regulated product at the time of entry, the product must still comply with U.S.
laws and regulations when it is in the U.S.

The following FDA webpages have more detailed information about importing products into the
U.S.:

Import Program – Food and Drug Administration (FDA) (/industry/import-program-

food-and-drug-administration-fda)
Importing - Animal Food (/animal-veterinary/import-exports/importing-animal-food)

Regulatory Procedures Manual (/inspections-compliance-enforcement-and-criminal-

investigations/compliance-manuals/regulatory-procedures-manual) - Chapter 9: Import
Operations and Actions

Foreign Supplier Verification Program (FSVP)

The Foreign Supplier Verification Program (FSVP) regulation in 21 CFR part 1, subpart L
(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L), applies to
U.S. importers of human and animal food. Under the FSVP, an importer is the U.S. owner or
consignee of a food offered for import into the United States. If there is no U.S. owner or
consignee, the importer is the U.S. agent or representative of the food’s foreign owner or
consignee (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-
L/section-1.500) at the time of entry, as confirmed in a signed statement of intent. You can find
more information about whether the FSVP regulation applies to you on the Am I Subject to
FSVP? (/media/94281/download) fact sheet.

Importers of animal food must have an FSVP in place. The FSVP requires importers to verify
that the processes and procedures their foreign suppliers are using to make animal food give the
same level of public health protection that the PCAF regulation does and ensures that the
supplier’s animal food is not adulterated. Importers must:

Determine whether there are known or reasonably foreseeable hazards associated with
each animal food;
Evaluate the risk posed by an animal food, based on the hazard analysis, and the foreign
supplier’s performance;
Use that evaluation of the risk posed by the imported animal food and the supplier’s
performance to approve suppliers and determine appropriate supplier verification
activities;
Conduct supplier verification activities; and
Conduct correction actions.
You can find more information about the FSVP rule, including information on compliance dates,
on the FDA FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers
of Food for Humans and Animals webpage (/food/food-safety-modernization-act-fsma/fsma-
final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals).

Exporting Animal Food

Some animal food businesses will export their animal food to other countries. You can find more
information about the requirements for exporting animal food, including the types of export
certificates an animal food business can request on CVM’s Exporting—Animal Feed and Animal
Drugs webpage (/animal-veterinary/import-exports/exporting-animal-feed-and-animal-
drugs).

Resources
How to Start a Food Business (/food/food-industry/how-start-food-business)