1

This guideline is designed 

to help establishments

determine:

• The supporting 

documentation needed 

when submitting labels 

that bear an animal 

raising claim.

• Whether a modified 

label with an animal 

raising claim that has 

been approved is 

required to come back 

for approval or can be 

changed generically.

• How to add additional 

suppliers to a label with 

an animal raising claim 

that has been approved.

 

This guideline is designed 

to help establishments

determine:

• The supporting 

documentation needed 

when submitting labels 

that bear an animal 

raising claim.

• How to add additional 

suppliers to a label with 

an animal raising claim 

that has been approved.

 

Food Safety and Inspection Service

Labeling Guideline on

Documentation Needed to Substantiate Animal 

Raising Claims for Label Submissions

December 2019
2

FSIS Compliance Guideline for Label Approval

Table of Contents

Preface............................................................................................................................ 3

Documentation Needed to Substantiate Animal Raising Claims for Label Submission... 6

Animal Welfare and Environmental Stewardship.......................................... 7

Breed................................................................................................. 8

Diet.................................................................................................... 9

Living/Raising/Raising Conditions........................................................... 10

Negative Antibiotics Use - Livestock/Red Meat...........................................12

Negative Antibiotics Use - Poultry.......................................................... ..12

Negative Hormones Use....................................................................... 13

Source/Traceability.............................................................................. 14

Third-Party Certification........................................................................ 15

Organic............................................................................................. 15

Adding a New Supplier................................................................................... 16

Label Example............................................................................................. 17

Additional Resources .................................................................................................... 18
3

Preface

What is the purpose of this Compliance Guideline?

The purpose of this compliance guideline is to 

outline the documentation that establishments 

need to submit in support of label applications 

for products that bear animal raising claims. 

The Food Safety and Inspection Service (FSIS) 

is the Agency in USDA with the responsibility for 

ensuring that the labeling of meat and poultry 

products is truthful and not misleading. Labeling 

bearing claims referring to the way that the 

source animal for a meat or poultry product was 

raised need to be evaluated and approved by 

FSIS prior to use. 

For the past 25 years, FSIS has evaluated 

animal raising claims by considering information 

on animal raising practices submitted by 

companies as part of their label approval 

requests. The Agency has approved such claims if the animal raising information 

submitted with the label application supported the claim being made and the claim is 

truthful and not misleading. 

FSIS developed this guideline to respond to numerous requests to the Labeling 

Program and Delivery Staff (LPDS) through phone calls, askFSIS questions, and other 

correspondence regarding the type of information needed to support the approval of 

labels bearing animal raising claims. This guideline is intended to facilitate the approval

process for labels bearing animal raising claims. The information in this guideline is 

provided as guidance to assist meat and poultry establishments and is not legally 

binding from a regulatory perspective.

Who is this guideline designed for? 

This guideline is for establishments that are designing or modifying meat or poultry 

product labels with animal raising claims. The establishment must determine what 

supporting documentation is required for the various types of animal raising claims. 

This guideline will assist the establishment in making this determination. 

How will FSIS verify whether establishments meet requirements related 

to this guideline?

FSIS in-plant personnel verify that establishments comply with labeling regulations, 

when performing the General Labeling task assigned through the Public Health 

Information System (PHIS). For product bearing animal raising claims, in-plant 

personnel verify whether establishments maintain an FSIS approved label on file. 

Animal raising claims are special statements and claims that establishments are 

Key Points

The following are examples of 

animal raising claims that are 

required to be approved by FSIS 

prior to use in commerce:

1. Raised Without Antibiotics

2. Organic

3. Grass Fed

4. Raised Without the Use of 

Hormones
4

required to submit to FSIS for approval for compliance with 9 CFR 412.1, USDA’s Label 

Approval Regulations.

Changes made to the guideline from the previous version

After reviewing the comments received, FSIS has revised the guideline by section as 

follows:

• Product Labeling: Use of Animal-Raising Claims on the Labels of Meat or Poultry 

Products

o Added information about labeling needed for products bearing claims certified 

by third-party organization, including when products certified as “organic” 

need to disclose the certifying entity’s website address on the product label.

o Added information about carrying claims forward on additional products.

o Removed age claims section because establishments are not using these 

claims.

o Animal Welfare and Environmental Stewardship Claims:

o Added descriptive language or information (terminology) that should 

accompany these claims to explain the meaning of the claim to 

consumers, including the type of information that needs to appear on 

the label when the product is certified by a third-party organization.

o Breed claims: 

o Added information about carrying these claims forward to other 

products. 

o Living- or Raising-Condition Claims:

o Reorganized section for clarity regarding labeling terminology and 

recommended documentation for approval.

o Added information about additional terminology that typically 

accompanies these claims to explain the meaning of the claim to 

consumers, including where the information must appear on the label.

o Added information on the use of “Free Range” and synonymous claims 

(“Free Roaming,” “Pasture Fed,” Pasture Grown,” “Pasture Raised,” 

and “Meadow Raised”) on labels of poultry products and the 

documentation needed to substantiate these claims.

o Raised Without Antibiotics – Livestock/Red Meat or Poultry:

o Added “Raised Antibiotic Free” and “No added antibiotics” as examples 

of claims that may be used to disclose the fact that animals were not 

administered antibiotics at any point in the animal production process.

o Added information on claims that include the term “sub-therapeutic

antibiotics” to ensure that consumers understand that the claim means 

that antibiotics may only be administered in the event of an illness and

includes the circumstances for which FSIS will approve labels bearing 

these claims. 

o Raised Without Hormones (No Hormones Administered or No Steroids 

Administered):

o Updated information to clarify that FSIS will no longer require a 

qualifying statement on pork products labeled with “raised without 

hormones” claim because Federal law permits the use of certain 

hormones in swine, e.g., for gestation.
5

o Added new examples of this type of claim.

o Updated information to clarify why a qualifying statement is necessary 

for products made from a kind or species for which Federal law 

prohibits hormone use and to emphasize that this information must be 

displayed on the label in a manner that is likely to be read and 

understood by the ordinary individual for FSIS to approve the claim..

o Third-Party Certification: 

o Added information about documentation needed to support labels 

bearing animal raising claims that have been “Verified” or “Certified” by 

third-party organizations. 

o Added information about “organic” claims, including other claims that 

could be substantiated with an Organic Certificate.

o Added section on procedures for adding an additional supplier for a label with 

animal-raising claims that was previously approved by FSIS.

The updated guideline is posted at:

https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/complianceguides-index/. FSIS will update this document, as necessary.

What if I still have questions after I read this guideline?

If the desired information cannot be found within the Compliance Guideline, FSIS 

recommends that users search the publicly posted Questions & Answers (Q&As) in the 

askFSIS database or submit questions through askFSIS. Documenting the questions 

helps FSIS improve and refine present and future versions of the Compliance Guideline

and associated issuances. 

When submitting a question, use the Submit a Question tab, and enter the following 

information in the fields provided: 

SubjectField: “Documentation Needed to Substantiate Animal Raising Claims”

QuestionField: Enter question with as much detail as possible.

ProductField: Select Labeling from the drop-down menu.

CategoryField: Select Labeling Regulations, Policies and Claims from the dropdown menu.

Policy Arena: Select Domestic (U.S.) only from the drop-down menu.

When all fields are complete, press Continue.

Congressional Review Act

 Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq., the Office of 

Information and Regulatory Affairs has determined that this guideline is not a “major 

rule,” as defined by 5 U.S.C. 804(2).
6

Product Labeling: Use of the Animal Raising Claims on the Labels of Meat and 

Poultry Products

A Federal establishment is required to use labels that are in compliance with the 

Federal Meat Inspection Act (FMIA; 21 U.S.C. § 601, 607) and the Poultry Products 

Inspection Act (PPIA; 21 U.S.C. § 451, 457) (the Acts), and the implementing 

regulations. Requirements include all mandatory labeling requirements as prescribed in 

Title 9 of the Code of Federal Regulations (CFR) section 317.2 and Part 381 Subpart N.

Although FSIS does not exercise its authority of prior label approval to point of purchase 

materials (e.g., pamphlets and placards) displayed in conjunction with products sold at 

retail and bearing animal raising claims, FSIS does require these materials be neither 

false or misleading, in compliance with the Acts and Federal regulations.

As stated in 9 CFR 412.1, labels with special statements and claims are required to be 

approved by FSIS prior to use in commerce.

Labels bearing animal raising claims are required to be submitted to LPDS with specific 

documentation to support all animal raising claims that appear on that label. Examples 

of animal raising claims include, but are not limited to: Raised Without Antibiotics, Grass 

Fed, Free-Range, and Raised Without the Use of Hormones. For most animal raising 

claims, the documentation typically needed to support these claims is:

1. A detailed written description explaining the controls used for ensuring that the 

raising claim is valid from birth to harvest or the period of raising being 

referenced by the claim;

2. A signed and dated document describing how the animals are raised which may 

include feed formulations (e.g., vegetarian fed, raised without antibiotics, grass 

fed), to support that the specific claim made is truthful and not misleading;

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution;

4. A written description for the identification, control, and segregation of nonconforming animals/product; and

5. If a third-party certifies a claim, a current copy of the certificate from the certifying 

organization.

NOTE: If the claim was certified by a third-party certifying organization, FSIS will not 

approve the label bearing the claim if it does not include the certifying entities name, 

website address,1 and logo, when the organization has a logo. An asterisk or other 

symbol must connect the claim to this information.

1 Products certified as “organic” would not need to disclose a website address on the label, except when the 

address is required under 7 CFR Part 205.
7

In general, a purchased product bearing an approved animal raising claim may be used 

to support the claim in lieu of numbers 1 – 3 above. If a company purchases product 

bearing animal raising claims and would like to carry forward those claims onto its 

labeled product, the company needs to provide a copy of the purchased product label 

and segregation procedures when entering their federal establishment. However, 

companies cannot carry forward certified claims, logos and/or websites from purchased 

products that are certified by a third-party entity unless the companies that are carrying 

the claim forward are also under that same certification. Companies cannot carry 

forward USDA organic claims, logos and/or websites without being certified organic 

themselves.

Types of Animal Raising Claims and Guideline on the Documentation Needed to 

Substantiate the Claims

Animal Welfare and Environmental Stewardship

These claims describe how animals are raised based on the care they receive by the 

producer or how the producer maintains the land and replenishes the environment.

FSIS has not defined these claims in regulations or policy guidelines. For animal welfare 

claims, such as “Raised with Care,” or environmental stewardship claims, such as 

“Sustainably Raised,” FSIS will only approve a claim if a statement is provided on the 

label showing the name of the entity that established the standard and includes

additional terminology explaining the meaning of the claim for consumers, e.g., "TMB 

Ranch Defines Raised with Care/Sustainably Raised as [explain the meaning of the 

claim on the label]." If the entity has a website that describes the standards used to 

define the claim, the label may provide the website address instead of explaining what 

the claim means on the product label, e.g., “Raised with Care as defined by TMB Ranch 

at: [website address].” As an alternative, animal welfare and environmental 

stewardship claims can be certified by a third-party certifying organization that posts the 

standards used to define the claim on its website. If the claim is certified by a third-party 

certifying organization, FSIS will not approve the label bearing the claim if it does not 

include the certifying entities name, website address, and logo, when the organization 

has a logo.

The claims may appear on any panel of the package. The additional terminology that 

explains the meaning of the claim may appear with the claim or may be connected to 

the claim by an asterisk or another symbol and placed elsewhere on the same panel 

that bears the claim. For example, if a claim is made on the principal display panel 

(PDP), the part of the label most likely to be seen by consumers when offered for retail 

sale, the explanation of the claim’s meaning may be placed with the claim or placed 

elsewhere on the PDP provided the claim and explanation are connected by a symbol.

If the claim is certified by a third-party certifying organization, an asterisk or other 

symbol must connect the claim to the certifying entities name, website address, and/or

logo, when the organization has a logo, for FSIS to be able to approve the label.

Examples of these types of claims include, but are not limited to: Humanely Raised*, 

Sustainably Farmed*, and Raised with Environmental Stewardship*. 
8

*TMB Ranch defines “Humanely Raised”/”Sustainably Farmed/Raised with 

Environmental Stewardship” as [insert description of standards used to define the 

claim]

Documentation needed: 

1. A detailed written description explaining the meaning of the animal welfare or 

environmental stewardship claim and the controls used for ensuring that the 

raising claim is valid from birth to harvest; or the period of raising being 

referenced by the claim;

2. A signed and dated document describing how the animals are raised to support 

that the claims are not false or misleading;

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description for the identification, control, and segregation of nonconforming animals/product (e.g., how animals not raised in accordance with the 

specific animal welfare guidelines or stewardship program are segregated from 

animals eligible to bear the claim).

Breed

Breed claims refer to the declaration of a specific breed of livestock or poultry.

Examples of this type of claim include, but are not limited to: Angus, Wagyu (American 

Kobe), Hereford, Berkshire, Duroc, Muscovy, Silkie, and heritage poultry, pork or beef 

breeds. 

Documentation needed:

 

1. A signed and dated document that substantiates the breed claim, e.g., under a 

Agricultural Marketing Service (AMS) Certified Meat and Poultry Program or a 

certificate from a breed organization; 

2. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution;

3. Documentation to support the breed by phenotype (for example, hide color) or 

genotype (traceable to one registered parent or two registered grandparents with 

a breed association); and

4. A written description for the identification, control, and segregation of nonconforming animals/product.

Alternatively, a purchased product label may be used in lieu of numbers 1 – 3 above. If 

a company purchases product bearing a breed claim and would like to carry forward the 

claim on to their product, the company needs to provide a copy of the purchased label 

and segregation procedures for product entering the federal establishment when 

submitting for label approval.

NOTE: See label example 
9

Diet

Diet claims refer to what animals are fed prior to harvest and processing. These claims 

require that the animals only eat the diet claimed for the lifetime of the animal, with the 

exception of milk consumed prior to weaning. 

FSIS considers Grassfed, Grass Fed and Grass-Fed synonymous terms. “Grass Fed” 

or “100% Grass Fed” claims may only be applied to meat and meat product labels 

derived from cattle that were only (100%) fed grass (forage) after being weaned from 

their mother’s milk. The diet must be derived solely from forage, and animals cannot be 

fed grain or grain by-products and must have continuous access to pasture during the 

growing season until slaughter. This means 100% grass-fed animals are never confined 

to a feedlot. Forage consists of grass (annual and perennial), forbs (e.g., legumes, 

Brassica), browse, or cereal grain crops in the vegetative (pre-grain) state. Hay, 

haylage, baleage, silage, crop residue without grain, and other roughage sources may 

also be included as acceptable feed sources. Routine mineral and vitamin 

supplementation may also be included in the feeding regimen. If incidental 

supplementation occurs due to inadvertent exposure to non-forage feedstuffs or to 

ensure the animal’s wellbeing at all times during adverse environmental or physical 

conditions, the producer should provide a signed and dated document to the 

establishment attesting the above incident is not a routine occurrence. The 

establishment should include this information as part of the labeling documentation 

verifying the product qualifies for a grass fed claim.

When animals have less than 100-percent access to grass or forage the partial “grass 

fed” claim must accurately reflect the circumstances of raising, e.g., “Made from cows 

fed 85% grass and 15% corn.”

The claim “Grass Finished” is not the same as “Grass Fed” because animals that are 

“grass finished” can be fed grain, in which case the claim “Grain Fed, Grass Finished” 

would be truthful and not misleading. 

Historically, the AMS Grass (Forage) Fed Marketing Claim Standard was considered 

one form of proof to FSIS that the claim “grass fed” was truthful and not misleading. In 

January 2016, AMS withdrew the standard. This change did not change FSIS’s

documentation requirements for companies wishing to label their products as “Grass

Fed.” 

Examples of this type of claim include, but are not limited to: Grass (Forage) Fed, Grain 

Fed, Vegetarian Feed, Raised Using Vegetarian Feeds [This means all vegetable feeds 

and no animal products (e.g., whey) are fed to the animal.], Raised Using Vegetarian 

Feeds (with a disclaimer to clarify animal products are fed to the animal for a certain 

period of time, e.g., “except for dairy products fed from birth to eight weeks” or “after 8 

weeks”), and Fed No Animal By-Products.

Documentation needed: 

1. A detailed written description explaining controls for ensuring that the raising 

claim is valid from birth to harvest or the period of raising being referenced by the 
10

claim; (e.g., controls to ensure cattle that are supposed to be raised 100% grass 

fed are not fed grains);

2. A signed and dated document describing the diet of the animals to support that 

the claims are not false or misleading;

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description for the identification, control, and segregation of nonconforming animals/product.

As an alternative, a producer may use the USDA Process Verified Program (PVP)

(carried out by AMS) to verify their product meets their own grass-fed standard in lieu of 

documentation needed for 1-4 above. The USDA PVP is a voluntary, user-fee 

verification service that offers applicants a unique way to market their products to 

customers using clearly defined, implemented, and transparent process points. An 

applicant’s program may include one or more agricultural processes or portions of 

processes independently verified by a qualified AMS auditor. Examples of process 

points include, but are not limited to: adherence to a recognized standard or one 

created by a company or organization; definitions included within this guidance; a 

production, raising and/or handling practice that provides specific information to 

consumers to enable them to make informed decisions on the products that they buy; or 

a characteristic, practice, or requirement that is specifically requested by a customer or 

consumer. AMS auditors conduct a comprehensive review of a company’s program, 

which includes an on-site audit of all facilities and phases of the operation that impact 

process verified points. Additional information about the USDA PVP service, shield, 

certificate, and official listing are available at 

www.ams.usda.gov/services/auditing/process-verified-programs.

There are a number of private third-party certification programs that accomplish the 

same objectives. If the claim is certified by a third-party organization, an asterisk or 

other symbol must connect the claim to the certifying entities name, website address, 

and/or logo, when the organization has a logo. 

NOTE: See label example 

Living/Raising/Raising Conditions

These claims refer to the environment in which the animals or birds were raised during 

their lifespan.

Examples of this type of claim include but are not limited to: Cage or Crate Free, Free 

Range**, Not Confined, Free Roaming, Pasture Fed, Pasture Grown, Meadow Raised,

and Pasture Raised.

NOTE: For all of the above claims, additional terminology is necessary on the label to 

define its meaning on livestock products and to convey that the animals were never 

confined to a feedlot.

Because FSIS has not defined these claims in the regulations or policy guidelines, 

nearly all living/raising conditions claims need to describe the standards used to define
11

that claim as applied to that particular product, e.g., “Cage free. Chickens were never 

confined to cages during raising.” The information must appear with the claim or be 

connected by a symbol on the same panel on which the claim appears. As an 

alternative, these living/raising claims can be certified by a third-party certifying 

organization that posts its standards for defining the claim on its website. If the claim is 

certified by a third-party certifying organization, FSIS will not approve the label bearing 

the claim if it does not include the certifying entity’s name, website address, and logo, 

when the organization has a logo. An asterisk or other symbol must connect the claim to 

this information.

**Based on consultations with AMS, FSIS determined that additional terminology is not 

needed on the label for the claim Free Range or synonymous claims (“Free Roaming,” 

“Pasture Fed,” Pasture Grown,” “Pasture Raised,” and “Meadow Raised”) on poultry 

products. However, for FSIS to approve these claims, additional documentation must be 

submitted to substantiate the claim. Specific details about what additional information is 

needed is provided below.

Documentation needed: 

1. A detailed written description explaining controls for ensuring that the animals are 

raised in a manner consistent with the meaning of the raising claim that is valid 

from birth to harvest or the period of raising being referenced by the claim. 

2. A signed and dated document describing how the animals are raised to support 

that the claims are not false or misleading;

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description of the identification, control, and segregation of nonconforming animals/product.

As part of 1 or 2 above, for the claim Free Range on poultry products, the 

documentation must describe the housing conditions for the birds and demonstrate 

continuous, free access to the outside throughout their normal growing cycle. During the 

winter months in a northern climate, birds are not free range if they stay in poultry 

housing or coops all winter. Producer documentation to support the use of the claim for 

birds raised in a northern climate during winter months would also need to describe the 

housing conditions for the birds and demonstrate continuous, free access to the outside 

throughout their normal growing cycle.

As part of 1 or 2 above, for the claims Free Roaming, Pasture Fed, Pasture Grown,

Pasture Raised, and Meadow Raised on meat or poultry products, documentation that 

will typically substantiate these claims will show that the animals or birds have 

continuous, free access to the outdoors throughout their usual grow-out period. For 

ruminants, this means the entire grazing season for the geographical area.

NOTE: See label example 
12

Negative Antibiotics Use – Livestock/Red Meat

Raised Without Antibiotics:

To use this claim, source animals cannot be administered antibiotics in their feed, water 

or by injections at any point in the production process. This includes ionophores which 

are recognized as antibiotics by FSIS.

Examples of this type of claim include, but are not limited to: Raised Without Antibiotics, 

No Antibiotics Administered, No Added Antibiotics, No Antibiotics Ever and Raised 

Antibiotic Free. 

No Sub-Therapeutic Antibiotics: 

FSIS will approve a claim that states that animals have not been administered subtherapeutic antibiotics if the claim is part of a complete claim that explain what the term 

“sub-therapeutic” means, e.g., “No sub-therapeutic antibiotics. Animals do not receive 

antibiotics on a daily basis; animals only receive antibiotics in the case of illness.” 

Other examples of this claim that FSIS is likely to find to be truthful and not misleading 

include: “Beef Raised with No Sub-Therapeutic Antibiotics Ever, animals may be given 

antibiotics for the treatment of illness” or “Beef Raised with No Sub-Therapeutic 

Antibiotics, Animal do not receive antibiotics on a daily basis only in the case of illness.”

Documentation needed: 

1. A detailed written description explaining controls for ensuring that the animals are 

not given antibiotics from birth to harvest or the period of raising being referenced 

by the claim including feed formulation;

2. A signed and dated document describing how the animals are raised to support 

that the claims are not false or misleading;

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description for the identification, control, and segregation of nonconforming animals/product (e.g., if beef raised without the use of antibiotics 

need to be treated with antibiotics due to illness).

NOTE: See label example 

Negative Antibiotics Use – Poultry

Raised Without Antibiotics

For FSIS to find this claim to be truthful and not misleading, source animals cannot be 

administered antibiotics in their feed, water, or by injections. Animals cannot be 

administered Ionophores, which are recognized as antibiotics by FSIS.

Examples of this type of claim include: Raised Without Antibiotics, No Antibiotics 

Administered, No Added Antibiotics, No Antibiotics Ever, and Antibiotics Free.

No Sub-Therapeutic Antibiotics:
13

This claim requires additional explanation on the label to ensure consumers understand 

antibiotics will be administered to the animals in the event of illness. Examples of this 

claim include: “Turkey Raised with No Sub-Therapeutic Antibiotics Ever, birds may be 

given antibiotics for the treatment of illness” or “Chicken Raised with No SubTherapeutic Antibiotics, birds do not receive antibiotics on a daily basis only in the case 

of illness.”

Documentation needed: 

1. A detailed written description explaining controls for ensuring that the raising 

claim is valid from birth to harvest; or the period of raising being referenced by 

the claim;

2. A signed and dated document describing how the animals are raised without 

antibiotics to support that the claims are not false or misleading;

3. A written description of product tracing and segregation mechanism from time of 

slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description for the identification, control, and segregation of nonconforming animals/product (e.g., if chicken raised without the use of antibiotics 

need to be treated with antibiotics due to illness).

In addition to the documentation listed above, the establishment needs to submit a 

company letter (signed and on company letterhead) answering the following questions:

1. Do you use antibiotics pre-hatch in any way with respect to the eggs that you 

hatch for the poultry that will bear the claim? If so, please describe how you use 

antibiotics?

2. Do you inject any vaccines in ovo? If so, please state whether any of the 

vaccines includes an antibiotic. If any of them does, please state what antibiotics 

are used, what the antibiotics are used for, and in what amount they are used.

3. Do you inject any antibiotics in ovo? If so, please state what antibiotics are used, 

what the antibiotics are used for, and in what amount they are used. What is the 

withdrawal time for the antibiotics?

4. Have you verified that the poultry that you use to produce your products was not 

derived from eggs or poultry that were injected or otherwise treated in any way 

with antibiotics? If so, how have you verified these conclusions?

NOTE: See label example 

Negative Hormones Use

Under Federal law, hormones are only approved for use in beef cattle, swine***, and 

lamb production. There are no hormones approved for use in the production of poultry, 

goat, veal calves, mature sheep, or exotic, non-amenable species (such as bison, 

buffalo, elk, and venison). Thus, additional terminology is necessary on these labels to 

convey that Federal law prohibits hormone use in these species.
14

FSIS will only approve a negative hormone claim on products made from a kind or 

species for which Federal law prohibits hormone use when it is accompanied by the

qualifying statement: “There are no hormones approved for use in (kind or species 

[poultry, goat, veal, mature sheep, or exotic, non-amenable]) by Federal Regulations.” 

The qualifying statement must be prominently and conspicuously displayed on the label, 

e.g., it appears adjacent to the claim or is in type at least one-third the height, in 

accordance with 9 CFR 317.2(b) for meat products or 9 CFR 381.116(b) for poultry 

products. As for any labeling claim, FSIS confirms compliance with these regulations 

during the label approval process.

***NOTE: In the previous draft of this guideline, FSIS stated that no hormones had 

been approved for use in the production of swine. After additional research, FSIS has 

found that there are several hormones approved by the Food and Drug Administration 

and marketed by drug makers to be used in swine in the United States for various 

reasons (e.g., gestation). Establishments do not need to resubmit their labels for 

approval to remove the previously required disclaimer statement from pork product 

labels. The change can be made generically under 9 CFR 412.1.

Examples of this type of claim include: Raised Without Added Hormones, No Added 

Hormones Administered, Raised Without Steroids. 

Documentation needed: 

1. A detailed written description explaining controls for ensuring the animals are 

raised without hormones or steroids to support the claim is valid from birth to 

harvest; or the period of raising being referenced by the claim;

2. A signed and dated document describing how the animals are raised (e.g., 

without the use of hormones) to support that the claims are not false or 

misleading;

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description for the identification, control, and segregation of nonconforming animals/product.

NOTE: See label example 

Source/Traceability

This type of claim demonstrates how the animal can be traced back to its farm of origin 

from birth to slaughter/harvest. 

Examples of this type of claim include: Source Verified and Traceable to [Name of Farm 

of Origin].

Documentation needed: 

1. A detailed written description explaining controls for ensuring the source of the 

animal can be verified from birth to harvest or the period of raising being 

referenced by the claim;

2. A signed and dated document describing how the animals are raised to support 

that the claims are not false or misleading;
15

3. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution; and

4. A written description for the identification, control, and segregation of nonconforming animals/product; and

5. Live animal raising records demonstrating how individual animals or a group of 

animals are identifiable and traceable to their farm or ranch of birth, and if 

verified, the individual or entity verifying the claim.

NOTE: See label example 

Third-Party Certification

Generally, FSIS accepts animal raising claims verified by a third-party auditing or 

certifying program. The standards for acceptance of the third-party certifier need to be 

credible and reliable. FSIS evaluates certifiers’ acceptance standards as necessary to 

assess suitability for animal raising claims on labels. The label bearing the claim needs 

to include the certifying entity’s name, website address, and logo, when the organization 

has a logo. An asterisk or other symbol must connect the claim to this information.

Examples of this type of claim include but are not limited to: USDA PVP (administered 

by AMS), Animal Welfare Approved (AWA), or GAP Step ratings (Global Animal 

Partnership (GAP)).

Documentation needed: 

1. A current copy of the certificate; and

2. A written description of the product tracing and segregation mechanism from time 

of slaughter or further processing through packaging and wholesale or retail 

distribution.

NOTE: If used in conjunction with any other animal raising claim(s) that are not covered 

by the third-party organization certification, refer to the documentation needed for the 

particular claim(s). However, third-party certification cannot be carried over to other 

products unless the company has the same certification. 

 

NOTE: See label example 

Organic

USDA organic regulations describe the specific standards required for a company to 

use the word “organic” or the USDA organic seal on food, feed, or fiber products. See 

https://www.ams.usda.gov/services/organic-certification and/or 

https://www.ams.usda.gov/rules-regulation/organic/labeling. 

The USDA organic regulations are administered by AMS’s National Organic Program

(NOP) and described at 7 CFR Part 205. For animal products to be labeled as organic, 

livestock producers must be certified organic and any operations that subsequently 

handle the organic product must be certified organic (e.g., slaughter plants, meat 
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packing facilities). Organic operations are inspected annually by USDA-accredited 

certifying agents. The label bearing the claim needs to include the certifying entity’s 

name, website address, and logo, when the organization has a logo.

1. FSIS accepts current organic certificates to substantiate certain animal raising 

claims such as: “raised without antibiotics,” “no added hormones,” “vegetarian 

diet,” “no animal-by-products,” “NON-GMO” and “humanely raised” with 

company’s description and qualifier [“These are consistent with the USDA 

organic regulations”]. 

2. As referenced previously in this document, organic claims, logos and/or websites 

from purchased products cannot be carried over to other products unless the 

company has the same certification.

3. If an establishment produces meat or poultry products that qualify for an organic

claim under the NOP, the establishment would not need to provide a written 

description of the product tracing and segregation mechanism because these 

activities are a condition of NOP certification. 

NOTE: See label example 

Requesting approval for the addition of new suppliers to the documentation for a 

product with a previously approved label bearing animal raising claims

LPDS has procedures in place that allow for an establishment to add a new supplier to 

the documentation of a previously approved label and not have to resubmit the label for 

another sketch approval. For the purposes of this section, a supplier is a producer, 

farmer, or even another establishment that provides animals or products to another 

establishment to use in its products that bear the same animal raising claims. Examples 

would include but not limited to suppliers added for an approved product label bearing 

animal raising claims, meat or poultry cuts for specific breeds. Additional suppliers 

must be approved by LPDS and upon approval the labeling record must be updated to 

reflect the new supplier(s). To obtain approval, the producing establishment would need 

to submit a signed and dated request to LPDS by email or letter that includes the 

following:

1. The product name;

2. The producing establishment’s name, address, and establishment number; the 

prior label approval number; and a copy of the previously approved label 

application;

3. The specific claim(s) that will be used on the product label containing source 

materials from the new supplier; 

4. The new supplier’s name, address, and one copy of any labels with the same 

claim(s) previously approved by LPDS associated with the supplier or 

documentation to support why the claim(s) also applies to the new supplier; and

5. Finally, for claims certified by a third-party, include a copy of the current 

certificate(s). Due to the fact that most certifications expire after one year, FSIS 

will consider a certificate current based on a one-year time span unless the 

certificate states otherwise.
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Once all the documentation above is evaluated, LPDS will notify the applicant in writing 

of its final determination. As mentioned above, this letter needs to be included as part of 

the supporting documentation in the producing establishment’s official labeling record. 

Label Example 

The above label contains the following types of claims: 

- Breed (Angus);

- Diet (Grass-fed);

- Living/Raising/Raising Conditions (Free-Range);

- Raised Without Antibiotics – Livestock/Red Meat (No Added Antibiotics);

- Raised Without Added Hormones (No Added Hormones Administered);

- Source/Traceability (Source Verified and Traceable to TMB Ranch);

- Third-Party Certification (LPDS True 2 Earth); and

- Organic (USDA Organic)
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http://askfsis.custhelp.com/

FSIS/USDA

www.fsis.usda.gov

2019