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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products

This document provides guidance for companies that seek to make label or labeling claims concerning the fact that bioengineered or GM ingredients were not used in a meat, poultry or egg product.  This guidance also provides information on how companies can make label or labeling claims that a product was produced from livestock or poultry that were not fed bioengineered or GM feed.  For purposes of this guidance document, these claims will be referred to as “negative claims.”

FSIS has approved negative claims through its prior label approval process.  Because FSIS does not have the ability to independently verify negative claims for ingredients or feed, FSIS has required establishments that make these claims to comply with standards established by a third-party certifying organization.  FSIS currently requires that the third-party certifying organization’s standards be publicly available on a web site and the label or labeling disclose the web site address of the third-party certifying organization.  FSIS currently requires that the establishment demonstrate that its claims of third-party certification are truthful and not misleading. FSIS will retain these requirements in this guidance. 

As a policy matter, FSIS has not allowed the use of the terms “genetically modified organism” or “GMO” in negative claims.  FSIS has allowed the use of the terms “genetically modified organism” or “GMO” on product labels or labeling only if the name of the third-party certifying organization contains these terms (e.g. “Non-GMO Project”).   However, recent legislation was enacted (Pub. L. 114-216) requiring the Secretary of Agriculture to develop and implement a mandatory national bioengineered food disclosure standard within 2 years. This legislation also addresses negative claims, providing that “a food may not be considered to be ‘not bioengineered’ or ‘non-GMO’, or any other similar claim describing the absence of bioengineering in the food solely because the food is not required to bear a disclosure that the food is bioengineered under this subtitle.”  (Pub. L. 114-216, section 294(c)).  Therefore, FSIS has reconsidered its position and will allow the use of the terms “genetically modified organism” or “GMO” in negative claims provided that the label or labeling is otherwise truthful and not misleading.   Effective immediately,  FSIS will begin approving negative claims for meat, poultry and egg products that do not contain bioengineered ingredients or that are derived from livestock that do not consume bioengineered feed and that contain the terms “genetically modified organism” or “GMO”.   In evaluating such claims, FSIS will utilize the definition of “bioengineering” in Pub. L. 114-216.  In that law, the term “bioengineering” refers to a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. Consistent with our past practice, FSIS will continue to allow the use of synonymous terms such as “genetically engineered.”   

EXAMPLES OF LABEL CLAIMS

Examples of such claims for the meat or poultry component that was raised on feed containing non-genetically modified ingredients that FSIS will accept are: “Pasture raised beef fed a vegetarian diet with no bioengineered ingredients,” “Chicken raised on a diet containing no genetically engineered ingredients,” or Derived from beef fed no GMO feed.

NOTE: See label example 1

With respect to acceptable claim terminology for multi-ingredient products, examples of such claims FSIS will accept are: “Contains No GMO ingredients,“No genetically modified ingredients,” “Ingredients used are not bioengineered,” or “No genetically engineered ingredients through the use of modern biotechnology.” 

NOTE: See label example 2

As explained above, negative claims will continue to be approved only if the third-party certifying organization is identified and the label or labeling discloses a website address where consumers can obtain additional information regarding the claim and the certification process.   

An organic certifying organization accredited by USDA’s Agricultural Marking Service (AMS) National Organic Program (NOP) is one example of a third-party certifying organization. For products that qualify for an “organic” claim under the NOP, establishments are not required to provide FSIS with additional documentation for approval of negative claims.  The NOP regulations (7 CFR 205.2) prohibit the use of an ingredient that was bioengineered in the production of an organic product.  Certified organic products must be derived from animals that did not consume feed that contains bioengineered substances.  Therefore, an organic certificate is sufficient documentation to support a negative claim. 

NOTE: See label example 3

LABEL APPROVAL SUBMISSION

Negative claims are “special statements and claims” as defined in 9 CFR 412.1(e) and are not generically approved unless previously approved in the manner described below.  Therefore, unless they meet the criteria below, establishments are required to submit labels with negative claims to FSIS for prior approval before using them on labels or labeling (9 CFR 412.1(c)(3)). 

GENERIC APPROVAL FOR CERTAIN LABELS

For meat, poultry or egg products with negative claims that FSIS has previously approved, the establishment is allowed to change the terms “non-genetically engineered” or “non-GE” to “non-GMO” or “no genetically modified organisms” without approval from FSIS.  Such changes are generically approved under 9 CFR 412.2.  If FSIS has approved an organic claim on the product label, establishments may add an applicable negative claim of the kind discussed in this guidance.  Any other changes to the label or labeling must be approved by FSIS. 

FSIS VERIFICATION

FSIS will verify that the labeling record is complete during inspection.  The establishment will be given a non-compliance record during label verification activities under FSIS Directive 7221.1 if this action is not properly documented in the establishment’s labeling records.

REQUEST FOR COMMENT

FSIS is requesting comments on this guidance and may update it in response to comments.  However, the information contained in this guidance is FSIS’ current position and establishments may make label or labeling changes consistent with this guidance immediately.   

FSIS is seeking comments on this guidance as part of its efforts to continuously assess and improve the effectiveness of policy documents. All interested persons may submit comments regarding any aspect of this document within 60 days, and the document will be updated in response to the comments.

Comments may be submitted by either of the following methods:

Federal eRulemaking Portal Online submission at regulations.gov: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov and follow the online instructions at that site for submitting comments.

Mail, including - CD-ROMs, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, Patriots Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, 8-163A, Washington, DC 20250-3700.

All items submitted by mail or electronic mail must include the Agency name, FSIS, and the title of this guidance. Comments received will be made available for public inspection and posted without change, including any personal information, to http://www.regulations.gov.

For additional information about FSIS labeling policies and programs, including Generic Label Approval, please review the FSIS web page at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling or contact the LPDS at (301) 504-0878 or (301) 504-0879.

 

Label Example 1 - SINGLE INGREDIENT LABEL WITH “Raised on a diet containing no genetically engineered ingredients”

Label Example 1 - SINGLE INGREDIENT LABEL WITH “Raised on a diet containing no genetically engineered ingredients

 


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Label Example 2 - MULTI-INGREDIENT LABEL WITH “No GE Ingredients”

Label Example 2 – MULTI-INGREDIENT LABEL WITH “No GE Ingredients”

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Label Example 3 - ORGANIC LABEL WITH “Fed a vegetarian diet with no GMO feed ingredients”

Label Example 3 – ORGANIC LABEL WITH “Fed a vegetarian diet with no GMO feed ingredients”

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Last Modified Aug 19, 2016