[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71359-71367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27845]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2016-0021]


Food Safety and Inspection Service Labeling Guideline on 
Documentation Needed To Substantiate Animal Raising Claims for Label 
Submission

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of an updated version of its guideline on 
documentation needed to support animal-raising claims made on meat or 
poultry product labeling. Official establishments submit this 
documentation to the Agency when they apply for approval of labels with 
animal raising claims. The updated guideline includes changes made in 
response to comments on the guideline posted in October 2016. This 
Federal Register notice also summarizes and responds to issues raised 
in petitions submitted to the Agency by animal welfare advocacy 
organizations.

DATES: Submit comments on or before February 25, 2020.

ADDRESSES: A downloadable version of the compliance guideline is 
available to view and print at http://www.fsis.usda.gov/Regulations_&_Policies/Compliance_Guides_Index/index.asp. No hard 
copies of the compliance guideline have been published.
    FSIS invites interested persons to submit comments relevant to 
clarification provided in this notice on the label claim ``free range'' 
for poultry products. Only comments addressing this specific issue will 
be considered at this time. Comments may be submitted by one of the 
following methods:
     Federal eRulemaking Portal: This website provides 
commenters the ability to type short comments directly into the comment 
field on the web page or to attach a file for lengthier comments. Go to 
http://www.regulations.gov. Follow the on-line instructions at that 
site for submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2016-0021. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    Under the Federal Meat Inspection Act and Poultry Products 
Inspection Act (21 U.S.C. 601-695, at 601(n), 607; 21 U.S.C 451-470, at 
453(h), 457) (the Acts), FSIS develops and implements regulations to 
require that the labels of meat and poultry products are truthful and 
not misleading. Under the Acts, the Secretary of Agriculture, who has 
delegated this authority to FSIS, must approve the labels of meat and 
poultry products before the products can enter commerce (21 U.S.C. 
601(d); 21 U.S.C. 457(c)).\1\
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    \1\ FSIS has similar authority over egg products under the Egg 
Products Inspection Act, 21 U.S.C. 1036(b).
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    FSIS allows certain labels that bear only mandatory labeling 
features and that comply with the Agency's labeling regulations to be 
generically approved (9 CFR 412.2(a)(1)). Generically approved labels 
do not need to be submitted to FSIS for approval before they can be 
used on product in commerce. However, a label with a special statement 
or claim (9 CFR 412.1(c)(3) and 412.1(e)), including an animal-raising 
claim, must be submitted to FSIS for approval before it may be used on 
a product distributed in commerce. A label bearing an animal-raising 
claim must be submitted to the Office of Policy and Program 
Development, Labeling and Program Delivery Staff (LPDS), in FSIS, with 
necessary documentation to support the special statement or claim. 
Examples of animal-raising claims include but are not limited to: 
``Vegetarian-fed,'' ``Grass-fed,'' and ``Raised without the use of 
antibiotics.''
    On October 5, 2016, FSIS announced the availability of and 
requested comments on its Labeling Guideline on Documentation Needed to 
Substantiate Animal Raising Claims for Label Submission (81 FR 68993). 
FSIS published the guideline to advise establishments of the type of 
documentation that they should submit in support of animal-raising 
claims on meat or poultry product labels. FSIS needs this documentation 
to determine whether these claims are truthful and not misleading.
    After reviewing the comments received, the Agency has revised the 
guideline. A summarized list of major changes to the guideline follows. 
The revised guideline is posted at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. The 
information in this guideline is provided as guidance to assist meat 
and poultry establishments and is not legally

[[Page 71360]]

binding from a regulatory perspective. FSIS will update this document, 
as necessary.

Summarized List of Major Changes to the Guideline

     Product Labeling: Use of Animal-Raising Claims on the 
Labels of Meat or Poultry Products
    [cir] 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.
    [cir] Added information about carrying claims forward on additional 
products.
     Removed age claims section because establishments are not 
using these claims.
     Animal Welfare and Environmental Stewardship Claims:
    [cir] 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.
     Breed claims:
    [cir] Added information about carrying these claims forward to 
other products.
     Living- or Raising-Condition Claims:
    [cir] Reorganized section for clarity regarding labeling 
terminology and recommended documentation for approval.
    [cir] Added information about additional terminology that typically 
should accompany these claims to explain the meaning of the claim to 
consumers, including where the information must appear on the label.
    [cir] 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.
     Raised Without Antibiotics--Livestock/Red Meat or Poultry:
    [cir] 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.
    [cir] Added information on claims that include the term ``sub-
therapeutic antibiotics'' to ensure that consumers understand that the 
claim means that antibiotics may be administered only in the event of 
an illness and includes the circumstances for which FSIS will approve 
labels bearing these claims.
     Raised Without Hormones (No Hormones Administered or No 
Steroids Administered):
    [cir] Updated information to clarify that a qualifying statement is 
no longer required on pork products labeled as having been raised 
without hormones because Federal law permits the use of certain 
hormones in swine, e.g., for gestation.
    [cir] Added new examples of this type of claim.
     Added 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 statement must be 
prominently- and conspicuously-displayed on the label, as verified by 
FSIS.
     Third-Party Certification:
    [cir] Added information about documentation needed to support 
labels bearing animal raising claims that have been ``Verified'' or 
``Certified'' by third party organizations.
    [cir] Added information about ``organic'' claims, including other 
claims that could be substantiated with an organic certificate.
     Added a section on procedures for adding an additional 
supplier for a label with animal-raising claims that was previously 
approved by FSIS.

Comments and FSIS Responses

    FSIS received over 4,600 comments on the Labeling Guideline on 
Documentation Needed to Substantiate Animal Raising Claims for Label 
Submission. The majority are similar comments or groups of comments 
from individuals who made them as part of what appears to be organized 
write-in campaigns. FSIS received thirty individual comment letters 
from animal-welfare advocacy organizations, consumer advocacy 
organizations, trade associations representing the poultry, poultry and 
meat, egg, or organic industry, beef marketing companies, organizations 
that provide third-party certification services, agriculture-specific 
coalitions/cooperatives, producers, and an environmental advocacy 
organization.
    Comments from two animal welfare advocacy organizations also 
included over 87,000 and 35,000 signatures, respectively. FSIS also 
received a spreadsheet with similar comments opposing the guidance from 
15,477 members of an animal welfare advocacy organization.
    Comments from trade associations representing the poultry and meat 
industry generally found the information in the guideline to be helpful 
to establishments. Other comments, including those participating in the 
various write-in campaigns, strongly opposed parts of the guideline, as 
well as FSIS's general label approval procedures for animal-raising 
claims.
    FSIS also received petitions from animal welfare organizations that 
raise issues associated with animal-raising claims similar to the 
issues raised by many of the comments. Therefore, the comment summaries 
and FSIS's responses address the issues raised in the petitions.
    Following is a summary of the issues raised in the comments and 
petitions and FSIS's responses.

Regulatory Guidance and Administrative Procedure Act

    Comment: Animal-welfare and consumer advocacy organizations 
asserted the Agency is violating the Administrative Procedure Act (APA) 
by effectively promulgating ``requirements'' for establishments without 
following due notice-and-comment procedure. They said that FSIS should 
follow the APA procedures because the guideline ``grants rights, 
imposes obligations, and produces significant effects on private 
interests.''
    Response: The guideline does not promulgate new requirements 
subject to notice-and-comment requirements under the APA. As noted 
above, under 9 CFR 412.1(c) and (e), labels bearing animal-raising 
claims are required to be submitted to FSIS for prior approval. FSIS 
published the guideline to assist establishments that manufacture meat 
and poultry products labeled with animal-raising claims to prepare 
their label approval applications and to facilitate FSIS's review of 
labels bearing animal-raising claims. Animal raising claims are 
voluntary marketing claims, and establishments are not required to use 
any of the claims listed in the guideline. However, if they do, 
establishments may refer to the guideline to help them provide the 
documentation that FSIS needs to evaluate labels bearing animal raising 
claims and to determine whether such claims are truthful and not 
misleading.
    Notably, FSIS has sought to engage the public in the consideration 
and revision of the guideline and has provided extensive opportunity 
for public comment. We have made many substantive changes based on the 
comments we have received. We also note that this is not a novel 
approach. FSIS routinely publishes guidance on how FSIS interprets 
labels to be truthful or not misleading, with examples of acceptable 
supporting documentation.

[[Page 71361]]

Defining Animal-Raising Claims

    Comment: Animal-welfare advocacy organizations, consumer-advocacy 
organizations, petitioners, and individuals, said that FSIS must define 
animal-raising claims in the regulations and not allow the use of 
animal-raising claims that are not defined in the regulations.
    Response: FSIS disagrees that it needs to establish codified 
definitions for animal raising claims to prevent product misbranding. 
Animal production practices vary and are continuously developing; 
maintaining a current list of codified allowable claims would be 
impractical. Further, FSIS does not have the authority to regulate on-
farm animal production and thus its codification of animal raising 
claims could inappropriately restrict developments in animal production 
practices by operations that would benefit from the use of a truthful 
claim.
    The Acts and implementing regulations prohibit the sale and 
distribution of ``misbranded'' meat and poultry products, i.e., meat 
and poultry products bearing labels that are misleading or untrue (21 
U.S.C. 453(h)(1); 21 U.S.C. 601(n)(1), implemented at 9 CFR parts 
381.129 and 317.8, respectively). Accordingly, FSIS is responsible for 
ensuring that the labeling of meat, poultry, and egg products is 
truthful and not misleading. To prevent labeling claims that are false 
and misleading, any label with a special statement or claim, including 
an animal-raising claim, not defined in FSIS regulations or the Food 
Standards and Labeling Policy Book must be submitted to FSIS for prior-
approval (9 CFR 412.1(c)(3) and 412.1(e)). As part of the label 
approval process, FSIS verifies the accuracy of the special statement 
or claim by reviewing supporting documentation submitted with the label 
approval application.
    Consistent with this approach, FSIS evaluates labels bearing 
animal-raising claims on a case-by-case basis by reviewing the animal 
production protocol submitted with the label approval application. FSIS 
approves the label if the documentation supports the claim made, if the 
claim is truthful and not misleading, and if the claim (including any 
qualifying information) is prominently- and conspicuously-displayed on 
the label. At establishments that label product with animal raising 
claims, FSIS inspectors verify that establishments have FSIS label 
approval on file. In addition, they are to take the appropriate 
regulatory control action, such as retention of product, when they 
determine that misbranded product would otherwise enter commerce (i.e., 
it is shipped from the establishment). FSIS could also rescind approval 
of false or misleading labels per 9 CFR 500.8. Under this approach, 
FSIS is able to prevent the sale of misbranded meat and poultry 
products by ensuring that labels bearing animal-raising claims 
accurately reflect the conditions under which the source animal was 
raised.

Consistency With Other Federal Agency Standards

    Comment: An animal-welfare advocacy organization argued that FSIS's 
labeling standards must be in harmony with Federal Trade Commission 
(FTC) and Securities and Exchange (SEC) standards, and that the Agency 
should consult with the FTC and SEC in the rulemaking that it ought to 
be carrying out following APA procedures. Several advocacy 
organizations asserted that inconsistently defined claims are 
inherently ``false and misleading in any particular,'' and therefore 
misbranded under the Acts.
    Response: The labeling requirements for meat and poultry products 
in the Acts and implementing regulations are aimed at preventing 
product misbranding. For the reasons given previously, FSIS considers 
its review and approval of labels bearing animal-raising claims, under 
the conditions described in the guideline, to provide sufficient 
assurance that product labeling bearing claims is not be false or 
misleading in any particular. As a result, the products will not be 
misbranded.
    FSIS is aware of the statutory authorities under which the FTC and 
SEC operate to require substantiation of claims companies make about 
their products. For example, Section 12 of the Federal Trade Commission 
Act (15 U.S.C. 52) prohibits false advertisement of foods, drugs, and 
cosmetics. FSIS generally coordinates its activities with the FTC and 
other agencies to avoid duplication of effort and advises companies to 
consult FSIS labeling regulations, rules, and policies when developing 
advertising for meat and poultry products. (On coordination with the 
FTC, See A Guide to Federal Food Labeling Requirements for Meat, 
Poultry, and Egg Products (FSIS/USDA, Washington, DC 2007)).

Third-Party Certification

    Comment: Comments from animal welfare advocacy organizations, 
consumer advocacy organizations, individuals, organizations that 
provide third-party certification, and producers argued that, because 
FSIS does not conduct on-farm verifications, the Agency should require 
animal-raising claims to be verified by a third-party certifying 
organization. These commenters stated that the required certification 
would constitute evidence that the claim is truthful and meets consumer 
expectations for the claim. Several commenters included their 
recommendations for third-party certification programs that they 
believe reflect consumer expectations for these claims.
    Response: FSIS believes it would not be economically feasible for 
many small and very small establishments to incur the additional costs 
of independent third-party certification because of their low sales 
volumes. FSIS also believes that requiring third-party certification 
could reduce the variety of products labeled with animal-raising claims 
these establishments would have to offer. Reductions in purchase 
options could also result in a cost to consumers. FSIS believes that 
its current procedure, which provides for case-by-case review of the 
producer's animal-raising protocol, is effective in ensuring that 
labels bearing animal-raising claims are truthful and not misleading. 
While the Agency has determined that it will not require independent 
third-party certification for all animal-raising claims, this 
determination should not in any way diminish the utility of third-party 
certifying organizations. Establishments can choose to use third-party 
certification programs to support animal raising claims on labels.

Font Size for Claim Statements

    Comment: Animal-welfare and consumer-advocacy organizations urged 
FSIS to set minimum type sizes for animal-raising claims and any 
additional text or qualifying information on the label that explains 
the claims. They said this information is often so small that it goes 
unnoticed.
    Response: When the disclosure of qualifying information is 
necessary to prevent a claim from being false and misleading, FSIS 
agrees the information must be presented truthfully on the label. FSIS 
also agrees such information must be prominently- and conspicuously-
displayed on the label and in terms likely to be read and understood by 
the ordinary individual (21 U.S.C. 601(n)(6); 21 U.S.C. 453(h)(6), 
implemented at 9 CFR 317.2(b) and 381.116(b), respectively). To that 
end, through its label prior-approval program, FSIS confirms that any 
qualifying information consists of clear language, that its type is 
prominent and conspicuous (as compared to with other

[[Page 71362]]

words, statements, or designs on the label), and that it is placed on 
the same panel of the package as the claim being qualified.
    As discussed below, several comments expressed concern that claims 
associated with hormone use during animal production may be 
particularly misleading to consumers, particularly when hormones are 
not allowed during the production of certain species. To address these 
concerns, FSIS has updated the guideline to clarify why qualifying 
information is necessary on certain products and to emphasize that this 
information must be prominently- and conspicuously-displayed on the 
label for FSIS to approve the claim. This specific issue is discussed 
in more detail below.

Posting of Company-Specific Information

    Comment: Commenters urged FSIS to make establishments' supporting 
documentation public, preferably in an open, online format.
    Response: Developing and maintaining a public database of 
supporting documentation for establishments' claims would be overly 
cumbersome for FSIS. However, interested persons can submit a request 
for copies of any records not normally prepared for public distribution 
in accordance with the Freedom of Information Act (FOIA)(5 U.S.C. 552). 
Please note that certain records may be withheld in whole or in part 
from the requestor if they fall within one of nine FOIA exemptions. For 
example, Exemption 4 protects trade secrets and confidential commercial 
or financial information.

Organic Certification

    Comment: Producers, a coalition that promotes sustainable 
agriculture, a trade association representing organic producers, and a 
foreign beef marketing agency urged FSIS to consider organic 
certificates to be sufficient support for other animal-raising claims, 
such as ``no antibiotics administered.'' The comments said additional 
documentation, e.g., a segregation protocol, is unnecessary for certain 
claims and is an undue burden on certified-organic producers. 
Similarly, a trade association representing the poultry industry asked 
FSIS to state whether third-party program certificates, other than 
organic certificates, may be used in place of the documentation listed 
in the guideline.
    Response: Any agricultural product that is sold, labeled, or 
represented as ``organic'' must be produced in accordance with the 
Agricultural Marketing Service's (AMS) National Organic Program (NOP) 
regulations in 7 CFR 205, as verified by a NOP-accredited third-party 
certifier. Therefore, if an establishment produces meat or poultry 
products that qualify for an organic claim under the NOP regulations, 
the establishment may not need to provide FSIS with additional 
documentation to support a separate animal-raising claim if the 
standards for the animal-raising claim are supported by the organic 
claim, i.e., the standard for the animal-raising claim is explicitly 
addressed in the NOP regulations. For example, the organic certificate 
would be sufficient support for the claim ``no antibiotics 
administered'' on certified organic livestock products, because 7 CFR 
205.238(c)(1) explicitly prohibits antibiotics for this purpose. 
Furthermore, a written description of the product tracing and 
segregation mechanism would not be needed as support for certified 
organic products because these activities are a condition of NOP 
certification.
    For meat and poultry products certified under non-NOP third-party 
organization programs involving separate animal-raising claims, such as 
Global Animal Partnership's 5-Step Certification Program, FSIS would 
likewise accept their certificate as support for separate animal-
raising claims or in place of the documentation listed in the 
guideline.
    FSIS has updated the guideline by indicating the circumstances for 
which an organic certificate could also be used to support a specific 
animal-raising claim or in place of the documentation listed in the 
guideline. We would again note, however, that establishments are not 
required to use any animal-raising claim, including those listed in the 
guideline.

Support for Claims; Company Information

    Comment: Animal welfare advocacy organizations and individuals 
opposed FSIS's approving animal-raising claims based on what the 
commenters consider to be ``minimal support,'' e.g., a brief affidavit 
from the entity making the claim. Instead, they urged FSIS to 
stipulate, at a minimum, detailed animal-care protocols and 
photographic evidence when making any label approval determination.
    Response: For FSIS to approve an animal-raising claim, an 
establishment must submit to FSIS documentation that supports the 
claim. The kind and amount of supporting documentation depends on the 
claim and could vary according to circumstances. FSIS comprehensively 
evaluates these label applications on a case-by-case basis. Further, 
FSIS often consults with its Federal partners, e.g., the USDA's AMS, to 
decide whether the documentation submitted in support of an animal-
raising claim provides the level of detail needed to ensure that the 
claim is truthful and not misleading. The type and amount of supporting 
documentation needed to adequately support an animal-raising claim 
varies with the type of claim being made. There are a few claims, such 
as ``made from Angus beef,'' that could be supported with a brief 
affidavit, e.g., a certificate from a breed organization, when the 
establishment produces only those products. However, that is not 
necessarily the case for all animal-raising claims.

Animal Welfare and Environmental Stewardship

    Comment: FSIS received several comments from animal welfare 
advocacy organizations, consumer advocacy organizations, and 
individuals on the Agency's guidance on animal welfare and 
environmental stewardship claims. Additionally, in May 2014, before 
FSIS published the 2016 guidance, the Animal Welfare Institute (AWI) 
petitioned the Agency to amend its regulations to require third-party 
certification for the approval of animal welfare and environmental 
stewardship claims in the labeling of meat and poultry products.\2\ 
Both the comments and petition asserted that FSIS does not have the 
expertise or resources to adequately approve animal welfare and 
environmental stewardship claims. According to the comments and 
petition, the Agency currently approves claims based on standards that 
do not meet consumer expectations. To address these concerns, the 
comments and the petition stated that FSIS should only approve animal 
welfare and environmental stewardship claims that have been certified 
by an independent third-party certifying organization that has 
established standards that exceed the conventional industry standards 
defined by meat and poultry trade associations.
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    \2\ FSIS denied the petition on February 22, 2019. The petition 
and FSIS's response are available on the FSIS petitions web page at: 
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/petitions.
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    Response: FSIS disagrees. As noted in the guideline, animal welfare 
and environmental stewardship 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. The

[[Page 71363]]

issues raised in the comments and petition show that consumers, 
producers, and certifying entities have different views on the specific 
animal production practices that should be associated with certain 
animal welfare or environmental stewardship claims. Thus, because 
animal welfare or environmental stewardship claims mean different 
things to different people, a claim that is defined by a specific 
third-party certifying organization's animal-raising standards cannot 
reflect the diverse views associated with these types of claims.
    To ensure that animal welfare and environmental stewardship claims 
continue to accurately reflect the animal production practices that 
define a specific claim, FSIS has updated its guidance with additional 
information on, as well as examples of, animal welfare and 
environmental stewardship claims for which the Agency is likely to find 
their use to be truthful and not misleading. Specifically, the 
guideline provides for the approval of animal welfare and environmental 
stewardship claims if the product label also describes the animal-
raising standards that define the claim and identifies the entity that 
established the standards, e.g., ``Raised with Care: TMB Ranch Defines 
Raised with Care 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 to the additional terminology, 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 approve the label bearing the claim 
if it includes the certifying entity's name, website address,\3\ and 
logo, when the organization has a logo, as described in the guideline. 
Under this approach, the labeling of a meat or poultry product that 
bears an animal welfare or environmental stewardship claim includes the 
information that consumers need to determine whether the animal-raising 
practices used to define a particular animal claim meets their 
expectations for the claim.
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    \3\ 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.
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    Comment: Comments from animal welfare advocacy organizations and 
consumer advocacy organizations stated that although FSIS will only 
approve animal welfare or environmental stewardship claims if the claim 
is defined on the labeling, companies have different standards for 
defining animal welfare and environmental stewardship, and they use 
different types of documentation to support these claims. The comments 
stated that because of these differences, the same claim may reflect 
different practices depending on the producer's standards for the 
claim, which, according to the comments, results in claims that are 
misleading and confusing to consumers. The comments also asserted that 
it is unlikely that a producer's ``humane'' or ``sustainable'' 
practices can be adequately described in the limited space provided on 
a product label.
    Response: As discussed above, FSIS recognizes that the same animal 
welfare or environmental stewardship claim may reflect different animal 
production practices depending on the producer's or certifying entity's 
standards for the claim. However, FSIS disagrees that these differences 
result in claims that are misleading or confusing to consumers. As 
noted above, FSIS has updated the guideline with additional information 
on and examples of claims the Agency will likely find to be truthful 
and not misleading if accompanied by the appropriate documentation. The 
labels of products bearing animal welfare and environmental stewardship 
claims need to include information that consumers can use to determine 
whether the animal-raising practices used to define a particular claim 
meet their expectations for the claim, i.e., the name of the entity 
that established the standard with a statement explaining the meaning 
of the claim as applied to that particular product or a website address 
that provides the entity's standards for defining the claim. If a 
third-party certifying organization established the claim, the website 
address would need to provide the certifying organization's standards 
for defining the claim. FSIS will not approve an animal welfare or 
environmental stewardship claim if the product label does not include 
complete information on the animal-raising standards that define the 
claim or identify the entity that established the standards. Or, 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, and logo, when the 
organization has a logo.
    Comment: The above comments and the 2014 AWI petition stated that 
many animal welfare and environmental stewardship claims are misleading 
because they reflect conventional industry standards defined by meat 
and poultry trade associations. The comments and petition both 
referenced surveys that, according to the comments and petition, show 
that consumers believe animal welfare claims, such as ``humanely 
raised,'' represent a standard of care higher than that of the 
conventional animal agriculture industry. Specifically, they stated 
that surveys show that a majority of consumers believe that products 
that bear ``humanely raised'' claims in their labeling should be 
derived from animals that have access to the outdoors and adequate 
space to move about freely. They asserted that FSIS should only approve 
third-party certified claims if the party employs standards that align 
with these consumer expectations for the claim in question. The 
comments and petition included examples of certification programs that 
they believe meet consumer expectations for animal welfare claims.
    Response: As noted above, FSIS will only approve labels of products 
bearing animal welfare and environmental stewardship claims that 
include information that consumers need to determine whether the 
animal-raising practices used to define a particular claim meet their 
expectations for the claim. Thus, consumers who have specific 
expectations for the standard of care used to define a claim may 
identify meat and poultry products that meet their expectations from 
the information included in the product's labeling.
    Comments: The 2014 AWI petition and comments from animal welfare 
advocacy organizations stated that the current guideline places 
producers who choose to use third-party certification at an economic 
disadvantage. The comments noted that producers who choose to use a 
third-party certification typically incur costs associated with the 
certification and in maintaining systems that go beyond conventional 
production standards in terms of animal welfare and environmental 
stewardship. The comments and petition said that producers who make 
animal welfare or environmental claims that are not independently 
certified can make the same claims and charge a premium for their 
products while avoiding the cost of certification and production. They 
also asserted that requiring third-party certification will increase 
consumer confidence in animal welfare and environmental stewardship 
claims because third-party certification programs are independent of 
the

[[Page 71364]]

companies they are certifying and have expertise in establishing 
standards.
    Response: FSIS disagrees that the guideline places companies that 
choose to use third-party certification for animal raising claims at an 
economic disadvantage. A producer's decision to use a third-party 
certifying organization's certification program is a voluntary business 
decision. Producers that use certifying entities do so because they 
have determined that the benefits of labeling a meat or poultry product 
with a certified animal welfare or environmental stewardship claim 
outweigh the cost associated with the certification program. Consumers 
who have more confidence in claims that have been certified by a third-
party organization can identify products that meet a certifying 
entity's standards from the information included in the product's 
labeling.
    However, as noted above, FSIS disagrees that third-party 
certification be required because the Agency believes it would not be 
economically feasible for many small and very small establishments to 
incur the additional costs of independent third-party certification 
because of their low sales volumes. In addition, because FSIS reviews 
all animal raising claims on a case-by-case basis, the Agency does not 
believe that it is necessary to require third party certification to 
ensure that labels bearing animal welfare and environmental stewardship 
claims are truthful and not misleading.

Diet

    Comment: A producer urged FSIS to only accept the term ``grassfed'' 
and not the terms ``Grass Fed'' or ``grass-fed.''
    Response: FSIS considers all three terms synonymous and will 
continue to approve them when adequate documentation is provided to 
substantiate the claim.
    Comment: A producer urged FSIS to require that official 
establishments submit to FSIS annual monitoring and reporting of soil 
health as a condition for approval of ``grass-fed'' claims. The 
commenter argued that requiring the data will promote better land 
management practices and healthy grasslands.
    Response: FSIS believes that information about land management 
practices is not necessary for the Agency to evaluate ``grass-fed'' 
claims in the labeling of meat and poultry products because land 
management practices are not part of the animal's diet. However, land 
management practices information may be included as a part of the 
supporting documentation if the claim includes information about soil 
health or other land management practices.
    Comment: An environmental advocacy organization urged FSIS to 
establish a standard for ``grass-fed'' based on four conditions: (1) No 
confinement; (2) no routine antibiotics; (3) no added hormones; and (4) 
a forage-based diet throughout the lifetime of the animal after 
weaning. Likewise, comments from consumers, animal advocacy 
organizations, and consumer advocacy groups requested that FSIS 
establish a standard for ``grass-fed'' that is applicable from weaning 
to slaughter, prohibits the use of feedlots, and for which animals have 
100 percent access to a forage-based diet. In addition, an animal 
welfare advocacy organization asked that FSIS clarify whether products 
made from animals with less than 100 percent access to grass or forage 
can bear ``grass-fed'' label claims, such as 85 percent grass-fed.
    Response: In response to these comments, FSIS has updated the 
guideline to clarify that ``100% grass-fed'' claims are not permitted 
for animals raised on feedlots. FSIS has also added that when animals 
have less than 100 percent access to grass or forage, any ``grass-fed'' 
claim must accurately reflect the circumstances of raising (e.g., 
``Made from cows that are fed 85% grass and 15% corn''). Similar to 
other dietary claims, FSIS will verify these claims by reviewing 
records that describe the animal's diet from birth to harvest or the 
period of raising being referenced by the claims. With these changes, 
FSIS believes the information in the guideline is adequate as it 
relates to use of ``grass-fed'' and ``100% grass-fed'' label claims. As 
outlined in the guideline, for FSIS to approve these particular claims, 
animals must be fed only grass or forage, with the exception of milk 
consumed before weaning. In addition, these animals cannot be fed grain 
or grain byproducts and must have continuous access to pasture during 
the growing season until slaughter.

Living/Raising/Raising Conditions

    Comment: Comments from animal welfare advocacy organizations, 
consumer advocacy organizations, and individuals stated that FSIS 
should update the guideline on claims related to living/raising 
conditions by defining separate ``range'' and ``pasture'' claims for 
meat and poultry products, by defining ``crate free,'' and other 
similar claims. The comments noted that under the guideline, certain 
claims, such as ``Free Range'' and ``Pasture Raised'' require the 
producer to define the claim on the product label, while other claims, 
such as ``Free Roaming'' and ``Pasture Grown,'' are acceptable without 
a definition when the animal from which the products are derived has 
continuous access to the outdoors for a minimum of 120 days per year. 
The comments stated that FSIS should set minimum standards that reflect 
consumer expectations for these claims and clarify whether certain 
claims may only be used for products derived from livestock or birds. 
The comments included recommendations on how to define ``range'' or 
``pasture'' claims for birds and separate recommendations on how to 
define ``range'' or ``pasture'' claims for livestock. According to the 
comments, the recommended standards included in the comments reflect 
consumer expectations for these claims, which include some degree of 
vegetative cover, a minimum amount of space per animal, and protection 
from risks to animal welfare.
    Response: As explained above, FSIS does not believe that the Agency 
should define specific living/raising conditions claims in the 
regulations or in guideline because our current procedure, which 
provides for case-by-case review of the producer's animal-raising 
protocol, is effective in ensuring that labels bearing these claims are 
truthful and not misleading. However, these comments showed confusion 
regarding the labeling of products with living/raising conditions 
claims. To ensure that living/raising conditions claims continue to 
accurately reflect the animal production practices that define a 
specific claim, FSIS updated the guideline by reorganizing the living/
raising conditions section to make clear which claims do not require 
additional terminology and the documentation that is needed to 
substantiate these claims.
    In addition, FSIS added information to clarify that nearly all 
living/raising conditions claims require additional terminology 
explaining the meaning of the claim, e.g., ``Cage free. Chickens were 
never confined to cages during raising.'' FSIS also clarified that, as 
an alternative to the additional terminology, 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 only 
approve the label bearing the claim if it includes the certifying 
entity's name, website address, and logo, when the organization has a 
logo, as described in the guideline.
    Based on consultations with AMS in the 1990s, FSIS determined that 
additional terminology is not needed on the label for the claim ``Free 
Range'' and synonymous claims (``Free Roaming,''

[[Page 71365]]

``Pasture Fed,'' Pasture Grown,'' ``Pasture Raised,'' and ``Meadow 
Raised'') on poultry products. However, for FSIS to approve these 
claims, additional information must be submitted to substantiate the 
claim. Specific details about what additional information is needed 
have been added to the guideline. Although FSIS believes its current 
approach is adequate because it can accommodate various production 
situations while still providing for an animal-raising environment that 
allows birds to express natural behaviors, FSIS requests comments on 
this approach.
    Comment: In January 2016, AWI submitted a different petition \4\ 
requesting that FSIS initiate rulemaking to define ``free range'' and 
equivalent claims for poultry and to establish substantiation 
requirements for the approval of these claims. As an alternative, the 
petition requested that FSIS update its guidance on ``free range'' 
claims to incorporate the changes requested in the petition.
---------------------------------------------------------------------------

    \4\ The petition is available at https://www.fsis.usda.gov/wps/wcm/connect/368eba0b-4195-4641-91d7-7f772ead9a3e/16-01-AWI-Petition-012016.pdf?MOD=AJPERES.
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    The petition asserted that outdoor access should not be the sole 
defining factor of the ``free range'' claim. According to the petition, 
in order for a producer to properly illustrate that their birds are 
free range, they should be required to address several living 
conditions in addition to outdoor access. The petition stated that 
producers should be required to provide evidence that birds have easy, 
continuous access to vegetation, shade, and soil; protection against 
predators and adverse weather; and an outdoor space that is at least as 
large as the indoor space. According to the petition, only when 
producers are required to provide this information does this claim 
become valuable for consumers.
    The petition and other commenters stated that the current guideline 
does not reflect consumer expectation because, under the guideline, 
poultry labeled as ``free range'' may come from birds raised indoors 
under crowded conditions, as long as the birds have access to the 
outside. The comments and petition stated that the current guideline 
and approval process for ``free range'' poultry claims results in 
claims that are inconsistent and misleading to consumers.
    Response: As noted above, FSIS has updated the guideline by adding 
information on the type of documentation typically needed to 
substantiate a ``free range'' claim on poultry products. The update 
reflects FSIS's longstanding policy for approving these claims. For 
FSIS to approve this specific claim, the establishment must include a 
description of the housing conditions of the birds, as well as 
demonstrate the birds have continuous, free access to the outside.
    Comment: Comments from animal welfare advocacy organizations stated 
that ``cage free'' claims should not be allowed on chicken and turkey 
products because birds raised for food are not typically kept in cages 
before being transported to slaughter. The comments asserted that 
``cage free'' claims on poultry products are misleading because they 
give consumers the false impression that there are poultry products in 
the market that came from caged birds.
    Response: When supported by documentation, the claim that birds 
were ``raised cage free'' is a true and accurate statement about a 
producer's raising practices that the establishment has chosen to 
communicate to consumers on the product label. If the claim is 
factually accurate and supported by documentation, FSIS will approve a 
``cage free'' claim in the labeling of poultry products if it is part 
of a complete claim that is truthful and not misleading, e.g., ``Cage 
free. Chickens were never confined to cages during raising.'' Any 
producer that raises poultry without cages may label their poultry 
products as ``cage free'' if the claim is substantiated by 
documentation. Even if raising birds as cage free is a common practice, 
that fact does not make the claim false or misleading.

Raised Without Antibiotics

    Comment: A group of animal welfare advocacy organizations noted 
that the guideline allows producers to make a number of voluntary 
claims with respect to antibiotic use during animal production but does 
not require that producers disclose antibiotic use. The comments 
asserted that FSIS must require that antibiotic use during animal 
production be disclosed in the labeling of meat and poultry products to 
prevent product misbranding and foster informed consumer decision 
making.
    In addition, in June 2013, before FSIS published the initial 
guideline, the Animal Legal Defense Fund (ALDF) petitioned FSIS to 
initiate rulemaking to require mandatory labeling to disclose routine 
antibiotic use in animals used to produce meat and poultry products.\5\ 
The petition requested that FSIS require that the labels of all meat 
and poultry products disclose whether the source animals were 
administered antibiotics. The petition included a study that suggests 
that bacteria found in meat from animals raised with antibiotics may be 
more likely to be resistant to antibiotics than bacteria in meat from 
animals raised without antibiotics. The petition also referenced 
surveys that showed that consumers are concerned about issues related 
to the use of antibiotics in animal production and the development of 
antibiotic resistant strains of bacteria.
---------------------------------------------------------------------------

    \5\ The petition is available at https://www.fsis.usda.gov/wps/wcm/connect/12aeca93-4d3e-4ac7-b624-d5fc0b0dbae0/Petition_Animal_Legal_Defense_Fund_060313.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    The petition and the comments asserted that the current regulatory 
scheme, which allows producers that do not use antibiotics to 
voluntarily disclose this fact on the product labeling, fails to 
provide uniform, meaningful disclosure of antibiotic use on the farm. 
Both the petition and comments stated that the failure to disclose 
material facts about antibiotic use prevents consumers from making 
informed purchasing choices with respect to an animal production 
practice that many consumers believe presents a threat to public 
health.
    Response: FSIS does not require that the labeling of meat and 
poultry products disclose the fact that antibiotics were administered 
to animals as part of the production process because the Agency does 
not consider animal production practices to be material facts that must 
be disclosed in the product label. Animal-raising claims, including 
claims about antibiotic use, are voluntary marketing claims that 
highlight certain aspects about the way source animals used to produce 
meat and poultry product were raised. These claims do not provide 
information on the characteristics or components of the meat or poultry 
products themselves.
    FSIS conducts testing for residues in meat and poultry to verify 
that product does not include any prohibited chemical, including 
antibiotics. As discussed above, FSIS regulates the marking, labeling, 
and packaging of meat and poultry products to ensure that these 
products are not misbranded. Under the Acts, a product is misbranded, 
among other circumstances, if its labeling if ``false and misleading in 
any particular'' (21 U.S.C. 601(n)(1), 21 U.S.C. 453(h)(1)). FSIS has 
historically interpreted ``false or misleading in any particular'' to 
be a material misrepresentation directly related to the inherent 
characteristics of

[[Page 71366]]

the food itself.\6\ In other words, the elements required to appear on 
the label must inform the consumer of the constituents of the product. 
Information that may be of interest to certain consumers, such as the 
use of antibiotics in animal production, but that does not pertain to 
the product's nutritional, organoleptic, or functional characteristics, 
or any other essential attributes of the food, is not considered a 
``material fact'' that must be disclosed in the product's labeling. 
Although the 2013 petition submitted by ALDF includes information to 
demonstrate that the administration of antibiotics as part of the 
animal production may lead to the development of antibiotic resistant 
strains of bacteria, the supporting data do not demonstrate that the 
proper use of antibiotics in animal production affects the attributes 
of the meat or poultry product itself.
---------------------------------------------------------------------------

    \6\ See FSIS's final response to petition #12-02 submitted by 
SOIA available at: https://www.fsis.usda.gov/wps/wcm/connect/dcda4cb4-2612-4283-a9a7-0f97d976e022/12-02-FSIS-Final-Response-090916.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    As noted in the petition, most major grocery stores carry meat and 
poultry products labeled as ``antibiotic-free.'' Thus, consumers who 
want to avoid purchasing meat and poultry products from animals that 
may have received antibiotics during the production process can 
identify these products from current voluntary animal production 
claims. FSIS is currently testing certain products with ``raised 
without antibiotics'' claims to verify that those products are not 
misbranded. This effort will help ensure that such label claims are 
accurate and not misleading.
    Comment: The 2013 ALDF petition and consumer advocacy organizations 
stated that FSIS must adopt a uniform labeling standard for all meat 
and poultry products to disclose whether animals were fed antibiotics. 
The comments stated that the guideline provides for producers to make a 
number of voluntary claims, such as ``No Antibiotics Administered,'' 
``No Antibiotics Ever,'' ``Raised without Sub-therapeutic 
Antibiotics,'' and ``No Antibiotics Administered the last 150 days,'' 
which the comments believe make it difficult for consumers to make 
informed decisions on what they consider to be public health issues. 
The petition recommended that FSIS prescribe standard terminology and 
definitions for the claims ``Raised with Antibiotics,'' ``Raised 
without Antibiotics,'' and ``Given Antibiotics for Therapeutic 
Antibiotic Use Only.'' Finally, according to the commenters and the 
petition, antibiotic claims need to be set apart from other animal-
raising claims on the label because the use of antibiotics in animal 
agriculture has potential human health consequences that make labeling 
clarity particularly important.
    Response: FSIS believes that its current case-by-case approach for 
the approval of labels bearing claims on the use of antibiotics during 
animal production is effective in ensuring that these types of claims 
are truthful and not misleading. Therefore, the Agency is not 
establishing standard definitions for these types of claims as 
recommended by the comments and petition.
    FSIS will approve a label bearing an animal-raising claim related 
to antibiotic use if the claim is supported by documentation and the 
claim accurately reflects the conditions under which the source animal 
was raised. As noted by the comments, FSIS approves claims that reflect 
variations in the use of antibiotics during animal production, such as 
``raised without antibiotics'' and ``no antibiotics administered for 
growth promotion, antibiotics administered in the event of illness.'' 
The variations in claims reflect differences in the use of antibiotics 
during animal production. FSIS disagrees that these claims are 
misleading or confusing to consumers because FSIS will only approve a 
claim associated with antibiotic use that accurately reflects the 
conditions under which the source animal was raised.
    Comment: Several comments from consumer advocacy organizations and 
individuals said FSIS should prohibit the claim ``raised without sub-
therapeutic antibiotics'' because the term ``sub-therapeutic'' has no 
commonly recognized meaning.
    Response: FSIS will only approve claims that animals have not been 
administered sub-therapeutic antibiotics if such claims are part of a 
complete claim that is truthful and not misleading, e.g., ``No sub-
therapeutic antibiotics. Animals do not receive antibiotics on a daily 
basis; animals only receive antibiotics in the case of illness.'' 
However, to avoid related confusion, FSIS updated the guideline to 
include additional examples of claims where the Agency is likely to 
find the use of the term ``sub-therapeutic'' to be truthful and not 
misleading.

Raised Without Added Hormones

    Comment: Several comments from consumers, animal advocacy 
organizations, consumer advocacy organizations, and an environmental 
advocacy organization urged FSIS to establish standards in the 
guideline for the claim ``raised without growth promotants 
(stimulants).'' According to the comments, FSIS should approve the 
claim only if the source animals were not treated with or fed any 
chemical compound used for growth promotion and feed efficiency, 
including, but not limited to, hormones, beta-agonists, and 
antibiotics.
    Response: FSIS agrees that documentation for the claim ``raised 
without growth promotants (stimulants)'' would need to demonstrate that 
the animals were not treated with or fed any chemical compound used by 
producers for growth promotion and feed efficiency throughout the life 
of the animal. However, in FSIS's experience, use of this specific 
claim is rare. Therefore, FSIS has not made any changes related to its 
expectations for growth promotant claims but has updated the examples 
in the guideline with more commonly used negative hormone claims, like 
``Raised without Added Hormones'' and ``No added Hormones 
Administered.''
    Comment: A consumer advocacy organization said FSIS should no 
longer stipulate the qualifying statement ``Federal regulations 
prohibit the use of hormones in (species)'' on pork products labeled 
with a negative hormone claim. ``The organization argued the statement 
is misleading on these products because several hormones, e.g., 
Altrenogest, a synthetic progestin, and Oxytocin, have been approved 
for use in swine by the Food and Drug Administration.
    Response: FSIS agrees with the comment and has updated the 
guideline to clarify that the qualifying statement is no longer 
applicable to pork products. To be clear, a qualifying statement will 
still be required on products made from poultry, veal, calf, goat, 
mature sheep, or exotic (non-amenable) species bearing a negative 
hormone claim, such as ``raised without added hormones.''
    Establishments do not need to resubmit their labels for approval to 
remove the qualifying statement from pork product labels. 
Establishments can remove the qualifying statement generically under 9 
CFR 412.1, e.g., at next printing, to be consistent with FSIS's updated 
guideline.
    Comment: Several comments from animal advocacy organizations and an 
environmental advocacy organization urged FSIS to prohibit negative 
hormone claims on products made from species for which Federal law 
prohibits hormone use. They argued that allowing such claims may 
mislead consumers who may be unaware that hormones are not to be used 
even in animals whose products do not bear the claim.
    Response: If the claim is factually accurate and supported by

[[Page 71367]]

documentation, the guideline explains FSIS will approve a negative 
hormone claim on products made from poultry, veal, goats, mature sheep, 
and exotic species (such as buffalo and elk) when accompanied with the 
following qualifying statement on the label: ``Federal regulations do 
not permit the use of hormones in [name the species or kind].'' As 
explained above, this information must be prominently- and 
conspicuously-displayed on the label in accordance with the 
regulations.
    However, FSIS acknowledges consumers who are unaware that hormones 
are prohibited for use in certain livestock and poultry species could 
potentially be misled by a negative hormone claim due to its unique 
nature. To address this concern, FSIS has updated the guideline to 
clarify why the qualifying information is necessary on certain 
products. The guideline was also updated to emphasize that FSIS only 
approves these claims when the necessary qualifying information is 
prominently and clearly displayed on the label, e.g., it appears 
directly adjacent to the claim or is in type at least one-third the 
height.

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 notice is not a ``major rule,'' as defined by 5 U.S.C. 804(2).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to it through the FSIS 
Constituent Update, which is used to provide information regarding FSIS 
policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to our constituents and stakeholders. The 
Constituent Update is available on the FSIS web page. Through the web 
page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination, any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-27845 Filed 12-26-19; 8:45 am]
 BILLING CODE 3410-DM-P