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

 
CONTENT
Federal Register, Volume 84 Issue 248 (Friday, December 27, 2019)
[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.
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    \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.
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    \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.
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    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