Food Safety and Inspection Service Labeling Guideline on Documentation Needed To Substantiate Animal Raising Claims for Label Submission, 71359-71367 [2019-27845]
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Federal Register / Vol. 84, No. 248 / Friday, December 27, 2019 / Notices
which the Administrator bases the
reason to believe ASF exists in a region.
Section 94.8(b) prohibits the
importation of pork and pork products
from regions listed in accordance with
§ 94.8 except if processed and treated in
accordance with the provisions
specified in that section or consigned to
an APHIS-approved establishment for
further processing. Section 96.2 restricts
the importation of swine casings that
originated in or were processed in a
region where ASF exists, as listed under
§ 94.8(a).
On August 13, 2019, the veterinary
authorities of Serbia reported to the OIE
the occurrence of ASF in that country.
Therefore, in response to this outbreak,
on August 14, 2019, APHIS added
Serbia to the list of regions where ASF
exists or is reasonably believed to exist.
This notice serves as an official record
and public notification of that action.
As a result, pork and pork products
from Serbia, including casings, are
subject to APHIS import restrictions
designed to mitigate the risk of ASF
introduction into the United States.
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this action as not a major
rule, as defined by 5 U.S.C. 804(2).
Authority: 7 U.S.C. 1633, 7701–7772,
7781–7786, and 8301–8317; 21 U.S.C. 136
and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80,
and 371.4.
Done in Washington, DC, this 20th day of
December 2019.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2019–27908 Filed 12–26–19; 8:45 am]
BILLING CODE 3410–34–P
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
Food Safety and Inspection
Service, USDA.
ACTION: Notice of availability and
response to comments.
AGENCY:
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
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SUMMARY:
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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 https://
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 https://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 https://
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:
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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
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 animalraising 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,’’ ‘‘Grassfed,’’ 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: https://
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
1 FSIS has similar authority over egg products
under the Egg Products Inspection Act, 21 U.S.C.
1036(b).
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binding from a regulatory perspective.
FSIS will update this document, as
necessary.
Summarized List of Major Changes to
the Guideline
• Product Labeling: Use of AnimalRaising Claims on the Labels of Meat or
Poultry Products
Æ 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.
Æ 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:
Æ 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:
Æ Added information about carrying
these claims forward to other products.
• Living- or Raising-Condition
Claims:
Æ Reorganized section for clarity
regarding labeling terminology and
recommended documentation for
approval.
Æ 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.
Æ 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:
Æ 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.
Æ 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.
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• Raised Without Hormones (No
Hormones Administered or No Steroids
Administered):
Æ 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.
Æ 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:
Æ Added information about
documentation needed to support labels
bearing animal raising claims that have
been ‘‘Verified’’ or ‘‘Certified’’ by third
party organizations.
Æ 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, agriculturespecific 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
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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.
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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 animalraising 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 conspicuouslydisplayed 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
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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 animalraising 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
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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 thirdparty certifying organizations.
Establishments can choose to use thirdparty 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
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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.
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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
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accordance with the Agricultural
Marketing Service’s (AMS) National
Organic Program (NOP) regulations in 7
CFR 205, as verified by a NOPaccredited 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
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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 animalraising 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 animalraising 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.
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
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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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 thirdparty certifying organization’s animalraising 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 animalraising practices used to define a
particular animal claim meets their
expectations for the claim.
Comment: Comments from animal
welfare advocacy organizations and
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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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
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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
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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.
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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
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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 foragebased 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% grassfed’’ 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
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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,’’
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‘‘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.
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.
4 The petition is available at https://
www.fsis.usda.gov/wps/wcm/connect/368eba0b4195-4641-91d7-7f772ead9a3e/16-01-AWI-Petition012016.pdf?MOD=AJPERES.
5 The petition is available at https://
www.fsis.usda.gov/wps/wcm/connect/12aeca934d3e-4ac7-b624-d5fc0b0dbae0/Petition_Animal_
Legal_Defense_Fund_060313.pdf?MOD=AJPERES.
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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
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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.
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
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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.
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 Subtherapeutic 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
6 See FSIS’s final response to petition #12–02
submitted by SOIA available at: https://
www.fsis.usda.gov/wps/wcm/connect/dcda4cb42612-4283-a9a7-0f97d976e022/12-02-FSIS-FinalResponse-090916.pdf?MOD=AJPERES.
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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 subtherapeutic 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 ‘‘subtherapeutic’’ 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
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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
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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.
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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: https://
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:
https://www.fsis.usda.gov/subscribe.
Options range from recalls to export
information, regulations, directives, and
VerDate Sep<11>2014
18:44 Dec 26, 2019
Jkt 250001
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: https://
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: program.intake@usda.gov.
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
DEPARTMENT OF COMMERCE
International Trade Administration
[A–583–814]
Certain Circular Welded Non-Alloy
Steel Pipe From Taiwan: Preliminary
Determination of No Shipments; 2017–
2018
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: The Department of Commerce
(Commerce) preliminarily determines
that there were no shipments of subject
merchandise during the period of
review (POR) November 1, 2017 through
October 31, 2018. We invite interested
AGENCY:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
71367
parties to comment on these preliminary
results.
DATES: Applicable December 27, 2019.
FOR FURTHER INFORMATION CONTACT:
Chelsey Simonovich, AD/CVD
Operations, Office VI, Enforcement and
Compliance, International Trade
Administration, U.S. Department of
Commerce, 1401 Constitution Avenue
NW, Washington, DC 20230; telephone:
(202) 482–1979.
SUPPLEMENTARY INFORMATION:
Background
On November 1, 2018, Commerce
published in the Federal Register a
notice of opportunity to request an
administrative review of the order on
certain circular welded non-alloy steel
pipe (circular welded pipe) from
Taiwan for the POR.1 On November 30,
2018, Commerce received a request for
administrative review covering imports
of circular welded pipe from Taiwan,
which was filed in proper form by
Independence Tube Corporation and
Southland Tube (collectively, the
petitioners).2 Commerce published the
notice of initiation of this administrative
review on February 6, 2019, covering
the two companies for which we
received a request for review.3
On December 26, 2018, Commerce
received a notification of no shipments
from Founder Land.4 On March 4, 2019,
Commerce received notifications of no
shipments from Shin Yang Steel Co.,
Ltd. (Shin Yang), Tension Steel
Enterprise Co., Ltd. (Tension Steel),
Yieh Hsing Enterprise Co., Ltd. (Yieh
Hsing), and Yieh Phui Enterprise Co.,
Ltd. (Yieh Phui).5 On August 5, 2019,
Commerce made inquiries to U.S.
Customs and Border Protection (CBP)
informing CBP that Commerce’s records
indicated no shipments from Founder
1 See Antidumping or Countervailing Duty Order,
Finding, or Suspended Investigation; Opportunity
To Request Administrative Review, 83 FR 54912
(November 1, 2018).
2 See Petitioners’ Letter, ‘‘Certain Circular Welded
Non-Alloy Steel Pipe from Taiwan: Request for
Administrative Review,’’ dated November 30, 2018.
3 See Initiation of Antidumping and
Countervailing Duty Administrative Reviews, 84 FR
2160 (February 6, 2019).
4 See Founder Land’s Letter, ‘‘Certain Circular
Welded Non-Alloy Steel Pipe from Taiwan: Request
for Administrative Review,’’ dated December 26,
2018.
5 See Shin Yang’s Letter, ‘‘Certain Circular
Welded Non-Alloy Steel Pipe from Taiwan; No
Shipment Certification,’’ dated March 4, 2019;
Tension Steel’s Letter, ‘‘Certain Circular Welded
Non-Alloy Steel Pipe from Taiwan; No Shipment
Certification,’’ dated March 4, 2019; Yieh Hsing’s
Letter, ‘‘Certain Circular Welded Non-Alloy Steel
Pipe from Taiwan; No Shipment Certification,’’
dated March 4, 2019; and Yieh Phui’s Letter,
‘‘Certain Circular Welded Non-Alloy Steel Pipe
from Taiwan; No Shipment Certification,’’ dated
March 4, 2019.
E:\FR\FM\27DEN1.SGM
27DEN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
https://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 https://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\
---------------------------------------------------------------------------
\1\ FSIS has similar authority over egg products under the Egg
Products Inspection Act, 21 U.S.C. 1036(b).
---------------------------------------------------------------------------
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: https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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:
https://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: https://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: https://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