[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7380 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 7380
To amend the Federal Food, Drug, and Cosmetic Act to clarify and update
the authority of the Food and Drug Administration to ensure national
uniformity in the regulation of the marketing and labeling of companion
animal pet food, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 15, 2024
Mr. LaTurner (for himself, Mr. Cuellar, Mr. Womack, Ms. Davids of
Kansas, and Mr. Harder of California) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to clarify and update
the authority of the Food and Drug Administration to ensure national
uniformity in the regulation of the marketing and labeling of companion
animal pet food, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pet Food Uniform
Regulatory Reform Act of 2024'' or the ``PURR Act of 2024''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Pet food regulation.
Sec. 4. Responsibilities.
Sec. 5. Regulations.
SEC. 2. FINDINGS.
Congress finds the following:
(1) The pet food industry is a growing sector in the United
States. Pet food exports have increased by double digits over
the last few years.
(2) United States pet food manufacturers contribute to the
national economy by buying nearly $7,000,000,000 worth of
agricultural products from farmers, ranchers, and farm-product
processors every year.
(3) Pet ownership has consistently grown in the United
States, resulting in an increase in pet food sales and an
accompanying increase in the interest by pet owners in how
their companion animals' food is regulated and produced.
(4) Historically, pet food and livestock feed have been
regulated under the same framework. However, as pet owners'
relationships with their pets have changed, so too has their
understanding of pets' nutritional needs and preferences. Pet
food is specifically formulated to ensure complete nutrition
for the long and healthy lives of companion animals. Owning a
companion animal provides profound mental, social, and physical
health benefits for pet owners such as reduced blood pressure
and stress levels, and research indicates that companion
animals can play a role in managing depression. Before the
enactment of this Act, the regulatory framework that was
originally created for livestock feed no longer met the needs
of pets or their owners.
(5) Before the enactment of this Act, the regulatory
framework governing pet food manufacture and sale, from
ingredient approvals to labeling requirements, was multifaceted
and wildly inconsistent. Regulatory regimes varied by State,
were developed in part by a combination of nongovernmental
entities and State government agencies, and were overseen by
the Food and Drug Administration's Center for Veterinary
Medicine.
(6) Creating a more streamlined Federal regulatory process
for new pet food ingredients allows for expedited advances for
nutrition, greater innovation, and more functionality in a more
predictable regulatory environment.
(7) Replacing the patchwork of regulation of pet food with
a uniform Federal regulatory framework improves marketplace
certainty, allows for more consistent and predictable
ingredient review and market introductions, and enhances
companion animal nutrition.
(8) The nationwide availability of nutritious, safe, and
affordable pet food is substantially improved through a unified
comprehensive Federal system of oversight of the manufacture
and sale of pet food.
(9) The manufacture of pet food and its marketing and sale
is undertaken throughout the United States and its territories
and is interstate commerce.
SEC. 3. PET FOOD REGULATION.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended by adding at the end the following:
``SEC. 425. PET FOOD.
``(a) Definitions.--In this section:
``(1) The term `companion animal' means a domesticated
canine or feline.
``(2) The terms `generally recognized as safe' and `GRAS'
mean generally recognized as safe under section 201(s).
``(3) The term `pet food' means any food manufactured and
distributed for consumption by companion animals, including
treats, nutritional supplements, and pet food ingredients.
``(4) The term `pet food ingredient' means an ingredient
intended for use in pet food.
``(5) The term `pet food ingredient submission' means a
submission to the Food and Drug Administration for a pet food
ingredient that is a petition under section 409 for any food
additive, a petition under section 721 for a color additive, or
a GRAS ingredient notification under subpart E of part 570 of
subchapter E of chapter I of title 21, Code of Federal
Regulations (or successor regulations).
``(b) Preemption.--No State or a political subdivision of a State
may directly or indirectly establish, maintain, implement, or enforce
any authority or requirement relating to the marketing or labeling of
pet food.
``(c) GRAS Ingredients.--
``(1) Ingredients deemed gras.--Ingredients that are
intended for use in pet food, and are not specifically
authorized for such use by the Food and Drug Administration as
a food additive, a color additive, or otherwise as of the date
of enactment of the PURR Act of 2024, are deemed to be GRAS
if--
``(A) such ingredients are identified as acceptable
for use in pet food in chapter 6 of the 2024 edition of
the `AAFCO Official Publication' (or any subsequent
amendments thereto or editions thereof); and
``(B) there is no finding by the Food and Drug
Administration that such ingredients are not GRAS.
``(2) Voluntary notification.--A pet food manufacturer is
not required to notify the Food and Drug Administration of GRAS
ingredients used in pet food, but may voluntarily notify the
Food and Drug Administration of such GRAS ingredients that have
not previously been recognized by the Food and Drug
Administration as GRAS for use in pet food.
``(d) Timely Review.--Not later than 90 days after receipt of a pet
food ingredient submission, the Secretary shall review such submission
and issue an action letter that--
``(1) approves such submission or, in the case of a GRAS
ingredient notification, does not object to use; or
``(2) sets forth--
``(A) the specific deficiencies in such submission;
and
``(B) where appropriate, the actions necessary--
``(i) for such submission to be approved;
or
``(ii) in the case of a GRAS ingredient
notification, to resolve any concerns of the
Secretary.
``(e) Ingredients Sometimes Present.--
``(1) In general.--Pet food shall not be treated as
misbranded by reason of stating in the pet food ingredient list
on the product label that an ingredient of a type described in
paragraph (2) is sometimes, but not always, present in the pet
food.
``(2) Types of ingredients.--Paragraph (1) applies with
respect to the following types of ingredients:
``(A) Fat or oil ingredients.
``(B) Flavor ingredients.
``(C) Grain ingredients (including grain protein
ingredients).
``(3) Language to be used.--For an ingredient in pet food
to be labeled as sometimes present for purposes of paragraph
(1), such ingredient shall be identified by--
``(A) words such as `or', `and/or', or `contains
one or more of the following:'; or
``(B) other words indicating that the ingredient
may not be present.
``(f) Order of Ingredient Listing.--
``(1) In general.--Pet food shall be treated as misbranded
unless the ingredients required to be declared on the labeling
of a pet food are listed by common or usual name in descending
order of predominance by weight.
``(2) Exception.--If an ingredient in pet food is present
in amounts of 2 percent or less by weight, then instead of
identifying the ingredient in the order required by paragraph
(1), the ingredient may be placed at the end of the pet food
ingredient list following an appropriate quantifying statement,
such as `Contains __ percent or less of ______' or `Less than
__ percent of ______', with the blank percentage filled in with
a threshold level of 2 percent, or, if desired, 1.5 percent,
1.0 percent, or 0.5 percent, as applicable.
``(g) Permissible Marketing Claims.--Pet food shall not be treated
as misbranded by reason of the following claims in labeling and
promotional materials for pet food, without premarket approval of such
claims by the Food and Drug Administration, if truthful, nonmisleading,
and adequately substantiated:
``(1) Claims regarding hairball control.
``(2) Claims regarding tartar control, plaque removal, and
bad breath odor.
``(3) Claims regarding the ability of pet food to support
general urinary tract health.
``(4) `Human grade' claims for finished pet food (not for
individual ingredients) if made under the following
circumstances:
``(A) Every ingredient in the pet food and the
finished product is--
``(i) stored, handled, processed, and
transported in accordance with--
``(I) section 117 of title 21, Code
of Federal Regulations (or successor
regulations); and
``(II) the laws applicable to food
for human consumption, including such
laws relating to ingredients, process,
or facility type; and
``(ii) manufactured in accordance with
section 507 of title 21, Code of Federal
Regulations (or successor regulations).
``(B) Each facility that manufactures the finished
pet food or an ingredient in the finished pet food is
registered pursuant to section 415 as a human food
facility.
``(C) The `human grade' claims clearly indicate
that the food is pet food, such as by stating `dog
food' or `cat treats'.
``(5) `Natural' claims if made under the following
circumstances.
``(A) Subject to subparagraph (C), the term
`natural' refers to a food or ingredient derived solely
from plant, animal, or mined sources--
``(i) in its unprocessed state; or
``(ii) having been subject to physical
processing, heat processing, rendering,
purification, extraction, hydrolysis,
enzymolysis, or fermentation, but not having
been produced by or subject to a chemically
synthetic process and not containing any
additives or processing aids that are
chemically synthetic except in amounts as might
occur unavoidably in good manufacturing
practices.
``(B) The term `natural' is only used to reference
the product as a whole when all of the ingredients and
components of ingredients meet the description in
subparagraph (A).
``(C) If the food or ingredient contains chemically
synthesized vitamins, minerals, or other trace
nutrients used as ingredients in pet food, a
disclaimer--
``(i) identifies these ingredients;
``(ii) is juxtaposed with the term
`natural'; and
``(iii) appears with the largest or most
prominent use of the term `natural' on each
panel of the label on which the term appears,
in the same style and color print and at least
one-half the size of the term natural.
``(D) A disclaimer under subparagraph (C) is not
required when the term `natural' is used in reference
to one ingredient and is not referring to the whole
product.
``(h) Guidance on Certain Topics.--
``(1) In general.--The Secretary shall issue guidance with
respect to pet food addressing each of the following topics:
``(A) Methods for substantiating nutritional
adequacy of pet foods.
``(B) Pet food metabolizable energy protocols.
``(C) Affidavits for pet food testing protocol
completion.
``(D) Data to support a calorie content claim.
``(E) Analytical variations (Avs).
``(F) Recommendations for use of menadione sodium
bisulfite complex (MSBC) in animal feed.
``(2) Initial guidance.--
``(A) Timing.--Not later than 18 months after the
date of enactment of the PURR Act of 2024, the
Secretary shall issue initial guidance under this
subsection.
``(B) Basis.--The initial guidance under
subparagraph (A) shall be based on the guidance
contained in the 2024 edition of the `AAFCO Official
Publication'.''.
SEC. 4. RESPONSIBILITIES.
Title X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391
et seq.) is amended by adding at the end the following:
``SEC. 1015. RESPONSIBILITIES FOR PET FOOD REGULATION.
``(a) Delegation of Responsibility.--The Secretary shall delegate
to the Director of the Center for Veterinary Medicine responsibility
for carrying out section 425 and, as appropriate, other
responsibilities and authorities of the Food and Drug Administration
with respect to pet food.
``(b) Duties.--The responsibilities of the Director of the Center
for Veterinary Medicine shall include--
``(1) conducting and coordinating science-based reviews of
pet food ingredient submissions;
``(2) submitting an annual report to the Congress on
performance metrics, including performance on--
``(A) the review of submissions and issuance of
action letters under section 425(d);
``(B) the issuance of initial guidance under
section 425(h) and any subsequent revisions to such
guidance; and
``(C) the proposal and finalization of initial
regulations under section 5 of the PURR Act of 2024 and
any subsequent revisions to such regulations;
``(3) educating pet owners, veterinarians, and the
companion animal industry about pet food;
``(4) communicating and educating consumers on the safety
of pet food; and
``(5) carrying out research to support and improve policies
and regulatory decisions regarding pet food.
``(c) Definitions.--In this section, the terms `companion animal',
`pet food', and `pet food ingredient submission' have the meanings
given to those terms in section 425.''.
SEC. 5. REGULATIONS.
(a) In General.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall--
(1) not later than one year after the date of enactment of
this Act, issue proposed regulations to implement the
amendments made by this Act; and
(2) not later than two years after the date of enactment of
this Act, finalize such regulations.
(b) Contents.--The initial regulations promulgated to implement the
amendments made by this Act shall include PF 1 through PF 12 of the
``Model Regulations for Pet Food and Specialty Pet Food Under the Model
Bill'' in chapter 4 of the 2024 edition of the ``AAFCO Official
Publication''.
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