[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7380 Introduced in House (IH)]

<DOC>






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''.
                                 <all>