[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2469 Reported in House (RH)]





                                                 Union Calendar No. 177

105th CONGRESS

  1st Session

                               H. R. 2469

                          [Report No. 105-306]

_______________________________________________________________________

                                 A BILL

To amend the Federal Food, Drug, and Cosmetic Act and other statutes to 
    provide for improvements in the regulation of food ingredients, 
  nutrient content claims, and health claims, and for other purposes.

_______________________________________________________________________

                            October 6, 1997

Reported with amendments, committed to the Committee of the Whole House 
          on the State of the Union, and ordered to be printed





                                                 Union Calendar No. 177
105th CONGRESS
  1st Session
                                H. R. 2469

                          [Report No. 105-306]

To amend the Federal Food, Drug, and Cosmetic Act and other statutes to 
    provide for improvements in the regulation of food ingredients, 
  nutrient content claims, and health claims, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 11, 1997

Mr. Whitfield (for himself, Mr. Towns, Mr. Klug, Mr. Hall of Texas, Mr. 
  Greenwood, Mr. Manton, Mr. Burr of North Carolina, Ms. McCarthy of 
   Missouri, Mr. Barton of Texas, Mr. Coburn, Mr. Upton, Mr. Deal of 
  Georgia, Mr. Bilirakis, Mr. Engel, and Mr. Dingell) introduced the 
    following bill; which was referred to the Committee on Commerce

                            October 6, 1997

   Additional sponsors: Mr. Green, Mr. Strickland, Mr. Hastert, Mr. 
             Sawyer, Mr. Cannon, Mr. Bliley, and Mr. McHale

                            October 6, 1997

Reported with amendments, committed to the Committee of the Whole House 
          on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
    [For text of introduced bill, see copy of bill as introduced on 
                          September 11, 1997]

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and other statutes to 
    provide for improvements in the regulation of food ingredients, 
  nutrient content claims, and health claims, 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; REFERENCE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food and Nutrition 
Information Reform Act of 1997''.
    (b) Reference.--Unless otherwise stated, whenever in this Act an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.).
    (c) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title; reference; table of contents.

         TITLE I--IMPROVING THE REGULATION AND LABELING OF FOOD

Sec. 101. Flexibility for regulations regarding claims.
Sec. 102. Petitions for claims.
Sec. 103. Health claims for food products.
Sec. 104. Nutrient content claims.
Sec. 105. Referral statements.
Sec. 106. Disclosure of irradiation.
Sec. 107. Irradiation petition.
Sec. 108. Glass and ceramic ware.
Sec. 109. Food contact substances.
Sec. 110. Margarine.

                        TITLE II--EFFECTIVE DATE

Sec. 201. Effective date.

         TITLE I--IMPROVING THE REGULATION AND LABELING OF FOOD

SEC. 101. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.

    Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended by adding at the 
end the following:
    ``(D) Subject to the time period in the last sentence of clause 
(A)(i), proposed regulations under this paragraph may be made effective 
upon publication at the discretion of the Secretary, notwithstanding 
the provisions of section 553 of title 5, United States Code, pending 
consideration of public comment and publication of a final regulation. 
Such regulations shall be deemed final agency action for purposes of 
judicial review.''.

SEC. 102. PETITIONS FOR CLAIMS.

    Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended--
            (1) by adding after the second sentence the following: ``If 
        the Secretary does not act within such 100 days, the petition 
        shall be deemed to be denied unless an extension is mutually 
        agreed upon by the Secretary and the petitioner.'';
            (2) in the fourth sentence (as amended by paragraph (1)) by 
        inserting immediately before the comma the following: ``or the 
        petition is deemed to be denied''; and
            (3) by adding at the end the following: ``If the Secretary 
        does not act within such 90 days, the petition shall be deemed 
        to be denied unless an extension is mutually agreed upon by the 
        Secretary and the petitioner. If the Secretary issues a 
        proposed regulation, the rulemaking shall be completed within 
        540 days of the date the petition is received by the Secretary. 
        If the Secretary does not issue such a proposed regulation 
        within such 540 days, the Secretary shall provide the Committee 
        on Commerce of the House of Representatives and the Committee 
        on Labor and Human Resources of the Senate the reasons action 
        on the proposed regulation did not occur within such 540 
        days.''.

SEC. 103. HEALTH CLAIMS FOR FOOD PRODUCTS.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the 
end thereof the following:
    ``(C) Notwithstanding the provisions of clauses (A)(i) and (B), a 
claim of the type described in subparagraph (1)(B) which is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause (B) shall be authorized and may be made with respect to a 
food if--
            ``(i) a scientific body of the United States Government 
        with official responsibility for public health protection or 
        research directly relating to human nutrition (such as the 
        National Institutes of Health or the Centers for Disease 
        Control and Prevention) or the National Academy of Sciences or 
        any of its subdivisions has published an authoritative 
        statement, which is currently in effect, about the relationship 
        between a nutrient and a disease or health-related condition to 
        which the claim refers;
            ``(ii) a person has submitted to the Secretary, at least 
        150 days (during which the Secretary may issue a regulation 
        described in subparagraph (4)(D) and may notify any person who 
        is making a claim as authorized by clause (C) that such person 
        has not submitted all the information required by such clause) 
        before the first introduction into interstate commerce of the 
        food with a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the claim 
        and shall include a concise description of the basis upon which 
        such person relied for determining that the requirements of 
        subclause (i) have been satisfied, (II) a copy of the statement 
        referred to in subclause (i) upon which such person relied in 
        making the claim, and (III) a balanced representation of the 
        scientific literature, including a bibliography of such 
        literature, relating to the relationship between a nutrient and 
        a disease or health-related condition to which the claim 
        refers;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clause (A)(ii) and are otherwise in 
        compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an 
authoritative statement of a scientific body described in subclause (i) 
only if the statement is published by the scientific body and shall not 
include a statement of an employee of the scientific body made in the 
individual capacity of the employee.
    ``(D) A claim submitted under the requirements of clause (C) may be 
made until--
            ``(i) such time as the Secretary issues a regulation 
        (including a regulation described in subparagraph (4)(D)) under 
        the standard in clause (B)(i)--
                    ``(I) prohibiting or modifying the claim and the 
                regulation has become effective, or
                    ``(II) finding that the requirements of clause (C) 
                have not been met, including finding that the 
                petitioner has not submitted all the information 
                required by such clause; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (C) have not been met.''.

SEC. 104. NUTRIENT CONTENT CLAIMS.

    Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the 
end the following:
    ``(G) A claim of the type described in subparagraph (1)(A) for a 
nutrient, for which the Secretary has not promulgated a regulation 
under clause (A)(i), shall be authorized and may be made with respect 
to a food if--
            ``(i) a scientific body of the United States Government 
        with official responsibility for public health protection or 
        research directly relating to human nutrition (such as the 
        National Institutes of Health or the Centers for Disease 
        Control and Prevention) or the National Academy of Sciences or 
        any of its subdivisions has published an authoritative 
        statement, which is currently in effect, which identifies the 
        nutrient level to which the claim refers;
            ``(ii) a person has submitted to the Secretary, at least 
        150 days (during which the Secretary may issue a regulation 
        described in subparagraph (4)(D) and may notify any person who 
        is making a claim as authorized by clause (C) that such person 
        has not submitted all the information required by such clause) 
        before the first introduction into interstate commerce of the 
        food with a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the claim 
        and shall include a concise description of the basis upon which 
        such person relied for determining that the requirements of 
        subclause (i) have been satisfied, (II) a copy of the statement 
        referred to in subclause (i) upon which such person relied in 
        making the claim, and (III) a balanced representation of the 
        scientific literature, including a bibliography of such 
        literature, relating to the nutrient level to which the claim 
        refers;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clauses (A) and (B), and are otherwise 
        in compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an 
authoritative statement of a scientific body described in subclause (i) 
only if the statement is published by the scientific body and shall not 
include a statement of an employee of the scientific body made in the 
individual capacity of the employee.
    ``(H) A claim submitted under the requirements of clause (G) may be 
made until--
            ``(i) such time as the Secretary issues a regulation 
        (including a regulation described in subparagraph (4)(D))--
                    ``(I) prohibiting or modifying the claim and the 
                regulation has become effective, or
                    ``(II) finding that the requirements of clause (G) 
                have not been met, including finding that the 
                petitioner had not submitted all the information 
                required by such clause; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (G) have not been met.''.

SEC. 105. REFERRAL STATEMENTS.

    Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as 
follows:
    ``(B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food, and the Secretary makes a 
determination that the food contains a nutrient at a level that 
increases to persons in the general population the risk of a disease or 
health-related condition that is diet related, then the label or 
labeling of such food shall contain, prominently and in immediate 
proximity to such claim, the following statement: `See nutrition 
information for ____ content.' The blank shall identify the nutrient 
associated with the increased disease or health-related condition risk. 
In making the determination described in this clause, the Secretary 
shall take into account the significance of the food in the total daily 
diet.''.

SEC. 106. DISCLOSURE OF IRRADIATION.

    Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after 
section 403B the following:

                              ``disclosure

    ``Sec. 403C. (a) No provision of section 201(n), 403(a), or 409 
shall be construed to require on the label or labeling of a food a 
separate radiation disclosure statement that is more prominent than the 
declaration of ingredients required by section 403(i)(2).
    ``(b) In this section, the term `radiation disclosure statement' 
means a written statement or symbol that discloses that a food or a 
component of the food has been intentionally subject to radiation.''.

SEC. 107. IRRADIATION PETITION.

    Not later than 60 days following the date of the enactment of this 
Act, the Secretary of Health and Human Services shall--
            (1) make a final determination on any petition pending with 
        the Food and Drug Administration that would permit the 
        irradiation of red meat under section 409(b)(1) of the Federal 
        Food, Drug, and Cosmetic Act; or
            (2) provide the Committee on Commerce of the House of 
        Representatives and the Committee on Labor and Human Resources 
        of the Senate an explanation of the process followed by the 
        Food and Drug Administration in reviewing the petition referred 
        to in paragraph (1) and the reasons action on the petition was 
        delayed.

SEC. 108. GLASS AND CERAMIC WARE.

    (a) In General.--The Secretary may not implement any requirement 
which would ban, as an unapproved food additive, lead and cadmium based 
paints in the lip and rim area of glass and ceramic ware before the 
expiration of one year after the date such requirement is published.
    (b) Lead and Cadmium Based Paint.--Lead and cadmium based paint may 
not be banned as an unapproved food additive if it is on glass and 
ceramic ware--
            (1) which has less than 60 millimeters of decorating area 
        below the external rim; and
            (2) which is not, by design, representation, or custom of 
        usage intended for use by children.

SEC. 109. FOOD CONTACT SUBSTANCES.

    (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 348(a)) is 
amended--
            (1) in paragraph (1)--
                    (A) by striking ``subsection (i)'' and inserting 
                ``subsection (j)''; and
                    (B) by striking at the end ``or'';
            (2) by striking the period at the end of paragraph (2) and 
        inserting ``; or'';
            (3) by inserting after paragraph (2) the following:
            ``(3) in the case of a food additive that is a food contact 
        substance, there is--
                    ``(A) in effect for such substance a regulation 
                issued under this section prescribing the conditions 
                under which such substance may be safely used and such 
                substance and the use of such substance are in 
                conformity with such regulation; or
                    ``(B) a notification submitted under subsection (h) 
                that is in effect.''; and
            (4) in the flush matter following paragraph (3) (as added 
        by paragraph (3)), by inserting ``or notification'' after 
        ``regulation'' each place it appears.
    (b) Notification for Food Contact Substances.--Section 409 (21 
U.S.C. 348), as amended by subsection (a), is further amended--
            (1) by redesignating subsections (h) and (i), as 
        subsections (i) and (j), respectively;
            (2) by inserting after subsection (g) the following:

          ``Notification Relating to a Food Contact Substance

    ``(h)(1) Subject to such regulations as may be promulgated under 
paragraph (3), a person manufacturing or supplying a food contact 
substance may, at least 120 days prior to the introduction or delivery 
for introduction into interstate commerce of the food contact 
substance, notify the Secretary of the--
            ``(A) name of the person;
            ``(B) identity and intended use of the food contact 
        substance; and
            ``(C) determination of the person that the intended use of 
        such food contact substance is safe under the standard 
        described in subsection (c)(3)(A).
The notification shall contain the information that forms the basis of 
the determination and all information required to be submitted by 
regulations promulgated by the Secretary.
    ``(2)(A) A notification submitted under paragraph (1) shall become 
effective 120 days after the date of receipt by the Secretary and the 
food contact substance may be introduced or delivered for introduction 
into interstate commerce, unless, within the 120-day period, the 
Secretary--
            ``(i) makes a determination that, based on the data and 
        information before the Secretary, such use of the food contact 
        substance has not been shown to be safe under the standard 
        described in subsection (c)(3)(A), or
            ``(ii) makes a determination under paragraph (3) with 
        respect to the need for a petition under subsection (b) for 
        such food contact substance,
and informs the person of such determination.
    ``(B) A determination by the Secretary under subparagraph (A)(i) 
shall constitute final agency action subject to judicial review.
    ``(C) A notification under this subsection shall be effective only 
with respect to the person identified in the notification.
    ``(3)(A) The notification process in this subsection shall be 
utilized for authorizing the marketing of a food contact substance 
except where the Secretary determines that submission and review of a 
petition under subsection (b) is necessary to provide adequate 
assurance of safety, or where the Secretary and the person 
manufacturing or supplying the food contact substance agree that such 
person should submit a petition under subsection (b).
    ``(B) The Secretary may promulgate regulations to identify the 
circumstances in which a petition shall be filed under subsection (b) 
and shall consider criteria such as the probable consumption of a food 
contact substance and potential toxicity of the food contact substance 
in determining the circumstances in which a petition shall be filed 
under subsection (b) with respect to the food contact substance.
    ``(4) The Secretary shall keep confidential any information 
provided in a notification under paragraph (1) for 120 days after 
receipt by the Secretary of the notification. After the expiration of 
such 120 days, the information shall be available to any interested 
party except for any matter in the notification that is a trade secret 
or confidential commercial information.
    ``(5) In this section, the term `food contact substance' means any 
substance intended for use as a component of materials used in 
manufacturing, packing, packaging, transporting, or holding food if 
such use is not intended to have any technical effect in such food.'';
            (3) in subsection (i), as so redesignated by paragraph (1), 
        by adding at the end the following: ``The Secretary shall by 
        regulation prescribe the procedure by which the Secretary may 
        deem a notification under subsection (h) to be no longer in 
        effect.''; and
            (4) in subsection (j), as so redesignated by paragraph (1), 
        by striking ``subsections (b) to (h)'' and inserting 
        ``subsections (b) to (i)''.
    (c) Effective Date.--Notifications under section 409(h) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (b), may 
be submitted beginning 18 months after the date of enactment of this 
Act.

SEC. 110. MARGARINE.

    (a) Section 301(m).--Paragraph (m) of section 301 (21 U.S.C. 331) 
is amended by striking ``section 407(b) or 407(c)'' and inserting 
``section 407''.
    (b) Section 407.--Section 407 (21 U.S.C. 347) is amended to read as 
follows:

                     ``oleomargarine and margarine

    ``Sec. 407. No person shall sell, or offer for sale, oleomargarine 
or colored margarine unless the principal display panel of such 
oleomargarine or margarine bears as one of its principal features the 
word `oleomargarine' or `margarine' which is in--
            ``(1) bold type on such panel;
            ``(2) a size reasonably related to the most prominent 
        printed matter; and
            ``(3) lines generally parallel to the base on which the 
        package rests as it is designed to be displayed.''.
    (c) Act of March 16, 1950.--Sections 3(a) and 6 of the Act of March 
16, 1950 (21 U.S.C. 347a, 347b) are repealed.

                        TITLE II--EFFECTIVE DATE

SEC. 201. EFFECTIVE DATE.

    The amendments made by this Act shall take effect on the date of 
the enactment of this Act.
            Amend the title so as to read: ``A bill to amend the 
        Federal Food, Drug, and Cosmetic Act and other statutes to 
        provide for improvements in the regulation of food, nutrient 
        content claims, and health claims, and for other purposes.''.