[House Report 105-306]
[From the U.S. Government Publishing Office]



105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 1st Session                                                    105-306
_______________________________________________________________________


 
           FOOD AND NUTRITION INFORMATION REFORM ACT OF 1997

                                _______
                                

October 6, 1997.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce,  submitted the following

                              R E P O R T

                        [To accompany H.R. 2469]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Commerce, to whom was referred the bill 
(H.R. 2469) 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, having considered the 
same, report favorably thereon with amendments and recommend 
that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     6
Background and Need for Legislation..............................     6
Hearings.........................................................     8
Committee Consideration..........................................     8
Rollcall Votes...................................................     8
Committee Oversight Findings.....................................    10
Committee on Government Reform and Oversight.....................    10
New Budget Authority and Tax Expenditures........................    10
Committee Cost Estimate..........................................    10
Congressional Budget Office Estimate.............................    10
Federal Mandates Statement.......................................    13
Advisory Committee Statement.....................................    13
Constitutional Authority Statement...............................    13
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    14
Changes in Existing Law Made by the Bill, as Reported............    20

                               Amendment

  The amendments are as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

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.

                          Purpose and Summary

    The purpose of H.R. 2469, the Food and Nutrition 
Information Reform Act of 1997, is to enhance consumer 
knowledge of the health benefits of foods and food treatments 
by updating the statute, reducing decision-making times, and 
improving the processes by which information can be 
communicated to consumers that will enable them to adopt more 
healthful diets.

                  Background and Need for Legislation

    H.R. 2469, the Food and Nutrition Information Reform Act of 
1997, is a compilation of common-sense reforms pertaining to 
existing statutory and regulatory requirements on the labeling 
of food products. In order to expand consumer access to 
important dietary information, these reforms focus on a number 
of problems which are summarized below.
    As a result of the procedural requirements of the 
Administrative Procedures Act and the Nutrition Labeling and 
Education Act, it often takes an estimated two years following 
submission of a health or nutrient content claim petition 
before the Food and Drug Administration (FDA) is able to 
approve a claim, thereby delaying the provision of important 
dietary information to consumers. In addition, there currently 
exists no time limit within which the FDA is to take final 
action on petitions for health and nutrient content claims. 
Instead, current law only requires the FDA to deny a claim 
petition or issue a proposed rule authorizing the claim within 
190 days. Earlier this year, the U.S. District Court for the 
Southern District of New York ruled in the case of Nutritional 
Health Alliance v. Shalala, 953 F. Supp. 526 (S.D.N.Y. 1997), 
that this lack of a timeframe for a final rule violates First 
Amendment protections. It also ordered the Secretary of Health 
and Human Services (the Secretary) to establish an appropriate 
deadline for agency action on petitions, which the FDA has 
internally (and flexibly) set as 270 days following the 
proposed rule.
    With regard to health and nutrient content claims, several 
obstacles exist to enhanced consumer education. Under the 
Nutrition Labeling and Education Act of 1990, a health claim 
may be made only in those instances where the Secretary has 
promulgated a regulation permitting such a claim to be made. 
Health claims include statements about such diet/disease 
relationships as calcium and osteoporosis, and folic acid and 
neural tube defects. To date, the FDA has allowed claims for 
only ten different diet/disease relationships. The perception 
of a time-consuming process without predictability of end point 
is widely believed to serve as a disincentive to the proposal 
of new claims.
    Similarly, nutrient content claims may be made only in 
those instances where the Secretary has promulgated a 
regulation setting forth the daily value or nutrient specific 
level upon which a nutrient content claim may be made. Since 
the making of such claims is limited solely to those nutrients 
which the FDA has already authorized, important information 
that can benefit diet-conscious consumers cannot be 
communicated to them. For example, a product cannot advise 
consumers that it is ``high in soluble fiber'' because the FDA 
has not yet promulgated a regulation for that nutrient 
specifying a nutrient level for soluble fiber.
    Additional outdated requirements complicate the provision 
of helpful dietary information to consumers. For example, under 
existing law, nutrient content claims must be accompanied by a 
referral statement (``See back panel for nutrition 
information''). Although this labeling requirement served a 
purpose at one time by alerting consumers about the presence 
and location of nutrient information, such notice is no longer 
needed. Mandatory nutrition information has been present on 
virtually all food labels for several years, and consumers are 
aware of their presence and location. As a result, this type of 
statement is viewed by many as no longer necessary.
    Another such example pertains to irradiation. Currently, 
food products treated with irradiation to remove harmful 
bacteria, parasites, mold and fungus (which, in the U.S., 
include such agricultural products as poultry, spices, and 
certain fruits and vegetables) are required to post a notice to 
consumers, including an irradiation graphic, that is more 
prominent than the product's ingredients listing. There is a 
growing concern among producers, consumer safety experts, and 
academics, however, that this type of disclosure may frighten 
consumers away from products that may benefit from this 
treatment.
    Procedures utilized by the Food and Drug Administration to 
process and review applications for approval of certain types 
of packaging also need updating. At present, petitions for 
marketing approval of substances that come into contact with 
foods (such as plastic wrap) are reviewed by the same 
individuals charged with the responsibility for review of 
direct food additive petitions. As a result, the backlog on 
indirect additive petitions has approached nearly two hundred.
    Finally, current regulations relating to margarine are also 
antiquated and in need of reform. These requirements, which 
originally were promulgated to ensure that colored margarine 
would not be confused with butter, include prohibitions on the 
sale of margarine in packaging larger than one pound, overly 
detailed labeling restrictions, and consumer notice 
specifications for food service establishments where margarine 
is served.

                                Hearings

    The Committee on Commerce has not held hearings on H.R. 
2469. However, in preparation for action on modernization of 
the Food and Drug Administration, the Committee held 17 
hearings on reform of the FDA over the last 30 months.

                        Committee Consideration

    On September 17, 1997, the Subcommittee on Health and 
Environment met in an open markup session and approved H.R. 
2469 for Full Committee consideration, amended, by a voice 
vote. On September 25, 1997, the Full Committee met in an open 
markup session and ordered H.R. 2469, reported to the House, 
amended, by a rollcall vote of 43 yeas to 0 nays.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and amendments thereto. The following are 
the recorded votes on the motion to report H.R. 2469 and on 
amendments offered to the measure, including the names of those 
Members voting for and against.


                 Committee on Commerce--105th Congress

                    Voice Votes--September 25, 1997

    Bill: H.R. 2469, Food and Nutrition Information Reform Act 
of 1997.
    Amendment: Amendment in the Nature of a Substitute by Mr. 
Whitfield.
    Disposition: Agreed To, amended, by a voice vote.
    Amendment: Amendment to the Whitfield Amendment in the 
Nature of a Substitute by Mr. Stupak re: establishment of an 
expedited food contact substance petition review process.
    Disposition: Agreed To, by a voice vote.
    Amendment: Amendment to the Whitfield Amendment in the 
Nature of a Substitute by Mr. Klink re: delay in the 
effectiveness of, and a limitation on, restrictions relating to 
decorative glass and ceramic ware.
    Disposition: Agreed To, by a voice vote.

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee has not held 
oversight or legislative hearings on this legislation.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight with respect to this legislation. However, 
on December 21, 1995, the Committee on Government Reform and 
Oversight submitted a report to the House entitled ``The FDA 
Food Additive Review Process: Backlog and Failure to Observe 
Statutory Deadline'' (H. Rpt. 104-436), which concerned issues 
addressed in H.R. 2469.

               New Budget Authority and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee finds that 
H.R. 2469 would result in no new or increased budget authority 
or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 403 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the Rules of 
the House of Representatives, the following is the cost 
estimate provided by the Congressional Budget Office pursuant 
to section 403 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                   Washington, DC, October 1, 1997.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2469, the Food and 
Nutrition Information Reform Act of 1997.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Cynthia 
Dudzinski.
            Sincerely,
                                 June E. O'Neill, Director.
    Enclosure.

H.R. 2469--Food and Nutrition Information Reform Act of 1997

    Summary: H.R. 2469 would change parts of the process of 
regulating food ingredients and claims related to the 
nutritional content and healthy effects of food, and would 
provide avenues for approval outside of the petition processes 
currently required. In addition, it would expedite the issuance 
of final rules promulgated by the Food and Drug Administration 
(FDA) in response to petitions and require the completion of 
action on a pending claim regarding the radiation of red meat.
    The bill would result in additional costs to the FDA, but 
CBO cannot estimate the amount of such costs, which would be 
subject to appropriation action. Because H.R. 2469 would not 
affect direct spending or receipts, pay-as-you-go procedures 
would not apply. The bill contains no intergovernmental 
mandates, and would improve no costs on state, local, or tribal 
governments. While it would impose a mandate on the private 
sector, the costs of carrying out that mandate would be 
negligible.
    Estimated Cost to the Federal Government: CBO cannot 
estimate the cost of implementing this bill because we do no 
have sufficient information to project the cost of provisions 
regarding food contact substances.
    Basis of Estimate: For the purposes of this estimate, CBO 
assumes that all amounts authorized in H.R. 2469 would be 
appropriated by the start of each fiscal year and that outlays 
would follow the historical spending patterns of the Food and 
Drug Administration. The costs of this legislation fall within 
budget function 550 (Health).
    Flexibility for Regulations Regarding Claims.--Under H.R. 
2469, regulations published by the Secretary regarding claims 
about the level of a nutrient in a food item or about the 
relationship of a nutrient to a health-related condition would 
be effective for a limited time while they were awaiting pubic 
review and final regulation. CBO estimates no cost for these 
provisions because the FDA would not be required to take any 
additional action.
    Petitions for Claims.--Under current law, the Secretary is 
required to act on a petition within a specified amount of 
time. Under the bill, petitions not acted upon within the time 
limits would be denied unless an extension were agreed upon 
between the Secretary and the petitioner. According to the FDA, 
the Secretary is already meeting these deadlines, so there 
would be no additional costs as a result of this provision.
    In addition, in cases where the Secretary issues a proposed 
regulation in response to a petition, the bill would require 
the rulemaking process to be completed within 540 days of the 
date the petition was received by the Secretary. Any regulation 
that exceeded this deadline would be considered final. To date, 
there have been only two regulations that became final rules, 
and both took longer than 540 days to complete the process. 
According to the FDA, one and a half additional full-time 
employees would be necessary to complete the regulations within 
the deadline and to publish as final rules those regulations 
not meeting the 540-day deadline. CBO estimates that the 
additional staff would cost an additional $1 million over the 
1988-2002 period.
    Health Claims for Food Products and Nutrient Content 
Claims.--The bill would permit claims to be made on food labels 
concerning the level of a nutrient or its relationship to a 
health condition without the Secretary's authorization, 
provided the claim met specific conditions. These conditions 
include existence of an authorization statement by the National 
Academy of Sciences or other qualified scientific entity in 
support of the claim, notification of the FDA 150 days before 
the claim is published, and submission of a balanced 
representation of the scientific literature relating to the 
claim. A claim would be valid until a regulation issued by the 
Secretary regarding it became effective or until the Secretary 
or U.S. district court determined that the requirements of this 
provision had not been met. Based on information from the FDA, 
CBO estimates handling the new submission process would cost 
less than $1 million over the 1988-2002 period.
    Irradiation Petition.--Within sixty days of enactment, the 
bill would require FDA to complete all pending petitions 
regarding the radiation of red meat. Otherwise, the Secretary 
must report to the House of Commerce and Senate Labor and Human 
Resources Committees the reason why action on any incomplete 
petition was delayed. According to the FDA, there is only one 
such petition currently pending and the agency has made 
completion of the work on this petition a high priority. Given 
the level of effort already devoted to this project, enactment 
of this provision would not likely subject the agency to 
significant additionalcosts. If the sixty-day deadline were not 
met, however, there would be a small cost associated with the 
additional responsibility of preparing the report.
    Food Contact Substances.--Currently in most cases, any food 
contact substance--a substance intended to contact food but not 
to have any chemical effect on it--may be marketed only after 
the FDA has promulgated a regulation permitting its use in 
response to a petition submitted to the agency. The bill would 
provide for a notification system that is quicker and simpler 
than the petition process and that would apply only to the 
substance that was the specific subject of the notification. 
While the new process would be simpler to administer, it could 
attract additional applications necessitating additional 
resources to be devoted to this approval process. However, CBO 
cannot estimate the magnitude of these costs at this time.
    Pay-as-you-go Considerations: None.
    Estimated Impact on State, Local, and Tribal Governments: 
H.R. 2469 contains no intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act of 1995 and would impose no 
costs on state, local, or tribal governments.
    Estimated Impact on the Private Sector: H.R. 2469 would 
abolish several existing private-sector mandates and impose a 
new mandate on sellers of colored oleomargarine and margarine. 
CBO estimates that the direct costs of the new mandate would 
most likely be less than the costs of the existing private-
sector mandates that would be replaced. In addition, the bill 
would make an existing mandate related to nutrient food claims 
less burdensome.
    Under current law, the sale or offering for sale of colored 
oleomargarine or margarine, or the possession of those products 
in a form ready for serving, is prohibited if the products do 
not meet certain labeling, packaging, weight, and restaurant 
notification requirements. Section 109 of H.R. 2469 would 
abolish these requirements and impose a new labeling 
requirement on sellers of colored oleomargarine or margarine. 
Because current regulations already require extensive labeling 
for these products, CBO estimates that the cost of the new 
labeling requirement would be negligible.
    Section 105 of the bill would amend an existing private-
sector mandate to be less burdensome. Under current law, 
nutrient food claims are subject to a labeling requirement. 
Under the bill, the labeling requirement would apply only if 
the Secretary makes a determination that the food contains a 
nutrient at a level that increases risk of a disease or health-
related condition that is diet-related.
    Estimate Prepared By: Federal Cost: Cynthia Dudzinski. 
Impact on State, Local, and Tribal Governments: Leo Lex. Impact 
on the Private Sector: Anna Cook.
    Estimate Approved By: Robert A. Sunshine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 2(l)(4) of rule XI of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

           sec. 1. short title; reference; table of contents

    The short title for this Act is the ``Food and Nutrition 
Information Act of 1997.'' All references are to sections or 
provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA; 
21 U.S.C. 321 et seq.), unless otherwise specified.

         TITLE I--IMPROVING THE REGULATION AND LABELING OF FOOD

Sec. 101. Flexibility for regulations regarding claims

    This section amends Sec. 403(r)(4) of the FFDCA to allow 
proposed regulations on claims to become effective upon 
publication, at the discretion of the Secretary, pending 
consideration of public comment and publication of a final 
regulation. Such regulations would be considered final agency 
action for purposes of judicial review.
    This provision is intended to enable the Food and Drug 
Administration to permit nutrient content claims and health 
claims to be made as soon as a regulation proposing to 
authorize their use would be published. This would help 
expedite the communication to consumers of information on 
nutritional and health benefits through food labeling. This 
also would enable the FDA to take prompt action as necessary to 
address necessary changes in labeling. It is the Committee's 
intention that the FDA will use this authority primarily for 
the purpose of expediting reviews of petitions for health and 
nutrient content claims based on authoritative statements 
(petitions processed under sections 103 and 104 of this 
legislation).
    The Committee requests the Secretary, in keeping with this 
legislation's focus on improved FDA performance, to consider 
the creation of the position of Chief Operating Office at the 
agency. Such a role could facilitate the administration of the 
agency's operations, with possible responsibilities including 
the establishment of standards of performance, determination of 
performance reviews and employee compensation, and oversight of 
audits of the performance of reviewers at the FDA.

Sec. 102. Petitions for claims

    This section amends Sec. 403(r)(4) of the FFDCA to provide 
that if the Secretary does not act within 100 days after a 
claims petition is received, it would be considered to be 
denied, unless the Secretary and petitioner have reached a 
mutual agreement on an extension. In addition, if the Secretary 
does not propose a regulation authorizing a claim or denying a 
petition within 90 days after deciding to file the petition, it 
is considered to be denied, unless there is a mutually agreed 
upon extension. Further, if the Secretary issues a proposed 
regulation for a petition, the final rules are to be completed 
within 540 days (18 months) of receiving the petition, a period 
of time the Committee believes is the maximum reasonable time 
necessary to complete final rulemaking. If final rulemaking is 
not completed within 540 days, the Secretary is required to 
provide to the House Committee on Commerce and the Senate 
Committee on Labor and Human Resources the reasons the final 
rulemaking was not completed within that time period.
    This provision is intended by the Committee to serve as a 
response to the FDA's failure to review health and nutrient 
content claims within a reasonable period. In addition, the 
Committee notes the ruling of the U.S. District Court for the 
Southern District of New York in Nutritional Health Alliance v. 
Shalala, 953 F. Supp. 526 (S.D.N.Y. 1997), which directed that 
a deadline be established within which the FDA would be 
required to act on health claim petitions. The legislation 
establishes a deadline for both nutrient content and health 
claim petitions requiring the FDA to complete rulemaking within 
540 days of the date the petition is received by the agency.

Sec. 103. Health claims for food products

    This section amends Sec. 403(r)(3) of the FFDCA by adding a 
section that allows a health claim which is not otherwise 
authorized in a regulation by the Secretary to be made under 
the following conditions. First, the claim would be allowed if 
a specified scientific body has published an authoritative 
statement, currently in effect, about the relationship between 
a nutrientand a disease or health-related condition to which 
the claim refers. The provision specifies such governmental bodies as 
the National Institutes of Health and the Centers for Disease Control 
and Prevention, as well as the National Academy of Sciences. The 
Committee intends this process to enable the Secretary to permit claims 
based on such statements in order that consumers will be assisted in 
maintaining healthy dietary practices.
    Second, at least 150 days before a food labeled with the 
new claim is first introduced into interstate commerce, the 
manufacturer making the claim must notify the Secretary. A 
claim that meets the requirements of this provision could be 
made until the Secretary issues a regulation, that has become 
effective, that either prohibits or modifies the claim or finds 
that the requirements for making the claim have not been met, 
or a U.S. district court determines that the requirements for 
making the claim have not been met.
    The claim notification must include the exact wording of 
the claim, a concise description of the basis for determining 
that the claim meets the requirements of an authoritative 
statement, a copy of the specific statement being relied on to 
make the claim, and a balanced representation of the scientific 
literature related to the relationship between the nutrient and 
a disease or health-related condition to which the claim 
refers. The purpose of this requirement is to facilitate the 
Secretary's determination whether the authoritative statement 
upon which the notification is based is supported by scientific 
consensus to the extent the Secretary considers appropriate to 
allow the claim.
    In addition, the claim and the food on which it appears 
must also be in compliance with other applicable rules, and the 
claim must be stated in a manner that is an accurate 
representation of the authoritative statement on which it is 
based and that will enable consumers to comprehend the relative 
significance of the claim in the context of a total daily diet. 
Finally, the statement on which the claim is based would be 
considered to be authoritative only if it is published by the 
scientific body and is not simply a statement of an employee of 
the body made in an individual capacity.
    The Committee views the history of the folic acid and 
neural tube defects health claim as important evidence of the 
need for this provision. In 1992, the Centers for Disease 
Control and Prevention (CDC) issued the following 
recommendation to women of childbearing age, aimed at reducing 
the risk of pregnancies affected by neural tube birth defects: 
``All women of childbearing age in the United States who are 
capable of becoming pregnant should consume 0.4 mg of folic 
acid per day for the purpose of reducing their risk of having a 
pregnancy affected with spina bifida or [other neural tube 
defects].'' [Centers for Disease Control, 41 Morbidity and 
Mortality Weekly Report (September 11, 1992)]. The CDC 
estimated that adherence to this recommendation could reduce 
the number of cases of spina bifida and other neural tube 
defects in the United States by 50 percent.
    Despite this recommendation, foods containing folic acid 
could not include on their labels truthful, nonmisleading 
claims about the folic acid/birth defect connection until the 
FDA approved the claim through an arduous and costly notice and 
comment rulemaking procedure. In January 1993, the FDA 
promulgated a rule prohibiting claims concerning the 
relationship. In the wake of the controversy that met the FDA's 
action, and despite the absence of any change in the scientific 
evidence, the agency reversed course, proposing to authorize 
such claims in October 1993. Final regulations authorizing the 
claim were promulgated in March 1996. The Committee has 
expressed in the past, and remains concerned, that many 
children may have suffered preventable neural tube defects as a 
result of this delay in authorizing health claims based on the 
1992 CDC recommendation.
    The folic acid example is among the earliest illustrations 
of this problem, and the Committee does not view it as being 
the only justification for this legislation. Authoritative 
scientific bodies, as part of their official responsibilities 
for public health protection, regularly undertake deliberative 
reviews of the scientific evidence to evaluate potential diet/
disease relationships, and issue authoritative statements 
concerning such relationships. The Committee intends that this 
provision will establish a presumption of validity with respect 
to claims that are appropriately based on statements by such 
authoritative scientific bodies. As a result, a streamlined 
procedure would be available for the Secretary to permit more 
scientifically sound nutrition information to be provided to 
consumers. This provision would thereby prevent a reoccurrence 
of such problems as the one presented by the folic acid/neural 
tube defect claim.

Sec. 104. Nutrient content claims

    This section makes amendments parallel to those made by 
section 103 with respect to nutrient content claim provisions. 
Currently, claims characterizing the level of a nutrient in 
food (e.g., ``only 5 grams . . .'') may be made only for 
nutrients for which there are established Reference Daily 
Intakes or Daily Reference Values (together referred to as 
``Daily Values''). This provision would amend Sec. 403(r)(2) of 
the FFDCA by adding a provision that allows that a nutrient 
content claim that is not otherwise authorized in a regulation 
by the Secretary to be made under the following conditions. 
First, the claim would be allowed if a specified scientific 
body has published an authoritative statement which provides a 
daily value or nutrient level that is currently in effect and 
serves as a basis for the claim. The provision specifies such 
governmental bodies as the National Institutes of Health and 
the Centers for Disease Control and Prevention, as well as the 
National Academy of Sciences. Second, at least 150 days before 
the food labeled with the new claim is first introduced into 
interstate commerce, the manufacturer making the claim must 
notify the Secretary.
    The claim notification must include the exact wording of 
the claim, a concise description of the basis for determining 
that the claim meets the requirements of an authoritative 
statement, a copy of the specific statement being relied on to 
make the claim, and a balanced representation of the scientific 
literature relating to the nutrient level to which the claim 
refers. In addition, the claim and the food on which it appears 
must also be in compliance with other applicable rules, and the 
claim must be stated in a manner that is an accurate 
representation of the authoritative statement on which it is 
based and that will enable consumers to comprehend the relative 
significance of the claim in the context of a total daily diet. 
Finally, the statement on which the claim is based would be 
considered to be authoritative only if it is published by 
thescientific body and is not simply a statement of an employee of the 
body made in an individual capacity. A claim that meets the 
requirements of this provision could be made until the Secretary issues 
a regulation, that has become effective, that either prohibits or 
modifies the claim or finds that the requirements for making the claim 
have not been met, or a U.S. district court determines that the 
requirements for making the claim have not been met.
    The Committee emphasizes that this provision maintains the 
full range of existing FDA enforcement powers with respect to 
claims made in violation of the statutory requirements. In 
addition, the legislation gives the FDA enhanced rulemaking 
authority, enabling the agency to promptly ban or modify such 
claims by issuing proposed regulations that are effective upon 
the date of publication. It is the Committee's intent that this 
provision will enable consumers to be more promptly and 
effectively informed of beneficial levels of nutrients in foods 
for which Daily Values have not been established. Further, the 
Committee intends that this process will establish a 
presumption of validity with respect to claims that are 
appropriately based on authoritative statements by designated 
scientific bodies, so that consumers will be assisted in 
maintaining healthy dietary practices.
    As noted above, this section requires a petitioner to 
provide the Secretary with a balanced representation of the 
scientific literature relating to the nutrient level to which 
the claim refers. The purpose of this requirement is to 
facilitate the Secretary's determination of whether the 
authoritative statement upon which the petition is based is 
supported by scientific consensus to the extent the Secretary 
considers appropriate to allow the claim. It is also intended 
to ensure that the petition properly references the context 
within which the authoritative statement is made to ensure that 
it is accurately used in the claim.

Sec. 105. Referral statements

    This section amends Sec. 403(r)(2)(B) of the FFDCA to 
require that if a nutrient content claim is made for a food, 
which the Secretary determines contains another nutrient at a 
level that increases the risk to the general public of a diet-
related disease or health-related condition, the label must 
include a statement that is prominent and in immediate 
proximity to such claim, which states: ``See nutrition 
information for ______ content.'' The blank is to identify the 
nutrient associated with the increased disease or health-
related risk. In determining risk associated with a given 
nutrient under this provision, the Secretary is to take into 
account the significance of the food in the total daily diet.

Sec. 106. Disclosure of irradiation

    Section 106 inserts a new Sec. 403(C) into the FFDCA to 
provide that no existing provision of the FFDCA could be 
considered to require a separate radiation disclosure statement 
that is more prominent than the declaration of ingredients on 
the food label. For purposes of this section, the term 
``radiation disclosure statement'' refers to any written 
statement or symbol that discloses that a food or any component 
of it has been intentionally subjected to radiation.
    To ensure the intended effect of this provision during the 
process of implementation, the Committee directs the Secretary 
to promptly publish for public comment proposed amendments to 
current regulations relating to the labeling of foods treated 
with ionizing radiation. The Committee expects final 
regulations to be issued not more than 12 months after the date 
of enactment of this measure. The public comment process should 
be utilized by the Secretary to provide an opportunity to 
comment on whether the regulations should be amended to revise 
the prescribed nomenclature for the labeling of irradiated 
foods and on whether such labeling requirements should expire 
at a specified date in the future. The Committee intends for 
any required disclosure to be of a character such that it would 
not be perceived to be a warning or give rise to inappropriate 
consumer anxiety.

Sec. 107. Irradiation petition

    This section requires that within 60 days of enactment, the 
Secretary make a final determination on any pending food 
additive petition before the FDA that would permit the 
irradiation of red meat. If this regulatory decision is not 
completed in 60 days, the agency is to explain, in writing, to 
the House Committee on Commerce and the Senate Committee on 
Labor and Human Resources the process used in reviewing the 
petition and the reasons that action on the petition has been 
delayed.

Sec. 108. Glass and ceramic ware

    Section 108 delays for one year after publication of 
applicable guidance relating to glass and ceramic ware the 
implementation of any requirements that would ban, as an 
unapproved food additive, either lead- or cadmium-based paints 
in the lip and rim area of glass and ceramic ware. In addition, 
lead- and cadmium-based paints would not be banned as 
unapproved food additives in glass and ceramic ware if they 
cover less than 60 millimeters of decoration below the external 
rims of containers not intended for use by children.

Sec. 109. Food contact substances

    This section adds a new Sec. 409(h)(1) to the FFDCA which 
would establish a notification process for the regulation of 
indirect food additives, known as food contact substances. At 
least 120 days before a food contact substance is introduced 
into interstate commerce, a manufacturer or supplier could 
notify the Secretary of the name, identity, and intended use of 
the substance and the information on which a designated person 
has determined that the intended use of the substance is safe. 
The food contact substance could be introduced into interstate 
commerce 120 days after the date of receipt by the Secretary of 
the notification, unless the Secretary has determined during 
the 120-day period that the substance has not been shown to be 
safe or that a standard petition is needed. Such a 
determination of the Secretary would be based on the data and 
information provided in the notification and would constitute 
final agency action. Notification under this provision would be 
effective only with respect to the person identified in the 
notification.
    The notification process under this provision would be used 
for authorizing the marketing of a food contact substance 
except where the Secretary determines that submission and 
review of a food additive petition is necessary to provide 
adequate determination of safety. A petition may also be 
necessary when the Secretary and the person planning to use the 
substance agree that it should be submitted. The Secretary 
could promulgate regulations to identify the circumstances 
under which a petition is to be filed and could consider such 
criteria as the probable consumption and potential toxicity of 
the substance in determining the circumstances in which a 
petition is necessary. The Secretary is required to maintain 
confidentiality of any information provided in a notification 
for 120 days after its receipt. Following that 120-day period, 
the information may be made available to any interested party, 
except for any trade secret or confidential commercial 
information. For purposes of 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 its use is not 
intended to have any technical effect in the food. The 
Secretary is to prescribe, in regulation, the procedure by 
which a determination will be made that notification is no 
longer in effect. Notifications under this provision may be 
submitted to the Secretary beginning 18 months after the date 
of enactment.

Sec. 110. Margarine

    This section amends Sec. 301 of the FFDCA by striking Sec. 
407(b) and (c) that concern the current labeling, packaging, 
and restaurant use of margarine. In addition, Section 110 
amends Sec. 407 to eliminate all current requirements related 
to margarine except that oleomargarine or colored margarine may 
not be sold unless the package's principal display panel bears 
as a principal feature the word ``oleomargarine'' or 
``margarine'' in bold type that is in a size reasonably related 
to the most prominent printed matter and in lines generally 
parallel to the base on which the package rests as it is 
displayed. Under this provision, existing Sections 3(a) and 6 
of the Act of March 16, 1950 would be repealed.
    This provision codifies for margarine the ``statement of 
identity'' regulations that are in place for most food 
products. Specifically, the provision uses language specifying 
that the size of the words ``margarine'' and ``oleomargarine'' 
appear in a size reasonably related to the most prominent 
printed matter on the margarine package label. With respect to 
margarine, the Committee expects the reasonably related size to 
be at least half the size of the largest printed matter on a 
product's label. The Committee notes that this standard for 
reasonably related type size should not be rigidly applied, or 
considered a precedent, with respect to foods other than 
margarine.

                        TITLE II--EFFECTIVE DATE

Sec. 201. Effective date

    Section 201 states that the provisions of this Act would 
become effective on the date of enactment.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3 of rule XIII of the Rules of the 
House of Representatives, changes in existing law made by the 
bill, as reported, are shown as follows (existing law proposed 
to be omitted is enclosed in black brackets, new matter is 
printed in italic, existing law in which no change is proposed 
is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT

          * * * * * * *

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *
          * * * * * * *
  (m) The sale or offering for sale of colored oleomargarine or 
colored margarine, or the possession or serving of colored 
oleomargarine or colored margarine in violation of section 
[407(b) or 407(c)] section 407.
          * * * * * * *

                            CHAPTER IV--FOOD

          * * * * * * *

                            misbranded food

  Sec. 403. A food shall be deemed to be misbranded--
  (a) * * *
          * * * * * * *
  (r)(1) * * *
  (2)(A) * * *
  [(B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food, the label or labeling of such 
food shall contain, prominently and in immediate proximity to 
such claim, the following statement: ``See ____________ for 
nutrition information.'' In the statement--
          [(i) the blank shall identify the panel on which the 
        information described in the statement may be found, 
        and
          [(ii) if the Secretary determines that the food 
        contains a nutrient at a level which increases to 
        persons in the general population the risk of a disease 
        or health-related condition which is diet related, 
        taking into account the significance of the food in the 
        total daily diet, the statement shall also identify 
        such nutrient.]
  (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.
          * * * * * * *
  (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.
  (3)(A) * * *
          * * * * * * *
  (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.
  (4)(A)(i) Any person may petition the Secretary to issue a 
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a 
claim described in subparagraph (1)(A) or (1)(B). Not later 
than 100 days after the petition is received by the Secretary, 
the Secretary shall issue a final decision denying the petition 
or file the petition for further action by the Secretary. 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. If the 
Secretary denies the petition or the petition is deemed to be 
denied, the petition shall not be made available to the public. 
If the Secretary files the petition, the Secretary shall deny 
the petition or issue a proposed regulation to take the action 
requested in the petition not later than 90 days after the date 
of such decision. 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.
          * * * * * * *
  (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.
          * * * * * * *


                               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.
          * * * * * * *

                      [oleomargarine or margarine

  [Sec. 407. (a) Colored oleomargarine or colored margarine 
which is sold in the same State or Territory in which it is 
produced shall be subject in the same manner and to the same 
extent to the provisions of this Act as if it had been 
introduced in interstate commerce.
  [(b) No person shall sell, or offer for sale, colored 
oleomargarine or colored margarine unless--
          [(1) such oleomargarine or margarine is packaged,
          [(2) the net weight of the contents of any package 
        sold in a retail establishment is one pound or less,
          [(3) there appears on the label of the package (A) 
        the word ``oleomargarine'' or ``margarine'' in type or 
        lettering at least as large as any other type or 
        lettering on such label, and (B) a full and accurate 
        statement of all the ingredients contained in such 
        oleomargarine, or margarine, and
          [(4) each part of the contents of the package is 
        contained in a wrapper which bears the word 
        ``oleomargarine'' or ``margarine'' in type or lettering 
        not smaller than 20-point type.
The requirements of this subsection shall be in addition to and 
not in lieu of any of the other requirements of this Act.
  [(c) No person shall possess in a form ready for serving 
colored oleomargarine or colored margarine at a public eating 
place unless a notice that oleomargarine or margarine is served 
is displayed prominently and conspicuously in such place and in 
such manner as to render it likely to be read and understood by 
the ordinary individual being served in such eating place or is 
printed or is otherwise set forth on the menu in type or 
lettering not smaller than that normally used to designate the 
serving of other food items. No person shall serve colored 
oleomargarine or colored margarine at a public eating place, 
whether or not any charge is made therefor, unless (1) each 
separate serving bears or is accompanied by labeling 
identifying it as oleomargarine or margarine, or (2) each 
separate serving thereof is triangular in shape.
  [(d) Colored oleomargarine or colored margarine when served 
with meals at a public eating place shall at the time of such 
service be exempt from the labeling requirements of section 403 
(except (a) and 403 (f)) if it complies with the requirements 
of subsection (b) of this section.
  [(e) For the purpose of this section colored oleomargarine or 
colored margarine is oleomargarine or margarine having a tint 
or shade containing more than one and six-tenths degrees of 
yellow, or of yellow and red collectively, but with an excess 
of yellow over red, measured in terms of Lovibond tintometer 
scale or its equivalent.]


                      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.
          * * * * * * *

                             food additives

                         Unsafe Food Additives

  Sec. 409. (a) A food additive shall, with respect to any 
particular use or intended use of such additives, be deemed to 
be unsafe for the purposes of the application of clause (2)(C) 
of section 402(a), unless--
          (1) it and its use or intended use conform to the 
        terms of an exemption which is in effect pursuant to 
        subsection [(i)] (j) of this section; [or]
          (2) there is in effect, and it and its use or 
        intended use are in conformity with, a regulation 
        issued under this section prescribing the conditions 
        under which such additive may be safely used[.]; or
          (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.
While such a regulation or notification relating to a food 
additive is in effect, a food shall not, by reason of bearing 
or containing such an additive in accordance with the 
regulation or notification, be considered adulterated within 
the meaning of clause (1) of section 402(a).
          * * * * * * *

           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.

                   Amendment or Repeal of Regulations

  [(h)] (i) The Secretary shall by regulation prescribe the 
procedure by which regulations under the foregoing provisions 
of this section may be amended or repealed, and such procedure 
shall conform to the procedure provided in this section for the 
promulgation of such regulations. 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.

                   Exemptions for Investigational Use

  [(i)] (j) Without regard to subsections (b) to [(h)] (i), 
inclusive, of this section, the Secretary shall by regulation 
provide for exempting from the requirements of this section any 
food additive, and any food bearing or containing such 
additive, intended solely for investigational use by qualified 
experts when in his opinion such exemption is consistent with 
the public health.
          * * * * * * *
                              ----------                              


                         ACT OF MARCH 16, 1950

 AN ACT To regulate oleomargarine, to repeal certain taxes relating to 
                 oleomargarine, and for other purposes.

          * * * * * * *
  Sec. 3. [(a) The Congress hereby finds and declares that the 
sale, or the serving in public eating places, of colored 
oleomargarine or colored margarine without clear identification 
as such or which is otherwise adulterated or misbranded within 
the meaning of the Federal Food, Drug, and Cosmetic Act 
depresses the market in interstate commerce for butter and for 
oleomargarine or margarine clearly identified and neither 
adulterated nor misbranded, and constitutes a burden on 
interstate commerce in such articles. Such burden exists, 
irrespective of whether such oleomargarine or margarine 
originates from an interstate source or from the State in which 
it is sold.]
          * * * * * * *
  [Sec. 6. Nothing in this Act shall be construed as 
authorizing the possession, sale, or serving of colored 
oleomargarine or colored margarine in any State or Territory in 
contravention of the laws of such State or Territory.]
          * * * * * * *

                                
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