[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2900 Received in Senate (RDS)]

103d CONGRESS
  1st Session
                                H. R. 2900


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               August 6 (legislative day, June 30), 1993

                                Received

_______________________________________________________________________

                                 AN ACT


 
 To clarify and revise the small business exemption from the nutrition 
 labeling requirements of the Federal Food, Drug, and Cosmetic Act 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.

    This Act may be cited as the ``Nutrition Labeling and Education Act 
Amendments of 1993''.

SEC. 2. SMALL BUSINESS EXEMPTION.

    (a) Application of Existing Exemption.--
            (1) Before may 8, 1995.--Before May 8, 1995, the exemption 
        provided by section 403(q)(5)(D) of the Federal Food, Drug, and 
        Cosmetic Act shall be available in accordance with the 
        regulations of the Secretary of Health and Human Services 
        published at 21 C.F.R. 101.9(j)(1)(i)(1993).
            (2) After may 8, 1995.--After May 8, 1995, the exemption 
        provided by section 403(q)(5)(D) of the Federal Food, Drug, and 
        Cosmetic Act shall only be available with respect to food when 
        it is sold to consumers.
    (b) New Exemption.--Section 403(q)(5) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by redesignating 
clauses (E) and (F) as clauses (F) and (G), respectively, and by adding 
after clause (D) the following:
    ``(E)(i) During the 12-month period for which an exemption from 
subparagraphs (1) and (2) is claimed pursuant to this subclause, the 
requirements of such subparagraphs shall not apply to any food product 
if--
            ``(I) the labeling for such product does not provide 
        nutrition information or make a claim subject to paragraph (r),
            ``(II) the person who claims for such product an exemption 
        from such subparagraphs employed fewer than an average of 100 
        full-time equivalent employees,
            ``(III) such person provided the notice described in 
        subclause (iii), and
            ``(IV) in the case of a food product which was sold in the 
        12-month period preceding the period for which an exemption was 
        claimed, fewer than 100,000 units of such product were sold in 
        the United States during such preceding period, or in the case 
        of a food product which was not sold in the 12-month period 
        preceding the period for which such exemption is claimed, fewer 
        than 100,000 units of such product are reasonably anticipated 
        to be sold in the United States during the period for which 
        such exemption is claimed.
    ``(ii) During the 12-month period after the applicable date 
referred to in this sentence, the requirements of subparagraphs (1) and 
(2) shall not apply to any food product which was first introduced into 
interstate commerce before May 8, 1994, if the labeling for such 
product does not provide nutrition information or make a claim subject 
to paragraph (r), if such person provided the notice described in 
subclause (iii), and if--
            ``(I) during the 12-month period preceding May 8, 1994, the 
        person who claims for such product an exemption from such 
        subparagraphs employed fewer than an average of 300 full-time 
        equivalent employees and fewer than 600,000 units of such 
        product were sold in the United States,
            ``(II) during the 12-month period preceding May 8, 1995, 
        the person who claims for such product an exemption from such 
        subparagraphs employed fewer than an average of 300 full-time 
        equivalent employees and fewer than 400,000 units of such 
        product were sold in the United States, or
            ``(III) during the 12-month period preceding May 8, 1996, 
        the person who claims for such product an exemption from such 
        subparagraphs employed fewer than an average of 200 full-time 
        equivalent employees and fewer than 200,000 units of such 
        product were sold in the United States.
    ``(iii) The notice referred to in subclauses (i) and (ii) shall be 
given to the Secretary prior to the beginning of the period during 
which the exemption under subclause (i) or (ii) is to be in effect, 
shall state that the person claiming such exemption for a food product 
has complied with the applicable requirements of subclause (i) or (ii), 
and shall--
            ``(I) state the average number of full-time equivalent 
        employees such person employed during the 12 months preceding 
        the date such person claims such exemption,
            ``(II) state the approximate number of units the person 
        claiming the exemption sold in the United States,
            ``(III) if the exemption is claimed for a food product 
        which was sold in the 12-month period preceding the period for 
        which the exemption was claimed, state the approximate number 
        of units of such product which were sold in the United States 
        during such preceding period, and, if the exemption is claimed 
        for a food product which was not sold in such preceding period, 
        state the number of units of such product which such person 
        reasonably anticipates will be sold in the United States during 
        the period for which the exemption was claimed, and
            ``(IV) contain such information as the Secretary may 
        require to verify the information required by the preceding 
        provisions of this subclause if the Secretary has questioned 
        the validity of such information.
If a person is not an importer, has fewer than 10 full-time equivalent 
employees, and sells fewer than 10,000 units of any food product in any 
year, such person is not required to file a notice for such product 
under this subclause for such year.
    ``(iv) In the case of a person who claimed an exemption under 
subclause (i) or (ii), if, during the period of such exemption, the 
number of full-time equivalent employees of such person exceeds the 
number in such subclause or if the number of food products sold in the 
United States exceeds the number in such subclause, such exemption 
shall extend to the expiration of 18 months after the date the number 
of full-time equivalent employees or food products sold exceeded the 
applicable number.
    ``(v) For any food product first introduced into interstate 
commerce after May 8, 2002, the Secretary may by regulation lower the 
employee or units of food products requirement of subclause (i) if the 
Secretary determines that the cost of compliance with such lower 
requirement will not place an undue burden on persons subject to such 
lower requirement.
    ``(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)--
            ``(I) the term `unit' means the packaging or, if there is 
        no packaging, the form in which a food product is offered for 
        sale to consumers,
            ``(II) the term `food product' means food in any sized 
        package which is manufactured by a single manufacturer or which 
        bears the same brand name, which bears the same statement of 
        identity, and which has similar preparation methods, and
            ``(III) the term `person' in the case of a corporation 
        includes all domestic and foreign affiliates of the 
        corporation.''.

SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Reference.--Whenever in this section 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.
    (b) Section 201.--Paragraphs (w), (x), (y), (z), (aa), (bb), (cc), 
(dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated as 
paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) 
respectively.
    (c) Section 301.--Section 301 (21 U.S.C. 331) is amended--
            (1) in subsection (j), by striking out ``721, or 708'' and 
        inserting in lieu thereof ``708, or 721''; and
            (2) in subsection (s), by striking out ``412(d)'' and 
        inserting in lieu thereof ``412(e)''.
    (d) Section 302.--Section 302 (21 U.S.C. 332) is amended
            (1) in subsection (a), by striking out ``, and subject to'' 
        and all that follows through ``381),'', and
            (2) in subsection (b), by striking out the second sentence.
    (e) Section 303.--Section 303 (21 U.S.C. 333) is amended by 
redesignating the second subsection (e) and subsection (f) as 
subsections (f) and (g), respectively.
    (f) Section 304.--Section 304 (21 U.S.C. 334) is amended--
            (1) in subsection (a)(1), by striking out ``: Provided, 
        however, That no'' and inserting in lieu thereof a period and 
        ``No'', and
            (2) in subsection (d)(1)--
                    (A) by striking out ``: Provided, That after'' and 
                inserting in lieu thereof a period and ``After'',
                    (B) by striking out ``: Provided, however, That 
                the'' and inserting in lieu thereof a period and 
                ``The'',
                    (C) by striking out ``: And provided further, That 
                where'' and inserting in lieu thereof a period and 
                ``Where'', and
                    (D) by striking out ``the foregoing proviso'' and 
                inserting in lieu thereof ``the preceding sentence''
    (g) Section 307.--Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A)) is 
amended by striking out ``Act'' and inserting in lieu thereof 
``section''.
    (h) Section 401.--Section 401 (21 U.S.C. 341) is amended by 
striking out ``and/or reasonable standards of fill of container: 
Provided, That no'' and inserting in lieu thereof ``or reasonable 
standards of fill of container. No''.
    (i) Section 402.--Section 402 (21 U.S.C. 342) is amended--
            (1) by striking out ``; or'' at the end of subparagraphs 
        (1) and (2) of paragraph (a) and inserting in lieu thereof a 
        period and by striking out ``if it'' at the beginning of 
        subparagraph (3) of such paragraph and inserting in lieu 
        thereof ``If it'',
            (2) in paragraph (d)(1), by striking out ``: Provided, That 
        this clause'' and inserting in lieu thereof ``, except that 
        this subparagraph'', and
            (3) in paragraph (d)(3), by striking out ``: Provided, That 
        this clause'' and inserting in lieu thereof ``, except that 
        this subparagraph'' and by striking out ``: And provided 
        further, That the Secretary may, for the purpose of avoiding or 
        resolving uncertainty as to the application of this clause'' 
        and inserting in lieu thereof ``, except that the Secretary 
        may, for the purpose of avoiding or resolving uncertainty as to 
        the application of this subparagraph''.
    (j) Section 403.--Section 403 (21 U.S.C. 343) is amended--
            (1) in paragraph (e), by striking out ``: Provided, That'' 
        and inserting in lieu thereof ``, except that'',
            (2) in paragraph (i), by striking out ``, other than those 
        sold as such'' and inserting in lieu thereof ``unless sold as 
        spices, flavorings, or such colors'' and by striking out ``: 
        Provided, That, to the extent'' and inserting in lieu thereof a 
        period and ``To the extent'',
            (3) in paragraph (k), by striking out ``: Provided, That'' 
        and inserting in lieu thereof ``, except that'',
            (4) in paragraph (l), by striking out ``: Provided, 
        however, That'' and inserting in lieu thereof ``, except 
        that'';
            (5) in paragraph (r)(1)(B), by striking out ``5(D)'' and 
        inserting in lieu thereof ``(5)(D)''; and
            (6) in paragraph (r)(4)(B), by striking out ``subsection'' 
        and inserting in lieu thereof ``paragraph''.
    (k) Section 408.--Section 408 (21 U.S.C. 346a) is amended--
            (1) in subsection (a)(1), by striking out ``Secretary of 
        Health and Human Services'' and inserting in lieu thereof 
        ``Administrator of the Environmental Protection Agency 
        (hereinafter in this section referred to as the 
        `Administrator')'',
            (2) in subsection (d)(5), by striking out ``section 7(c) of 
        the Administrative Procedure Act (5 U.S.C., sec. 1006(c))'' and 
        inserting in lieu thereof ``section 556(c) of title 5, United 
        States Code'',
            (3) in subsection (l), by striking out ``It the event'' and 
        inserting in lieu thereof ``In the event'',
            (4) in subsection (n), by striking out ``of the Federal 
        Food, Drug, and Cosmetic Act'',
            (5) in subsection (o), by striking out ``Secretary of 
        Health and Human Services'' each place it occurs and inserting 
        in lieu thereof ``Administrator'', and
            (6) by striking out ``Secretary'' each place it occurs 
        except when followed by ``of Agriculture'' and inserting in 
        lieu thereof ``Administrator''.
    (l) Section 412.--Section 412(h) (21 U.S.C. 350a(h)) is amended by 
striking out ``(c)(1)(B),'' and inserting in lieu thereof 
``(e)(1)(B)''.
    (m) Section 502.--Section 502 (21 U.S.C. 352) is amended--
            (1) in paragraph (e)(3), by striking out ``: Provided 
        further, That'' and inserting in lieu thereof ``, except 
        that'',
            (2) in paragraph (f), by striking out ``: Provided, That'' 
        and inserting in lieu thereof ``, except that'',
            (3) in paragraph (g), by striking out ``: Provided, That 
        the method'' and inserting in lieu thereof a period and ``The 
        method'' and by striking out ``: Provided further, That,'' and 
        inserting in lieu thereof ``, except that'', and
            (4) in paragraph (n), by striking out ``: Provided, That'' 
        and inserting in lieu thereof ``, except that''.
    (n) Section 505.--Section 505 (21 U.S.C. 355) is amended--
            (1) in subsection (j)(6)(A)--
                    (A) by striking out ``Secretry'' in clause (ii) and 
                inserting in lieu thereof ``Secretary'', and
                    (B) by inserting a comma after ``Secretary'' the 
                first time it appears in clause (iii).
            (2) in subsection (k)(1), by striking out ``: Provided, 
        however, That regulations'' and inserting in lieu thereof a 
        period and ``Regulations''.
    (o) Section 506.--Section 506(a) (21 U.S.C. 356(a)) is amended by 
striking out ``Federal Security Administrator'' and ``Administrator'' 
each place it appears and inserting in lieu thereof ``Secretary''.
    (p) Section 507.--Section 507 (21 U.S.C. 357) is amended--
            (1) in subsection (a), by striking out ``Federal Security 
        Administrator'' and ``Administrator'' each place it appears and 
        inserting in lieu thereof ``Secretary'',
            (2) in subsection (e)--
                    (A) by striking out ``section 507'' each place it 
                occurs and inserting in lieu thereof ``this section'',
                    (B) by striking out ``or 507'' and inserting in 
                lieu thereof ``or this section'', and
                    (C) by striking out ``: Provided, That, for 
                purposes'' and inserting in lieu thereof a period and 
                ``For purposes'',
            (3) in subsection (g)(1), by striking out ``: Provided, 
        however, That regulations'' and inserting in lieu thereof a 
        period and ``Regulations''.
            (4) in subsection (h), by striking out ``507''.
    (q) Section 508.--Subsections (c) and (e) of section 508 (21 U.S.C. 
358) are each amended by striking out ``section 4 of the Administrative 
Procedure Act (5 U.S.C. 1003)'' and inserting in lieu thereof ``section 
553 of title 5, United States Code''.
    (r) Section 512.--Section 512 (21 U.S.C. 360b) is amended--
            (1) in subsection (c)(2)(A)(ii), by inserting ``in'' after 
        ``provided'',
            (2) in subsection (c)(2)(F)(i), by striking out 
        ``(C)(iii)'' and inserting in lieu thereof ``(D)(iii)'',
            (3) in subsection (c)(2)(H), by striking out ``subclause'' 
        the first time it appears and inserting in lieu thereof 
        ``subclauses'',
            (4) in subsection (d)(1), by striking out ``subparagraphs 
        (A) through (G)'' and inserting in lieu thereof ``subparagraphs 
        (A) through (I)'', and
            (5) in subsection (n)(1)--
                    (A) by striking out ``201(w)'' in subparagraphs 
                (B)(ii)(II) and (C)(ii)(I) and inserting in lieu 
                thereof ``201(v)'', and
                    (B) by striking out in the last sentence ``(H)'' 
                and inserting in lieu thereof ``(I)''.
    (s) Section 513.--Section 513(b)(3) (21 U.S.C 360c(b)(3)) is 
amended by striking out ``5703(b)'' and inserting in lieu thereof 
``5703''.
    (t) Section 515.--Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is 
amended by striking out ``refer such application''.
    (u) Section 519.--Section 519(a) (21 U.S.C. 360i(a)) is amended by 
striking out ``paragraph (4)'' and inserting in lieu thereof 
``paragraph (7)''.
    (v) Section 527.--Section 527(b) (21 U.S.C. 360cc(b)) is amended--
            (1) by striking out ``507,,'' and inserting in lieu thereof 
        ``507,'', and
            (2) in paragraph (1), by striking out ``The'' and inserting 
        in lieu thereof ``the''.
    (w) Section 534.--Section 534(f)(2) (21 U.S.C. 360kk) is amended by 
striking out ``this Act'' and inserting in lieu thereof ``the Public 
Health Service Act''.
    (x) Section 601.--Section 601(a) (21 U.S.C. 361) is amended by 
striking out ``: Provided, That this'' and inserting in lieu thereof 
``, except that this''.
    (y) Section 701.--Section 701 (21 U.S.C. 371) is amended--
            (1) in subsection (e)(1), by striking out the period after 
        ``Regulations)'' the second time it occurs, and
            (2) in subsection (f)(4), by striking out ``sections 239 
        and 240 of the Judicial Code, as amended'' and inserting in 
        lieu thereof ``section 1254 of title 28, United States Code''.
    (z) Section 703.--Section 703 (21 U.S.C. 373) is amended--
            (1) by striking out ``: Provided, That'' and inserting in 
        lieu thereof ``, except that'',
            (2) by striking out ``: Provided further, That'' and 
        inserting in lieu thereof ``, and except that''
    (aa) Section 704.--Section 704(a)(1) (21 U.S.C. 374(a)(1) is 
amended--
            (1) by striking out the semicolon after ``materials'' and 
        inserting in lieu thereof a comma, and
            (2) by striking out ``(j)'' the first time it appears and 
        inserting in lieu thereof ``(k)''.
    (bb) Section 721.--Section 721(b)(5)(D) (21 U.S.C. 379e(b)(5)(D)) 
is amended by striking out ``5703(b)'' and inserting in lieu thereof 
``5703''.
    (cc) Section 801.--Section 801(b) (21 U.S.C. 381(b) is amended--
            (1) by striking out ``Administrator'' the first time it 
        occurs and inserting in lieu thereof ``Secretary of Health and 
        Human Services'',
            (2) by striking out ``Administrator'' the second and third 
        time it occurs and inserting in lieu thereof ``Secretary'',
            (3) by striking out ``Administrator's'' and inserting in 
        lieu thereof ``Secretary's'', and
            (4) by striking out ``Federal Security Agency'' and 
        inserting in lieu thereof ``Department of Health and Human 
        Services''.
    (dd) Agriculture.--
            (1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 
        321(c), 321(d), 371(b), and 381(a) are each amended by striking 
        out ``Agriculture'' each place it appears and inserting in lieu 
        thereof ``Health and Human Services''.
            (2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) are 
        each amended by striking out ``of Agriculture'' each place it 
        appears.

SEC. 4. TECHNICAL AMENDMENTS TO AMENDATORY ACTS.

    (a) Safe Medical Devices Act of 1990.--
            (1) Section 18(b) of the Safe Medical Devices Act of 1990 
        (Public Law 101-629) is amended by striking out ``(b)(4)(B)'' 
        and inserting in lieu thereof ``(b)'',
            (2) Section 19(a)(4) of the Safe Medical Devices Act of 
        1990 (Public Law 101-629) is amended--
                    (A) by striking out ``as amended by paragraphs (1) 
                and (2)'' and inserting in lieu thereof ``as amended by 
                paragraphs (1), (2), and (3)'',
                    (B) by striking out ``530'' and inserting in lieu 
                thereof ``531'', and
                    (C) by striking out ``354'' and inserting in lieu 
                thereof ``355''.
    (b) Medical Device Amendments of 1992.--Section 6(a) of the Medical 
Device Amendments of 1992 (Public Law 102-300) is amended by inserting 
``wherever appearing'' after `` `any of its principal' ''.
    (c) Nutrition Labeling and Education Act of 1990.--Section 8 of the 
Nutrition Labeling and Education Act of 1990 is amended by striking the 
period at the end and inserting close quotation marks and a period.

            Passed the House of Representatives August 6, 1993.

            Attest:

                                           DONNALD K. ANDERSON,

                                                                 Clerk.