`[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2900 Enrolled Bill (ENR)]

        H.R.2900
                       One Hundred Third Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
  the fifth day of January, one thousand nine hundred and ninety-three


                                 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'', and
        (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'', and
        (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)'', and
        (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.







                                Speaker of the House of Representatives.







                             Vice President of the United States and    
                                                President of the Senate.`