IIA
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 Representa-
tives 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 ex-
emption from subparagraphs (1) and (2) is claimed pursu-
ant to this subclause, the requirements of such subpara-
graphs shall not apply to any food product if—
‘‘(I) the labeling for such product does not pro-
vide 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 employ-
ees,
‘‘(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 Unit-
ed 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 sub-
paragraphs (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 employ-
ees 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 prod-
uct an exemption from such subparagraphs em-
ployed fewer than an average of 300 full-time equiv-
alent 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 prod-
uct an exemption from such subparagraphs em-
ployed fewer than an average of 200 full-time equiv-
alent 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 pre-
ceding 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 antici-
pates 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 Sec-
retary has questioned the validity of such informa-
tion.
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 exemp-
tion under subclause (i) or (ii), if, during the period of
such exemption, the number of full-time equivalent em-
ployees 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 employ-
ees or food products sold exceeded the applicable number.
‘‘(v) For any food product first introduced into inter-
state 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 cor-
poration 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 amend-
ment to, or repeal of, a section or other provision, the ref-
erence 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 ‘‘: Pro-
vided, however, That no’’ and inserting in lieu there-
of 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 fur-
ther, 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 sen-
tence’’
(g) SECTION 307.—Section 307(b)(3)(A) (21 U.S.C.
337(b)(3)(A)) is amended by striking out ‘‘Act’’ and in-
serting 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 sub-
paragraphs (1) and (2) of paragraph (a) and insert-
ing 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 ‘‘: Pro-
vided, That this clause’’ and inserting in lieu thereof
‘‘, except that this subparagraph’’, and
(3) in paragraph (d)(3), by striking out ‘‘: Pro-
vided, 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 uncer-
tainty as to the application of this clause’’ and in-
serting in lieu thereof ‘‘, except that the Secretary
may, for the purpose of avoiding or resolving uncer-
tainty 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 ‘‘: Pro-
vided, 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 there-
of ‘‘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 ‘‘: Pro-
vided, That’’ and inserting in lieu thereof ‘‘, except
that’’,
(4) in paragraph (l), by striking out ‘‘: Pro-
vided, 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 ‘‘para-
graph’’.
(k) SECTION 408.—Section 408 (21 U.S.C. 346a) is
amended—
(1) in subsection (a)(1), by striking out ‘‘Sec-
retary of Health and Human Services’’ and inserting
in lieu thereof ‘‘Administrator of the Environmental
Protection Agency (hereinafter in this section re-
ferred to as the ‘Administrator’)’’,
(2) in subsection (d)(5), by striking out ‘‘sec-
tion 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 oc-
curs 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 in-
serting 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 ‘‘: Pro-
vided further, That’’ and inserting in lieu thereof ‘‘,
except that’’,
(2) in paragraph (f), by striking out ‘‘: Pro-
vided, That’’ and inserting in lieu thereof ‘‘, except
that’’,
(3) in paragraph (g), by striking out ‘‘: Pro-
vided, That the method’’ and inserting in lieu there-
of 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 ‘‘: Pro-
vided, 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 ‘‘Sec-
retary’’ the first time it appears in clause (iii).
(2) in subsection (k)(1), by striking out ‘‘: Pro-
vided, 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 Ad-
ministrator’’ 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 ‘‘: Pro-
vided, 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 ‘‘sub-
paragraphs (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 subpara-
graphs (B)(ii)(II) and (C)(ii)(I) and inserting
in lieu thereof ‘‘201(v)’’, and