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103D CONGRESS

1ST SESSION H. R. 2900

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.

IN THE HOUSE OF REPRESENTATIVES

AUGUST 5, 1993

Mr. DINGELL (for himself, Mr. WAXMAN, Mr. MOORHEAD, and Mr. BLILEY)

introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Nutrition Labeling and

5 Education Act Amendments of 1993’’.

6 SEC. 2. SMALL BUSINESS EXEMPTION.

7 (a) APPLICATION OF EXISTING EXEMPTION.—

8 (1) BEFORE MAY 8, 1995.—Before May 8, 1995,

9 the exemption provided by section 403(q)(5)(D) of
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1 the Federal Food, Drug, and Cosmetic Act shall be

2 available in accordance with the regulations of the

3 Secretary of Health and Human Services published

4 at 21 C.F.R. 101.9(j)(1)(i)(1993).

5 (2) AFTER MAY 8, 1995.—After May 8, 1995,

6 the exemption provided by section 403(q)(5)(D) of

7 the Federal Food, Drug, and Cosmetic Act shall

8 only be available with respect to food when it is sold

9 to consumers.

10 (b) NEW EXEMPTION.—Section 403(q)(5) of the

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

12 343(q)(5)) is amended by redesignating clauses (E) and

13 (F) as clauses (F) and (G), respectively, and by adding

14 after clause (D) the following:

15 ‘‘(E)(i) During the 12-month period for which an ex16 emption from subparagraphs (1) and (2) is claimed pursu17 ant to this subclause, the requirements of such subpara18 graphs shall not apply to any food product if—

19 ‘‘(I) the labeling for such product does not pro20 vide nutrition information or make a claim subject

21 to paragraph (r),

22 ‘‘(II) the person who claims for such product an

23 exemption from such subparagraphs employed fewer

24 than an average of 100 full-time equivalent employ25 ees,
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1 ‘‘(III) such person provided the notice described

2 in subclause (iii), and

3 ‘‘(IV) in the case of a food product which was

4 sold in the 12-month period preceding the period for

5 which an exemption was claimed, fewer than

6 100,000 units of such product were sold in the Unit7 ed States during such preceding period, or in the

8 case of a food product which was not sold in the 12-

9 month period preceding the period for which such

10 exemption is claimed, fewer than 100,000 units of

11 such product are reasonably anticipated to be sold in

12 the United States during the period for which such

13 exemption is claimed.

14 ‘‘(ii) During the 12-month period after the applicable

15 date referred to in this sentence, the requirements of sub16 paragraphs (1) and (2) shall not apply to any food product

17 which was first introduced into interstate commerce before

18 May 8, 1994, if the labeling for such product does not

19 provide nutrition information or make a claim subject to

20 paragraph (r), if such person provided the notice described

21 in subclause (iii), and if—

22 ‘‘(I) during the 12-month period preceding May

23 8, 1994, the person who claims for such product an

24 exemption from such subparagraphs employed fewer

25 than an average of 300 full-time equivalent employ-
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1 ees and fewer than 600,000 units of such product

2 were sold in the United States,

3 ‘‘(II) during the 12-month period preceding

4 May 8, 1995, the person who claims for such prod5 uct an exemption from such subparagraphs em6 ployed fewer than an average of 300 full-time equiv7 alent employees and fewer than 400,000 units of

8 such product were sold in the United States, or

9 ‘‘(III) during the 12-month period preceding

10 May 8, 1996, the person who claims for such prod11 uct an exemption from such subparagraphs em12 ployed fewer than an average of 200 full-time equiv13 alent employees and fewer than 200,000 units of

14 such product were sold in the United States.

15 ‘‘(iii) The notice referred to in subclauses (i) and (ii)

16 shall be given to the Secretary prior to the beginning of

17 the period during which the exemption under subclause

18 (i) or (ii) is to be in effect, shall state that the person

19 claiming such exemption for a food product has complied

20 with the applicable requirements of subclause (i) or (ii),

21 and shall—

22 ‘‘(I) state the average number of full-time

23 equivalent employees such person employed during

24 the 12 months preceding the date such person

25 claims such exemption,
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1 ‘‘(II) state the approximate number of units the

2 person claiming the exemption sold in the United

3 States,

4 ‘‘(III) if the exemption is claimed for a food

5 product which was sold in the 12-month period pre6 ceding the period for which the exemption was

7 claimed, state the approximate number of units of

8 such product which were sold in the United States

9 during such preceding period, and, if the exemption

10 is claimed for a food product which was not sold in

11 such preceding period, state the number of units of

12 such product which such person reasonably antici13 pates will be sold in the United States during the

14 period for which the exemption was claimed, and

15 ‘‘(IV) contain such information as the Secretary

16 may require to verify the information required by

17 the preceding provisions of this subclause if the Sec18 retary has questioned the validity of such informa19 tion.

20 If a person is not an importer, has fewer than 10 full21 time equivalent employees, and sells fewer than 10,000

22 units of any food product in any year, such person is not

23 required to file a notice for such product under this

24 subclause for such year.
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1 ‘‘(iv) In the case of a person who claimed an exemp2 tion under subclause (i) or (ii), if, during the period of

3 such exemption, the number of full-time equivalent em4 ployees of such person exceeds the number in such

5 subclause or if the number of food products sold in the

6 United States exceeds the number in such subclause, such

7 exemption shall extend to the expiration of 18 months

8 after the date the number of full-time equivalent employ9 ees or food products sold exceeded the applicable number.

10 ‘‘(v) For any food product first introduced into inter11 state commerce after May 8, 2002, the Secretary may by

12 regulation lower the employee or units of food products

13 requirement of subclause (i) if the Secretary determines

14 that the cost of compliance with such lower requirement

15 will not place an undue burden on persons subject to such

16 lower requirement.

17 ‘‘(vi) For purposes of subclauses (i), (ii), (iii), (iv),

18 and (v)—

19 ‘‘(I) the term ‘unit’ means the packaging or, if

20 there is no packaging, the form in which a food

21 product is offered for sale to consumers,

22 ‘‘(II) the term ‘food product’ means food in any

23 sized package which is manufactured by a single

24 manufacturer or which bears the same brand name,
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1 which bears the same statement of identity, and

2 which has similar preparation methods, and

3 ‘‘(III) the term ‘person’ in the case of a cor4 poration includes all domestic and foreign affiliates

5 of the corporation.’’.

6 SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD,

7 DRUG, AND COSMETIC ACT.

8 (a) REFERENCE.—Whenever in this section an

9 amendment or repeal is expressed in terms of an amend10 ment to, or repeal of, a section or other provision, the ref11 erence shall be considered to be made to a section or other

12 provision of the Federal Food, Drug, and Cosmetic Act.

13 (b) SECTION 201.—Paragraphs (w), (x), (y), (z),

14 (aa), (bb), (cc), (dd), (ee), and (ff) of section 201 (21

15 U.S.C 321) are redesignated as paragraphs (v), (w), (x),

16 (y), (z), (aa), (bb), (cc), (dd), and (ee) respectively.

17 (c) SECTION 301.—Section 301 (21 U.S.C. 331) is

18 amended—

19 (1) in subsection (j), by striking out ‘‘721, or

20 708’’ and inserting in lieu thereof ‘‘708, or 721’’;

21 and

22 (2) in subsection (s), by striking out ‘‘412(d)’’

23 and inserting in lieu thereof ‘‘412(e)’’.

24 (d) SECTION 302.—Section 302 (21 U.S.C. 332) is

25 amended
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1 (1) in subsection (a), by striking out ‘‘, and

2 subject to’’ and all that follows through ‘‘381),’’,

3 and

4 (2) in subsection (b), by striking out the second

5 sentence.

6 (e) SECTION 303.—Section 303 (21 U.S.C. 333) is

7 amended by redesignating the second subsection (e) and

8 subsection (f) as subsections (f) and (g), respectively.

9 (f) SECTION 304.—Section 304 (21 U.S.C. 334) is

10 amended—

11 (1) in subsection (a)(1), by striking out ‘‘: Pro12 vided, however, That no’’ and inserting in lieu there13 of a period and ‘‘No’’, and

14 (2) in subsection (d)(1)—

15 (A) by striking out ‘‘: Provided, That

16 after’’ and inserting in lieu thereof a period and

17 ‘‘After’’,

18 (B) by striking out ‘‘: Provided, however,

19 That the’’ and inserting in lieu thereof a period

20 and ‘‘The’’,

21 (C) by striking out ‘‘: And provided fur22 ther, That where’’ and inserting in lieu thereof

23 a period and ‘‘Where’’, and
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1 (D) by striking out ‘‘the foregoing proviso’’

2 and inserting in lieu thereof ‘‘the preceding sen3 tence’’

4 (g) SECTION 307.—Section 307(b)(3)(A) (21 U.S.C.

5 337(b)(3)(A)) is amended by striking out ‘‘Act’’ and in6 serting in lieu thereof ‘‘section’’.

7 (h) SECTION 401.—Section 401 (21 U.S.C. 341) is

8 amended by striking out ‘‘and/or reasonable standards of

9 fill of container: Provided, That no’’ and inserting in lieu

10 thereof ‘‘or reasonable standards of fill of container. No’’.

11 (i) SECTION 402.—Section 402 (21 U.S.C. 342) is

12 amended—

13 (1) by striking out ‘‘; or’’ at the end of sub14 paragraphs (1) and (2) of paragraph (a) and insert15 ing in lieu thereof a period and by striking out ‘‘if

16 it’’ at the beginning of subparagraph (3) of such

17 paragraph and inserting in lieu thereof ‘‘If it’’,

18 (2) in paragraph (d)(1), by striking out ‘‘: Pro19 vided, That this clause’’ and inserting in lieu thereof

20 ‘‘, except that this subparagraph’’, and

21 (3) in paragraph (d)(3), by striking out ‘‘: Pro22 vided, That this clause’’ and inserting in lieu thereof

23 ‘‘, except that this subparagraph’’ and by striking

24 out ‘‘: And provided further, That the Secretary

25 may, for the purpose of avoiding or resolving uncer-
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1 tainty as to the application of this clause’’ and in2 serting in lieu thereof ‘‘, except that the Secretary

3 may, for the purpose of avoiding or resolving uncer4 tainty as to the application of this subparagraph’’.

5 (j) SECTION 403.—Section 403 (21 U.S.C. 343) is

6 amended—

7 (1) in paragraph (e), by striking out ‘‘: Pro8 vided, That’’ and inserting in lieu thereof ‘‘, except

9 that’’,

10 (2) in paragraph (i), by striking out ‘‘, other

11 than those sold as such’’ and inserting in lieu there12 of ‘‘unless sold as spices, flavorings, or such colors’’

13 and by striking out ‘‘: Provided, That, to the extent’’

14 and inserting in lieu thereof a period and ‘‘To the

15 extent’’,

16 (3) in paragraph (k), by striking out ‘‘: Pro17 vided, That’’ and inserting in lieu thereof ‘‘, except

18 that’’,

19 (4) in paragraph (l), by striking out ‘‘: Pro20 vided, however, That’’ and inserting in lieu thereof ‘‘,

21 except that’’;

22 (5) in paragraph (r)(1)(B), by striking out

23 ‘‘5(D)’’ and inserting in lieu thereof ‘‘(5)(D)’’; and
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1 (6) in paragraph (r)(4)(B), by striking out

2 ‘‘subsection’’ and inserting in lieu thereof ‘‘para3 graph’’.

4 (k) SECTION 408.—Section 408 (21 U.S.C. 346a) is

5 amended—

6 (1) in subsection (a)(1), by striking out ‘‘Sec7 retary of Health and Human Services’’ and inserting

8 in lieu thereof ‘‘Administrator of the Environmental

9 Protection Agency (hereinafter in this section re10 ferred to as the ‘Administrator’)’’,

11 (2) in subsection (d)(5), by striking out ‘‘sec12 tion 7(c) of the Administrative Procedure Act (5

13 U.S.C., sec. 1006(c))’’ and inserting in lieu thereof

14 ‘‘section 556(c) of title 5, United States Code’’,

15 (3) in subsection (l), by striking out ‘‘It the

16 event’’ and inserting in lieu thereof ‘‘In the event’’,

17 (4) in subsection (n), by striking out ‘‘of the

18 Federal Food, Drug, and Cosmetic Act’’,

19 (5) in subsection (o), by striking out ‘‘Secretary

20 of Health and Human Services’’ each place it occurs

21 and inserting in lieu thereof ‘‘Administrator’’, and

22 (6) by striking out ‘‘Secretary’’ each place it oc23 curs except when followed by ‘‘of Agriculture’’ and

24 inserting in lieu thereof ‘‘Administrator’’.
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1 (l) SECTION 412.—Section 412(h) (21 U.S.C.

2 350a(h)) is amended by striking out ‘‘(c)(1)(B),’’ and in3 serting in lieu thereof ‘‘(e)(1)(B)’’.

4 (m) SECTION 502.—Section 502 (21 U.S.C. 352) is

5 amended—

6 (1) in paragraph (e)(3), by striking out ‘‘: Pro7 vided further, That’’ and inserting in lieu thereof ‘‘,

8 except that’’,

9 (2) in paragraph (f), by striking out ‘‘: Pro10 vided, That’’ and inserting in lieu thereof ‘‘, except

11 that’’,

12 (3) in paragraph (g), by striking out ‘‘: Pro13 vided, That the method’’ and inserting in lieu there14 of a period and ‘‘The method’’ and by striking out

15 ‘‘: Provided further, That,’’ and inserting in lieu

16 thereof ‘‘, except that’’, and

17 (4) in paragraph (n), by striking out ‘‘: Pro18 vided, That’’ and inserting in lieu thereof ‘‘, except

19 that’’.

20 (n) SECTION 505.—Section 505 (21 U.S.C. 355) is

21 amended—

22 (1) in subsection (j)(6)(A)—

23 (A) by striking out ‘‘Secretry’’ in clause

24 (ii) and inserting in lieu thereof ‘‘Secretary’’,

25 and
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1 (B) by inserting a comma after ‘‘Sec2 retary’’ the first time it appears in clause (iii).

3 (2) in subsection (k)(1), by striking out ‘‘: Pro4 vided, however, That regulations’’ and inserting in

5 lieu thereof a period and ‘‘Regulations’’.

6 (o) SECTION 506.—Section 506(a) (21 U.S.C.

7 356(a)) is amended by striking out ‘‘Federal Security Ad8 ministrator’’ and ‘‘Administrator’’ each place it appears

9 and inserting in lieu thereof ‘‘Secretary’’.

10 (p) SECTION 507.—Section 507 (21 U.S.C. 357) is

11 amended—

12 (1) in subsection (a), by striking out ‘‘Federal

13 Security Administrator’’ and ‘‘Administrator’’ each

14 place it appears and inserting in lieu thereof ‘‘Sec15 retary’’,

16 (2) in subsection (e)—

17 (A) by striking out ‘‘section 507’’ each

18 place it occurs and inserting in lieu thereof

19 ‘‘this section’’,

20 (B) by striking out ‘‘or 507’’ and inserting

21 in lieu thereof ‘‘or this section’’, and

22 (C) by striking out ‘‘: Provided, That, for

23 purposes’’ and inserting in lieu thereof a period

24 and ‘‘For purposes’’,
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1 (3) in subsection (g)(1), by striking out ‘‘: Pro2 vided, however, That regulations’’ and inserting in

3 lieu thereof a period and ‘‘Regulations’’.

4 (4) in subsection (h), by striking out ‘‘507’’.

5 (q) SECTION 508.—Subsections (c) and (e) of section

6 508 (21 U.S.C. 358) are each amended by striking out

7 ‘‘section 4 of the Administrative Procedure Act (5 U.S.C.

8 1003)’’ and inserting in lieu thereof ‘‘section 553 of title

9 5, United States Code’’.

10 (r) SECTION 512.—Section 512 (21 U.S.C. 360b) is

11 amended—

12 (1) in subsection (c)(2)(A)(ii), by inserting ‘‘in’’

13 after ‘‘provided’’,

14 (2) in subsection (c)(2)(F)(i), by striking out

15 ‘‘(C)(iii)’’ and inserting in lieu thereof ‘‘(D)(iii)’’,

16 (3) in subsection (c)(2)(H), by striking out

17 ‘‘subclause’’ the first time it appears and inserting

18 in lieu thereof ‘‘subclauses’’,

19 (4) in subsection (d)(1), by striking out ‘‘sub20 paragraphs (A) through (G)’’ and inserting in lieu

21 thereof ‘‘subparagraphs (A) through (I)’’, and

22 (5) in subsection (n)(1)—

23 (A) by striking out ‘‘201(w)’’ in subpara24 graphs (B)(ii)(II) and (C)(ii)(I) and inserting

25 in lieu thereof ‘‘201(v)’’, and
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1 (B) by striking out in the last sentence

2 ‘‘(H)’’ and inserting in lieu thereof ‘‘(I)’’.

3 (s) SECTION 513.—Section 513(b)(3) (21 U.S.C

4 360c(b)(3)) is amended by striking out ‘‘5703(b)’’ and in5 serting in lieu thereof ‘‘5703’’.

6 (t) SECTION 515.—Section 515(c)(2)(A) (21 U.S.C.

7 360e(c)(2)(A)) is amended by striking out ‘‘refer such ap8 plication’’.

9 (u) SECTION 519.—Section 519(a) (21 U.S.C.

10 360i(a)) is amended by striking out ‘‘paragraph (4)’’ and

11 inserting in lieu thereof ‘‘paragraph (7)’’.

12 (v) SECTION 527.—Section 527(b) (21 U.S.C.

13 360cc(b)) is amended—

14 (1) by striking out ‘‘507,,’’ and inserting in lieu

15 thereof ‘‘507,’’, and

16 (2) in paragraph (1), by striking out ‘‘The’’ and

17 inserting in lieu thereof ‘‘the’’.

18 (w) SECTION 534.—Section 534(f)(2) (21 U.S.C.

19 360kk) is amended by striking out ‘‘this Act’’ and insert20 ing in lieu thereof ‘‘the Public Health Service Act’’.

21 (x) SECTION 601.—Section 601(a) (21 U.S.C. 361)

22 is amended by striking out ‘‘: Provided, That this’’ and

23 inserting in lieu thereof ‘‘, except that this’’.

24 (y) SECTION 701.—Section 701 (21 U.S.C. 371) is

25 amended—
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1 (1) in subsection (e)(1), by striking out the pe2 riod after ‘‘Regulations)’’ the second time it occurs,

3 and

4 (2) in subsection (f)(4), by striking out ‘‘sec5 tions 239 and 240 of the Judicial Code, as amend6 ed’’ and inserting in lieu thereof ‘‘section 1254 of

7 title 28, United States Code’’.

8 (z) SECTION 703.—Section 703 (21 U.S.C. 373) is

9 amended—

10 (1) by striking out ‘‘: Provided, That’’ and in11 serting in lieu thereof ‘‘, except that’’,

12 (2) by striking out ‘‘: Provided further, That’’

13 and inserting in lieu thereof ‘‘, and except that’’

14 (aa) SECTION 704.—Section 704(a)(1) (21 U.S.C.

15 374(a)(1) is amended—

16 (1) by striking out the semicolon after ‘‘mate17 rials’’ and inserting in lieu thereof a comma, and

18 (2) by striking out ‘‘(j)’’ the first time it ap19 pears and inserting in lieu thereof ‘‘(k)’’.

20 (bb) SECTION 721.—Section 721(b)(5)(D) (21

21 U.S.C. 379e(b)(5)(D)) is amended by striking out

22 ‘‘5703(b)’’ and inserting in lieu thereof ‘‘5703’’.

23 (cc) SECTION 801.—Section 801(b) (21 U.S.C.

24 381(b) is amended—
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1 (1) by striking out ‘‘Administrator’’ the first

2 time it occurs and inserting in lieu thereof ‘‘Sec3 retary of Health and Human Services’’,

4 (2) by striking out ‘‘Administrator’’ the second

5 and third time it occurs and inserting in lieu thereof

6 ‘‘Secretary’’,

7 (3) by striking out ‘‘Administrator’s’’ and in8 serting in lieu thereof ‘‘Secretary’s’’, and

9 (4) by striking out ‘‘Federal Security Agency’’

10 and inserting in lieu thereof ‘‘Department of Health

11 and Human Services’’.

12 (dd) AGRICULTURE.—

13 (1) Sections 201(c), 201(d), 701(b), and 801(a)

14 (21 U.S.C. 321(c), 321(d), 371(b), and 381(a) are

15 each amended by striking out ‘‘Agriculture’’ each

16 place it appears and inserting in lieu thereof

17 ‘‘Health and Human Services’’.

18 (2) Sections 702(c) and 706 (21 U.S.C. 372(c)

19 and 376) are each amended by striking out ‘‘of Agri20 culture’’ each place it appears.

21 SEC. 4. TECHNICAL AMENDMENTS TO AMENDATORY ACTS.

22 (a) SAFE MEDICAL DEVICES ACT OF 1990.—

23 (1) Section 18(b) of the Safe Medical Devices

24 Act of 1990 (Public Law 101–629) is amended by
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1 striking out ‘‘(b)(4)(B)’’ and inserting in lieu thereof

2 ‘‘(b)’’,

3 (2) Section 19(a)(4) of the Safe Medical De4 vices Act of 1990 (Public Law 101–629) is amend5 ed—

6 (A) by striking out ‘‘as amended by para7 graphs (1) and (2)’’ and inserting in lieu there8 of ‘‘as amended by paragraphs (1), (2), and

9 (3)’’,

10 (B) by striking out ‘‘530’’ and inserting in

11 lieu thereof ‘‘531’’, and

12 (C) by striking out ‘‘354’’ and inserting in

13 lieu thereof ‘‘355’’.

14 (b) MEDICAL DEVICE AMENDMENTS OF 1992.—Sec15 tion 6(a) of the Medical Device Amendments of 1992

16 (Public Law 102–300) is amended by inserting ‘‘wherever

17 appearing’’ after ‘‘ ‘any of its principal’ ’’.

18 (c) NUTRITION LABELING AND EDUCATION ACT OF

19 1990.—Section 8 of the Nutrition Labeling and Education

20 Act of 1990 is amended by striking the period at the end

21 and inserting close quotation marks and a period.

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