II

106TH CONGRESS

2D SESSION S. 2080

To amend the Federal Food, Drug, and Cosmetic Act to require that food

that contains a genetically engineered material, or that is produced

with a genetically engineered material, be labeled accordingly, and for

other purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 22, 2000

Mrs. BOXER introduced the following bill; which was read twice and referred

to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

require that food that contains a genetically engineered

material, or that is produced with a genetically engineered material, be labeled accordingly, 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 ‘‘Genetically Engineered

5 Food Right-to-Know Act’’.

6 SEC. 2. FINDINGS.

7 Congress finds the following:
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1 (1) In 1999, 98,600,000 acres in the United

2 States were planted with genetically engineered

crops, and more than 1 3 ⁄3 of the soybean crop, and

1 4 ⁄4 of the corn crop, in the United States was geneti5 cally engineered.

6 (2) The process of genetically engineering foods

7 results in the material change of such foods.

8 (3) The health and environmental effects of ge9 netically engineered foods are not yet known.

10 (4) Individuals in the United States have the

11 right to know whether food contains or has been

12 produced with genetically engineered material.

13 (5) Federal law gives individuals in the United

14 States the right to know whether food contains arti15 ficial colors and flavors, chemical preservatives, and

16 artificial sweeteners by requiring the labeling of such

17 food.

18 (6) Requirements that genetically engineered

19 food be labeled as genetically engineered would in20 crease consumer knowledge about, and consumer

21 control over consumption of, genetically engineered

22 food.

23 (7) Genetically engineered material can be de24 tected in food at levels as low as 0.1 percent by rea25 sonably available technology.
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1 SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED

2 MATERIAL; AMENDMENTS TO FEDERAL

3 FOOD, DRUG, AND COSMETIC ACT.

4 (a) IN GENERAL.—Section 403 of the Federal Food,

5 Drug, and Cosmetic Act (21 U.S.C. 343) is amended by

6 adding at the end the following paragraph:

7 ‘‘(t)(1) If it contains a genetically engineered mate8 rial, or was produced with a genetically engineered mate9 rial, unless it bears a label (or labeling, in the case of a

10 raw agricultural commodity) that provides notices in ac11 cordance with each of the following requirements:

12 ‘‘(A) The label or labeling bears the following

13 notice: ‘GENETICALLY ENGINEERED’.

14 ‘‘(B) The label or labeling bears the following

15 notice: ‘THIS PRODUCT CONTAINS A GENETI16 CALLY ENGINEERED MATERIAL, OR WAS

17 PRODUCED WITH A GENETICALLY ENGI18 NEERED MATERIAL’.

19 ‘‘(C) The notice required in clause (A) imme20 diately precedes the notice required in clause (B)

21 and the type for the notice required in clause (A) is

22 not less than twice the size of the type for the notice

23 required in clause (B).

24 ‘‘(D) The notice required in clause (B) is the

25 same size as would be required if the notice provided
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1 nutrition information that is required in paragraph

2 (q)(1).

3 ‘‘(E) The notices required in clauses (A) and

4 (B) are clearly legible and conspicuous.

5 ‘‘(2) This paragraph does not apply to food that—

6 ‘‘(A) is served in restaurants or other similar

7 eating establishments, such as cafeterias and

8 carryouts;

9 ‘‘(B) is a medical food as defined in section

10 5(b) of the Orphan Drug Act; or

11 ‘‘(C) was grown on a tree that was planted be12 fore the date of enactment of the Genetically Engi13 neered Food Right-to-Know Act, in a case in which

14 the producer of the food does not know if the food

15 contains a genetically engineered material, or was

16 produced with a genetically engineered material.

17 ‘‘(3) In this paragraph:

18 ‘‘(A) The term ‘genetically engineered material’

19 means material derived from any part of a geneti20 cally engineered organism, without regard to wheth21 er the altered molecular or cellular characteristics of

22 the organism are detectable in the material.

23 ‘‘(B) The term ‘genetically engineered orga24 nism’ means—
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1 ‘‘(i) an organism that has been altered at

2 the molecular or cellular level by means that are

3 not possible under natural conditions or proc4 esses (including recombinant DNA and RNA

5 techniques, cell fusion, microencapsulation,

6 macroencapsulation, gene deletion and doubling,

7 introduction of a foreign gene, and a process

8 that changes the positions of genes), other than

9 a means consisting exclusively of breeding, con10 jugation, fermentation, hybridization, in vitro

11 fertilization, or tissue culture; and

12 ‘‘(ii) an organism made through sexual or

13 asexual reproduction, or both, involving an or14 ganism described in subclause (i), if possessing

15 any of the altered molecular or cellular charac16 teristics of the organism so described.

17 ‘‘(C) The term ‘produced with a genetically en18 gineered material’, used with respect to a food,

19 means a food if—

20 ‘‘(i) the organism from which the food is

21 derived has been injected or otherwise treated

22 with a genetically engineered material (except

23 that the use of manure as a fertilizer for raw

24 agricultural commodities may not be construed
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1 to be production with a genetically engineered

2 material);

3 ‘‘(ii) the animal from which the food is de4 rived has been fed genetically engineered mate5 rial; or

6 ‘‘(iii) the food contains an ingredient that

7 is a food to which subclause (i) or (ii) applies.’’.

8 (b) GUARANTY.—

9 (1) IN GENERAL.—Section 303(d) of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C.

11 333(d)) is amended—

12 (A) by striking ‘‘(d)’’ and inserting

13 ‘‘(d)(1)’’; and

14 (B) by adding at the end the following

15 paragraph:

16 ‘‘(2)(A) No person shall be subject to the penalties

17 of subsection (a)(1) or (h) for a violation of section 301(a),

18 301(b), or 301(c) involving food that is misbranded within

19 the meaning of section 403(t) if such person (referred to

20 in this paragraph as the ‘recipient’) establishes a guaranty

21 or undertaking that—

22 ‘‘(i) is signed by, and contains the name and

23 address of, a person residing in the United States

24 from whom the recipient received in good faith the
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1 food (including the receipt of seeds to grow raw agri2 cultural commodities); and

3 ‘‘(ii) contains a statement to the effect that the

4 food does not contain a genetically engineered mate5 rial or was not produced with a genetically engi6 neered material.

7 ‘‘(B) In the case of a recipient who, with respect to

8 a food, establishes a guaranty or undertaking in accord9 ance with subparagraph (A), the exclusion under such sub10 paragraph from being subject to penalties applies to the

11 recipient without regard to the manner in which the recipi12 ent uses the food, including whether the recipient is—

13 ‘‘(i) processing the food;

14 ‘‘(ii) using the food as an ingredient in a food

15 product;

16 ‘‘(iii) repacking the food; or

17 ‘‘(iv) growing, raising, or otherwise producing

18 the food.

19 ‘‘(C) No person may avoid responsibility or liability

20 for a violation of section 301(a), 301(b), or 301(c) involv21 ing food that is misbranded within the meaning of section

22 403(t) by entering into a contract or other agreement that

23 specifies that another person shall bear such responsibility

24 or liability, except that a recipient may require a guaranty

25 or undertaking as described in this subsection.
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1 ‘‘(D) In this paragraph, the terms ‘genetically engi2 neered material’ and ‘produced with a genetically engi3 neered material’ have the meanings given the terms in sec4 tion 403(t).’’.

5 (2) FALSE GUARANTY.—Section 301(h) of the

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

7 331(h)) is amended by inserting ‘‘or 303(d)(2)’’ be8 fore ‘‘, which guaranty or undertaking is false’’ the

9 first place it appears.

10 (c) UNINTENDED CONTAMINATION.—Section 303(d)

11 of the Federal Food, Drug, and Cosmetic Act, as amended

12 by subsection (b)(1), is further amended by adding at the

13 end the following paragraph:

14 ‘‘(3)(A) No person shall be subject to the penalties

15 of subsection (a)(1) or (h) for a violation of section 301(a),

16 301(b), or 301(c) involving food that is misbranded within

17 the meaning of section 403(t) if—

18 ‘‘(i) such person is an agricultural producer and

19 the violation occurs because food that is grown,

20 raised, or otherwise produced by such producer,

21 which food does not contain a genetically engineered

22 material and was not produced with a genetically en23 gineered material, is contaminated with a food that

24 contains a genetically engineered material or was
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1 produced with a genetically engineered material (in2 cluding contamination by mingling the 2 foods); and

3 ‘‘(ii) such contamination is not intended by the

4 agricultural producer.

5 ‘‘(B) Subparagraph (A) does not apply to an agricul6 tural producer to the extent that the contamination occurs

7 as a result of the negligence of the producer.’’.

8 (d) CIVIL PENALTIES.—Section 303 of the Federal

9 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend10 ed by adding at the end the following subsection:

11 ‘‘(h)(1) With respect to a violation of section 301(a),

12 301(b), or 301(c) involving food that is misbranded within

13 the meaning of section 403(t), any person engaging in

14 such a violation shall be liable to the United States for

15 a civil penalty in an amount not to exceed $1,000 for each

16 such violation.

17 ‘‘(2) Paragraphs (3) through (5) of subsection (g)

18 apply with respect to a civil penalty assessed under para19 graph (1) to the same extent and in the same manner as

20 such paragraphs (3) through (5) apply with respect to a

21 civil penalty assessed under paragraph (1) or (2) of sub22 section (g).’’.
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1 SEC. 4. GRANTS FOR RESEARCH ON GENETICALLY ENGI2 NEERED FOOD.

3 Chapter IX of the Federal Food, Drug, and Cosmetic

4 Act (21 U.S.C. 391 et seq.) is amended by adding at the

5 end the following:

6 ‘‘SEC. 908. GRANTS FOR RESEARCH ON GENETICALLY ENGI7 NEERED FOOD.

8 ‘‘(a) IN GENERAL.—The Secretary may make grants

9 to appropriate individuals, organizations, and institutions

10 to conduct research into the public health and environ11 mental risks associated with genetically engineered mate12 rials, food that contains a genetically engineered material,

13 and food that is produced with a genetically engineered

14 material, including risks related to—

15 ‘‘(1) increased allergenicity;

16 ‘‘(2) increased toxicity;

17 ‘‘(3) cross-pollination between genetically engi18 neered materials and materials that are not geneti19 cally engineered materials; and

20 ‘‘(4) interference with the soil ecosystem and

21 other impacts on the ecosystem.

22 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—

23 ‘‘(1) IN GENERAL.—There is authorized to be

24 appropriated $5,000,000 for fiscal year 2001 to

25 carry out the objectives of this section.
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1 ‘‘(2) AVAILABILITY.—Any sums appropriated

2 under the authorization contained in this subsection

3 shall remain available, without fiscal year limitation,

4 until expended.

5 ‘‘(c) DEFINITIONS.—The terms ‘genetically engi6 neered material’ and ‘produced with a genetically engi7 neered material’ have the meanings given the terms in sec8 tion 403(t)(3) of the Federal Food, Drug, and Cosmetic

9 Act.’’.

10 SEC. 5. CONFORMING AMENDMENTS.

11 (a) Section 1(n) of Public Law 90–201 is amended—

12 (1) in paragraph (11), by striking ‘‘or’’ at the

13 end;

14 (2) in paragraph (12), by striking the period at

15 the end and inserting ‘‘; or’’; and

16 (3) by adding at the end the following:

17 ‘‘(13) if—

18 ‘‘(A) it contains a genetically engineered

19 material, or was produced with a genetically en20 gineered material; and

21 ‘‘(B)(i) it does not bear a label or labeling,

22 as appropriate, that provides the notices re23 quired under the terms and conditions of sec24 tion 403(t) of the Federal Food, Drug, and

25 Cosmetic Act (21 U.S.C. 343(t)); or
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1 ‘‘(ii) it is the subject of a false guaranty or

2 undertaking,

3 subject to the terms and conditions of section 303(d)

4 of that Act (21 U.S.C. 333(d)) and subject to the

5 penalties described in section 303(h) of that Act (21

6 U.S.C. 333(h)) and remedies available under this

7 Act.’’.

8 (b) Section 4(h) of Public Law 85–172 is amended—

9 (1) in paragraph (11), by striking ‘‘or’’ at the

10 end;

11 (2) in paragraph (12), by striking the period at

12 the end and inserting ‘‘; or’’; and

13 (3) by adding at the end the following:

14 ‘‘(13) if—

15 ‘‘(A) it contains a genetically engineered

16 material, or was produced with a genetically en17 gineered material; and

18 ‘‘(B)(i) it does not bear a label or labeling,

19 as appropriate, that provides the notices re20 quired under the terms and conditions of sec21 tion 403(t) of the Federal Food, Drug, and

22 Cosmetic Act (21 U.S.C. 343(t)); or

23 ‘‘(ii) it is the subject of a false guaranty or

24 undertaking,
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1 subject to the terms and conditions of section 303(d)

2 of that Act (21 U.S.C. 333(d)) and subject to the

3 penalties described in section 303(h) of that Act (21

4 U.S.C. 333(h)) and remedies available under this

5 Act.’’.

6 SEC. 6. EFFECTIVE DATE.

7 This Act and the amendments made by this Act take

8 effect 180 days after the date of enactment of this Act.

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