"Genetically Engineered Food Right to Know Act" H.R. 3377

Reps. Kucinich (D-Ohio), Metcalf (R-Washington) & 17 other Members of Congress Announce Bipartisan Pro-Consumer Measure

10nov99

[ Summary of HR 3377 | Text of HR 377 ]

Washington, DC--Representatives Dennis J. Kucinich (D-Ohio) and Jack Metcalf (R-Washington) and a bipartisan coalition of 17 other Members of Congress will introduce today the Genetically Engineered Food Right to Know Act, legislation which requires the labeling of packaged food products that have been genetically engineered, altered or otherwise modified. The legislation has been endorsed by several food safety, consumer, farmer, and environmental organizations.

Rep. Kucinich and 18 other members of Congress advocate the labeling of genetically engineered food to give consumers additional health- and safety-related information. Several food safety and environmental concerns have been raised in regards to genetically engineered foods, so until proven completely safe, consumer choice should be possible.

"No one is suggesting that genetically engineered food has proven to be dangerous or deadly," said Kucinich. "But today’s limited scientific knowledge warrants allowing consumers to make a better, more informed choice. If we are what we eat, then consumers must know what they are eating."

Summary

Purpose of the Legislation

Genetically engineered material has become a major component of many foods in the diets of consumers in the United States, but consumers are largely unaware of which foods contain or are produced with genetically engineered material. Consumers wish to know if the food they purchase and consume contains any genetically engineered material because of concerns over health and safety risks, environmental protection, and religiously and ethically based dietary restrictions. Minimal long-term research is available today, thus using caution while tinkering with our food supply is appropriate. This bill protects the consumers’ right to know by requiring producers and manufacturers to label all foods that contain or are produced with genetically engineered material.

Scope

All foods that contain genetically engineered material or are produced with genetically engineered material must be labeled. Genetically engineered material is material derived from a genetically modified organism. For example, foods containing genetically modified soy and genetically modified corn would have to be labeled as containing genetically engineered material. Foods that contain milk from a cow injected with genetically engineered hormones would have to be labeled as produced with genetically engineered material. However, plant varieties developed through traditional processes such as crossbreeding are not considered genetically engineered. The labeling requirements apply if reasonably available technology can detect the presence of altered molecular or cellular characteristics in the food or if the original organism contained altered molecular or cellular characteristics.

Label for Genetically Engineered Foods

Foods that contain genetically engineered material or are produced with genetically engineered material must bear this label:

GENETICALLY ENGINEERED

followed by this subtext:

UNITED STATES GOVERNMENT NOTICE: THIS PRODUCT CONTAINS GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A GENETICALLY ENGINEERED MATERIAL.

Verification System: A Two-Track Approach

At each stage of food production--from seed company to farmer to manufacturers to retailers--this bill requires the food entity to ensure the identity of its genetic origins. Foods that contain genetically engineered material must be labeled as such at each stage of food production. Furthermore, food entities with food that does not contain genetically engineered material will issue a guaranty stating the non-genetically engineered nature of the food. If a food entity holds a valid guaranty, they will not be subject to civil or criminal penalties under this bill if they fail to label a food later found to contain genetically engineered material. Farmers, manufacturers and retailers can avoid testing because they can rely on the labeling and guarantees. Thus, this bill establishes an efficient and highly effective two-track system to ensure that farmers, manufacturers, and retailers label all foods that contain or are produced with genetically engineered material. A guaranty defense already exists in U.S. food law with respect to adulterated and misbranded food for dealers who receive an item and transfer the identical item to another person.

Drugs will not have to be labeled under the bill’s provisions. Restaurants, bakeries, and other establishments that prepare food for immediate consumption will not have to label under the provisions of the bill.

Contamination of Non-Genetically Engineered Crops

Farmers who plant non-genetically engineered seeds will not be subject to criminal or civil penalties under this bill if surrounding crops grown from genetically engineered seeds contaminate their crops.

Voluntary Labeling

Although this bill imposes mandatory labeling requirements, producers and manufacturers may voluntarily label foods that do not contain or are not produced with genetically engineered material. However, because few manufacturers have voluntarily labeled their food product to date, mandatory labels are necessary to ensure the consumer’s right to know. Under this bill, manufacturers who choose to voluntarily label their foods would be able to rely on the two-track verification system to establish that their food is not genetically engineered.

For more information on the Genetically Engineered Food Right to Know Act, please contact the office of Representative Dennis Kucinich at   (202) 225-5871.

November 16, 1999

(Original Signature of Member)  .....................................................................

106TH CONGRESS

1ST SESSION

H. R. 

IN THE HOUSE OF REPRESENTATIVES

Mr. KUCINICH (for himself [see attached list of cosponsors]) introduced

the following bill; which was referred to the Committee on

A BILL

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

Federal Meat Inspection Act, and the Poultry Products

Inspection Act to require that food that contains a genetically

engineered material, or that is produced with

a genetically engineered material, be labeled accordingly.

Be it enacted by the Senate and House of Representa- 1

tives of the United States of America in Congress assembled, 2

2

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 1

(a) SHORT TITLE.—This Act may be cited as the 2

‘‘Genetically Engineered Food Right to Know Act’’. 3

(b) TABLE OF CONTENTS.—The table of contents of 4

this Act is as follows: 5

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. Labeling regarding genetically engineered material; amendments to Fed-eral

Food, Drug, and Cosmetic Act.

Sec. 4. Labeling regarding genetically engineered material; amendments to Fed-eral

Meat Inspection Act.

Sec. 5. Labeling regarding genetically engineered material; amendments to

Poultry Products Inspection Act.

Sec. 6. Effective date.

SEC. 2. FINDINGS. 6

The Congress finds as follows: 7

(1) The process of genetically engineering foods 8

results in the material change of such foods. 9

(2) The Congress has previously required that 10

all foods bear labels that reveal material facts to 11

consumers. 12

(3) Federal agencies have failed to uphold Con- 13

gressional intent by allowing genetically engineered 14

foods to be marketed, sold and otherwise used with- 15

out labeling that reveals material facts to the public. 16

(4) Consumers wish to know whether the food 17

they purchase and consume contains or is produced 18

with a genetically engineered material for a variety 19

of reasons, including the potential transfer of aller- 20

gens into food and other health risks, concerns 21

3

about potential environmental risks associated with 1

the genetic engineering of crops, and religiously and 2

ethically based dietary restrictions. 3

(5) Consumers have a right to know whether 4

the food they purchase contains or was produced 5

with genetically engineered material. 6

(6) Reasonably available technology permits the 7

detection in food of genetically engineered material, 8

generally acknowledged to be as low as 0.1 percent. 9

SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED 10

MATERIAL; AMENDMENTS TO FEDERAL 11

FOOD, DRUG, AND COSMETIC ACT. 12

(a) IN GENERAL.—Section 403 of the Federal Food, 13

Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 14

adding at the end the following paragraph: 15

‘‘(t)(1) If it contains a genetically engineered mate- 16

rial, or was produced with a genetically engineered mate- 17

rial, unless it bears a label (or labeling, in the case of a 18

raw agricultural commodity, other than the sale of such 19

a commodity at retail) that provides notices in accordance 20

with the following: 21

‘‘(A) A notice as follows: ‘GENETICALLY 22

ENGINEERED’. 23

‘‘(B) A notice as follows: ‘UNITED STATES 24

GOVERNMENT NOTICE: THIS PRODUCT 25

4

CONTAINS A GENETICALLY ENGINEERED 1

MATERIAL, OR WAS PRODUCED WITH A GE- 2

NETICALLY ENGINEERED MATERIAL’. 3

‘‘(C) The notice required in clause (A) imme- 4

diately precedes the notice required in clause (B) 5

and is not less than twice the size of the notice re- 6

quired in clause (B). 7

‘‘(D) The notice required in clause (B) is of the 8

same size as would apply if the notice provided nu- 9

trition information that is required in paragraph 10

(q)(1). 11

‘‘(E) The notices required in clauses (A) and 12

(B) are clearly legible and conspicuous. 13

‘‘(2) For purposes of subparagraph (1): 14

‘‘(A) The term ‘genetically engineered material’ 15

means material derived from any part of a geneti- 16

cally engineered organism, without regard to wheth- 17

er the altered molecular or cellular characteristics of 18

the organism are detectable in the material. 19

‘‘(B) The term ‘genetically engineered orga- 20

nism’ means— 21

‘‘(i) an organism that has been altered at 22

the molecular or cellular level by means that are 23

not possible under natural conditions or proc- 24

esses (including but not limited to recombinant 25

5

DNA and RNA techniques, cell fusion, micro- 1

encapsulation, macroencapsulation, gene dele- 2

tion and doubling, introducing a foreign gene, 3

and changing the positions of genes), other 4

than a means consisting exclusively of breeding, 5

conjugation, fermentation, hybridization, in 6

vitro fertilization, or tissue culture, and 7

‘‘(ii) an organism made through sexual or 8

asexual reproduction (or both) involving an or- 9

ganism described in subclause (i), if possessing 10

any of the altered molecular or cellular charac- 11

teristics of the organism so described. 12

‘‘(3) For purposes of subparagraph (1), a food shall 13

be considered to have been produced with a genetically en- 14

gineered material if— 15

‘‘(A) the organism from which the food is de- 16

rived has been injected or otherwise treated with a 17

genetically engineered material (except that the use 18

of manure as a fertilizer for raw agricultural com- 19

modities may not be construed to mean that such 20

commodities are produced with a genetically engi- 21

neered material); 22

‘‘(B) the animal from which the food is derived 23

has been fed genetically engineered material, or 24

6

‘‘(C) the food contains an ingredient that is a 1

food to which clause (A) or (B) applies. 2

‘‘(4) This paragraph does not apply to food that— 3

‘‘(A) is served in restaurants or other establish- 4

ments in which food is served for immediate human 5

consumption, 6

‘‘(B) is processed and prepared primarily in a 7

retail establishment, is ready for human consump- 8

tion, which is of the type described in clause (A), 9

and is offered for sale to consumers but not for im- 10

mediate human consumption in such establishment 11

and is not offered for sale outside such establish- 12

ment, or 13

‘‘(C) is a medical food as defined in section 5(b) 14

of the Orphan Drug Act.’’. 15

(b) CIVIL PENALTIES.—Section 303 of the Federal 16

Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend- 17

ed by adding at the end the following subsection: 18

‘‘(h)(1) With respect to a violation of section 301(a), 19

301(b), or 301(c) involving the misbranding of food within 20

the meaning of section 403(t), any person engaging in 21

such a violation shall be liable to the United States for 22

a civil penalty in an amount not to exceed $100,000 for 23

each such violation. 24

7

‘‘(2) Paragraphs (3) through (5) of subsection (g) 1

apply with respect to a civil penalty under paragraph (1) 2

of this subsection to the same extent and in the same man- 3

ner as such paragraphs (3) through (5) apply with respect 4

to a civil penalty under paragraph (1) or (2) of subsection 5

(g).’’. 6

(c) GUARANTY.— 7

(1) IN GENERAL.—Section 303(d) of the Fed- 8

eral Food, Drug, and Cosmetic Act (21 U.S.C. 9

333(d)) is amended— 10

(A) by striking ‘‘(d)’’ and inserting 11

‘‘(d)(1)’’; and 12

(B) by adding at the end the following 13

paragraph: 14

‘‘(2)(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 the misbranding of food within 17

the meaning of section 403(t) if such person (referred to 18

in this paragraph as the ‘recipient’) establishes a guaranty 19

or undertaking signed by, and containing the name and 20

address of, the person residing in the United States from 21

whom the recipient received in good faith the food (includ- 22

ing the receipt of seeds to grow raw agricultural commod- 23

ities), to the effect that (within the meaning of section 24

403(t)) the food does not contain a genetically engineered 25

8

material or was not produced with a genetically engineered 1

material. 2

‘‘(B) In the case of a recipient who with respect to 3

a food establishes a guaranty or undertaking in accord- 4

ance with subparagraph (A), the exclusion under such sub- 5

paragraph from being subject to penalties applies to the 6

recipient without regard to the use of the food by the re- 7

cipient, including— 8

‘‘(i) processing the food, 9

‘‘(ii) using the food as an ingredient in a food 10

product, 11

‘‘(iii) repacking the food, or 12

‘‘(iv) growing, raising, or otherwise producing 13

the food.’’. 14

(2) FALSE GUARANTY.—Section 301(h) of the 15

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 16

331(h)) is amended by inserting ‘‘or 303(d)(2)’’ 17

after ‘‘303(c)(2)’’. 18

(d) UNINTENDED CONTAMINATION.—Section 303(d) 19

of the Federal Food, Drug, and Cosmetic Act, as amended 20

by subsection (c)(1) of this section, is amended by adding 21

at the end the following paragraph: 22

‘‘(3)(A) No person shall be subject to the penalties 23

of subsection (a)(1) or (h) for a violation of section 301(a), 24

9

301(b), or 301(c) involving the misbranding of food within 1

the meaning of section 403(t) if— 2

‘‘(i) such person is an agricultural producer and 3

the violation occurs because food that is grown, 4

raised, or otherwise produced by such producer, 5

which food does not contain a genetically engineered 6

material and was not produced with a genetically en- 7

gineered material, is contaminated with a food that 8

contains a genetically engineered material or was 9

produced with a genetically engineered material (in- 10

cluding contamination by mingling the two), and 11

‘‘(ii) such contamination is not intended by the 12

agricultural producer. 13

‘‘(B) Subparagraph (A) does not apply to an agricul- 14

tural producer to the extent that the contamination occurs 15

as a result of the negligence of the producer.’’. 16

SEC. 4. LABELING REGARDING GENETICALLY ENGINEERED 17

MATERIAL; AMENDMENTS TO FEDERAL MEAT 18

INSPECTION ACT. 19

(a) REQUIREMENTS.—The Federal Meat Inspection 20

Act is amended by inserting after section 7 (21 U.S.C. 21

607) the following section: 22

‘‘SEC. 7A. REQUIREMENTS FOR LABELING REGARDING GE- 23

NETICALLY ENGINEERED MATERIAL. 24

‘‘(a) DEFINITIONS.—In this section: 25

10

‘‘(1) The term ‘meat food’ means a carcass, 1

part of a carcass, meat, or meat food product that 2

is derived from cattle, sheep, swine, goats, horses, 3

mules, or other equines and is capable of use as 4

human food. 5

‘‘(2) The term ‘genetically engineered material’ 6

means material derived from any part of a geneti- 7

cally engineered organism, without regard to wheth- 8

er the altered molecular or cellular characteristics of 9

the organism are detectable in the material (and 10

without regard to whether the organism is capable 11

of use as human food). 12

‘‘(3) The term ‘genetically engineered organism’ 13

means— 14

‘‘(A) an organism that has been altered at 15

the molecular or cellular level by means that are 16

not possible under natural conditions or proc- 17

esses (including but not limited to recombinant 18

DNA and RNA techniques, cell fusion, micro- 19

encapsulation, macroencapsulation, gene dele- 20

tion and doubling, introducing a foreign gene, 21

and changing the positions of genes), other 22

than a means consisting exclusively of breeding, 23

conjugation, fermentation, hybridization, in 24

vitro fertilization, or tissue culture; and 25

11

‘‘(B) an organism made through sexual or 1

asexual reproduction (or both) involving an or- 2

ganism described in subparagraph (A), if pos- 3

sessing any of the altered molecular or cellular 4

characteristics of the organism so described. 5

‘‘(b) LABELING REQUIREMENT.— 6

‘‘(1) REQUIRED LABELING TO AVOID MIS- 7

BRANDING.—For purposes of sections 1(n) and 10, 8

a meat food is misbranded if it— 9

‘‘(A) contains a genetically engineered ma- 10

terial or was produced with a genetically engi- 11

neered material; and 12

‘‘(B) does not bear a label (or include la- 13

beling, in the case of a meat food that is not 14

packaged in a container) that provides, in a 15

clearly legible and conspicuous manner, the no- 16

tices described in subsection (c). 17

‘‘(2) RULE OF CONSTRUCTION.—For purposes 18

of paragraph (1)(A), a meat food shall be considered 19

to have been produced with a genetically engineered 20

material if— 21

‘‘(A) the organism from which the food is 22

derived has been injected or otherwise treated 23

with a genetically engineered material; 24

12

‘‘(B) the animal from which the food is de- 1

rived has been fed genetically engineered mate- 2

rial; or 3

‘‘(C) the food contains an ingredient that 4

is a food to which subparagraph (A) or (B) ap- 5

plies. 6

‘‘(c) SPECIFICS OF LABEL NOTICES.— 7

‘‘(1) REQUIRED NOTICES.—The notices referred 8

to in subsection (b)(1)(B) are the following: 9

‘‘(A) A notice as follows: ‘GENETICALLY 10

ENGINEERED’. 11

‘‘(B) A notice as follows: ‘UNITED 12

STATES GOVERNMENT NOTICE: THIS 13

PRODUCT CONTAINS A GENETICALLY 14

ENGINEERED MATERIAL, OR WAS PRO- 15

DUCED WITH A GENETICALLY ENGI- 16

NEERED MATERIAL’. 17

‘‘(2) LOCATION AND SIZE.—(A) The notice re- 18

quired in paragraph (1)(A) shall immediately pre- 19

cede the notice required in paragraph (1)(B) and 20

shall be not less than twice the size of the notice re- 21

quired in paragraph (1)(B). 22

‘‘(B) The notice required in paragraph (1)(B) 23

shall be of the same size as would apply if the notice 24

provided nutrition information that is required in 25

13

section 403(q)(1) of the Federal Food, Drug, and 1

Cosmetic Act. 2

‘‘(d) EXCEPTIONS TO REQUIREMENTS.—Subsection 3

(a) does not apply to any meat food that— 4

‘‘(1) is served in restaurants or other establish- 5

ments in which food is served for immediate human 6

consumption; or 7

‘‘(2) is processed and prepared primarily in a 8

retail establishment, is ready for human consump- 9

tion, is offered for sale to consumers but not for im- 10

mediate human consumption in such establishment, 11

and is not offered for sale outside such establish- 12

ment. 13

‘‘(e) GUARANTY.— 14

‘‘(1) IN GENERAL.—A packer, processor, or 15

other person shall not be considered to have violated 16

the requirements of this section with respect to the 17

labeling of meat food if the packer, processor, or 18

other person (referred to in this subsection as the 19

‘recipient’) establishes a guaranty or undertaking 20

signed by, and containing the name and address of, 21

the person residing in the United States from whom 22

the recipient received in good faith the meat food or 23

the animal from which the meat food was derived, 24

or received in good faith food intended to be fed to 25

14

such animal, to the effect that the meat food, or 1

such animal, or such food, respectively, does not con- 2

tain genetically engineered material or was not pro- 3

duced with a genetically engineered material. 4

‘‘(2) SCOPE OF GUARANTY.—In the case of a 5

recipient who establishes a guaranty or undertaking 6

in accordance with paragraph (1), the exclusion 7

under such paragraph from being subject to pen- 8

alties applies to the recipient without regard to the 9

use of the meat food by the recipient (or the use by 10

the recipient of the animal from which the meat food 11

was derived, or of food intended to be fed to such 12

animal), including— 13

‘‘(A) processing the meat food; 14

‘‘(B) using the meat food as an ingredient 15

in another food product; 16

‘‘(C) packing or repacking the meat food; 17

or 18

‘‘(D) raising the animal from which the 19

meat food was derived. 20

‘‘(3) FALSE GUARANTY.—It is a violation of 21

this Act for a person to give a guaranty or under- 22

taking in accordance with paragraph (1) that the 23

person knows or has reason to know is false. 24

‘‘(f) CIVIL PENALTIES.— 25

15

‘‘(1) IN GENERAL.—The Secretary may assess 1

a civil penalty against a person that violates sub- 2

section (b) or (c)(3) in an amount not to exceed 3

$100,000 for each such violation. 4

‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR- 5

ING.—A civil penalty under paragraph (1) shall be 6

assessed by the Secretary by an order made on the 7

record after opportunity for a hearing provided in 8

accordance with this subparagraph and section 554 9

of title 5, United States Code. Before issuing such 10

an order, the Secretary shall give written notice to 11

the person to be assessed a civil penalty under such 12

order of the Secretary’s proposal to issue such order 13

and provide such person an opportunity for a hear- 14

ing on the order. In the course of any investigation, 15

the Secretary may issue subpoenas requiring the at- 16

tendance and testimony of witnesses and the produc- 17

tion of evidence that relates to the matter under in- 18

vestigation. 19

‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF 20

PENALTY.—In determining the amount of a civil 21

penalty under paragraph (1), the Secretary shall 22

take into account the nature, circumstances, extent, 23

and gravity of the violation or violations and, with 24

respect to the violator, ability to pay, effect on abil- 25

16

ity to continue to do business, any history of prior 1

such violations, the degree of culpability, and such 2

other matters as justice may require. 3

‘‘(4) CERTAIN AUTHORITIES.—The Secretary 4

may compromise, modify, or remit, with or without 5

conditions, any civil penalty under paragraph (1). 6

The amount of such penalty, when finally deter- 7

mined, or the amount agreed upon in compromise, 8

may be deducted from any sums owing by the 9

United States to the person charged. 10

‘‘(5) JUDICIAL REVIEW.—Any person who re- 11

quested, in accordance with paragraph (2), a hearing 12

respecting the assessment of a civil penalty under 13

paragraph (1) and who is aggrieved by an order as- 14

sessing a civil penalty may file a petition for judicial 15

review of such order with the United States Court 16

of Appeals for the District of Columbia Circuit or 17

for any other circuit in which such person resides or 18

transacts business. Such a petition may only be filed 19

within the 60-day period beginning on the date the 20

order making such assessment was issued. 21

‘‘(6) FAILURE TO PAY.—If a person fails to pay 22

an assessment of a civil penalty— 23

‘‘(A) after the order making the assess- 24

ment becomes final, and if such person does not 25

17

file a petition for judicial review of the order in 1

accordance with paragraph (5); or 2

‘‘(B) after a court in an action brought 3

under paragraph (4) has entered a final judg- 4

ment in favor of the Secretary; 5

the Attorney General shall recover the amount 6

assessed (plus interest at currently prevailing rates 7

from the date of the expiration of the 60-day period 8

referred to in paragraph (5) or the date of such final 9

judgment, as the case may be) in an action brought 10

in any appropriate district court of the United 11

States. In such an action, the validity, amount, and 12

appropriateness of such penalty shall not be subject 13

to review.’’. 14

(b) INCLUSION OF LABELING REQUIREMENTS IN 15

DEFINITION OF MISBRANDED.—Section 1(n) of the Fed- 16

eral Meat Inspection Act (21 U.S.C. 601(n)) is 17

amended— 18

(1) by striking ‘‘or’’ at the end of paragraph 19

(11); 20

(2) by striking the period at the end of para- 21

graph (12) and inserting ‘‘; or’’; and 22

(3) by adding at the end the following para- 23

graph: 24

18

‘‘(13) if it fails to bear a label or labeling as re- 1

quired by section 7A.’’. 2

SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED 3

MATERIAL; AMENDMENTS TO POULTRY 4

PRODUCTS INSPECTION ACT. 5

The Poultry Products Inspection Act is amended by 6

inserting after section 8 (21 U.S.C. 457) the following sec- 7

tion: 8

‘‘SEC. 8A. REQUIREMENTS FOR LABELING REGARDING GE- 9

NETICALLY ENGINEERED MATERIAL. 10

‘‘(a) DEFINITIONS.—In this section: 11

‘‘(1) The term ‘genetically engineered material’ 12

means material derived from any part of a geneti- 13

cally engineered organism, without regard to wheth- 14

er the altered molecular or cellular characteristics of 15

the organism are detectable in the material (and 16

without regard to whether the organism is capable 17

of use as human food). 18

‘‘(2) The term ‘genetically engineered organism’ 19

means— 20

‘‘(A) an organism that has been altered at 21

the molecular or cellular level by means that are 22

not possible under natural conditions or proc- 23

esses (including but not limited to recombinant 24

DNA and RNA techniques, cell fusion, micro- 25

19

encapsulation, macroencapsulation, gene dele- 1

tion and doubling, introducing a foreign gene, 2

and changing the positions of genes), other 3

than a means consisting exclusively of breeding, 4

conjugation, fermentation, hybridization, in 5

vitro fertilization, or tissue culture; and 6

‘‘(B) an organism made through sexual or 7

asexual reproduction (or both) involving an or- 8

ganism described in subparagraph (A), if pos- 9

sessing any of the altered molecular or cellular 10

characteristics of the organism so described. 11

‘‘(b) LABELING REQUIREMENT.— 12

‘‘(1) REQUIRED LABELING TO AVOID MIS- 13

BRANDING.—For purposes of sections 4(h) and 9(a), 14

a poultry product is misbranded if it— 15

‘‘(A) contains a genetically engineered ma- 16

terial or was produced with a genetically engi- 17

neered material; and 18

‘‘(B) does not bear a label (or include la- 19

beling, in the case of a poultry product that is 20

not packaged in a container) that provides, in 21

a clearly legible and conspicuous manner, the 22

notices described in subsection (c). 23

‘‘(2) RULE OF CONSTRUCTION.—For purposes 24

of paragraph (1)(A), a poultry product shall be con- 25

20

sidered to have been produced with a genetically en- 1

gineered material if— 2

‘‘(A) the poultry from which the food is de- 3

rived has been injected or otherwise treated 4

with a genetically engineered material; 5

‘‘(B) the poultry from which the food is 6

derived has been fed genetically engineered ma- 7

terial; or 8

‘‘(C) the food contains an ingredient that 9

is a food to which subparagraph (A) or (B) ap- 10

plies. 11

‘‘(c) SPECIFICS OF LABEL NOTICES.— 12

‘‘(1) REQUIRED NOTICES.—The notices referred 13

to in subsection (b)(1)(B) are the following: 14

‘‘(A) A notice as follows: ‘GENETICALLY 15

ENGINEERED’. 16

‘‘(B) A notice as follows: ‘UNITED 17

STATES GOVERNMENT NOTICE: THIS 18

PRODUCT CONTAINS A GENETICALLY 19

ENGINEERED MATERIAL, OR WAS PRO- 20

DUCED WITH A GENETICALLY ENGI- 21

NEERED MATERIAL’. 22

‘‘(2) LOCATION AND SIZE.—(A) The notice re- 23

quired in paragraph (1)(A) shall immediately pre- 24

cede the notice required in paragraph (1)(B) and 25

21

shall be not less than twice the size of the notice re- 1

quired in paragraph (1)(B). 2

‘‘(B) The notice required in paragraph (1)(B) 3

shall be of the same size as would apply if the notice 4

provided nutrition information that is required in 5

section 403(q)(1) of the Federal Food, Drug, and 6

Cosmetic Act. 7

‘‘(d) EXCEPTIONS TO REQUIREMENTS.—Subsection 8

(a) does not apply to any poultry product that— 9

‘‘(1) is served in restaurants or other establish- 10

ments in which food is served for immediate human 11

consumption; or 12

‘‘(2) is processed and prepared primarily in a 13

retail establishment, is ready for human consump- 14

tion, is offered for sale to consumers but not for im- 15

mediate human consumption in such establishment, 16

and is not offered for sale outside such establish- 17

ment. 18

‘‘(e) GUARANTY.— 19

‘‘(1) IN GENERAL.—An official establishment or 20

other person shall not be considered to have violated 21

the requirements of this section with respect to the 22

labeling of a poultry product if the official establish- 23

ment or other person (referred to in this subsection 24

as the ‘recipient’) establishes a guaranty or under- 25

22

taking signed by, and containing the name and ad- 1

dress of, the person residing in the United States 2

from whom the recipient received in good faith the 3

poultry product or the poultry from which the poul- 4

try product was derived, or received in good faith 5

food intended to be fed to poultry, to the effect that 6

the poultry product, poultry, or such food, respec- 7

tively, does not contain genetically engineered mate- 8

rial or was not produced with a genetically engi- 9

neered material. 10

‘‘(2) SCOPE OF GUARANTY.—In the case of a 11

recipient who establishes a guaranty or undertaking 12

in accordance with paragraph (1), the exclusion 13

under such paragraph from being subject to pen- 14

alties applies to the recipient without regard to the 15

use of the poultry product by the recipient (or the 16

use by the recipient of the poultry from which the 17

poultry product was derived, or of food intended to 18

be fed to such poultry), including— 19

‘‘(A) processing the poultry; 20

‘‘(B) using the poultry product as an in- 21

gredient in another food product; 22

‘‘(C) packing or repacking the poultry 23

product; or 24

23

‘‘(D) raising the poultry from which the 1

poultry product was derived. 2

‘‘(3) FALSE GUARANTY.—It is a violation of 3

this Act for a person to give a guaranty or under- 4

taking in accordance with paragraph (1) that the 5

person knows or has reason to know is false. 6

‘‘(f) CIVIL PENALTIES.— 7

‘‘(1) IN GENERAL.—The Secretary may assess 8

a civil penalty against a person that violates sub- 9

section (b) or (c)(3) in an amount not to exceed 10

$100,000 for each such violation. 11

‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR- 12

ING.—A civil penalty under paragraph (1) shall be 13

assessed by the Secretary by an order made on the 14

record after opportunity for a hearing provided in 15

accordance with this subparagraph and section 554 16

of title 5, United States Code. Before issuing such 17

an order, the Secretary shall give written notice to 18

the person to be assessed a civil penalty under such 19

order of the Secretary’s proposal to issue such order 20

and provide such person an opportunity for a hear- 21

ing on the order. In the course of any investigation, 22

the Secretary may issue subpoenas requiring the at- 23

tendance and testimony of witnesses and the produc- 24

24

tion of evidence that relates to the matter under in- 1

vestigation. 2

‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF 3

PENALTY.—In determining the amount of a civil 4

penalty under paragraph (1), the Secretary shall 5

take into account the nature, circumstances, extent, 6

and gravity of the violation or violations and, with 7

respect to the violator, ability to pay, effect on abil- 8

ity to continue to do business, any history of prior 9

such violations, the degree of culpability, and such 10

other matters as justice may require. 11

‘‘(4) CERTAIN AUTHORITIES.—The Secretary 12

may compromise, modify, or remit, with or without 13

conditions, any civil penalty under paragraph (1). 14

The amount of such penalty, when finally deter- 15

mined, or the amount agreed upon in compromise, 16

may be deducted from any sums owing by the 17

United States to the person charged. 18

‘‘(5) JUDICIAL REVIEW.—Any person who re- 19

quested, in accordance with paragraph (2), a hearing 20

respecting the assessment of a civil penalty under 21

paragraph (1) and who is aggrieved by an order as- 22

sessing a civil penalty may file a petition for judicial 23

review of such order with the United States Court 24

of Appeals for the District of Columbia Circuit or 25

25

for any other circuit in which such person resides or 1

transacts business. Such a petition may only be filed 2

within the 60-day period beginning on the date the 3

order making such assessment was issued. 4

‘‘(6) FAILURE TO PAY.—If a person fails to pay 5

an assessment of a civil penalty— 6

‘‘(A) after the order making the assess- 7

ment becomes final, and if such person does not 8

file a petition for judicial review of the order in 9

accordance with paragraph (5); or 10

‘‘(B) after a court in an action brought 11

under paragraph (4) has entered a final judg- 12

ment in favor of the Secretary; 13

the Attorney General shall recover the amount 14

assessed (plus interest at currently prevailing rates 15

from the date of the expiration of the 60-day period 16

referred to in paragraph (5) or the date of such final 17

judgment, as the case may be) in an action brought 18

in any appropriate district court of the United 19

States. In such an action, the validity, amount, and 20

appropriateness of such penalty shall not be subject 21

to review.’’. 22

(b) INCLUSION OF LABELING REQUIREMENTS IN 23

DEFINITION OF MISBRANDED.—Section 4(h) of the Poul- 24

26

try Products Inspection Act (21 U.S.C. 453(h)) is 1

amended— 2

(1) by striking ‘‘or’’ at the end of paragraph 3

(11); 4

(2) by striking the period at the end of para- 5

graph (12) and inserting ‘‘; or’’; and 6

(3) by adding at the end the following para- 7

graph: 8

‘‘(13) if it fails to bear a label or labeling as re- 9

quired by section 8A.’’. 10

SEC. 6. EFFECTIVE DATE. 11

This Act and the amendments made by this Act take 12

effect upon the expiration of the 180-day period beginning 13

on the date of the enactment of this Act. 14

November 16, 1999