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K2K
April 2000

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THE GENETICALLY ENGINEERED

FOOD RIGHT-TO-KNOW ACT, S. 2080

 

Mrs. BOXER. Mr. President, today I am pleased to introduce the Genetically

Engineered Food Right-to-Know Act. This legislation requires that all foods

containing or produced with genetically engineered material bear a neutral

label stating that: `this product contains a genetically engineered material

or was produced with a genetically engineered material.'

The bill adds this labeling requirement to the provisions of the Federal

Food, Drug, and Cosmetic Act (FFDCA), the Federal Meat Inspection Act, and

the Poultry Products Inspection Act which contain the general standards for

labeling foods.

 

Recent polls have demonstrated that Americans want to know if they are eating

genetically engineered food. A January 1999 Time magazine poll revealed that

81% of respondents wanted genetically engineered food to be labeled. A

January 2000 MSNBC poll showed identical results.

 

This pressure has already led some companies not to use genetically

engineered materials in their foods. Gerber and Heinz have said they will no

longer use genetically engineered material in their baby food. Whole Foods

and Wild Oats Supermarkets also have said they will use no genetically

engineered material in their own products.

 

Great Britain, France, Germany, the Netherlands, Belgium, Luxembourg,

Denmark, Sweden, Finland, Ireland, Spain, Austria, Italy, Portugal, Greece,

New Zealand, and Japan already require genetically engineered food to be

labeled.

 

If the U.S. wants to sell its genetically engineered food to these countries,

it will have to label the food for foreign consumers. It is only fair that

American consumers be given similar information.

 

Why do I feel it's important for consumers to know that their food is

genetically engineered?

 

First, we don't know whether genetically engineered food is harmful or

whether it is safe. However, scientists have raised concerns about

genetically engineered food. These concerns include the risks of increased

exposure to allergens, decreased nutritional value, increased toxicity and

increased antibiotic resistance.

 

In addition, scientists have raised concerns about the ecological risks

associated with genetically engineered food. Some of those risks include the

destruction of species, cross pollination that breeds new weeds that are

resistant to herbicides, and increases in pesticide use over the long-term.

 

Earlier this year, for example, researchers at Cornell University reported

that Monarch butterflies were either killed or developed abnormally when

eating milkweed dusted with the pollen of Bt-corn, a genetically engineered

food.

 

Second, the Food and Drug Administration does not require pre-market health

and safety testing of genetically engineered foods. Therefore, it is only

fair that consumers know they are eating products that have not been tested.

 

Third, the Environmental Protection Agency and the Department of Agriculture

do not require substantive environmental review of genetically engineered

materials under their jurisdiction.

 

My Genetically Engineered Food Right-to-Know Act not only mandates labels,

but does something even more important: it authorizes $5 million in grants to

conduct studies into the health and environmental risks raised by genetically

engineered food.

 

Specifically, it directs the Secretary of HHS to make grants to individuals,

organizations and institutions to study risks like increased toxicity,

increased allergenicity, negative effects on soil ecology and on the

environment in general.

 

What is the extent of genetically engineered crops today?

 

Last year, 98.6 million acres in the U.S. were planted with genetically

engineered crops. More than one-third of the U.S. soybean crop and

one-quarter of corn were genetically engineered. This represents a 23-fold

increase in genetically engineered crop production from just four years ago.

 

And waiting to come into the marketplace are more than 60 different

genetically engineered crops--from apples and strawberries to potatoes and

tomatoes.

 

Providing consumers with information about the foods they eat is hardly new.

 

For example, I was proud to be the author of the law to provide for the

`dolphin safe' label on tuna. The label indicated that the tuna was harvested

by methods that don't harm dolphins.

 

I was also proud to lead the fight in the Senate to make sure that chicken

frozen as solid as a blowing ball could not be labeled fresh. At the time,

USDA's position was that frozen chicken could be labeled `fresh.'

 

In 1996, I succeeded in amending the Safe Drinking Water Act to require that

drinking water providers give their consumers annual reports concerning the

quality of their water.

 

Others in Congress led the fight to tell consumers whether their products

contain artificial colors or sweeteners, preservatives, additives, and

whether they are from concentrate. I supported those labels as well.

 

Food manufacturers also label their products with information that is of

little value to consumers. Certain brands of pretzels, for example, bear a

label which states that the manufacturer is a `Member of the Snack Food

Association: An International Trade Association.'

 

I don't think this is information consumers are clamoring for, yet the

manufacturer is willing to go through the trouble of putting it on the bag.

 

My legislation builds on the existing food labeling system, and would be

simple to implement. It would require that all foods containing or made with

genetically engineered foods be labeled with this information: `this product

contains a genetically engineered material or was produced with a genetically

engineered material.'

 

For example, corn flakes made with genetically engineered corn would be a

`product that contains' genetically engineered material. To take another

example, milk from a cow treated with genetically engineered bovine growth

hormone would be a product `produced with' genetically engineered material.

 

Specifically, my bill requires that food that contains or was produced with

genetically engineered material be labeled at each stage of the food

production process--from seed company to farmer to manufacturer to retailer.

The labeling requirement in my bill, however, does not to apply to drugs or

to food sold in restaurants, bakeries, and other similar establishments.

 

Genetically engineered material is defined under the bill as material that

`has been altered at the molecular or cellular level by means that are not

possible under natural conditions or processes.' Food developed through

traditional processes such as crossbreeding is not considered to be

genetically engineered, and the legislation's labeling requirement would not

apply to foods produced in that way.

 

Under the bill, persons need not label food if they obtain a written guaranty

from the party from whom they received the food that the food does not

contain and was not produced with genetically engineered material. Persons

who obtain a valid guaranty are not subject to penalties under the bill if

they are later found to have failed to label food that contains genetically

engineered material.

 

For example, a farmer who plants genetically engineered corn must label that

corn. Each person who then buys and then sells that corn, or food derived

from it, will also be required to label it as genetically engineered.

 

Conversely, farmers who obtain a guaranty that the corn they are planting is

not genetically engineered may issue a guaranty to purchasers that their corn

is not genetically engineered. The purchaser then would not have to label

that corn or product made with that corn.

 

If the corn or food is later found to have contained or been produced with

genetically engineered material but was not labeled accordingly, the

purchaser would not be subject to penalties under the bill.

 

This guaranty system is used today to enforce provisions of existing law

concerning the distribution of adulterated or mislabeled foods. The system is

much less expensive than a system which would require food to be tested at

every phase of the food production process.

 

Failure to label food that contains or was produced with genetically

engineered material carries a civil penalty of up to $1,000 amount for each

violation.

 

Importantly, the bill provides that if a party fraudulently warrants that a

product is not genetically engineered, no party further down the chain of

custody may be held liable for mislabeling. This provision is particularly

meant to protect small farmers from the possibility that their suppliers

would by contract provide that any liability for mislabeling be borne by the

farmer regardless of the suppliers' own actions.

 

The bill also provides another protection for farmers. Under the bill, a

farmer who plants a non-genetically engineered crop, but whose crop came to

contain genetically engineered material from natural causes such as wind

carrying pollen from a genetically engineered plant is not subject to

penalties under the bill. This is the case so long as the farmer did not

intend or did not negligently permit this to occur.

 

And, finally, the bill directs the Secretary of HHS to make grants to study

the possible health and environmental risks associated with genetically

engineered foods. The bill authorizes $5 million for this purpose.

 

In closing, Mr. President, during the recent negotiations on the Biosafety

Protocol, it was the United States' negotiating position that international

shipments of seeds, grains and plants that may contain genetically engineered

material be labeled accordingly.

 

If the United States took the position that it is appropriate to provide this

information to its trading partners, shouldn't we make similar information

available to American consumers?

 

I am hopeful that my House and Senate colleagues can act quickly to ensure

the passage of my legislation to give American families the right-to-know

whether their food contains or was produced with genetically engineered

material.

 

I ask that the text of my legislation be printed in the Record.

 

The text of the legislation follows:

 

S. 2080

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 `Genetically Engineered Food Right-to-Know Act'.

 

 

SEC. 2. FINDINGS.

Congress finds the following:

 

(1) In 1999, 98,600,000 acres in the United States were planted with

genetically engineered crops, and more than 1/3 of the soybean crop, and 1/4

of the corn crop, in the United States was genetically engineered.

 

(2) The process of genetically engineering foods results in the material

change of such foods.

 

(3) The health and environmental effects of genetically engineered foods are

not yet known.

 

(4) Individuals in the United States have the right to know whether food

contains or has been produced with genetically engineered material.

 

(5) Federal law gives individuals in the United States the right to know

whether food contains artificial colors and flavors, chemical preservatives,

and artificial sweeteners by requiring the labeling of such food.

 

(6) Requirements that genetically engineered food be labeled as genetically

engineered would increase consumer knowledge about, and consumer control over

consumption of, genetically engineered food.

 

(7) Genetically engineered material can be detected in food at levels as low

as 0.1 percent by reasonably available technology.

 

SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS TO

FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) In General: Section 403 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 343) is amended by adding at the end the following paragraph:

`(t)(1) If it contains a genetically engineered material, or was produced

with a genetically engineered material, unless it bears a label (or labeling,

in the case of a raw agricultural commodity) that provides notices in

accordance with each of the following requirements:

 

`(A) The label or labeling bears the following notice: `GENETICALLY

ENGINEERED'.

 

`(B) The label or labeling bears the following notice: `THIS PRODUCT CONTAINS

A GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A GENETICALLY

ENGINEERED MATERIAL'.

 

`(C) The notice required in clause (A) immediately precedes the notice

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

not less than twice the size of the type for the notice required in clause

(B).

 

`(D) The notice required in clause (B) is the same size as would be required

if the notice provided nutrition information that is required in paragraph

(q)(1).

 

`(E) The notices required in clauses (A) and (B) are clearly legible and

conspicuous.

`(2) This paragraph does not apply to food that--

 

`(A) is served in restaurants or other similar eating establishments, such as

cafeterias and carryouts;

 

`(B) is a medical food as defined in section 5(b) of the Orphan Drug Act; or

 

`(C) was grown on a tree that was planted before the date of enactment of the

Genetically Engineered Food Right-to-Know Act, in a case in which the

producer of the food does not know if the food contains a genetically

engineered material, or was produced with a genetically engineered material.

`(3) In this paragraph:

 

`(A) The term `genetically engineered material' means material derived from

any part of a genetically engineered organism, without regard to whether the

altered molecular or cellular characteristics of the organism are detectable

in the material.

 

`(B) The term `genetically engineered organism' means--

 

`(i) an organism that has been altered at the molecular or cellular level by

means that are not possible under natural conditions or processes (including

recombinant DNA and RNA techniques, cell fusion, microencapsulation,

macroencapsulation, gene deletion and doubling, introduction of a foreign

gene, and a process that changes the positions of genes), other than a means

consisting exclusively of breeding, conjugation, fermentation, hybridization,

in vitro fertilization, or tissue culture; and

 

`(ii) an organism made through sexual or asexual reproduction, or both,

involving an organism described in subclause (i), if possessing any of the

altered molecular or cellular characteristics of the organism so described.

 

`(C) The term `produced with a genetically engineered material', used with

respect to a food, means a food if--

 

`(i) the organism from which the food is derived has been injected or

otherwise treated with a genetically engineered material (except that the use

of manure as a fertilizer for raw agricultural commodities may not be

construed to be production with a genetically engineered material);

 

`(ii) the animal from which the food is derived has been fed genetically

engineered material; or

 

`(iii) the food contains an ingredient that is a food to which subclause (i)

or (ii) applies.'.

(b) Guaranty:

 

(1) In general: Section 303(d) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 333(d)) is amended--

 

(A) by striking `(d)' and inserting `(d)(1)'; and

 

(B) by adding at the end the following paragraph:

`(2)(A) No person shall be subject to the penalties of subsection (a)(1) or

(h) for a violation of section 301(a), 301(b), or 301(c) involving food that

is misbranded within the meaning of section 403(t) if such person (referred

to in this paragraph as the `recipient') establishes a guaranty or

undertaking that--

 

`(i) is signed by, and contains the name and address of, a person residing in

the United States from whom the recipient received in good faith the food

(including the receipt of seeds to grow raw agricultural commodities); and

 

`(ii) contains a statement to the effect that the food does not contain a

genetically engineered material or was not produced with a genetically

engineered material.

`(B) In the case of a recipient who, with respect to a food, establishes a

guaranty or undertaking in accordance with subparagraph (A), the exclusion

under such subparagraph from being subject to penalties applies to the

recipient without regard to the manner in which the recipient uses the food,

including whether the recipient is--

 

`(i) processing the food;

 

`(ii) using the food as an ingredient in a food product;

 

`(iii) repacking the food; or

 

`(iv) growing, raising, or otherwise producing the food.

`(C) No person may avoid responsibility or liability for a violation of

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

the meaning of section 403(t) by entering into a contract or other agreement

that specifies that another person shall bear such responsibility or

liability, except that a recipient may require a guaranty or undertaking as

described in this subsection.

`(D) In this paragraph, the terms `genetically engineered material' and

`produced with a genetically engineered material' have the meanings given the

terms in section 403(t).'.

 

(2) False guaranty: Section 301(h) of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 331(h)) is amended by inserting `or 303(d)(2)' before `, which

guaranty or undertaking is false' the first place it appears.

(c) Unintended Contamination: Section 303(d) of the Federal Food, Drug, and

Cosmetic Act, as amended by subsection (b)(1), is further amended by adding

at the end the following paragraph:

`(3)(A) No person shall be subject to the penalties of subsection (a)(1) or

(h) for a violation of section 301(a), 301(b), or 301(c) involving food that

is misbranded within the meaning of section 403(t) if--

 

`(i) such person is an agricultural producer and the violation occurs because

food that is grown, raised, or otherwise produced by such producer, which

food does not contain a genetically engineered material and was not produced

with a genetically engineered material, is contaminated with a food that

contains a genetically engineered material or was produced with a genetically

engineered material (including contamination by mingling the 2 foods); and

 

`(ii) such contamination is not intended by the agricultural producer.

`(B) Subparagraph (A) does not apply to an agricultural producer to the

extent that the contamination occurs as a result of the negligence of the

producer.'.

(d) Civil Penalties: Section 303 of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 333) is amended by adding at the end the following subsection:

`(h)(1) With respect to a violation of section 301(a), 301(b), or 301(c)

involving food that is misbranded within the meaning of section 403(t), any

person engaging in such a violation shall be liable to the United States for

a civil penalty in an amount not to exceed $1,000 for each such violation.

`(2) Paragraphs (3) through (5) of subsection (g) apply with respect to a

civil penalty assessed under paragraph (1) to the same extent and in the same

manner as such paragraphs (3) through (5) apply with respect to a civil

penalty assessed under paragraph (1) or (2) of subsection (g).'.

 

SEC. 4. GRANTS FOR RESEARCH ON GENETICALLY ENGINEERED FOOD.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et

seq.) is amended by adding at the end the following:

 

`SEC. 908. GRANTS FOR RESEARCH ON GENETICALLY ENGINEERED FOOD.

`(a) In General: The Secretary may make grants to appropriate individuals,

organizations, and institutions to conduct research into the public health

and environmental risks associated with genetically engineered materials,

food that contains a genetically engineered material, and food that is

produced with a genetically engineered material, including risks related to--

 

`(1) increased allergenicity;

 

`(2) increased toxicity;

 

`(3) cross-pollination between genetically engineered materials and materials

that are not genetically engineered materials; and

 

`(4) interference with the soil ecosystem and other impacts on the ecosystem.

`(b) Authorization of Appropriations:

 

`(1) In general: There is authorized to be appropriated $5,000,000 for fiscal

year 2001 to carry out the objectives of this section.

 

`(2) Availability: Any sums appropriated under the authorization contained in

this subsection shall remain available, without fiscal year limitation, until

expended.

`(c) Definitions: The terms `genetically engineered material' and `produced

with a genetically engineered material' have the meanings given the terms in

section 403(t)(3) of the Federal Food, Drug, and Cosmetic Act.'.

 

SEC. 5. CONFORMING AMENDMENTS.

(a) Section 1(n) of Public Law 90-201 is amended--

 

(1) in paragraph (11), by striking `or' at the end;

 

(2) in paragraph (12), by striking the period at the end and inserting `;

or'; and

 

(3) by adding at the end the following:

 

`(13) if--

 

`(A) it contains a genetically engineered material, or was produced with a

genetically engineered material; and

 

`(B)(i) it does not bear a label or labeling, as appropriate, that provides

the notices required under the terms and conditions of section 403(t) of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)); or

 

`(ii) it is the subject of a false guaranty or undertaking,

 

subject to the terms and conditions of section 303(d) of that Act (21 U.S.C.

333(d)) and subject to the penalties described in section 303(h) of that Act

(21 U.S.C. 333(h)) and remedies available under this Act.'.

(b) Section 4(h) of Public Law 85-172 is amended--

 

(1) in paragraph (11), by striking `or' at the end;

 

(2) in paragraph (12), by striking the period at the end and inserting `;

or'; and

 

(3) by adding at the end the following:

 

`(13) if--

 

`(A) it contains a genetically engineered material, or was produced with a

genetically engineered material; and

 

`(B)(i) it does not bear a label or labeling, as appropriate, that provides

the notices required under the terms and conditions of section 403(t) of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)); or

 

`(ii) it is the subject of a false guaranty or undertaking,

 

subject to the terms and conditions of section 303(d) of that Act (21 U.S.C.

333(d)) and subject to the penalties described in section 303(h) of that Act

(21 U.S.C. 333(h)) and remedies available under this Act.'.

 

SEC. 6. EFFECTIVE DATE.

This Act and the amendments made by this Act take effect 180 days after the

date of enactment of this Act.

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