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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.
