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108th CONGRESS
2d Session
S. 2546
To amend the Federal Food, Drug, and Cosmetic Act to require premarket
consultation and approval with respect to genetically engineered foods,
and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 17, 2004
Mr. Durbin 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 premarket
consultation and approval with respect to genetically engineered foods,
and for other purposes.
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 Foods Act''.
SEC. 2. FINDINGS.
Congress finds that--
(1) genetically engineered food is rapidly becoming an
integral part of domestic and international food supplies;
(2) the potential positive effects of genetically
engineered foods are enormous;
(3) the potential for both anticipated and unanticipated
effects exists with genetic engineering of foods;
(4) genetically engineered food not approved for human
consumption has, in the past, entered the human food supply;
(5) environmental issues have been identified as a major
science-based concern associated with animal biotechnology;
(6) it is essential to maintain--
(A) public confidence in--
(i) the safety of the food supply; and
(ii) the ability of the Federal Government
to exercise adequate oversight of genetically
engineered foods; and
(B) the ability of agricultural producers and other
food producers of the United States to market,
domestically and internationally, foods that have been
genetically engineered;
(7) public confidence can best be maintained through
careful review and formal determination of the safety of
genetically engineered foods, and monitoring of the positive
and negative effects of genetically engineered foods as the
foods become integrated into the food supply, through a review
and monitoring process that--
(A) is scientifically sound, open, and transparent;
(B) fully involves the general public; and
(C) does not subject most genetically engineered
foods to the lengthy food additive approval process;
and
(8) because genetically engineered foods are developed
worldwide and imported into the United States, it is imperative
that imported genetically engineered food be subject to the
same level of oversight as domestic genetically engineered
food.
SEC. 3. DEFINITIONS.
(a) This Act.--In this Act, the terms ``genetic engineering
technique'', ``genetically engineered animal'', ``genetically
engineered food'', ``interstate commerce'', ``producer'', ``safe'', and
``Secretary'' have the meanings given those terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by
subsection (b)).
(b) Federal Food, Drug, and Cosmetic Act.--Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
(1) in subsection (v)--
(A) by striking ``(v) The term'' and inserting the
following:
``(v) New Animal Drug.--
``(1) In general.--The term'';
(B) by striking ``(1) the composition'' and
inserting ``(A) the composition'';
(C) by striking ``(2) the composition'' and
inserting ``(B) the composition''; and
(D) by adding at the end the following:
``(2) Inclusion.--The term `new animal drug' includes--
``(A) a genetic engineering technique intended to
be used to produce an animal; and
``(B) a genetically engineered animal.''; and
(2) by adding at the end the following:
``(nn) Genetically Engineered Animal.--
``(1) In general.--The term `genetically engineered animal'
means an animal that--
``(A) is intended to be used--
``(i) in the production of a food or
dietary supplement; or
``(ii) for any other purpose;
``(B)(i) is produced in the United States; or
``(ii) is offered for import into the United
States; and
``(C) is produced using a genetic engineering
technique.
``(2) Exclusion.--The term `genetically engineered animal'
does not include an established line of a genetically modified
animal that--
``(A) is used solely in scientific research; and
``(B) is not intended or expected--
``(i) to enter the food supply; or
``(ii) to be released into the environment.
``(oo) Genetically Engineered Food.--
``(1) In general.--The term `genetically engineered food'
means a food or dietary supplement, or a seed, microorganism,
or ingredient intended to be used to produce a food or dietary
supplement, that--
``(A)(i) is produced in the United States; or
``(ii) is offered for import into the United
States; and
``(B) is produced using a genetic engineering
technique.
``(2) Inclusion.--The term `genetically engineered food'
includes a split use food.
``(3) Exclusion.--The term `genetically engineered food'
does not include a genetically engineered animal.
``(pp) Genetic Engineering Technique.--The term `genetic
engineering technique' means the use of a transformation event to
derive food from a plant or animal or to produce an animal.
``(qq) Producer.--The term `producer', with respect to a
genetically engineered animal, genetically engineered food, or genetic
engineering technique, means a person that--
``(1) develops, manufactures, or imports the genetically
engineered animal or genetically engineered food;
``(2) uses the genetic engineering technique; or
``(3) takes other action to introduce the genetically
engineered animal, genetically engineered food, or genetic
engineering technique into interstate commerce.
``(rr) Safe.--The term `safe', with respect to a genetically
engineered food, means--
``(1) as safe as comparable food that is not produced using
a genetic engineering technique; or
``(2) if there is no such comparable food, having a
reasonable certainty of causing no harm.
``(ss) Split Use Food.--The term `split use food' means a product
that--
``(1)(A) is produced in the United States; or
``(B) is offered for import into the United States;
``(2) is produced using a genetic engineering technique;
and
``(3) could be used as food by both humans and animals but
that the producer does not intend to market as food for humans.
``(tt) Transformation Event.--The term `transformation event' means
the introduction into a plant or an animal of genetic material that has
been manipulated in vitro.''.
SEC. 4. GENETICALLY ENGINEERED FOODS.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended--
(1) by inserting after the chapter heading the following:
``Subchapter A--General Provisions'';
and
(2) by adding at the end the following:
``Subchapter B--Genetically Engineered Foods
``SEC. 421. PREMARKET CONSULTATION AND APPROVAL.
``(a) In General.--A producer of genetically engineered food,
before introducing a genetically engineered food into interstate
commerce, shall first obtain approval through the use of a premarket
consultation and approval process.
``(b) Regulations.--The Secretary shall promulgate regulations that
describe--
``(1) all information that is required to be submitted for
the premarketing approval process, including--
``(A) specification of the species or other
taxonomic classification of plants for which approval
is sought;
``(B) identification of the genetically engineered
food;
``(C)(i) a description of each type of genetic
manipulation made to the genetically engineered food;
``(ii) identification of the manipulated genetic
material; and
``(iii) the techniques used in making the
manipulation;
``(D) the effect of the genetic manipulation on the
composition of the genetically engineered food
(including information describing the specific
substances that were expressed, removed, or otherwise
manipulated);
``(E) a description of the actual or proposed
applications and uses of the genetically engineered
food;
``(F) information pertaining to--
``(i) the safety of the genetically
engineered food as a whole; and
``(ii) the safety of any specific
substances introduced, altered, or produced as
a result of the genetic manipulation (including
information on allergenicity and toxicity);
``(G) test methods for detection of the genetically
engineered ingredients in food;
``(H) a summary and overview of information and
issues that have been or will be addressed by other
regulatory programs for the review of genetically
engineered food;
``(I) procedures to be followed to initiate and
complete the premarket approval process (including any
preconsultation and consultation procedures); and
``(J) any other matters that the Secretary
determines to be necessary.
``(2) Split use food.--
``(A) In general.--The regulations under paragraph
(1) shall provide for the approval of--
``(i) split use foods that are not approved
for human consumption;
``(ii) split use foods that are intended
for human use but are marketed under restricted
conditions; and
``(iii) other categories of split use food.
``(B) Issues.--For each category of split use food,
the regulations shall address--
``(i)(I) whether a protocol is needed for
segregating a restricted split use food from
the food supply; and
``(II) if so, what the protocol shall be;
``(ii)(I) whether action is needed to
ensure the purity of any seed to prevent
unintended introduction of a
genetically engineered trait into a seed that is not designed for that
trait; and
``(II) if so, what action is needed and
what industry practices represent the best
practices for maintaining the purity of the
seed;
``(iii)(I) whether a tolerance level should
exist regarding cross-mixing of segregated
split use foods; and
``(II) if so, the means by which the
tolerance level shall be determined;
``(iv) the manner in which the food safety
analysis under this section should be
conducted, specifying different standards and
procedures that are permitted to be applied for
nonfood products grown in food crops depending
on the degree of containment for that product
and the likelihood of the product to enter the
food supply;
``(v)(I) the kinds of surveillance that are
needed to ensure that appropriate segregation
of split use foods is being maintained;
``(II) the manner in which and by whom the
surveillance shall be conducted; and
``(III) the manner in which the results of
surveillance shall be reported; and
``(vi) clarification of responsibility in
cases of breakdown of segregation of a split
use food.
``(C) Recall authority.--The regulations shall
provide that, in addition to other authority that the
Secretary has regarding split use food, the Secretary
may order a recall of any split use food (whether or
not the split use food has been approved under this
section) that--
``(i) is not approved, but has entered the
food supply; or
``(ii) has entered the food supply in
violation of a condition of restriction under
an approval.
``(c) Application.--The regulations shall require that, as part of
the consultation and approval process, a producer submit to the
Secretary an application that includes a summary and a complete copy of
each research study, test result, or other information referenced by
the producer.
``(d) Review.--
``(1) In general.--After receiving an application under
subsection (c), the Secretary shall--
``(A) determine whether the producer submitted
information that appears to be adequate to enable the
Secretary to fully assess the safety of the genetically
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