Genetically Engineered Safety Act - Genetically Engineered Pharmaceutical and Industrial Crop Safety Act of 2011 - Prohibits: (1) a pharmaceutical crop or industrial crop from being grown, raised, or otherwise cultivated until the final regulations and tracking system required by this Act are in effect; and (2) cultivation of a pharmaceutical crop or industrial crop in an open air environment, or in a food commonly used for human food or domestic animal feed.
Directs the Department of Agriculture (USDA) to establish a tracking system to regulate the growing, handling, transportation, and disposal of all pharmaceutical and industrial crops and their byproducts to prevent contamination.
Authorizes the Secretary of Agriculture to assess civil penalties for violations of such provisions.
Directs the National Academy of Sciences to report on alternative methods to produce pharmaceuticals or industrial chemicals that may be conducted in controlled production facilities without the risk of contamination.
Genetically Engineered Food Safety Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include genetically engineered food in the definition of "food additive."
Sets forth requirements governing petitions to the Secretary of Health and Human Services (HHS) for a regulation prescribing the conditions of safe use of a genetically engineered food additive, including information to be included in the petition and factors to be considered by the Secretary in making a decision.
Authorizes civil actions against: (1) a person alleged to have violated FFDCA provisions regulating genetic food additives, and (2) the Secretary of Health and Human Services for failure to perform a mandatory act or duty related to genetic food additives.
Requires the Secretary of Health and Human Services to collect a filing fee for petitions to: (1) defray costs related to such petitions, and (2) provide for research on the safety of genetic food additives.
Authorizes an officer or employee conducting an inspection to order the detention of food if such person has reason to believe that such food violates the FFDCA. Requires all food retailers to register with the Food and Drug Administration (FDA) to expedite recalls, embargoes, and seizures.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3554 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 3554
To prohibit the open-air cultivation of genetically engineered
pharmaceutical and industrial crops, to prohibit the use of common
human food or animal feed as the host plant for a genetically
engineered pharmaceutical or industrial chemical, to establish a
tracking system to regulate the growing, handling, transportation, and
disposal of pharmaceutical and industrial crops and their byproducts to
prevent human, animal, and general environmental exposure to
genetically engineered pharmaceutical and industrial crops and their
byproducts, to amend the Federal Food, Drug, and Cosmetic Act with
respect to the safety of genetically engineered foods, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 2, 2011
Mr. Kucinich (for himself, Mr. Grijalva, and Mr. Stark) introduced the
following bill; which was referred to the Committee on Agriculture, and
in addition to the Committee on Energy and Commerce, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To prohibit the open-air cultivation of genetically engineered
pharmaceutical and industrial crops, to prohibit the use of common
human food or animal feed as the host plant for a genetically
engineered pharmaceutical or industrial chemical, to establish a
tracking system to regulate the growing, handling, transportation, and
disposal of pharmaceutical and industrial crops and their byproducts to
prevent human, animal, and general environmental exposure to
genetically engineered pharmaceutical and industrial crops and their
byproducts, to amend the Federal Food, Drug, and Cosmetic Act with
respect to the safety of 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Genetically
Engineered Safety Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--GENETICALLY ENGINEERED PHARMACEUTICAL AND INDUSTRIAL CROP
SAFETY
Sec. 101. Short title.
Sec. 102. Findings.
Sec. 103. Definitions.
Sec. 104. Regulation of production of pharmaceutical crops and
industrial crops.
Sec. 105. Civil penalties for violation.
Sec. 106. Report to Congress on alternative methods to produce
pharmaceutical and industrial crops.
TITLE II--GENETICALLY ENGINEERED FOOD SAFETY
Sec. 201. Short title.
Sec. 202. Findings.
Sec. 203. Federal determination of safety of genetically engineered
food; regulation as food additive.
Sec. 204. User fees regarding determination of safety of genetic food
additives.
Sec. 205. Embargo authority.
Sec. 206. Rulemaking; effective date; previously unregulated marketed
additives.
TITLE I--GENETICALLY ENGINEERED PHARMACEUTICAL AND INDUSTRIAL CROP
SAFETY
SEC. 101. SHORT TITLE.
This title may be cited as the ``Genetically Engineered
Pharmaceutical and Industrial Crop Safety Act of 2011''.
SEC. 102. FINDINGS.
Congress finds the following:
(1) A pharmaceutical crop or industrial crop is a plant
that has been genetically engineered to produce a medical or
industrial product, including a human or veterinary drug,
biologic, industrial, or research chemical, or enzyme.
(2) The Department of Agriculture has issued more than 270
permits for more than 300 outdoor field trials of plants
genetically engineered to produce experimental pharmaceuticals,
industrial enzymes and novel proteins. More than 80 percent of
the field trial permits involved feed crops, including corn,
soybeans, rice, safflower, barley, alfalfa, mustard greens,
peas, sugarcane, tomatoes, and wheat.
(3) Many of the novel substances produced in pharmaceutical
crops and industrial crops exhibit high levels of biological
activity and are intended to be used for particular medical or
industrial purposes, under very controlled circumstances. None
of these substances is intended to be incorporated in food or
to be spread into the environment.
(4) The magnitude of the risks posed by pharmaceutical
crops and industrial crops depends on many factors, including
the chemicals involved, the organisms or environments exposed,
and the level and duration of the exposure. Humans, animals,
and the environment at large could be at risk from
contamination, a major concern of which is that bioactive
nonfood substances, which have not been tested, will
contaminate or otherwise adversely affect the food supply.
Substances intended for use as human drugs are especially
problematic because they are intended to be biologically active
in people.
(5) Pharmaceutical crops and industrial crops also pose
substantial liability and other economic risks to farmers,
grain handlers, food companies, and other persons in the food
and feed supply chain. These risks include liability for
contamination episodes, costly food recalls, losses in export
markets, reduced prices for a contaminated food or feed crop,
and loss of confidence in the safety of the American food
supply among foreign importers and consumers of American
agricultural commodities.
(6) These risks necessitate a zero tolerance standard for
the presence of pharmaceutical crops and industrial crops and
their byproducts in crops used to produce human food or animal
feed.
(7) While there presently exists a pro forma zero tolerance
standard, the Department of Agriculture and experts in the
field acknowledge that contamination of human food and animal
feed is inevitable due to the inherent imprecision of
biological and agricultural systems, as well as the laxity of
the regulatory regime. This is illustrated, for example, in the
Department of Agriculture's regulations, which aim not for
prevention (recognized as unattainable), but rather mitigation
of the gene flow that results in contamination of food/feed
crops with these substances. Some experts in the field are
calling for establishment of tolerances, despite the potential
risks involved.
(8) The rapidly emerging field of synthetic biology is an
extreme form of genetic engineering that has been heralded as a
remedy for numerous societal ills ranging from climate change
to environmental pollutants. The goal of synthetic biology is
to create life from scratch with synthetic DNA or without the
use of DNA entirely. DNA is synthesized by a computer is then
inserted into organisms. There are a range of practices which
can be classified as synthetic biology, but such practices are
more commonly defined as the design and construction of new
biological parts, devices and systems that do not exist in the
natural world and also the redesign of existing biological
systems to perform specific tasks.
(9) Proponents of synthetic biology are developing products
that they may soon seek approval for entry into the food supply
of the United States.
(10) Therefore, appropriate regulatory controls, as
established by this title, are urgently needed to ensure that
the byproducts of pharmaceutical crops, industrial crops and
organisms created as a result of synthetic biology, as well as
their byproducts, do not enter human food or animal feed crops
at any level.
SEC. 103. DEFINITIONS.
In this title:
(1) The term ``genetically engineered plant'' means a plant
that contains a genetically engineered material or was produced
from a genetically engineered seed. A plant shall be considered
to contain a genetically engineered material if the plant has
been injected or otherwise treated with a genetically
engineered material (except that the use of manure as a
fertilizer for the plant may not be construed to mean that the
plant is produced with a genetically engineered material).
(2) The term ``genetically engineered material'' means
material 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, introducing a foreign gene, and changing
the positions of genes), other than a means consisting
exclusively of breeding, conjugation, fermentation,
hybridization, in vitro fertilization, tissue culture, or
mutagenesis.
(3) The term ``genetically engineered seed'' means a seed
that contains a genetically engineered material or was produced
with a genetically engineered material. A seed shall be
considered to contain a genetically engineered material or to
have been produced with a genetically engineered material if
the seed (or the plant from which the seed is derived) has been
injected or otherwise treated with a genetically engineered
material (except that the use of manure as a fertilizer for the
plant may not be construed to mean that any resulting seeds are
produced with a genetically engineered material).
(4) The term ``pharmaceutical crop'' means a genetically
engineered plant that is designed to produce medical products,
including human and veterinary drugs and biologics. The term
includes a crop intentionally treated with genetically
engineered material that, in turn, produces a medical
substance.
(5) The term ``industrial crop'' means a genetically
engineered plant that is designed to produce industrial
products, including industrial and research chemicals and
enzymes. The term includes a crop intentionally treated with
genetically engineered material that, in turn, produces an
industrial substance.
SEC. 104. REGULATION OF PRODUCTION OF PHARMACEUTICAL CROPS AND
INDUSTRIAL CROPS.
(a) Temporary Moratorium Pending Regulations.--No pharmaceutical
crop or industrial crop may be grown, raised, or otherwise cultivated
until the final regulations and tracking system required by this
section are in effect.
(b) Prohibition on Open-Air Cultivation.--No person may grow, raise
or otherwise cultivate a pharmaceutical crop or industrial crop in an
open air environment.
(c) Prohibition on Use of Common Human Foods or Animal Feeds.--No
person may grow, raise, or otherwise cultivate a pharmaceutical crop or
industrial crop in a food commonly used for human food or domestic
animal feed.
(d) Biotech Tracking System.--The United States Department of
Agriculture shall establish a tracking system to regulate the growing,
handling, transportation, and disposal of all pharmaceutical and
industrial crops and their byproducts to prevent contamination.
(e) Regulations.--The Secretary of Agriculture shall issue
regulations--
(1) to enforce the prohibitions imposed by subsections (b)
and (c);
(2) to designate the foods commonly used for human food or
domestic animal feed, the use of which as a source of a
pharmaceutical crop or industrial crop is prohibited by
subsection (c); and
(3) to establish the tracking system required by subsection
(d).
SEC. 105. CIVIL PENALTIES FOR VIOLATION.
(a) Authority To Access Penalties.--The Secretary of Agriculture
may assess, by written order, a civil penalty against a person that
violates a provision of section 105, including a regulation promulgated
or order issued under such section. Each violation, and each day during
which a violation continues, shall be a separate offense.
(b) Amount and Factors in Accessing Penalties.--The maximum amount
that may be accessed under this section for a violation may not exceed
$1,000,000. In determining the amount of the civil penalty, the
Secretary shall take into account--
(1) the gravity of the violation;
(2) the degree of culpability;
(3) the size and type of the business; and
(4) any history of prior offenses under such section or
other laws administered by the Secretary.
(c) Notice and Opportunity for Hearing.--The Secretary shall not
assess a civil penalty under this section against a person unless the
company is given notice and opportunity for a hearing on the record
before the Secretary in accordance with sections 554 and 556 of title
5, United States Code.
(d) Judicial Review.--(1) An order assessing a civil penalty
against a person under subsection (a) may be reviewed only in
accordance with this subsection. The order shall be final and
conclusive unless the person--
(A) not later than 30 days after the effective date of the
order, files a petition for judicial review in the United
States court of appeals for the circuit in which the person
resides or has its principal place of business or in the United
States Court of Appeals for the District of Columbia; and
(B) simultaneously sends a copy of the petition by
certified mail to the Secretary.
(2) The Secretary shall promptly file in the court a certified copy
of the record on which the violation was found and the civil penalty
assessed.
(e) Collection Action for Failure To Pay Assessment.--If a person
fails to pay a civil penalty after the order assessing the civil
penalty has become final and unappealable, the Secretary shall refer
the matter to the Attorney General, who shall bring a civil action to
recover the amount of the civil penalty in United States district
court. In the collection action, the validity and appropriateness of
the order of the Secretary imposing the civil penalty shall not be
subject to review.
SEC. 106. REPORT TO CONGRESS ON ALTERNATIVE METHODS TO PRODUCE
PHARMACEUTICAL AND INDUSTRIAL CROPS.
The National Academy of Sciences shall submit to Congress a report
that explores alternative methods to produce pharmaceuticals or
industrial chemicals that have the advantage of being conducted in
controlled production facilities and do not present the risk of
contamination.
TITLE II--GENETICALLY ENGINEERED FOOD SAFETY
SEC. 201. SHORT TITLE.
This title may be cited as the ``Genetically Engineered Food Safety
Act''.
SEC. 202. FINDINGS.
The Congress finds as follows:
(1) Genetic engineering is an artificial gene transfer
process wholly different from traditional breeding.
(2) Genetic engineering can be used to produce new versions
of virtually all plant and animal foods. Thus, within a short
time, the food supply could consist almost entirely of
genetically engineered products.
(3) This conversion from a food supply based on
traditionally bred organisms to one based on organisms produced
through genetic engineering could be one of the most important
changes in our food supply in this century.
(4) Genetically engineered foods present new issues of
safety that have not been adequately studied.
(5) The Congress has previously required that food
additives be analyzed for their safety prior to their placement
on the market.
(6) Adding new genes into a food should be considered
adding a food additive, thus requiring an analysis of safety
factors.
(7) Federal agencies have failed to uphold congressional
intent of the Food Additives Amendment of 1958 by allowing
genetically engineered foods to be marketed, sold and otherwise
used without requiring pre-market safety testing addressing
their unique characteristics.
(8) The food additive process gives the Food and Drug
Administration discretion in applying the safety factors that
are generally recognized as appropriate to evaluate the safety
of food and food ingredients.
(9) Given the consensus among the scientific community that
genetic engineering can potentially introduce hazards, such as
allergens or toxins, genetically engineered foods need to be
evaluated on a case-by-case basis and cannot be presumed to be
generally recognized as safe.
SEC. 203. FEDERAL DETERMINATION OF SAFETY OF GENETICALLY ENGINEERED
FOOD; REGULATION AS FOOD ADDITIVE.
(a) Inclusion in Definition of Food Additive.--Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
(1) in paragraph (s), by adding after and below
subparagraph (6) the following sentence:
``Such term includes the different genetic constructs, proteins of such
constructs, vectors, promoters, marker systems, and other appropriate
terms that are used or created as a result of the creation of a
genetically engineered food (as defined in paragraph (ss)), other than
a genetic construct, protein, vector, promoter, or marker system or
other appropriate term for which an application under section 505 or
512 has been filed. For purposes of this Act, the term `genetic food
additive' means a genetic construct, protein, vector, promoter, or
marker system or other appropriate term that is so included.''; and
(2) by adding at the end the following:
``(ss)(1) The term `genetically engineered food' means food that
contains or was produced with a genetically engineered material.
``(2) 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.
``(3) The term `genetically engineered organism' means--
``(A) an organism that has been altered at the molecular or
cellular level by means that are not possible under natural
conditions or processes (including but not limited to
recombinant DNA and RNA techniques, cell fusion,
microencapsulation, macroencapsulation, gene deletion and
doubling, introducing a foreign gene, and changing the
positions of genes), other than a means consisting exclusively
of breeding, conjugation, fermentation, hybridization, in vitro
fertilization, tissue culture, or mutagenesis; and
``(B) an organism made through sexual or asexual
reproduction (or both) involving an organism described in
clause (A), if possessing any of the altered molecular or
cellular characteristics of the organism so described.
``(4) For purposes of subparagraph (1), a food shall be considered
to have been produced with a genetically engineered material if 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 mean that such commodities are produced with a genetically
engineered material).''.
(b) Petition To Establish Safety.--
(1) Data in petition.--Section 409(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(2)) is amended
by adding after and below subparagraph (E) the following
sentence:
``In the case of a genetic food additive, such reports shall include
all data that was collected or developed pursuant to the
investigations, including data that does not support the claim of
safety for use.''.
(2) Notices; public availability of information.--Section
409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 348(b)(5)) is amended--
(A) by striking ``(5)'' and inserting ``(5)(A)'';
and
(B) by adding at the end the following
subparagraphs:
``(B) In the case of a genetic food additive:
``(i) Promptly after providing the notice under
subparagraph (A), the Secretary shall make available to the
public all reports and data described in paragraph (2)(E) that
are contained in the petition involved, and all other
information in the petition to the extent that the information
is relevant to a determination of the safety for use of the
additive.
``(ii) Such notice shall state whether any information in
the petition is not being made available to the public because
the Secretary has made a determination that the information
does not relate to the safety for use of the additive. Any
person may petition the Secretary for a reconsideration of such
a determination.
``(C) In the case of genetic food additives:
``(i) The Secretary shall maintain and make available to
the public through telecommunications a list of petitions that
are pending under this subsection and a list of petitions for
which regulations under subsection (c)(1)(A) have been
established. Such list shall include information on the
additives involved, including the source of the additives, and
including any information received by the Secretary pursuant to
clause (ii).
``(ii) If a regulation is in effect under subsection
(c)(1)(A) for a genetic food additive, any person who
manufactures such additive for commercial use shall submit to
the Secretary a notification of any knowledge of data that
relate to the adverse health effects of the additive, when
knowledge is acquired by the person after the date on which the
regulation took effect. If the manufacturer is in possession of
the data, the notification shall include the data. The
Secretary shall by regulation establish the scope of the
responsibilities of manufacturers under this clause, including
such limits on the responsibilities as the Secretary determines
to be appropriate.''.
(3) Effective date of regulation regarding safe use;
opportunity for public comment.--Section 409(c)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)(2)) is
amended--
(A) by striking ``(2)'' and inserting ``(2)(A)'';
and
(B) by adding at the end the following
subparagraph:
``(B)(i) In the case of a genetic food additive, an order under
paragraph (1)(A) may not be issued regarding the petition involved
before the expiration of the applicable period under clause (ii).
During such period, and continuing until an order under paragraph (1)
is issued, the Secretary shall provide interested persons an
opportunity to submit to the Secretary comments on the petition. In
publishing such notice, the Secretary shall inform the public of such
opportunity.
``(ii) For purposes of clause (i), the applicable period under this
clause regarding a petition is the 30-day period beginning on the date
on which the Secretary has under subparagraph (B)(i) of subsection
(b)(5) made information available to the public regarding the petition,
except that, if under subparagraph (B)(ii) of such subsection the
Secretary finds in favor of a person who files for reconsideration
(relating to a determination by the Secretary that information does not
relate to safety), such 30-day period is extended by an additional
period of 30-days. For purposes of the preceding sentence, a discrete
30-day extension applies to each such reconsideration for which the
Secretary finds in favor of the person filing for reconsideration.''.
(4) Consideration of certain factors.--Section 409(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)) is
amended by adding at the end the following paragraph:
``(6) In the case of a genetic food additive, the factors
considered by the Secretary regarding safety for use shall include (but
not be limited to) the results of the following analyses:
``(A) Allergenicity effects resulting from the added
proteins, including proteins not found in the food supply.
``(B) Pleiotropic effects. The Secretary shall require
tests to determine the potential for such effects (using
molecular characterization, biochemical characterization, mRNA
profiling, or other techniques, or as appropriate, combinations
of such techniques).
``(C) Appearance of new toxins or increased levels of
existing toxins.
``(D) Changes in the functional characteristics of food.
``(E) Changes in the levels of important nutrients.
``(F) Changes in the levels of anti-nutrients.''.
(5) Certain tests.--Section 409(c) of the Federal Food,
Drug, and Cosmetic Act, as amended by paragraph (4), is amended
by adding at the end the following paragraph:
``(7) In the case of genetic food additives:
``(A) If a genetic food additive is a protein from a
commonly or severely allergenic food, the Secretary may not
establish a regulation under paragraph (1)(A) if the petition
under subsection (b)(1) fails to include full reports of
investigations that used serum or skin tests (or other advanced
techniques) on a sensitive population to determine whether such
additive is commonly or severely allergenic.
``(B)(i) If a genetic food additive is a protein that has
not undergone the investigations described in subparagraph (A),
the Secretary may not establish a regulation under paragraph
(1)(A) if the petition under subsection (b)(1) fails to include
full reports of investigations that used the best available
biochemical and physiological protocols to evaluate whether it
is likely that the protein involved is an allergen.
``(ii) For purposes of clause (i), the Secretary shall by
regulation determine the best available biochemical and
physiological protocols. In carrying out rulemaking under the
preceding sentence, the Secretary shall consult with the
Director of the National Institutes of Health.''.
(6) Prohibited additives.--Section 409(c) of the Federal
Food, Drug, and Cosmetic Act, as amended by paragraph (5), is
amended by adding at the end the following paragraph:
``(8) In the case of a genetic food additive, the Secretary may not
establish a regulation under paragraph (1)(A) if--
``(A) the additive is a protein and a report of an
investigation finds that the additive is likely to be commonly
or severely allergenic;
``(B) the additive is a protein and a report of an
investigation that uses a protocol described in paragraph
(7)(B) fails to find with reasonable certainty that the
additive is unlikely to be an allergen; or
``(C) effective June 1, 2006, a selective marker is used
with respect to the additive, the selective marker will remain
in the food involved when the food is marketed, and the
selective marker inhibits the function of one or more
antibiotics.''.
(7) Additional provisions.--Section 409(c) of the Federal
Food, Drug, and Cosmetic Act, as amended by paragraph (6), is
amended by adding at the end the following paragraph:
``(9)(A) In determining the safety for use of genetic food
additives, the Secretary may (directly or through contract) conduct
investigations of such additives for purposes of supplementing the
information provided to the Secretary pursuant to petitions under
subsection (b)(1).
``(B) To provide the Congress with a periodic independent, external
review of the Secretary's formulation of the approval process under
paragraph (1)(A) that relates to genetic food additives, the Secretary
shall enter into an agreement with the Institute of Medicine. Such
agreement shall provide that, if the Institute of Medicine has any
concerns regarding the approval process, the Institute of Medicine will
submit to the Congress a report describing such concerns.''.
(c) Regulation Issued on Secretary's Initiative.--Section 409(d) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(d)) is
amended--
(1) by striking ``(d) The Secretary'' and inserting
``(d)(1) Subject to paragraph (2), the Secretary''; and
(2) by adding at the end the following paragraph:
``(2) The provisions of subsections (b) and (c) that expressly
reference genetic food additives apply with respect to a regulation
proposed by the Secretary under paragraph (1) to the same extent and in
the same manner as such provisions apply with respect to a petition
filed under subsection (b)(1).''.
(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 the adulteration of food by reason of failure to
comply with the provisions of section 409 that relate to genetic food
additives, any person engaging in such a violation shall be liable to
the United States for a civil penalty in an amount not to exceed
$100,000 for each such violation.
``(2) Paragraphs (5) through (7) of subsection (f) apply with
respect to a civil penalty under paragraph (1) of this subsection to
the same extent and in the same manner as such paragraphs (5) through
(7) apply with respect to a civil penalty under paragraph (1), (2),
(3), (4), or (9) of subsection (f).''.
(e) Citizen Suits.--Chapter III of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end
the following section:
``SEC. 311. CITIZEN SUITS REGARDING GENETIC FOOD ADDITIVES.
``(a) In General.--Except as provided in subsection (c), any person
may on his or her behalf commence a civil action in an appropriate
district court of the United States against--
``(1) a person who is alleged to have engaged in a
violation of section 301(a), 301(b), or 301(c) involving the
adulteration of food by reason of failing to comply with the
provisions of section 409 that relate to genetic food
additives; or
``(2) the Secretary where there is alleged a failure of the
Secretary to perform any act or duty under section 409 that
relates to such additives and is not discretionary.
``(b) Relief.--In a civil action under subsection (a), the district
court involved may, as the case may be--
``(1) enforce the compliance of a person with the
applicable provisions referred to paragraph (1) of such
subsection; or
``(2) order the Secretary to perform an act or duty
referred to in paragraph (2) of such subsection.
``(c) Limitations.--
``(1) Notice to secretary.--A civil action may not be
commenced under subsection (a)(1) prior to 60 days after the
plaintiff has provided to the Secretary notice of the violation
involved.
``(2) Relation to actions of secretary.--A civil action may
not be commenced under subsection (a)(2) if the Secretary has
commenced and is diligently prosecuting a civil or criminal
action in a district court of the United States to enforce
compliance with the applicable provisions referred to in
subsection (a)(1).
``(d) Right of Secretary To Intervene.--In any civil action under
subsection (a), the Secretary, if not a party, may intervene as a
matter of right.
``(e) Award of Costs; Filing of Bond.--In a civil action under
subsection (a), the district court involved may award costs of
litigation (including reasonable attorney and expert witness fees) to
any party whenever the court determines such an award is appropriate.
The court may, if a temporary restraining order or preliminary
injunction is sought, require the filing of a bond or equivalent
security in accordance with the Federal Rules of Civil Procedure.
``(f) Savings Provision.--This section does not restrict any right
that a person (or class of persons) may have under any statute or
common law to seek enforcement of the provisions referred to subsection
(a)(1), or to seek any other relief (including relief against the
Secretary).''.
(f) Rule of Construction.--With respect to section 409 of the
Federal Food, Drug, and Cosmetic Act as amended by this section,
compliance with the provisions of such section 409 that relate to
genetic food additives does not constitute an affirmative defense in
any cause of action under Federal or State law for personal injury
resulting in whole or in part from a genetic food additive.
SEC. 204. USER FEES REGARDING DETERMINATION OF SAFETY OF GENETIC FOOD
ADDITIVES.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended by inserting after section 409 the following
section:
``SEC. 409A. USER FEES REGARDING SAFETY OF GENETIC FOOD ADDITIVES.
``(a) In General.--In the case of genetic food additives, the
Secretary shall in accordance with this section assess and collect a
fee on each petition that is filed under section 409(b)(1). The fee
shall be collected from the person who submits the petition, is due
upon submission of the petition, and shall be assessed in an amount
determined under subsection (c). This section applies as of the first
fiscal year that begins after the date of promulgation of the final
rule required in section 206 of the Genetically Engineered Food Safety
Act (referred to in this section as the `first applicable fiscal
year').
``(b) Purpose of Fees.--
``(1) In general.--The purposes of fees under subsection
(a) are as follows:
``(A) To defray increases in the costs of the
resources allocated for carrying out section 409 for
the first applicable fiscal year over the costs of
carrying out such section for the preceding fiscal
year, other than increases that are not attributable to
the responsibilities of the Secretary with respect to
genetic food additives.
``(B) To provide for a program of basic and applied
research on the safety of genetic food additives (to be
carried out by the Commissioner). The program shall
address fundamental questions and problems that arise
repeatedly during the process of reviewing petitions
under section 409(b)(1) with respect to genetic food
additives, and shall not directly support the
development of new genetically engineered foods.
``(2) Allocations by secretary.--Of the total fee revenues
collected under subsection (a) for a fiscal year, the Secretary
shall reserve and expend--
``(A) 95 percent for the purpose described in
paragraph (1)(A); and
``(B) 5 percent for the purpose described in
paragraph (1)(B).
``(3) Certain provisions regarding increased administrative
costs.--With respect to fees under subsection (a):
``(A) Increases referred to in paragraph (1)(A)
include the costs of the Secretary in providing for
investigations under section 409(c)(9)(A).
``(B) Increases referred to in paragraph (1)(A)
include increases in costs for an additional number of
full-time equivalent positions in the Department of
Health and Human Services to be engaged in carrying out
section 409 with respect to genetic food additives.
``(c) Total Fee Revenues; Individual Fee Amounts.--The total fee
revenues collected under subsection (a) for a fiscal year shall be the
amounts appropriated under subsection (f)(2) for such fiscal year.
Individual fees shall be assessed by the Secretary on the basis of an
estimate by the Secretary of the amount necessary to ensure that the
sum of the fees collected for such fiscal year equals the amount so
appropriated. In assessing the individual fees, the Secretary shall by
regulation provide for the assessment of reduced fee amounts for
entities that are small businesses, or nonprofit private entities, as
defined by the Secretary for purposes of this section.
``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver
from or a reduction of a fee assessed under subsection (a) if the
Secretary finds that the fee to be paid will exceed the anticipated
present and future costs incurred by the Secretary in carrying out the
purposes described in subsection (b) (which finding may be made by the
Secretary using standard costs).
``(e) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after the first
applicable fiscal year unless the amount appropriated for
salaries and expenses of the Food and Drug Administration for
such fiscal year is equal to or greater than the amount
appropriated for salaries and expenses of the Food and Drug
Administration for the first applicable fiscal year multiplied
by the adjustment factor applicable to the fiscal year
involved, except that in making determinations under this
paragraph for the fiscal years involved there shall be
excluded--
``(A) the amounts appropriated under subsection
(f)(2) for the fiscal years involved; and
``(B) the amounts appropriated under sections
736(g), 738(h), 740(g), and 741(g) for such fiscal
years.
``(2) Authority.--If under paragraph (1) the Secretary does
not have authority to assess fees under subsection (a) during a
portion of a fiscal year, but does at a later date in such
fiscal year have such authority, the Secretary, notwithstanding
the due date under such subsection for fees, may assess and
collect such fees at any time in such fiscal year, without any
modification in the rate of the fees.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees collected for a fiscal year
pursuant to subsection (a) shall be credited to the
appropriation account for salaries and expenses of the Food and
Drug Administration and shall be available in accordance with
appropriation Acts until expended without fiscal year
limitation. Such sums as may be necessary may be transferred
from the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for the purposes described in paragraph (1) of
subsection (b), and the sums are subject to allocations under
paragraph (2) of such subsection.
``(2) Authorization of appropriations.--
``(A) First fiscal year.--For the first applicable
fiscal year--
``(i) there is authorized to be
appropriated for fees under subsection (a) an
amount equal to the amount of increase
determined under subsection (b)(1)(A) by the
Secretary (which amount shall be published in
the Federal Register); and
``(ii) in addition, there is authorized to
be appropriated for fees under subsection (a)
an amount determined by the Secretary to be
necessary to carry out the purpose described in
subsection (b)(1)(B) (which amount shall be so
published).
``(B) Subsequent fiscal years.--For each of the
four fiscal years following the first applicable fiscal
year--
``(i) there is authorized to be
appropriated for fees under subsection (a) an
amount equal to the amount that applied under
subparagraph (A)(i) for the first applicable
fiscal year, except that such amount shall be
adjusted under paragraph (3)(A) for the fiscal
year involved; and
``(ii) in addition, there is authorized to
be appropriated for fees under subsection (a)
an amount equal to the amount that applied
under subparagraph (A)(ii) for the first
applicable fiscal year, except that such amount
shall be adjusted under paragraph (3)(B) for
the fiscal year involved.
``(3) Adjustments.--
``(A) Agency cost of resources.--For each fiscal
year other than the first applicable fiscal year, the
amount that applied under paragraph (2)(A)(i) for the
first applicable fiscal year shall be multiplied by the
adjustment factor (as defined in subsection (i)).
``(B) Research program.--For each fiscal year other
than the first applicable fiscal year, the amount that
applied under paragraph (2)(A)(ii) for the first
applicable fiscal year shall be adjusted by the
Secretary (and as adjusted shall be published in the
Federal Register) to reflect the greater of--
``(i) the total percentage change that
occurred during the preceding fiscal year in
the Consumer Price Index for all urban
consumers (all items; U.S. city average); or
``(ii) the total percentage change for such
fiscal year in basic pay under the General
Schedule in accordance with section 5332 of
title 5, United States Code, as adjusted by any
locality-based comparability payment pursuant
to section 5304 of such title for Federal
employees stationed in the District of
Columbia.
``(4) Offset.--Any amount of fees collected for a fiscal
year under subsection (a) that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for a subsequent fiscal year.
``(g) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of
title 31, United States Code.
``(h) Construction.--This section may not be construed as requiring
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employers, and advisory
committees not engaged in carrying out section 409 with respect to
genetic food additives be reduced to offset the number of officers,
employees, and advisory committees so engaged.
``(i) Definition of Adjustment Factor.--For purposes of this
section, the term `adjustment factor' applicable to a fiscal year is
the lower of--
``(1) the Consumer Price Index for all urban consumers (all
items; United States city average) for April of the preceding
fiscal year divided by such Index for April of the first
applicable fiscal year; or
``(2) the total of discretionary budget authority provided
for programs in categories other than the defense category for
the immediately preceding fiscal year (as reported in the
Office of Management and Budget sequestration preview report,
if available, required under section 254(c) of the Balanced
Budget and Emergency Deficit Control Act of 1985) divided by
such budget authority for the first applicable fiscal year (as
reported in the Office of Management and Budget final
sequestration report submitted for such year).
For purposes of this subsection, the terms `budget authority' and
`category' have the meaning given such terms in the Balanced Budget and
Emergency Deficit Control Act of 1985.''.
SEC. 205. EMBARGO AUTHORITY.
(a) Embargo.--
(1) Temporary detention.--Section 304(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)(1)) is amended--
(A) in the first sentence--
(i) by striking ``If during'' and all that
follows through ``order the device or tobacco
product detained'' and inserting the following:
``If, during an inspection conducted under
section 704, an officer or employee of the
Department has reason to believe that a food,
device, or tobacco product is in violation of
this Act, such officer or employee may order
the food, device, or tobacco product
detained''; and
(ii) by striking ``he may authorize'' and
inserting ``the Secretary may authorize'';
(B) in the second and third sentences, by striking
``device or tobacco product'' each place it appears and
inserting ``food, device, or tobacco product'';
(C) by striking the fourth and fifth sentences; and
(D) by adding at the end the following sentence:
``A detention order under this paragraph shall be
considered final agency action.''.
(2) Conforming amendments.--Chapter III of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is
amended--
(A) in section 301(r)--
(i) by striking ``device or tobacco
product'' the first place such term appears and
inserting ``food, device, or tobacco product'';
and
(ii) by striking ``the device or tobacco
product'' and inserting ``such food, device, or
tobacco product''; and
(B) in section 304(g)(2)--
(i) in subparagraph (A), by striking
``device or tobacco product'' and inserting
``food, device, or tobacco product''; and
(ii) in subparagraph (B), by striking
``device'' each place it appears and inserting
``food or device''.
(b) Date Certain for Proposed and Final Rules.--Within six months
of the date of the enactment of this title, the Secretary of Health and
Human Services shall propose a revision to the regulations in effect on
such date under section 304(g) of the Federal Food, Drug, and Cosmetic
Act to include food. Within three months of the date such proposed
revision is published in the Federal Register, the Secretary shall
issue a final revision of such regulations.
(c) Confidentiality.--For any food embargoed, seized, or recalled
under the Federal Food, Drug, and Cosmetic Act, the Food and Drug
Administration shall disclose all necessary information without regard
to business confidentiality, if such disclosure is necessary to fully
embargo, seize, or recall any adulterated food.
(d) Food Retailer Registration.--All food retailers shall register
with the Food and Drug Administration for the purpose of expediting
recalls, embargoes, and seizures under the Federal Food, Drug, and
Cosmetic Act.
SEC. 206. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UNREGULATED MARKETED
ADDITIVES.
(a) Rulemaking; Effective Date.--Not later than one year after the
date of the enactment of this title, the Secretary of Health and Human
Services shall by regulation establish criteria for carrying out
section 409 of the Federal Food, Drug, and Cosmetic Act in accordance
with the amendments made by section 203, and criteria for carrying out
section 409A of such Act (as added by section 204). Such amendments
take effect upon the expiration of the 30-day period beginning on the
date on which the Secretary promulgates the final rule under the
preceding sentence, subject to subsection (b).
(b) Previously Unregulated Marketed Additives.--
(1) In general.--In the case of a genetic food additive (as
defined pursuant to the amendments made by section 203) that in
the United States was in commercial use in food as of the day
before the date on which the final rule under subsection (a) is
promulgated, the amendments made by this title apply to the
additive upon the expiration of the two-year period beginning
on the date on which the final rule is promulgated, subject to
paragraph (2).
(2) User fees.--With respect to a genetic food additive
described in paragraph (1), such paragraph does not waive the
applicability of section 409A of the Federal Food, Drug, and
Cosmetic Act to a petition under section 409(b)(1) of such Act
that is filed before the expiration of the two-year period
described in such paragraph.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Agriculture, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Agriculture, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture.
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