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[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>
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