2015 -- H 5078

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LC000023

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2015

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A N   A C T

RELATING TO FOOD AND DRUGS -- GENETICALLY ENGINEERED FOOD

     

     Introduced By: Representatives Hull, MacBeth, Bennett, Handy, and Slater

     Date Introduced: January 14, 2015

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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     SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 37

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GENETICALLY ENGINEERED FOOD

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     21-37-1. Definitions. -- For the purposes of this chapter, the following terms shall have

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the meanings hereinafter specified:

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     (1) "Advertisement" means all representations disseminated in any manner or by any

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means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly

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or indirectly, the purchase of food, drugs, devices or cosmetics.

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     (2)(i) "Color additive" means a material which:

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     (A) Is a dye, pigment or other substance made by a process of synthesis or similar

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artifice, or extracted, isolated or otherwise derived, with or without intermediate or final change

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of identity, from a vegetable, animal, mineral or other source; and

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     (B) When added or applied to a food, drug or cosmetic, or to the human body or any of

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its parts, is capable, alone or through reaction with other substance(s), of imparting color thereto,

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except that the term "color additive" does not include any material exempted by regulation under

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the federal act, or which the commissioner, by regulation, determines is used, or intended to be

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used, solely for a purpose or purposes other than coloring;

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     (ii) The term "color" includes black, white and intermediate grays, as well as all other

 

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colors;

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     (iii) Nothing in subsection (2)(i) of this section shall be construed to apply to any

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pesticide chemical, soil or plant nutrient, or other agricultural chemical used, or intended to be

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used, solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly,

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the growth or other natural physiological processes of produce of the soil which thereby affects

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its color, whether before or after harvest.

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     (3) "Contaminated with filth" applies to any food, drug, device or cosmetic not securely

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protected from dust or dirt, and as far as may be necessary, by all reasonable means, from all

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foreign or injurious contaminations.

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     (4) "Cosmetic" means articles intended to be rubbed, poured, sprinkled or sprayed on,

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introduced into, or otherwise applied to the human body or any of its parts for cleansing,

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beautifying, promoting attractiveness or altering the appearance, and articles intended for use as a

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component of any such articles, except that such term shall not include soap.

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     (5) "Device" means instruments, apparatus and contrivances, including their components,

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parts and accessories, intended:

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     (i) For use in the diagnosis, cure, mitigation, treatment or prevention of disease in persons

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or other animals, or

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     (ii) To affect the structure or any function of the body of persons or other animals.

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     (6) "Director" means the director of health or the director's duly appointed agents.

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     (7) "Distributor" means a person or entity that sells, supplies, furnishes or transports food

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intended for human consumption in this state that such person or entity does not produce.

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     (8) "Drug" means:

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     (i) Articles recognized in the official United States Pharmacopoeia, official Homeopathic

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Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of

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them;

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     (ii) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of

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disease in persons or other animals;

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     (iii) Articles, other than food, intended to affect the structure or any function of the body

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of persons or any other animal; and

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     (iv) Articles intended for use as a component of any articles specified in this subdivision;

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but shall not include devices or their components, parts or accessories.

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     (9) "Enzyme" means a protein that catalyzes chemical reactions of other substances

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without being destroyed or altered upon completion of such reactions.

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     (10) "Federal act" means the Federal Food, Drug and Cosmetic Act, as amended, Title 21

 

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U.S.C. 301 et seq.; 52 Stat. 1040 et seq.

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     (11) "Food" means:

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     (i) Articles used for food or drink for persons or other animals;

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     (ii) Chewing gum;

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     (iii) Infant formula; and

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     (iv) Articles used for components of any such article.

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     (12) "Food additive" means any substance the intended use of which results or reasonably

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may be expected to result, directly or indirectly, in its becoming a component or otherwise

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affecting the characteristics of any food, including any substance intended for use in producing,

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manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food;

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and including any source of radiation intended for any such use, if such substance is not generally

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recognized, among experts qualified by scientific training and experience to evaluate its safety, as

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having been adequately shown through scientific procedures or, in the case of a substance used in

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food prior to January 1, 1958, through either scientific procedures or experience based on

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common use in food, to be safe under the conditions of its intended use, except that such term

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does not include:

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     (i) A pesticide chemical in or on a raw agricultural commodity;

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     (ii) A pesticide chemical to the extent that it is intended for use or is used in the

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production, storage or transportation of any raw agricultural commodity;

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     (iii) A color additive;

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     (iv) Any substance used in accordance with a sanction or approval granted prior to June

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12, 1963, or the federal Food, Drug and Cosmetic Act, the Poultry Products Inspection Act 21

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U.S.C. 451 et seq., or the Meat Inspection Act of March 4, 1907, as amended, 21 U.S.C. 601 et

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seq.

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     (13) "Genetic engineering" means a process by which a food or food ingredient that is

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produced from an organism or organisms in which the genetic material has been changed through

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the application of:

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     (i) In vitro nucleic acid techniques, including recombinant DNA (deoxyribonucleic acid)

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techniques and the direct injection of nucleic acid into cells or organelles; or

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     (ii) Fusion of cells, including protoplast fusion, or hybridization techniques that

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overcome natural physiological, reproductive or recombination barriers, where the donor cells or

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protoplasts do not fall within the same taxonomic group, in a way that does not occur by natural

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multiplication or natural recombination.

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     (14) "Immediate container" shall not include package liners.

 

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     (15) "Infant formula" means a milk-based or soy-based powder, concentrated liquid or

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ready-to-feed substitute for human breast milk that is intended for infant consumption and is

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commercially available.

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     (16) "Intrastate commerce" means any and all commerce within the state of Rhode Island

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and subject to its jurisdiction, and shall include the operation of any business or service

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establishment.

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     (17) "In vitro nucleic acid techniques" means techniques, including, but not limited to,

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recombinant deoxyribonucleic acid techniques, that use vector systems and techniques involving

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the direct introduction into organisms of hereditary materials prepared outside the organisms such

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as microinjection, macroinjection, chemoporation, electroporation, microencapsulation and

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liposome fusion.

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     (18) "Label" means a display of written, printed or graphic matter upon the immediate

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container of any article, provided a requirement made by or under authority of this chapter that

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any information or other word or statement appear on the label shall not be considered to be

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complied with unless such information or other word or statement also appears on the outside

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container or wrapper, if any, of the retail package of such article, or is easily legible through the

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outside container or wrapper.

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     (19) "Labeling" means all labels and other written, printed or graphic matter:

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     (i) Upon any article or any of its containers or wrappers; or

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     (ii) Accompanying such article; provided, if an article is alleged to be misbranded

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because the labeling is misleading, or if an advertisement is alleged to be false because it is

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misleading, then, in determining whether the labeling or advertisement is misleading, there shall

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be taken into account, among other things, not only representations made or suggested by

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statement, word, design, device or sound, or any combination thereof, but also the extent to which

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the labeling or advertisement fails to reveal facts material in the light of such representations or

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material with respect to consequences which may result from the use of the article to which the

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labeling or advertisement relates under the conditions of use prescribed in the labeling or

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advertisement thereof or under such conditions of use as are customary or usual, and provided the

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representation of a drug, in its labeling or advertisement, as an antiseptic shall be considered to be

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a representation that it is a germicide, except in the case of a drug purporting to be, or represented

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as, an antiseptic for inhibitory use as a wet dressing, ointment or dusting powder or for such other

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use as involves prolonged contact with the body.

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     (20) "Manufacturer" means a person who produces food intended for human

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consumption or seed or seed stock that is intended to produce food for human consumption and

 

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sells such item to a retailer or distributor.

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     (21) "Natural food" means food:

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     (i) Which has not been treated with preservatives, antibiotics, synthetic additives,

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artificial flavoring or artificial coloring;

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     (ii) Which has not been processed in a manner that makes such food significantly less

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nutritive; and

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     (iii) Which has not been genetically engineered. Processing of food by extracting,

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purifying, heating, fermenting, concentrating, dehydrating, cooling or freezing shall not, of itself,

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prevent the designation of such food as "natural food."

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     (22) "New drug" means:

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     (i) Any drug the composition of which is such that such drug is not generally recognized,

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among experts qualified by scientific training and experience to evaluate the safety and

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effectiveness of drugs, as safe and effective for use under the conditions prescribed,

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recommended or suggested in its labeling; or

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     (ii) Any drug the composition of which is such that such drug, as a result of investigation

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to determine its safety and effectiveness for use under such conditions, has become so recognized,

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but which has not, otherwise than in such investigations, been used to a material extent or for a

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material time under such conditions, except that the provisions of this subsection pertaining to

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"effectiveness" shall not apply to any drug which:

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     (A) Was commercially sold or used in the United States on October 9, 1962;

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     (B) Was not a new drug as defined by this subsection prior to the enactment of these

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provisions; and

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     (C) Was not covered by an effective application under Section 355 of the federal act,

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when such drug is intended solely for use under conditions prescribed, recommended, or

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suggested in labeling with respect to such drug on whichever of the above dates is applicable.

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     (23) "Official compendium" means the official United States Pharmacopoeia, official

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Homeopathic Pharmacopoeia of the United States, official National Formulary, or any

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supplement to any of them.

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     (24) "Organically grown" means produced through organic farming methods, which

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involve a system of ecological soil management and mechanical or biological methods to control

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insects, weeds, pathogens and other pests and which rely on crop rotation, crop residues,

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composted animal manures, legumes, green manures, composted organic waste or mineral-

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bearing rocks.

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     (25) "Organism" means any biological entity capable of replication, reproduction or

 

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transferring genetic material.

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     (26) "Person" includes any individual, partnership, corporation, limited liability company

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or association.

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     (27) "Pesticide chemical" means any substance which, alone, in chemical combination or

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in formulation with one or more other substances is an "economic poison" within the meaning of

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the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. 136 et seq., and which is used in

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the production, storage or transportation of raw agricultural commodities.

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     (28) "Processed food" means any food intended for human consumption other than a raw

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agricultural commodity and includes any such food produced from a raw agricultural commodity

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that has been processed through canning, smoking, pressing, cooking, freezing, dehydration,

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fermentation or milling.

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     (29) "Processing aid" means:

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     (i) Any substance that is added to a food intended for human consumption during the

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processing of such food but that is removed in some manner from the food before the food is

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packaged in a finished form;

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     (ii) Any substance that is added to such food during processing, that is converted into

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constituents normally present in the food, and that does not significantly increase the amount of

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the constituents naturally found in the food; or

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     (iii) Any substance that is added to such food for its technical or functional effect in the

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processing but that is present in the finished food at insignificant levels and that does not have

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any technical or functional effect in the finished food.

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     (30) "Raw agricultural commodity" means any food in its raw or natural state, including

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all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to

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marketing.

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     (31) "Retailer" means a person or entity that engages in the sale of food intended for

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human consumption to a consumer.

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     (32) "Safe" has reference to the health of persons or animals.

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     (33) "Sale" means any and every sale and includes:

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     (i) Manufacture, processing, packing, canning, bottling or any other production,

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preparation or putting up;

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     (ii) Exposure, offer or any other proffer;

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     (iii) Holding, storing or any other possessing;

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     (iv) Dispensing, giving, delivering, serving or any other supplying; and

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     (v) Applying, administering or any other using.

 

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     21-37-2. Genetically engineered food. -- (a) Food intended for human consumption, and

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seed or seed stock that is intended to produce food for human consumption, that is entirely or

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partially genetically-engineered, except a processed food subject to the provisions of this chapter

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solely because one or more processing aids or enzymes were produced or derived from genetic

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engineering, shall be labeled as follows:

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     (1) In the case of such food that is sold wholesale and is not intended for retail sale, on

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the bill of sale accompanying such food during shipping, with the clear and conspicuous words:

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"Produced with Genetic Engineering";

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     (2) In the case of such food for retail sale contained in a package, with the clear and

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conspicuous words: "Produced with Genetic Engineering";

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     (3) In the case of such food that is a raw agricultural commodity, on the package offered

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for retail sale or, in the case of any such commodity that is not separately packaged or labeled, on

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the bill of sale or invoice for such commodity and on the retail store shelf or bin that holds such

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commodity displayed for sale with the clear and conspicuous words: "Produced with Genetic

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Engineering"; and

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     (4) In the case of any such seed or seed stock, on the container holding the seed or seed

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stock displayed for sale or on any label identifying ownership or possession of the commodity

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with the clear and conspicuous words: "Produced with Genetic Engineering." Such food labeling

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shall be displayed in the same size and font as the ingredients in the nutritional facts panel on the

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food label.

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     (b) The requirements of this section shall not apply to any of the following:

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     (1) Alcoholic beverages;

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     (2) Food intended for human consumption that is not packaged for retail sale and that

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either:

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     (i) Is a processed food prepared and intended for immediate consumption; or

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     (ii) Is served, sold or otherwise provided in any restaurant or other food facility that is

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primarily engaged in the sale of food prepared and intended for immediate consumption;

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     (3) Farm products that are sold by a farmer or the farmer's agent to a consumer at a pick-

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your-own farm, roadside stand, on-farm market or farmers' market; and

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     (4) Food consisting entirely of, or derived entirely from, an animal that was not

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genetically engineered, regardless of whether such animal was fed or injected with any

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genetically-engineered food or any drug that was produced through means of genetic engineering.

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     (c) Any person selling, offering for sale or distributing in this state any food, seed or seed

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stock required to be labeled as provided in this chapter shall be responsible for ensuring that such

 

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food, seed or seed stock is so labeled.

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     21-37-3. Penalties for violations. -- (a) Any person found to knowingly violate this

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chapter shall be liable for a civil penalty not to exceed one thousand dollars ($1,000) per day, per

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product. Calculation of such civil penalty shall not be made or multiplied by the number of

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individual packages of the same product displayed or offered for retail sale. Civil penalties

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assessed under this chapter shall accrue and be assessed per each uniquely named, designated or

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marketed product.

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     (b) Notwithstanding the provisions of this chapter, a retailer shall not be penalized or

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otherwise held liable for the failure to label pursuant to this chapter unless:

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     (1) The retailer is the producer or the manufacturer of the genetically-engineered food,

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seed or seed stock and sells the genetically-engineered food under a brand it owns; or

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     (2) The retailer's failure to label was knowing and willful. In any action in which it is

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alleged that a retailer has violated the provisions of this chapter, it shall be a defense that such

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retailer reasonably relied on:

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     (i) Any disclosure concerning genetically-engineered foods contained in the bill of sale or

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invoice provided by the wholesaler or distributor pursuant to ยง 21-37-2; or

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     (ii) The lack of any such disclosure.

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     (c) The director of the department of health may adopt rules and regulations to implement

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and enforce the provisions of this chapter.

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     21-37-4. Enforcement. -- All such proceedings for the enforcement, or to restrain

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violations, of this chapter shall be brought by either the department of health or the department of

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the attorney general.

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     SECTION 2. This act shall take effect on January 1, 2016.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- GENETICALLY ENGINEERED FOOD

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     This act requires that any genetically-engineered foods be labeled as such.

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     This act would take effect on January 1, 2016.

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