2015 -- H 5692

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LC001411

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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 -- RHODE ISLAND FOOD, DRUGS, AND

COSMETICS ACT

     

     Introduced By: Representatives Handy, Maldonado, Tanzi, Regunberg, and Edwards

     Date Introduced: February 26, 2015

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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     SECTION 1. Section 21-31-2 of the General Laws in Chapter 21-31 entitled "Rhode

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Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:

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     21-31-2. Definitions. -- For the purpose of this chapter:

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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) "Biodegradable" means the capability of a substance to break down completely in the

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natural environment that the substance is likely to encounter within twenty-four (24) months of its

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disposal, through a biological process of decomposition into elements or compounds commonly

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found in that environment.

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

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

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all foreign or injurious contaminations.

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      (3)(4) "Cosmetics" means: (i) articles intended to be rubbed, poured, sprinkled, or

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sprayed on, introduced into, or applied to the humanbody or any part of the body for cleansing,

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beautifying, promoting attractiveness, or altering the appearance, and (ii) articles intended for use

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as a component of any articles described in this subdivision, except that this term shall not

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include soap.

 

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      (4)(5) "Device" (except when used in subdivision (23) (28) of this section and in §§ 21-

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31-3(10), 21-31-11(6), 21-31-15(a)(3), and 21-31-18(3)) means instruments, apparatus, and

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contrivances, including their components, parts, and accessories, intended: (i) for use in the

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diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or (ii)

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to affect the structure or any function of the body of humans or other animals.

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      (5)(6) "Director" means the director of health.

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      (6)(7) "Distressed merchandise" means any food which has had the label lost or which

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has been subjected to possible damage due to accident, fire, flood, adverse weather, or to any

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other similar cause, and which may have been rendered unsafe or unsuitable for human or animal

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consumption or use.

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      (7)(8) "Dosage form" means the form of the completed drug product (such as tablet,

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syrup, or suppository).

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      (8)(9) "Drug" means: (i) articles recognized in the official United States Pharmacopoeia,

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

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supplement to any of them; (ii) articles intended for use in the diagnosis, cure, mitigation,

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treatment, or prevention of disease in humans or other animals; (iii) articles (other than food)

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intended to affect the structure or any function of the body of humans or other animals; and (iv)

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articles intended for use as a component of any article specified in paragraphs (i), (ii) or (iii) of

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this subdivision; but does not include devices or their components, parts, or accessories.

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      (9)(10) "Drug product" means a dosage form containing one or more active therapeutic

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ingredients along with other substances included during the manufacturing process.

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      (10)(11) (i) "Equivalent and interchangeable" means having the same generic name,

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dosage form, and labeled potency, meeting standards of the United States Pharmacopoeia or

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National Formulary, or their successors, if applicable, and not found in violation of the

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requirements of the United States Food and Drug Administration, or its successor agency, or the

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department of health.

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      (ii) "Generic" means the chemical or established name of a drug or drug product.

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      (11)(12) "Federal Act" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §

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301 et seq.

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      (12)(13)"Food" means: (i) articles used for food or drink for humans or other animals,

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(ii) chewing gum, and (iii) articles used for components of any article described in this

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subdivision.

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     (14) "Household cleansing product" means any product, including soaps and detergents

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used for domestic or commercial cleaning purposes, including the cleansing of fabric, dishes,

 

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food utensils, and household and commercial premises. Household cleansing product shall not

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mean:

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     (i) Food, drugs, and cosmetics, including personal care items such as toothpaste,

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shampoo, and hand soap;

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     (ii) Products labeled, advertised, marketed, and distributed for use primarily as economic

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poisons.

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      (13)(15) (i) "Label" means a display of written, printed, or graphic matter upon the

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immediate container of any article; and a requirement made by or under authority of this chapter

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that any word, statement, or other information appearing on the label shall not be considered to be

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

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

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outside container or wrapper.

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      (ii) "Immediate container" does not include package liners.

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

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an article or any of its containers or wrappers, or (B) accompanying the article.

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      (iv) If an article is alleged to be misbranded because the labeling is misleading, or if an

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advertisement is alleged to be false because it is misleading, then in determining whether the

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labeling or advertisement is misleading there shall be taken into account (among other things) not

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only representations made or suggested by statement, word, design, device, sound, or in any

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combination of them, but also the extent to which the labeling or advertisement fails to reveal

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facts material in the light of the representations or material with respect to consequences which

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may result from the use of the article to which the labeling or advertisement relates under the

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

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are customary or usual.

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      (14)(16) "Native" means a product harvested in Rhode Island and is limited to the

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following:

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      (i) "Bay scallop" means Argopecten irradians.

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      (ii) "Bay quahog" means Mercenaria mercenaria.

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      (iii) "Steamer clams" means Mya arenaria.

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      (iv) "Mussels" means Mytilus edulis.

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      (v) "Oysters" means Crassostrea virginica.

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      (15)(17) "New drug" means: (i) any drug the composition of which is such that the drug

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is not generally recognized among experts qualified by scientific training and experience to

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evaluate the safety of drugs as safe for use under conditions prescribed, recommended, or

 

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suggested in the labeling of it; or (ii) any drug the composition of which is such that the drug, as a

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result of investigations to determine its safety for use under those conditions has become so

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recognized, but which has not, otherwise than in the investigations, been used to a material extent

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or for a material time under those conditions.

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

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

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supplement to any of them.

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     (19) "Over-the-counter drug" means a compound, substance, or preparation that contains

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a label that identifies the product as a drug, as required by 21 C.F.R. § 201.66, and that includes a

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drug facts panel or a statement of the active ingredient or ingredients contained in the compound,

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substance, or preparation.

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      (17)(20) "Patient" means, as the case may be: (i) the individual medically requiring a

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drug, for whom a drug is prescribed; or (ii) the owner or the agent of the owner of an animal

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medically requiring a drug, for which a drug is prescribed.

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      (18)(21) "Person" includes individual, partnership, corporation, and association.

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     (22) "Personal care product" means any article intended to be rubbed, poured, sprinkled,

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or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for

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cleansing, beautifying, promoting attractiveness, or altering the appearance, and any article

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intended for use as a component of any such article. "Personal care product" shall not include any

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prescription drug.

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      (19)(23) "Pharmacist" means a person duly registered with the board of pharmacy as a

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compounder, dispenser, or supplier of drugs upon prescription, including registered assistant

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pharmacists as defined by law.

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      (20)(24) "Pharmacy" means a place where drugs, medicines, or poisons are sold at retail

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or where prescriptions of physicians, dentists, veterinarians, and other practitioners authorized to

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issue prescriptions for drugs, medicines, and poisons are compounded, dispensed, supplied or

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sold.

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     (25) "Plastic" means a synthetic material made from linking monomers through a

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chemical reaction to create an organic polymer chain that can be molded or extruded at high heat

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into various solid forms retaining their defined shapes during its life cycle and after disposal.

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      (21)(26) "Practitioner" means a person authorized by law to practice medicine, dentistry,

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osteopathy, chiropody, or veterinary medicine in this state.

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      (22)(27) "Prescription" means an order, issued in good faith in the course of professional

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practice only, by a practitioner to a pharmacist for a drug for a particular patient, which specifies

 

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the date of its issue, the name and address of the practitioner, the name and address of the patient

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(and, if the drug is prescribed for an animal, the species of the animal), the name and quantity of

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the drug prescribed, directions for the use of the drug, and the signature of the practitioner;

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provided, that a prescription received by word of mouth, telephone, or other means of

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communication shall be reduced promptly to writing by the pharmacist in the form prescribed in

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this subdivision, and the record so made shall constitute the original prescription to be filed and

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preserved by the pharmacist; and, provided, further, that any refill authorization received by word

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of mouth, telephone, or other means of communication shall be reduced promptly to writing by

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the pharmacist, with the date of it on the face or on the reverse side of the original prescription.

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     (28) "Synthetic plastic microbead" means an intentionally added nonbiodegradable solid

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plastic particle less than five (5) millimeters in size.

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      (23)(29) The representation of a drug, in its labeling or advertisement, as an antiseptic

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shall be considered to be a representation that it is a germicide, except in the case of a drug

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purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment,

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dusting powder, or any other use that involves prolonged contact with the body.

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      (24)(30) The provisions of this chapter regarding the selling of food, drugs, devices,

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household cleansing products or cosmetics shall be considered to include the manufacture,

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production, processing, packing, exposure, offer, possession, and holding of any article for sale,

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and the sale, dispensing, and giving of any article, and the supplying or applying of the articles in

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the conduct of any food, drug, or cosmetic establishment.

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     SECTION 2. Chapter 21-31 of the General Laws entitled "Rhode Island Food, Drugs,

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and Cosmetics Act" is hereby amended by adding thereto the following section:

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     21-31-18.1. Prohibition of personal care products, over-the-counter drugs,

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microbeads and household cleansing products. – (a) Findings. – The general assembly finds:

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     (1) Microbeads are a synthetic alternative ingredient in personal care products and over-

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the-counter drugs that are used in place of natural materials such as ground almonds, oatmeal, and

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pumice.

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     (2) Microbeads are found in over one hundred (100) personal care products and over-the-

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counter drugs that are sold in the state and that ultimately are flushed down drains as part of the

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intended use of the product.

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     (3) Most municipal wastewater treatment plants in the state do not effectively filter

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microbeads from water discharged to rivers and lakes.

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     (4) Plastic microbeads are persistent inorganic compounds that attract other pollutants

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commonly present in the environment, many of which are recognized to have serious deleterious

 

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impacts on human health or the environment, including dichlorodiphenyltrichloroethane (DDT),

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dichlorodiphenyldichloroethylene (DDE), polychlorinated biphenyl (PCBs), and flame-retardants.

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     (5) Chemicals from plastics, such as PCBs, polycyclic aromatic hydrocarbons (PAHs),

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and polybrominated diphenyl ethers (PBDEs), transfer to fish tissue during digestion,

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bioaccumulate, and result in liver damage.

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     (6) Fish consumed by humans have been found to have ingested plastic microbeads.

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     (7) There are economically feasible alternatives to plastic microbeads, as indicated by the

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current use of biodegradable, natural, and abrasive materials in many consumer personal care

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products.

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     (8) Updating municipal wastewater treatment plants so that they effectively filter

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microbeads likely would be costly and take many years.

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     (9) To prevent the continued harmful effects of microbeads on state waters without

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expending significant time and money to update wastewater treatment plants, synthetic

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microbeads should be banned from manufacture and sale in the state.

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     (b) Manufacture of personal care products. Beginning on December 31, 2017, no person

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shall manufacture in the state a personal care product that contains synthetic plastic microbeads,

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except for an over-the-counter drug.

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     (c) Sale of personal care products. Beginning on December 31, 2018, no person shall sell,

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offer for sale, offer for promotion, or otherwise distribute in the state a personal care product that

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contains synthetic plastic microbeads, except for an over-the-counter drug.

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     (d) Manufacture of over-the-counter drugs. Beginning on December 31, 2018, no person

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shall manufacture in the state an over-the-counter drug containing synthetic plastic microbeads.

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     (e) Sale of over-the-counter drugs. Beginning on December 31, 2019, no person shall

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sell, offer for sale, offer for promotion, or otherwise distribute in the state an over-the-counter

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drug that contains synthetic plastic microbeads.

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     (f) Household cleansing products.

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     (1) No household cleansing products containing a phosphorus compound in

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concentrations in excess of a trace quantity may be distributed, sold, offered for sale at retail or

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wholesale, exposed for sale at retail or wholesale, or used in a commercial establishment in this

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state, except as set forth in subdivisions (2) and (3) of this subsection.

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     (2) No household cleansing product used in a dishwasher in a commercial establishment,

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used to cleanse food and beverage processing equipment, including dishes, pots, pans and

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utensils, used to cleanse medical or surgical equipment, or used to cleanse dairy equipment may

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be distributed, sold, offered for sale at retail or wholesale, exposed for sale at retail or wholesale,

 

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or used in a commercial establishment if it contains a phosphorus compound in concentrations in

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excess of eight and seven tenths percent (8.7%) by weight expressed as elemental phosphorus.

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     (3) As of July 1, 2016, no household cleansing product used in a residential dishwasher

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may be distributed, sold, offered for sale at retail or wholesale, or exposed for sale at retail or

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wholesale if it contains a phosphorus compound in concentrations in excess of a trace quantity,

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except for product inventory purchased by retailers prior to July 1, 2016.

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     (4) The provisions of this subsection shall not be construed to limit the phosphorus

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content of household cleansing products used in agricultural production and for cleansing

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equipment used in processing agricultural products.

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     (5) The provisions of this subsection shall not be construed to limit the phosphorus

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content of household cleansing products approved by the commissioner of health for use in lead

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hazard management projects.

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     SECTION 3. This act shall take effect on July 1, 2015.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND

COSMETICS ACT

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     This act would prohibit the manufacture and sale of personal care products, over-the-

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counter drugs, microbeads and household cleansing products containing synthetic plastic

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microbeads or phosphorus gradually from July 1, 2016 though December 31, 2019.

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     This act would take effect on July 1, 2015.

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