2019 -- S 0447

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LC001617

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

FOOD AND DRUGS - REGULATION OF PERSONAL CARE PRODUCTS

     

     Introduced By: Senators Valverde, Goldin, Coyne, Lawson, and Euer

     Date Introduced: February 27, 2019

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Declaration of legislative findings and purpose. The general assembly

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hereby finds and declares that:

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     (1) There are tens of thousands of chemicals used commercially in the United States, and

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each year approximately one thousand (1,000) chemicals are added for commercial use. The

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majority of chemicals in commercial use in the United States, including those used as ingredients

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in personal care products, have never been fully tested for potential impacts on human health or

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the environment.

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     (2) Some chemicals used in personal care products have been identified through scientific

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studies as being carcinogenic, reproductive or developmental toxicants, or endocrine disruptors.

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They have also been found through biomonitoring studies to be present in human blood, breast

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milk, and urine. Some of these chemicals have been listed by respected national and international

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scientific authoritative bodies as chemicals of concern based on the chemicals' potential to

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negatively impact human health and the environment, yet they are present in personal care

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products that consumers and professional salon workers use every day.

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     (3) Federal law requires personal care products sold at the retail level and marketed to

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consumers to list ingredients on the product label. However, information concerning the potential

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health effects of exposure to these chemical ingredients is not widely available, chemicals used as

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fragrances or flavoring are exempt from labelling requirements, and personal care products sold

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for use by hair, nail and beauty professionals are not required to carry any ingredient labeling. At

 

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present, it is extremely challenging for consumers or salon workers to identify a product as

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containing a chemical of concern.

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     (4) Furthermore, independent testing and laboratory analyses by other states have

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identified products that contain substances that could potentially cause harmful health effects but

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that are not identified as an ingredient on the product's label. Nevertheless, under the Federal

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Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.), personal care products and their

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ingredients are not subject to premarket safety testing, review, or approval by the Federal Food

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and Drug Administration before they are sold to the public.

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     (5) Therefore, the general assembly hereby finds and declares that the disclosures

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required under federal law of ingredients contained in personal care products fail to adequately

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educate and protect consumers and salon workers. In order to empower consumers and salon

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workers with the information needed to make well-informed decisions regarding products that

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they or their families are exposed to daily in their homes or workplaces, it shall be the policy of

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the state to require the personal care product industry to more fully disclose the ingredients they

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use and, where applicable, identify ingredients that have been published as a chemical of concern

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on one or more designated list(s). This will benefit consumers and salon workers, encourage

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manufacturers to remove potentially harmful chemicals from their products, and encourage

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development of innovative methods, including green chemistry, to replace these ingredients with

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those that are safer for human health and the environment.

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     SECTION 2. 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 31.2

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REGULATION OF PERSONAL CARE PRODUCTS

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     21-31.2-1. Short title.

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     This chapter shall be known and may be cited as the "Regulation of Personal Care

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Products".

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     21-31.2-2. Definitions.

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     As used in this chapter, the following words and terms shall have the following meanings

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unless the context shall clearly indicate another or different meaning or intent:

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     (1) "Designated list(s)" means any of the following:

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     (i) Chemicals found on the Rhode Island hazardous substance list (Source: T - ACGIH F

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- NFPA49 C - IARC).

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     (ii) Chemicals classified by the European Union as carcinogens, mutagens, or

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reproductive toxicants pursuant to Category 1A or 1B in Annex VI to Regulation (EC)

 

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1272/2008.

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     (iii) Chemicals included in the European Union Candidate List of Substances of Very

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High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article

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57(f) for endocrine disrupting properties.

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     (iv) Chemicals for which a reference dose or reference concentration has been developed

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based on neurotoxicity in the federal Environmental Protection Agency's Integrated Risk

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Information System.

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     (v) Chemicals that are identified as carcinogenic to humans, likely to be carcinogenic to

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humans, or as Group A, B1, or B2 carcinogens in the federal Environmental Protection Agency's

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Integrated Risk Information System.

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     (vi) Chemicals included in the European Chemicals Agency Candidate List of Substances

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of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis

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of Article 57(d), Article 57(e), or Article 57(f) of Regulation (EC) 1907/2006 for persistent,

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bioaccumulative and toxic, or very persistent and very bioaccumulative properties.

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     (vii) Chemicals that are identified as persistent, bioaccumulative, and inherently toxic to

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the environment by the Canadian Environmental Protection Act Environmental Registry

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Domestic Substances List.

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     (viii) Chemicals classified by the European Union in Annex VI to Regulation (EC)

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1272/2008 as respiratory sensitizer category 1.

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     (ix) Group 1, 2A, or 2B carcinogens identified by the International Agency for Research

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on Cancer.

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     (x) Neurotoxicants that are identified in the Federal Agency for Toxic Substances and

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Disease Registry's Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens,

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Nervous System.

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     (xi) Persistent bioaccumulative and toxic priority chemicals that are identified by the

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federal Environmental Protection Agency National Waste Minimization Program.

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     (xii) Reproductive or developmental toxicants identified in Monographs on the Potential

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Human Reproductive and Developmental Effects published by the Federal National Toxicology

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Program, Office of Health Assessment and Translation.

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     (xiii) Chemicals identified by the Federal Environmental Protection Agency's Toxics

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Release Inventory as persistent, bioaccumulative and toxic chemicals that are subject to reporting

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under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42

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U.S.C. Sec. 11001, et seq.).

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     (xiv) The Washington Department of Ecology's Persistent, Bioaccumulative, Toxic

 

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(PBT) Chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative

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Code.

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     (xv) Chemicals that are identified as known to be, or reasonably anticipated to be, human

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carcinogens by the thirteenth (13th) Report on Carcinogens prepared by the Federal National

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Toxicology Program.

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     (xvi) Chemicals for which notification levels, as defined in Section 116455, have been

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established by the California department of public health or the state water resources control

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board.

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     (xvii) Chemicals for which primary maximum contaminant levels have been established

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and adopted under Section 64431 or 64444 of Title 22 of the California Code of Regulations.

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     (xviii) Chemicals identified as toxic air contaminants under Section 93000 or 93001 of

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Title 17 of the California Code of Regulations.

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     (xix) Chemicals that are identified as priority pollutants in the California water quality

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control plans pursuant to subdivision (c) of Section 303 of the Federal Clean Water Act and in

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Section 131.38 of Title 40 of the Code of Federal Regulations, or identified as pollutants by the

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state or the federal Environmental Protection Agency for one or more water bodies in the state

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under subdivision (d) of Section 303 of the Federal Clean Water Act and Section 130.7 of Title

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40 of the Code of Federal Regulations.

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     (xx) Chemicals that are identified with noncancerous endpoints and listed with an

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inhalation or oral reference exposure level by the California office of environmental health hazard

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assessment pursuant to paragraph (2) of subdivision (b) of section 44360.

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     (xxi) Chemicals identified as priority chemicals by the California environmental

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contaminant biomonitoring program pursuant to section 105449.

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     (xxii) Chemicals that are identified on Part A of the list of Chemicals for Priority Action

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prepared by the Oslo and Paris Conventions for the Protection of the Marine Environment of the

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North-East Atlantic.

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     (xxiii) Chemicals that are identified on the Centers for Disease Control and Prevention's

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Fourth National Report on Human Exposure to Environmental Chemicals and Updated Tables

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Volume 1 and Volume 2.

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     (xxiv) Annex III of the EU Cosmetics Regulation No. 1223/2009 as required to be

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labeled by the EU Detergents Regulation No. 648/2004.

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     (xxv) Chemicals designated as asthmagens by the Association of Occupational and

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Environmental Clinics (AOEC).

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     (xxvi) European Union candidate list of Substances of Very High Concern in accordance

 

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with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(f) for endocrine

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disrupting properties.

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     (xxvii) Danish Environmental Protection Agency List of Endocrine Disrupting

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Compounds.

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     (xxviii) Chemicals known to the State of California to cause cancer or reproductive

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toxicity (including developmental, female and male toxicity) that are listed pursuant to the Safe

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Drinking Water and Toxic Enforcement Act of 1986 (California Code of Regulations, Title 22,

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Division 2, Subdivision 1, Chapter 3, Sections 1200 et seq., also known as Proposition 65).

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     (xxix) Chemicals identified as Chemicals of Mutual Concern developed under the 2012

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U.S./Canada Great Lakes Water Quality Agreement (GLWQA) Annex 3.

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     (xxx) Chemicals identified as high toxicity air contaminants in Part 212 of Title 6 of the

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New York Codes of Rules and Regulations (6 NYCRR Subpart 212-2.2, as defined in Subpart

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212-1.2 (b)(9)).

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     (2) "Director" means the director of the Rhode Island department of health.

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     (3) "Ingredient" means all of the following:

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     (i) An intentionally added ingredient present in any quantity in the personal care product;

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     (ii) A nonfunctional byproduct or nonfunctional contaminant, present in a personal care

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product in any quantity exceeding one half of one percent (0.5%) of the content of the product by

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weight or other amount as determined by the director;

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     (iii) A nonfunctional byproduct present in a personal care product in any quantity not

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exceeding one half of one percent (0.5%) of the content of the product by weight, provided such

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element or compound has been published as a chemical of concern on one or more designated

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list(s);

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     (iv) A nonfunctional contaminant present in a personal care product in a quantity

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determined by the director and not exceeding one half of one percent (0.5%) of the content of the

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product by weight, provided such element or compound has been published as a chemical of

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concern on one or more designated list(s).

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     (4) "Intentionally added ingredient" means any element or compound that a manufacturer

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has intentionally added to a personal care product, and which has a functional or technical effect

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in the finished product, including, but not limited to, the components of intentionally added

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fragrance, flavoring and colorants, and the intentional breakdown products of an added element

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or compound that also have a functional or technical effect on the finished product.

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     (5) "Nonfunctional byproduct," means any element or compound which has no functional

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or technical effect in the finished product which:

 

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     (i) Was intentionally added during the manufacturing process for a personal care product

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at any point in a product's, a raw material's or ingredient's supply chain; or

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     (ii) Was created or formed during the manufacturing process as an intentional or

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unintentional consequence of the manufacturing process at any point in the product's, raw

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material's, or an ingredient's supply chain. This includes, but is not limited to, an unreacted raw

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material, a breakdown product of an intentionally added ingredient, or a byproduct of the

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manufacturing process.

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     (6) "Nonfunctional contaminant" means any element or compound present in a personal

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care product as an unintentional consequence of manufacturing which has no functional or

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technical effect in the finished product. Nonfunctional contaminants include, but are not limited

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to, elements or compounds present in the environment as contaminants which were introduced

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into a product, raw material, or a product ingredient as a result of the use of an environmental

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medium, such as a naturally occurring mineral, air, soil or water, in the manufacturing process at

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any point in a product's, raw material's, or an ingredient's supply chain.

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     (7) "Manufacturer" means any person, firm, association, partnership, limited liability

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company, or corporation that has its brand name affixed to a personal care product. In the case of

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a personal care product imported into the United States, "manufacturer" means the importer or

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first domestic distributor of the product if the entity that manufactures the product or whose brand

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name is affixed to the product does not have a presence in the United States.

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

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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; except that such term shall not include soap.

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     (9) "Professional Use" means the use of any cosmetic by an employee (within the scope

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of the employment of such employee) or purchased by a consumer in a hair salon, nail salon,

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beauty salon, spa, or other establishment that provides cosmetic treatment services for humans.

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     (10) "Soap" means any article comprised entirely of an alkali salt of fatty acids where the

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detergent properties of the article are due to the alkali-fatty acid compounds, and the article shall

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be labeled, sold, and represented only as soap.

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     21-31.2-3. Disclosure.

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     (a) Manufacturers of personal care products distributed, sold or offered for sale in this

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state, whether at retail or wholesale, for personal or professional use, or distributed for

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promotional purposes, shall furnish to the public records administrator such information

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regarding such products pursuant to rules and regulations promulgated by the director of the

 

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department of health.

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     For each personal care product, such information shall include, but shall not be limited to:

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     (1) A list naming each ingredient, as defined in ยง 21-31.2-2 of this chapter, of the product

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in descending order of predominance by weight in the product, except that ingredients present at a

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weight below one percent (1%) may be listed following other ingredients without respect to the

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order of predominance by weight;

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     (2) The nature and extent of investigations and research performed by or for the

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manufacturer concerning the effects on human health and the environment of such product or

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such ingredients, including which studies were performed by or for them, and any other

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information in their knowledge or possession; and

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     (3) Where applicable, a statement disclosing that an ingredient is published as a chemical

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of concern on one or more designated list(s).

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     (b) Manufacturers shall furnish such information on or before July 1, 2020 and every two

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(2) years thereafter. In addition, such manufacturers shall furnish such information:

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     (1) Prior to the sale of any new personal care product;

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     (2) Prior to the sale of a currently disclosed product when the formulation of such product

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is changed;

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     (3) Prior to the sale of any currently disclosed product when any chemicals of concern

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included on a designated list(s) pursuant to this chapter is changed to include an ingredient

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present in a personal care product subject to this chapter; or

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     (4) At such other times as may be required by the director.

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     (c) Information shall be made available to the public by the director, in accordance with

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this section, with the exception of ingredients which the manufacturer is claiming to be a trade

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secret. The director shall not approve any exceptions under this subsection with respect to any

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ingredient published as a chemical of concern on one or more designated list(s).

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     (d) A manufacturer that protects a fragrance or flavor ingredient, or combination of

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fragrance or flavor ingredients pursuant to the uniform trade secrets act set forth in chapter 41 of

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title 6 shall maintain justification for protecting confidential business information consistent with

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the requirements of the act and provide that justification on request for audit by the attorney

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general.

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     (e) In lieu of the manufacturer's providing notice to the authority under subsection (a) of

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this section, the director may require that the notice described in subsection (a) of this section be

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submitted to the Interstate Chemicals Clearinghouse. The authority by rule shall specify

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procedures for the provision of such notice by manufacturers to the Interstate Chemicals

 

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Clearinghouse.

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     21-31.2-4. Penalties.

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     A manufacturer in violation of this chapter is subject to a civil penalty not to exceed five

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thousand dollars ($5,000) dollars for each violation in the case of a first offense. Manufacturers

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who are repeat violators are subject to a civil penalty not to exceed ten thousand dollars ($10,000)

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dollars for each repeat offense.

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     SECTION 3. This act shall take effect on January 1, 2020, provided that, upon passage,

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effective immediately, the director of health shall be authorized to promulgate any and all rules

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and regulations necessary to implement the provisions of this act on its effective date.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

FOOD AND DRUGS - REGULATION OF PERSONAL CARE PRODUCTS

***

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     This act would require the personal care product industry to more fully disclose the

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ingredients they use and, where applicable, identify ingredients that have been published as a

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chemical of concern on one or more designated list included in the act.

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     This act would take effect on January 1, 2020, provided that, upon passage, effective

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immediately, the director of health shall be authorized to promulgate any and all rules and

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regulations necessary to implement the provisions of this act on its effective date.

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