2019 -- S 0447

========

LC001617

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

____________

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:

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

hereby finds and declares that:

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

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

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

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

the environment.

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

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

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

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

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

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

products that consumers and professional salon workers use every day.

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

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

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

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

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

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

containing a chemical of concern.

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

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

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

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

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

and Drug Administration before they are sold to the public.

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

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

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

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

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

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

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

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

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

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

those that are safer for human health and the environment.

     SECTION 2. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby

amended by adding thereto the following chapter:

CHAPTER 31.2

REGULATION OF PERSONAL CARE PRODUCTS

     21-31.2-1. Short title.

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

Products".

     21-31.2-2. Definitions.

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

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

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

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

- NFPA49 C - IARC).

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

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

LC001617 - Page 2 of 9

1272/2008.

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

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

57(f) for endocrine disrupting properties.

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

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

Information System.

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

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

Integrated Risk Information System.

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

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

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

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

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

the environment by the Canadian Environmental Protection Act Environmental Registry

Domestic Substances List.

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

1272/2008 as respiratory sensitizer category 1.

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

on Cancer.

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

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

Nervous System.

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

federal Environmental Protection Agency National Waste Minimization Program.

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

Human Reproductive and Developmental Effects published by the Federal National Toxicology

Program, Office of Health Assessment and Translation.

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

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

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

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

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

LC001617 - Page 3 of 9

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

Code.

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

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

Toxicology Program.

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

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

board.

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

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

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

Title 17 of the California Code of Regulations.

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

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

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

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

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

40 of the Code of Federal Regulations.

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

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

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

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

contaminant biomonitoring program pursuant to section 105449.

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

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

North-East Atlantic.

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

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

Volume 1 and Volume 2.

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

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

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

Environmental Clinics (AOEC).

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

LC001617 - Page 4 of 9

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

disrupting properties.

     (xxvii) Danish Environmental Protection Agency List of Endocrine Disrupting

Compounds.

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

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

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

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

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

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

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

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

212-1.2 (b)(9)).

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

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

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

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

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

weight or other amount as determined by the director;

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

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

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

list(s);

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

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

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

concern on one or more designated list(s).

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

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

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

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

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

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

or technical effect in the finished product which:

LC001617 - Page 5 of 9

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

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

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

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

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

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

manufacturing process.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

intended for use as a component of any such article; except that such term shall not include soap.

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

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

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

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

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

be labeled, sold, and represented only as soap.

     21-31.2-3. Disclosure.

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

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

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

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

LC001617 - Page 6 of 9

department of health.

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

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

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

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

order of predominance by weight;

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

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

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

information in their knowledge or possession; and

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

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

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

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

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

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

is changed;

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

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

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

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

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

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

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

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

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

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

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

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

general.

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

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

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

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

LC001617 - Page 7 of 9

Clearinghouse.

     21-31.2-4. Penalties.

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

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

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

dollars for each repeat offense.

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

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

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

========

LC001617

========

LC001617 - Page 8 of 9

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

FOOD AND DRUGS - REGULATION OF PERSONAL CARE PRODUCTS

***

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

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

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

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

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

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

========

LC001617

========

LC001617 - Page 9 of 9