2020 -- S 2810 | |
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LC005250 | |
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STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2020 | |
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A N A C T | |
RELATING TO FOOD AND DRUGS -- REGULATION OF PERSONAL CARE PRODUCTS | |
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Introduced By: Senators Valverde, Goldin, Coyne, Euer, and Lawson | |
Date Introduced: March 12, 2020 | |
Referred To: Senate Health & Human Services | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Declaration of legislative findings and purpose. The general assembly hereby |
2 | finds and declares that: |
3 | (1) There are tens of thousands of chemicals used commercially in the United States, and |
4 | each year approximately one thousand (1,000) chemicals are added for commercial use. The |
5 | majority of chemicals in commercial use in the United States, including those used as ingredients |
6 | in personal care products, have never been fully tested for potential impacts on human health or the |
7 | environment. |
8 | (2) Some chemicals used in personal care products have been identified through scientific |
9 | studies as being carcinogenic, reproductive or developmental toxicants, or endocrine disruptors. |
10 | They have also been found through biomonitoring studies to be present in human blood, breast |
11 | milk, and urine. Some of these chemicals have been listed by respected national and international |
12 | scientific authoritative bodies as chemicals of concern based on the chemicals' potential to |
13 | negatively impact human health and the environment, yet they are present in personal care products |
14 | that consumers and professional salon workers use every day. |
15 | (3) Federal law requires personal care products sold at the retail level and marketed to |
16 | consumers to list ingredients on the product label. However, information concerning the potential |
17 | health effects of exposure to these chemical ingredients is not widely available, chemicals used as |
18 | fragrances or flavoring are exempt from labelling requirements, and personal care products sold for |
19 | use by hair, nail and beauty professionals are not required to carry any ingredient labeling. At |
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1 | present, it is extremely challenging for consumers or salon workers to identify a product as |
2 | containing a chemical of concern. |
3 | (4) Furthermore, independent testing and laboratory analyses by other states have identified |
4 | products that contain substances that could potentially cause harmful health effects but that are not |
5 | identified as an ingredient on the product's label. Nevertheless, under the Federal Food, Drug and |
6 | Cosmetic Act (21 U.S.C. Sec. 301 et seq.), personal care products and their ingredients are not |
7 | subject to premarket safety testing, review, or approval by the Federal Food and Drug |
8 | Administration before they are sold to the public. |
9 | (5) Therefore, the general assembly hereby finds and declares that the disclosures required |
10 | under federal law of ingredients contained in personal care products fail to adequately educate and |
11 | protect consumers and salon workers. In order to empower consumers and salon workers with the |
12 | information needed to make well-informed decisions regarding products that they or their families |
13 | are exposed to daily in their homes or workplaces, it shall be the policy of the state to require the |
14 | personal care product industry to more fully disclose the ingredients they use and, where applicable, |
15 | identify ingredients that have been published as a chemical of concern on one or more designated |
16 | list(s). This will benefit consumers and salon workers, encourage manufacturers to remove |
17 | potentially harmful chemicals from their products, and encourage development of innovative |
18 | methods, including green chemistry, to replace these ingredients with those that are safer for human |
19 | health and the environment. |
20 | SECTION 2. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby |
21 | amended by adding thereto the following chapter: |
22 | CHAPTER 31.2 |
23 | REGULATION OF PERSONAL CARE PRODUCTS |
24 | 21-31.2-1. Short title. |
25 | This chapter shall be known and may be cited as the "Regulation of Personal Care |
26 | Products". |
27 | 21-31.2-2. Definitions. |
28 | As used in this chapter, the following words and terms shall have the following meanings |
29 | unless the context shall clearly indicate another or different meaning or intent: |
30 | (1) "Designated list(s)" means any of the following: |
31 | (i) Chemicals found on the Rhode Island hazardous substance list (Source: T - ACGIH F - |
32 | NFPA49 C - IARC). |
33 | (ii) Chemicals classified by the European Union as carcinogens, mutagens, or reproductive |
34 | toxicants pursuant to Category 1A or 1B in Annex VI to Regulation (EC) 1272/2008. |
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1 | (iii) Chemicals included in the European Union Candidate List of Substances of Very High |
2 | Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(f) |
3 | for endocrine disrupting properties. |
4 | (iv) Chemicals for which a reference dose or reference concentration has been developed |
5 | based on neurotoxicity in the federal Environmental Protection Agency's Integrated Risk |
6 | Information System. |
7 | (v) Chemicals that are identified as carcinogenic to humans, likely to be carcinogenic to |
8 | humans, or as Group A, B1, or B2 carcinogens in the federal Environmental Protection Agency's |
9 | Integrated Risk Information System. |
10 | (vi) Chemicals included in the European Chemicals Agency Candidate List of Substances |
11 | of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of |
12 | Article 57(d), Article 57(e), or Article 57(f) of Regulation (EC) 1907/2006 for persistent, |
13 | bioaccumulative and toxic, or very persistent and very bioaccumulative properties. |
14 | (vii) Chemicals that are identified as persistent, bioaccumulative, and inherently toxic to |
15 | the environment by the Canadian Environmental Protection Act Environmental Registry Domestic |
16 | Substances List. |
17 | (viii) Chemicals classified by the European Union in Annex VI to Regulation (EC) |
18 | 1272/2008 as respiratory sensitizer category 1. |
19 | (ix) Group 1, 2A, or 2B carcinogens identified by the International Agency for Research |
20 | on Cancer. |
21 | (x) Neurotoxicants that are identified in the Federal Agency for Toxic Substances and |
22 | Disease Registry's Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens, |
23 | Nervous System. |
24 | (xi) Persistent bioaccumulative and toxic priority chemicals that are identified by the |
25 | federal Environmental Protection Agency National Waste Minimization Program. |
26 | (xii) Reproductive or developmental toxicants identified in Monographs on the Potential |
27 | Human Reproductive and Developmental Effects published by the Federal National Toxicology |
28 | Program, Office of Health Assessment and Translation. |
29 | (xiii) Chemicals identified by the Federal Environmental Protection Agency's Toxics |
30 | Release Inventory as persistent, bioaccumulative and toxic chemicals that are subject to reporting |
31 | under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42 |
32 | U.S.C. Sec. 11001, et seq.). |
33 | (xiv) The Washington Department of Ecology's Persistent, Bioaccumulative, Toxic (PBT) |
34 | Chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative Code. |
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1 | (xv) Chemicals that are identified as known to be, or reasonably anticipated to be, human |
2 | carcinogens by the thirteenth Report on Carcinogens prepared by the Federal National Toxicology |
3 | Program. |
4 | (xvi) Chemicals for which notification levels, as defined in Section 116455, have been |
5 | established by the California department of public health or the state water resources control board. |
6 | (xvii) Chemicals for which primary maximum contaminant levels have been established |
7 | and adopted under Section 64431 or 64444 of Title 22 of the California Code of Regulations. |
8 | (xviii) Chemicals identified as toxic air contaminants under Section 93000 or 93001 of |
9 | Title 17 of the California Code of Regulations. |
10 | (xix) Chemicals that are identified as priority pollutants in the California water quality |
11 | control plans pursuant to subdivision (c) of Section 303 of the Federal Clean Water Act and in |
12 | Section 131.38 of Title 40 of the Code of Federal Regulations, or identified as pollutants by the |
13 | state or the federal Environmental Protection Agency for one or more water bodies in the state |
14 | under subdivision (d) of Section 303 of the Federal Clean Water Act and Section 130.7 of Title 40 |
15 | of the Code of Federal Regulations. |
16 | (xx) Chemicals that are identified with noncancerous endpoints and listed with an |
17 | inhalation or oral reference exposure level by the California office of environmental health hazard |
18 | assessment pursuant to paragraph (2) of subdivision (b) of section 44360. |
19 | (xxi) Chemicals identified as priority chemicals by the California environmental |
20 | contaminant biomonitoring program pursuant to section 105449. |
21 | (xxii) Chemicals that are identified on Part A of the list of Chemicals for Priority Action |
22 | prepared by the Oslo and Paris Conventions for the Protection of the Marine Environment of the |
23 | North-East Atlantic. |
24 | (xxiii) Chemicals that are identified on the Centers for Disease Control and Prevention's |
25 | Fourth National Report on Human Exposure to Environmental Chemicals and Updated Tables |
26 | Volume 1 and Volume 2. |
27 | (xxiv) Annex III of the EU Cosmetics Regulation No. 1223/2009 as required to be labeled |
28 | by the EU Detergents Regulation No. 648/2004. |
29 | (xxv) Chemicals designated as asthmagens by the Association of Occupational and |
30 | Environmental Clinics (AOEC). |
31 | (xxvi) European Union candidate list of Substances of Very High Concern in accordance |
32 | with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(f) for endocrine disrupting |
33 | properties. |
34 | (xxvii) Danish Environmental Protection Agency List of Endocrine Disrupting |
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1 | Compounds. |
2 | (xxviii) Chemicals known to the State of California to cause cancer or reproductive toxicity |
3 | (including developmental, female and male toxicity) that are listed pursuant to the Safe Drinking |
4 | Water and Toxic Enforcement Act of 1986 (California Code of Regulations, Title 22, Division 2, |
5 | Subdivision 1, Chapter 3, Sections 1200 et seq., also known as Proposition 65). |
6 | (xxix) Chemicals identified as Chemicals of Mutual Concern developed under the 2012 |
7 | U.S./Canada Great Lakes Water Quality Agreement (GLWQA) Annex 3. |
8 | (xxx) Chemicals identified as high toxicity air contaminants in Part 212 of Title 6 of the |
9 | New York Codes of Rules and Regulations (6 NYCRR Subpart 212-2.2, as defined in Subpart 212- |
10 | 1.2 (b)(9)). |
11 | (2) "Director" means the director of the Rhode Island department of health. |
12 | (3) "Ingredient" means all of the following: |
13 | (i) An intentionally added ingredient present in any quantity in the personal care product; |
14 | (ii) A nonfunctional byproduct or nonfunctional contaminant, present in a personal care |
15 | product in any quantity exceeding one half of one percent (0.5%) of the content of the product by |
16 | weight or other amount as determined by the director; |
17 | (iii) A nonfunctional byproduct present in a personal care product in any quantity not |
18 | exceeding one half of one percent (0.5%) of the content of the product by weight, provided such |
19 | element or compound has been published as a chemical of concern on one or more designated |
20 | list(s); |
21 | (iv) A nonfunctional contaminant present in a personal care product in a quantity |
22 | determined by the director and not exceeding one half of one percent (0.5%) of the content of the |
23 | product by weight, provided such element or compound has been published as a chemical of |
24 | concern on one or more designated list(s). |
25 | (4) "Intentionally added ingredient" means any element or compound that a manufacturer |
26 | has intentionally added to a personal care product, and which has a functional or technical effect in |
27 | the finished product, including, but not limited to, the components of intentionally added fragrance, |
28 | flavoring and colorants, and the intentional breakdown products of an added element or compound |
29 | that also have a functional or technical effect on the finished product. |
30 | (5) "Nonfunctional byproduct," means any element or compound which has no functional |
31 | or technical effect in the finished product which: |
32 | (i) Was intentionally added during the manufacturing process for a personal care product |
33 | at any point in a product's, a raw material's or ingredient's supply chain; or |
34 | (ii) Was created or formed during the manufacturing process as an intentional or |
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1 | unintentional consequence of the manufacturing process at any point in the product's, raw |
2 | material's, or an ingredient's supply chain. This includes, but is not limited to, an unreacted raw |
3 | material, a breakdown product of an intentionally added ingredient, or a byproduct of the |
4 | manufacturing process. |
5 | (6) "Nonfunctional contaminant" means any element or compound present in a personal |
6 | care product as an unintentional consequence of manufacturing which has no functional or technical |
7 | effect in the finished product. Nonfunctional contaminants include, but are not limited to, elements |
8 | or compounds present in the environment as contaminants which were introduced into a product, |
9 | raw material, or a product ingredient as a result of the use of an environmental medium, such as a |
10 | naturally occurring mineral, air, soil or water, in the manufacturing process at any point in a |
11 | product's, raw material's, or an ingredient's supply chain. |
12 | (7) "Manufacturer" means any person, firm, association, partnership, limited liability |
13 | company, or corporation that has its brand name affixed to a personal care product. In the case of |
14 | a personal care product imported into the United States, "manufacturer" means the importer or first |
15 | domestic distributor of the product if the entity that manufactures the product or whose brand name |
16 | is affixed to the product does not have a presence in the United States. |
17 | (8) "Personal care product" means any article intended to be rubbed, poured, sprinkled, or |
18 | sprayed on, introduced into, or otherwise applied to the human body or any part thereof for |
19 | cleansing, beautifying, promoting attractiveness, or altering the appearance, and any article |
20 | intended for use as a component of any such article; except that such term shall not include soap. |
21 | (9) "Professional Use" means the use of any cosmetic by an employee (within the scope of |
22 | the employment of such employee) or purchased by a consumer in a hair salon, nail salon, beauty |
23 | salon, spa, or other establishment that provides cosmetic treatment services for humans. |
24 | (10) "Soap" means any article comprised entirely of an alkali salt of fatty acids where the |
25 | detergent properties of the article are due to the alkali-fatty acid compounds, and the article shall |
26 | be labeled, sold, and represented only as soap. |
27 | 21-31.2-3. Disclosure. |
28 | (a) Manufacturers of personal care products distributed, sold or offered for sale in this state, |
29 | whether at retail or wholesale, for personal or professional use, or distributed for promotional |
30 | purposes, shall furnish to the public records administrator such information regarding such products |
31 | pursuant to rules and regulations promulgated by the director of the department of health. |
32 | For each personal care product, such information shall include, but shall not be limited to: |
33 | (1) A list naming each ingredient, as defined in ยง 21-31.2-2, of the product in descending |
34 | order of predominance by weight in the product, except that ingredients present at a weight below |
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1 | one percent (1%) may be listed following other ingredients without respect to the order of |
2 | predominance by weight; |
3 | (2) The nature and extent of investigations and research performed by or for the |
4 | manufacturer concerning the effects on human health and the environment of such product or such |
5 | ingredients, including which studies were performed by or for them, and any other information in |
6 | their knowledge or possession; and |
7 | (3) Where applicable, a statement disclosing that an ingredient is published as a chemical |
8 | of concern on one or more designated list(s). |
9 | (b) Manufacturers shall furnish such information on or before July 1, 2020 and every two |
10 | (2) years thereafter. In addition, such manufacturers shall furnish such information: |
11 | (1) Prior to the sale of any new personal care product; |
12 | (2) Prior to the sale of a currently disclosed product when the formulation of such product |
13 | is changed; |
14 | (3) Prior to the sale of any currently disclosed product when any chemicals of concern |
15 | included on a designated list(s) pursuant to this chapter is changed to include an ingredient present |
16 | in a personal care product subject to this chapter; or |
17 | (4) At such other times as may be required by the director. |
18 | (c) Information shall be made available to the public by the director, in accordance with |
19 | this section, with the exception of ingredients which the manufacturer is claiming to be a trade |
20 | secret. The director shall not approve any exceptions under this subsection with respect to any |
21 | ingredient published as a chemical of concern on one or more designated list(s). |
22 | (d) A manufacturer that protects a fragrance or flavor ingredient, or combination of |
23 | fragrance or flavor ingredients pursuant to the uniform trade secrets act set forth in chapter 41 of |
24 | title 6 shall maintain justification for protecting confidential business information consistent with |
25 | the requirements of the act and provide that justification on request for audit by the attorney general. |
26 | (e) In lieu of the manufacturer's providing notice to the authority under subsection (a) of |
27 | this section, the director may require that the notice described in subsection (a) of this section be |
28 | submitted to the Interstate Chemicals Clearinghouse. The authority by rule shall specify procedures |
29 | for the provision of such notice by manufacturers to the Interstate Chemicals Clearinghouse. |
30 | 21-31.2-4. Penalties. |
31 | A manufacturer in violation of this chapter is subject to a civil penalty not to exceed five |
32 | thousand dollars ($5,000) dollars for each violation in the case of a first offense. Manufacturers |
33 | who are repeat violators are subject to a civil penalty not to exceed ten thousand dollars ($10,000) |
34 | dollars for each repeat offense. |
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1 | SECTION 3. This act shall take effect on January 1, 2021, provided that, upon passage, |
2 | effective immediately, the director of health shall be authorized to promulgate any and all rules and |
3 | regulations necessary to implement the provisions of this act on its effective date. |
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LC005250 | |
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EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO FOOD AND DRUGS -- REGULATION OF PERSONAL CARE PRODUCTS | |
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1 | This act would require the personal care product industry to more fully disclose the |
2 | ingredients they use and, where applicable, identify ingredients that have been published as a |
3 | chemical of concern on one or more designated list included in the act. |
4 | This act would take effect on January 1, 2021, provided that, upon passage, effective |
5 | immediately, the director of health shall be authorized to promulgate any and all rules and |
6 | regulations necessary to implement the provisions of this act on its effective date. |
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LC005250 | |
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