Safe Cosmetics and Personal Care Products Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4296 To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 12, 2019 Ms. SCHAKOWSKY (for herself, Mr. SEAN PATRICK MALONEY of New York, Ms. LEE of California, Mr. TED LIEU of California, Mr. GRIJALVA, Ms. DELAURO, Mr. HUFFMAN, Ms. PRESSLEY, Mr. HASTINGS, Mr. LOWENTHAL, Ms. JUDY CHU of California, Ms. SPEIER, Ms. JAYAPAL, Ms. DEGETTE, Ms. PINGREE, Ms. MATSUI, and Ms. WASSERMAN SCHULTZ) introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committee on Education and Labor, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Safe Cosmetics and Personal Care Products Act of 5 2019’’. 6 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 2 •HR 4296 IH (b) TABLE OF CONTENTS.—The table of contents of 1 this Act is as follows: 2 Sec. 1. Short title; table of contents. Sec. 2. Cosmetic regulation. ‘‘SUBCHAPTER A—ADULTERATED AND MISBRANDED COSMETICS ‘‘SUBCHAPTER B—REGULATION OF COSMETICS ‘‘Sec. 611. Definitions. ‘‘Sec. 612. Registration of establishments and registration fees. ‘‘Sec. 613. Ingredients labels and website disclosure for cosmetics. ‘‘Sec. 614. Safety standard and good manufacturing practices. ‘‘Sec. 615. Cosmetic and ingredient safety information. ‘‘Sec. 616. Lists of ingredients and required responses. ‘‘Sec. 617. Treatment of cosmetics based on ingredient lists. ‘‘Sec. 618. Treatment of contaminants. ‘‘Sec. 619. Cosmetic and ingredient statements. ‘‘Sec. 620. Notification, nondistribution, and recall of adulterated or mis- branded cosmetics. ‘‘Sec. 621. Petitions. ‘‘Sec. 622. Mandatory reporting of serious adverse events. ‘‘Sec. 623. Nonconfidential information. ‘‘Sec. 624. Ban on use of animal testing. ‘‘Sec. 625. Product testing and review audit. ‘‘Sec. 626. Resources for small businesses. ‘‘Sec. 627. Interagency cooperation. ‘‘Sec. 628. Savings clause. ‘‘Sec. 629. Authorization of appropriations. Sec. 3. Adulterated and misbranded cosmetics. Sec. 4. Support for creating safer alternatives. Sec. 5. Support by National Institute of Environmental Health Sciences for re- search on health disparities impacting communities of color. ‘‘Sec. 463C. Research on health disparities related to cosmetics impacting communities of color. Sec. 6. Worker issues. SEC. 2. COSMETIC REGULATION. 3 Chapter VI of the Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 361 et seq.) is amended— 5 (1) by inserting before section 601 the fol- 6 lowing: 7 ‘‘Subchapter A—Adulterated and Misbranded 8 Cosmetics’’; 9 and 10 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 3 •HR 4296 IH (2) by adding at the end the following: 1 ‘‘Subchapter B—Regulation of Cosmetics 2 ‘‘SEC. 611. DEFINITIONS. 3 ‘‘In this subchapter: 4 ‘‘(1) BRAND OWNER.—The term ‘brand owner’ 5 means the entity responsible for bringing a cosmetic 6 to market. 7 ‘‘(2) CONTAMINANT.—The term ‘contaminant’ 8 means unintended substances, such as those that 9 can originate from sources outside the chemical 10 pathway, chemical processes, storage of primary sub- 11 stances, instability of the packaging or harmful by- 12 products of the manufacturing process. 13 ‘‘(3) DOMESTIC ESTABLISHMENT.—The term 14 ‘domestic establishment’ means an establishment lo- 15 cated in any State that brings a cosmetic to market. 16 ‘‘(4) FOREIGN ESTABLISHMENT.—The term 17 ‘foreign establishment’ means an establishment that 18 brings a cosmetic to market and exports those cos- 19 metics to the United States. 20 ‘‘(5) INGREDIENT.—The term ‘ingredient’ 21 means a chemical in a cosmetic, including— 22 ‘‘(A) chemicals that have a technical or 23 functional effect in the cosmetic, including the 24 breakdown products of an intentionally added 25 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 4 •HR 4296 IH chemical that also have a functional or technical 1 effect in the cosmetic; 2 ‘‘(B) substances that are present by reason 3 of having been added to a cosmetic during proc- 4 essing for their technical or functional effect; 5 ‘‘(C) the components of a fragrance, flavor, 6 preservative, or colorant; and 7 ‘‘(D) any individual component that the 8 Secretary deems an ingredient for purposes of 9 this chapter. 10 ‘‘(6) MANUFACTURER.—The term ‘manufac- 11 turer’ means the entity that produces ingredients or 12 combines one or more ingredients to produce a cos- 13 metic product. 14 ‘‘(7) MICROBUSINESS.—The term ‘microbusi- 15 ness’ means a business— 16 ‘‘(A) that is a brand owner as defined in 17 this subchapter; and 18 ‘‘(B) that has annual sales receipts for cos- 19 metic products that do not exceed $1,000,000. 20 ‘‘(8) PROFESSIONAL USE.—The term ‘profes- 21 sional use’ means— 22 ‘‘(A) the application of a cosmetic to a 23 human customer or client by an employee or 24 contractor of a hair salon, nail salon, beauty 25 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 5 •HR 4296 IH salon, spa, or other establishment within the 1 scope of the work conducted by such employee 2 or contractor; or 3 ‘‘(B) the use by or application to a human 4 of a cosmetic purchased from a hair salon, nail 5 salon, beauty salon, spa, or other establishment 6 that provides cosmetic treatment services for 7 humans. 8 ‘‘(9) REASONABLE CERTAINTY OF NO HARM.— 9 With respect to an ingredient or cosmetic, the term 10 ‘reasonable certainty of no harm’ means that no 11 harm will be caused to members of the general popu- 12 lation or any vulnerable population by aggregate ex- 13 posure to the cosmetic or ingredient, taking into ac- 14 count possible harmful effects from— 15 ‘‘(A) low-dose exposures to the cosmetic or 16 ingredient; 17 ‘‘(B) additive effects resulting from re- 18 peated exposure to the cosmetic or ingredient 19 over time; or 20 ‘‘(C) cumulative exposure resulting from 21 all sources, including both the cosmetic or in- 22 gredient and environmental sources. 23 ‘‘(10) REPRODUCTIVE OR DEVELOPMENTAL 24 TOXICITY.—With respect to an ingredient or cos- 25 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 6 •HR 4296 IH metic, the term ‘reproductive or developmental tox- 1 icity’ means that the ingredient or cosmetic can con- 2 tribute to biologically adverse effects on the develop- 3 ment of humans or animals, including effects on the 4 female or male reproductive system, the endocrine 5 system, fertility, pregnancy, pregnancy outcomes, or 6 modifications in other functions of the body that are 7 dependent on the integrity of the reproductive sys- 8 tem as well as normal fetal development. 9 ‘‘(11) SERIOUS ADVERSE EVENT.—The term 10 ‘serious adverse event’ means— 11 ‘‘(A) an acute or chronic response that re- 12 sults in death, a life-threatening experience, 13 short- or long-term hospitalization, a persistent 14 or significant disability or incapacity, a con- 15 genital anomaly or birth defect, serious and 16 persistent rashes or infections, significant hair 17 loss, permanent or significant alteration of ap- 18 pearance, or impacts to maternal health, includ- 19 ing placentia previa, gestational diabetes, and 20 miscarriage; 21 ‘‘(B) an event that requires, based on a 22 reasonable medical judgment, a medical or sur- 23 gical intervention; or 24 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 7 •HR 4296 IH ‘‘(C) any other serious adverse health-re- 1 lated event associated with the use of the prod- 2 uct. 3 ‘‘(12) SUPPLIER.—The term ‘supplier’ means 4 the entity that supplies ingredients, raw materials, 5 or specific components of a cosmetic or cosmetic 6 packaging. 7 ‘‘(13) VULNERABLE POPULATIONS.—The term 8 ‘vulnerable populations’ includes pregnant women, 9 infants, children, the elderly, individuals with a com- 10 promised immune system, and highly exposed popu- 11 lations including workers in a hair salon, nail salon, 12 beauty salon, spa, or cosmetic manufacturing plant. 13 ‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG- 14 ISTRATION FEES. 15 ‘‘(a) REGISTRATION.— 16 ‘‘(1) IN GENERAL.—Beginning 1 year after the 17 date of the enactment of this subchapter, and annu- 18 ally thereafter, any brand owner engaged in bringing 19 a cosmetic to market for use in the United States 20 shall register with the Secretary and pay to the Sec- 21 retary the applicable fee, as established under the 22 fee schedule in subsection (e). 23 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 8 •HR 4296 IH ‘‘(2) EXCEPTION FOR MICROBUSINESSES.—The 1 requirements of this section do not apply with re- 2 spect to microbusinesses. 3 ‘‘(3) RULES FOR DOMESTIC AND FOREIGN ES- 4 TABLISHMENTS.—To be registered under paragraph 5 (1)— 6 ‘‘(A) as a domestic establishment, the 7 owner, operator, or agent in charge of the do- 8 mestic establishment shall submit a registration 9 to the Secretary; or 10 ‘‘(B) as a foreign establishment, the owner, 11 operator, or agent in charge of the foreign es- 12 tablishment shall— 13 ‘‘(i) submit a registration to the Sec- 14 retary; and 15 ‘‘(ii) include with the registration the 16 name of the United States agent for the 17 foreign establishment. 18 ‘‘(4) NEW ESTABLISHMENTS.—Any brand 19 owner that initially brings a cosmetic to market 20 after the date on which the requirements of para- 21 graph (1) apply shall, not later than 60 days after 22 the date on which the establishment brings a cos- 23 metic to market, register with the Secretary and pay 24 the applicable fee, as required under paragraph (1). 25 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 9 •HR 4296 IH ‘‘(b) SUBMISSION OF REGISTRATION.— 1 ‘‘(1) IN GENERAL.—In order to register under 2 subsection (a), an establishment (referred to in this 3 section as the ‘registrant’) shall submit to the Sec- 4 retary, with respect to any cosmetics that the estab- 5 lishment brings to market, all of the following: 6 ‘‘(A) Any information necessary to notify 7 the Secretary of the name, address, and legal 8 status of each establishment at which, and all 9 trade names under which, the registrant brings 10 cosmetics to market. 11 ‘‘(B) A description of the establishment’s 12 activities with respect to cosmetics, including a 13 list of all cosmetic products brought to market 14 by the establishment and the functions of such 15 cosmetics. 16 ‘‘(C) The gross receipts or sales for the es- 17 tablishment from cosmetics. 18 ‘‘(2) NOTIFICATION OF CHANGES.—When sub- 19 mitting the annual registration, the registrant shall 20 notify the Secretary of changes to the information 21 described in paragraph (1). 22 ‘‘(c) PROCEDURE.—Upon receipt of a completed reg- 23 istration submitted under subsection (a), the Secretary 24 shall notify the registrant of the receipt of such registra- 25 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 10 •HR 4296 IH tion and assign a registration number to each registered 1 establishment. 2 ‘‘(d) LIST OF REGISTERED ESTABLISHMENTS.— 3 ‘‘(1) MAINTENANCE OF LIST.—The Secretary 4 shall— 5 ‘‘(A) compile, maintain, and update as ap- 6 propriate, a list of establishments that are reg- 7 istered under this section; 8 ‘‘(B) make such list publicly available, in- 9 cluding by posting such list on the public 10 website of the Food and Drug Administration; 11 ‘‘(C) remove from such list the name of 12 any establishment that fails to register in ac- 13 cordance with this section; and 14 ‘‘(D) indicate on such list any establish- 15 ment which has had its registration suspended 16 or cancelled by the Secretary under this section. 17 ‘‘(2) APPLICATION OF FOIA.— 18 ‘‘(A) REGISTRATION DOCUMENTS.—Any 19 registration documents submitted pursuant to 20 this section shall not be subject to disclosure 21 under section 552 of title 5, United States 22 Code. 23 ‘‘(B) OTHER INFORMATION.—Information 24 derived from— 25 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 11 •HR 4296 IH ‘‘(i) the list under paragraph (1); or 1 ‘‘(ii) registration documents submitted 2 pursuant to this section, 3 shall not be subject to disclosure under section 4 552 of title 5, United States Code, except to the 5 extent that such information discloses the iden- 6 tity or location of a specific registrant. 7 ‘‘(e) FEE SCHEDULE.—A schedule of fees shall be de- 8 veloped by the Secretary to provide for oversight and en- 9 forcement of this subchapter. The fee structure shall— 10 ‘‘(1) be prorated based on the establishment’s 11 gross receipts or sales; and 12 ‘‘(2) only be assessed on companies with annual 13 gross receipts or sales of cosmetics that exceed 14 $5,000,000. 15 ‘‘(f) SUSPENSION AND CANCELLATION OF REGISTRA- 16 TION.— 17 ‘‘(1) CRITERIA FOR SUSPENSION.—Registration 18 under this section is subject to suspension if the 19 Secretary finds— 20 ‘‘(A) the information submitted by the es- 21 tablishment for registration under subsection 22 (a) is incomplete, inaccurate, or out of date; 23 VerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296 kjohnson on DSK79L0C42 with BILLS 12 •HR 4296 IH ‘‘(B) the establishment fails to notify the 1 Secretary of changes required under subsection 2 (b)(2); 3 ‘‘(C) the establishment fails to pay reg- 4 istration fees, as required under subsection (a), 5 in a timely manner; or 6 ‘‘(D) the establishment violates any portion 7 of this chapter. 8 ‘‘(2) SUSPENS [Text truncated for display. 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