,i #aafth ,,congress #ast ,session ,h4 ,r4 #dbif ,,in ,,the ,,house ,,of ,,representatives ,september #ab1 #bjai,ms4 ,schakowsky 7for herself1 ,mr4 ,sean ,patrick ,maloney of ,new ,york1 ,ms4 ,lee of ,california1 ,mr4 ,ted ,lieu of ,california1 ,mr4 ,grijalva1 ,ms4 ,de,lauro1 ,mr4 ,huffman1 ,ms4 ,pressley1 ,mr4 ,hastings1 ,mr4 ,lowenthal1 ,ms4 ,judy ,chu of ,california1 ,ms4 ,speier1 ,ms4 ,jayapal1 ,ms4 ,de,gette1 ,ms4 ,pingree1 ,ms4 ,matsui1 and ,ms4 ,wasserman ,schultz7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,education and ,labor1 for a period to be subsequently determined by the ,speaker1 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 ,food1 ,drug1 and ,cosmetic ,act to ensure the safe use of cosmetics1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,safe ,cosmetics and ,personal ,care ,products ,act of #bjai4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,cosmetic regulation4 ,subchapter ,a--,adulterated and ,misbranded ,cosmetics ,subchapter ,b--,regulation of ,cosmetics ,sec4 #faa4 ,definitions4 ,sec4 #fab4 ,registration of establishments and registration fees4 ,sec4 #fac4 ,ingredients labels and website disclosure for cosmetics4 ,sec4 #fad4 ,safety standard and good manufacturing practices4 ,sec4 #fae4 ,cosmetic and ingredient safety information4 ,sec4 #faf4 ,lists of ingredients and required responses4 ,sec4 #fag4 ,treatment of cosmetics based on ingredient lists4 ,sec4 #fah4 ,treatment of contaminants4 ,sec4 #fai4 ,cosmetic and ingredient statements4 ,sec4 #fbj4 ,notification1 nondistribution1 and recall of adulterated or misbranded cosmetics4 ,sec4 #fba4 ,petitions4 ,sec4 #fbb4 ,mandatory reporting of serious adverse events4 ,sec4 #fbc4 ,nonconfidential information4 ,sec4 #fbd4 ,ban on use of animal testing4 ,sec4 #fbe4 ,product testing and review audit4 ,sec4 #fbf4 ,resources for small businesses4 ,sec4 #fbg4 ,interagency cooperation4 ,sec4 #fbh4 ,savings clause4 ,sec4 #fbi4 ,authorization of appropriations4 ,sec4 #c4 ,adulterated and misbranded cosmetics4 ,sec4 #d4 ,support for creating safer alternatives4 ,sec4 #e4 ,support by ,national ,institute of ,environmental ,health ,sciences for research on health disparities impacting communities of color4 ,sec4 #dfc;,c4 ,research on health disparities related to cosmetics impacting communities of color4 ,sec4 #f4 ,worker issues4 #b4 ,cosmetic regulation ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is amended-- 7#a7 by inserting before section #fja the following3 ,a ,adulterated and ,misbranded ,cosmetics 2 and 7#b7 by adding at the end the following3 ,b ,regulation of ,cosmetics #faa4 ,definitions ,in this subchapter3 7#a7 ,brand owner ,the term brand owner means the entity responsible for bringing a cosmetic to market4 7#b7 ,contaminant ,the term contaminant means unintended substances1 such as those that can originate from sources outside the chemical pathway1 chemical processes1 storage of primary substances1 instability of the packaging or harmful byproducts of the manufacturing process4 7#c7 ,domestic establishment ,the term domestic establishment means an establishment located in any ,state that brings a cosmetic to market4 7#d7 ,foreign establishment ,the term foreign establishment means an establishment that brings a cosmetic to market and exports those cosmetics to the ,united ,states4 7#e7 ,ingredient ,the term ingredient means a chemical in a cosmetic1 including-- 7,a7 chemicals that have a technical or functional effect in the cosmetic1 including the breakdown products of an intentionally added chemical that also have a functional or technical effect in the cosmetic2 7,b7 substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect2 7,c7 the components of a fragrance1 flavor1 preservative1 or colorant2 and 7,d7 any individual component that the ,secretary deems an ingredient for purposes of this chapter4 7#f7 ,manufacturer ,the term manufacturer means the entity that produces ingredients or combines one or more ingredients to produce a cosmetic product4 7#g7 ,microbusiness ,the term microbusiness means a business-- 7,a7 that is a brand owner as defined in this subchapter2 and 7,b7 that has annual sales receipts for cosmetic products that do not exceed #a1jjj1jjj4 7#h7 ,professional use ,the term professional use means-- 7,a7 the application of a cosmetic to a human customer or client by an employee or contractor of a hair salon1 nail salon1 beauty salon1 spa1 or other establishment within the scope of the work conducted by such employee or contractor2 or 7,b7 the use by or application to a human of a cosmetic purchased from a hair salon1 nail salon1 beauty salon1 spa1 or other establishment that provides cosmetic treatment services for humans4 7#i7 ,reasonable certainty of no harm ,with respect to an ingredient or cosmetic1 the term reasonable certainty of no harm means that no harm will be caused to members of the general population or any vulnerable population by aggregate exposure to the cosmetic or ingredient1 taking into account possible harmful effects from-- 7,a7 low-dose exposures to the cosmetic or ingredient2 7,b7 additive effects resulting from repeated exposure to the cosmetic or ingredient over time2 or 7,c7 cumulative exposure resulting from all sources1 including both the cosmetic or ingredient and environmental sources4 7#aj7 ,reproductive or developmental toxicity ,with respect to an ingredient or cosmetic1 the term reproductive or developmental toxicity means that the ingredient or cosmetic can contribute to biologically adverse effects on the development of humans or animals1 including effects on the female or male reproductive system1 the endocrine system1 fertility1 pregnancy1 pregnancy outcomes1 or modifications in other functions of the body that are dependent on the integrity of the reproductive system as well as normal fetal development4 7#aa7 ,serious adverse event ,the term serious adverse event means-- 7,a7 an acute or chronic response that results in death1 a life-threatening experience1 short- or long-term hospitalization1 a persistent or significant disability or incapacity1 a congenital anomaly or birth defect1 serious and persistent rashes or infections1 significant hair loss1 permanent or significant alteration of appearance1 or impacts to maternal health1 including placentia previa1 gestational diabetes1 and miscarriage2 7,b7 an event that requires1 based on a reasonable medical judgment1 a medical or surgical intervention2 or 7,c7 any other serious adverse health-related event associated with the use of the product4 7#ab7 ,supplier ,the term supplier means the entity that supplies ingredients1 raw materials1 or specific components of a cosmetic or cosmetic packaging4 7#ac7 ,vulnerable populations ,the term vulnerable populations includes pregnant women1 infants1 children1 the elderly1 individuals with a compromised immune system1 and highly exposed populations including workers in a hair salon1 nail salon1 beauty salon1 spa1 or cosmetic manufacturing plant4 #fab4 ,registration of establishments and registration fees 7a7 ,registration 7#a7 ,in general ,beginning #a year after the date of the enactment of this subchapter1 and annually thereafter1 any brand owner engaged in bringing a cosmetic to market for use in the ,united ,states shall register with the ,secretary and pay to the ,secretary the applicable fee1 as established under the fee schedule in subsection 7e74 7#b7 ,exception for microbusinesses ,the requirements of this section do not apply with respect to microbusinesses4 7#c7 ,rules for domestic and foreign establishments ,to be registered under paragraph 7#a7-- 7,a7 as a domestic establishment1 the owner1 operator1 or agent in charge of the domestic establishment shall submit a registration to the ,secretary2 or 7,b7 as a foreign establishment1 the owner1 operator1 or agent in charge of the foreign establishment shall-- 7i7 submit a registration to the ,secretary2 and 7ii7 include with the registration the name of the ,united ,states agent for the foreign establishment4 7#d7 ,new establishments ,any brand owner that initially brings a cosmetic to market after the date on which the requirements of paragraph 7#a7 apply shall1 not later than #fj days after the date on which the establishment brings a cosmetic to market1 register with the ,secretary and pay the applicable fee1 as required under paragraph 7#a74 7b7 ,submission of registration 7#a7 ,in general ,in order to register under subsection 7a71 an establishment 7referred to in this section as the registrant7 shall submit to the ,secretary1 with respect to any cosmetics that the establishment brings to market1 all of the following3 7,a7 ,any information necessary to notify the ,secretary of the name1 address1 and legal status of each establishment at which1 and all trade names under which1 the registrant brings cosmetics to market4 7,b7 ,a description of the establishment's activities with respect to cosmetics1 including a list of all cosmetic products brought to market by the establishment and the functions of such cosmetics4 7,c7 ,the gross receipts or sales for the establishment from cosmetics4 7#b7 ,notification of changes ,when submitting the annual registration1 the registrant shall notify the ,secretary of changes to the information described in paragraph 7#a74 7c7 ,procedure ,upon receipt of a completed registration submitted under subsection 7a71 the ,secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered establishment4 7d7 ,list of registered establishments 7#a7 ,maintenance of list ,the ,secretary shall-- 7,a7 compile1 maintain1 and update as appropriate1 a list of establishments that are registered under this section2 7,b7 make such list publicly available1 including by posting such list on the public website of the ,food and ,drug ,administration2 7,c7 remove from such list the name of any establishment that fails to register in accordance with this section2 and 7,d7 indicate on such list any establishment which has had its registration suspended or cancelled by the ,secretary under this section4 7#b7 ,application of ,,foia 7,a7 ,registration documents ,any registration documents submitted pursuant to this section shall not be subject to disclosure under section #eeb of title #e1 ,united ,states ,code4 7,b7 ,other information ,information derived from-- 7i7 the list under paragraph 7#a72 or 7ii7 registration documents submitted pursuant to this section1 shall not be subject to disclosure under section #eeb of title #e1 ,united ,states ,code1 except to the extent that such information discloses the identity or location of a specific registrant4 7e7 ,fee schedule ,a schedule of fees shall be developed by the ,secretary to provide for oversight and enforcement of this subchapter4 ,the fee structure shall-- 7#a7 be prorated based on the establishment's gross receipts or sales2 and 7#b7 only be assessed on companies with annual gross receipts or sales of cosmetics that exceed #e1jjj1jjj4 7f7 ,suspension and cancellation of registration 7#a7 ,criteria for suspension ,registration under this section is subject to suspension if the ,secretary finds-- 7,a7 the information submitted by the establishment for registration under subsection 7a7 is incomplete1 inaccurate1 or out of date2 7,b7 the establishment fails to notify the ,secretary of changes required under subsection 7b77#b72 7,c7 the establishment fails to pay registration fees1 as required under subsection 7a71 in a timely manner2 or 7,d7 the establishment violates any portion of this chapter4 7#b7 ,suspension of registration ,if the ,secretary determines that an establishment is subject to suspension under this subsection and that it is appropriate to suspend the registration of such establishment the ,secretary shall-- 7,a7 suspend the registration of such establishment2 and 7,b7 provide a notice of suspension to such establishment4 7#c7 ,cancellation ,if the establishment fails to correct the issue that resulted in the suspension under paragraph 7#b7 before the last day of the #cj-;day period beginning on the date that the establishment receives notice under such paragraph1 the ,secretary may cancel the registration of such establishment4 7g7 ,recordkeeping ,all establishments that are required to register under this section shall maintain records that include a current list of suppliers and manufacturers if the registrant does not manufacture or package its own product4 ,those records shall be accessible by the ,secretary upon request for review or audit4 #fac4 ,ingredients labels and website disclosure for cosmetics 7a7 ,in general ,subject to subsections 7b7 and 7c71 the ,secretary shall require that the label on each package of cosmetics 7including cosmetics for retail sale and professional use7 bears a declaration of the name of each ingredient in such cosmetic in descending order of predominance4 7b7 ,adjustments for label size 7#a7 ,rules for small products ,not later than #f months after the date of the enactment of this subchapter1 the ,secretary shall issue regulations that apply to any cosmetic for which the product packaging is not of sufficient size to bear or contain a label that meets the requirements of subsection 7a74 7#b7 ,requirements for public disclosure ,such regulations shall establish requirements for listing ingredients on the label of such cosmetics and additional requirements1 as appropriate1 for public disclosure of the ingredients in such cosmetics4 7c7 ,special rule for contaminants ,the ,secretary shall require1 in the case of a contaminant 7as defined by section #fah71 that a contaminant be declared on the label of a cosmetic1 in the same manner as an ingredient under subsection 7a71 if the contaminant is present in a personal care product in any quantity exceeding one half of one percent of the content of the product by weight4 7d7 ,labeling of nanomaterials in cosmetics ,the ,secretary may require that-- 7#a7 minerals and other particulate ingredients be labeled as nano-scale on a cosmetic ingredient label or list if not less than #a percent of the ingredient particles in the cosmetic are #ajj nanometers or smaller in not less than #a dimension2 and 7#b7 other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties4 7e7 ,website disclosure of cosmetic ingredients ,the ,secretary shall require that the website of a brand owner of a cosmetic include a declaration of the ingredients in the cosmetic in descending order of predominance1 including the function of each ingredient4 7f7 ,labeling of ingredients in cosmetics sold through internet commerce ,the ,secretary shall require-- 7#a7 in the case of a cosmetic sold on the website of an internet vendor1 that the brand owner of such cosmetic provide to such internet vendor a list of the ingredients in the cosmetic2 and 7#b7 that each internet vendor display the list of ingredients in a cosmetic sold by such vendor on the web page that is the primary web page providing information relating to the sale of such cosmetic on the website of the vendor4 7g7 ,product labeling of fragrance and flavor ingredients 7#a7 ,requirements ,the ,secretary shall require that all fragrance and flavor ingredients in a cosmetic that are deemed hazardous to human health or the environment by paragraph 7#b7 appear on the label of the cosmetic4 7#b7 ,list of ingredients deemed hazardous ,the following ingredients 7including chemicals added by the relevant government agency or authoritative body subsequent to the date of enactment of this subchapter7 are deemed hazardous to human health or the environment for purposes of paragraph 7#a77;,a73 7,a7 ,chemicals known to cause cancer or reproductive toxicity that are listed pursuant to ,california ,health ,safety ,code ,section #bebdi4e et seq4 7,b7 ,chemicals classified by the ,european ,union as carcinogens1 mutagens1 or reproductive toxicants pursuant to ,category #a;,a or #a;,b in ,annex ,,vi to ,regulation 7,,ec7 ,no4 #abgb_/bjjh4 7,c7 ,chemicals included in the ,european ,union ,candidate ,list of ,substances of ,very ,high ,concern in accordance with ,article #ei of ,regulation 7,,ec7 ,no4 #aijg_/bjjf on the basis of ,article #eg7;f7 for endocrine disrupting properties4 7,d7 ,chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity in the ,environmental ,protection ,agency's ,integrated ,risk ,information ,system4 7,e7 ,chemicals that are identified as carcinogenic to humans1 likely to be carcinogenic to humans1 or as ,group ,a1 ,b#a1 or ,b#b carcinogens1 in the ,environmental ,protection ,agency's ,integrated ,risk ,information ,system4 7,f7 ,chemicals included in the ,european ,chemicals ,agency ,candidate ,list of ,substances of ,very ,high ,concern in accordance with ,article #ei of ,regulation 7,,ec7 ,no4 #aijg_/bjjf on the basis of ,article #eg7;d71 ,article #eg7;e71 or ,article #eg7;f7 of ,regulation 7,,ec7 ,no4 #aijg_/bjjf for persistent1 bioaccumulative and toxic1 or very persistent and very bioaccumulative1 properties4 7,g7 ,chemicals that are identified as persistent1 bioaccumulative1 and inherently toxic to the environment by the ,canadian ,environmental ,protection ,act ,environmental ,registry ,domestic ,substances ,list pursuant to subsection #ff7a7 of the ,canadian ,environmental ,protection ,act1 #aiii4 7,h7 ,chemicals classified by the ,european ,union in ,annex ,,vi to ,regulation 7,,ec7 ,no4 #abgb_/bjjh as respiratory sensitizer category #a4 7,i7 ,group #a1 #b;,a1 or #b;,b carcinogens identified by the ,international ,agency for ,research on ,cancer4 7,j7 ,neurotoxicants that are identified in the ,agency for ,toxic ,substances and ,disease ,registry's ,toxic ,substances ,portal4 7,k7 ,persistent bioaccumulative and toxic priority chemicals that are identified by the ,environmental ,protection ,agency's ,national ,waste ,minimization ,program as of ,february #bb1 #bjaf4 7,l7 ,reproductive and developmental toxicants identified by ,national ,toxicology ,program ,center for the ,evaluation of ,risks monographs4 7,m7 ,chemicals identified as ,persistent ,bioaccumulative ,toxic by the ,environmental ,protection ,agency on the ,toxics ,release ,inventory under section #cac of the ,emergency ,planning and ,community ,right-to-,know ,act of #aihf 7#db ,u4,s4,c4 #aajbc74 7,n7 ,the ,state of ,washington ,department of ,ecology's ,persistent1 ,bioaccumulative1 ,toxic 7,,pbt7 ,chemicals identified in ,chapter #agc-ccc of ,title #agc of the ,washington ,administrative ,code4 7,o7 ,chemicals that are identified as known to be1 or reasonably anticipated to be1 human carcinogens by the most recent ,report on ,carcinogens prepared by the ,federal ,national ,toxicology ,program4 7,p7 ,chemicals for which primary maximum contaminant levels have been established for drinking water by the ,environmental ,protection ,agency4 7,q7 ,chemicals identified as hazardous air pollutants by the ,environmental ,protection ,agency pursuant to section #aab of the ,clean ,air ,act 7#db ,u4,s4,c4 #gdab74 7,r7 ,toxic pollutants listed under section #cjg7;a77#a7 of the ,federal ,water ,pollution ,control ,act 7#cc ,u4,s4,c4 #acag7 and priority pollutants identified in appendix ,a to part #dbc of title #dj1 ,code of ,federal ,regulations4 7,s7 ,chemicals that are identified on the ,centers for ,disease ,control and ,prevention's most recent ,report on ,human ,exposure to ,environmental ,chemicals and ,updated ,tables ,volume #a and ,volume #b4 7,t7 ,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 ,atlantic4 7,u7 ,chemicals identified as hazardous under section #aja7ad7 or #ajb of the ,comprehensive ,environmental ,response1 ,compensation1 and ,liability ,act of #aihj 7#db ,u4,s4,c4 #ifja7ad71 #ifjb74 7h7 ,fragrance allergens ,the ,secretary shall require that any fragrance allergen in a cosmetic be included on the label of the cosmetic and identified as a fragrance allergen if the fragrance allergen is-- 7#a7 included in ,annex ,,iii of ,european ,union ,cosmetics ,regulation ,no4 #abbc_/bjji1 as required to be disclosed pursuant to ,european ,union ,detergents ,regulation ,no4 #bafdh_/bjjd1 and subsequent updates to those regulations2 and 7#b7 is present in-- 7,a7 a rinse-off cosmetic at a concentration at or above #j4ja percent2 or 7,b7 a leave-on cosmetic product at a concentration at or above #j4jja percent4 7i7 ,trade secrets ,notwithstanding any other provision of law1 an ingredient required to be listed on a product label or on a brand owner or internet commerce website under this section shall not be treated as a trade secret4 7j7 ,application ,beginning #ah months after the date of the enactment of this subchapter1 the requirements of this section shall apply to-- 7#a7 all cosmetics that are available for retail sale 7including such cosmetics for professional use72 and 7#b7 brand owners and internet vendors of such cosmetics4 #fad4 ,safety standard and good manufacturing practices 7a7 ,safety standard 7#a7 ,in general ,taking into account the expected or reasonably foreseeable use of a cosmetic1 the ,secretary shall establish a safety standard that1 with respect to a cosmetic or an ingredient in a cosmetic1 provides a reasonable certainty of no harm 7as such term is defined in section #faa7i77 from exposure to the cosmetic or ingredient and protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient4 7#b7 ,standards for establishing safety standard ,in establishing the safety standard under paragraph 7#a71 the ,secretary shall ensure that-- 7,a7 the likely level of exposure to all sources of the ingredient or cosmetic 7including environmental sources7 that will result under the safety standard presents not more than a one in a million risk for any adverse health effect in any vulnerable population at the lower #ieth percentile confidence interval2 or 7,b7 the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects1 incorporating a margin of safety of at least #a1jjj and considering the impact of cumulative exposure from all sources 7including environmental sources74 7#c7 ,use of other ,federal standards ,if any ,federal agency has promulgated a standard for an ingredient that satisfies the requirements of paragraph 7#a71 the ,secretary may treat such standard as the safety standard under paragraph 7#a7 for purposes of such ingredient4 7b7 ,good manufacturing practices 7#a7 ,in general ,the ,secretary shall issue guidance prescribing good manufacturing practices for cosmetics and ingredients1 including quality control procedures that the ,secretary determines are necessary1 and shall update such guidance as necessary4 7#b7 ,consideration of small business ,in developing the guidance under paragraph 7#a71 the ,secretary shall consider how such practices will impact small businesses4 #fae4 ,cosmetic and ingredient safety information 7a7 ,required submission of all safety information 7#a7 ,in general ,brand owners of cosmetics shall submit electronically to the ,secretary all data and information that the brand owner can access regarding the safety of-- 7,a7 the ingredients listed on the cosmetic label and the brand owner's website under section #fac for a cosmetic2 and 7,b7 the cosmetic itself4 7#b7 ,required information ,the required data and information under paragraph 7#a7 shall include1 for each ingredient in a cosmetic and for the cosmetic1 the following3 7,a7 ,functions and uses4 7,b7 ,data and information on the physical1 chemical1 and toxicity properties of each such ingredient or cosmetic4 7,c7 ,exposure and fate information4 7,d7 ,results of all safety tests that the brand owner can access or has conducted4 7,e7 ,any other information used to substantiate the safety of such ingredient and cosmetic4 7#c7 ,deadlines 7,a7 ,initial submission ,a brand owner shall submit the data and information required under paragraph 7#a7-- 7i7 in the case of an ingredient or cosmetic which is marketed for sale in interstate commerce on or before the date of the enactment of this subchapter1 not later than #a year after such date2 and 7ii7 in the case of an ingredient or cosmetic which is not marketed for sale on or before such date-- 7,i7 not later than the end of the #ad-month period beginning on the date of the enactment of this subchapter2 or 7,,ii7 if the ingredient or cosmetic is first marketed for sale in interstate commerce after the end of the period described in subclause 7,i71 not later than #fj days after the date on which such ingredient or cosmetic is first marketed for sale4 7,b7 ,updates 7i7 ,in general ,subject to clause 7ii71 a brand owner shall update the data and information submitted under subparagraph 7,a7 annually4 7ii7 ,adverse health effects ,in the case of information related to an adverse health effect that is suspected to be caused by an ingredient or a cosmetic1 a brand owner shall update the information not later than #fj days after receiving such information4 7#d7 ,supplier and manufacturer information 7,a7 ,use of supplier or manufacturer information ,in order to meet the requirements of paragraph 7#a7 with respect to an ingredient1 a brand owner may submit safety data and information provided by the supplier or manufacturer of the ingredient or cosmetic4 7,b7 ,supplier or manufacturer provision of information ,if a brand owner requests that a supplier or manufacturer of an ingredient provide to such brand owner any of the data and information described under paragraph 7#b7 or under section #fag1 such supplier or manufacturer shall provide such data and information to such brand owner not later than #ij days after receiving such request4 7b7 ,database 7#a7 ,initial publication ,not later than #a year after the date of the enactment of this subchapter1 the ,secretary shall publish a comprehensive database that-- 7,a7 is publicly accessible1 including on the public website of the ,food and ,drug ,administration2 and 7,b7 contains all nonconfidential information 7as such term is used in section #fbc7 submitted under subsection 7a77#a74 7#b7 ,updates ,not later than #ij days after the ,secretary receives new or updated information under subsection 7a77#c77;,b71 the ,secretary shall update the database under paragraph 7#a7 with such information4 7c7 ,review and evaluation of information 7#a7 ,in general ,based on the data and information submitted under subsection 7a77#a71 available from an authoritative source 7as such term is defined in paragraph 7#c71 including data described in section #fbg7;b771 and such other information as the ,secretary may have available1 the ,secretary shall review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce4 7#b7 ,consideration of nanomaterials ,the ,secretary shall-- 7,a7 monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetics 7including progress in the standardization of testing methods and specific size definitions for nanomaterials72 and 7,b7 consider scale-specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph 7#a74 7#c7 ,authoritative source defined ,for purposes of this subsection1 the term authoritative source means-- 7,a7 the ,environmental ,protection ,agency2 7,b7 the ,international ,agency for ,research on ,cancer2 7,c7 the ,national ,institutes of ,health2 7,d7 the ,california ,environmental ,protection ,agency2 and 7,e7 any other authoritative international1 ,federal1 or ,state entity1 as determined by the ,secretary4 #faf4 ,lists of ingredients and required responses 7a7 ,placement on list 7#a7 ,in general ,based on an initial review and evaluation of the chronic health impacts associated with an ingredient that is used in one or more cosmetics1 the ,secretary shall create and periodically update a list of ingredients for safety review4 ,from such list1 the ,secretary shall place ingredients on a priority assessment list and1 after comprehensive safety review1 place each ingredient on the priority assessment list on one of the following lists3 7,a7 ,the prohibited and restricted lists under subsection 7b74 7,b7 ,the safe without limits list under subsection 7c74 7,c7 ,the insufficient data list under subsection 7d74 7#b7 ,initial list ,the ,secretary shall add #bj ingredients to the initial priority assessment list created under paragraph 7#a7 immediately after the enactment of this subchapter4 7#c7 ,considerations ,in determining the placement of an ingredient on the priority assessment list under paragraph 7#a71 the ,secretary shall consider the scientific evidence linking that ingredient to harm and conduct further prioritization based on whether the ingredient-- 7,a7 is found to be present in the body through biomonitoring2 7,b7 is found in drinking water or air2 7,c7 is a known or suspected neurological or immunological toxicant1 respiratory asthmagen1 carcinogen1 teratogen1 or endocrine disruptor1 or have other toxicity concerns 7including reproductive or developmental toxicity72 7,d7 is known to persist in the environment or bioaccumulate2 or 7,e7 is of particular concern to a community disproportionately impacted by cosmetic chemicals in products marketed to them because of their particular race1 ethnicity1 or occupation4 7#d7 ,prioritization of ingredients that are food ,in placing ingredients on the lists under paragraph 7#a71 the ,secretary shall prioritize the placement of ingredients that are food 7as such term is defined under section #bja7;f77 on such lists4 7b7 ,prohibited and restricted lists 7#a7 ,in general ,the ,secretary shall issue1 by regulation1 two lists of ingredients that are identified by the ,secretary-- 7,a7 in the first list1 as prohibited for use in cosmetics because the ,secretary determines that such ingredients are unsafe for use in cosmetics in any amount because such ingredients fail to meet the safety standard under section #fad7;a72 or 7,b7 in the second list1 as being subject to necessary restrictions in use or concentration to allow the use of the ingredient in a cosmetic to satisfy the safety standard4 7#b7 ,initial prohibited list 7,a7 ,immediately prohibited ingredients ,effective as of the date of enactment of this subchapter1 the following ingredients are deemed to be listed pursuant to paragraph 7#a77;,a7 as prohibited for use3 7i7 ,benzophenones1 including benzophenone-#a1 benzophenone-#c 7also known as ozybenzone71 benzophenone-#d1 and benzophenone-#e4 7ii7 ,octinoxate4 7iii7 ,butylated ,hydroxyanisole and ,butylated ,hydroxyoluen4 7iv7 ,coal tar dyes 7,p-phenylenediamine74 7v7 ,cocamide ,diethanolamine4 7vi7 ,dibutyalated ,phthalate 7,phthalates ,,dbp71 ,bis7#b-;ethylhexyl7 ,phthalate 7,,dehp74 7vii7 ,toluene4 7viii7 ,styrene or ,styrene acrylates4 7ix7 ,formaldehydes 7,methylene glycol_/methanediol_/formaldehyde7 and ,formaldehyde-releasing preservatives 7,,dmdm hydantoin1 diazolidinyl urea1 imidazolidinyl urea1 methenamine1 quaternium-#ae1 and sodium hydroxymethylglycinate74 7x7 ,triclosan4 7xi7 ,lead acetate or other lead compounds4 7xii7 ,parabens 7isoproylparaben1 isobutylparaben1 pheylparaben1 benzylparaben1 pentylparaben1 propylparaben1 and butylparaben74 7,b7 ,first ingredients listed by regulation ,not later than #b years after the date of enactment of this subchapter1 the ,secretary shall promulgate by final regulation the lists required by subparagraphs 7,a7 and 7,b7 of paragraph 7#a71 to supplement the ingredients deemed by subparagraph 7,a7 of this paragraph to be listed pursuant to paragraph 7#a77;,a74 7#c7 ,specification of restrictions ,in the case of any ingredient listed under paragraph 7#a77;,b71 the ,secretary shall specify the restrictions on use or concentration that are necessary to satisfy the safety standard for such ingredient4 7#d7 ,updates 7,a7 ,in general ,after promulgating the initial list pursuant to paragraph 7#b77;,b71 the ,secretary shall update the lists under paragraph 7#a7 at a minimum annually1 including-- 7i7 updates to determinations under subsection 7d77#c72 or 7ii7 any updates prompted by new information that demonstrates that an ingredient fails to meet the safety standard1 or requires restrictions on use to meet such standard4 7,b7 ,chemicals identified pursuant to ,,nih-funded research ,the ,secretary shall-- 7i7 consult with the ,director of the ,national ,institute of ,environmental ,health ,sciences to identify any chemicals that are determined to be of concern pursuant to investigations funded under section #dfc;,c of the ,public ,health ,service ,act2 and 7ii7 review any such chemicals in accordance with this section to determine whether such chemicals should be prohibited or subject to restrictions under this section4 7#e7 ,manufacturer requirements ,not later than #a year after the date on which an ingredient is placed on a list under this subsection1 any manufacturer using such ingredient in a cosmetic shall reformulate such cosmetic to-- 7,a7 eliminate the use of the ingredient1 if it is listed under paragraph 7#a77;,a72 or 7,b7 modify the use of the ingredient if it is listed under paragraph 7#a77;,b71 to meet the restrictions specified under paragraph 7#c74 7c7 ,safe without limits list 7#a7 ,in general ,not later than #b years after the date of the enactment of this subchapter1 the ,secretary shall issue1 by regulation1 a list of ingredients that the ,secretary has determined are safe for use in cosmetics1 without limits or restrictions4 7#b7 ,standard for inclusion in list ,the ,secretary may only include an ingredient on the list under paragraph 7#a7 if the ,secretary determines that the ingredient meets the safety standard under section #fad7;a71 regardless of-- 7,a7 the type and form of cosmetic the ingredient is used in2 and 7,b7 the concentration of the ingredient that is used in a cosmetic4 7#c7 ,updates and redeterminations ,after promulgating the initial list pursuant to paragraph 7#a71 the ,secretary-- 7,a7 shall annually update the list under paragraph 7#a72 and 7,b7 may redetermine whether an ingredient distributed in commerce meets the safety standard under section #fad7;a7 if1 in the judgment of the ,secretary1 new information raises a credible question as to whether the ingredient continues to meet the safety standard4 7d7 ,priority assessment list and related safety determinations 7#a7 ,in general ,not later than #a year after the creation of the initial priority assessment list of ingredients for review under subsection 7a77#a71 the ,secretary shall evaluate the safety of not less than #aj ingredients for which the ,secretary has determined it is a priority to conduct a safety determination under paragraph 7#c74 7#b7 ,annual addition of ingredients ,after the initial evaluation of #aj ingredients pursuant to paragraph 7#a71 the ,secretary shall annually add at least #aj additional ingredients to such list until all ingredients that are used in the formulation or manufacture of cosmetics have been evaluated for safety and added to-- 7,a7 the prohibited and restricted lists under subsection 7b72 7,b7 the safe without limits list under subsection 7c72 or 7,c7 the insufficient data list under this subsection4 7#c7 ,determination of whether ingredient meets safety standard 7,a7 ,review of priority ingredients ,during the #b-year period following the date on which an ingredient is listed pursuant to paragraph 7#a7 or 7#b71 the ,secretary shall-- 7i7 collect data and information on such ingredient2 and 7ii7 review and evaluate the safety of such ingredient4 7,b7 ,determination of list placement ,not later than the end of the period under subparagraph 7,a71 the ,secretary shall issue a determination1 based on the review and evaluation under such subparagraph1 that the ingredient meets the requirements for inclusion on a list specified in subparagraph 7,a71 7,b71 or 7,c7 of paragraph 7#b74 7,c7 ,guidance in the case of insufficient or no data ,if the ,secretary determines under subparagraph 7,b7 that1 with respect to an ingredient1 insufficient or no data exists to place such ingredient on either the prohibited and restricted list under subsection 7b7 or the safe without limits list under subsection 7c71 the ,secretary shall provide guidance on the data and information 7including minimum data requirements and safety testing protocols7 that the ,secretary requires to evaluate whether the ingredient meets the safety standard under section #fad7;a7 for purposes of placing such ingredient on either such list4 7,d7 ,comment period ,upon issuing the determination under subparagraph 7,b71 and1 if applicable1 the guidance under subparagraph 7,c71 the ,secretary shall provide a period of not less than #fj days for public comment on the determination before applying such determination to an ingredient1 except that a shorter period for comment may be provided if the ,secretary-- 7i7 finds that it would be in the public interest to have a shorter period2 and 7ii7 publicly declares the reasons for such finding4 7#d7 ,response to inadequate information ,not later than #ah months after the date that the ,secretary issues guidance under paragraph 7#c77;,c7 with respect to an ingredient subject to a determination under paragraph 7#c77;,b71 a brand owner using such ingredient in a cosmetic shall-- 7,a7 reformulate such cosmetic to eliminate the use of the ingredient2 or 7,b7 provide the ,secretary with the data and information specified in such guidance4 7#e7 ,evaluation of additional data and information ,with respect to an ingredient1 not later than #f months after the ,secretary receives the data and information under paragraph 7#d77;,b71 the ,secretary shall-- 7,a7 review such data and information2 and 7,b7 make a redetermination under paragraph 7#c77;,b7 for such ingredient1 subject to the comment period under paragraph 7#c77;,d74 #fag4 ,treatment of cosmetics based on ingredient lists 7a7 ,in general ,subject to subsections 7b77#e7 and 7d77#d7 of section #faf1 a brand owner may only distribute in interstate commerce a cosmetic that meets the safety standard under section #fad7;a74 7b7 ,presumption related to the safety of cosmetics 7#a7 ,in general ,subject to paragraph 7#b71 for purposes of subsection 7a71 the ,secretary shall presume that the following cosmetics meet the safety standard under section #fad7;a73 7,a7 ,a cosmetic that is made solely of ingredients on the list under section #faf7;c77#a7 7relating to ingredients that are safe without limits74 7,b7 ,a cosmetic that is made solely of ingredients on the list under section #faf7;b77#a77;,b7 7relating to ingredients subject to restrictions7 and the use of each of such ingredients in such cosmetic is in compliance with the restrictions on the use of such ingredients specified under section #faf7;b77#c74 7,c7 ,a cosmetic that is made solely of ingredients described in subparagraph 7,a7 and subparagraph 7,b74 7#b7 ,exceptions ,the ,secretary may require that a brand owner demonstrate that a cosmetic meets the safety standard under section #fad7;a7 7including by requiring that the brand owner conduct safety testing1 or request such safety testing from relevant suppliers and manufacturers1 of a cosmetic described under paragraph 7#a77 if-- 7,a7 the cosmetic contains-- 7i7 penetration enhancers1 sensitizers1 endocrine-disrupting compounds1 or other similar ingredients2 or 7ii7 ingredients that react with each other or with other substances to form harmful byproducts2 or 7,b7 the ,secretary has any additional reason to believe that such cosmetic does not meet the safety standard under section #fad7;a74 7#c7 ,guidance ,if1 under paragraph 7#b71 the ,secretary requires that a brand owner demonstrate that a cosmetic meets the safety standard under section #fad7;a71 the ,secretary shall provide the brand owner with guidance on the data and information that the ,secretary requires to evaluate whether the cosmetic meets the safety standard under such section4 7c7 ,notification of failure of ,secretary ,to act ,if the ,secretary fails to act by an applicable deadline under section #faf or this section1 brand owners and manufacturers of an ingredient or a cosmetic affected by such failure of the ,secretary to act shall issue to the ,secretary1 the public1 and each known customer of the ingredient or cosmetic1 a written and electronic notice that a determination by the ,secretary of the safety of the ingredient or cosmetic is pending4 #fah4 ,treatment of contaminants 7a7 ,publication of list ,not later than #a year after the date of the enactment of this subchapter1 and annually thereafter1 the ,secretary shall publish a list of contaminants of concern linked to severe acute reactions or chronic adverse health effects1 including-- 7#a7 ingredients used in cosmetics that may contain contaminants of concern2 7#b7 combinations of ingredients that may create contaminants of concern when such ingredients interact2 7#c7 contaminants of concern that may leech from product packaging into a cosmetic2 and 7#d7 any other contaminant of concern identified by the ,secretary that are present in cosmetics4 7b7 ,evaluation2 labeling ,the ,secretary shall use the process described in sections #fae and #faf to evaluate contaminants of concern for possible elimination or restriction in cosmetics4 ,the ,secretary shall require that a contaminant on the list under subsection 7a7 be declared on the label of a cosmetic1 in the same manner as an ingredient under section #fac4 7c7 ,requirements for testing 7#a7 ,in general ,not later than #a year after the date of enactment of this subchapter1 the ,secretary shall establish1 by rule1 requirements for testing ingredients and cosmetics for contaminants listed under subsection 7a74 7#b7 ,contents ,the requirements under paragraph 7#a7 shall include-- 7,a7 testing methods and applicable protocols2 and 7,b7 maximum allowable detection limits for each contaminant in an ingredient or cosmetic4 7#c7 ,update ,the ,secretary shall annually update the requirements under paragraph 7#a74 7d7 ,supplier requirements ,beginning not later than #a year after the promulgation of the rule under subsection 7c77#a7 with respect to an ingredient that is used in a cosmetic1 a supplier of the ingredient shall1 with respect to such ingredient-- 7#a7 comply with the requirements under subsection 7c77#a7 for any ingredient listed under subsection 7a72 7#b7 conduct similar testing on any ingredient that-- 7,a7 the supplier expects may be used in a cosmetic2 7,b7 the supplier suspects may contain a contaminant of concern2 and 7,c7 is not listed under subsection 7a72 and 7#c7 upon the sale of an ingredient to the manufacturer of a cosmetic1 provide to the manufacturer specifications for the ingredient that-- 7,a7 include the levels of contaminants present in such ingredient2 and 7,b7 are based on the results of the tests under paragraph 7#a7 and paragraph 7#b74 7e7 ,brand owner requirements ,not later than #a year after the promulgation of the rule under subsection 7c77#a71 a brand owner of a cosmetic shall1 with respect to each ingredient that the brand owner uses in a cosmetic-- 7#a7 obtain1 from each supplier or manufacturer of the ingredient1 specifications for the ingredient that include-- 7,a7 the level of each contaminant present in the ingredient2 and 7,b7 the detection limits of the analytical test used to detect the contaminant2 or 7#b7 comply with the requirements under paragraphs 7#a7 and 7#b7 of subsection 7d7 for the ingredient1 in the same manner as if the brand owner were a supplier4 #fai4 ,cosmetic and ingredient statements 7a7 ,in general ,beginning #a year after the date of the enactment of this subchapter1 each brand owner of a cosmetic intended to be marketed in the ,united ,states shall submit electronically to the ,secretary1 for each cosmetic that is intended to be marketed in the ,united ,states1 a statement containing-- 7#a7 the registration number of the brand owner2 7#b7 the brand name and the product name for the cosmetic2 7#c7 the applicable use for the cosmetic2 7#d7 a list of the ingredients in the product1 including fragrance1 flavorants1 and the particle size range of any nanoscale cosmetic ingredients2 7#e7 any warnings and directions for use from the cosmetic label or insert2 and 7#f7 the name1 title1 and full contact information for the individual responsible for submitting and maintaining such statement4 7b7 ,new cosmetics ,any brand owner that begins to market a cosmetic after the date of the enactment of this subchapter shall comply with the requirements of subsection 7a7 beginning on the later of the following3 7#a7 ,the end of the #ah-month period beginning on the date of the enactment of this subchapter4 7#b7 ,the end of the #f-month period after the date on which the establishment begins to manufacture such cosmetic4 7c7 ,notification of changes ,the brand owner shall notify the ,secretary annually of any change to the information required under subsection 7a74 7d7 ,procedure ,upon receipt of a completed statement described under subsection 7a71 the ,secretary shall notify the brand owner of the receipt of such statement and assign a cosmetic statement number4 7e7 ,list ,the ,secretary shall compile1 maintain1 and update as appropriate1 a list of cosmetics for which statements are submitted under this section4 7f7 ,access to safety information ,the cosmetic and ingredient statements collected under this section shall be added to the publicly accessible database created by the ,secretary under section #fae7;b74 #fbj4 ,notification1 nondistribution1 and recall of adulterated or misbranded cosmetics 7a7 ,notification of adulterated or misbranded cosmetics 7#a7 ,in general ,a responsible party that has reason to believe that a cosmetic1 when introduced into or while in interstate commerce1 or while held for sale 7regardless of whether such sale is the first sale of such cosmetic7 after shipment in interstate commerce1 is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic 7or an ingredient or component used in any such cosmetic7 will cause a threat of a serious adverse event shall notify the ,secretary of the identity and location of the cosmetic4 7#b7 ,manner of notification ,notification under paragraph 7#a7 shall be made in such manner and by such means as the ,secretary may require by regulation or guidance4 7#c7 ,responsible party defined ,for purposes of this subsection1 the term responsible party means a brand owner1 manufacturer1 packager1 retailer1 or distributor of the cosmetic4 7b7 ,voluntary recall ,the ,secretary may request that any person who distributes a cosmetic that the ,secretary has reason to believe is adulterated1 misbranded1 or otherwise in violation of this ,act voluntarily-- 7#a7 recall such cosmetic2 and 7#b7 provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 7c7 ,order ,to cease distribution 7#a7 ,in general ,if the ,secretary has reason to believe that-- 7,a7 the use of1 or exposure to1 a cosmetic may cause a serious adverse event2 7,b7 the cosmetic is misbranded2 or 7,c7 the cosmetic is marketed1 manufactured1 packaged1 or distributed by an unregistered brand owner1 the ,secretary may issue an order requiring any person who distributes such cosmetic to immediately cease distribution of such cosmetic4 7#b7 ,cease distribution and notice ,any person who is subject to an order under paragraph 7#a7 shall immediately cease distribution of such cosmetic and provide notification as required by such order4 7#c7 ,appeal 7,a7 #bd hours ,a person subject to an order under paragraph 7#a7 may appeal such order to the ,secretary within #bd hours of the issuance of such order4 7,b7 ,contents of appeal ,such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person1 including after a request under subsection 7b74 7,c7 ,informal hearing ,except as provided in subsection 7d77#b71 an informal hearing shall be held as soon as practicable1 but not later than #e calendar days 7or less as determined by the ,secretary7 after such an appeal is filed1 unless the parties jointly agree to an extension4 7,d7 ,impact on recall ,if an appeal is filed under subparagraph 7,a71 the ,secretary may not amend the order to require a recall under subsection 7d7 until after the conclusion of the hearing under subparagraph 7,c74 7#d7 ,vacation of order ,if the ,secretary determines that inadequate grounds exist to support the actions required by the order under paragraph 7#a71 the ,secretary shall vacate the order4 7d7 ,mandatory recall orders 7#a7 ,in conjunction with order ,to cease distribution 7,a7 ,amendment ,except as provided under paragraph 7#b7 and subject to subsection 7c77#c77;,d71 if the ,secretary determines that a recall of a cosmetic subject to an order under subsection 7c7 is appropriate1 the ,secretary shall amend the order to require a recall4 7,b7 ,contents ,an amended order under subparagraph 7,a7 shall-- 7i7 specify a timetable in which the recall will occur2 7ii7 require periodic reports to the ,secretary describing the progress of the recall2 and 7iii7 provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 7,c7 ,assistance in providing notice ,in providing for notice under subparagraph 7,b71 the ,secretary may allow for the assistance of health professionals1 ,state or local officials1 or other individuals designated by the ,secretary4 7,d7 ,determination ,if the ,secretary determines that inadequate grounds exist to support the amendment made to the order under subparagraph 7,a71 the ,secretary shall remove such amendment from such order4 7#b7 ,for imminent threat of a serious adverse event 7,a7 ,in general ,if the ,secretary has credible evidence or information that a cosmetic subject to an order under subsection 7c7 presents an imminent threat of a serious adverse event1 the ,secretary shall issue an order requiring any person who distributes such cosmetic-- 7i7 to immediately recall such cosmetic2 and 7ii7 to provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 7,b7 ,recall and notice ,any person who is subject to an emergency recall order under this subsection shall immediately recall such cosmetic and provide notification as required by such order4 7#c7 ,appeal 7,a7 #bd hours ,any person subject to such an order 7including an amended order7 under paragraph 7#a7 or 7#b7 may appeal such order to the ,secretary within #bd hours of the issuance of such order4 7,b7 ,contents of appeal ,such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person1 including after a request under subsection 7b74 7,c7 ,informal hearing ,an informal hearing shall be held as soon as practicable after the appeal is filed under subparagraph 7,a71 but not later than #e calendar days after such an appeal is filed1 or fewer days 7as determined by the ,secretary71 unless the parties jointly agree to an extension4 7,d7 ,vacation of order ,if the ,secretary determines that inadequate grounds exist to support the actions required by the order under paragraph 7#a7 or 7#b71 the ,secretary shall vacate the order4 7#d7 ,nondelegation ,an order 7including an amended order7 under paragraph 7#a7 or 7#b7 may only be issued by the ,secretary or an official designated by the ,secretary1 and may not be delegated to another official or employee4 7e7 ,notice to consumers and health officials ,the ,secretary shall post on the ,food and ,drug ,administration's website and provide notice of a recall order under this section to consumers to whom the cosmetic was1 or may have been1 distributed and to appropriate ,state and local health officials4 7f7 ,supply chain information 7#a7 ,in general ,in the case of a cosmetic that the ,secretary has reason to believe is adulterated1 misbranded1 or otherwise in violation of this ,act1 the ,secretary shall request that the brand owner named on the label of such cosmetic 7as required under section #fjb7;b77#a77 submit all of the following information3 7,a7 ,the name and place of business of the manufacturer1 packager1 supplier1 or distributor from which such entity received the cosmetic or ingredients for manufacturing such cosmetic4 7,b7 ,the name and place of business of any entity 7including any retailer7 that was provided with such cosmetic by the entity named on the label4 7#b7 ,collection of additional supply chain information ,in the case of a cosmetic that the ,secretary has reason to believe is adulterated1 misbranded1 or otherwise in violation of this ,act1 to the extent necessary to protect the safety of the public1 the ,secretary may request that any entity 7including a supplier of an ingredient1 manufacturer1 packer1 distributor1 or retailer7 in the supply chain of such cosmetic submit to the ,secretary information that is similar to the information described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a74 7#c7 ,maintenance of records ,any entity in the supply chain of a cosmetic 7including the brand owner named on the label of a cosmetic7 shall-- 7,a7 maintain records sufficient to provide the information described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a72 and 7,b7 provide such information to the ,secretary upon the request of the ,secretary4 7g7 ,savings clause ,nothing contained in this section shall be construed as limiting the authority of the ,secretary to issue an order to cease distribution of1 or to recall1 a cosmetic under any other provision of this ,act4 #fba4 ,petitions 7a7 ,in general ,the ,secretary shall complete and publish a review1 and1 if appropriate1 immediately revise related1 relevant information1 including ingredient lists1 ingredient restrictions or prohibitions1 or ingredient or cosmetic safety determinations1 not later than #f months after the date on which the ,secretary receives from any individual or entity a reasonable petition-- 7#a7 to prohibit or restrict an ingredient for use in cosmetics and list such ingredient on the list under section #faf7;b72 7#b7 to remove an ingredient from the list of ingredients that are safe without limits under section #faf7;c72 7#c7 to add an ingredient to the priority assessment list under section #faf7;d72 7#d7 to add an ingredient to the list of ingredients with insufficient data under section #faf7;d72 or 7#e7 to add an ingredient to the list of contaminants under section #fah4 7b7 ,reasonable petition ,not later than #a year after the date of enactment of this subchapter1 the ,secretary shall issue rules specifying the criteria which the ,secretary will use to determine if a petition submitted under this section is a reasonable petition4 #fbb4 ,mandatory reporting of serious adverse events 7a7 ,submission of report on serious adverse events ,the ,secretary shall require that the brand owner of a cosmetic whose name appears on the label of a cosmetic marketed in the ,united ,states submit to the ,secretary a report containing information received concerning any serious adverse event associated with the use of the cosmetic4 7b7 ,timing of report ,a report under subsection 7a7 shall be submitted to the ,secretary not later than #ae business days after information concerning the serious adverse event is received at the place of business of the brand owner4 7c7 ,content of report ,a report under subsection 7a7 shall include the following information1 to the extent to which the brand owner submitting the report has been able to verify the information3 7#a7 ,the identity of the individual experiencing the adverse health event4 7#b7 ,an identifiable report of such effect4 7#c7 ,the name of the cosmetic suspected of causing such effect4 7#d7 ,a description of the adverse health event4 7d7 ,public availability and privacy 7#a7 ,public availability ,subject to paragraph 7#b71 the serious adverse event reports collected by the ,secretary under this section shall be submitted electronically and shall be made accessible to the public in a summary fashion on the ,food and ,drug ,administration's website4 7#b7 ,privacy 7,a7 ,personally identifiable information ,notwithstanding any other provision of law1 personally identifiable information in serious adverse event reports provided to the ,secretary under this section1 shall not-- 7i7 be made publicly available pursuant to any ,state or other law requiring disclosure of information or records2 or 7ii7 otherwise be disclosed or distributed to any party without the written consent of the ,secretary and the person submitting such information to the ,secretary4 7,b7 ,treatment of information under ,privacy ,act and ,,foia ,a report submitted to the ,secretary under this section1 shall be considered to be a record about an individual under section #eeb;a of title #e1 ,united ,states ,code 7commonly referred to as the ,privacy ,act of #aigd7 and a medical or similar file the disclosure of which would constitute a violation of section #eeb of such title #e 7commonly referred to as the ,freedom of ,information ,act71 and shall not be publicly disclosed unless all personally identifiable information is redacted4 #fbc4 ,nonconfidential information 7a7 ,information available to public ,subject to subsection 7c7 and section #fbb7;d77#b71 all nonconfidential information submitted pursuant to this subchapter shall be made available to the public1 including the following types of information3 7#a7 ,the name1 identity1 and structure of a chemical substance1 contaminant1 or impurity that is an ingredient4 7#b7 ,all information concerning function1 exposure1 toxicity data1 health hazards1 and environmental hazards for a cosmetic4 7#c7 ,the functions of ingredients in cosmetics4 7#d7 ,fragrance1 flavor1 and colorants in a cosmetic4 7b7 ,confidential information ,the concentration of cosmetic ingredients used in a finished cosmetic shall be considered confidential business information and may not be made available to the public under subsection 7a74 7c7 ,petition for information ,to remain confidential 7#a7 ,in general ,the ,secretary shall create a process for an entity to petition for nonconfidential information described in subsection 7a7 to remain confidential if the entity shows that there would be a serious negative impact to the entity's commercial interests if such information were disclosed to the public4 7#b7 ,limitation ,the ,secretary may not approve a petition under paragraph 7#a7 to the extent that such petition would prevent the public disclosure of-- 7,a7 the name1 identity1 and structure of any chemical substance1 contaminant1 or impurity that is an ingredient2 7,b7 all health and safety data related to that substance1 contaminant1 or impurity2 or 7,c7 any data used to substantiate the safety of that substance1 contaminant1 or impurity4 #fbd4 ,ban on use of animal testing 7a7 ,ban ,beginning on the date of enactment of this subchapter1 it shall be unlawful for any entity to conduct1 directly or pursuant to contract1 animal testing for the purpose of developing a cosmetic for sale in or affecting interstate commerce4 7b7 ,limitation on consideration of data ,the ,secretary shall not take into consideration any animal testing on a finished cosmetic product or an ingredient that occurs on or after the date of enactment of this subchapter with respect to any determination as to whether a cosmetic or ingredient meets the safety standard under section #fad7;a74 7c7 ,exception ,subsections 7a7 and 7b7 shall not apply with respect to animal testing if-- 7#a7 the animal testing is for the purpose of determining whether an ingredient1 or the relevant category of ingredients1 meets the safety standard under section #fad7;a72 and 7#b7 the ,secretary determines that the safety of the ingredient1 or the relevant category of ingredients1 cannot be established using a non-animal testing method that is validated by the ,interagency ,coordinating ,committee on the ,validation of ,alternative ,methods authorized by section #c of the ,,iccvam ,authorization ,act of #bjjj 7#db ,u4,s4,c4 #bhel-#c7 4 7d7 ,validated1 eligible non-,animal testing methods 7#a7 ,list ,the ,secretary shall develop1 maintain1 and make publicly available a list of non-animal testing methods that-- 7,a7 are validated by the ,interagency ,coordinating ,committee on the ,validation of ,alternative ,methods2 and 7,b7 are eligible for use pursuant to the exception described in subsection 7c74 7#b7 ,initial list2 updates ,the ,secretary shall-- 7,a7 not later than #a year after the date of enactment of this subchapter1 publish the initial list under paragraph 7#a72 and 7,b7 annually thereafter1 update such list4 7e7 ,grants ,the ,secretary shall award grants for the development of testing methods that may be used to replace animal testing pursuant to the exception described in subsection 7c74 #fbe4 ,product testing and review audit ,the ,secretary shall conduct annual audits of random samples of cosmetics to assess or test for acute negative reactions1 pathogen hazards1 contaminants1 leaching of packaging additives1 mislabeling1 or other relevant issues of concern 7as determined by the ,secretary74 #fbf4 ,resources for small businesses ,the ,secretary shall provide technical support to assist small businesses in carrying out the requirements of this subchapter4 #fbg4 ,interagency cooperation 7a7 ,interagency council on cosmetic safety ,there is established an ,interagency ,council on ,cosmetic ,safety for the purpose of sharing data and promoting collaboration on cosmetic safety between the ,food and ,drug ,administration1 the ,national ,institute of ,environmental ,health ,sciences1 the ,centers for ,disease ,control and ,prevention1 the ,occupational ,safety and ,health ,administration1 and the ,environmental ,protection ,agency4 7b7 ,use of data from federal sources ,for purposes of this subchapter1 the ,secretary1 as appropriate1 shall request and utilize ingredient and cosmetic toxicity1 use1 and exposure data from other ,federal agencies4 #fbh4 ,savings clause ,nothing in this ,act affects the right of a ,state or a political subdivision of a ,state to adopt or enforce any regulation1 requirement1 or standard of performance that is different from1 or in addition to1 a regulation1 requirement1 liability1 or standard for performance established pursuant to this ,act unless compliance with both this ,act and the ,state or political subdivision of a ,state's regulation1 requirement1 liability1 or standard of performance is impossible1 in which case the applicable provisions of this ,act shall control4 #fbi4 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary to carry out this subchapter for each of the fiscal years #bjbj through #bjbd4 4 #c4 ,adulterated and misbranded cosmetics 7a7 ,adulterated cosmetics ,section #fja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is amended-- 7#a7 in paragraph 7a71 by striking 1 except that this provision shall not apply to coal-tar hair dye and all that follows through or eyebrow dyes2 and 7#b7 by adding at the end the following3 7f7 ,if it is manufactured in a manner that fails to comply with section #fag7;a74 7g7 ,if it is imported1 distributed1 or marketed and-- 7#a7 it contains an ingredient on the list under section #faf7;b77#a77;,a71 and the manufacturer has not complied with section #faf7;b77#e7 with respect to such ingredient and such cosmetic2 or 7#b7 it contains an ingredient on the list under section #faf7;b77#a77;,b71 such ingredient is being used in a manner that violates the limit on use or concentration of such ingredient under section #faf7;b77#c71 and the manufacturer has not complied with section #faf7;b77#e7 with respect to such ingredient and such cosmetic4 7h7 ,if it is marketed by a brand owner that1 with respect to such cosmetic1 is required to demonstrate1 under section #fag7;b77#b71 that the cosmetic meets the safety standard and the brand owner has not yet submitted the required data under section #fag7;b77#c74 4 7b7 ,misbranded cosmetics ,section #fjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is amended-- 7#a7 in paragraph 7a71 by inserting or fails to meet the requirements of section #fac or #fah7;b7 before the period2 and 7#b7 by adding at the end the following3 7g7 ,if it-- 7#a7 was brought to market by a brand owner that failed to register and pay the applicable fee as required under section #fab2 7#b7 is brought to market1 manufactured1 packaged1 distributed1 or sold in retail by a brand owner1 manufacturer1 packager1 distributor1 or retailer1 respectively1 who fails to notify the ,secretary as required under section #fbj7;a77#a72 7#c7 is distributed in violation of an order under section #fbj7;c72 7#d7 is not recalled as required by an order under section #fbj7;d72 7#e7 is manufactured in a manner that fails to comply with good manufacturing practices prescribed by the ,secretary under section #fad7;b72 or 7#f7 is brought to market by a brand owner who fails-- 7,a7 to submit the statement required under section #fai2 or 7,b7 notify the ,secretary of changes to information contained in such report1 as required by such section4 4 7c7 ,additional prohibitions ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended-- 7#a7 in paragraph 7e71 by inserting #fab1 after #efd1 each place it appears2 and 7#b7 by adding at the end the following3 7fff7 ,the failure of a brand owner1 manufacturer1 or supplier of a cosmetic or an ingredient for use in a cosmetic to submit and update data and information as required under section #fae7;a74 7ggg7 ,the manufacture1 importation1 distribution1 or marketing of an ingredient for use in a cosmetic that is on the list under section #faf7;b77#a77;,a74 7hhh7 ,the failure of a supplier of an ingredient for use in a cosmetic-- 7#a7 to provide data and information as required by section #fae7;a77#d77;,b72 or 7#b7 to comply with the testing requirements under section #fah7;d74 7iii7 ,the failure of a manufacturer to comply with the requirements of section #fah7;e74 7jjj7 ,the failure of a brand owner of a cosmetic to comply with the requirement of reporting serious adverse events under section #fbb4 7kkk7 ,the conduct of animal testing in violation of section #fbd4 4 #d4 ,support for creating safer alternatives 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 in consultation with the ,administrator of the ,environmental ,protection ,agency1 shall award grants to eligible entities to support research focused on the design of safer alternatives to chemicals in cosmetics with inherent toxicity or associated with chronic adverse health effects4 7b7 ,eligible entities ,to be eligible to receive a grant under subsection 7a71 an entity shall-- 7#a7 be a public institution such as a university1 a not-for-profit research institution1 or a small business2 and 7#b7 not benefit from a financial relationship with a cosmetics manufacturer1 supplier1 or trade association4 7c7 ,priority ,in awarding grants under subsection 7a71 the ,secretary shall give priority to applicants proposing to focus on-- 7#a7 replacing chemicals in professional cosmetic products used by nail and hair and beauty salon workers with safer alternatives2 or 7#b7 replacing chemicals in cosmetic products marketed to women and girls of color1 including any such beauty1 personal hygiene1 and intimate care products1 with safer alternatives4 7d7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary for fiscal years #bjbj through #bjbe4 #e4 ,support by ,national ,institute of ,environmental ,health ,sciences for research on health disparities impacting communities of color ,subpart #ab of part ,c of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhel et seq47 is amended by adding at the end the following new section3 #dfc;,c4 ,research on health disparities related to cosmetics impacting communities of color 7a7 ,in general ,the ,director of the ,institute shall award grants to eligible entities-- 7#a7 to expand support for basic1 epidemiological1 and social scientific investigations into-- 7,a7 the chemicals linked to adverse health effects most commonly found in cosmetics marketed to women and girls of color1 including beauty1 personal hygiene1 and intimate care products2 7,b7 the marketing and sale of such cosmetics containing chemicals linked to adverse health effects to women and girls of color across their lifespans2 or 7,c7 the use of such cosmetics by women and girls of color across their lifespans2 and 7#b7 to disseminate the results of any such research described in subparagraph 7,a7 or 7,b7 of paragraph 7#a7 7conducted by the grantee pursuant to this section or otherwise7 to help communities identify and address potentially unsafe chemical exposures in the use of cosmetics4 7b7 ,eligible entities ,to be eligible to receive a grant under subsection 7a71 an entity shall-- 7#a7 be a public institution such as a university1 a not-for-profit research institution1 or a small business2 and 7#b7 not benefit from a financial relationship with a cosmetics manufacturer1 supplier1 or trade association4 7c7 ,report ,not later than the end #a year after awarding grants under this section1 the ,director of the ,institute shall issue for the public and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the results of the investigations funded under subsection 7a71 including-- 7#a7 summary findings on-- 7,a7 marketing strategies1 product categories1 and specific cosmetics containing ingredients linked to adverse health effects2 and 7,b7 the demographics of the populations marketed to and using these cosmetics2 and 7#b7 recommended public health information strategies to reduce potentially unsafe exposures to cosmetics4 7d7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary for fiscal years #bjbj through #bjbe4 4 #f4 ,worker issues 7a7 ,in general ,the ,secretary of ,labor shall promulgate an occupational safety and health standard under section #f of the ,occupational ,safety and ,health ,act of #aigj 7#bi ,u4,s4,c4 #fee7 that requires the following3 7#a7 ,manufacturers and importers ,each manufacturer or importer selling any cosmetic for professional use shall-- 7,a7 obtain or develop a material safety data sheet described in subsection 7b7 for each such cosmetic or personal care product that-- 7i7 the manufacturer or importer produces or imports2 and 7ii7 includes a hazardous chemical1 or a product ingredient associated with any chemical hazard1 that is classified as a health hazard in accordance with the criteria found in section #aiaj4abjj7;d7 of title #bi of the ,code of ,federal ,regulations1 and any successor regulations2 and 7,b7 make the material safety data sheet available on the manufacturer or importer's website 7in addition to any other required manner of making such sheet available7 to distributors and employers1 including owners of hair1 nail1 and beauty salons or spas or other establishments that provide cosmetic services for humans1 in ,english1 ,spanish1 ,vietnamese1 ,chinese1 ,korean1 and upon request other languages4 7#b7 ,distributors ,each distributor of a cosmetic or personal care product for professional use shall distribute and provide material safety data sheets described in subsection 7b7 in the same manner as a distributor of a chemical hazard is required to distribute and provide material safety data sheets under section #aiaj4abjj7;g7 of title #bi1 ,code of ,federal ,regulations1 or any successor regulations4 7#c7 ,employers ,each employer1 including any operator of a salon or other establishment described in paragraph 7#a77;,b71 shall-- 7,a7 have a material safety data sheet in the workplace for each cosmetic or personal care product for professional use that is used in the course of the employer's business2 7,b7 make such material safety data sheet available to all employees of the employer who are exposed or use the product to the same extent and in the same manner as material safety data sheets are required to be made available under section #aiaj4abjj7;g7 of title #bi1 ,code of ,federal ,regulations1 or any successor regulations2 and 7,c7 upon request1 provide employees with translations of such material safety data sheet in other languages1 including ,spanish1 ,vietnamese1 ,chinese1 ,korean1 and upon request other languages4 7b7 ,contents of material safety data sheet ,a material safety data sheet for a cosmetic or personal care product for professional use described in this section shall-- 7#a7 contain the information required in a material safety data sheet under section #aiaj4abjj7;g7 of title #bi1 ,code of ,federal ,regulations1 or any successor regulations1 for each hazardous chemical1 or product ingredient associated with any chemical hazard1 described in subsection 7a77#a77;,a77ii72 and 7#b7 include the following statement3 ,this material safety data sheet is also available in multiple languages by contacting the manufacturer1 using the contact information provided on this sheet44 7c7 ,professional use defined ,in this section1 the term professional use has the meaning given such term in section #faa of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 except to the extent that such term applies to a product that is sold as a retail product in any of the establishments listed under such definition4