,,ii #aaeth ,,congress #ast ,session ,s4 #aaac ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #aa1 #bjag,mrs4 ,feinstein 7for herself and ,ms4 ,collins7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to ensure the safety of cosmetics4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,personal ,care ,products ,safety ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,cosmetic safety,sec4 #aja4 ,registration of cosmetics facilities and cosmetic ingredient statements4,sec4 #ajb4 ,review of ingredients and non-functional constituents2 safety of finished products4,sec4 #ajc4 ,good manufacturing practices for cosmetics4,sec4 #ajd4 ,adverse event reports4,sec4 #aje4 ,records inspection2 mandatory recall authority4,sec4 #ajf4 ,labeling4,sec4 #ajg4 ,coal tar chemicals4,sec4 #ajh4 ,animal testing alternatives4,sec4 #aji4 ,preemption4,sec4 #aaj4 ,reporting4,sec4 #aaa4 ,small businesses4,sec4 #aab4 ,applicability with respect to certain cosmetics4,sec4 #aac4 ,enforcement4,sec4 #aad4 ,consumer information4,,title ,,ii--,fees related to cosmetic safety,sec4 #bja4 ,findings4,sec4 #bjb4 ,authority to assess and use cosmetic safety fees4,sec4 #bjc4 ,direct hiring authority to support activities related to cosmetics4 ,i ,cosmetic safety #aja4 ,registration of cosmetics facilities and cosmetic ingredient statements 7a7 ,amendments ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is amended by adding at the end the following3 #fjd4 ,definitions ,in this chapter3 7#a7 ,cosmetic formulation ,the term cosmetic formulation means a preparation of cosmetic raw materials with a qualitatively and quantitatively set composition4 7#b7 ,cosmetic product ,the term cosmetic product means a cosmetic comprised of a specified set of ingredients1 which may come in a range of possible amounts for each ingredient and which may include a variety of fragrances1 flavors1 and colors4 7#c7 ,facility ,the term facility includes any factory1 warehouse1 or establishment 7including a factory1 warehouse1 or establishment of an importer7 that manufactures1 processes1 packs1 or holds cosmetic products or cosmetic formulations1 or any other entity whose name and address appear on the label of a cosmetic product4 ,such term does not include-- 7,a7 beauty shops and salons that do not otherwise manufacture1 process1 or package cosmetics at that location2 7,b7 cosmetic product retailers1 including individual sales representatives1 retail distribution facilities1 and pharmacies1 that do not otherwise manufacture1 process1 or package cosmetics at that location2 7,c7 hospitals1 physicians' offices1 and health care clinics2 7,d7 public health agencies and other nonprofit entities that provide cosmetics directly to the consumer2 7,e7 hotels and other entities that provide complimentary cosmetics to guests2 7,f7 trade shows and other venues where cosmetic product samples are provided free of charge2 or 7,g7 a factory1 warehouse1 or establishment of-- 7i7 domestic manufacturers with less than #ejj1jjj in average gross annual sales of cosmetic products in the ,united ,states for the previous #c-year period1 or less than #a1jjj1jjj in such sales of cosmetic products produced in a private residence2 or 7ii7 entities that manufacture or compound cosmetic products solely for use in research1 teaching1 or pilot plant production and not for sale4 7#d7 ,foreign facility ,the term foreign facility means a facility that manufactures1 processes1 packs1 or holds1 a cosmetic formulation or cosmetic product that is exported to the ,united ,states without further processing or packaging inside the ,united ,states4 ,a cosmetic is not considered to have undergone further processing or packaging for purposes of this definition solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the cosmetic4 7#e7 ,non-functional constituent ,the term non-functional constituent means any substance that is an incidental component of an ingredient1 a breakdown product of an ingredient or a byproduct of the manufacturing process that has not been intentionally added as a separate substance and serves no technical function in the cosmetic4 7#f7 ,responsible person ,the term responsible person means-- 7,a7 the brand owner who is the domestic or foreign manufacturer1 packer1 or entity whose name appears on a cosmetic product label of a cosmetic product distributed in the ,united ,states1 except for entities described in subparagraphs 7,a7 through 7,g7 of paragraph 7#c72 or 7,b7 a contract manufacturer who provides cosmetic products to the entities described in subparagraphs 7,a7 through 7,g7 of paragraph 7#c74 4 #fje4 ,registration of cosmetic facilities 7a7 ,registration and fees for existing manufacturing or processing of cosmetics 7#a7 ,registration1 in general ,not later than ,december #a1 #bjag1 and at a similar time in each subsequent year1 as determined by the ,food and ,drug ,administration1 each responsible person engaged in manufacturing or processing a cosmetic product or a cosmetic formulation distributed in the ,united ,states shall register all of the responsible person's facilities with the ,food and ,drug ,administration4 7#b7 ,fees ,if the average gross annual sales in the ,united ,states of cosmetic products of all of the responsible person's facilities registered under paragraph 7#a7 for the previous #c-year period is greater than #b1jjj1jjj1 a registration shall not be complete under this subsection until the responsible person has paid any registration fee required under section #gdd,l4 7b7 ,registration for existing packing or holding of cosmetics ,not later than ,december #a1 #bjag1 and at a similar time once every #c years thereafter1 as determined by the ,food and ,drug ,administration1 each person who owns or operates a cosmetic facility or facilities engaged in packing or holding a cosmetic product distributed in the ,united ,states shall register each such facility with the ,food and ,drug ,administration4 7c7 ,registration by new facilities ,any facility first engaging after the date of enactment of the ,personal ,care ,products ,safety ,act in an activity that would require it to register under subsection 7a7 or 7b7 shall register with the ,food and ,drug ,administration within #fj days of first engaging in such activity1 and thereafter in accordance with subsection 7a7 or 7b74 7d7 ,changes to information ,a registrant who has submitted a registration under this section shall notify the ,food and ,drug ,administration of any change to the information required under subsection 7a7 or 7b7 not later than #fj days after the date of such change1 unless otherwise specified by the ,food and ,drug ,administration4 7e7 ,format2 contents 7#a7 ,electronic format ,each registration shall be submitted using an electronic format1 as specified in a registration form provided by the ,food and ,drug ,administration4 7#b7 ,contents 7,a7 ,in general ,the registration shall contain the following information3 7i7 ,each facility's name and full address1 identifying the precise physical location of the facility4 7ii7 ,the identity of the facility1 including the unique facility identifier1 if any1 previously assigned by the ,food and ,drug ,administration to the facility under subsection 7g74 7iii7 ,all business trading names used by the facility4 7iv7 ,the product category or categories of each cosmetic product or cosmetic formulation manufactured1 processed1 packed1 or held at the facility or on whose label the facility's name and address appear4 7v7 ,the type of activity conducted at the facility 7such as manufacturing1 processing1 packing1 or holding74 7vi7 ,the name1 title1 street address1 telephone number1 and electronic contact information of the emergency contact for the facility4 7vii7 ,in the case of a foreign facility1 the name1 street address1 telephone number1 emergency contact information for the facility1 the name of the ,united ,states agent for the facility1 and1 if available1 the electronic contact information of the ,united ,states agent4 7viii7 ,the name1 title1 street address1 telephone number1 and electronic contact information of the individual submitting the registration4 7ix7 ,an assurance that the ,food and ,drug ,administration will be permitted to inspect such facility at the times and in the manner permitted by this ,act4 7x7 ,additional information pertaining to the facility or to the cosmetic products or cosmetic formulations manufactured1 processed1 packed1 or held at the facility1 or on whose label the facility's name and address appear1 including all brand names known to consumers1 as the ,food and ,drug ,administration may require by regulation4 7,b7 ,small businesses 7i7 ,requirements ,in the case of a registrant described in clause 7ii71 the registration shall contain the following information3 7,i7 ,each facility's name and full address1 identifying the precise physical location of the facility4 7,,ii7 ,the name1 title1 street address1 telephone number1 and electronic contact information of the emergency contact for the facility4 7,,iii7 ,the consumer product category or categories of each cosmetic product or cosmetic formulation manufactured1 processed1 packed1 or held at the facility or on whose label the facility's name and address appear4 7ii7 ,small business registrants ,a registrant described in this clause is a domestic registrant-- 7,i7 whose average gross annual sales in the ,united ,states of cosmetic products for the previous #c-year period is between #ejj1jjj and #b1jjj1jjj 7or between #a1jjj1jjj and #b1jjj1jjj in the case of sales of cosmetic products produced in a private residence72 and 7,,ii7 who does not produce-- 7aa7 products that are intended to go on the eye area2 7bb7 lip products with color2 7cc7 products that are injected2 7dd7 products that are intended for internal use2 and 7ee7 products that are meant to alter appearance for more than #bd hours4 7#c7 ,abbreviated registration ,the ,food and ,drug ,administration shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to the required information with respect to the facility or facilities involved since the registrant submitted the preceding registration4 7f7 ,incomplete or inaccurate registration 7#a7 ,in general ,not earlier than #aj days after providing notice of the intent to cancel a registration and the basis for such cancellation1 the ,food and ,drug ,administration may cancel a registration under this section if the ,food and ,drug ,administration has reasonable grounds to believe that the registration was not properly completed or updated in accordance with this section or otherwise contains false1 incomplete1 or inaccurate information4 7#b7 ,timely update or correction ,if1 not later than #g days after receipt of a notice of intent to cancel1 the sponsor corrects the registration in accordance with the basis for the cancellation1 and the required registration fee1 if any1 is paid1 the ,food and ,drug ,administration shall not cancel such registration4 7g7 ,unique identifier ,at the time of the initial registration of any cosmetic facility under this section1 the ,food and ,drug ,administration shall assign a unique identifier to the facility4 7h7 ,registry of facilities 7#a7 ,in general ,the ,food and ,drug ,administration shall compile1 maintain1 and update a registry of facilities that are registered under this section1 and shall remove from such registry the name of any facility whose registration under this section is cancelled4 ,the registry shall be publicly available4 7#b7 ,public availability exceptions ,information derived from the registry or registration documents that discloses the residential address of a registrant or that discloses specific facilities where specific cosmetic products are manufactured or processed shall not be subject to disclosure under section #eeb of title #e1 ,united ,states ,code4 #fjf4 ,cosmetic ingredient statements 7a7 ,in general ,for each cosmetic product1 the responsible person shall submit to the ,food and ,drug ,administration a cosmetic ingredient statement1 at such time and in such manner as the ,food and ,drug ,administration may prescribe4 ,the cosmetic ingredient statement shall not become effective until the responsible person pays any applicable fee required under section #gdd,l4 7b7 ,submission of a cosmetic ingredient statement 7#a7 ,existing cosmetic products ,in the case of a cosmetic product that is marketed on the date of enactment of the ,personal ,care ,products ,safety ,act1 the responsible person shall submit a cosmetic ingredient statement not later than ,december #a1 #bjag4 ,the responsible person shall submit to the ,food and ,drug ,administration a renewal of such statement on a yearly basis4 7#b7 ,cosmetic ingredient statement for new cosmetic products 7,a7 ,in general ,except as provided under subparagraph 7,b71 in the case of a cosmetic product that is first marketed after the date of enactment of the ,personal ,care ,products ,safety ,act or a cosmetic product that is reformulated after such date of enactment1 the responsible person shall submit a cosmetic ingredient statement to the ,food and ,drug ,administration within #fj days of first marketing the new cosmetic product or the reformulated cosmetic product1 and annually thereafter4 7,b7 ,small businesses ,the ,food and ,drug ,administration shall allow a responsible person that is a business that meets the applicable industry-based small business size standard established by the ,administrator of the ,small ,business ,administration under section #c of the ,small ,business ,act to have a period longer than #fj days to submit an initial new cosmetic ingredient statement under subparagraph 7,a74 ,such responsible person shall submit a cosmetic ingredient statement annually thereafter4 7,c7 ,definition ,a cosmetic product shall not be considered first marketed or reformulated after the date of enactment under subparagraph 7,a7 if the only change in such product is in-- 7i7 the amount of an existing ingredient if it is within the range previously reported under subsection 7c77#b77;,e72 or 7ii7 the addition or subtraction of a fragrance1 flavor1 or color1 or such other interchangeable ingredients specified by the ,food and ,drug ,administration in regulations or guidance1 previously reported as a potential ingredient under subsection 7c77#b77;,e71 if1 in the case of such an addition1 the amount is within the range previously reported4 7c7 ,format2 contents 7#a7 ,form ,for each cosmetic product1 the cosmetic ingredient statement shall be submitted using an electronic format1 as specified in a cosmetic and ingredient form provided by the ,food and ,drug ,administration4 7#b7 ,contents ,the cosmetic ingredient statement shall include the following information3 7,a7 ,the unique identifier1 assigned under section #fje7;g71 as applicable1 of-- 7i7 each facility where the cosmetic product is manufactured1 processed1 packed1 or held2 and 7ii7 the facility whose name and address appear on the label1 unless the statement is filed by a contract manufacturer1 described in section #fjd7f77;,b74 7,b7 ,the brand name and the full name for the cosmetic product as it appears on the label4 7,c7 ,the cosmetic product listing number1 if any1 previously assigned by the ,food and ,drug ,administration under subsection 7f7 to the cosmetic product4 7,d7 ,the applicable cosmetic category for the cosmetic product4 7,e7 ,a list of ingredients in the cosmetic product1 including a range of possible amounts of each ingredient1 and with each ingredient identified by the name adopted in regulations promulgated by the ,food and ,drug ,administration1 if any1 or by the common or usual name of the ingredient4 ,the cosmetic ingredient statement shall contain-- 7i7 a list of fragrances1 flavors1 and colors that may be included in the product1 interchangeably1 with ranges of possible amounts1 which shall include-- 7,i7 in the case of fragrances that are purchased from a fragrance supplier1 identification of the fragrances by the name or code provided by the supplier1 including the name and contact information for the fragrance supplier2 and 7,,ii7 in the case of flavors that are purchased from a flavor supplier1 identification of the flavors by the name or code provided by the supplier1 including the name and contact information for the flavor supplier2 and 7ii7 other appropriate interchangeable ingredients as the ,food and ,drug ,administration may specify in regulations or guidance that may be included in the product1 with ranges of possible amounts4 7,f7 ,the title and full contact information of each individual submitting the statement4 7,g7 ,if applicable1 information on the labeling required under section #fad4 7,h7 ,such additional information pertaining to the cosmetic product as the ,food and ,drug ,administration may require4 7#c7 ,additional information ,in the case of a cosmetic ingredient statement that includes a list of fragrances or flavors that are purchased from a fragrance or flavor supplier as described in paragraph 7#b77;,e77i71 upon request by the ,food and ,drug ,administration1 the fragrance or flavor supplier shall submit to the ,food and ,drug ,administration the complete list of ingredients in specific fragrances1 or flavors not later than #cj days after receiving such request4 7d7 ,incomplete or inaccurate cosmetic ingredient statement 7#a7 ,in general ,not earlier than #aj days after providing notice to the responsible person of the intent to cancel the cosmetic ingredient statement and the basis for such cancellation1 the ,food and ,drug ,administration may nullify a cosmetic ingredient statement filed under this section if the ,food and ,drug ,administration has reasonable grounds to believe that the cosmetic ingredient statement was not completed or updated in accordance with this section or otherwise contains false1 incomplete1 or inaccurate information4 7#b7 ,timely update or correction ,if the cosmetic ingredient statement is appropriately updated or corrected not later than #g days after notice is provided under paragraph 7#a71 the ,food and ,drug ,administration shall not nullify such cosmetic ingredient statement4 7e7 ,additional requirements 7#a7 ,safety requirements ,in filing each cosmetic ingredient statement cosmetic product1 the responsible person shall include an attestation that the safety of the product1 including the individual ingredients of such product and the product as a whole1 has been substantiated in accordance with section #fji4 ,in the case of a cosmetic ingredient statement that includes a range of possible amounts 7as described in subsection 7c77#b77;,e771 the responsible person shall include an attestation that such person has substantiated the safety of the product and its ingredients in accordance with the requirements of section #fji4 7#b7 ,abbreviated filing ,the ,food and ,drug ,administration shall provide for an abbreviated renewal process for any such filing with respect to which there has been no change since the responsible person submitted the previous filing4 7#c7 ,changes to information 7,a7 ,in general ,except as provided in subparagraph 7,b71 the responsible person shall notify the ,food and ,drug ,administration within #fj days of any change to the information required to be in a cosmetic ingredient statement1 including discontinuation of the manufacture of a cosmetic product1 except that notification under this paragraph is not required for a change in-- 7i7 the amount of an existing ingredient if it is within the range previously reported under subsection 7c77#b77;,e72 or 7ii7 the addition or subtraction of a fragrance1 flavor or color1 or such other interchangeable ingredients specified by the ,food and ,drug ,administration in regulations or guidance1 previously reported as a potential ingredient under subsection 7c77#b77;,e71 if1 in the case of an addition of such an ingredient1 the amount is within the range previously reported4 7,b7 ,exceptions 7i7 ,small businesses ,the ,food and ,drug ,administration shall allow a responsible person that is a business that meets the applicable industry-based small business size standard established by the ,administrator of the ,small ,business ,administration under section #c of the ,small ,business ,act to have a period longer than #fj days1 but not longer than the next annual registration deadline under section #fje7;a77#a71 to submit any change to the information required to be in a cosmetic ingredient statement as described in subparagraph 7,a74 7ii7 ,other businesses ,any business that has an average of not more than #b1jjj1jjj in annual domestic cosmetic sales over the previous #c years is not required to report the discontinuation of the manufacture of a cosmetic product or cosmetic product category as described in subparagraph 7,a7 until the next annual registration period under section #fje4 7f7 ,cosmetic products list ,at the time of the initial submission of any cosmetic ingredient statement under this section1 the ,food and ,drug ,administration shall assign a unique cosmetic product listing number to the cosmetic ingredient statement4 ,based on such cosmetic ingredient statements1 the ,food and ,drug ,administration shall compile and maintain a list of cosmetic products distributed in the ,united ,states1 including the ingredients of each such product1 and shall make available such list to any ,state1 upon request4 ,information disclosed to a ,state that is exempt from disclosure under section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 shall be treated as a trade secret and confidential information by the ,state4 #fjg4 ,suspension of registration or cosmetic ingredient statement 7a7 ,suspension of registration of a facility ,if the ,food and ,drug ,administration determines that a cosmetic formulation or cosmetic product manufactured1 processed1 packed1 or held by a registered facility and distributed in the ,united ,states has a reasonable probability of causing serious adverse health consequences or death to humans1 and the ,food and ,drug ,administration has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a single product or products or is sufficiently pervasive to raise concerns about other products manufactured in the facility1 the ,food and ,drug ,administration may suspend the registration of a facility4 7b7 ,suspension of cosmetic ingredient statement ,if the ,food and ,drug ,administration determines that a cosmetic product manufactured in a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans1 the ,food and ,drug ,administration may suspend the cosmetic ingredient statement of that product4 7c7 ,notice of suspension ,before suspending a facility registration or a cosmetic ingredient statement under this section1 the ,food and ,drug ,administration shall provide-- 7#a7 notice to the facility registrant of the cosmetic product or formulation or other responsible person1 as appropriate1 of the intent to suspend the facility registration or the cosmetic ingredient statement1 which shall specify the basis of the determination by the ,food and ,drug ,administration that the facility or the cosmetic ingredient should be suspended and recommendations for specific actions to avoid suspension2 and 7#b7 an opportunity1 within #b business days of the notice provided under paragraph 7#a71 for the responsible person to address the reasons for possible suspension of the facility registration or cosmetic ingredient statement4 7d7 ,reinstatement ,upon a determination by the ,food and ,drug ,administration that adequate grounds do not exist to continue the suspension actions1 the ,food and ,drug ,administration shall promptly vacate the suspension and reinstate the registration of the facility or the cosmetic ingredient statement4 7e7 ,effect of suspension 7#a7 ,registration ,if the registration of a facility is suspended under this section1 no person shall introduce or deliver for introduction into interstate commerce cosmetics or cosmetic products from such facility4 7#b7 ,cosmetic ingredient statement ,if the cosmetic ingredient statement for a cosmetic product is suspended under this section1 no person shall introduce or deliver for introduction into interstate commerce any cosmetic product that is the subject of such statement4 7f7 ,no delegation ,the authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the ,commissioner4 4 #ajb4 ,review of ingredients and non-functional constituents2 safety of finished products 7a7 ,amendments ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #aja1 is further amended by adding at the end the following3 #fjh4 ,review of ingredients and non-functional constituents 7a7 ,ingredients and non-,functional constituents subject to review 7#a7 ,in general ,beginning in fiscal year #bjah1 the ,food and ,drug ,administration shall review the safety of the cosmetic ingredients and non-functional constituents under paragraph 7#c71 as modified under subsection 7c71 if applicable1 and issue an order under subsection 7d7 with respect to the use of each such ingredient and presence of each such non-functional constituent4 7#b7 ,public notice and comment ,at the initiation of the review of each cosmetic ingredient or non-functional constituent1 the ,food and ,drug ,administration shall open a docket for the submission of public comment and additional data relevant to the safety of the ingredient or non-functional constituent4 ,the ,food and ,drug ,administration shall provide #fj days for public comment4 7#c7 ,cosmetic ingredients 7,a7 ,ingredients to be considered in first year ,during fiscal year #bjah1 the ,food and ,drug ,administration shall initiate the review for safety of the following cosmetic ingredients3 7i7 ,diazolidinyl urea4 7ii7 ,lead acetate4 7iii7 ,methylene glycol_/methanediol_/formaldehyde4 7iv7 ,propyl paraben4 7v7 ,quaternium-#ae4 7,b7 ,ingredients to be considered in subsequent years 7i7 ,in general ,beginning in fiscal year #bjai1 the ,food and ,drug ,administration shall annually select and complete a review of at least #e cosmetic ingredients or non-functional constituents that were not reviewed in the prior #c years from a list determined in consultation with industry and consumer groups for review of safety4 ,the ,food and ,drug ,administration may combine selected cosmetics ingredients or non-functional constituents into categories for purposes of such review4 ,the ,food and ,drug ,administration may modify such list under subsection 7c74 7ii7 ,considerations ,the determination of which ingredients or functional ingredients will be reviewed in a given year shall be publicized in annual reports to ,congress and the public1 in accordance with section #fah1 and subject to consultation as provided for in clause 7iii74 ,the review of any cosmetic ingredient or non-functional constituent shall commence with a public announcement by the ,food and ,drug ,administration and the opening of a docket as required under paragraph 7#b74 7iii7 ,consultation ,the ,food and ,drug ,administration shall establish a ,cosmetics ,safety ,advisory ,committee1 which shall include equal numbers of individuals from the cosmetics industry and consumer groups1 and other individuals1 as the ,food and ,drug ,administration determines appropriate1 including medical practitioners4 ,such advisory committee shall advise the ,food and ,drug ,administration on cosmetic ingredients and non-functional constituents to be considered for review1 summarize public comments received pursuant to paragraph 7#d71 and recommend #e cosmetic ingredients or non-functional constituents to be reviewed for safety each year1 as described in clause 7i74 ,the ,food and ,drug ,administration may consult with the ,cosmetics ,safety ,advisory ,committee on other matters pertaining to cosmetic safety4 7#d7 ,comment period ,as part of the annual reporting to ,congress and the public under section #fah1 the ,food and ,drug ,administration shall solicit public comment on which cosmetic ingredients or non-functional constituents on the list are of greatest interest to be reviewed next for early review and which additional cosmetic ingredients or non-functional constituents should be added to the list4 ,the public may submit comments to the ,food and ,drug ,administration at any time during the year regarding which cosmetic ingredients or non-functional constituents of interest the ,food and ,drug ,administration may consider during that year or subsequent years4 7b7 ,list ,the ,food and ,drug ,administration shall maintain a list1 posted on the ,internet website of the ,food and ,drug ,administration1 of the cosmetic ingredients and non-functional constituents for which final orders have been issued under subsection 7d77#c71 the finding made for each such ingredient or non-functional constituent under subsection 7d77#d71 as modified by any order under subsection 7f71 if applicable1 and1 if applicable1 compliance dates that are the subject of a final order under subsection 7e74 7c7 ,initiative of the ,,fda ,the ,food and ,drug ,administration may at any time1 after consultation with the ,cosmetics ,safety ,advisory ,committee1 propose the issuance of an order on the safety of a cosmetic ingredient or non-functional constituent that was not previously listed in subsection 7a7 or under section #fah7;a77#c74 ,the ,food and ,drug ,administration shall follow the same procedures and policies for review of any cosmetic ingredient or non-functional constituent so proposed as for the ingredients and constituents reviewed pursuant to subsection 7a74 7d7 ,determination on safety 7#a7 ,initial proposed administrative order ,following consideration of data and comments to the public docket and any other information before the ,food and ,drug ,administration1 the ,food and ,drug ,administration shall determine whether there is adequate evidence to make an initial finding on the safety of the ingredient or non-functional constituent4 ,if the ,food and ,drug ,administration determines that there is adequate evidence1 the ,food and ,drug ,administration shall issue a proposed administrative order and shall post such order on the ,internet website of the ,food and ,drug ,administration1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7#b7 ,public comment ,upon publication of the proposed administrative order described in paragraph 7#a71 the ,food and ,drug ,administration shall open a docket for the submission of public comment4 ,the ,food and ,drug ,administration shall provide #cj days for public comment following publication of the proposed administrative order4 7#c7 ,final administrative order ,following the public comment period described in paragraph 7#b7 and consideration of comments to the public docket and any other information before the ,food and ,drug ,administration1 the ,food and ,drug ,administration shall determine whether there is adequate evidence to make a final finding on the safety of the ingredient or non-functional constituent4 ,if the ,food and ,drug ,administration determines that there is adequate evidence1 the ,food and ,drug ,administration shall issue a final administrative order and shall post such order on the ,internet website of the ,food and ,drug ,administration1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7#d7 ,determinations ,in the proposed administrative order or the final administrative order1 as applicable1 the ,food and ,drug ,administration shall make a determination that the ingredient or non-functional constituent is-- 7,a7 safe in cosmetic products under specified conditions of use or tolerances2 7,b7 safe in cosmetic products without the need for specified conditions of use or tolerances2 or 7,c7 not safe in cosmetic products4 7#e7 ,conditions of use and tolerances ,an order under paragraph 7#d77;,a7 shall include such conditions on the use of an ingredient or such tolerances on the presence of a non-functional constituent as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent1 including-- 7,a7 limits on the amount or concentration of the ingredient or non-functional constituent that may be present in a cosmetic product1 including limits in products intended for children and other vulnerable populations1 and limits on use near the eye or mucosal membranes2 7,b7 warnings that are necessary or appropriate under section #fad1 including warnings related to use by children1 pregnant women1 populations with high exposure to the ingredient 7such as workers who are exposed through production practices or handling of final products71 or other vulnerable populations1 to help ensure safe use of cosmetic products containing the ingredient or non-functional constituent2 and 7,c7 such other conditions as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent4 7#f7 ,public notice ,a final order under this subsection shall set forth the determination of the ,food and ,drug ,administration on safety1 any conditions of use or tolerances under subparagraph 7,a7 or 7,b7 of paragraph 7#d7 and a summary of the valid scientific evidence supporting the finding4 ,the order shall be effective upon its publication on the ,internet website of the ,food and ,drug ,administration and shall be considered final agency action4 7e7 ,order 7#a7 ,in general ,if the ,food and ,drug ,administration issues a final administrative order under subparagraph 7,a7 or 7,c7 of subsection 7d77#d71 the ,food and ,drug ,administration shall1 at the same time as publication of the notice under subsection 7d77#f71 publish a proposed order identifying dates by which use of the ingredient or non-functional constituent in cosmetic products shall comply with the final administrative order1 and provide #fj days for public comment1 including comment on whether compliance is feasible within the proposed dates4 ,after considering comments on the proposed order1 the ,food and ,drug ,administration shall publish in the ,federal ,register a final order4 7#b7 ,content ,the public notice information regarding the final order under paragraph 7#a7 shall include a summary that is written in plain and understandable language that is comprehensible and meaningful for consumers4 ,the summary shall include information on any conditions of use or warnings required under section #fad1 including the application to vulnerable populations1 the types of safety studies evaluated1 and any additional relevant information that was part of the review process4 7f7 ,modification of an order ,an order issued under subsection 7d7 or 7e7 may be modified or revoked by the ,food and ,drug ,administration on the initiative of the ,food and ,drug ,administration or in response to a petition4 7g7 ,inadequate evidence 7#a7 ,notice2 ,extension ,if the ,food and ,drug ,administration determines that the available data and information are not adequate to make a proposed or final determination regarding safety under subsection 7d77#d71 with respect to a cosmetic ingredient or non-functional constituent1 the ,food and ,drug ,administration shall-- 7,a7 publish such finding on the ,internet website of the ,food and ,drug ,administration not later than #ij days after the close of the relevant comment period for the ingredient or non-functional constituent under subsection 7a77#b71 in the case of a proposed order1 or subsection 7d77#b71 in the case of a final order2 and 7,b7 7i7 include a notice providing interested persons an additional #cj days from the notice date to provide additional data and information2 and 7ii7 if1 after the #cj-;day period under clause 7i71 the ,food and ,drug ,administration determines that additional safety substantiation with respect to such ingredient or non-functional constituent is necessary to make a safety determination-- 7,i7 include a notice specifying an additional time period1 not to exceed #ah months from the notice date1 during which time the determination made by a responsible person under subsection 7a7 or 7b7 of section #fji with respect to the safety of such cosmetic ingredient or non-functional constituent shall be deemed to be in compliance with the requirements of this ,act1 but shall not affect final determinations of safety under subsection 7d72 and 7,,ii7 plan to obtain such data and information4 7#b7 ,determination2 ,order 7,a7 ,inadequate data and information ,if the ,food and ,drug ,administration determines1 after considering any additional data and information submitted under paragraph 7#a77;,b71 that the available data and information still are not adequate to make a determination regarding safety under subsection 7d77#d71 the ,food and ,drug ,administration shall1 within #ij days of the close of the additional time period provided under paragraph 7#a77;,b71 issue a proposed order or a final administrative order-- 7i7 making a determination that the ingredient or non-functional constituent has not been shown to be safe in cosmetic products2 and 7ii7 explaining why the available data and information are not adequate to assess the safety of the ingredient or non-functional constituent4 7,b7 ,adequate data and information ,if the ,food and ,drug ,administration determines1 after considering any additional data and information submitted under paragraph 7#a77;,b71 that the available data and information are adequate to make a determination regarding safety under subsection 7d77#d71 the ,food and ,drug ,administration shall1 within #ahj days of the close of the comment period1 issue a proposed order1 followed by a final order1 on such cosmetic ingredient or non-functional constituent1 in accordance with such subsection4 7h7 ,safety assessment 7#a7 ,in general ,in assessing the safety of an ingredient or non-functional constituent1 the ,food and ,drug ,administration shall consider whether there is adequate evidence to support a reasonable certainty among competent scientists that the ingredient is not harmful under the recommended or suggested conditions of use or customary or usual use1 or that a non-functional constituent is not harmful under the recommended or suggested tolerance levels or the level at which it is customarily or usually present4 ,the ,food and ,drug ,administration may not consider an ingredient or non-functional constituent harmful solely because it can cause minor adverse health reactions1 such as minor transient allergic reactions or minor transient skin irritations1 in some users4 7#b7 ,factors ,in assessing the safety of an ingredient or non-functional constituent1 the ,food and ,drug ,administration shall consider1 among other relevant factors1 the following3 7,a7 ,the probable human exposure to the ingredient or non-functional constituent from expected use in cosmetics4 7,b7 ,the probable cumulative and aggregate effect in humans of relevant exposure to the ingredient or non-functional constituent or to any chemically or pharmacologically related substances from use in cosmetics or other products with similar routes of exposure under recommended or suggested conditions of use or their customary use1 to the extent adequate data is available for analysis4 ,in appropriate cases1 the ,food and ,drug ,administration may consider available information on the total exposure to an ingredient or non-functional constituent from all sources4 7,c7 ,whether warnings or recommendations in a product label required under section #fad1 as part of any conditions of use or tolerances imposed by the ,food and ,drug ,administration1 would be necessary and appropriate to help ensure the safety of the ingredient or non-functional constituent4 7#c7 ,data and information 7,a7 ,required information ,a determination that an ingredient or non-functional constituent is safe in cosmetics shall be based upon adequate evidence submitted or otherwise known to the ,food and ,drug ,administration1 which shall include full reports of all available studies1 published or unpublished1 that are adequately designed to show whether the ingredient or non-functional constituent is safe4 ,such studies may include in vitro and in silico studies and epidemiological studies1 biomonitoring studies1 and studies focused on various points during the lifespan of the subject1 that use scientifically valid methodology4 7,b7 ,additional relevant information ,the ,food and ,drug ,administration shall consider any other relevant information related to the safety of the ingredient or non-functional constituent1 including-- 7i7 adverse event reports2 7ii7 findings and information from ,state1 ,federal1 national1 and international entities and other bodies composed of scientific and medical experts2 7iii7 if the ingredient or non-functional constituent is lawfully used or present in other products regulated by the ,food and ,drug ,administration1 the scientific basis for such use2 and 7iv7 experience with the ingredient or non-functional constituent in products that are distributed in the ,united ,states or in other countries1 if such experience is well-documented and has resulted in substantial human exposure to the ingredient or non-functional constituent over time4 4 #fji4 ,safety of finished cosmetic products 7a7 ,determination 7#a7 ,in general ,each responsible person for a finished cosmetic product1 before first introducing or delivering for introduction into interstate commerce1 or1 in the case of such a product in interstate commerce on the date of enactment of the ,personal ,care ,products ,safety ,act1 not later than the date on which registration is first required under subsection #fje7;b71 shall make a written determination that the product is safe under the conditions of use recommended in the labeling of the product4 ,such determination shall be based on adequate evidence that each ingredient in the finished product is safe for the use recommended or suggested in the labeling of the product and that the finished product is safe4 7#b7 ,new information ,if new information relevant to the determination becomes available1 the responsible person shall promptly update the determination to address that information4 7#c7 ,safety with respect to ranges of possible amounts ,in the case of a cosmetic product for which there is a range of possible amounts of cosmetic ingredients included in the cosmetic ingredient statement1 as described in section #fjf7;c77#b77;,e71 the safety determination under paragraph 7#a7 shall include substantiation of the safety of the full range in the finished product4 7#d7 ,small businesses ,a small business registrant 7as defined in section #fje7;e77#b77;,b77ii77 may satisfy the requirements of this section by using the ingredients in concentrations recommended by available medical or scientific guidelines1 or cosmetic manufacturing reference1 and following any other specific instructions for use recommended by the ingredient manufacturer4 7b7 ,presumption of adequate evidence 7#a7 ,in general ,except as provided in subsection 7c71 a determination made under subsection 7a7 shall be presumed to be based on adequate evidence if it is supported by-- 7,a7 with respect to each ingredient in the finished product-- 7i7 references to an official statement by one or more expert medical or scientific bodies that the ingredient is safe under the conditions of use recommended or suggested in the product's labeling2 or 7ii7 appropriate safety testing of the ingredient2 and 7,b7 appropriate safety substantiation of the finished product beyond the safety substantiation of individual ingredients and consideration of the combination of ingredients4 7#b7 ,statement of an expert medical or scientific body ,for purposes of this section1 a statement of an expert medical or scientific body is an official statement of that body1 if-- 7,a7 the medical or scientific body is a ,federal1 ,state1 national1 or international entity with recognized expertise in chemical or cosmetic safety1 or other similarly recognized body composed of scientific and medical experts2 7,b7 the statement is based upon adequate data to support the finding of safety1 and such data are available to the ,food and ,drug ,administration2 and 7,c7 the statement is published and endorsed by the medical or scientific body and is not a statement of an employee of such body made in the individual capacity of the employee4 7c7 ,rebuttal of presumption ,notwithstanding subsection 7b71 a determination under subsection 7a7 will not be presumed to be based on adequate evidence if-- 7#a7 the ,food and ,drug ,administration issues an order under section #fjh that an ingredient or non-functional constituent in the finished product is not safe under the product's conditions of use or customary or usual use2 or 7#b7 the ,food and ,drug ,administration has provided the manufacturer with notice that-- 7,a7 the manufacturer has not met the criteria for a presumption of adequate information under subsection 7b72 or 7,b7 the ,food and ,drug ,administration has information that raises significant questions about the safety of the product or any of its ingredients4 7d7 ,timely update ,upon notice of inadequate evidence under subsection 7c71 the responsible person shall have #aj days to submit additional evidence to the ,food and ,drug ,administration regarding the safety of an ingredient1 non-functional constituent1 or the entire cosmetic product1 and the ,food and ,drug ,administration shall have #cj days from the date of receipt of such additional evidence to provide the responsible person with notice that the criteria under subsection 7b7 have been met or not met4 7e7 ,records maintenance ,the responsible person shall maintain records documenting the determination required under this section and the information on which such determination is based until #e years after the finished product is no longer marketed1 except that a responsible person for a domestic company whose sales are under #b1jjj1jjj per year shall maintain such records for at least #b years after the finished product is no longer marketed4 7f7 ,submission of records 7#a7 ,in general ,the records required under subsection 7e7 shall1 upon the written request of the ,food and ,drug ,administration to the responsible person1 be provided to the ,food and ,drug ,administration within a reasonable timeframe not to exceed #fj days1 in either electronic or paper form4 7#b7 ,criteria ,the ,food and ,drug ,administration may require records under paragraph 7#a7 if-- 7,a7 the ,food and ,drug ,administration has a reasonable belief1 described in written notice1 that-- 7i7 the finished product may be harmful based on adverse event reports or other scientific information2 7ii7 scientific information raises credible and relevant questions about the safety of the product or any of its ingredients2 7iii7 the responsible person has not made the determination required under subsection 7a71 or such determination is not supported by adequate evidence2 or 7iv7 one or more of the criteria to establish a presumption of adequate evidence of safety in subsection 7b7 has not been satisfied2 7,b7 the ,food and ,drug ,administration1 an expert regulatory body1 or an expert body composed of scientific and medical experts finds an ingredient in the product to be unsafe under the conditions of use of the product2 or 7,c7 the ,food and ,drug ,administration concludes that submission of the records will serve the public health or otherwise enable the ,food and ,drug ,administration to fulfill the cosmetic safety purposes of this section4 7g7 ,guidance and regulations 7#a7 ,in ,general ,the ,food and ,drug ,administration shall issue guidance describing the evidence necessary to support a determination under subsection 7a71 and may1 by regulation1 establish exemptions to the requirements of this section1 if the ,food and ,drug ,administration determines that such exemptions are supported by adequate evidence and would have no adverse effect on public health4 7#b7 ,small businesses ,the ,food and ,drug ,administration shall1 after consultation with the ,small ,business ,administration and small businesses that manufacture cosmetics1 provide additional guidance for small businesses on compliance with the requirements of this section that would apply to small business registrants4 ,such guidance shall include specific examples of options for compliance that do not place an undue burden on small businesses4 4 7b7 ,effective date ,section #fji of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 shall take effect #ahj days after the date of enactment of this ,act4 #ajc4 ,good manufacturing practices for cosmetics 7a7 ,in general ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #ajb1 is further amended by adding at the end the following3 #faj4 ,good manufacturing practices for cosmetics 7a7 ,in general ,the ,food and ,drug ,administration shall review national and international standards for cosmetic good manufacturing practices that are in existence on the date of enactment of the ,personal ,care ,products ,safety ,act and shall develop and implement1 through regulations1 standards consistent1 to the extent the ,food and ,drug ,administration determines practicable and appropriate1 with such national and international standards for cosmetic good manufacturing practices to ensure that requirements of this chapter with respect to the manufacture of cosmetic products are in harmony4 7b7 ,consultation ,the standards under subsection 7a7 shall include simplified good manufacturing practices for small businesses that take into account the size and scope of the business1 developed in consultation with the ,small ,business ,administration4 7c7 ,timeframe ,the ,food and ,drug ,administration shall publish a proposed rule described in subsection 7a7 not later than #ah months after the date of enactment of the ,personal ,care ,products ,safety ,act and shall publish a final such rule not later than #c years after such date of enactment4 4 7b7 ,effective date for cosmetic manufacturers 7#a7 ,large businesses ,for businesses of a size greater than the ,small ,business ,administration's standard for a small business1 section #faj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77 shall take effect beginning #ahj days after the date on which the ,food and ,drug ,administration makes effective cosmetic good manufacturing practices4 7#b7 ,small businesses ,for businesses of a size that meets the ,small ,business ,administration's standard for a small business1 section #faj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77 shall take effect beginning #b years after the date the ,food and ,drug ,administration makes effective cosmetic good manufacturing practices4 #ajd4 ,adverse event reports ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #ajc7;a71 is further amended by adding at the end the following3 #faa4 ,adverse event reporting for cosmetics 7a7 ,in general ,with respect to any cosmetic product distributed in the ,united ,states1 the responsible person shall submit to the ,food and ,drug ,administration a report of any serious adverse event associated with such cosmetic product1 when used in the ,united ,states1 accompanied by a copy of the label on or with the retail packaging of the cosmetic1 any new medical information1 related to a submitted serious adverse event report that is received by the responsible person1 and an annual report for all adverse events received by the responsible person4 7b7 ,definitions ,in this section3 7#a7 ,an adverse event for a cosmetic product is a health-related event associated with the use of this product that is adverse4 7#b7 ,a serious adverse event for a cosmetic product is an adverse event that-- 7,a7 results in-- 7i7 death2 7ii7 a life-threatening experience2 7iii7 inpatient hospitalization2 7iv7 a persistent or significant disability or incapacity2 7v7 congenital anomaly or birth defect2 or 7vi7 significant disfigurement1 including serious and persistent rashes or infections and significant hair loss2 or 7,b7 requires1 based on appropriate medical judgment1 a medical or surgical intervention to prevent an outcome described in subparagraph 7,a74 7c7 ,submission of reports 7#a7 ,serious adverse event reports ,except as provided in paragraph 7#b71 with respect to a cosmetic product distributed in the ,united ,states1 the responsible person shall submit a serious adverse event report to the ,food and ,drug ,administration not later than #ae business days after information concerning the adverse event is received4 ,if a serious adverse event report for a cosmetic with drug properties is filed using ,form ,,fda #cejj;,a 7or any successor form developed for such purpose7 or its electronic equivalent for over-the-counter drugs1 the responsible person shall not have to submit a duplicative serious adverse event report under this section4 7#b7 ,new medical information ,the responsible person shall submit to the ,food and ,drug ,administration any new medical information1 related to a submitted serious adverse event report that is received by the responsible person within #a year of the initial report1 and shall submit such information not later than #ae business days after the new information is received by the responsible person4 7#c7 ,annual report 7,a7 ,in general ,not later than ,march #a of each year1 except as provided under subparagraph 7,c71 the responsible person shall submit an electronic report for the prior calendar year for each cosmetic product marketed during that year4 7,b7 ,contents ,each report under this paragraph shall contain a summary of all adverse events received during the reporting period1 a complete list of individual reports1 and an estimate of the total number of product units estimated to have been distributed to consumers during such period4 ,the report shall not include consumer complaints that are solely regarding efficacy and do not contain any information about an adverse event4 ,the ,food and ,drug ,administration shall further specify the contents of the annual electronic report by regulation or guidance4 7,c7 ,small business exception ,in the case of a domestic facility for which the average gross annual sales in cosmetic products in the ,united ,states over the previous #c-year period is not more than #b1jjj1jjj1 the responsible person is not required to submit an annual report under this paragraph4 7#d7 ,exemption ,the ,food and ,drug ,administration may establish by regulation an exemption to any of the requirements under this subsection if the ,food and ,drug ,administration determines that such exemption is supported by adequate evidence and would have no adverse effect on public health4 7d7 ,requirements 7#a7 ,in general ,each serious adverse event report under this section shall be submitted to the ,food and ,drug ,administration using an electronic system of the ,food and ,drug ,administration4 ,the ,food and ,drug ,administration shall make such electronic system available not later than #a year after the date of enactment of the ,personal ,care ,products ,safety ,act4 7#b7 ,modification ,the format of the reporting system may be modified by the ,food and ,drug ,administration and the reports may include additional information4 ,the ,food and ,drug ,administration may1 in guidance1 further specify the format and contents of required reports4 7#c7 ,scope of serious adverse event report ,a serious adverse event report 7including all information submitted in the initial report or added later7 submitted to the ,food and ,drug ,administration under subsection 7a7 includes-- 7,a7 a report under section #gef with respect to safety and related to a specific cosmetic product2 7,b7 a record about an individual who suffered the serious adverse event under section #eeb;a of title #e1 ,united ,states ,code2 7,c7 a medical or similar file documenting the serious adverse event1 the disclosure of which would constitute a violation of section #eeb7;b77#f7 of such title #e1 and shall not be publicly disclosed unless all personally identifiable information is redacted2 and 7,d7 contact information for the individual reporting the serious adverse event4 7#d7 ,responsibility to gather information ,after an individual initiates the reporting of a serious adverse event1 the responsible person for the cosmetic product shall actively gather all of the information to complete and file the report with the ,food and ,drug ,administration4 7#e7 ,no adverse events to report ,the ,food and ,drug ,administration shall provide an option as part of the electronic registration process for the responsible person to indicate if such responsible person had no adverse events to report over the previous year4 ,with respect to a responsible person who received no adverse event reports for a year1 the annual adverse event report requirement may be met by indicating no such events on the annual registration form4 7e7 ,limitation with respect to adverse event reports ,the submission of an adverse event report in compliance with subsection 7a7 shall not constitute an admission that the cosmetic involved caused or contributed to the adverse event4 7f7 ,contact information ,the label of a cosmetic shall bear the domestic telephone number or electronic contact information1 and it is encouraged that the label include both the telephone number and electronic contact information1 through which the responsible person may receive a report of an adverse event4 7g7 ,maintenance of records ,the responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of #f years4 7h7 ,availability to ,states ,the ,food and ,drug ,administration shall make available records submitted under this section to any ,state1 upon request4 ,information disclosed to a ,state that is exempt from disclosure under section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 shall be treated as a trade secret and confidential information by the ,state4 7i7 ,effective date of requirement with respect to serious adverse events ,the requirement under this section to report serious adverse events shall become effective on the date that the ,food and ,drug ,administration publicizes the availability of the electronic system described in subsection 7d77#a74 4 #aje4 ,records inspection2 mandatory recall authority ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #ajd1 is further amended by adding at the end the following3 #fab4 ,inspection of cosmetic records 7a7 ,inspection of records ,each manufacturer1 processor1 packer1 or holder of a cosmetic shall1 at the request of an officer or employee duly designated by the ,food and ,drug ,administration1 permit such officer or employee1 upon presentation of appropriate credentials and written notice to such person1 at reasonable times and within reasonable limits and in a reasonable manner1 to have access to and copy-- 7#a7 all records maintained under section #faa and in accordance with the rules promulgated by the ,food and ,drug ,administration under section #faj1 as applicable2 and 7#b7 except as provided in subsection 7b71 all other records1 if the ,food and ,drug ,administration-- 7,a7 has a reasonable belief that the cosmetic-- 7i7 is adulterated2 7ii7 has caused a reportable serious adverse event2 or 7iii7 contains an ingredient that substantial new scientific information shows may be unsafe when present in a cosmetic2 and 7,b7 provides written notice of the basis for the ,food and ,drug ,administration's reasonable belief described in subparagraph 7,a74 7b7 ,exclusions ,no inspection authorized by this section shall extend to financial data1 pricing data1 personnel data 7other than data as to qualification of technical and professional personnel performing functions subject to this ,act71 research data 7other than safety data71 or sales data other than shipment data4 7c7 ,scope ,the requirements under subsection 7a7 apply to records maintained by or on behalf of such person in any format 7including paper and electronic formats7 and at any location4 7d7 ,protection of sensitive information ,the ,food and ,drug ,administration shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the ,food and ,drug ,administration pursuant to this section4 ,information disclosed to a ,state that is exempt from disclosure under section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 shall be treated as a trade secret and confidential information by the ,state4 7e7 ,limitations ,this section shall not be construed-- 7#a7 to limit the authority of the ,food and ,drug ,administration to inspect records or to require establishment and maintenance of records under any other provision of this ,act2 or 7#b7 to have any legal effect on section #eeb of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 #fac4 ,mandatory recall authority 7a7 ,voluntary procedures ,if the ,food and ,drug ,administration determines that there is a reasonable probability that a cosmetic is adulterated under section #fja or misbranded under section #fjb and the use of or exposure to such cosmetic is likely to cause serious adverse health consequences or death1 the ,food and ,drug ,administration shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article4 7b7 ,prehearing order ,to mandatorily cease distribution and give notice 7#a7 ,in general ,if the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and in the manner prescribed by the ,food and ,drug ,administration1 the ,food and ,drug ,administration may order such person to-- 7,a7 immediately cease distribution of such cosmetic2 and 7,b7 as applicable1 immediately notify all persons-- 7i7 manufacturing1 processing1 packing1 transporting1 holding1 receiving1 distributing1 or importing and selling such cosmetic2 and 7ii7 to which such cosmetic has been distributed1 transported1 or sold1 to immediately cease distribution of such cosmetic4 7#b7 ,required additional information 7,a7 ,in general ,if a cosmetic covered by a recall order issued under paragraph 7#a77;,b7 has been distributed to a warehouse-based third-party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of such cosmetic covered by a recall order that is in its possession1 the notice provided by the responsible person subject to the order issued under paragraph 7#a77;,b7 shall include such information as is necessary for the warehouse-based third-party logistics provider to identify the cosmetic4 7,b7 ,rules of construction ,nothing in this paragraph shall be construed-- 7i7 to exempt a warehouse-based third-party logistics provider from the requirements of this chapter1 including the requirements of this section and section #fab2 or 7ii7 to exempt a warehouse-based third-party logistics provider from being the subject of a mandatory recall order4 7#c7 ,determination to limit areas affected ,if the ,food and ,drug ,administration requires a responsible person to cease distribution under paragraph 7#a77;,a7 of a cosmetic1 the ,food and ,drug ,administration may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health4 7c7 ,hearing on order ,the ,food and ,drug ,administration shall provide the responsible party subject to an order under subsection 7b7 with an opportunity for an informal hearing1 to be held as soon as possible1 but not later than #b days after the issuance of the order1 on the actions required by the order and on why the cosmetic that is the subject of the order should not be recalled4 7d7 ,post-,hearing recall order and modification of order 7#a7 ,amendment of order ,if1 after providing opportunity for an informal hearing under subsection 7c71 the ,food and ,drug ,administration determines that removal of the cosmetic from commerce is necessary1 the ,food and ,drug ,administration shall1 as appropriate-- 7,a7 amend the order to require recall of such cosmetic or other appropriate action2 7,b7 specify a timetable in which the recall shall occur2 7,c7 require periodic reports to the ,food and ,drug ,administration describing the progress of the recall2 and 7,d7 provide notice to consumers to whom such cosmetic was1 or may have been1 distributed4 7#b7 ,vacating of order ,if1 after such hearing1 the ,food and ,drug ,administration determines that adequate grounds do not exist to continue the actions required by the order1 or that such actions should be modified1 the ,food and ,drug ,administration shall vacate the order or modify the order4 7e7 ,cooperation and consultation ,the ,food and ,drug ,administration shall work with ,state and local public health officials in carrying out this section1 as appropriate4 7f7 ,public notification ,in conducting a recall under this section1 the ,food and ,drug ,administration shall-- 7#a7 ensure that a press release is published regarding the recall1 and that alerts and public notices are issued1 as appropriate1 in order to provide notification-- 7,a7 of the recall to consumers and retailers to whom such cosmetic was1 or may have been1 distributed2 and 7,b7 that includes1 at a minimum-- 7i7 the name of the cosmetic subject to the recall2 7ii7 a description of the risk associated with such article2 and 7iii7 to the extent practicable1 information for consumers about similar cosmetics that are not affected by the recall2 and 7#b7 ensure publication on the ,internet website of the ,food and ,drug ,administration an image of the cosmetic that is the subject of the press release described in paragraph 7#a71 if available4 7g7 ,no delegation ,the authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the ,commissioner4 7h7 ,effect ,nothing in this section shall affect the authority of the ,food and ,drug ,administration to request or participate in a voluntary recall1 or to issue an order to cease distribution or to recall under any other provision of this chapter or under the ,public ,health ,service ,act4 4 #ajf4 ,labeling 7a7 ,in general ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #aje1 is further amended by adding at the end the following3 #fad4 ,labeling 7a7 ,safety review and labeling ,following a review of cosmetic ingredients that determines that warnings are required to help ensure safe use of cosmetic products under section #fjh7;d77#e71 the ,food and ,drug ,administration shall require labeling of cosmetics that are not appropriate for use in the entire population1 including warnings that vulnerable populations1 such as children or pregnant women1 should limit or avoid using the product4 7b7 ,cosmetic products for professional use 7#a7 ,definition of professional ,with respect to cosmetics1 the term professional means an individual who-- 7,a7 is licensed by an official ,state authority to practice in the field of cosmetology1 nail care1 barbering1 or esthetics2 7,b7 has complied with all requirements set forth by the ,state for such licensing2 and 7,c7 has been granted a license by a ,state board or legal agency or legal authority4 7#b7 ,listing of ingredients ,cosmetic products used and sold by professionals shall list all ingredients and warnings1 as required for other cosmetic products under this chapter4 7#c7 ,professional use labeling ,in the case of a cosmetic product intended to be used only by a professional on account of a specific ingredient or increased concentration of an ingredient that requires safe handling by trained professionals1 the product shall bear a statement as follows3 ,to be ,administered ,only by ,licensed ,professionals4 7c7 ,requirements 7#a7 ,display ,a warning required under subsection 7a7 and a statement required under subsection 7b77#c7 shall be prominently displayed-- 7,a7 in the primary language used on the label2 and 7,b7 in conspicuous and legible type in contrast by typography1 layout1 or color with other material printed or displayed on the label4 7#b7 ,minimum warning requirements ,a responsible person may include on the labeling any additional warnings in addition to the minimum warnings required under subsection 7a74 7d7 ,internet sales ,in the case of ,internet sales of cosmetics1 each ,internet website offering a cosmetic product for sale to consumers shall provide the same information that is included on the packaging of the cosmetic product as regularly available through in-person sales1 except information that is unique to a single cosmetic product sold in a retail facility1 such as a lot number or expiration date1 and the warnings and statements described in subsection 7c7 shall be prominently and conspicuously displayed on the website4 7e7 ,contact information ,the label on each cosmetic shall bear the domestic telephone number or electronic contact information1 and it is encouraged that the label include both the telephone number and electronic contact information1 that consumers may use to contact the responsible person with respect to adverse events4 ,the contact number shall provide a means for consumers to obtain additional information about ingredients in a cosmetic1 including the ability to ask if a specific ingredient may be present that is not listed on the label1 including whether a specific ingredient may be contained in the fragrance or flavor used in the cosmetic4 ,the manufacturer of the cosmetic is responsible for providing such information1 including obtaining the information from suppliers if it is not readily available4 ,suppliers are required to release such information upon request of the cosmetic manufacturer4 4 7b7 ,effective date ,section #fad of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 shall take effect on the date that is #a year after the date of enactment of this ,act4 #ajg4 ,coal tar chemicals ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #ajf1 is further amended by adding at the end the following3 #fae4 ,coal tar chemicals ,specific chemicals in coal tar hair dyes may be selected and reviewed under section #fjh4 4 #ajh4 ,animal testing alternatives ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #ajg1 is further amended by adding the following3 #faf4 ,animal testing alternatives 7a7 ,in general ,to minimize the use of animal testing for safety of cosmetic ingredients1 non-functional constituents1 and finished cosmetic products1 the ,food and ,drug ,administration shall-- 7#a7 encourage the use of alternative testing methods that provide information that is equivalent or superior in scientific quality to the animal testing method to-- 7,a7 not involve the use of an animal to test a chemical substance for safe use in cosmetics2 or 7,b7 use fewer animals than conventional animal-based tests for safe use in cosmetics when non-animal methods are impracticable2 and 7#b7 encourage-- 7,a7 the sharing of data across companies and organizations that are testing for safety in cosmetics1 so as to avoid duplication of animal tests2 and 7,b7 funding for research and validation of alternative testing methods4 7b7 ,guidance ,not later than #c years after the date of enactment of the ,personal ,care ,products ,safety ,act1 the ,food and ,drug ,administration shall issue guidance on the acceptability of scientifically reliable and relevant alternatives to animal testing for the safety of cosmetic ingredients1 non-functional constituents1 and finished cosmetic products1 and encouraging the use of such methods4 ,the ,food and ,drug ,administration shall update such guidance on an annual basis4 7c7 ,resources regarding animal testing alternatives ,not later than #ahj days after the date of enactment of the ,personal ,care ,products ,safety ,act1 the ,food and ,drug ,administration shall provide information on the ,internet website of the ,food and ,drug ,administration regarding resources available for information about non-animal methods1 and methods that reduce animal usage1 in testing for the safety of cosmetic ingredients1 non-functional constituents1 and finished cosmetic products4 4 #aji4 ,preemption ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #ajh1 is further amended by adding the following3 #fag4 ,preemption 7a7 ,in general ,no ,state or political subdivision of a ,state may establish or continue in effect any requirement for cosmetics1 other than a requirement that is in full effect and implemented on the date of enactment of the ,personal ,care ,products ,safety ,act-- 7#a7 with respect to registration1 good manufacturing practices1 mandatory recalls1 or adverse event reporting2 or 7#b7 with respect to the safety of a cosmetic ingredient or non-functional constituent that is the subject of a final order on a determination of safety under this chapter1 unless the requirement of the ,state or political subdivision is more restrictive than the final order under section #fjh7;d77#c74 7b7 ,safety of cosmetic ingredients and non-,functional constituents 7#a7 ,delayed effect of new ,state requirements 7,a7 ,in general ,from the date that the ,food and ,drug ,administration has made public the final selection of a cosmetic ingredient or non-functional constituent to be reviewed in the coming year under section #fjh7;a77#c77;,b7 and opened the public comment period under section #fjh7;a77#b71 until the date that is one year after the ,food and ,drug ,administration has made public such selection1 no ,state or political subdivision of a ,state may establish any new requirement related to such cosmetic ingredient or non-functional constituent4 7,b7 ,initial review ,with respect to the cosmetic ingredients to be reviewed in the first year1 in accordance with section #fjh7;a77#c77;,a71 for the #a-year period beginning on the date that is #f months after the date of enactment of the ,personal ,care ,products ,safety ,act1 no ,state or political subdivision of a ,state may establish any new requirement related to such cosmetic ingredient or non-functional constituent4 7#b7 ,scope ,subsection 7a77#b7 shall not be construed to affect the authority of a ,state or political subdivision of a ,state with respect to any requirement for the safety of a cosmetic ingredient or non-functional constituent that is unrelated to the scope of the safety assessment under section #fjh4 7#c7 ,sense of ,congress ,it is the sense of ,congress that a ,state or political subdivision that regulates the safety of cosmetics with respect to the health of humans beyond the scope of section #fjh should utilize the safety assessment criteria described in section #fjh7;h74 7c7 ,state requirement that is in full effect and implemented ,for purposes of this section3 7#a7 ,state requirement ,a ,state requirement includes a ,state requirement that is adopted by a ,state public initiative or referendum4 7#b7 ,full effect and implemented ,the term full effect and implemented includes requirements of ,states that are implemented after the date of enactment of the ,personal ,care ,products ,safety ,act1 if such requirements are under a law that was in effect1 or a lawful program that was established and functioning1 prior to the date of enactment of the ,personal ,care ,products ,safety ,act4 7d7 ,limitation ,nothing in the amendments to this ,act made by the ,personal ,care ,products ,safety ,act shall be construed to preempt any ,state statute1 public initiative1 referendum1 or other ,state action1 except as expressly provided in this section4 7e7 ,savings ,nothing in the amendments to this ,act made by the ,personal ,care ,products ,safety ,act1 nor any standard1 rule1 requirement1 regulation1 adverse event report1 safety assessment1 safety determination1 scientific assessment1 or order issued or implemented pursuant to such amendments1 shall be construed to modify or otherwise affect1 preempt1 or displace any cause of action or ,state or ,federal law creating a remedy for civil relief or criminal cause of action1 whether statutory or based in common law4 4 #aaj4 ,reporting ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #aji1 is further amended by adding at the end the following3 #fah4 ,reporting 7a7 ,performance report ,beginning with fiscal year #bjah1 and not later than #fj days prior to the end of each fiscal year for which fees are collected under section #gdd,l1 the ,food and ,drug ,administration shall prepare and submit to ,congress a report concerning the progress of the ,food and ,drug ,administration in achieving the objectives of the ,personal ,care ,products ,safety ,act during such fiscal year and the future plans of the ,food and ,drug ,administration for meeting the objectives4 ,the annual report for a fiscal year shall include-- 7#a7 the number of registered facilities and cosmetic ingredient statements on file with the ,food and ,drug ,administration2 7#b7 identification of the cosmetic ingredients and non-functional constituents that have been fully reviewed for safety by the ,food and ,drug ,administration in the prior fiscal year and for which a final administrative order has been released2 7#c7 identification of at least #e specific cosmetic ingredients and non-functional constituents that will be reviewed by the ,food and ,drug ,administration in the next fiscal year2 7#d7 the number of facilities inspected and mandatory recalls that transpired during that fiscal year2 7#e7 the number of serious adverse event reports received by the ,food and ,drug ,administration during that fiscal year2 7#f7 any trends identified by the ,food and ,drug ,administration about adverse event reports related to specific cosmetic ingredients or non-functional constituents2 and 7#g7 efforts of the ,food and ,drug ,administration to reduce animal testing for safety of cosmetic ingredients1 non-functional constituents1 and cosmetic products4 7b7 ,public availability ,the ,food and ,drug ,administration shall make the reports required under subsection 7a7 available to the public on the ,internet website of the ,food and ,drug ,administration on the date of submission of such reports to ,congress4 7c7 ,public input on safety review ,upon release of the report described in subsection 7a71 the ,food and ,drug ,administration shall provide the public with an opportunity to provide feedback1 at any time during the year1 on subsection 7a77#c7 by-- 7#a7 providing an electronic portal1 upon release of the report1 enabling the public to-- 7,a7 comment on the cosmetic ingredients or non-functional constituents under review for the current year2 7,b7 recommend additional cosmetic ingredients and non-functional constituents to be considered for review for safety in future years2 and 7,c7 comment on the priorities for the specific cosmetic ingredients and non-functional constituents that the ,food and ,drug ,administration anticipates will be reviewed in the next fiscal year2 7#b7 announcing on the ,internet website of the ,food and ,drug ,administration1 within the first #cj days of the new fiscal year1 any amendments to the list of cosmetic ingredients and non-functional constituents submitted pursuant to subsection 7a77#c7 based on public input1 pursuant to paragraph 7#a72 and 7#c7 together with the final announcement of at least #e specific cosmetic ingredients and non-functional constituents that will be reviewed in the coming year under section #fjh1 providing a comment period for further public input1 pursuant to section #fjh7;a77#b74 4 #aaa4 ,small businesses ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #aaj1 is further amended by adding at the end the following3 #fai4 ,small businesses ,the ,commissioner1 in coordination with the ,administrator of the ,small ,business ,administration1 shall provide technical assistance1 such as guidance and expertise1 to small businesses regarding compliance with the ,personal ,care ,products ,safety ,act1 including the amendments made by such ,act4 4 #aab4 ,applicability with respect to certain cosmetics ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #aaa1 is further amended by adding at the end the following3 #fbj4 ,applicability with respect to certain cosmetics ,in the case of a cosmetic product or a facility that is subject to the requirements under this chapter and chapter ,v1 if any requirement under chapter ,v with respect to such cosmetic or facility is substantially similar to a requirement under this chapter1 the cosmetic product or facility shall be deemed to be in compliance with the applicable requirement under this chapter if such product or facility is in compliance with such substantially similar requirement under chapter ,v1 provided that the product or facility has not obtained a waiver from the requirement under chapter ,v4 ,in the case of a cosmetic product or facility that is subject to1 and in compliance with1 a fee under subchapter ,c of chapter ,,vii1 other than a fee under part #aj of such subchapter1 any fee under such part #aj shall be waived with respect to such cosmetic product or facility 7with respect to cosmetic products74 4 #aac4 ,enforcement 7a7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended-- 7#a7 in subsection 7e7-- 7,a7 by striking #ejd1 #efd1 and inserting #ejd1 #efd1 #faa1 #fab12 and 7,b7 by striking #eai1 #efd1 and inserting #eai1 #efd1 #faa12 7#b7 in subsection 7j71 by inserting #fjg1 #fjh1 #faj1 before #gjd2 7#c7 in subsection 7ii7-- 7,a7 by striking #gfj or #gfa7 or and inserting #fjd1 #gfj1 or #gfa7 or2 and 7,b7 by striking #gfj or #gfa7 submitted and inserting #faa1 #gfj1 or #gfa7 submitted2 7#d7 in subsection 7xx7 by inserting or #fac after #dbc2 and 7#e7 by adding at the end the following3 7eee7 ,the failure to register in accordance with section #fje1 the failure to submit a cosmetic ingredient statement under section #fjf1 the failure to provide any information required by section #fje or #fjf1 or the failure to update the information required by section #fje or #fjf1 as required4 4 7b7 ,adulteration ,section #fja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is amended by adding at the end the following3 7f7 ,if the methods used in1 or the facilities or controls used for1 its manufacture1 processing1 packing1 or holding do not conform to current good manufacturing practice1 as prescribed by the ,food and ,drug ,administration in accordance with section #faj4 7g7 ,if it contains1 after the date prescribed under section #fjh7;e71 an ingredient that the ,food and ,drug ,administration has determined under section #fjh7;d77#d7 to be not safe1 or not safe under the conditions of use recommended or suggested in the label or a non-functional constituent that the ,food and ,drug ,administration has determined under section #fjh7;d77#d7 to be not safe or not safe in the amount present in the cosmetic4 7h7 ,if it is a cosmetic product for which any requirement of section #fji 7relating to safety substantiation7 is not met4 4 7c7 ,misbranding ,section #fjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is amended-- 7#a7 in subsection 7b7-- 7,a7 by striking and 7#b7 and inserting 7#b72 and 7,b7 by inserting 2 and 7#c7 a domestic address or a domestic telephone number1 and it is encouraged that the label include both a domestic address and a domestic telephone number1 through which the responsible person may receive a report of an adverse event associated with the use of such cosmetic product after numerical count2 and 7#b7 by adding at the end the following3 7g7 ,if it has been manufactured1 processed1 packed1 or held in any factory1 warehouse1 or establishment and the responsible person1 operator1 or agent of such factory1 warehouse1 or establishment delays1 denies1 or limits an inspection1 or refuses to permit entry or inspection4 7h7 ,if its labeling does not conform with a requirement under section #fad4 4 7d7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,food and ,drug ,administration shall issue guidance that defines the circumstances that would constitute delaying1 denying1 or limiting inspection1 or refusing to permit entry or inspection1 for purposes of section #fjb7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7c77#b74 7e7 ,imports ,section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended-- 7#a7 by striking section #gfj or #gfa the first1 third1 and fourth place such term appears and inserting section #faa1 #gfj1 or #gfa2 and 7#b7 by striking #gfj or #gfa7 and inserting #fjd1 #gfj1 or #gfa74 7f7 ,factory inspection ,section #gjd7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is amended by inserting after the third sentence the following3 ,in the case of any person who manufactures1 processes1 packs1 holds1 distributes1 or imports a cosmetic product1 or distributes a cosmetic product and affixes its name on the cosmetic label1 the inspection shall extend to all records and other information described in section #fab 7regarding inspection of cosmetic records71 when the standard for records inspections under paragraph 7#a7 or 7#b7 of subsection 7a7 of such section applies1 subject to the limitations under subsections 7d7 and 7e7 of such section44 #aad4 ,consumer information ,the ,food and ,drug ,administration shall post on its ,internet website information for consumers regarding-- 7#a7 final orders regarding the safety of a cosmetic ingredient or non-functional constituent under section #fjh7;d77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#b7 cosmetic product recalls 7including voluntary and mandatory recalls72 and 7#c7 identified counterfeit cosmetic products4 ,,ii ,fees related to cosmetic safety #bja4 ,findings ,congress finds that the fees authorized by the amendments made by this title will be dedicated to cosmetic safety activities1 as set forth in the goals identified for purposes of part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjb4 ,authority to assess and use cosmetic safety fees ,subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is amended by adding at the end the following3 #aj ,fees relating to cosmetics #gdd,l4 ,registration fee 7a7 ,assessment and collection 7#a7 ,in general ,beginning in fiscal year #bjah1 the ,food and ,drug ,administration shall assess and collect an annual fee from every responsible person 7referred to in this section as a registrant7 who owns or operates any facility 7as defined in section #fjd7c77 engaged in manufacturing or processing1 or whose name and address appear on the label of a cosmetic product distributed in the ,united ,states1 except that this subsection shall not apply to contract manufacturers if a responsible person has already paid the appropriate fee with respect to the cosmetic product1 to ensure no double fees are paid4 7#b7 ,payable date ,a fee under this section shall be payable during the period of initial registration and on the date of registration each year thereafter as prescribed in section #fje7;a77#a74 7b7 ,definitions ,in this section3 7#a7 ,adjustment factor ,the term adjustment factor applicable to a fiscal year means the ,consumer ,price ,index for all urban consumers 7all items2 ,united ,states city average7 for ,october of the preceding fiscal year divided by such index for ,october #bjag4 7#b7 ,affiliate ,the term affiliate means any business entity that has a relationship with a second business entity if1 directly or indirectly-- 7,a7 one business entity controls1 or has power to control1 the other business entity2 or 7,b7 a third party controls1 or has the power to control1 both of the business entities4 7#c7 ,cosmetic product ,the term cosmetic product has the meaning given such term in section #fjd7b74 7#d7 ,cosmetic safety activities ,the term cosmetic safety activities-- 7,a7 means activities related to compliance by registrants under section #fje with the requirements of this ,act with respect to cosmetics1 including-- 7i7 administrative activities1 such as information technology support1 human resources1 financial management1 the administration and maintenance of the cosmetic registration system and the cosmetic ingredient statement system under sections #fje and #fjf1 and fee assessment and collection under this section2 and 7ii7 implementation and enforcement activities1 such as the establishment of good manufacturing practices1 the review of adverse event reports1 inspection planning and inspections1 and use of enforcement tools2 and 7,b7 includes activities related to implementation of section #fjh1 regarding the review of cosmetic ingredients and non-functional constituents4 7#e7 ,gross annual sales ,the term gross annual sales means the average ,united ,states gross annual sales for the previous #c-year period of cosmetics for a registrant1 including the sales of all of its affiliates1 as reported in the registration under section #fje4 7c7 ,fee setting and amounts 7#a7 ,in general ,subject to subsection 7d71 the ,food and ,drug ,administration shall establish the fees to be collected under this section for each fiscal year after fiscal year #bjah1 based on the methodology described in paragraph 7#c77;,b71 and shall publish such fees in a ,federal ,register notice not later than #fj days before the beginning of each such fiscal year4 7#b7 ,fee exemption ,any registrant whose gross annual sales of cosmetic products in the #c-year period immediately preceding the fiscal year for which the annual fee will be paid was not more than #b1jjj1jjj1 shall be exempt from registration fees under this section for that fiscal year4 7#c7 ,annual fee setting 7,a7 ,fiscal year #bjah ,for fiscal year #bjah1 to generate a total estimated revenue amount of #bj1fjj1jjj1 the amount of the registration fee under subsection 7a7 shall be as follows3 7i7 ,tier ,i-,a ,for a registrant that has gross annual sales of #e1jjj1jjj1jjj or more in #bjag1 #a1cej1jjj4 7ii7 ,tier ,i-,b ,for a registrant that has gross annual sales of at least #d1jjj1jjj1jjj per annum but less than #e1jjj1jjj1jjj in #bjag1 #hej1jjj4 7iii7 ,tier ,,ii-,a ,for a registrant that has gross annual sales of at least #c1jjj1jjj1jjj per annum but less than #d1jjj1jjj1jjj in #bjag1 #gcj1jjj4 7iv7 ,tier ,,ii-,b ,for a registrant that has gross annual sales of at least #b1jjj1jjj1jjj per annum but less than #c1jjj1jjj1jjj in #bjag1 #faj1jjj4 7v7 ,tier ,,iii-,a ,for a registrant that has gross annual sales of at least #a1jjj1jjj1jjj per annum but less than #b1jjj1jjj1jjj in #bjag1 #ejj1jjj4 7vi7 ,tier ,,iii-,b ,for a registrant that has gross annual sales of at least #ejj1jjj1jjj per annum but less than #a1jjj1jjj1jjj in #bjag1 #cie1jjj4 7vii7 ,tier ,,iv-,a ,for a registrant that has gross annual sales of at least #bjj1jjj1jjj per annum but less than #ejj1jjj1jjj in #bjag1 #cbe1jjj4 7viii7 ,tier ,,iv-,b ,for a registrant that has gross annual sales of at least #ajj1jjj1jjj per annum but less than #bjj1jjj1jjj in #bjag1 #bge1jjj4 7ix7 ,tier ,v-,a ,for a registrant that has gross annual sales of at least #hj1jjj1jjj per annum but less than #ajj1jjj1jjj in #bjag1 #ahe1jjj4 7x7 ,tier ,v-,b ,for a registrant that has gross annual sales of at least #fj1jjj1jjj per annum but less than #hj1jjj1jjj in #bjag1 #ie1jjj4 7xi7 ,tier ,,vi-,a ,for a registrant that has gross annual sales of at least #dj1jjj1jjj per annum but less than #fj1jjj1jjj in #bjag1 #ae1jjj4 7xii7 ,tier ,,iv-,b ,for a registrant that has gross annual sales of at least #bj1jjj1jjj per annum but less than #dj1jjj1jjj in #bjag1 #ab1jjj4 7xiii7 ,tier ,,vii-,a ,for a registrant that has gross annual sales of at least #aj1jjj1jjj per annum but less than #bj1jjj1jjj in #bjag1 #ejj4 7xiv7 ,tier ,,vii-,b ,for a registrant that has gross annual sales of at least #e1jjj1jjj per annum but less than #aj1jjj1jjj in #bjag1 #cej4 7xv7 ,tier ,,viii-,a ,for a registrant that has gross annual sales of at least #b1jjj1jjj per annum but less than #e1jjj1jjj in #bjag1 #bej4 7,b7 ,fiscal years #bjai-bjbd ,for fiscal years #bjai through #bjbd1 fees under subsection 7a7 shall be established to generate a total estimated revenue amount of #bj1fjj1jjj1 as adjusted by subsection 7d74 ,of that amount3 7i7 ,tier ,i-,a ,registrants that have gross annual sales of #e1jjj1jjj1jjj or more in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #aj4g percent4 7ii7 ,tier ,i-,b ,registrants that have gross annual sales of at least #d1jjj1jjj1jjj per annum but less than #e1jjj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #d4a percent4 7iii7 ,tier ,,ii-,a ,registrants that have gross annual sales of at least #c1jjj1jjj1jjj per annum but less than #d1jjj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #c4e percent4 7iv7 ,tier ,,ii-,b ,registrants that have gross annual sales of at least #b1jjj1jjj1jjj per annum but less than #c1jjj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #b4i percent4 7v7 ,tier ,,iii-,a ,registrants that have gross annual sales of at least #a1jjj1jjj1jjj per annum but less than #b1jjj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #g4c percent4 7vi7 ,tier ,,iii-,b ,registrants that have gross annual sales of at least #ejj1jjj1jjj per annum but less than #a1jjj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #ac4d percent4 7vii7 ,tier ,,iv-,a ,registrants that have gross annual sales of at least #bjj1jjj1jjj per annum but less than #ejj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #ae4h percent4 7viii7 ,tier ,,iv-,b ,registrants that have gross annual sales of at least #ajj1jjj1jjj per annum but less than #bjj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #ac4c percent4 7ix7 ,tier ,v-,a ,registrants that have gross annual sales of at least #hj1jjj1jjj per annum but less than #ajj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #i percent4 7x7 ,tier ,v-,b ,registrants that have gross annual sales of at least #fj1jjj1jjj per annum but less than #hj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #f4i percent4 7xi7 ,tier ,,vi-,a ,registrants that have gross annual sales of at least #dj1jjj1jjj per annum but less than #fj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #e4a percent4 7xii7 ,tier ,,vi-,b ,registrants that have gross annual sales of at least #bj1jjj1jjj per annum but less than #dj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #d4d percent4 7xiii7 ,tier ,,vii-,a ,registrants that have gross annual sales of at least #aj1jjj1jjj per annum but less than #bj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #a4b percent4 7xiv7 ,tier ,,vii-,b ,registrants that have gross annual sales of at least #e1jjj1jjj per annum but less than #aj1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #a4b percent1 except that no such registrant shall be responsible for more than #cej per fiscal year4 7xv7 ,tier ,,viii-,a ,registrants that have gross annual sales of at least #b1jjj1jjj per annum but less than #e1jjj1jjj in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid1 shall be responsible1 collectively1 for #a4b percent1 except that no such registrant shall be responsible for more than #bej per fiscal year4 7d7 ,adjustments 7#a7 ,inflation adjustment 7,a7 ,in general ,for fiscal year #bjai and each subsequent fiscal year1 the revenues and fee amounts under subsection 7c77#c77;,b7 shall be adjusted by the ,food and ,drug ,administration in the annual ,federal ,register notice establishing fees in subsection 7c77#a71 by an amount equal to the sum of-- 7i7 one2 7ii7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c of the preceding #d fiscal years for which data are available1 multiplied by the average proportion of personnel compensation and benefits costs to total ,food and ,drug ,administration costs for the first #c years of the preceding #d fiscal years for which data are available2 and 7iii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc#f ,,md-,,va-,,wv2 not seasonally adjusted2 all items less food and energy2 annual index7 for the first #c years of the preceding #d years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total ,food and ,drug ,administration costs for the first #c years of the preceding #d fiscal years for which data are available4 7,b7 ,compounded basis ,the adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year #bjah under this subsection4 7#b7 ,final year adjustment ,for fiscal year #bjbd1 the ,food and ,drug ,administration may1 in addition to adjustments under paragraph 7#a71 further increase the fee revenues and fees established in subsection 7c7 if such an adjustment is necessary to provide for not more than #c months of operating reserves of carryover fees for cosmetic safety activities for the first #c months of fiscal year #bjbe4 ,if such an adjustment is necessary1 the rationale for the increase1 shall be contained in the annual ,federal ,register notice establishing fees1 in subsection 7c77#a71 for fiscal year #bjbd4 ,if the ,food and ,drug ,administration has carryover balances for such activities in excess of #c months of such operating reserves1 the adjustment under this subparagraph shall not be made4 7#c7 ,workload adjustment 7,a7 ,in general ,for fiscal year #bjai and each subsequent fiscal year1 after fee revenues established in subsection 7c77#c77;,b7 are adjusted for a fiscal year for inflation in accordance with paragraph 7#a71 the fee revenues shall be adjusted further for each fiscal year to reflect changes in the workload of the ,food and ,drug ,administration for actual changes in workload volume due to the process of reviewing cosmetic ingredients or non-functional constituents not listed under section #fjh7;b74 7,b7 ,determination of adjustment ,the adjustment shall be determined by the ,food and ,drug ,administration based on the workload in the most recent #a-year period for which workload data is available4 ,the ,food and ,drug ,administration shall publish in the ,federal ,register the fee revenues and fees resulting from the adjustment and the supporting methodologies4 7,c7 ,minimum revenues ,the adjustment shall not result in fee revenues for a fiscal year that are less than the sum of the amount under subsection 7c77#c77;,b71 as adjusted for inflation under subparagraph 7#a74 7e7 ,limitations 7#a7 ,in general ,with respect to the amount that1 under the salaries and expenses account of the ,food and ,drug ,administration1 is appropriated for a fiscal year for the cosmetics program in the ,center for ,food ,safety and ,applied ,nutrition and related field activities1 fees may not be assessed under subsection 7a7 for the fiscal year unless the amount so appropriated for the fiscal year 7excluding the amount of fees appropriated for the fiscal year71 is equal to or greater than that assessed for fiscal year #bjag1 multiplied by the adjustment factor applicable to the fiscal year involved4 7#b7 ,authority ,if the ,food and ,drug ,administration does not assess fees under subsection 7a7 during any portion of a fiscal year because of paragraph 7#a7 and if at a later date in such fiscal year the ,food and ,drug ,administration may assess such fees1 the ,food and ,drug ,administration may assess and collect such fees1 without any modification in the rate1 for registration under section #fje at any time in such fiscal year4 7f7 ,crediting and availability of fees 7#a7 ,in general ,fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for cosmetic safety activities4 7#b7 ,collections and appropriations acts 7,a7 ,in general ,subject to subparagraphs 7,c7 and 7,d71 the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation ,acts1 or otherwise made available for obligation for such fiscal year4 7,b7 ,use of fees and limitation ,the fees authorized by this section shall be collected and available only to defray the costs of cosmetic safety activities4 7,c7 ,fee collections during first program year ,until the date of enactment of an ,act making appropriations through ,september #cj1 #bjag1 for the salaries and expenses account of the ,food and ,drug ,administration1 fees authorized by this section for fiscal year #bjah may be collected and shall be credited to such account to remain available until expended4 ,fees collected under this subparagraph shall be considered discretionary for purposes of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe4 7,d7 ,reimbursement of start-up amounts ,any amounts allocated to establish programs under sections #fje and #fjf1 prior to collection of fees1 may be reimbursed through any appropriated fees collected under this section1 in such manner as the ,food and ,drug ,administration determines appropriate4 ,any amounts reimbursed under this subparagraph shall be available for the programs and activities for which funds allocated to establish the programs were available1 prior to such allocation1 until the end of the fiscal year in which the reimbursement occurs1 notwithstanding any otherwise applicable limits on amounts for such program or activities for a fiscal year4 7#c7 ,authorization of appropriations ,for each of fiscal years #bjah through #bjbd1 there are authorized to be appropriated for fees under this section #bj1fjj1jjj1 as adjusted by subsection 7d74 7#d7 ,offset of overcollections2 recovery of collection shortfalls 7,a7 ,offset of overcollections ,if the sum of the cumulative amount of fees collected under this section for the fiscal years #bjah through #bjbb exceeds the cumulative amount appropriated pursuant to paragraph 7#c7 for fiscal years #bjah through #bjbc1 the excess amount shall be credited to the appropriation account of the ,food and ,drug ,administration as provided in paragraph 7#a71 and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation ,acts for fiscal year #bjbd4 7,b7 ,recovery of collection shortfalls 7i7 #bjbj ,for fiscal year #bjbj1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjah falls below the amount of fees authorized for fiscal year #bjah under paragraph 7#c74 7ii7 #bjba ,for fiscal year #bjba1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjai falls below the amount of fees authorized for fiscal year #bjai under paragraph 7#c74 7iii7 #bjbb ,for fiscal year #bjbb1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjbj falls below the amount of fees authorized for fiscal year #bjbj under paragraph 7#c74 7iv7 #bjbc ,for fiscal year #bjbc1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjba falls below the amount of fees authorized for fiscal year #bjba under paragraph 7#c74 7v7 #bjbd ,for fiscal year #bjbd1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjbb falls below the amount of fees authorized for fiscal year #bjbb under paragraph 7#c74 7g7 ,effect of failure ,to pay fees ,the ,food and ,drug ,administration shall not consider a registration submitted to be complete until such fee under subsection 7a7 is paid4 ,until the fee is paid1 the registration is incomplete and the registrant is deemed to have failed to register in accordance with section #fje4 7h7 ,false statements ,any statement or representation made to the ,food and ,drug ,administration shall be subject to section #ajja of title #ah1 ,united ,states ,code4 7i7 ,collection of unpaid fees ,in any case where the ,food and ,drug ,administration does not receive payment of a fee assessed under subsection 7a71 such fee shall be treated as a claim of the ,united ,states ,government subject to subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7j7 ,construction ,this section may not be construed to require that the number of full-time equivalent positions in the ,department of ,health and ,human ,services1 for officers1 employees1 and advisory committees not engaged in cosmetic activities1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 7k7 ,records ,each facility shall retain all records necessary to demonstrate the facility's gross annual sales for at least #b fiscal years after such information is reported in the facility's registration4 ,such records shall be made available to the ,food and ,drug ,administration for review and duplication upon request of the ,food and ,drug ,administration4 4 #bjc4 ,direct hiring authority to support activities related to cosmetics ,part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bjb1 is amended by inserting after section #gdd,l the following3 #gdd,m4 ,direct hiring authority to support activities related to cosmetics 7a7 ,in general ,the ,food and ,drug ,administration shall have direct hiring authority with respect to the appointment of employees into the competitive service or the excepted service to administer the amendments made by title ,i of the ,personal ,care ,products ,safety ,act4 7b7 ,sunset ,the authority under subsection 7a7 shall terminate on the date that is #c years after the date of enactment of such title4 4