,i #aafth ,,congress #ast ,session ,h4 ,r4 #ebgi ,,in ,,the ,,house ,,of ,,representatives ,december #c1 #bjai,mr4 ,pallone introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to improve cosmetic safety1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,cosmetic ,safety ,enhancement ,act of #bjai4 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 nonfunctional 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 ,labeling and internet sales4 ,sec4 #ajg4 ,consumer information4 ,sec4 #ajh4 ,small businesses4 ,sec4 #aji4 ,animal testing restrictions4 ,sec4 #aaj4 ,counterfeit cosmetics4 ,sec4 #aaa4 ,foreign supplier verification4 ,sec4 #aab4 ,applicability with respect to certain cosmetics4 ,sec4 #aac4 ,saving clause4 ,sec4 #aad4 ,enforcement4 ,title ,,ii--,fees ,related to ,cosmetic ,products ,sec4 #bja4 ,findings4 ,sec4 #bjb4 ,authority to assess and use cosmetic product fees4 ,sec4 #bjc4 ,direct hiring authority to support activities related to cosmetics4 ,sec4 #bjd4 ,sunset dates4 ,i ,cosmetic ,safety #aja4 ,registration of cosmetics facilities and cosmetic ingredient statements ,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 ,animal test ,the term animal test means the internal or external application or exposure of a cosmetic product1 cosmetic formulation1 or cosmetic ingredient to the skin1 eyes1 or other body part of a live non-human vertebrate for the purpose of evaluating the safety of a cosmetic product1 cosmetic formulation1 or cosmetic ingredient4 7#b7 ,contract manufacturer ,the term contract manufacturer means a manufacturer 7including the owner1 operator1 or agent in charge 7or any affiliate thereof77 of a cosmetic ingredient1 cosmetic formulation1 or cosmetic product that does not sell any such cosmetic ingredient1 cosmetic formulation1 or cosmetic product unless there is a specific contractual agreement in place with respect to that sale4 7#c7 ,cosmetic formulation ,the term cosmetic formulation means a preparation of cosmetic raw materials with a qualitatively and quantitatively set composition4 7#d7 ,cosmetic ingredient ,the term cosmetic ingredient means any single chemical entity or mixture used as a component in the manufacture of a finished cosmetic product or cosmetic formulation4 7#e7 ,cosmetic product 7,a7 ,the term cosmetic product means a finished cosmetic comprised of a specified set of cosmetic ingredients1 which may come in a range of possible amounts for each cosmetic ingredient and which may include a variety of fragrances and colors1 and in some specific cosmetic applications1 flavors4 7,b7 ,such term shall include tattoo ink whether or not labeled as a finished cosmetic4 7#f7 ,facility ,the term facility includes any factory1 warehouse1 or establishment 7including a factory1 warehouse1 or establishment of an importer or of any other entity whose name and address appear on the label of a cosmetic product7 that manufactures1 processes1 packs1 or holds cosmetic products or cosmetic formulations4 ,such term does not include-- 7,a7 beauty shops and salons that do not otherwise manufacture1 process1 or package cosmetic products or cosmetic formulations at that location1 including beauty stores or counters that offer customized or personalized cosmetic products or cosmetic formulations tailored to individual consumers for sale solely in-person2 7,b7 cosmetic product retailers1 including individual sales representatives1 direct sellers 7as defined in section #cejh of the ,internal ,revenue ,code of #aihf71 retail distribution facilities1 retail franchises1 retail warehouses1 and pharmacies1 that do not otherwise manufacture1 process1 or package cosmetic products or cosmetic formulations at that location2 7,c7 entities that manufacture or compound cosmetic products solely for use in research1 teaching1 or pilot plant production and not for sale2 7,d7 hospitals1 physicians' offices1 and health care clinics2 7,e7 hotels1 airlines1 and other entities that provide complimentary cosmetic products to guests2 7,f7 public health agencies and other nonprofit entities that provide cosmetic products or cosmetic formulations directly to the consumer2 or 7,g7 trade shows and other venues where cosmetic product samples are provided free of charge4 7#g7 ,foreign facility ,the term foreign facility means a facility that manufactures1 processes1 packs1 or holds1 cosmetic products or cosmetic formulations that are exported to the ,united ,states without further processing or packaging inside the ,united ,states4 ,a cosmetic product or cosmetic formulation 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 cosmetic product or cosmetic formulation4 7#h7 ,nonfunctional constituent ,the term nonfunctional constituent means any substance that is an incidental component of an ingredient1 a breakdown product of an ingredient1 or a byproduct of the manufacturing process that has not been intentionally added as a separate substance and serves no technical function in the cosmetic product4 7#i7 ,professional ,with respect to a cosmetic product1 the term professional means-- 7,a7 a dermatologist or other health care professional that administers or provides cosmetic products to patients2 or 7,b7 a cosmetologist1 nail technician1 barber1 or esthetician who administers or provides cosmetics within the scope of their business practices4 7#aj7 ,professional use ,with respect to a cosmetic product1 the term professional use means a preparation of a cosmetic formulation intended only for use by professionals in settings such as cosmetology1 nail care1 barbering1 esthetics1 health care1 and other professions as determined by the ,secretary through regulation4 7#aa7 ,responsible person ,the term responsible person means the brand owner1 operator1 or agent in charge who is the domestic or foreign manufacturer1 processor1 or entity whose name appears on the label of a cosmetic product or a cosmetic formulation distributed in the ,united ,states4 #fje4 ,registration of cosmetic facilities 7a7 ,registration for manufacturing and processing facilities 7#a7 ,in general ,the owner1 operator1 or agent in charge of 7or an affiliate thereof7 a facility engaged in manufacturing1 or processing1 of a cosmetic product or a cosmetic formulation distributed in the ,united ,states shall register with the ,secretary4 7#b7 ,electronic registration system ,the ,secretary shall-- 7,a7 maintain an electronic registration system for purposes of this section2 and 7,b7 not later than one year after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 announce that such system is operational4 7#c7 ,initial registration of existing facilities ,not later than the date that is #f months after the date of the announcement required by paragraph 7#b77;,b71 each facility engaged in an activity described in paragraph 7#a7 shall be registered under such paragraph4 7#d7 ,initial registration of new facilities ,in the case of a facility that first engages in an activity described in paragraph 7#a7 on or after the date that is #ah months after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 such a facility shall register with the ,secretary immediately upon engaging in such activity4 7#e7 ,single registration ,the ,secretary shall require only a single registration per registration period for a facility required to be registered under paragraph 7#a71 regardless of whether such facility is manufacturing or processing-- 7,a7 its own cosmetic products or cosmetic formulations2 or 7,b7 cosmetic products or cosmetic formulations on behalf of more than one owner1 operator1 or agent in charge 7or affiliate thereof74 7b7 ,registration for packing or holding facilities ,each facility engaged in packing or holding a cosmetic product or cosmetic formulation distributed in the ,united ,states shall register with the ,food and ,drug ,administration4 ,each such facility shall1 not later than #f months after the ,secretary announces the establishment of an electronic registration system for purposes of this section1 submit a registration utilizing such system4 7c7 ,annual registration renewal ,a facility that continues to engage in any activity that would require registration under subsection 7a7 or 7b7 shall submit to the ,secretary an annual registration during the first quarter of the fiscal year for which such renewed registration shall be effective4 7d7 ,fees ,if the average gross annual sales of cosmetic products in the ,united ,states of all of the facilities of the responsible person registered under subsection 7a77#a7 for the previous #c-;fiscal-year period is greater than #a1jjj1jjj1 a registration shall not be complete under this subsection until the responsible person has paid any registration fee required under section #gdd,m4 7e7 ,changes to information ,a facility that submitted a registration under this section shall notify the ,secretary of any change to the information required under subsection 7a7 or 7b7 not later than #cj days after the date of such change1 unless otherwise specified by the ,secretary4 7f7 ,format2 contents 7#a7 ,electronic format ,each registration shall be submitted using an electronic format1 as specified in a registration form provided by the ,secretary4 7#b7 ,contents ,the registration shall contain the following information3 7,a7 ,each facility's name 7including any parent company of the facility7 and full address1 identifying the precise physical location of the facility4 7,b7 ,the identity of the facility1 including the unique facility identifier1 if any1 previously assigned by the ,secretary to the facility under subsection 7i74 7,c7 ,all business trading names used by the facility4 7,d7 ,the product category 7as identified under section #gbj4d7;c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation771 or other cosmetic categories as determined appropriate by the ,secretary 7including by guidance7 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 7,e7 ,the type or types of activities conducted at the facility 7such as manufacturing1 processing1 packing1 or holding74 7,f7 ,the name1 title1 street address1 telephone number1 and electronic contact information of the emergency contact for the facility4 7,g7 ,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 and the phone number and electronic contact information of the ,united ,states agent4 7,h7 ,the name1 title1 street address1 telephone number1 and electronic contact information of the individual submitting the registration4 7,i7 ,an assurance that the ,secretary will be permitted to inspect such facility at the times and in the manner permitted by this ,act4 7,j7 ,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 ,secretary may require by regulation4 7#c7 ,abbreviated registration ,the ,secretary shall provide for an abbreviated registration renewal process for any facility that has not had any changes to the information submitted by the facility for the preceding registration4 7g7 ,incomplete or inaccurate registration 7#a7 ,in general ,subject to paragraph 7#b71 the ,secretary may cancel a registration of a facility under this section if-- 7,a7 the ,secretary has reasonable grounds to believe that the registration was not properly completed or updated in accordance with this section2 7,b7 a required registration fee has not been paid within #cj days2 or 7,c7 the registration otherwise contains false1 incomplete1 or inaccurate information4 7#b7 ,notification ,the ,secretary shall1 at least #aj days before canceling a registration pursuant to paragraph 7#a71 provide notice to the facility of the intent of the ,secretary to cancel such registration that contains the ,secretary's basis for the determination to so cancel the registration4 7#c7 ,timely update or correction ,if1 not later than #g days after receipt of a notice of intent to cancel under paragraph 7#b71 the facility corrects the registration in accordance with the basis for the cancellation1 and the required registration fee1 if any1 is paid1 the ,secretary shall not cancel such registration4 7h7 ,unique identifier ,at the time of the initial registration of any cosmetic facility under this section1 the ,secretary shall assign a unique identifier to the facility and provide such identifier to such facility in writing4 7i7 ,registry of facilities 7#a7 ,in general ,the ,secretary 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 an owner1 operator1 or agent in charge of 7or an affiliate thereof7 a facility engaged in manufacturing1 processing1 packing1 or holding a cosmetic product or formulation1 or a facility owned by such person1 or that discloses specific facilities where specific brands of 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 ,secretary a cosmetic ingredient statement1 at such time and in such manner as the ,secretary may prescribe4 ,the cosmetic ingredient statement shall not become effective until the responsible person pays any applicable fee required under section #gdd,m4 7b7 ,submission of a cosmetic ingredient statement 7#a7 ,existing cosmetic products ,in the case of a cosmetic product or cosmetic formulation that is marketed on the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 the responsible person shall-- 7,a7 not later than the date that is #f months after the date of the announcement of an electronic registration system required by section #fje1 submit to the ,secretary a cosmetic ingredient statement in accordance with this section2 and 7,b7 beginning one year after the ingredient statement is submitted under subparagraph 7,a7 and each year thereafter1 submit to the ,secretary a renewal of such statement1 consistent with the requirements in subsection 7e71 during the first quarter of the fiscal year for which such renewed statement is applicable4 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 or cosmetic formulation that is first marketed after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai or a cosmetic product or cosmetic formulation that is reformulated after such date of enactment1 the responsible person shall-- 7i7 submit to the ,secretary a cosmetic ingredient statement prior to first marketing the new cosmetic product1 new cosmetic formulation1 or the reformulated cosmetic product or reformulated cosmetic formulation2 and 7ii7 beginning one year after the ingredient statement is submitted under clause 7i71 submit to the ,secretary annually thereafter a renewal of such statement during the first quarter of the fiscal year for which the cosmetic ingredient statement is applicable1 consistent with the requirements in subsection 7e74 7,b7 ,small businesses ,in the case of a responsible person that is a small business1 the ,secretary shall allow such responsible person to have an additional time period1 of a duration to be determined by the ,secretary1 in which to submit the first cosmetic ingredient statement under subparagraph 7,a74 ,such responsible person shall1 consistent with the requirements in subsection 7e71 submit a cosmetic ingredient statement annually thereafter during the first quarter of the applicable fiscal year4 7,c7 ,applicability ,in applying subparagraph 7,a71 a cosmetic product or cosmetic formulation shall not be considered to be first marketed or reformulated after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai if the only change in such product or formulation is-- 7i7 a change in the amount of an existing ingredient that is 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 ,secretary in regulations or guidance1 previously reported as a potential ingredient under subsection 7c77#b74 7#c7 ,abbreviated renewal ,the ,secretary shall provide for an abbreviated process for the renewal of any cosmetic ingredient statement under this subsection with respect to which there has been no change since the responsible person submitted the previous statement4 7c7 ,format2 contents 7#a7 ,form ,for each cosmetic ingredient statement submitted with respect to a cosmetic product or cosmetic formulation under this section1 such statement shall be submitted using an electronic format1 in a form specified by the ,secretary4 7#b7 ,contents ,each such cosmetic ingredient statement shall include the following information3 7,a7 ,the unique identifier1 assigned under section #fje7;h71 as applicable1 of-- 7i7 the facility or facilities where the cosmetic product or cosmetic formulation is manufactured1 processed1 packed1 or held or1 if the same cosmetic product or cosmetic formulation is manufactured1 processed1 packed1 or held in more than one facility1 the unique facility identifier of each facility where it 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 or cosmetic formulation as it appears on the label4 7,c7 ,the listing number1 if any1 previously assigned by the ,secretary under subsection 7f7 to the cosmetic product or cosmetic formulation4 7,d7 ,the applicable cosmetic category for the cosmetic product or cosmetic formulation4 7,e7 ,a list of ingredients in the cosmetic product or cosmetic formulation that-- 7i7 with respect to each such ingredient1 the name adopted in regulations promulgated by the ,secretary1 if any1 or by the common or usual name of the ingredient2 7ii7 is consistent with the regulations promulgated by the ,food and ,drug ,administration related to cosmetic labeling requirements2 and 7iii7 contains a list of fragrances1 flavors1 and colors that may be included in the product1 interchangeably1 which shall include-- 7,i7 in the case of fragrances1 each fragrance allergen contained in the cosmetic product as described in section #fae1 and for fragrances that are purchased from a fragrance supplier1 the fragrances shall be identified by the name or code provided by the supplier1 and include the name and contact information for the fragrance supplier2 and 7,,ii7 in the case of flavors that are purchased from a flavor supplier1 the flavors shall be identified by the name or code provided by the supplier1 and include the name and contact information for the flavor supplier2 7iv7 other appropriate interchangeable ingredients as the ,secretary may specify in regulations or guidance that may be included in the product2 and 7v7 in the case of an ingredient 7other than a fragrance1 flavor1 or color7 that has been designated for review under section #fjh1 includes potential ranges and amounts of such ingredient4 7,f7 ,the title and full contact information of each individual submitting the statement4 7,g7 ,if applicable1 information on labeling required under section #fad4 7,h7 ,such additional information pertaining to the cosmetic product as the ,secretary may require by regulation4 7#c7 ,confidentiality ,fragrance ingredients included in a cosmetic ingredient statement under paragraph 7#b77;,e71 other than fragrance allergens1 shall be treated as confidential commercial or trade secret information4 7#d7 ,contract manufacturing organization facilities ,if a facility manufactures or processes cosmetic products or cosmetic formulations on behalf of an owner1 operator1 or agent in charge whose name appears on the label of such products or formulations1 the ,secretary shall require only a single cosmetic ingredient statement for such cosmetic product4 ,such single cosmetic ingredient statement shall be submitted to the ,secretary by the responsible person4 7#e7 ,cosmetic ingredient statement for certain small businesses 7,a7 ,in ,general ,notwithstanding any other provision of this subsection1 in the case of a responsible person that has had an average of less than #a1jjj1jjj in annual domestic cosmetic sales over the previous #c years1 the ,secretary may allow such responsible person-- 7i7 to submit a simplified cosmetic ingredient statement under this section2 and 7ii7 an additional time period1 of a duration to be determined by the ,secretary1 in which to submit such simplified cosmetic ingredient statement4 7,b7 ,contents ,a responsible person described in subparagraph 7,a7 shall include in each cosmetic ingredient statement submitted under this section1 at a minimum-- 7i7 a list of ingredients in the cosmetic product or cosmetic formulation1 including any fragrance allergens as described in section #fae2 7ii7 the applicable cosmetic category for the cosmetic product or cosmetic formulation2 and 7iii7 in the case of a cosmetic product or cosmetic formulation that includes a fragrance or flavor purchased from a fragrance or flavor supplier1 the contact information for the fragrance or flavor supplier1 including the supplier's name1 street address1 telephone number1 and electronic contact information4 7d7 ,incomplete or inaccurate cosmetic ingredient statement 7#a7 ,in general ,not earlier than #cj days after providing notice under paragraph 7#b7 and subject to paragraph 7#c71 the ,secretary may nullify a cosmetic ingredient statement submitted under this section if the ,secretary has reasonable grounds to believe that1 except for minor or immaterial errors1 the cosmetic ingredient statement was not completed or updated in accordance with this section or otherwise contains false1 incomplete1 or inaccurate information4 7#b7 ,notice of nullification ,if the ,secretary nullifies a cosmetic ingredient statement under paragraph 7#a71 the ,secretary shall provide to the responsible person submitting such cosmetic ingredient statement under this section notice of any such nullification1 including the basis for such nullification4 7#c7 ,timely update or correction ,in the case of a cosmetic ingredient statement with respect to which the ,secretary has provided notice under paragraph 7#b71 the ,secretary shall not nullify such cosmetic ingredient statement if the cosmetic ingredient statement is appropriately updated or corrected not later than #aj days after the date on which such notice is provided4 7#d7 ,effect of nullification ,no person shall import1 export1 or otherwise distribute any cosmetic product or cosmetic formulation that is the subject of a cosmetic ingredient statement that is nullified under this subsection4 7e7 ,additional requirements 7#a7 ,safety requirements ,in submitting a cosmetic ingredient statement for each cosmetic product or cosmetic formulation under this section1 a responsible person shall include an attestation that the safety of the product or formulation1 including the individual ingredients of such product or formulation1 has been substantiated in accordance with section #fji4 7#b7 ,changes to information ,not later than #ij days after any change to the information required to be in a cosmetic ingredient statement under this section1 the responsible person shall notify the ,secretary of such change1 including the discontinuation of the manufacture of a cosmetic product4 ,such notification is not required for a change described in subsection 7b77#b77;,c74 7f7 ,cosmetic products list 7#a7 ,listing number ,at the time of the initial submission of any cosmetic ingredient statement under this section1 the ,secretary shall-- 7,a7 assign a unique cosmetic product listing number to the cosmetic ingredient statement2 and 7,b7 provide such number to the responsible person who submitted such statement in writing4 7#b7 ,cosmetic products list ,using cosmetic ingredient statements submitted under this section1 the ,secretary shall-- 7,a7 compile and maintain a list of cosmetic products or cosmetic formulations distributed in the ,united ,states1 including the ingredients of each such product or formulation2 and 7,b7 upon request of any ,state1 shall make such list available to such ,state4 7#c7 ,confidentiality ,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 ,such ,state and its employees in possession of such information shall be subject to the same laws governing information disclosure as employees of the ,food and ,drug ,administration4 7g7 ,exemption ,a responsible person shall be exempt from the requirements of this section if such person has had an average of less than #ejj1jjj in annual domestic cosmetic product sales over the previous three years4 ,such exemption shall not apply to cosmetic products that are intended to be injected under the skin or into the eye1 including tattoo ink1 or ingredients selected by the ,food and ,drug ,administration for review under section #fjh if such ingredient is included in a cosmetic product or cosmetic formulation distributed by such person described4 #fjg4 ,suspension of registration or cosmetic ingredient statement 7a7 ,suspension of registration of a facility ,if the ,secretary determines that a cosmetic product or cosmetic formulation manufactured1 processed1 packed1 or held by a facility registered under section #fje has a reasonable probability of causing serious adverse health consequences or death to humans1 the ,secretary may suspend the registration of such facility4 7b7 ,suspension of cosmetic ingredient statement ,if the ,secretary determines that a cosmetic product or cosmetic formulation manufactured in a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans1 the ,secretary may suspend the cosmetic ingredient statement of that product or formulation4 7c7 ,notice of suspension ,before suspending the registration of a facility or a cosmetic ingredient statement under this section1 the ,secretary shall provide-- 7#a7 notice to the facility or responsible person1 as appropriate1 of the intent to suspend such registration or the cosmetic ingredient statement1 which shall specify the basis of the determination by the ,secretary for that suspension2 and 7#b7 an opportunity1 within #b business days of the notice provided under paragraph 7#a71 for the facility or responsible person that is the subject of such notice1 as appropriate1 to address the reasons for possible suspension of the registration of the facility or cosmetic ingredient statement4 7d7 ,reinstatement ,upon a determination by the ,secretary that adequate grounds do not exist to continue the suspension actions under subsection 7a7 or 7b71 the ,secretary shall promptly vacate the suspension and reinstate the registration of the facility or the cosmetic ingredient statement4 7e7 ,effect of suspension ,if the registration of a facility is suspended under this section1 no person shall import or export cosmetics or otherwise distribute cosmetic products or cosmetic formulations from such facility4 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 nonfunctional 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 nonfunctional constituents 7a7 ,ingredients and nonfunctional constituents subject ,to review 7#a7 ,in general ,not later than #c years after the date of the enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 the ,secretary shall review the safety of cosmetic ingredients or nonfunctional constituents 7or categories thereof74 ,upon the completion of such review1 the ,secretary shall issue an order under subsection 7d7 with respect to the use of each such ingredient 7or a category thereof7 and presence of each such nonfunctional constituent in cosmetic products or cosmetic formulations 7or a category thereof74 7#b7 ,ingredients and nonfunctional constituents to be reviewed ,the ,secretary shall select and complete a review1 on an ongoing basis1 of cosmetic ingredients or nonfunctional constituents that were not reviewed in the prior #c years4 ,such ingredients or nonfunctional constituents1 including any classes of ingredients or nonfunctional constituents1 should be selected after consultation with stakeholders1 including industry and consumer groups4 7#c7 ,process for review ,the ,secretary shall-- 7,a7 publish in the ,federal ,register a list of the ingredients1 nonfunctional constituents 7or categories thereof7 identified for review under paragraph 7#b72 and 7,b7 open a public docket to solicit public input and data relevant to the safety of the ingredients1 nonfunctional constituents 7or classes or categories thereof7 so listed for a period of not less than #fj days4 7#d7 ,public comment ,comments may be submitted to the ,secretary at any time with respect to the safety of cosmetic ingredients or nonfunctional constituents 7or categories thereof71 regardless of whether such ingredients or constituents 7or categories thereof7 have been selected for review under this subsection4 7b7 ,reviewed ingredients and nonfunctional constituents ,the ,secretary shall maintain a list1 posted on the internet website of the ,food and ,drug ,administration1 of each cosmetic ingredient1 nonfunctional constituent1 and category of ingredients or nonfunctional constituents for which final orders have been issued under subsection 7d77#c71 and with respect to each such ingredient or nonfunctional constituent-- 7#a7 the finding made for each such ingredient1 nonfunctional constituent1 or category under subsection 7d77#d71 as modified by any order under subsection 7e72 and 7#b7 if applicable1 compliance dates that are the subject of a final order under subsection 7d77#c74 7c7 ,initiative of the ,,fda ,the ,secretary may1 at any time1 propose the issuance of an order on the safety of a cosmetic ingredient or nonfunctional constituent 7or category thereof7 that was not previously listed pursuant to subsection 7a74 7d7 ,determination on safety 7#a7 ,proposed administrative order ,following consideration of data and comments to the public docket opened under subsection 7a77#c7 and any other information before the ,secretary with respect to the safety of a cosmetic ingredient or nonfunctional constituent 7or category thereof71 the ,secretary shall-- 7,a7 determine whether there is adequate evidence to make an initial finding for purposes of making a determination described in paragraph 7#d72 7,b7 if the ,secretary determines that there is adequate evidence to make such a finding1 issue a proposed administrative order containing the ,secretary's initial determination on the safety of such ingredient or nonfunctional constituent 7or category thereof7 as described in paragraph 7#d7 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 ,code2 and 7,c7 in the case of a proposed administrative order in which the ,secretary makes a determination described in subparagraph 7,b7 or 7,c7 of paragraph 7#d71 include in such order a compliance date4 7#b7 ,public comment ,the ,secretary shall open a public docket for the submission of public comments 7including comments on whether any proposed compliance date included in such order is feasible7-- 7,a7 in the case of a proposed administrative order under paragraph 7#a71 for a period of not less than #fj days1 beginning on the date of the issuance of the order2 or 7,b7 in the case of a final administrative order under paragraph 7#c71 for a period of not less than #fj days1 beginning on the date that is at least #fj days before the effective date of the order4 7#c7 ,final administrative order ,following the public comment period under paragraph 7#b7 and consideration of comments to the public docket under such paragraph and any other information before the ,secretary1 the ,secretary shall-- 7,a7 determine whether there is adequate evidence to make an initial finding for purposes of making a determination described in paragraph 7#d72 7,b7 if the ,secretary determines that there is adequate evidence to make such a final finding1 the ,secretary 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 ,code2 and 7,c7 in the case of a final administrative order in which the ,secretary makes the determination described in subparagraph 7,b7 or 7,c7 of paragraph 7#d71 include in such order a compliance date4 7#d7 ,determinations ,in a proposed administrative order issued under paragraph 7#a7 or a final administrative order issued under paragraph 7#c71 as applicable1 the ,secretary shall make a determination that the ingredient or nonfunctional constituent is-- 7,a7 safe in cosmetic products without the need for specified conditions of use or tolerances2 7,b7 safe in cosmetic products under 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;,b7 shall include such conditions on the use of an ingredient or such tolerances on the presence of a nonfunctional constituent 7or category thereof7 as are necessary for the safety of cosmetic products containing such ingredient or nonfunctional constituent 7or category thereof71 including-- 7,a7 limits on the amount or concentration of the ingredient or nonfunctional constituent 7or category thereof7 that may be present in a cosmetic product1 including limits in products intended for children1 pregnant women1 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 nonfunctional constituent 7or a category thereof72 and 7,c7 such other conditions as are necessary for the safety of cosmetic products containing such ingredient or nonfunctional constituent 7or category thereof74 7#f7 ,contents of order ,a final administrative order under this subsection shall-- 7,a7 set forth the determination of the ,secretary on safety2 7,b7 include a summary of the valid scientific evidence supporting the determination2 7,c7 include any conditions of use or tolerances under paragraph 7#d77;,b72 and 7,d7 be effective upon its publication on the internet website of the ,food and ,drug ,administration and shall be considered final agency action unless a later compliance date is otherwise specified4 7e7 ,modification of an order ,an order issued under subsection 7d7 may be modified or revoked by the ,secretary on the initiative of the ,secretary or in response to a petition4 7f7 ,inadequate evidence 7#a7 ,notice2 ,extension ,if the ,secretary determines that available data and information are not adequate to make a proposed or final determination under subsection 7d71 with respect to the safety of a cosmetic ingredient or nonfunctional constituent 7or a category thereof71 the ,secretary shall-- 7,a7 publish such determination on the internet website of the ,food and ,drug ,administration not later than #ahj days after the close of the relevant comment period for the ingredient or nonfunctional constituent 7or category thereof7 under paragraph 7#b7 or 7#c7 of subsection 7d71 as applicable2 and 7,b7 include in such publication a notice providing interested persons an additional #cj days from the date on which the notice is published to provide additional data and information and an opportunity for a meeting pursuant to paragraph 7#b74 7#b7 ,meetings ,the ,secretary may offer a responsible person of such cosmetic ingredient or nonfunctional constituent 7or category thereof7 a confidential meeting with respect to a finding under paragraph 7#a71 to discuss matters relating to the data and information requirements to support a determination of safety of such ingredient or nonfunctional constituent 7or category thereof71 which may involve confidential information4 ,such meeting should be convened in a reasonable time period agreed upon between the responsible person and the ,secretary4 7#c7 ,determination2 ,order 7,a7 ,inadequate data and information ,if the ,secretary determines that the available data and information are not adequate to make a proposed or final determination under subsection 7d7 with respect to the safety of a cosmetic ingredient or nonfunctional constituent 7or category thereof71 the ,secretary shall-- 7i7 publish such finding on the internet website of the ,food and ,drug ,administration not later than #ahj days after the close of the relevant comment period for the ingredient or nonfunctional constituent 7or category thereof7 under paragraph 7#b7 or 7#c7 of subsection 7d71 as applicable2 and 7ii7 include in such publication a notice providing interested persons an additional #cj days from the date on which the notice is published to provide additional data and information and an opportunity for a meeting pursuant to paragraph 7#b74 7,b7 ,adequate data and information ,if the ,secretary determines1 after considering any additional data and information submitted pursuant to paragraph 7#a77;,b71 that the available data and information are adequate to make a determination with respect to the safety of a cosmetic ingredient or nonfunctional constituent 7or category thereof71 the ,secretary shall-- 7i7 in the case of a determination described in subparagraph 7,a7 of subsection 7d77#d71 within #ahj days of the close of the applicable comment period under subsection 7d77#b71 issue a final administrative order1 with respect to such cosmetic ingredient or nonfunctional constituent 7or category thereof71 in accordance with subsection 7d77#c72 7ii7 in the case of a determination described in subparagraph 7,b7 of subsection 7d77#d71 within #ahj days of the close of the applicable comment period under subsection 7d77#b71 issue a proposed administrative order1 followed by a final administrative order1 with respect to such cosmetic ingredient or nonfunctional constituent 7or category thereof71 in accordance with subsection 7d77#c72 and 7iii7 in the case of a determination described in subparagraph 7,c7 of subsection 7d77#d71 within #ahj days of the close of the applicable comment period under subsection 7d77#b71 issue a final administrative order1 with respect to such cosmetic ingredient or nonfunctional constituent 7or category thereof71 in accordance with subsection 7d77#c7 specifying the date by which sale of such ingredient or nonfunctional constituent must cease4 7g7 ,safety assessment standards 7#a7 ,in general ,in assessing the safety of an ingredient or nonfunctional constituent 7or category thereof7 under this section1 the ,secretary shall consider-- 7,a7 whether there is adequate evidence to support a reasonable certainty among competent scientists that-- 7i7 in the case of a cosmetic ingredient1 the ingredient is not harmful under the recommended or suggested conditions of use or customary or usual use2 or 7ii7 in the case of a nonfunctional constituent1 that the nonfunctional constituent is not harmful under the recommended or suggested tolerance levels or the level at which it is customarily or usually present2 7,b7 the probable human exposure to the ingredient or nonfunctional constituent 7or category thereof7 from expected use in cosmetic products and cosmetic formulations2 7,c7 the probable cumulative and aggregate effect in humans of relevant exposure to the ingredient or nonfunctional constituent 7or category thereof7 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 are available for analysis1 and if appropriate1 available information on the total exposure to a cosmetic ingredient or nonfunctional constituent from all sources2 and 7,d7 whether warnings or recommendations in a cosmetic product label1 as part of any conditions of use or tolerances imposed by the ,secretary in a determination described in subparagraph 7,b7 of subsection 7d77#d71 would be necessary and appropriate to help ensure the safety of the ingredient or nonfunctional constituent 7or category thereof74 7#b7 ,minor adverse reactions ,the ,secretary may not consider a cosmetic ingredient or nonfunctional constituent 7or category thereof7 harmful under paragraph 7#a7 solely because it can cause minor adverse health reactions1 such as minor transient allergic reactions or minor transient skin irritations1 in some users4 7#c7 ,data and information 7,a7 ,required information ,a determination that a cosmetic ingredient or nonfunctional constituent 7or category thereof7 is safe in cosmetics under this section shall be based upon adequate evidence submitted or otherwise known to the ,secretary1 which shall include full reports of all available studies1 published or unpublished1 that are adequately designed to show whether the ingredient or nonfunctional 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 ,secretary shall consider any other relevant information related to the safety of a cosmetic ingredient or nonfunctional constituent 7or category thereof71 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 nonfunctional constituent 7or category thereof7 is lawfully used or present in other products regulated by the ,secretary1 the scientific basis for such use2 and 7iv7 experience with the ingredient or nonfunctional constituent 7or category thereof7 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 nonfunctional constituent over time4 7h7 ,coal tar hair dye ,in assessing for purposes of this section the safety of coal tar hair dye or any ingredient or nonfunctional constituent therein1 the ,secretary shall not make a determination that the dye1 ingredient1 or nonfunctional constituent is not safe for use in cosmetic products solely because the dye1 ingredient1 or nonfunctional constituent can cause allergic reactions4 #fji4 ,safety of finished cosmetic products 7a7 ,determination 7#a7 ,in general ,each responsible person for a finished cosmetic product shall1 before first distributing the product for sale1 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-- 7,a7 each ingredient in the finished product is safe for the use recommended or suggested in the labeling of the product and for the customary or usual use of the product2 and 7,b7 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 7b7 ,presumption of adequate evidence 7#a7 ,in general ,except as provided in subsection 7c71 a determination made under subsection 7a7 with respect to a finished cosmetic product shall be presumed to be based on adequate evidence if it is supported by-- 7,a7 with respect to each ingredient in the finished cosmetic 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 labeling or under such conditions of use as are customary or usual2 or 7ii7 appropriate safety testing of the ingredient2 and 7,b7 appropriate safety substantiation of the finished cosmetic 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 applying paragraph 7#a77;,a77i71 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 ,secretary2 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 ,secretary issues an order under section #fjh that an ingredient or nonfunctional constituent in the finished product is not safe under the product's conditions of use or customary or usual use2 or 7#b7 the ,secretary has provided the manufacturer with notice that-- 7,a7 the manufacturer has not met the criteria under subsection 7b72 or 7,b7 the ,secretary 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 ,secretary regarding the safety of an ingredient1 nonfunctional constituent1 or the entire cosmetic product1 and the ,secretary 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 it is based until #e 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 ,secretary to the responsible person1 be provided to the ,secretary within a reasonable timeframe not to exceed #cj days1 in electronic form4 7#b7 ,criteria ,the ,secretary may require records under paragraph 7#a7 if-- 7,a7 the ,secretary 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 determination required under subsection 7a7 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 ,secretary1 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 ,secretary concludes that submission of the records will serve the public health or otherwise enable the ,secretary to fulfill the cosmetic safety purposes of this section4 7g7 ,guidance and regulations 7#a7 ,in general ,the ,secretary 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 ,secretary determines that such exemptions are supported by adequate evidence and would have no adverse effect on public health4 7#b7 ,small businesses ,the ,secretary 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 section4 ,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 7c7 ,public meeting and guidance 7#a7 ,public meeting ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall convene a public meeting to describe and solicit public input regarding the ingredient review process under section #fjh of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a774 ,such meeting shall include representatives from the cosmetics industry1 medical practitioners and scientific experts with cosmetic expertise1 and consumer and public health advocacy organizations4 7#b7 ,guidance ,not less than one year after the public meeting conducted under paragraph 7#a71 the ,secretary shall issue one or more guidance documents to implement section #fjh of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a774 ,such guidance documents shall include information regarding-- 7,a7 the types of scientific evidence1 clinical studies1 data1 or other information needed to support the review of cosmetic ingredients or nonfunctional constituents 7or categories thereof7 selected for review under such section2 7,b7 the recommended format in which to submit to the ,secretary such data and information1 including any applicable foreign data and information1 related to a cosmetic ingredient or nonfunctional constituent 7or category thereof7 that has been selected for such review2 7,c7 the manner and the number of days by which the ,secretary intends to review and respond to such data and information1 including with respect to providing a scientific rationale for any additional data and information2 7,d7 the process for communication between the ,secretary and industry related to an ingredient or nonfunctional constituent 7or a category thereof7 that has been selected for review2 and 7,e7 includes such other information as the ,secretary determines appropriate4 7#c7 ,timing ,not later than #bd months after the date of the enactment of this ,act1 the ,secretary shall issue draft guidance under paragraph 7#a7 on the implementation of section #fjh of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a774 ,the ,secretary shall issue final guidance on the implementation of such section not later than #f months after the date on which the comment period for the draft guidance closes4 7d7 ,,gao study ,not later than #f years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report addressing the effectiveness and overall impact of the ingredient review program established under section #fjh of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a771 including with respect to its impact on the safety of cosmetic ingredients-- 7#a7 for each ingredient or nonfunctional constituent 7or category thereof7 selected for review-- 7,a7 whether the ingredient or nonfunctional constituent 7or category thereof7 was determined-- 7i7 to be safe in cosmetic products without the need for specified conditions of use or tolerances2 7ii7 to be safe in cosmetic products under specified conditions of use of tolerances2 or 7iii7 to be not safe in cosmetic products2 7,b7 the timeline for such review2 7,c7 the types of scientific evidence1 clinical studies1 data1 or other information used to make such a determination2 7,d7 whether1 and to what extent1 the review of the ingredient or nonfunctional constituent 7or category thereof7 resulted in cosmetic products being reformulated or removed from the market2 and 7,e7 the impact the review and determination had on consumer use and access to such product2 and 7#b7 an analysis of the ingredient1 nonfunctional constituent 7or category thereof7 review conducted under such section #fjh1 including-- 7,a7 the resources used by the ,secretary in reviewing ingredients and nonfunctional constituents 7or categories thereof71 including the effects of the program on other cosmetic safety activities of the ,secretary2 7,b7 the impact of such section on innovation and consumer access to cosmetic products2 and 7,c7 whether any improvements to the program under such section #fjh are necessary for increasing the efficiency and effectiveness of the review of cosmetic ingredients1 nonfunctional constituents1 or categories thereof4 #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 ,secretary shall-- 7#a7 review national and international standards for cosmetic good manufacturing practices that are in effect on the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai2 and 7#b7 issue a rule establishing current good manufacturing standards consistent1 to the extent the ,secretary determines practicable and appropriate1 with such national and international standards4 7b7 ,content of regulations ,the regulations issued pursuant to subsection 7a77#b7-- 7#a7 may specify requirements for the use of certain analytical or recordkeeping methods by a manufacturer as may be necessary to ensure that a cosmetic product or cosmetic formulation is not injurious to health under the recommended or suggested conditions of use1 or customary or usual use of the product or formulation2 and 7#b7 shall not-- 7,a7 impose standards for which there is no current and generally available analytic method2 or 7,b7 apply to facilities meeting the criteria to be considered a facility under section #fjd7f71 including retail stores or counters offering customized or personalized cosmetics to consumers1 or to entities that are in compliance with the good manufacturing practice regulations specified in parts #baj and #baa of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7c7 ,timeframe ,the ,secretary shall publish a proposed rule described in subsection 7a7 not later than #bd months after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai and shall publish a final such rule not later than #cf months after such date of enactment4 4 7b7 ,effective date for cosmetic manufacturers ,regulations issued pursuant to section #faj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77 shall apply with respect to-- 7#a7 large manufacturers 7as defined in section #gdd,l of such ,act 7as added by section #bjb of this ,act771 beginning #ahj days after the date on which the final rule described in subsection 7a7 is effective2 7#b7 midsize manufacturers 7as defined in section #gdd,l of such ,act 7as added by section #bjb of this ,act771 beginning #baj days after such date2 and 7#c7 small manufacturers 7as defined in section #gdd,l of such ,act 7as added by section #bjb of this ,act771 beginning #b years after such date4 7c7 ,enforcement ,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 ,secretary4 4 #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 ,submission of serious adverse event reports 7#a7 ,in general ,with respect to any cosmetic product distributed in the ,united ,states1 the responsible person shall submit1 not later than #ae days after the receipt by the responsible person1 using an electronic system developed under subsection 7b71 to the ,secretary any report of a serious adverse event associated with the use of the cosmetic product1 accompanied by a copy of the label on or with the retail packaging of the cosmetic product4 7#b7 ,new medical information ,during the #ab-month period following the submission of a serious adverse event report under paragraph 7#a71 with respect to any cosmetic product distributed in the ,united ,states1 the responsible person shall submit1 not later than #ae days after the receipt by the responsible person1 using an electronic system developed under subsection 7b71 to the ,secretary any new medical information related to such serious adverse event report that is received by the responsible person4 7#c7 ,publication ,the ,secretary shall make publicly available on the internet website of the ,food and ,drug ,administration reports submitted under paragraph 7#a74 7#d7 ,no duplication ,in the case of cosmetic product that is also a drug for which a serious adverse event report 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 be required to submit a serious adverse event report under paragraph 7#a7 with respect to that cosmetic product4 7b7 ,requirements for serious adverse event reports 7#a7 ,electronic system 7,a7 ,in general ,the ,secretary shall1 not later than #a year after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 develop and implement an electronic system for use for the submission of serious adverse event reports under this section4 7,b7 ,modification ,the format of the electronic system developed and implemented under paragraph 7#a7 may be modified by the ,secretary and the reports may include additional information4 ,the ,secretary may1 in guidance1 further specify the format and contents of required reports4 7#b7 ,content of reports ,a serious adverse event report submitted under paragraph 7#a7 of subsection 7a7 shall include all information submitted with the initial report and any information subsequently added to such report pursuant to paragraph 7#b7 of such subsection and-- 7,a7 any report by the responsible person under section #gef with respect to the safety of the cosmetic product that is the subject of the report2 7,b7 information on the individual or individuals with respect to whom the adverse event report is submitted1 in accordance with the disclosure requirements of section #eeb;a of title #e1 ,united ,states ,code2 7,c7 notwithstanding section #eeb7;b77#f7 of title #e1 ,united ,states ,code1 medical 7or similar7 documentation of the serious adverse event that is the subject of the report1 with all personally identifiable information redacted2 and 7,d7 contact information for the individual or individuals reporting the serious adverse event4 7#c7 ,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 reasonably available to such person to complete and file the report with the ,secretary under subsection 7a77#a74 7#d7 ,no adverse events to report ,the ,secretary 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 7#e7 ,exemption ,the ,secretary may establish by regulation an exemption to any of the requirements under this section if the ,secretary determines that such exemption is supported by adequate evidence and would have no adverse effect on public health4 7c7 ,requirements for other adverse event reports 7#a7 ,in general ,each responsible person shall maintain records related to each report of an adverse event 7including serious adverse events7 associated with each cosmetic product marketed by such responsible person and received by such responsible person for a period of #f years4 ,such records shall be made available to an officer or an employee duly designated by the ,secretary upon request1 at reasonable times and within reasonable limits and in a reasonable manner1 including allowing electronic access and to copy such records4 7#b7 ,content ,records required to be maintained under this paragraph shall contain all information reasonably available1 including-- 7,a7 a summary of all adverse events received during the calendar year for each cosmetic product marketed2 7,b7 a complete list of individual reports of adverse events for each cosmetic product marketed and with respect to each such event1 the same information required to be included in a report with respect to a serious adverse event under subsection 7b77#b71 subject to the same conditions with respect to the disclosure of such information2 7,c7 an estimate of the total number of product units estimated to have been distributed to consumers during the period specified in paragraph 7#a72 and 7,d7 such other information as may be specified in regulation or guidance issued by the ,secretary4 7#c7 ,rule of construction ,this section shall not be construed to require the inclusion in any report under this section any consumer complaint that concerns solely efficacy and does not contain any information about an adverse event4 7d7 ,limitation with respect to adverse event reports ,section #gef shall apply with respect to the submission of an adverse event report in compliance with subsection 7a74 7e7 ,contact information ,the label of a cosmetic product shall bear the domestic address1 and either the domestic telephone number or electronic contact information1 through which the responsible person may receive a report of an adverse event4 7f7 ,availability to ,states ,the ,secretary shall make records submitted under this section available to any ,state1 upon request1 to the extent permissible under the laws governing disclosure of information by the ,secretary4 ,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 ,such ,state and its employees in possession of such information shall be subject to the same laws governing information disclosure as employees of the ,food and ,drug ,administration4 7g7 ,protection of information ,a serious adverse event report submitted to the ,secretary under subsection 7a71 including any new medical information submitted under paragraph 7#b7 of such subsection1 or an adverse event report voluntarily submitted to the ,secretary1 shall be considered to be a safety report under section #gef and may be accompanied by a statement1 which shall be a part of any report that is released for public disclosure1 that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event4 7h7 ,effective dates 7#a7 ,serious adverse events ,the requirement under this section to report serious adverse events shall become effective on the date that the ,secretary publicizes the availability of the electronic system described in subsection 7b77#a74 7#b7 ,other adverse events ,the requirement under this section to maintain records relating to adverse events which are not serious adverse events shall become effective #ah months after the date of the enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai4 7i7 ,definitions ,in this section3 7#a7 ,adverse event ,the term adverse event means1 with respect to a cosmetic product1 a health-related or medical event associated with the use of such product1 including a risk of illness or injury4 ,such term does not include any instance of a consumer complaint that such product did not work as advertised or marketed4 7#b7 ,serious adverse event ,the term serious adverse event means1 with respect to a cosmetic product1 an adverse event that-- 7,a7 results in-- 7i7 death2 7ii7 a life-threatening experience2 7iii7 inpatient hospitalization2 7iv7 a persistent or significant adverse health condition1 disability1 or incapacity2 7v7 congenital anomaly or birth defect2 or 7vi7 significant disfigurement1 including serious or persistent rashes and infections1 burns1 or significant hair loss2 or 7,b7 requires1 based on reasonable medical judgment1 a medical or surgical intervention to prevent an outcome described in subparagraph 7,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 facility1 including a facility owned or operated by a responsible person for a cosmetic product shall1 at the request of an officer or employee duly designated by the ,secretary1 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 copy1 or receive electronically records maintained by or on behalf of such person in any format 7including paper and electronic formats7 and at any location1 including-- 7#a7 all records maintained under section #faa and in accordance with the rules promulgated by the ,secretary under section #faj1 as applicable2 7#b7 all records maintained under section #fji2 7#c7 any records relating to the list of ingredients in specific fragrances or flavors of a cosmetic product or cosmetic formulation1 if requested by the ,secretary by means of a written notification2 and 7#d7 except as provided in subsection 7b71 all other records relating to the cosmetic product or cosmetic formulation and to any other cosmetic product or cosmetic formulation the ,secretary reasonably believes is likely to be affected in a similar manner1 if the ,secretary-- 7,a7 has a reasonable belief that the cosmetic product or cosmetic formulation-- 7i7 is adulterated2 7ii7 has caused a reportable serious adverse event2 or 7iii7 contains an ingredient for which new scientific information shows may be unsafe when present in a cosmetic product or cosmetic formulation2 and 7,b7 provides written notice to the responsible person of the basis for the ,secretary's reasonable belief described in subparagraph 7,a71 as applicable4 7b7 ,exclusions 7#a7 ,in general ,no inspection authorized by this section shall extend to-- 7,a7 recipes1 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 data7 or sales data other than shipment and distribution data2 or 7,b7 except as provided in paragraph 7#b71 information related to ingredients in fragrances or flavors of a cosmetic product or cosmetic formulation4 7#b7 ,exception ,the ,secretary may obtain information related to the ingredients in fragrances or flavors in an identified cosmetic product or cosmetic formulation only by a request in a written notification provided to the manufacturer pursuant to a for-cause inspection4 ,in response to such written notification1 the manufacturer of such fragrance or flavor shall provide information about the ingredients in the specified fragrance or flavor that the ,secretary determines is necessary to assist its investigation1 in the manufacturer's preferred electronic or written format1 to the ,secretary upon receipt of such notification4 ,any information provided in response to such written notification shall be considered a trade secret under section #cja7;j7 and1 notwithstanding such section1 shall only be disclosed if the ,secretary determines such disclosure is necessary to protect the public health4 ,the authority to determine such disclosure is necessary to protect the public health shall not be delegated to any officer or employee other than the director of the applicable office4 7c7 ,protection of sensitive information ,the ,secretary 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 ,secretary pursuant to this section4 ,information disclosed to a ,state shall be pursuant to the laws governing disclosure of information4 ,confidential information disclosed to the ,state that is exempt from disclosure under section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 shall be treated as confidential information by the ,state4 ,such ,state and its employees in possession of such information under this section shall be subject to the same laws governing information disclosure as employees of the ,food and ,drug ,administration4 7d7 ,limitations ,this section shall not be construed-- 7#a7 to limit the authority of the ,secretary to inspect records or to require establishment and maintenance of records under any other provision of this ,act2 or 7#b7 to require the ,secretary to publicly disclose any information that is exempt from disclosure under section #ebb of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #fac4 ,mandatory recall authority 7a7 ,voluntary procedures ,if the ,secretary determines that there is a reasonable probability that a cosmetic product is adulterated under section #fja or misbranded under section #fjb and the use of1 and exposure to1 such cosmetic product is likely to cause serious adverse health consequences or death1 the ,secretary 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 domestic responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic product within the time and in the manner prescribed by the ,secretary1 the ,secretary may order such person to-- 7,a7 immediately cease distribution of such cosmetic product2 and 7,b7 as applicable1 immediately order all facilities-- 7i7 manufacturing1 processing1 packing1 transporting1 holding1 receiving1 distributing1 or importing and selling such cosmetic product2 and 7ii7 to which such cosmetic product has been distributed1 transported1 or sold1 to immediately cease distribution of such cosmetic product4 7#b7 ,required additional information 7,a7 ,in general ,in the case of a cosmetic product that is subject to a recall order issued under paragraph 7#a77;,b7 with respect to which the responsible person1 before the issuance of such order1 distributed to a warehouse-based1 third-party logistics provider without providing such logistics provider with sufficient information to know or reasonably determine the precise identity of such cosmetic product1 the notice provided by the domestic responsible person pursuant to such order shall include such information as is necessary for the logistics provider to identify the cosmetic product4 7,b7 ,rules of construction ,nothing in this paragraph shall be construed to exempt a warehouse-based1 third-party logistics provider from-- 7i7 the requirements of this chapter1 including the requirements of this section and section #fab2 or 7ii7 being the subject of a mandatory recall order under this section4 7#c7 ,determination to limit areas affected ,if the ,secretary requires a domestic responsible person to cease distribution under paragraph 7#a77;,a7 of a cosmetic product1 the ,secretary 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 ,secretary shall provide the responsible person 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 product that is the subject of the order should not be recalled4 7d7 ,posthearing recall order and modification of order 7#a7 ,amendment of order ,if1 after providing opportunity for an informal hearing under subsection 7c71 the ,secretary determines that removal of the cosmetic product from commerce is necessary1 the ,secretary shall1 as appropriate-- 7,a7 amend the order to require recall of such cosmetic product or other appropriate action2 7,b7 specify a timetable in which the recall shall occur2 7,c7 require periodic reports to the ,secretary describing the progress of the recall2 and 7,d7 provide notice to consumers to whom such cosmetic product was1 or may have been1 distributed4 7#b7 ,vacating of order ,if1 after such hearing1 the ,secretary determines that adequate grounds do not exist to continue the actions required by the order1 or that such actions should be modified1 the ,secretary shall vacate the order or modify the order4 7e7 ,cooperation and consultation ,the ,secretary 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 ,secretary 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 product was1 or may have been1 distributed2 and 7,b7 that includes1 at a minimum-- 7i7 the name of the cosmetic product subject to the recall2 7ii7 a description of the risk associated with the use of such cosmetic product2 and 7iii7 to the extent practicable1 information for consumers about similar cosmetic products that are not affected by the recall2 and 7#b7 ensure publication on the internet website of the ,food and ,drug ,administration of an image of the cosmetic product 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 ,commissioner of ,food and ,drugs4 7h7 ,rule of construction ,nothing in this section shall affect the authority of the ,secretary to request or participate in a voluntary recall1 or to issue an order to cease distribution or to recall any article under any other provision of this ,act or under the ,public ,health ,service ,act4 7i7 ,definition ,in this section1 the term domestic responsible person means a person who is the domestic contact for a responsible person4 4 #ajf4 ,labeling and internet sales 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 and internet sales 7a7 ,safety review and labeling ,if a warning or condition of use is required pursuant to section #fjh7;d77#d7 to ensure the safe use of a cosmetic ingredient1 the ,secretary shall require appropriate labeling of any cosmetic product that contains such ingredient1 including if such ingredient-- 7#a7 is not appropriate for use in the entire population2 or 7#b7 requires warnings that children1 pregnant women1 and other vulnerable populations should limit or avoid using the product4 7b7 ,cosmetic products for professional use 7#a7 ,listing of ingredients ,the labeling of cosmetic products used and sold by professionals shall list all ingredients1 as required for other cosmetic products pursuant to section #fjb7;g74 7#b7 ,professional use labeling ,in the case of a cosmetic product that is intended to be used only by a professional on account of a specific ingredient or increased concentration of an ingredient and requires safe handling by trained professionals1 the product shall bear a statement as follows3 ,for ,professional ,use ,only4 7c7 ,display ,a warning required under subsection 7a7 and any statement required under subsection 7b77#b7 shall be prominently displayed-- 7#a7 in the primary language used on the label or on packaging2 and 7#b7 in conspicuous and legible type in contrast by typography1 layout1 or color with other material printed or displayed on the label4 7d7 ,internet sales 7#a7 ,in general ,in the case of internet sales of cosmetic products1 each primary seller offering a cosmetic product for sale to consumers on an internet website shall prominently and conspicuously display on such internet website-- 7,a7 the same information that is included on the packaging of the cosmetic product as regularly available1 such as any warnings1 ingredient list1 and contact information2 and 7,b7 the warnings and statements described in subsection 7c74 7#b7 ,definition ,for purposes of this subsection1 the term primary seller refers to the entity who offers a cosmetic product for sale on an internet website1 including the responsible person4 #fae4 ,fragrance ingredients 7a7 ,fragrance ingredients ,not later than #b years after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 the responsible person shall include on the label of any cosmetic products containing one or more fragrance allergens1 a list of each such fragrance allergen included in such cosmetic product that is consistent with national and international regulations for fragrance allergens labeling4 7b7 ,contact information 7#a7 ,in general ,the contact information on the label on a cosmetic product for consumers to report adverse events shall also provide a means for consumers to obtain additional information about the inclusion of any recognized fragrance allergen required to be included on such label under subsection 7a74 7#b7 ,response 7,a7 ,in general ,the responsible person shall-- 7i7 upon receipt of a request for information under paragraph 7#a71 promptly obtain and provide such information to the requesting consumer2 and 7ii7 in the case of information in the possession of a supplier1 promptly obtain such information from such supplier1 if reasonably available4 7,b7 ,supplier ,a supplier shall promptly provide information requested pursuant to subparagraph 7,a77ii74 4 7b7 ,ingredient statement ,section #fjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is amended by adding at the end the following3 7g7 ,if its labeling or packaging does not contain a listing of ingredients that meets the requirements of part #gja of title #ba1 ,code of ,federal ,regulations 7as in effect on date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai7 7or any successor regulations74 4 7c7 ,effective date ,the amendments made by this section shall apply with respect to products introduced or delivered for introduction into interstate commerce on or after the date that is #b years after the date of enactment of this ,act4 #ajg4 ,consumer information ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall post on its internet website information for consumers regarding-- 7#a7 final orders regarding the safety of a cosmetic ingredient or nonfunctional constituent under section #fjh7;d77#c72 7#b7 cosmetic product recalls 7including voluntary and mandatory recalls72 and 7#c7 identified counterfeit cosmetic products4 #ajh4 ,small businesses ,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 #faf4 ,small businesses 7a7 ,in general ,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 ,cosmetic ,safety ,enhancement ,act of #bjai1 including the amendments made by such ,act4 7b7 ,compliance guide ,not later than #ahj days after the date of the enactment of ,cosmetic ,safety ,enhancement ,act of #bjai1 the ,secretary shall issue a small business guide setting forth in plain language the requirements of sections #fje and #fjf in order to assist small businesses in complying with such requirements4 4 #aji4 ,animal testing restrictions 7a7 ,in general ,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 cosmetic product1 cosmetic formulation1 or cosmetic ingredient was developed or manufactured using an animal test that was conducted or contracted by the manufacturer1 or any affiliate or supplier of the manufacturer1 unless one of the following applies3 7#a7 ,with respect to a cosmetic ingredient of the cosmetic product or cosmetic formulation1 an animal test is required by the ,secretary to evaluate the safety of such ingredient or formulation4 7#b7 ,with respect to a cosmetic ingredient of the cosmetic product or cosmetic formulation1 the cosmetic ingredient or cosmetic formulation is in wide use and cannot be replaced by another ingredient that is capable of performing a similar function without posing a potentially greater risk to human health and there is not an alternative method for testing the cosmetic ingredient that is accepted by the ,secretary and the ,interagency ,coordinating ,committee on ,validation of ,alternative ,methods4 7#c7 ,the animal test was conducted to comply with a requirement of another ,federal agency or a ,state or foreign regulatory authority4 7#d7 ,in the case of a cosmetic product1 cosmetic formulation1 or cosmetic ingredient that is also a drug1 the animal test was conducted with respect to the approval under chapter ,v of the application submitted with respect to such product1 formulation1 or ingredient4 7#e7 ,the animal test was conducted for purposes not related to developing or manufacturing the cosmetic product1 cosmetic formulation1 or cosmetic ingredient1 and in response to a requirement of a ,federal1 ,state1 or foreign regulatory authority4 4 7b7 ,applicability ,the amendment made by subsection 7a7 shall apply with respect to cosmetic products or cosmetic formulations introduced or delivered for introduction into interstate commerce on or after the date that is two years after the date of enactment of this ,act4 7c7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall issue guidance on the acceptability of scientifically reliable and relevant alternatives to animal testing for the safety of cosmetic products1 cosmetic formulations1 and cosmetic ingredients1 and encouraging the use of such methods4 7d7 ,resources regarding animal testing alternatives ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall publish 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 products1 cosmetic formulations1 and cosmetic ingredients4 7e7 ,rules of construction 7#a7 ,use of evidence ,nothing in this section1 or the amendment made by this section1 shall be construed to prohibit any entity from reviewing1 assessing1 or retaining evidence generated from animal testing4 7#b7 ,acceptance of data by ,secretary ,nothing in this section1 or the amendment made by this section1 shall be construed to prohibit the ,secretary from accepting data from animal testing conducted-- 7,a7 prior to the date specified in subsection 7b72 or 7,b7 on or after such date-- 7i7 in the case of a cosmetic product1 cosmetic formulation1 or cosmetic ingredient that is also a drug1 with respect to the approval under chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 of the application submitted with respect to such product1 formulation1 or ingredient2 or 7ii7 pursuant to requirements of a ,federal1 ,state1 or foreign regulatory authority4 #aaj4 ,counterfeit cosmetics 7a7 ,counterfeit cosmetics defined ,section #bja7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;i77 is amended-- 7#a7 by striking 7i7 ,the term inserting 7i77#a7 ,the term2 7#b7 by striking 7#a7 articles intended to be and inserting 7,a7 articles intended to be2 7#c7 by striking 7#b7 articles intended for use and inserting 7,b7 articles intended for use2 and 7#d7 by adding at the end the following3 7#b7 ,the term counterfeit cosmetic means a cosmetic which1 or the container or labeling of which1 without authorization-- 7,a7 bears the trademark1 trade name1 or other identifying mark1 imprint1 or device1 or any likeness thereof1 of a cosmetic manufacturer1 processor1 packer1 or distributor other than the person or persons who in fact manufactured1 processed1 packed1 or distributed such cosmetic2 and 7,b7 thereby falsely purports or is represented to be the product of1 or to have been packed or distributed by1 such other cosmetic manufacturer1 processor1 packer1 or distributor4 4 7b7 ,prohibited act ,section #cja7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;i77 is amended-- 7#a7 in subparagraph 7#b7-- 7,a7 by inserting digital printer1 after stone12 7,b7 by inserting cosmetic after drug or2 and 7,c7 by inserting before the period at the end the following3 or such cosmetic a counterfeit cosmetic2 and 7#b7 in subparagraph 7#c7-- 7,a7 by inserting or a cosmetic to be a counterfeit cosmetic after to be a counterfeit drug2 and 7,b7 by inserting or counterfeit cosmetic before the period at the end4 7c7 ,penalties ,section #cjc7;c77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;c77#e77 is amended-- 7#a7 by inserting digital printer after stone12 7#b7 by inserting or a cosmetic being a counterfeit cosmetic after drug being a counterfeit drug2 and 7#c7 by inserting before the period at the end the following3 or the cosmetic was a counterfeit cosmetic4 7d7 ,seizure ,section #cjd7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;a77#b77 is amended-- 7#a7 by striking 7,b7 ,any container and all that follows through 7,d7 ,any adulterated and inserting 7,b7 ,any cosmetic that is a counterfeit cosmetic1 7,c7 ,any container of a counterfeit drug or counterfeit cosmetic1 7,d7 ,any punch1 die1 plate1 stone1 labeling1 container1 digital printer1 or other thing used or designed for use in making a counterfeit drug or drugs or a counterfeit cosmetic or cosmetics1 7,e7 ,any adulterated2 and 7#b7 by striking 7,e7 and inserting 7,f7 before ,any adulterated or misbranded tobacco product4 7e7 ,examinations and investigations ,section #gjb7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgb7;e77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by inserting or counterfeit cosmetics after counterfeit drugs2 7#b7 in paragraph 7#d71 by inserting or cosmetics after such drugs2 and 7#c7 in paragraph 7#e7-- 7,a7 by striking drugs or containers and inserting drugs1 cosmetics1 or containers2 and 7,b7 by inserting digital printers1 after labeling14 #aaa4 ,foreign supplier verification 7a7 ,in general ,chapter ,,viii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha et seq47 is amended by adding at the end the following3 #haj4 ,cosmetics foreign supplier verification program 7a7 ,in general 7#a7 ,verification requirement ,except as provided under subsection 7e71 each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the cosmetic product or cosmetic ingredient imported by the importer 7or agent thereof7-- 7,a7 has been manufactured according to the cosmetic product good manufacturing practices established under section #faj2 and 7,b7 is not adulterated under section #fja or misbranded under section #fjb4 7#b7 ,importer defined ,for purposes of this section1 the term importer means1 with respect to a cosmetic product or cosmetic ingredient-- 7,a7 the ,united ,states owner or consignee of the cosmetic product or cosmetic ingredient at the time of entry of such cosmetic product or cosmetic ingredient into the ,united ,states2 or 7,b7 in the case when there is no ,united ,states owner or consignee as described in subparagraph 7,a71 the ,united ,states agent or representative of a foreign owner or consignee of the cosmetic product or cosmetic ingredient at the time of entry of such article into the ,united ,states4 7b7 ,guidance ,not later than #a year after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 the ,secretary shall issue guidance to assist importers in developing foreign supplier verification programs4 7c7 ,regulations 7#a7 ,in general ,not later than #a year after the date of enactment of ,cosmetic ,safety ,enhancement ,act of #bjai1 the ,secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection 7a74 7#b7 ,requirements ,the regulations promulgated under paragraph 7#a7-- 7,a7 shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported cosmetic product or cosmetic ingredient in compliance with-- 7i7 with cosmetic good manufacturing practices established under section #faj2 and 7ii7 sections #fja and #fjb2 and 7,b7 shall include such other requirements as the ,secretary deems necessary and appropriate to verify that cosmetic products and cosmetic ingredients imported into the ,united ,states are as safe as cosmetic products and cosmetic ingredients produced and sold within the ,united ,states4 7#c7 ,considerations ,in promulgating regulations under this subsection1 the ,secretary shall1 as appropriate1 take into account differences among importers and types of imported cosmetic products and cosmetic ingredients1 including based on the level of risk posed by the imported cosmetic product or cosmetic ingredient4 7#d7 ,activities ,verification activities under a foreign supplier verification program under this section may include monitoring records for shipments1 lot-by-lot certification of compliance1 annual on-site inspections1 compliance with cosmetic good manufacturing practices and other safety processes1 and periodically testing and sampling shipments4 7d7 ,record maintenance and access ,records of an importer related to a foreign supplier verification program shall-- 7#a7 be maintained for a period of not less than #b years2 and 7#b7 be made available promptly to a duly authorized representative of the ,secretary upon request4 7e7 ,exemptions ,the ,secretary1 by notice published in the ,federal ,register1 shall establish an exemption from the requirements of this section for cosmetic products or cosmetic ingredients imported in small quantities for research and evaluation purposes or for personal consumption1 provided that such cosmetic products or cosmetic ingredients are not intended for retail sale and are not sold or distributed to the public4 7f7 ,publication of list of participants ,the ,secretary shall publish and maintain on the internet website of the ,food and ,drug ,administration a current list that includes the name of1 location of1 and other information deemed necessary by the ,secretary about1 importers participating under this section4 4 7b7 ,prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by section #aac1 is further amended by adding at the end the following3 7ggg7 ,the importation or offering for importation of a cosmetic product or cosmetic ingredient if the importer 7as defined in section #haj7 does not have in place a foreign supplier verification program in compliance with such section #haj4 4 7c7 ,imports ,section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended by striking or the importer 7as defined in section #hje7 is in violation of such section #hje and inserting 1 or being imported or offered for import into the ,united ,states by an importer 7as defined in section #hje or #haj1 as applicable7 that is in violation of section #hje or #haj1 respectively4 7d7 ,effective date ,the amendments made by this section shall take effect #b years after the date of enactment of this ,act4 #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 #ajh1 is further amended by adding at the end the following3 #fag4 ,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 4 #aac4 ,saving clause ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #aab1 is further amended by adding the following3 #faf4 ,savings clause ,nothing in the amendments to this ,act made by the ,cosmetic ,safety ,enhancement ,act of #bjai1 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 #aad4 ,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 paragraph 7e7-- 7,a7 by striking #ejd1 #efd1 and inserting #ejd1 #efd1 #faa1 #fab2 and 7,b7 by striking #eai1 #efd1 and inserting #eai1 #efd1 #fji1 #faa12 7#b7 in paragraph 7j7 by inserting #fjg1 #fjh1 #faj1 #faa before #gjd2 7#c7 in paragraph 7ii7-- 7,a7 by striking #gfj or #gfa7 and inserting #fjd1 #gfj1 or #gfa72 and 7,b7 by striking #gfj or #gfa7 submitted and inserting #faa1 #gfj1 or #gfa7 submitted2 7#d7 in paragraph 7xx71 by inserting or #fac after #dbc2 and 7#e7 by adding at the end the following3 7fff7 ,the failure to register in accordance with section #fje1 the failure to submit a cosmetic ingredient statement under section #fjf1 the failure to provide 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 #cfa71 as amended by section #fjc1 is further amended by adding at the end the following3 7g7 ,if it contains1 after the date prescribed under section #fjh7;d77#c71 an ingredient that the ,secretary 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 based on an order issued by the ,secretary under section #fjh7;d77#d74 7h7 ,if it is a cosmetic product for which any requirement of section #fji is not met4 4 7c7 ,misbranding ,section #fjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb71 as amended by section #ajf1 is further amended-- 7#a7 in paragraph 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 or electronic contact information1 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 7h7 ,if it is a cosmetic product and it has been manufactured1 processed1 packed1 or held in any factory1 warehouse1 or establishment and the responsible person delays1 denies1 or limits an inspection1 or refuses to permit entry or inspection4 7i7 ,if a fragrance ingredient described in section #fae is not disclosed to consumers through a method identified by the ,food and ,drug ,administration in the guidance document issued under such section4 7j7 ,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 ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 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 ,facility 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 subject to the limitations under of such section44 ,,ii ,fees ,related to ,cosmetic ,products #bja4 ,findings ,the ,congress finds that the fees authorized by the amendment made by section #bjb of this ,act will be dedicated to cosmetic safety activities1 as defined in section #gdd,l of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by such section #bjb4 ,such fees should supplement1 not supplant1 funding dedicated to cosmetic safety activities of the ,food and ,drug ,administration4 ,future fees authorized by the reauthorization of part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act to be collected by the ,secretary of ,health and ,human ,services should be dedicated to cosmetic safety activities as set forth in the goals identified for purposes of such part #aj1 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 product 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 ,cosmetic ,products #gdd,l4 ,definitions ,for the purposes of this part3 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 #bjah4 7#b7 ,cosmetic formulation ,the term cosmetic formulation has the meaning given to such term in section #fjd4 7#c7 ,contract manufacturer ,the term contract manufacturer means a cosmetic manufacturer where neither the owner1 operator1 or agent in charge of such entity nor any affiliate of such owner1 operator1 or agent in charge sells the cosmetic ingredient1 cosmetic formulation1 or cosmetic product unless there is a specific contractual agreement in place4 7#d7 ,cosmetic product ,the term cosmetic product has the meaning given to such term in section #fjd4 7#e7 ,cosmetic safety activities ,the term cosmetic safety activities-- 7,a7 means activities of the ,secretary related to compliance by responsible persons required to register under section #fje with respect to cosmetics1 including administrative activities1 such as-- 7i7 information technology acquisition1 management1 maintenance1 and support2 7ii7 the acquisition1 administration1 and maintenance of the cosmetic registration system under section #fje and the cosmetic ingredient statement system under section #fjf2 7iii7 fee assessment and collection under this part2 and 7iv7 the acquisition1 leasing1 maintenance1 renovation1 and repair of facilities1 fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies for purposes of clauses 7i7 through 7iii72 7,b7 includes activities of the ,secretary related to implementation of section #fjh1 regarding the review of cosmetic ingredients and nonfunctional constituents2 7,c7 includes activities of the ,secretary related to implementation of section #fjf2 7,d7 includes activities of the ,secretary related to implementation and enforcement1 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,e7 includes activities of the ,secretary related to meetings with regulated industry regarding determinations under section #fjh4 7#f7 ,gross annual sales ,the term gross annual sales means the average ,united ,states gross annual sales for the previous #c fiscal years of cosmetic products for a responsible person1 including the sales of cosmetic products of all of its affiliates1 as reported in the registration under section #fje4 7#g7 ,large manufacturer ,the term large manufacturer means any entity that manufactures cosmetic products or cosmetic formulations for sale or distribution in the ,united ,states and has gross annual sales of over #ejj1jjj1jjj4 7#h7 ,midsize manufacturer ,the term midsize manufacturer means any entity that manufactures cosmetic products or cosmetic formulations for sale or distribution in the ,united ,states and has gross annual sales that are not more than #ejj1jjj1jjj and over #cj1jjj1jjj4 7#i7 ,small manufacturer ,the term small manufacturer means any entity that manufactures cosmetic products or cosmetic formulations for sale or distribution in the ,united ,states and has gross annual sales that are not more than #cj1jjj1jjj and over #a1jjj1jjj4 7#aj7 ,responsible person ,the term responsible person means the owner1 operator1 agent in charge1 or affiliate that owns the brand under which a cosmetic product is sold4 #gdd,m4 ,registration fee 7a7 ,assessment and collection 7#a7 ,in general ,beginning in fiscal year #bjbj1 the ,secretary shall in accordance with this section assess and collect an annual fee from every responsible person that manufactures or distributes cosmetic products or cosmetic formulations in the ,united ,states4 7#b7 ,payable date ,fees under this section shall be due and payable-- 7,a7 for fiscal year #bjbj1 with respect to responsible persons as described in paragraph 7#a7 for such first program year1 on the date that is #ahj days after the identification in subsection 7b72 and 7,b7 for fiscal year #bjba and each subsequent fiscal year1 on the later of-- 7i7 the date of registration or registration renewal1 as applicable1 under section #fje2 or 7ii7 the date of enactment of an appropriations ,act providing for the collection and obligation of fees under this section for the fiscal year involved4 7b7 ,one-,time identification of responsible persons for purposes of apportioning fees 7#a7 ,required identification of responsible persons ,not later than #abj days after enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai1 each responsible person that markets or sells a cosmetic product shall submit to the ,secretary the information required under this subsection4 7#b7 ,information required to be submitted ,at a minimum1 the submission required by paragraph 7#a7 shall include for each such responsible person-- 7,a7 the gross annual sales of cosmetic products or cosmetic formulations for the previous #c fiscal years as will be reported in the first registration under section #fje for such responsible person1 and an assessment of whether such responsible person qualifies as a small1 midsize1 or large manufacturer for the purposes of subsection 7c77#c77;,a72 7,b7 identification of facilities where such responsible person's cosmetic products or cosmetic formulations are manufactured1 which cosmetic products or cosmetic formulations are manufactured there1 and any other products regulated under this ,act that the facility manufactures2 7,c7 the location of all such facilities identified in subparagraph 7,b72 and 7,d7 whether the facility is owned and operated by a contract manufacturer4 7#c7 ,notice ,the ,secretary may1 by notice published in the ,federal ,register1 specify the means and format for submission of the information under paragraph 7#b7 and may specify1 as necessary for purposes of this section1 any additional information relevant to setting the annual fee under this section to be submitted4 7c7 ,fee setting and amounts 7#a7 ,in general ,subject to subsection 7d71 the ,secretary shall establish the fees to be collected under this section for each fiscal year beginning in fiscal year #bjbj1 based on the methodology described in paragraph 7#c77;,a71 and shall publish such fees in each fiscal year after fiscal year #bjbj in a ,federal ,register notice not later than #fj days before the beginning of each such fiscal year4 ,for fiscal year #bjbj1 the ,secretary shall publish the fees #aej days after the date of enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai4 7#b7 ,fee exemption ,any facility required to register under section #fje whose average gross annual sales of cosmetic products in the #c fiscal years immediately preceding the fiscal year for which the annual fee will be paid was not more than #a1jjj1jjj1 shall be exempt from registration fees under this section for that fiscal year4 7#c7 ,annual fee setting 7,a7 ,fee setting ,for fiscal years #bjbj to #bjbg1 the amount of the registration fee under subsection 7a7 shall be apportioned as follows3 7i7 ,seventy percent shall be derived from fees from large manufacturers4 7ii7 ,twenty percent shall be derived from fees from midsize manufacturers4 7iii7 ,ten percent shall be derived from fees from small manufacturers4 7,b7 ,total revenue ,the ,secretary shall establish the fee amounts for each fiscal year in accordance with subparagraph 7,a71 in order to generate a total estimated revenue of-- 7i7 #aj1jjj1jjj for fiscal year #bjbj2 7ii7 #bj1jjj1jjj for fiscal year #bjba2 7iii7 #ce1jjj1jjj for fiscal year #bjbb2 and 7iv7 #df1jjj1jjj for each of fiscal years #bjbc through #bjbg4 7d7 ,adjustments 7#a7 ,inflation adjustments 7,a7 ,adjustment to total revenue amounts ,for fiscal year #bjbj and each subsequent fiscal year1 the ,secretary shall adjust the total revenue amount specified in subsection 7c77#c7 for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph 7,b7 for such year4 7,b7 ,applicable inflation adjustment ,the applicable inflation adjustment for fiscal year #bjbb and each subsequent fiscal year is the product of-- 7i7 the base inflation adjustment under subparagraph 7,c7 for such fiscal year2 and 7ii7 the product of the base inflation adjustment under subparagraph 7,c7 for each of the fiscal years preceding such fiscal year1 beginning with fiscal year #bjbj4 7,c7 ,base inflation adjustment 7i7 ,in general ,subject to further adjustment under clause 7ii71 the base inflation adjustment for a fiscal year is the sum of one plus-- 7,i7 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 fiscal years of the preceding #d fiscal years1 multiplied by #j4fj2 and 7,,ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,arlington-,alexandria2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c fiscal years of the preceding #d years of available data multiplied by #j4dj4 7ii7 ,limitations ,for purposes of subparagraph 7,b71 if the base inflation adjustment for a fiscal year under clause 7i7-- 7,i7 is less than #a1 such adjustment shall be considered to be equal to #a2 or 7,,ii7 is greater than #a4jd1 such adjustment shall be considered to be equal to #a4jd4 7#b7 ,final year adjustment ,for fiscal year #bjbg1 the ,secretary 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 #bjbh4 ,if such an adjustment is necessary1 the rationale for the increase shall be contained in the annual ,federal ,register notice establishing fees for fiscal year #bjbg4 ,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 paragraph shall not be made4 7e7 ,limitations 7#a7 ,in general ,with respect to the amount that is appropriated for a fiscal year for the cosmetics program of the ,center for ,food ,safety and ,applied ,nutrition of the ,food and ,drug ,administration and related field activities1 fees may not be assessed under subsection 7a7 for the fiscal year unless the amount so appropriated 7excluding the amount of fees appropriated for the fiscal year71 is equal to or greater than the amount that is appropriated for such program for fiscal year #bjai1 multiplied by the adjustment factor applicable to the fiscal year involved4 ,if the amount so appropriated prevents the ,secretary from assessing fees under subsection 7a71 the ,secretary is not required to carry out any activities described in section #fjh during that fiscal year4 7#b7 ,authority ,if the ,secretary 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 ,secretary may assess such fees1 the ,secretary 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 obligation1 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 discretionary appropriations through ,september #cj1 #bjbj1 for the ,food and ,drug ,administration--,salaries and ,expenses account1 fees authorized by this section for fiscal year #bjbj may be collected1 and any fees so collected shall be credited to such account1 to remain available until expended4 7,d7 ,startup costs ,until one year after the ,secretary begins collecting user fees under subsection 7a71 any amounts available for the ,center for ,food ,safety and ,applied ,nutrition and related field activities 7excluding user fees7 shall be available and allocated as needed to pay the costs of any cosmetic safety activities not authorized before enactment of the ,cosmetic ,safety ,enhancement ,act of #bjai4 7,e7 ,reimbursement of startup amounts 7i7 ,in general ,any amounts allocated for the startup period pursuant to subparagraph 7,d7 shall be reimbursed through any appropriated fees collected under subsection 7a71 in such manner as the ,secretary determines appropriate to ensure that such allocation results in no net change in the total amount of funds otherwise available1 for a period not to exceed two years after the ,secretary begins collecting user fees under subsection 7a71 for the ,center for ,food ,safety and ,applied ,nutrition and related field activities 7other than cosmetic safety activities and related field activities funded through such allocation7 for such period4 7ii7 ,treatment of reimbursed amounts ,amounts reimbursed under clause 7i7 shall be available for the programs and activities for which funds allocated for the startup period were available1 prior to such allocation1 until #a year after the ,secretary begins collecting user fees under subsection 7a71 notwithstanding any otherwise applicable limits on amounts for such programs or activities for a fiscal year4 7#c7 ,authorization of appropriations ,there are authorized to be appropriated for fees under this section the following3 7,a7 #aj1jjj1jjj for fiscal year #bjbj2 7,b7 #bj1jjj1jjj for fiscal year #bjba2 7,c7 #ce1jjj1jjj for fiscal year #bjbb2 and 7,d7 #df1jjj1jjj for each of fiscal years #bjbc through #bjbg4 7g7 ,effect of failure ,to pay fees ,the ,secretary shall not consider a registration by a responsible person submitted under section #fje to be complete until all fees owed by such person under subsection 7a7 are paid4 ,until the fees are paid1 the registration is incomplete and the responsible person is deemed to have failed to register in accordance with section #fje4 7h7 ,collection of unpaid fees ,in any case where the ,secretary 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 7i7 ,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 safety activities1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 7j7 ,records ,each responsible person that is required to register under section #fje shall retain all records necessary to demonstrate gross annual sales for at least #b fiscal years after such information is reported in its registration4 ,such records shall be made available to the ,secretary for review and duplication upon request of the ,secretary4 7k7 ,limitation ,this part does not authorize the assessment or collection of a fee for registration under section #fje occurring after fiscal year #bjbg4 4 #bjc4 ,direct hiring authority to support activities related to cosmetics ,part #aj of subchapter ,c of chapter ,,vii1 as added by section #bjb1 is amended by inserting after section #gdd,m the following3 #gdd,n4 ,direct hiring authority to support activities related to cosmetics ,the ,secretary shall have direct hiring authority with respect to the appointment of employees into the competitive service or the excepted service to administer the ,cosmetic ,safety ,enhancement ,act of #bjai and the amendments made thereby4 #gdd,o4 ,reporting requirements2 reauthorization 7a7 ,performance report ,beginning with fiscal year #bjba1 and not later than #abj calendar days after the end of each fiscal year thereafter for which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report concerning the progress of the ,food and ,drug ,administration on cosmetic safety activities during such fiscal year1 including the future plans of the ,food and ,drug ,administration for such activities4 7b7 ,fiscal report ,not later than #abj calendar days after the end of fiscal year #bjba and each subsequent fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected for such fiscal year4 7c7 ,public availability ,the ,secretary shall make the reports required under subsections 7a7 and 7b7 available to the public on the internet website of the ,food and ,drug ,administration4 7d7 ,reauthorization 7#a7 ,consultation ,in developing recommendations to present to the ,congress with respect to performance goals developed by the ,food and ,drug ,administration1 and plans for meeting the goals1 for cosmetic safety activities for the first #e fiscal years after fiscal year #bjbg1 and for the reauthorization of this part for such fiscal years1 the ,secretary shall consult with-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,c7 scientific and academic experts2 7,d7 health care professionals2 7,e7 representatives of public health and consumer advocacy groups2 and 7,f7 the regulated industry4 7#b7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7,a7 present the recommendations developed under paragraph 7#a7 to the congressional committees specified in such paragraph2 7,b7 publish such recommendations in the ,federal ,register2 7,c7 provide for a period of #cj calendar days for the public to provide written comments on such recommendations2 7,d7 hold a meeting at which the public may present its views on such recommendations2 and 7,e7 after consideration of such public views and comments1 revise such recommendations as necessary4 7#c7 ,transmittal of recommendations ,not later than ,january #ae1 #bjbf1 the ,secretary shall transmit to the ,congress the revised recommendations under paragraph 7#b71 a summary of the views and comments received under such paragraph1 and any changes made to the recommendations in response to such views and comments4 4 #bjd4 ,sunset dates 7a7 ,authorization ,sections #gdd,l1 #gdd,m1 and #gdd,n of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bjb1 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gdd,o of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bjc1 shall cease to be effective ,january #ca1 #bjbh4