,,ii #aaeth ,,congress #ast ,session ,s4 #bjjc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #be1 #bjag ,mr4 ,hatch introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to modernize the regulation of cosmetics4 #a4 ,short title ,this ,act may be cited as the ,,fda ,cosmetic ,safety and ,modernization ,act4 #b4 ,adverse event reporting 7a7 ,in general ,subchapter ,h of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;aa et seq47 is amended by adding at the end the following3 #gfb4 ,serious adverse event reporting for cosmetics 7a7 ,definitions ,in this section3 7#a7 ,the term adverse event means any health-related event associated with the use of a cosmetic that is adverse4 7#b7 ,the term serious adverse event means an adverse event that-- 7,a7 results in-- 7i7 death2 7ii7 a life-threatening experience2 7iii7 inpatient hospitalization2 7iv7 a persistent or significant disability1 incapacity1 or disfigurement2 7v7 a congenital abnormality or birth defect2 or 7vi7 permanent alteration of appearance other than as intended1 under conditions of use that are customary or usual2 or 7,b7 requires1 based on reasonable medical judgment1 a medical or surgical intervention to prevent an outcome described in subparagraph 7,a74 7#c7 ,the term serious adverse event report means a report that is required to be submitted to the ,secretary under subsection 7b74 7b7 ,reporting requirement ,the manufacturer or distributor of a cosmetic whose name appears on the label of such cosmetic pursuant to section #fjb 7referred to in this section as a responsible person7 shall submit to the ,secretary any report received of a serious adverse event associated with such cosmetic when used in the ,united ,states1 accompanied by a copy of the label on or within the retail packaging of such cosmetic4 7c7 ,submission of reports 7#a7 ,timing of reports ,the responsible person shall submit to the ,secretary a serious adverse event report no later than #ae business days after the report is received4 7#b7 ,new medical information ,the responsible person shall submit to the ,secretary any new and material medical information1 related to a submitted serious adverse event report that is received by the responsible person within #a year of the initial report1 no later than #ae business days after such information is received by such responsible person4 7#c7 ,consolidation of reports ,the ,secretary shall provide for systems to enable responsible persons to submit a single report that includes duplicate reports of1 or new medical information related to1 a serious adverse event4 7#d7 ,exemption ,the ,secretary may establish an exemption to the requirements under paragraphs 7#a7 and 7#b7 if-- 7,a7 the ,secretary receives a report in accordance with section #gfj2 or 7,b7 after providing notice and an opportunity for comment from interested parties1 the ,secretary determines that such exemption would have no significant adverse effect on public health4 7d7 ,content of report ,each serious adverse event report under this section shall be submitted to the ,secretary1 and may be accompanied by additional information4 7e7 ,maintenance and inspection of records 7#a7 ,maintenance ,the responsible person shall maintain records related to each report of a serious adverse event received by the responsible person for a period of #f years4 7#b7 ,records inspection 7,a7 ,in general ,the responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section #gjd4 7,b7 ,authorized person ,for purposes of this paragraph1 the term authorized person means an officer or employee of the ,department of ,health and ,human ,services1 who has-- 7i7 appropriate credentials1 as determined by the ,secretary2 and 7ii7 been duly designated by the ,secretary to have access to the records required under this section4 7f7 ,protected information ,a serious adverse event report submitted to the ,secretary under this section1 including any new medical information submitted under subsection 7c77#b71 or an adverse event report voluntarily submitted to the ,secretary shall be considered to be-- 7#a7 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 event2 and 7#b7 a record about an individual under section #eeb;a of title #e1 ,united ,states ,code 7commonly referred to as the ,privacy ,act of #aigd71 and a medical or similar file the disclosure of which would constitute a violation of section #eeb of such title #e 7commonly referred to as the ,freedom of ,information ,act71 and shall not be publicly disclosed unless all personally identifiable information is redacted4 7g7 ,rule of construction ,the submission of any adverse event report under this section shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event4 7h7 ,preemption 7#a7 ,in general ,no ,state or local government shall establish or continue in effect any law1 regulation1 order1 or other requirement related to a mandatory system for adverse event reports for cosmetics4 7#b7 ,effect of section 7,a7 ,in general ,nothing in this section shall affect the authority of the ,secretary to provide adverse event reports and information to any health1 food1 or drug officer or employee of any ,state1 territory1 or political subdivision of a ,state or territory1 under a memorandum of understanding between the ,secretary and such ,state1 territory1 or political subdivision4 7,b7 ,personally-identifiable information ,notwithstanding any other provision of law1 personally-identifiable information in adverse event reports provided by the ,secretary to any health1 food1 or drug officer or employee of any ,state1 territory1 or political subdivision of a ,state or territory1 shall not-- 7i7 be made publicly available pursuant to any ,state or other law requiring disclosure of information or records2 or 7ii7 otherwise be disclosed or distributed to any party without the written consent of the ,secretary and the person submitting such information to the ,secretary4 7,c7 ,use of safety reports ,nothing in this section shall permit a ,state1 territory1 or political subdivision of a ,state or territory1 to use any safety report received from the ,secretary in a manner inconsistent with subsection 7g7 or section #gef4 7i7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section such sums as may be necessary4 4 7b7 ,conforming amendments ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba et seq47 is amended-- 7#a7 in section #cja7;ii7 7#ba ,u4,s4,c4 #cca7;ii771 by striking section #gfj or #gfa each place it appears and inserting section #gfj1 #gfa1 or #gfb2 and 7#b7 in section #hja 7#ba ,u4,s4,c4 #cha71 by striking section #gfj or #gfa each place it appears in subsections 7a7 and 7b7 and inserting section #gfj1 #gfa1 or #gfb4 #c4 ,adulterated cosmetics ,section #fja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7;a77 is amended-- 7#a7 by inserting 1 or consists in whole or in part of1 after bears or contains2 and 7#b7 by striking usual1 except that this and inserting usual4 ,for purposes of this clause1 a cosmetic may be adulterated regardless of whether it is known which particular substance or substances may render the cosmetic injurious to users under the conditions of use prescribed in the labeling thereof1 or under such conditions of use as are customary or usual4 ,this4 #d4 ,labeling ,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 it is a cosmetic that is marketed in the ,united ,states1 unless its label includes a domestic address1 domestic phone number1 or ,internet address through which the responsible person 7as described in section #gfb7 can receive a report of a serious adverse event with respect to such cosmetic product4 4 #e4 ,registration of cosmetic facilities ,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 ,registration of cosmetic facilities 7a7 ,registration 7#a7 ,in general ,the ,secretary shall by regulation require the manufacturer or distributor whose name appears on the label of a cosmetic marketed in the ,united ,states to register all facilities engaged in manufacturing of such cosmetic with the ,secretary4 ,to be registered-- 7,a7 for a domestic facility1 the responsible person1 owner1 or agent in charge of the facility shall submit a registration to the ,secretary2 and 7,b7 for a foreign facility1 the responsible person1 owner1 or agent in charge of the facility shall submit a registration to the ,secretary and shall include with the registration the name of the ,united ,states agent for the facility4 7#b7 ,registration 7,a7 ,in general ,an entity 7referred to in this section as the registrant7 shall submit a registration under paragraph 7#a7 to the ,secretary containing information necessary to notify the ,secretary of the name and address of each facility at which1 and all the trade names under which1 the registrant conducts business1 the e-mail address for the responsible person 7as described in section #gfb7;b77 of the facility or1 in the case of a foreign facility1 the ,united ,states agent for the facility4 7,b7 ,availability of information ,the ,secretary shall require-- 7i7 the information submitted under subparagraph 7,a7 to be maintained and available1 at the request of the ,secretary1 for a period to be determined by the ,secretary2 and 7ii7 the name and address of each facility with which the registrant contracts related to cosmetic manufacturing1 processing1 distributing1 or other activities1 as the ,secretary determines appropriate1 to be maintained and available at the request of the ,secretary1 for a period to be determined by the ,secretary4 7,c7 ,additional requirements ,the registration shall contain an assurance that-- 7i7 the ,secretary will be permitted to inspect the facility at the times and in the manner permitted by this ,act2 and 7ii7 the registrant will notify the ,secretary in a timely manner of changes to the information submitted4 7#c7 ,registration renewal ,a registrant that has submitted a registration under paragraph 7#a7 shall submit to the ,secretary a renewal registration containing the information described in paragraph 7#b7 every #b years during a period of time as determined by the ,secretary4 ,the ,secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved4 7#d7 ,procedure ,upon receipt of a completed registration described in paragraph 7#a71 the ,secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility4 7#e7 ,list ,the ,secretary shall compile and maintain an up-to-date list of facilities that are registered under this section4 ,such list and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under section #eeb of title #e1 ,united ,states ,code4 ,information derived from such list or registration documents shall not be subject to disclosure under section #eeb of title #e1 ,united ,states ,code1 to the extent that it discloses the identity or location of a specific registered person4 7b7 ,suspension of registration 7#a7 ,in general ,if the ,secretary determines that cosmetics manufactured or processed by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans1 the ,secretary may by order suspend the registration of any facility that is responsible for such reasonable probability or that knew of1 or had reason to know of1 such reasonable probability related to such cosmetics4 7#b7 ,hearing on suspension ,the ,secretary shall provide the registrant subject to an order under paragraph 7#a7 with an opportunity for an informal hearing1 to be held as soon as possible but not later than #b business days after the issuance of the order or such other time period1 as agreed upon by the ,secretary and the registrant1 on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated4 ,the ,secretary shall reinstate a registration if the ,secretary determines1 based on evidence presented1 that adequate grounds do not exist to continue the suspension of the registration4 7#c7 ,post-hearing corrective action plan2 vacating of order 7,a7 ,corrective action plan ,if1 after providing opportunity for an informal hearing under paragraph 7#b71 the ,secretary determines that the suspension of registration remains necessary1 the ,secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the ,secretary4 ,the ,secretary shall review such plan not later than #ad days after the submission of the corrective action plan or such other time period as determined by the ,secretary1 in consultation with the registrant4 7,b7 ,vacating of order ,upon a determination by the ,secretary that adequate grounds do not exist to continue the suspension actions required by the order1 or that such actions should be modified1 the ,secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order1 as appropriate4 7#d7 ,effect of suspension ,if the registration of a facility is suspended under this subsection1 no person shall import or export cosmetics into the ,united ,states from such facility1 offer to import or export cosmetics into the ,united ,states from such facility1 or otherwise introduce cosmetics from such facility into interstate or intrastate commerce in the ,united ,states4 7#e7 ,regulations 7,a7 ,in general ,the ,secretary shall promulgate regulations to implement this subsection4 7,b7 ,electronic registration requirement ,the ,secretary may require that registration under this section be submitted in an electronic format4 7#f7 ,application date ,facilities shall not be subject to the requirements of this subsection prior to the date that is #ahj days after the date on which the ,secretary issues final regulations under paragraph 7#e74 7#g7 ,no delegation ,the authority conferred by this subsection 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 7c7 ,facility ,for purposes of this section3 7#a7 ,the term facility-- 7,a7 includes any factory or other establishment that is engaged in the manufacturing or processing of a cosmetic or cosmetics2 and 7,b7 does not include-- 7i7 beauty salons1 spas1 retailers 7including individual sales representatives1 wholesale distributors1 or pharmacy locations72 7ii7 homes where persons are engaged in making handcrafted soaps or other cosmetics2 or 7iii7 any business with less than #a1jjj1jjj in annual net revenue in the previous year1 other than any such business that is engaged in the manufacturing or processing of products intended to be injected under the skin1 including tattoo ink4 7#b7 ,the term domestic facility means a facility located in any of the ,states or ,territories4 7#c7 ,the term foreign facility means a facility located outside of the ,united ,states or ,territories1 but only if the cosmetics from such facility are exported to the ,united ,states without further manufacturing outside the ,united ,states or ,territories4 7d7 ,rule of construction ,nothing in this section shall be construed to authorize the ,secretary to require an application1 review1 or licensing process for a facility to be registered1 except with respect to the reinstatement of a registration that is suspended under subsection 7b74 7e7 ,preemption ,no ,state or political subdivision of a ,state may establish or continue in effect any law1 regulation1 order1 or other requirement with respect to the registration of facilities engaged in the manufacturing or processing of a cosmetic or cosmetics that is different from the requirements under this section4 4 #f4 ,good manufacturing practices 7a7 ,good manufacturing practice standards ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #e1 is further amended by adding at the end the following3 #fje4 ,good manufacturing practices 7a7 ,establishment of good manufacturing practices 7#a7 ,in general ,the ,secretary shall by regulation establish good manufacturing practices for cosmetics in accordance with paragraphs 7a7 and 7d7 of section #fja4 ,such regulations-- 7,a7 shall be modeled after comparable good manufacturing practice standards for cosmetics in effect at the time of promulgation2 7,b7 may not impose standards for which there is no current and generally available analytical methodology2 7,c7 may ensure that cosmetics do not cause serious adverse health consequences or death2 7,d7 shall be intended to protect the public health2 and 7,e7 shall not apply to entities described in clauses 7i7 and 7ii7 of section #fjd7;c77#a77;,b74 7#b7 ,considerations ,in promulgating regulations under paragraph 7#a71 the ,secretary shall consider facilities that are subject to other1 similar regulations1 as appropriate4 7b7 ,notice and comment ,a regulation under subsection 7a7 shall be promulgated only after providing notice and an opportunity for comment in accordance with chapter #e of title #e1 ,united ,states ,code4 7c7 ,small businesses 7#a7 ,applicability to small businesses ,the ,secretary shall provide for an additional year after the effective date of the regulations under subsection 7a7 for small businesses 7as described in section #fjd7;c77#a77;,b77iii77 to comply with the good manufacturing practices established in accordance with subsection 7a71 and issue guidance for small businesses for purposes of compliance with this section4 7#b7 ,considerations ,in establishing good manufacturing practices under this section1 the ,secretary shall take into account the practices of small business1 including the size and scope of the business1 and consult with the ,small ,business ,administration1 as appropriate4 7d7 ,preemption ,no ,state or political subdivision of a ,state may establish or continue in effect any law1 regulation1 order1 or other requirement with respect to good manufacturing practice standards for cosmetics that is different from the requirements under this section4 4 7b7 ,prohibition ,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 it has been manufactured under conditions that do not meet current good manufacturing practice regulations established under section #fje4 4 #g4 ,identification and review of cosmetic ingredients ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #f1 is further amended by adding at the end the following3 #fjf4 ,identification and review of cosmetic ingredients 7a7 ,identification of ingredients and non-,functional constituents ,to be reviewed ,each year1 the ,secretary1 in consultation with industry and consumer groups1 and taking into consideration ingredients identified by a ,state or political subdivision as presenting a public health concern1 shall identify cosmetic ingredients1 as appropriate1 that may present a public health concern to be reviewed for safety1 including a class or classes of ingredients1 or a non-functional constituent or class of non-functional constituents4 ,the ,secretary shall publish in the ,federal ,register a list of the ingredients or non-functional constituents1 or classes of ingredients or constituents identified for review1 and solicit public input and provide the public notice and a period of #fj days to comment on any such ingredient1 constituent1 or class4 ,the ,secretary may identify a cosmetic ingredient or ingredients1 as appropriate1 to be reviewed for safety outside such annual process4 7b7 ,administrative orders and standards 7#a7 ,publication of determinations and findings 7,a7 ,proposed orders ,if the ,secretary determines that there is adequate scientific evidence to support a determination that there is reasonable certainty that an ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents is safe for use1 not safe for use1 or not safe for specified conditions of use1 the ,secretary shall post on the ,internet website of the ,food and ,drug ,administration a proposed administrative order consistent with such determination4 7,b7 ,findings of inadequate evidence ,if the ,secretary determines that there is inadequate scientific evidence to support a determination described in subparagraph 7,a71 the ,secretary shall post on the ,internet website of the ,food and ,drug ,administration such findings1 together with a rationale for the findings4 7,c7 ,additional evidence ,nothing in this paragraph shall prevent the ,secretary from considering additional scientific information or safety data related to the ingredient that is submitted to the ,secretary4 7#b7 ,final orders 7,a7 ,in general ,after allowing not less than #ij days for public comment on a proposed order under paragraph 7#a77;,a7 and a period for consideration of any such comments1 if the ,secretary determines that there is adequate scientific evidence to make a final determination on the safety of the applicable ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents1 the ,secretary shall issue a final administrative order that there is reasonable certainty that-- 7i7 the ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents is safe for use2 7ii7 the ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents is not safe for any use2 or 7iii7 the ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents is not safe under specified conditions of use4 7,b7 ,final action ,a final administrative order under subparagraph 7,a7 shall be considered final agency action for purposes of judicial review4 7#c7 ,standards ,a determination that an ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents is not safe under specified conditions of use may specify conditions of use such as-- 7,a7 the amount or concentration of such ingredient2 7,b7 the populations which may specifically use such ingredient or not use such ingredient2 7,c7 the area of the human body on which or near which such ingredient should not be used2 or 7,d7 such other conditions that may affect the safety of the cosmetic as a whole or in part4 7c7 ,cosmetic safety standard ,for purposes of this ,act1 including reviews for safety under this section and section #fjg1 a cosmetic is safe if there is reasonable certainty that the cosmetic is not injurious to users under conditions of use prescribed in labeling or under such conditions of use as are customary or usual4 7d7 ,preemption ,upon identification of a cosmetic ingredient or non-functional constituent by the ,secretary under subsection 7a71 no ,state or local government may establish or continue in effect any law1 regulation1 order1 or other requirement with respect to such ingredient or non-functional constituent1 except that a ,state or local government may continue in effect such a requirement that was in full effect with respect to such ingredient on the date of enactment of the ,,fda ,cosmetic ,safety and ,modernization ,act1 or that is exempted from preemption under section #geb7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7e7 ,definitions ,for purposes of this ,act-- 7#a7 the term non-functional constituent means a substance or chemical1 or other contaminant1 that was not intentionally added or included in the formula of a cosmetic product and serves no technical purpose1 but may be present as a breakdown product or by-product of manufacturing2 and 7#b7 the term cosmetic means a cosmetic product in finished form consistent with section #bja7;i77#a74 7f7 ,rule of construction ,this section shall not be construed to affect the right of a person to lawfully market a cosmetic product that is or that contains an ingredient1 class of ingredients1 non-functional constituent1 or class of non-functional constituents while such substance is under review or has been identified for review by the ,secretary for safety4 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary4 4 #h4 ,accredited third-party review ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #g1 is further amended by adding at the end the following3 #fjg4 ,accredited third-party review 7a7 ,in general ,the ,secretary may accredit persons to review and assess for safety cosmetic ingredients or non-functional constituents identified by the ,secretary under section #fjf7;a7 and make recommendations to the ,secretary for proposed administrative orders under section #fjf7;b77#a77;,a74 7b7 ,accreditation and review ,not later than #b years after the date of enactment of the ,,fda ,cosmetic ,safety and ,modernization ,act1 the ,secretary shall promulgate regulations establishing-- 7#a7 a process to accredit third parties for purposes of reviewing cosmetic ingredients1 classes of ingredients1 non-functional constituents1 and classes of non-functional constituents identified by the ,secretary under section #fjf7;a72 and 7#b7 criteria and qualifications for such accreditation of third parties4 7c7 ,requirements regarding review ,in making a recommendation to the ,secretary under subsection 7a71 an accredited third party shall notify the ,secretary in writing of the reasons for the recommendation1 and provide relevant scientific literature or data1 as the ,secretary requires4 7d7 ,review and administrative order ,the ,secretary shall establish a process by which to review recommendations from such accredited third party and to determine whether an ,administrative ,order is appropriate4 ,not later than #ahj calendar days after the date on which the ,secretary receives a recommendation from an accredited third party pertaining to a cosmetic ingredient or non-functional ingredient identified by the ,secretary under section #fjf7;a71 the ,secretary shall issue a proposed administrative order1 or issue a public rationale on the ,secretary's determination not to issue a proposed administrative order4 7e7 ,qualifications ,an accredited third party shall1 at a minimum1 meet the following requirements3 7#a7 ,such third party may not be affiliated with a government entity4 7#b7 ,such third party shall be an independent organization that is not owned or controlled by a manufacturer1 supplier1 or vendor of cosmetics and that has no financial affiliation with such a manufacturer1 supplier1 or vendor4 7#c7 ,such third party shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation4 7#d7 ,such third party shall not engage in the design1 manufacturer1 promotion1 or sale of cosmetics4 7#e7 ,such third party shall have scientific expertise in ingredient safety1 toxicology1 or chemical safety4 7#f7 ,the operations of such third party shall be in accordance with generally accepted professional and ethical business practices and such third party shall agree in writing that it will-- 7,a7 certify that reported information accurately reflects data reviewed2 7,b7 limit work to that within its competence and capacity2 7,c7 treat proprietary1 confidential1 and commercial information received1 including records1 reports1 and recommendations1 as confidential information2 7,d7 promptly respond and attempt to resolve complaints regarding the activities for which it is accredited2 and 7,e7 protect against the use1 in carrying out subsection 7a7 with respect to a cosmetic1 of any officer or employee of the entity who has a financial conflict of interest regarding the cosmetic1 and annually make available to the public disclosures of the extent to which the entity1 and the officers and employees of the entity1 have maintained compliance with requirements under this subparagraph relating to financial conflicts of interest4 7f7 ,rule of ,construction ,nothing in this section is intended to affect the ,secretary's authority to enter into contracts with non-accredited third parties for purposes of cosmetic safety review4 4 #i4 ,reporting ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #h1 is further amended by adding at the end the following3 #fjh4 ,cosmetic ingredient report 7a7 ,annual report to ,congress ,the ,commissioner shall submit an annual report to the appropriate committees of ,congress that includes a report or summary of-- 7#a7 the ingredients or non-functional constituents that the ,commissioner has identified for review under section #fjf7;a72 7#b7 the ingredients or non-functional constituents for which the ,commissioner has issued a proposed order1 a final order1 or a finding of incomplete evidence under section #fjf7;b72 7#c7 the ongoing ingredient or non-functional constituents being reviewed for safety at the time of submission of the report1 reviews the ,commissioner has determined to be needed1 and reviews for which ,commissioner is contracting with an accredited third party2 7#d7 a summary of serious adverse event reports submitted under section #gfb1 and the associated product category and serious adverse health consequence for each such report2 and 7#e7 enforcement actions1 if any1 the ,commissioner has taken as a result of serious adverse event reports or facility inspections1 including warning letters1 untitled letters1 suspension of registration1 or any other type of action4 4 #aj4 ,,gao report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall analyze1 and submit a report to ,congress on-- 7#a7 the types of ingredients or non-functional constituents that the ,food and ,drug ,administration has identified for purposes of a safety review under section #fjf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #g7 and the factors or methods1 if any1 that such agency considers in determining the need for a safety review2 7#b7 the level of coordination between the ,food and ,drug ,administration and the ,states in identifying ingredients that may present a public health concern for review1 and the process by which the ,food and ,drug ,administration considers public input as part of identifying ingredients that may present a public health concern2 7#c7 how the ,food and ,drug ,administration accounts for reports of serious adverse events under section #gfb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #b7 to inform cosmetic related inspections2 7#d7 the frequency and type of inspections conducted by the ,food and ,drug ,administration1 including inspections in response to reports of serious adverse events1 and an analysis of the outcome and related facility compliance2 7#e7 the time between identifying ingredients to be reviewed for safety under section #fjf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and issuance of final administrative orders under section #fjf7;b77#b7 of such ,act2 7#f7 ingredients1 if any1 that the ,food and ,drug ,administration took action to include on the prohibited and restricted ingredients list of the ,food and ,drug ,administration1 and a summary of ingredients with respect to which such agency has issued an administrative order2 and 7#g7 the ,food and ,drug ,administration's use of accredited third parties for purposes of cosmetic ingredient safety reviews in accordance with section #fjg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #h74