Personal Care Products Safety Act

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. 1. Short title; table of contents (a) Short title This Act may be cited as the Personal Care Products Safety Act (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—Cosmetic safety Sec. 101. Registration of cosmetics facilities and cosmetic ingredient statements. Sec. 102. Review of ingredients and non-functional constituents; safety of finished products. Sec. 103. Good manufacturing practices for cosmetics. Sec. 104. Adverse event reports. Sec. 105. Records inspection; mandatory recall authority. Sec. 106. Labeling. Sec. 107. Coal tar chemicals. Sec. 108. Animal testing alternatives. Sec. 109. Preemption. Sec. 110. Reporting. Sec. 111. Small businesses. Sec. 112. Applicability with respect to certain cosmetics. Sec. 113. Enforcement. Sec. 114. Consumer information. TITLE II—Fees related to cosmetic safety Sec. 201. Findings. Sec. 202. Authority to assess and use cosmetic safety fees. Sec. 203. Direct hiring authority to support activities related to cosmetics. I Cosmetic safety 101. Registration of cosmetics facilities and cosmetic ingredient statements (a) Amendments Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 604. Definitions In this chapter: (1) Cosmetic formulation The term cosmetic formulation (2) Cosmetic product The term cosmetic product (3) Facility The term facility (A) beauty shops and salons that do not otherwise manufacture, process, or package cosmetics at that location; (B) cosmetic product retailers, including individual sales representatives, retail distribution facilities, and pharmacies, that do not otherwise manufacture, process, or package cosmetics at that location; (C) hospitals, physicians’ offices, and health care clinics; (D) public health agencies and other nonprofit entities that provide cosmetics directly to the consumer; (E) hotels and other entities that provide complimentary cosmetics to guests; (F) trade shows and other venues where cosmetic product samples are provided free of charge; (G) domestic manufacturers with less than $100,000 in gross annual sales of cosmetic products; or (H) entities that manufacture or compound cosmetic products solely for use in research, teaching, or pilot plant production and not for sale. (4) Foreign facility The term foreign facility (5) Non-functional constituent The term non-functional constituent (6) Responsible person The term responsible person (A) the brand owner who is the domestic or foreign manufacturer, packer, or entity whose name appears on a cosmetic product label of a cosmetic product distributed in the United States, except for entities described in subparagraphs (A) through (H) of paragraph (3); or (B) a contract manufacturer who provides cosmetic products to the entities described in subparagraphs (A) through (H) of paragraph (3). . 605. Registration of cosmetic facilities (a) Registration and fees for existing manufacturing or processing of cosmetics (1) Registration, in general Not later than December 1, 2015, and at a similar time in each subsequent year, as determined by the Food and Drug Administration, each responsible person engaged in manufacturing or processing a cosmetic product or a cosmetic formulation distributed in the United States shall register all of the responsible person’s facilities with the Food and Drug Administration. (2) Fees If the average gross annual sales in the United States of cosmetic products of all of the responsible person’s facilities registered under paragraph (1) for the previous 3-year period is greater than $500,000, a registration shall not be complete under this subsection until the responsible person has paid any registration fee required under section 744L. (b) Registration for existing packing or holding of cosmetics Not later than December 1, 2015, and at a similar time once every 3 years thereafter, as determined by the Food and Drug Administration, each person who owns or operates a cosmetic facility or facilities engaged in packing or holding a cosmetic product distributed in the United States shall register each such facility with the Food and Drug Administration. (c) Registration by new facilities Any facility first engaging after the date of enactment of the Personal Care Products Safety Act (d) Changes to information A registrant who has submitted a registration under this section shall notify the Food and Drug Administration of any change to the information required under subsection (a) or (b) not later than 60 days after the date of such change, unless otherwise specified by the Food and Drug Administration. (e) Format; contents (1) Electronic format Each registration shall be submitted using an electronic format, as specified in a registration form provided by the Food and Drug Administration. (2) Contents The registration shall contain the following information: (A) Each facility’s name and full address, identifying the precise physical location of the facility. (B) The identity of the facility, including the unique facility identifier, if any, previously assigned by the Food and Drug Administration to the facility under subsection (g). (C) All business trading names used by the facility. (D) The product category or categories of each cosmetic product or cosmetic formulation manufactured, processed, packed, or held at the facility or on whose label the facility’s name and address appear. (E) The type of activity conducted at the facility (such as manufacturing, processing, packing, or holding). (F) The name, title, street address, telephone number, and electronic contact information of the emergency contact for the facility. (G) In the case of a foreign facility, the name, street address, telephone number, emergency contact information for the facility, the name of the United States agent for the facility, and, if available, the electronic contact information of the United States agent. (H) The name, title, street address, telephone number, and electronic contact information of the individual submitting the registration. (I) An assurance that the Food and Drug Administration will be permitted to inspect such facility at the times and in the manner permitted by this Act. (J) Additional information pertaining to the facility or to the cosmetic products or cosmetic formulations manufactured, processed, packed, or held at the facility, or on whose label the facility’s name and address appear, including all brand names known to consumers, as the Food and Drug Administration may require by regulation. (3) Abbreviated registration The Food and Drug Administration shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information with respect to the facility or facilities involved since the registrant submitted the preceding registration. (f) Incomplete or inaccurate registration (1) In general Not earlier than 10 days after providing notice of the intent to cancel a registration and the basis for such cancellation, the Food and Drug Administration may cancel a registration under this section if the Food and Drug Administration has reasonable grounds to believe that the registration was not properly completed or updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information. (2) Timely update or correction If, not later than 7 days after receipt of a notice of intent to cancel, the sponsor corrects the registration in accordance with the basis for the cancellation, and the required registration fee, if any, is paid, the Food and Drug Administration shall not cancel such registration. (g) Unique identifier At the time of the initial registration of any cosmetic facility under this section, the Food and Drug Administration shall assign a unique identifier to the facility. (h) Registry of facilities (1) In general The Food and Drug Administration shall compile, maintain, and update a registry of facilities that are registered under this section, and shall remove from such registry the name of any facility whose registration under this section is cancelled. The registry shall be publicly available. (2) Public availability exceptions Information derived from the registry or registration documents that discloses the residential address of a registrant or that discloses specific facilities where specific cosmetic products are manufactured or processed shall not be subject to disclosure under section 552 of title 5, United States Code. 606. Cosmetic ingredient statements (a) In general For each cosmetic product, the responsible person shall submit to the Food and Drug Administration a cosmetic ingredient statement, at such time and in such manner as the Food and Drug Administration may prescribe. The cosmetic ingredient statement shall not become effective until the responsible person pays any applicable fee required under section 744L. (b) Submission of a cosmetic ingredient statement (1) Existing cosmetic products In the case of a cosmetic product that is marketed on the date of enactment of the Personal Care Products Safety Act (2) Cosmetic ingredient statement for new cosmetic products (A) In general Except as provided under subparagraph (B), in the case of a cosmetic product that is first marketed after the date of enactment of the Personal Care Products Safety Act (B) Small businesses The Food and Drug Administration shall allow a responsible person that is a business that meets the applicable industry-based small business size standard established by the Administrator of the Small Business Administration under section 3 of the Small Business Act to have a period longer than 60 days to submit an initial new cosmetic ingredient statement under subparagraph (A). Such responsible person shall submit a cosmetic ingredient statement annually thereafter. (C) Definition A cosmetic product shall not be considered first marketed or reformulated after the date of enactment under subparagraph (A) if the only change in such product is in— (i) the amount of an existing ingredient if it is within the range previously reported under subsection (c)(2)(E); or (ii) the addition or subtraction of a fragrance, flavor, or color, or such other interchangeable ingredients specified by the Food and Drug Administration in regulations or guidance, previously reported as a potential ingredient under subsection (c)(2)(E), if, in the case of such an addition, the amount is within the range previously reported. (c) Format; contents (1) Form For each cosmetic product, the cosmetic ingredient statement shall be submitted using an electronic format, as specified in a cosmetic and ingredient form provided by the Food and Drug Administration. (2) Contents The cosmetic ingredient statement shall include the following information: (A) The unique identifier, assigned under section 605(g), as applicable, of— (i) the facility or facilities where the cosmetic product is manufactured, processed, packed, or held or, if the same cosmetic product is manufactured, processed, packed, or held in more than one facility, the unique facility identifier of each facility where it is manufactured, processed, packed, or held; and (ii) the facility whose name and address appear on the label, unless the statement is filed by a contract manufacturer, described in section 604(6)(B). (B) The brand name and the full name for the cosmetic product as it appears on the label. (C) The cosmetic product listing number, if any, previously assigned by the Food and Drug Administration under subsection (f) to the cosmetic product. (D) The applicable cosmetic category for the cosmetic product. (E) A list of ingredients in the cosmetic product, including a range of possible amounts of each ingredient, and with each ingredient identified by the name adopted in regulations promulgated by the Food and Drug Administration, if any, or by the common or usual name of the ingredient. The cosmetic ingredient statement shall contain— (i) a list of fragrances, flavors, and colors that may be included in the product, interchangeably, with ranges of possible amounts, which shall include— (I) in the case of fragrances that are purchased from a fragrance supplier, the fragrances shall be identified by the name or code provided by the supplier, and include the name and contact information for the fragrance supplier; (II) in the case of flavors that are purchased from a flavor supplier, the flavors shall be identified by the name or code provided by the supplier, and include the name and contact information for the flavor supplier; and (III) in the case of a notification provided by the Food and Drug Administration to the responsible person for the cosmetic manufacturer, the Food and Drug Administration may request, from the fragrance or flavor supplier, the complete list of ingredients in specific fragrances or flavors and the supplier shall have 30 days to provide such list to the Food and Drug Administration; and (ii) other appropriate interchangeable ingredients as the Food and Drug Administration may specify in regulations or guidance that may be included in the product, with ranges of possible amounts. (F) The title and full contact information of each individual submitting the statement. (G) If applicable, information on the labeling required under section 614. (H) Such additional information pertaining to the cosmetic product as the Food and Drug Administration may require. (3) Cosmetic ingredient statement for certain small businesses (A) In General Notwithstanding any other provision of this subsection, the Food and Drug Administration may permit a simplified cosmetic ingredient statement under this section for a responsible person that— (i) is a business that meets the applicable industry-based small business size standard established by the Administrator of the Small Business Administration under section 3 of the Small Business Act; and (ii) has had an average of less than $500,000 in annual domestic cosmetic sales over the previous 3 years. (B) Contents A responsible person described in subparagraph (A) shall include in each cosmetic ingredient statement under this section, at a minimum, a list of ingredients in the cosmetic product and the applicable cosmetic category for the cosmetic product. (d) Incomplete or inaccurate cosmetic ingredient statement (1) In general Not earlier than 10 days after providing notice under paragraph (2), the Food and Drug Administration may nullify a cosmetic ingredient statement filed under this section if the Food and Drug Administration has reasonable grounds to believe that the cosmetic ingredient statement was not completed or updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information. (2) Notice of nullification A nullification under paragraph (1) shall be preceded by notice to the responsible person of the intent to cancel the cosmetic ingredient statement and the basis for such cancellation. (3) Timely update or correction If the cosmetic ingredient statement is appropriately updated or corrected not later than 7 days after notice is provided under paragraph (1), the Food and Drug Administration shall not nullify such cosmetic ingredient statement. (e) Additional requirements (1) Safety requirements In filing each cosmetic ingredient statement cosmetic product, the responsible person shall include an attestation that the safety of the product, including the individual ingredients of such product and the product as a whole, has been substantiated in accordance with section 609. In the case of a cosmetic ingredient statement that includes a range of possible amounts (as described in subsection (c)(2)(E)), the responsible person shall include an attestation that the safety of the full range in the finished product has been substantiated, in accordance with section 609. (2) Abbreviated filing The Food and Drug Administration shall provide for an abbreviated renewal process for any such filing with respect to which there has been no change since the responsible person submitted the previous filing. (3) Changes to information (A) In General Except as provided in subparagraph (B), the responsible person shall notify the Food and Drug Administration within 60 days of any change to the information required to be in a cosmetic ingredient statement, including discontinuation of the manufacture of a cosmetic product, except that notification under this paragraph is not required for a change in— (i) the amount of an existing ingredient if it is within the range previously reported under subsection (c)(2)(E); or (ii) the addition or subtraction of a fragrance, flavor, or color, or such other interchangeable ingredients specified by the Food and Drug Administration in regulations or guidance, previously reported as a potential ingredient under subsection (c)(2)(E), if, in the case of an addition of such an ingredient, the amount is within the range previously reported. (B) Small business The Food and Drug Administration shall allow a responsible person that is a business that meets the applicable industry-based small business size standard established by the Administrator of the Small Business Administration under section 3 of the Small Business Act to have a period longer than 60 days, but not longer than the next annual registration deadline under section 605(a)(1), to submit any change to the information required to be in a cosmetic ingredient statement as described in subparagraph (A). (f) Cosmetic products list At the time of the initial submission of any cosmetic ingredient statement under this section, the Food and Drug Administration shall assign a unique cosmetic product listing number to the cosmetic ingredient statement. Based on such cosmetic ingredient statements, the Food and Drug Administration shall compile and maintain a list of cosmetic products distributed in the United States, including the ingredients of each such product, and shall make available such list to any State, upon request. Information disclosed to a State that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated as a trade secret and confidential information by the State. 607. Suspension of registration or cosmetic ingredient statement (a) Suspension of registration of a facility If the Food and Drug Administration determines that a cosmetic formulation or cosmetic product manufactured, processed, packed, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans, and there is reason to believe that other formulations or products manufactured, processed, packed, or held by the facility may be similarly affected because of a failure affecting multiple products in that facility, the Food and Drug Administration may suspend the registration of a facility. (b) Suspension of cosmetic ingredient statement If the Food and Drug Administration determines that a cosmetic product manufactured in a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans, the Food and Drug Administration may suspend the cosmetic ingredient statement of that product. (c) Notice of suspension Before suspending a facility registration or a cosmetic ingredient statement under this section, the Food and Drug Administration shall provide— (1) notice to the facility registrant of the cosmetic product or formulation or other responsible person, as appropriate, of the intent to suspend the facility registration or the cosmetic ingredient statement, which shall specify the basis of the determination by the Food and Drug Administration that the facility or the cosmetic ingredient should be suspended and recommendations for specific actions to avoid suspension; and (2) an opportunity, within 2 business days of the notice provided under paragraph (1), for the responsible person to address the reasons for possible suspension of the facility registration or cosmetic ingredient statement. (d) Reinstatement Upon a determination by the Food and Drug Administration that adequate grounds do not exist to continue the suspension actions, the Food and Drug Administration shall promptly vacate the suspension and reinstate the registration of the facility or the cosmetic ingredient statement. (e) Effect of suspension (1) Registration If the registration of a facility is suspended under this section, no person shall import or export cosmetics or otherwise distribute cosmetics from such facility. (2) Cosmetic ingredient statement If the cosmetic ingredient statement for a cosmetic product is suspended under this section, no person shall import or export such cosmetic product or otherwise distribute in the United States such cosmetic product that is the subject of such statement. (f) 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 Commissioner. . 102. Review of ingredients and non-functional constituents; safety of finished products (a) Amendments Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 608. Review of ingredients and non-functional constituents (a) Ingredients and non-Functional constituents subject to review (1) In general Beginning in fiscal year 2016, the Food and Drug Administration shall review the safety of the cosmetic ingredients and non-functional constituents under paragraph (3), as modified under subsection (c), if applicable, and issue an order under subsection (d) with respect to the use of each such ingredient and presence of each such non-functional constituent. (2) Public notice and comment At the initiation of the review of each cosmetic ingredient or non-functional constituent, the Food and Drug Administration shall open a docket for the submission of public comment and additional data relevant to the safety of the ingredient or non-functional constituent. The Food and Drug Administration shall provide 60 days for public comment. (3) Cosmetic ingredients (A) Ingredients to be considered in first year During fiscal year 2016, the Food and Drug Administration shall initiate the review for safety of the following cosmetic ingredients: (i) Diazolidinyl urea. (ii) Lead acetate. (iii) Methylene glycol/methanediol/formaldehyde. (iv) Propyl paraben. (v) Quaternium-15. (B) Ingredients to be considered in subsequent years (i) In general Beginning in fiscal year 2017, the Food and Drug Administration shall annually select and complete a review of at least 5 cosmetic ingredients or non-functional constituents that were not reviewed in the prior 3 years from a list determined in consultation with industry and consumer groups for review of safety. The Food and Drug Administration may modify such list under subsection (c). (ii) Considerations The determination of which ingredients or functional ingredients will be reviewed in a given year shall be publicized in annual reports to Congress and the public, in accordance with section 618, and subject to consultation as provided for in clause (iii). The review of any cosmetic ingredient or non-functional constituent shall commence with a public announcement by the Food and Drug Administration and the opening of a docket as required under paragraph (2). (iii) Consultation The Food and Drug Administration shall establish a Cosmetics Safety Advisory Committee, which shall include equal numbers of individuals from the cosmetics industry and consumer groups, and other individuals, as the Food and Drug Administration determines appropriate, including medical practitioners. Such advisory committee shall advise the Food and Drug Administration on cosmetic ingredients and non-functional constituents to be considered for review, summarize public comments received pursuant to paragraph (4), and recommend 5 cosmetic ingredients or non-functional constituents to be reviewed for safety each year, as described in clause (i). The Food and Drug Administration may consult with the Cosmetics Safety Advisory Committee on other matters pertaining to cosmetic safety. (4) Comment period As part of the annual reporting to Congress and the public under section 618, the Food and Drug Administration shall solicit public comment on which cosmetic ingredients or non-functional constituents on the list are of greatest interest to be reviewed next for early review and which additional cosmetic ingredients or non-functional constituents should be added to the list. The public may submit comments to the Food and Drug Administration at any time during the year regarding which cosmetic ingredients or non-functional constituents of interest that the Food and Drug Administration may consider during that year or subsequent years. (b) List The Food and Drug Administration shall maintain a list, posted on the Internet website of the Food and Drug Administration, of the cosmetic ingredients and non-functional constituents for which final orders have been issued under subsection (d)(3), the finding made for each such ingredient or non-functional constituent under subsection (d)(4), as modified by any order under subsection (f), and, if applicable, compliance dates that are the subject of a final order under subsection (e). (c) Initiative of the FDA The Food and Drug Administration may at any time, after consultation with the Cosmetics Safety Advisory Committee, propose the issuance of an order on the safety of a cosmetic ingredient or non-functional constituent that was not previously listed in subsection (a) or under section 618(a)(3). (d) Determination on safety (1) Initial proposed administrative order Following consideration of data and comments to the public docket and any other information before the Food and Drug Administration, the Food and Drug Administration shall determine whether there is adequate evidence to make an initial finding on the safety of the ingredient or non-functional constituent. If the Food and Drug Administration determines that there is adequate evidence, the Food and Drug Administration shall issue a proposed administrative order and shall post such order on the Internet website of the Food and Drug Administration, notwithstanding subchapter II of chapter 5 (2) Public comment Upon publication of the proposed administrative order described in paragraph (1), the Food and Drug Administration shall open a docket for the submission of public comment. The Food and Drug Administration shall provide 30 days for public comment following publication of the proposed administrative order. (3) Final administrative order Following the public comment period described in paragraph (2) and consideration of comments to the public docket and any other information before the Food and Drug Administration, the Food and Drug Administration shall determine whether there is adequate evidence to make a final finding on the safety of the ingredient or non-functional constituent. If the Food and Drug Administration determines that there is adequate evidence, the Food and Drug Administration shall issue a final administrative order and shall post such order on the Internet website of the Food and Drug Administration, notwithstanding subchapter II of chapter 5 (4) Determinations In the proposed administrative order or the final administrative order, as applicable, the Food and Drug Administration shall make a determination that the ingredient or non-functional constituent is— (A) safe in cosmetic products under specified conditions of use or tolerances; (B) safe in cosmetic products without the need for specified conditions of use or tolerances; or (C) not safe in cosmetic products. (5) Conditions of use and tolerances An order under paragraph (4)(A) shall include such conditions on the use of an ingredient or such tolerances on the presence of a non-functional constituent as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent, including— (A) limits on the amount or concentration of the ingredient or non-functional constituent that may be present in a cosmetic product, including limits in products intended for children and other vulnerable populations, and limits on use near the eye or mucosal membranes; (B) warnings that are necessary or appropriate under section 614, including warnings related to use by children, pregnant women, populations with high exposure to the ingredient (such as workers who are exposed through production practices or handling of final products), or other vulnerable populations, to help ensure safe use of cosmetic products containing the ingredient or non-functional constituent; and (C) such other conditions as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent. (6) Public notice A final order under this subsection shall set forth the determination of the Food and Drug Administration on safety, any conditions of use or tolerances under subparagraph (A) or (B) of paragraph (4) and a summary of the valid scientific evidence supporting the finding. The order shall be effective upon its publication on the Internet website of the Food and Drug Administration and shall be considered final agency action. (e) Order If the Food and Drug Administration issues a final administrative order under subparagraph (A) or (C) of subsection (d)(4), the Food and Drug Administration shall, at the same time as publication of the notice under subsection (d)(6), publish a proposed order identifying dates by which use of the ingredient or non-functional constituent in cosmetic products shall comply with the final administrative order, and provide 60 days for public comment, including comment on whether compliance is feasible within the proposed dates. After considering comments on the proposed order, the Food and Drug Administration shall publish in the Federal Register a final order. (f) Modification of an order An order issued under subsection (d) or (e) may be modified or revoked by the Food and Drug Administration on the initiative of the Food and Drug Administration or in response to a petition. (g) Inadequate evidence (1) Notice; Extension If the Food and Drug Administration determines that the available data and information are not adequate to make a proposed or final determination regarding safety under subsection (d)(4), with respect to a cosmetic ingredient or non-functional constituent, the Food and Drug Administration shall— (A) publish such finding on the Internet website of the Food and Drug Administration not later than 90 days after the close of the relevant comment period for the ingredient or non-functional constituent under subsection (a)(2), in the case of a proposed order, or subsection (d)(2), in the case of a final order; and (B) (i) include a notice providing interested persons an additional 30 days from the notice date to provide additional data and information; and (ii) if, after the 30-day period under clause (i), the Food and Drug Administration determines that additional safety substantiation with respect to such ingredient or non-functional constituent is necessary to make a safety determination, include a notice specifying an additional time period, not to exceed 18 months from the notice date, and plan to obtain such data and information. (2) Determination; Order (A) Inadequate data and information If the Food and Drug Administration determines, after considering any additional data and information submitted under paragraph (1)(B), that the available data and information still are not adequate to make a determination regarding safety under subsection (d)(4), the Food and Drug Administration shall, within 90 days of the close of the additional time period provided under paragraph (1)(B), issue a proposed order or a final administrative order— (i) making a determination that the ingredient or non-functional constituent has not been shown to be safe in cosmetic products; and (ii) explaining why the available data and information are not adequate to assess the safety of the ingredient or non-functional constituent. (B) Adequate data and information If the Food and Drug Administration determines, after considering any additional data and information submitted under paragraph (1)(B), that the available data and information are adequate to make a determination regarding safety under subsection (d)(4), the Food and Drug Administration shall, within 180 days of the close of the comment period, issue a proposed order, followed by a final order, on such cosmetic ingredient or non-functional constituent, in accordance with such subsection. (h) Safety assessment (1) In general In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider whether there is adequate evidence to support a reasonable certainty among competent scientists that the ingredient is not harmful under the recommended or suggested conditions of use or customary or usual use, or that a non-functional constituent is not harmful under the recommended or suggested tolerance levels or the level at which it is customarily or usually present. The Food and Drug Administration may not consider an ingredient or non-functional constituent harmful solely because it can cause minor adverse health reactions, such as minor transient allergic reactions or minor transient skin irritations, in some users. (2) Factors In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider, among other relevant factors, the following: (A) The probable human exposure to the ingredient or non-functional constituent from expected use in cosmetics. (B) The probable cumulative and aggregate effect in humans of relevant exposure to the ingredient or non-functional constituent or to any chemically or pharmacologically related substances from use in cosmetics or other products with similar routes of exposure under recommended or suggested conditions of use or their customary use, to the extent adequate data is available for analysis. In appropriate cases, the Food and Drug Administration may consider available information on the total exposure to an ingredient or non-functional constituent from all sources. (C) Whether warnings or recommendations in a product label, as part of any conditions of use or tolerances imposed by the Food and Drug Administration, would be necessary and appropriate to help ensure the safety of the ingredient or non-functional constituent. (3) Data and information (A) Required information A determination that an ingredient or non-functional constituent is safe in cosmetics shall be based upon adequate evidence submitted or otherwise known to the Food and Drug Administration, which shall include full reports of all available studies, published or unpublished, that are adequately designed to show whether the ingredient or non-functional constituent is safe. Such studies may include in vitro and in silico studies and epidemiological studies, biomonitoring studies, and studies focused on various points during the lifespan of the subject, that use scientifically valid methodology. (B) Additional relevant information The Food and Drug Administration shall consider any other relevant information related to the safety of the ingredient or non-functional constituent, including— (i) adverse event reports; (ii) findings and information from State, Federal, national, and international entities and other bodies composed of scientific and medical experts; (iii) if the ingredient or non-functional constituent is lawfully used or present in other products regulated by the Food and Drug Administration, the scientific basis for such use; and (iv) experience with the ingredient or non-functional constituent in products that are distributed in the United States or in other countries, if such experience is well-documented and has resulted in substantial human exposure to the ingredient or non-functional constituent over time. . 609. Safety of finished cosmetic products (a) Determination (1) In general Each responsible person for a finished cosmetic product shall, before first distributing the product for sale, make a written determination that the product is safe under the conditions of use recommended in the labeling of the product. Such determination shall be based on adequate evidence that each ingredient in the finished product is safe for the use recommended or suggested in the labeling of the product and that the finished product is safe. (2) New information If new information relevant to the determination becomes available, the responsible person shall promptly update the determination to address that information. (3) Safety with respect to ranges of possible amounts In the case of a cosmetic product for which there is a range of possible amounts of cosmetic ingredients included in the cosmetic ingredient statement, as described in section 606(c)(2)(E), the safety determination under paragraph (1) shall include substantiation of the safety of the full range in the finished product. (b) Presumption of adequate evidence (1) In general Except as provided in subsection (c), a determination made under subsection (a) shall be presumed to be based on adequate evidence if it is supported by— (A) with respect to each ingredient in the finished product— (i) 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 (ii) appropriate safety testing of the ingredient; and (B) appropriate safety substantiation of the finished product beyond the safety substantiation of individual ingredients and consideration of the combination of ingredients. (2) Statement of an expert medical or scientific body For purposes of this section, a statement of an expert medical or scientific body is an official statement of that body, if— (A) the medical or scientific body is a Federal, State, national, or international entity with recognized expertise in chemical or cosmetic safety, or other similarly recognized body composed of scientific and medical experts; (B) the statement is based upon adequate data to support the finding of safety, and such data are available to the Food and Drug Administration; and (C) 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 employee. (c) Rebuttal of presumption Notwithstanding subsection (b), a determination under subsection (a) will not be presumed to be based on adequate evidence if— (1) the Food and Drug Administration issues an order under section 608 that an ingredient or non-functional constituent in the finished product is not safe under the product’s conditions of use or customary or usual use; or (2) the Food and Drug Administration has provided the manufacturer with notice that— (A) the manufacturer has not met the criteria under subsection (b); or (B) the Food and Drug Administration has information that raises significant questions about the safety of the product or any of its ingredients. (d) Timely update Upon notice of inadequate evidence under subsection (c), the responsible person shall have 10 days to submit additional evidence to the Food and Drug Administration regarding the safety of an ingredient, non-functional constituent, or the entire cosmetic product, and the Food and Drug Administration shall have 30 days from the date of receipt of such additional evidence to provide the responsible person with notice that the criteria under subsection (b) have been met or not met. (e) Records maintenance The responsible person shall maintain records documenting the determination required under this section and the information on which it is based until 5 years after the finished product is no longer marketed. (f) Submission of records (1) In general The records required under subsection (e) shall, upon the written request of the Food and Drug Administration to the responsible person, be provided to the Food and Drug Administration within a reasonable timeframe not to exceed 60 days, in either electronic or paper form. (2) Criteria The Food and Drug Administration may require records under paragraph (1) if— (A) the Food and Drug Administration has a reasonable belief, described in written notice, that— (i) the finished product may be harmful based on adverse event reports or other scientific information; (ii) scientific information raises credible and relevant questions about the safety of the product or any of its ingredients; (iii) the responsible person has not made the determination required under subsection (a), or such determination is not supported by adequate evidence; or (iv) one or more of the criteria to establish a presumption of adequate evidence of safety in subsection (b) has not been satisfied; (B) the Food and Drug Administration, an expert regulatory body, 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 product; or (C) the Food and Drug Administration concludes that submission of the records will serve the public health or otherwise enable the Food and Drug Administration to fulfill the cosmetic safety purposes of this section. (g) Guidance and regulations (1) In General The Food and Drug Administration shall issue guidance describing the evidence necessary to support a determination under subsection (a), and may, by regulation, establish exemptions to the requirements of this section, if the Food and Drug Administration determines that such exemptions are supported by adequate evidence and would have no adverse effect on public health. (2) Small businesses The Food and Drug Administration shall, after consultation with the Small Business Administration and small businesses that manufacture cosmetics, provide additional guidance for small businesses on compliance with the requirements of this section. Such guidance shall include specific examples of options for compliance that do not place an undue burden on small businesses. . (b) Effective date Section 609 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall take effect 180 days after the date of enactment of this Act. 103. Good manufacturing practices for cosmetics (a) In general Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 610. Good manufacturing practices for cosmetics (a) In general The Food and Drug Administration shall review national and international standards for cosmetic good manufacturing practices that are in existence on the date of enactment of the Personal Care Products Safety Act (b) Timeframe The Food and Drug Administration shall publish a proposed rule described in subsection (a) not later than 18 months after the date of enactment of the Personal Care Products Safety Act . (b) Effective date for cosmetic manufacturers (1) Large businesses For businesses of a size greater than the Small Business Administration’s standard for a small business, section 610 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall take effect beginning 180 days after the date on which the Food and Drug Administration makes effective cosmetic good manufacturing practices. (2) Small businesses For businesses of a size that meets the Small Business Administration’s standard for a small business, section 610 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall take effect beginning 2 years after the date the Food and Drug Administration makes effective cosmetic good manufacturing practices. (c) Enforcement Section 601 of Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 (f) If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to current good manufacturing practice, as prescribed by the Food and Drug Administration. . 104. Adverse event reports Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 611. Adverse event reporting for cosmetics (a) In general With respect to any cosmetic product distributed in the United States, the responsible person shall submit to the Food and Drug Administration a report of any serious adverse event associated with such cosmetic product, when used in the United States, accompanied by a copy of the label on or with the retail packaging of the cosmetic, any new medical information, related to a submitted serious adverse event report that is received by the responsible person, and an annual report for all adverse events received by the responsible person. (b) Definitions In this section: (1) An adverse event (2) A serious adverse event (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) congenital anomaly or birth defect; or (vi) significant disfigurement, including serious and persistent rashes and infections; or (B) requires, based on appropriate medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A). (c) Submission of reports (1) Serious adverse event reports Except as provided in paragraph (2), the responsible person shall submit a serious adverse event report to the Food and Drug Administration not later than 15 business days after information concerning the adverse event is received. If a serious adverse event report for a cosmetic with drug properties is filed using Form FDA 3500A (or any successor form developed for such purpose) or its electronic equivalent for over-the-counter drugs, the responsible person shall not have to submit a duplicative serious adverse event report under this section. (2) New medical information The responsible person shall submit to the Food and Drug Administration any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, and shall submit such information not later than 15 business days after the new information is received by the responsible person. (3) Annual report (A) In general Not later than March 1 of each year, the responsible person shall submit an electronic report for the prior calendar year for each cosmetic product marketed during that year. (B) Contents Each report under this paragraph shall contain a summary of all adverse events received during the reporting period, a complete list of individual reports, and an estimate of the total number of product units estimated to have been distributed to consumers during such period. The report shall not include consumer complaints that are solely regarding efficacy and do not contain any information about an adverse event. The Food and Drug Administration shall further specify the contents of the annual electronic report by regulation or guidance. (4) Exemption The Food and Drug Administration may establish by regulation an exemption to any of the requirements under this subsection if the Food and Drug Administration determines that such exemption is supported by adequate evidence and would have no adverse effect on public health. (d) Requirements (1) In general Each serious adverse event report under this section shall be submitted to the Food and Drug Administration using an electronic system of the Food and Drug Administration. The Food and Drug Administration shall make such electronic system available not later than 1 year after the date of enactment of the Personal Care Products Safety Act (2) Modification The format of the reporting system may be modified by the Food and Drug Administration and the reports may include additional information. The Food and Drug Administration may, in guidance, further specify the format and contents of required reports. (3) Scope of serious adverse event report A serious adverse event report (including all information submitted in the initial report or added later) submitted to the Food and Drug Administration under subsection (a) includes— (A) a report under section 756 with respect to safety and related to a specific cosmetic product; (B) a record about an individual who suffered the serious adverse event under section 552a of title 5, United States Code; (C) a medical or similar file documenting the serious adverse event, the disclosure of which would constitute a violation of section 552(b)(6) of such title 5, and shall not be publicly disclosed unless all personally identifiable information is redacted; and (D) contact information for the individual reporting the serious adverse event. (4) Responsibility to gather information After an individual initiates the reporting of a serious adverse event, the responsible person for the cosmetic product shall actively gather all of the information to complete and file the report with the Food and Drug Administration. (5) No adverse events to report The Food and Drug Administration shall provide an option as part of the electronic registration process for the responsible person to indicate if such responsible person had no adverse events to report over the previous year. With respect to a responsible person who received no adverse event reports for a year, the annual adverse event report requirement may be met by indicating no such events on the annual registration form. (e) Limitation with respect to adverse event reports The submission of an adverse event report in compliance with subsection (a) shall not constitute an admission that the cosmetic involved caused or contributed to the adverse event. (f) Contact information The label of a cosmetic shall bear the domestic telephone number or electronic contact information, and it is encouraged that the label include both the telephone number and electronic contact information, through which the responsible person may receive a report of an adverse event. (g) Maintenance of records The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years. (h) Availability to States The Food and Drug Administration shall make available records submitted under this section to any State, upon request. Information disclosed to a State that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated as a trade secret and confidential information by the State. (i) Effective date of requirement with respect to serious adverse events The requirement under this section to report serious adverse events shall become effective on the date that the Food and Drug Administration publicizes the availability of the electronic system described in subsection (d)(1). . 105. Records inspection; mandatory recall authority Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 612. Inspection of cosmetic records (a) Inspection of records Each manufacturer, processor, packer, or holder of a cosmetic shall, at the request of an officer or employee duly designated by the Food and Drug Administration, permit such officer or employee, upon presentation of appropriate credentials and written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy— (1) all records maintained under section 611 and in accordance with the rules promulgated by the Food and Drug Administration under section 610, as applicable; and (2) except as provided in subsection (b), all other records, if the Food and Drug Administration— (A) has a reasonable belief that the cosmetic— (i) is adulterated; (ii) has caused a reportable serious adverse event; or (iii) contains an ingredient that substantial new scientific information shows may be unsafe when present in a cosmetic; and (B) provides written notice of the basis for the Food and Drug Administration’s reasonable belief described in subparagraph (A). (b) Exclusions No inspection authorized by this section shall extend to financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this Act), research data (other than safety data) or sales data other than shipment data. (c) Scope The requirements under subsection (a) apply to records maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location. (d) Protection of sensitive information The Food and Drug Administration shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Food and Drug Administration pursuant to this section. Information disclosed to a State that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated as a trade secret and confidential information by the State. (e) Limitations This section shall not be construed— (1) to limit the authority of the Food and Drug Administration to inspect records or to require establishment and maintenance of records under any other provision of this Act; or (2) to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code. . 613. Mandatory recall authority (a) Voluntary procedures If the Food and Drug Administration determines that there is a reasonable probability that a cosmetic is adulterated under section 601 or misbranded under section 602 and the use of or exposure to such cosmetic is likely to cause serious adverse health consequences or death, the Food and Drug Administration shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. (b) Prehearing order To mandatorily cease distribution and give notice (1) In general If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and in the manner prescribed by the Food and Drug Administration, the Food and Drug Administration may order such person to— (A) immediately cease distribution of such cosmetic; and (B) as applicable, immediately notify all persons— (i) manufacturing, processing, packing, transporting, holding, receiving, distributing, or importing and selling such cosmetic; and (ii) to which such cosmetic has been distributed, transported, or sold, to immediately cease distribution of such cosmetic. (2) Required additional information (A) In general If a cosmetic covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of such cosmetic covered by a recall order that is in its possession, the notice provided by the responsible person subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics provider to identify the cosmetic. (B) Rules of construction Nothing in this paragraph shall be construed— (i) to exempt a warehouse-based third party logistics provider from the requirements of this chapter, including the requirements of this section and section 612; or (ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order. (3) Determination to limit areas affected If the Food and Drug Administration requires a responsible person to cease distribution under paragraph (1)(A) of a cosmetic, the Food and Drug Administration may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health. (c) Hearing on order The Food and Drug Administration shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the cosmetic that is the subject of the order should not be recalled. (d) Post-Hearing recall order and modification of order (1) Amendment of order If, after providing opportunity for an informal hearing under subsection (c), the Food and Drug Administration determines that removal of the cosmetic from commerce is necessary, the Food and Drug Administration shall, as appropriate— (A) amend the order to require recall of such cosmetic or other appropriate action; (B) specify a timetable in which the recall shall occur; (C) require periodic reports to the Food and Drug Administration describing the progress of the recall; and (D) provide notice to consumers to whom such cosmetic was, or may have been, distributed. (2) Vacating of order If, after such hearing, the Food and Drug Administration determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Food and Drug Administration shall vacate the order or modify the order. (e) Cooperation and consultation The Food and Drug Administration shall work with State and local public health officials in carrying out this section, as appropriate. (f) Public notification In conducting a recall under this section, the Food and Drug Administration shall— (1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification— (A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and (B) that includes, at a minimum— (i) the name of the cosmetic subject to the recall; (ii) a description of the risk associated with such article; and (iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and (2) ensure publication on the Internet website of the Food and Drug Administration an image of the cosmetic that is the subject of the press release described in paragraph (1), if available. (g) 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. (h) Effect Nothing in this section shall affect the authority of the Food and Drug Administration to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this chapter or under the Public Health Service Act. . 106. Labeling (a) In general Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 614. Labeling (a) Safety review and labeling Following a review of cosmetic ingredients that determines that warnings are required to help ensure safe use of cosmetic products under section 608(d)(5), the Food and Drug Administration shall require labeling of cosmetics that are not appropriate for use in the entire population, including warnings that vulnerable populations, such as children or pregnant women, should limit or avoid using the product. (b) Cosmetic products for professional use (1) Definition of professional With respect to cosmetics, the term professional (A) is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, and or esthetics; (B) has complied with all requirements set forth by the State for such licensing; and (C) has been granted a license by a State board or legal agency or legal authority. (2) Listing of ingredients Cosmetic products used and sold by professionals shall list all ingredients, as required for other cosmetic products under this chapter. (3) Professional use labeling In the case of a cosmetic product intended to be used only by a professional on account of a specific ingredient or increased concentration of an ingredient that requires safe handling by trained professionals, the product shall bear a statement as follows: To be Administered Only by Licensed Professionals (c) Display The warning required under subsection (a) and the statement required under subsection (b)(3) shall be prominently displayed— (1) in the primary language used on the label; and (2) in conspicuous and legible type in contrast by typography, layout, or color with other material printed or displayed on the label. (d) Internet sales In the case of Internet sales of cosmetics, each Internet website offering cosmetic products for sale to consumers shall provide the same information that is included on the packaging of the cosmetic products as regularly available, and the warnings and statements described in subsection (c) shall be prominently and conspicuously displayed on the website. (e) Contact information The label on each cosmetic shall bear the domestic telephone number or electronic contact information, and it is encouraged that the label include both the telephone number and electronic contact information, that consumers may use to contact the responsible person with respect to adverse events. The contact number shall provide a means for consumers to obtain additional information about ingredients in a cosmetic, including the ability to ask if a specific ingredient may be present that is not listed on the label, including whether a specific ingredient may be contained in the fragrance or flavor used in the cosmetic. The manufacturer of the cosmetic is responsible for providing such information, including obtaining the information from suppliers if it is not readily available. Suppliers are required to release such information upon request of the cosmetic manufacturer. . (b) Effective date Section 614 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall take effect on the date that is 1 year after the date of enactment of this Act. 107. Coal tar chemicals Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 615. Coal tar chemicals (a) In general Under section 608, the Food and Drug Administration may review any cosmetic ingredient in order to determine if it is safe in cosmetic products without the need for specified conditions of use or tolerances, safe in cosmetic products under specified conditions of use or tolerances, or not safe in cosmetic products. (b) Coal tar hair dyes Specific chemicals in coal tar hair dyes may be selected and reviewed under section 608(a)(3). . 108. Animal testing alternatives Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 616. Animal testing alternatives (a) In general To minimize the use of animal testing for safety of cosmetic ingredients, non-functional constituents, and finished cosmetic products, the Food and Drug Administration shall— (1) encourage the use of alternative testing methods that provide information that is equivalent or superior in scientific quality to the animal testing method to— (A) not involve the use of an animal to test a chemical substance for safe use in cosmetics; or (B) use fewer animals than conventional animal-based tests for safe use in cosmetics when nonanimal methods are impracticable; and (2) encourage— (A) the sharing of data across companies and organizations that are testing for safety in cosmetics, so as to avoid duplication of animal tests; and (B) funding for research and validation of alternative testing methods. (b) Guidance Not later than 3 years after the date of enactment of the Personal Care Products Safety Act (c) Resources regarding animal testing alternatives Not later than 180 days after the date of enactment of the Personal Care Products Safety Act . 109. Preemption Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 617. Preemption (a) Registration, good manufacturing practices, recalls, adverse event reporting Except for a State requirement that is in full effect and implemented on the date of enactment of the Personal Care Products Safety Act (b) Safety of cosmetic ingredients and non-Functional constituents (1) In general Except for a State requirement that is more restrictive than a final order issued under section 608(d)(3) and that is in full effect and implemented on the date of enactment of the Personal Care Products Safety Act (2) Delayed effect of new State requirements From the date that the Food and Drug Administration has made public the final selection of a cosmetic ingredient or non-functional constituent to be reviewed in the coming year under section 608(a)(3)(B), and opened the public comment period under section 608(a)(2), until the date that is one year after the Food and Drug Administration has made public such selection, no State or political subdivision of a State may establish any new requirement related to such cosmetic ingredient or non-functional constituent. (3) Scope This subsection shall not be construed to modify or affect the authority of a State or political subdivision of a State with respect to such safety requirements unrelated to the scope of the safety assessment under section 608. (4) Sense of Congress It is the sense of Congress that a State or political subdivision that regulates the safety of cosmetics with respect to the health of humans beyond the scope of section 608 should utilize the safety assessment criteria described in section 608(h). (c) State requirement that is in full effect and implemented For purposes of this section: (1) State requirement A State requirement includes a State requirement that is adopted by a State public initiative or referendum. (2) Full effect and implemented The term full effect and implemented Personal Care Products Safety Act Personal Care Products Safety Act (d) Rule of construction regarding product liability Notwithstanding any other provision of this Act, no provision of this chapter relating to a cosmetic shall be construed to modify or otherwise affect any action or the liability of any person under State or Federal common law. (e) Limitation The Personal Care Products Safety Act . 110. Reporting Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 618. Reporting (a) Performance report Beginning with fiscal year 2016, and not later than 60 days prior to the end of each fiscal year for which fees are collected under section 744L, the Food and Drug Administration shall prepare and submit to Congress a report concerning the progress of the Food and Drug Administration in achieving the objectives of the Personal Care Products Safety Act (1) the number of registered facilities and cosmetic ingredient statements on file with the Food and Drug Administration; (2) identification of the cosmetic ingredients and non-functional constituents that have been fully reviewed for safety by the Food and Drug Administration in the prior fiscal year and for which a final administrative order has been released; (3) identification of at least 5 specific cosmetic ingredients and non-functional constituents that will be reviewed by the Food and Drug Administration in the next fiscal year; (4) the number of facilities inspected and mandatory recalls that transpired during that fiscal year; (5) the number of serious adverse event reports received by the Food and Drug Administration during that fiscal year; (6) any trends identified by the Food and Drug Administration about adverse event reports related to specific cosmetic ingredients or non-functional constituents; and (7) efforts of the Food and Drug Administration to reduce animal testing for safety of cosmetic ingredients, non-functional constituents, and cosmetic products. (b) Public availability The Food and Drug Administration shall make the reports required under subsections (a) available to the public on the Internet website of the Food and Drug Administration on the date of submission of such reports to Congress. (c) Public input on safety review Upon release of the report described in subsection (a), the Food and Drug Administration shall provide the public with an opportunity to provide feedback on subsection (a)(3) by— (1) providing an electronic portal, upon release of the report, enabling the public to— (A) recommend additional cosmetic ingredients and non-functional constituents to be considered for review for safety in future years; and (B) comment on the priorities for the specific cosmetic ingredients and non-functional constituents that the Food and Drug Administration anticipates will be reviewed in the next fiscal year; (2) announcing on the Internet website of the Food and Drug Administration, within the first 30 days of the new fiscal year, any amendments to subsection (a)(3) based on public input, pursuant to paragraph (1); and (3) together with the final announcement of 5 specific cosmetic ingredients and non-functional constituents that will be reviewed in the coming year under subsection (a)(3), providing a comment period for further public input, pursuant to section 608(a)(2). . 111. Small businesses Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 619. Small businesses The Commissioner, in coordination with the Administrator of the Small Business Administration, shall provide technical assistance, such as guidance and expertise, to small businesses regarding compliance with the Personal Care Products Safety Act . 112. Applicability with respect to certain cosmetics Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 620. 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 V, if any requirement under chapter V with respect to such cosmetic or facility is substantially similar to a requirement under this chapter, 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 V, provided that the product or facility has not obtained a waiver from the requirement under chapter V. . 113. Enforcement (a) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 (1) in subsection (e)— (A) by striking 504, 564 504, 564, 611, or 612 (B) by striking 519, 564 519, 564, 611, (2) in subsection (j) by inserting 607, 608, 610, 704 (3) in subsection (ii)— (A) by striking 760 or 761) 604, 760, or 761) (B) by striking 760 or 761) submitted 611, 760, or 761) submitted (4) in subsection (xx) by inserting or 613 423 (5) by adding at the end the following: (ddd) The failure to register in accordance with section 605, the failure to submit a cosmetic ingredient statement under section 606, the failure to provide any information required by section 605 or 606, or the failure to update the information required by section 605 or 606, as required. . (b) Adulteration Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 (g) If it contains, after the date prescribed under section 608(e), an ingredient that the Food and Drug Administration has determined under section 608(d)(4) to be not safe, or not safe under the conditions of use recommended or suggested in the label or a non-functional constituent that the Food and Drug Administration has determined under section 608(d)(4) to be not safe or not safe in the amount present in the cosmetic. (h) If it is a cosmetic product for which any requirement of section 609 (relating to safety substantiation) is not met. . (c) Misbranding Section 602 is amended— (1) in subsection (b)— (A) by striking and (2) (2) (B) by inserting ; and (3) a domestic address or a domestic telephone number, and it is encouraged that the label include both a domestic address and a domestic telephone number, through which the responsible person may receive a report of an adverse event associated with the use of such cosmetic product numerical count (2) by adding at the end the following: (g) If it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the responsible person, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. (h) If its labeling does not conform with a requirement under section 614. . (d) Guidance Not later than 1 year after the date of enactment of this Act, the Food and Drug Administration shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 602(g) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c)(2). (e) Imports Section 801(a) is amended— (1) by striking section 760 or 761 section 611, 760, or 761 (2) by striking 760 or 761) 604, 760, or 761) (f) Factory inspection Section 704(a)(1) is amended by inserting after the third sentence the following: In the case of any person who manufactures, processes, packs, holds, distributes, or imports a cosmetic product, or distributes a cosmetic product and affixes its name on the cosmetic label, the inspection shall extend to all records and other information described in section 612 (regarding inspection of cosmetic records), when the standard for records inspections under paragraph (1) or (2) of subsection (a) of such section applies, subject to the limitations under subsection (d) of such section. 114. Consumer information The Food and Drug Administration shall post on its Internet website information for consumers regarding— (1) final orders regarding the safety of a cosmetic ingredient or non-functional constituent under section 608(d)(3); (2) cosmetic product recalls (including voluntary and mandatory recalls); and (3) identified counterfeit cosmetic products. II Fees related to cosmetic safety 201. Findings Congress finds that the fees authorized by the amendments made by this title will be dedicated to cosmetic safety activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 202. Authority to assess and use cosmetic safety fees Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379f et seq. 10 Fees relating to cosmetics 744L. Registration fee (a) Assessment and collection (1) In general Beginning in fiscal year 2016, the Food and Drug Administration shall assess and collect an annual fee from every responsible person (referred to in this section as a registrant (2) Payable date A fee under this section shall be payable during the period of initial registration and on the date of registration each year thereafter as prescribed in section 605(a)(1). (b) Definitions In this section: (1) Adjustment factor The term adjustment factor (2) Affiliate The term affiliate (A) one business entity controls, or has power to control, the other business entity; or (B) a third-party controls, or has the power to control, both of the business entities. (3) Cosmetic safety activities The term cosmetic safety activities (A) means activities related to compliance by registrants under section 605 with the requirements of this Act with respect to cosmetics, including— (i) administrative activities, such as information technology support, human resources, financial management, the administration and maintenance of the cosmetic registration system and the cosmetic ingredient statement system under sections 605 and 606, and fee assessment and collection under this section; and (ii) implementation and enforcement activities, such as the establishment of good manufacturing practices, the review of adverse event reports, inspection planning and inspections, and use of enforcement tools; and (B) includes activities related to implementation of section 608, regarding the review of cosmetic ingredients and non-functional constituents. (4) Gross annual sales The term gross annual sales (c) Fee setting and amounts (1) In general Subject to subsection (d), the Food and Drug Administration shall establish the fees to be collected under this section for each fiscal year after fiscal year 2016, based on the methodology described in paragraph (3)(B), and shall publish such fees in a Federal Register notice not later than 60 days before the beginning of each such fiscal year. (2) Fee exemption Any registrant whose average gross annual sales of cosmetic products in the 3-year period immediately preceding the fiscal year for which the annual fee will be paid was not more than $500,000, shall be exempt from registration fees under this section for that fiscal year. (3) Annual fee setting (A) Fiscal year 2016 For fiscal year 2016, to generate a total estimated revenue amount of $20,600,000, the amount of the registration fee under subsection (a) shall be as follows: (i) Tier I–A For a registrant that has gross annual sales of $5,000,000,000 or more in 2015, $1,100,000. (ii) Tier I–B For a registrant that has gross annual sales of at least $4,000,000,000 per annum but less than $5,000,000,000 in 2015, $840,000. (iii) Tier II–A For a registrant that has gross annual sales of at least $3,000,000,000 per annum but less than $4,000,000,000 in 2015, $720,000. (iv) Tier II–B For a registrant that has gross annual sales of at least $2,000,000,000 per annum but less than $3,000,000,000 in 2015, $600,000. (v) Tier III–A For a registrant that has gross annual sales of at least $1,000,000,000 per annum but less than $2,000,000,000 in 2015, $500,000. (vi) Tier III–B For a registrant that has gross annual sales of at least $500,000,000 per annum but less than $1,000,000,000 in 2015, $395,000. (vii) Tier IV–A For a registrant that has gross annual sales of at least $200,000,000 per annum but less than $500,000,000 in 2015, $325,000. (viii) Tier IV–B For a registrant that has gross annual sales of at least $100,000,000 per annum but less than $200,000,000 in 2015, $275,000. (ix) Tier V–A For a registrant that has gross annual sales of at least $80,000,000 per annum but less than $100,000,000 in 2015, $185,000. (x) Tier V–B For a registrant that has gross annual sales of at least $60,000,000 per annum but less than $80,000,000 in 2015, $95,000. (xi) Tier VI–A For a registrant that has gross annual sales of at least $40,000,000 per annum but less than $60,000,000 in 2015, $15,000. (xii) Tier IV–B For a registrant that has gross annual sales of at least $20,000,000 per annum but less than $40,000,000 in 2015, $12,000. (xiii) Tier VII–A For a registrant that has gross annual sales of at least $2,500,000 per annum but less than $20,000,000 in 2015, $500. (xiv) Tier VII–B For a registrant that has gross annual sales of at least $500,000 per annum but less than $2,500,000 in 2015, $250. (B) Fiscal years 2017–2022 For fiscal years 2017–2022, fees under subsection (a) shall be established to generate a total estimated revenue amount of $20,600,000, as adjusted by subsection (d). Of that amount: (i) Tier I–A Registrants that have gross annual sales of $5,000,000,000 or more in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 10.7 percent. (ii) Tier I–B Registrants that have gross annual sales of at least $4,000,000,000 per annum but less than $5,000,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 4.1 percent. (iii) Tier II–A Registrants that have gross annual sales of at least $3,000,000,000 per annum but less than $4,000,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 3.5 percent. (iv) Tier II–B Registrants that have gross annual sales of at least $2,000,000,000 per annum but less than $3,000,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 2.9 percent. (v) Tier III–A Registrants that have gross annual sales of at least $1,000,000,000 per annum but less than $2,000,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 7.3 percent. (vi) Tier III–B Registrants that have gross annual sales of at least $500,000,000 per annum but less than $1,000,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 13.4 percent. (vii) Tier IV–A Registrants that have gross annual sales of at least $200,000,000 per annum but less than $500,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 15.8 percent. (viii) Tier IV–B Registrants that have gross annual sales of at least $100,000,000 per annum but less than $200,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 13.3 percent. (ix) Tier V–A Registrants that have gross annual sales of at least $80,000,000 per annum but less than $100,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 9 percent. (x) Tier V–B Registrants that have gross annual sales of at least $60,000,000 per annum but less than $80,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 6.9 percent. (xi) Tier VI–A Registrants that have gross annual sales of at least $40,000,000 per annum but less than $60,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 5.1 percent. (xii) Tier VI–B Registrants that have gross annual sales of at least $20,000,000 per annum but less than $40,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 4.4 percent. (xiii) Tier VII–A Registrants that have gross annual sales of at least $2,500,000 per annum but less than $20,000,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 1.2 percent. (xiv) Tier VII–B Registrants that have gross annual sales of at least $500,000 per annum but less than $2,500,000 in the fiscal year immediately preceding the fiscal year in which the annual fee will be paid, shall be responsible, collectively, for 2.4 percent, except that no such registrant shall be responsible for more than $250 per fiscal year. (d) Adjustments (1) Inflation adjustment (A) In general For fiscal year 2017 and each subsequent fiscal year, the revenues and fee amounts under subsection (c)(3)(B) shall be adjusted by the Food and Drug Administration in the annual Federal Register notice establishing fees in subsection (c)(1), by an amount equal to the sum of— (i) one; (ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available; and (iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC6 MD-VA-WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available. (B) Compounded basis The adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2016 under this subsection. (2) Final year adjustment For fiscal year 2022, the Food and Drug Administration may, in addition to adjustments under paragraph (1), further increase the fee revenues and fees established in subsection (c) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover fees for cosmetic safety activities for the first 3 months of fiscal year 2023. If such an adjustment is necessary, the rationale for the increase, shall be contained in the annual Federal Register notice establishing fees, in subsection (c)(1), for fiscal year 2022. If the Food and Drug Administration has carryover balances for such activities in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made. (3) Workload adjustment (A) In general For fiscal year 2017 and each subsequent fiscal year, after fee revenues established in subsection (c)(3)(B) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for each fiscal year to reflect changes in the workload of the Food and Drug Administration for actual changes in workload volume due to the process of reviewing cosmetic ingredients or non-functional constituents not listed under section 608(b). (B) Determination of adjustment The adjustment shall be determined by the Food and Drug Administration based on the workload in the most recent 1-year period for which workload data is available. The Food and Drug Administration shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies. (C) Minimum revenues The adjustment shall not result in fee revenues for a fiscal year that are less than the sum of the amount under subsection (c)(3)(B), as adjusted for inflation under subparagraph (1). (e) Limitations (1) In general With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for the cosmetics program in the Center for Food Safety and Applied Nutrition and related field activities, fees may not be assessed under subsection (a) for the fiscal year unless the amount so appropriated for the fiscal year (excluding the amount of fees appropriated for the fiscal year), is equal to or greater than that assessed for fiscal year 2015, multiplied by the adjustment factor applicable to the fiscal year involved. (2) Authority If the Food and Drug Administration does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Food and Drug Administration may assess such fees, the Food and Drug Administration may assess and collect such fees, without any modification in the rate, for registration under section 605 at any time in such fiscal year. (f) Crediting and availability of fees (1) In general Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. 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 limitation. The sums transferred shall be available solely for cosmetic safety activities. (2) Collections and appropriations acts The fees authorized by this section— (A) In general Subject to subparagraphs (C) and (D), 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 Acts, or otherwise made available for obligation for such fiscal year. (B) Use of fees and limitation The fees authorized by this section shall be collected and available only to defray the costs of cosmetic safety activities. (C) Fee collections during first program year Until the date of enactment of an Act making appropriations through September 30, 2015, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2016 may be collected and shall be credited to such account to remain available until expended. Fees collected under this subparagraph shall be considered discretionary for purposes of the Balanced Budget and Emergency Deficit Control Act of 1985. (D) Reimbursement of start-up amounts Any amounts allocated to establish programs under sections 605 and 606, prior to collection of fees, may be reimbursed through any appropriated fees collected under this section, in such manner as the Food and Drug Administration determines appropriate. Any amounts reimbursed under this subparagraph shall be available for the programs and activities for which funds allocated to establish the programs were available, prior to such allocation, until the end of the fiscal year in which the reimbursement occurs, notwithstanding any otherwise applicable limits on amounts for such program or activities for a fiscal year. (3) Authorization of appropriations For each of fiscal years 2016–2022, there are authorized to be appropriated for fees under this section $20,600,000, as adjusted by subsection (d). (4) Offset of overcollections; recovery of collection shortfalls (A) Offset of overcollections If the sum of the cumulative amount of fees collected under this section for the fiscal years 2016 through 2020 exceeds the cumulative amount appropriated pursuant to paragraph (3) for fiscal years 2016–2021, the excess amount shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2022. (B) Recovery of collection shortfalls (i) 2018 For fiscal year 2018, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2016 falls below the amount of fees authorized for fiscal year 2016 under paragraph (3). (ii) 2019 For fiscal year 2019, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2017 falls below the amount of fees authorized for fiscal year 2017 under paragraph (3). (iii) 2020 For fiscal year 2020, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2018 falls below the amount of fees authorized for fiscal year 2018 under paragraph (3). (iv) 2021 For fiscal year 2021, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2019 falls below the amount of fees authorized for fiscal year 2019 under paragraph (3). (v) 2022 For fiscal year 2022, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2020 falls below the amount of fees authorized for fiscal year 2020 under paragraph (3). (g) Effect of failure To pay fees The Food and Drug Administration shall not consider a registration submitted to be complete until such fee under subsection (a) is paid. Until the fee is paid, the registration is incomplete and the registrant is deemed to have failed to register in accordance with section 605. (h) False statements Any statement or representation made to the Food and Drug Administration shall be subject to section 1001 of title 18, United States Code. (i) Collection of unpaid fees In any case where the Food and Drug Administration does not receive payment of a fee assessed under subsection (a), such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 (j) Construction This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in cosmetic activities, be reduced to offset the number of officers, employees, and advisory committees so engaged. (k) Records Each facility shall retain all records necessary to demonstrate the facility’s gross annual sales for at least 2 fiscal years after such information is reported in the facility’s registration. Such records shall be made available to the Food and Drug Administration for review and duplication upon request of the Food and Drug Administration. . 203. Direct hiring authority to support activities related to cosmetics Part 10 of subchapter C of chapter VII, as added by section 202, is amended by inserting after section 744L the following: 744M. Direct hiring authority to support activities related to cosmetics (a) In general The Food and Drug Administration shall have direct hiring authority with respect to the appointment of employees into the competitive service or the excepted service to administer the amendments made by title I of the Personal Care Products Safety Act (b) Sunset The authority under subsection (a) shall terminate on the date that is 3 years after the date of enactment of such title. .

Summary: Personal Care Products Safety Act This bill amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities. If the FDA determines that a cosmetic has a reasonable probability of causing serious adverse health consequences, it may prohibit the cosmetic's distribution by suspending the cosmetic ingredient statement. If other cosmetics from the same facility may be affected, the FDA may prohibit distribution from the facility by suspending the facility's registration. The FDA must review the safety of at least five cosmetic ingredients each year, and it may establish conditions for safe use of an ingredient, including a limit on the amount of the ingredient or a requirement for a warning label. A cosmetic cannot be sold if it contains an ingredient that is not safe, not safe under the recommended conditions of use, or not safe in the amount present in the cosmetic. Cosmetics companies are required to report to the FDA any serious adverse health event associated with their cosmetics. The FDA must: develop and implement cosmetic manufacturing standards that are consistent with existing national and international standards, be allowed to inspect a company's cosmetic safety records, recall a cosmetic that is likely to cause serious adverse health consequences, and encourage cosmetic safety testing practices that minimize the use of animals.