II 114TH CONGRESS 1ST SESSION S. 1014 To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. IN THE SENATE OF THE UNITED STATES APRIL 20, 2015 Mrs. FEINSTEIN (for herself and Ms. COLLINS) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. 1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled, 3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 4 (a) SHORT TITLE.—This Act may be cited as the 5 ‘‘Personal Care Products Safety Act’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: smartinez on DSK4TPTVN1PROD with BILLS Sec. 1. Short title; table of contents. TITLE I—COSMETIC SAFETY Sec. 101. Registration of cosmetics facilities and cosmetic ingredient statements. VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S1014.IS S1014 2 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. 1 TITLE I—COSMETIC SAFETY 2 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 3 COSMETIC INGREDIENT STATEMENTS. 4 (a) AMENDMENTS.—Chapter VI of the Federal Food, 5 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend6 ed by adding at the end the following: 7 ‘‘SEC. 604. DEFINITIONS. 8 ‘‘In this chapter: 9 ‘‘(1) COSMETIC metic formulation’ means a preparation of cosmetic 11 raw materials with a qualitatively and quantitatively 12 set composition. ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 14 product’ means a cosmetic comprised of a specified 15 set of ingredients, which may come in a range of •S 1014 IS VerDate Sep 11 2014 term ‘cos- 10 13 smartinez on DSK4TPTVN1PROD with BILLS FORMULATION.—The 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 3 1 possible amounts for each ingredient and which may 2 include a variety of fragrances, flavors, and colors. 3 ‘‘(3) FACILITY.—The term ‘facility’ includes 4 any factory, warehouse, or establishment (including 5 a factory, warehouse, or establishment of an im- 6 porter) that manufactures, processes, packs, or holds 7 cosmetic products or cosmetic formulations, or any 8 other entity whose name and address appear on the 9 label of a cosmetic product. Such term does not in- 10 clude— 11 ‘‘(A) beauty shops and salons that do not 12 otherwise manufacture, process, or package cos- 13 metics at that location; 14 ‘‘(B) cosmetic product retailers, including 15 individual sales representatives, retail distribu- 16 tion facilities, and pharmacies, that do not oth- 17 erwise manufacture, process, or package cos- 18 metics at that location; 19 ‘‘(C) hospitals, physicians’ offices, and smartinez on DSK4TPTVN1PROD with BILLS 20 health care clinics; 21 ‘‘(D) public health agencies and other non- 22 profit entities that provide cosmetics directly to 23 the consumer; 24 ‘‘(E) hotels and other entities that provide 25 complimentary cosmetics to guests; •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 4 1 ‘‘(F) trade shows and other venues where 2 cosmetic product samples are provided free of 3 charge; 4 ‘‘(G) domestic manufacturers with less 5 than $100,000 in gross annual sales of cosmetic 6 products; or 7 ‘‘(H) entities that manufacture or com- 8 pound cosmetic products solely for use in re- 9 search, teaching, or pilot plant production and 10 not for sale. 11 ‘‘(4) FOREIGN FACILITY.—The term ‘foreign fa- 12 cility’ means a facility that manufactures, processes, 13 packs, or holds, a cosmetic formulation or cosmetic 14 product that is exported to the United States with- 15 out further processing or packaging inside the 16 United States. A cosmetic is not considered to have 17 undergone further processing or packaging for pur- 18 poses of this definition solely on the basis that label- 19 ing was added or that any similar activity of a de 20 minimis nature was carried out with respect to the 21 cosmetic. 22 ‘‘(5) NON-FUNCTIONAL CONSTITUENT.—The 23 term ‘non-functional constituent’ means any sub- 24 stance that is an incidental component of an ingre- 25 dient, a breakdown product of an ingredient or a by- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 5 1 product of the manufacturing process that has not 2 been intentionally added as a separate substance and 3 serves no technical function in the cosmetic. 4 ‘‘(6) RESPONSIBLE 5 sponsible person’ means— ‘‘(A) the brand owner who is the domestic 7 or foreign manufacturer, packer, or entity 8 whose name appears on a cosmetic product 9 label of a cosmetic product distributed in the 10 United States, except for entities described in 11 subparagraphs (A) through (H) of paragraph 12 (3); or 13 ‘‘(B) a contract manufacturer who provides 14 cosmetic products to the entities described in 15 subparagraphs (A) through (H) of paragraph 16 (3).’’. ‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES. 18 19 ‘‘(a) REGISTRATION UFACTURING OR 20 AND FEES FOR EXISTING MAN- PROCESSING OF COSMETICS.— ‘‘(1) REGISTRATION, IN GENERAL.—Not later 21 than December 1, 2015, and at a similar time in 22 each subsequent year, as determined by the Food 23 and Drug Administration, each responsible person 24 engaged in manufacturing or processing a cosmetic 25 product or a cosmetic formulation distributed in the •S 1014 IS VerDate Sep 11 2014 term ‘re- 6 17 smartinez on DSK4TPTVN1PROD with BILLS PERSON.—The 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 6 1 United States shall register all of the responsible 2 person’s facilities with the Food and Drug Adminis- 3 tration. 4 ‘‘(2) FEES.—If the average gross annual sales 5 in the United States of cosmetic products of all of 6 the responsible person’s facilities registered under 7 paragraph (1) for the previous 3-year period is 8 greater than $500,000, a registration shall not be 9 complete under this subsection until the responsible 10 person has paid any registration fee required under 11 section 744L. 12 ‘‘(b) REGISTRATION 13 HOLDING OF FOR EXISTING PACKING OR COSMETICS.—Not later than December 1, 14 2015, and at a similar time once every 3 years thereafter, 15 as determined by the Food and Drug Administration, each 16 person who owns or operates a cosmetic facility or facili17 ties engaged in packing or holding a cosmetic product dis18 tributed in the United States shall register each such facil19 ity with the Food and Drug Administration. 20 ‘‘(c) REGISTRATION BY NEW FACILITIES.—Any facil- 21 ity first engaging after the date of enactment of the Per22 sonal Care Products Safety Act in an activity that would smartinez on DSK4TPTVN1PROD with BILLS 23 require it to register under subsection (a) or (b) shall reg24 ister with the Food and Drug Administration within 60 •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 7 1 days of first engaging in such activity, and thereafter in 2 accordance with subsection (a) or (b). 3 ‘‘(d) CHANGES TO INFORMATION.—A registrant who 4 has submitted a registration under this section shall notify 5 the Food and Drug Administration of any change to the 6 information required under subsection (a) or (b) not later 7 than 60 days after the date of such change, unless other8 wise specified by the Food and Drug Administration. 9 ‘‘(e) FORMAT; CONTENTS.— 10 ‘‘(1) ELECTRONIC registration 11 shall be submitted using an electronic format, as 12 specified in a registration form provided by the Food 13 and Drug Administration. 14 15 ‘‘(2) CONTENTS.—The registration shall contain the following information: 16 ‘‘(A) Each facility’s name and full address, 17 identifying the precise physical location of the 18 facility. 19 ‘‘(B) The identity of the facility, including 20 the unique facility identifier, if any, previously 21 assigned by the Food and Drug Administration 22 to the facility under subsection (g). 23 smartinez on DSK4TPTVN1PROD with BILLS FORMAT.—Each ‘‘(C) All business trading names used by 24 the facility. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 8 1 ‘‘(D) The product category or categories of 2 each cosmetic product or cosmetic formulation 3 manufactured, processed, packed, or held at the 4 facility or on whose label the facility’s name 5 and address appear. 6 ‘‘(E) The type of activity conducted at the 7 facility (such as manufacturing, processing, 8 packing, or holding). 9 ‘‘(F) The name, title, street address, tele- 10 phone number, and electronic contact informa- 11 tion of the emergency contact for the facility. 12 ‘‘(G) In the case of a foreign facility, the 13 name, street address, telephone number, emer- 14 gency contact information for the facility, the 15 name of the United States agent for the facil- 16 ity, and, if available, the electronic contact in- 17 formation of the United States agent. 18 ‘‘(H) The name, title, street address, tele- 19 phone number, and electronic contact informa- 20 tion of the individual submitting the registra- 21 tion. 22 ‘‘(I) An assurance that the Food and Drug 23 Administration will be permitted to inspect such 24 facility at the times and in the manner per- 25 mitted by this Act. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 9 1 ‘‘(J) Additional information pertaining to 2 the facility or to the cosmetic products or cos- 3 metic formulations manufactured, processed, 4 packed, or held at the facility, or on whose label 5 the facility’s name and address appear, includ- 6 ing all brand names known to consumers, as 7 the Food and Drug Administration may require 8 by regulation. 9 ‘‘(3) ABBREVIATED REGISTRATION.—The 10 and Drug Administration shall provide for an abbre- 11 viated registration renewal process for any registrant 12 that has not had any changes to such information 13 with respect to the facility or facilities involved since 14 the registrant submitted the preceding registration. 15 ‘‘(f) INCOMPLETE 16 ‘‘(1) IN OR INACCURATE GENERAL.—Not REGISTRATION.— earlier than 10 days 17 after providing notice of the intent to cancel a reg- 18 istration and the basis for such cancellation, the 19 Food and Drug Administration may cancel a reg- 20 istration under this section if the Food and Drug 21 Administration has reasonable grounds to believe 22 that the registration was not properly completed or 23 updated in accordance with this section or otherwise 24 contains false, incomplete, or inaccurate information. •S 1014 IS VerDate Sep 11 2014 Food 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 10 1 ‘‘(2) TIMELY UPDATE OR CORRECTION.—If, not 2 later than 7 days after receipt of a notice of intent 3 to cancel, the sponsor corrects the registration in ac- 4 cordance with the basis for the cancellation, and the 5 required registration fee, if any, is paid, the Food 6 and Drug Administration shall not cancel such reg- 7 istration. 8 ‘‘(g) UNIQUE IDENTIFIER.—At the time of the initial 9 registration of any cosmetic facility under this section, the 10 Food and Drug Administration shall assign a unique iden11 tifier to the facility. 12 ‘‘(h) REGISTRY OF FACILITIES.— 13 ‘‘(1) IN Food and Drug Ad- 14 ministration shall compile, maintain, and update a 15 registry of facilities that are registered under this 16 section, and shall remove from such registry the 17 name of any facility whose registration under this 18 section is cancelled. The registry shall be publicly 19 available. 20 smartinez on DSK4TPTVN1PROD with BILLS GENERAL.—The ‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In- 21 formation derived from the registry or registration 22 documents that discloses the residential address of a 23 registrant or that discloses specific facilities where 24 specific cosmetic products are manufactured or proc- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 11 1 essed shall not be subject to disclosure under section 2 552 of title 5, United States Code. 3 ‘‘SEC. 606. COSMETIC INGREDIENT STATEMENTS. 4 ‘‘(a) IN GENERAL.—For each cosmetic product, the 5 responsible person shall submit to the Food and Drug Ad6 ministration a cosmetic ingredient statement, at such time 7 and in such manner as the Food and Drug Administration 8 may prescribe. The cosmetic ingredient statement shall 9 not become effective until the responsible person pays any 10 applicable fee required under section 744L. 11 ‘‘(b) SUBMISSION OF A COSMETIC INGREDIENT 12 STATEMENT.— 13 ‘‘(1) EXISTING case of a cosmetic product that is marketed on the 15 date of enactment of the Personal Care Products 16 Safety Act, the responsible person shall submit a 17 cosmetic ingredient statement not later than Decem- 18 ber 1, 2015. The responsible person shall submit to 19 the Food and Drug Administration a renewal of 20 such statement on a yearly basis. 22 ‘‘(2) COSMETIC INGREDIENT STATEMENT FOR NEW COSMETIC PRODUCTS.— 23 ‘‘(A) IN GENERAL.—Except as provided 24 under subparagraph (B), in the case of a cos- 25 metic product that is first marketed after the •S 1014 IS VerDate Sep 11 2014 the 14 21 smartinez on DSK4TPTVN1PROD with BILLS COSMETIC PRODUCTS.—In 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 12 1 date of enactment of the Personal Care Prod- 2 ucts Safety Act or a cosmetic product that is 3 reformulated after such date of enactment, the 4 responsible person shall submit a cosmetic in- 5 gredient statement to the Food and Drug Ad- 6 ministration within 60 days of first marketing 7 the new cosmetic product or the reformulated 8 cosmetic product, and annually thereafter. smartinez on DSK4TPTVN1PROD with BILLS 9 ‘‘(B) SMALL BUSINESSES.—The 10 Drug Administration shall allow a responsible 11 person that is a business that meets the appli- 12 cable industry-based small business size stand- 13 ard established by the Administrator of the 14 Small Business Administration under section 3 15 of the Small Business Act to have a period 16 longer than 60 days to submit an initial new 17 cosmetic ingredient statement under subpara- 18 graph (A). Such responsible person shall submit 19 a cosmetic ingredient statement annually there- 20 after. 21 ‘‘(C) DEFINITION.—A cosmetic product 22 shall not be considered first marketed or refor- 23 mulated after the date of enactment under sub- 24 paragraph (A) if the only change in such prod- 25 uct is in— •S 1014 IS VerDate Sep 11 2014 Food and 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 13 1 ‘‘(i) the amount of an existing ingre- 2 dient if it is within the range previously re- 3 ported under subsection (c)(2)(E); or 4 ‘‘(ii) the addition or subtraction of a 5 fragrance, flavor, or color, or such other 6 interchangeable ingredients specified by 7 the Food and Drug Administration in reg- 8 ulations or guidance, previously reported 9 as a potential ingredient under subsection 10 (c)(2)(E), if, in the case of such an addi- 11 tion, the amount is within the range pre- 12 viously reported. 13 ‘‘(c) FORMAT; CONTENTS.— 14 ‘‘(1) FORM.—For each cosmetic product, the 15 cosmetic ingredient statement shall be submitted 16 using an electronic format, as specified in a cosmetic 17 and ingredient form provided by the Food and Drug 18 Administration. 19 20 ‘‘(2) cosmetic ‘‘(A) The unique identifier, assigned under 22 section 605(g), as applicable, of— 23 ‘‘(i) the facility or facilities where the 24 cosmetic product is manufactured, proc- 25 essed, packed, or held or, if the same cos- •S 1014 IS VerDate Sep 11 2014 ingredient statement shall include the following information: 21 smartinez on DSK4TPTVN1PROD with BILLS CONTENTS.—The 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 14 1 metic product is manufactured, processed, 2 packed, or held in more than one facility, 3 the unique facility identifier of each facility 4 where 5 packed, or held; and is manufactured, ‘‘(ii) the facility whose name and ad- 7 dress appear on the label, unless the state- 8 ment is filed by a contract manufacturer, 9 described in section 604(6)(B). 10 ‘‘(B) The brand name and the full name 11 for the cosmetic product as it appears on the 12 label. 13 ‘‘(C) The cosmetic product listing number, 14 if any, previously assigned by the Food and 15 Drug Administration under subsection (f) to 16 the cosmetic product. ‘‘(D) The applicable cosmetic category for 18 the cosmetic product. 19 ‘‘(E) A list of ingredients in the cosmetic 20 product, including a range of possible amounts 21 of each ingredient, and with each ingredient 22 identified by the name adopted in regulations 23 promulgated by the Food and Drug Adminis- 24 tration, if any, or by the common or usual •S 1014 IS VerDate Sep 11 2014 processed, 6 17 smartinez on DSK4TPTVN1PROD with BILLS it 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 15 1 name of the ingredient. The cosmetic ingredient 2 statement shall contain— 3 ‘‘(i) a list of fragrances, flavors, and 4 colors that may be included in the product, 5 interchangeably, with ranges of possible 6 amounts, which shall include— 7 ‘‘(I) in the case of fragrances 8 that are purchased from a fragrance 9 supplier, the fragrances shall be iden- 10 tified by the name or code provided by 11 the supplier, and include the name 12 and contact information for the fra- 13 grance supplier; 14 ‘‘(II) in the case of flavors that 15 are purchased from a flavor supplier, 16 the flavors shall be identified by the 17 name or code provided by the sup- 18 plier, and include the name and con- 19 tact information for the flavor sup- 20 plier; and 21 ‘‘(III) in the case of a notifica- 22 tion provided by the Food and Drug 23 Administration to the responsible per- 24 son for the cosmetic manufacturer, 25 the Food and Drug Administration •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 16 1 may request, from the fragrance or 2 flavor supplier, the complete list of in- 3 gredients in specific fragrances or fla- 4 vors and the supplier shall have 30 5 days to provide such list to the Food 6 and Drug Administration; and 7 ‘‘(ii) other appropriate interchange- 8 able ingredients as the Food and Drug Ad- 9 ministration may specify in regulations or 10 guidance that may be included in the prod- 11 uct, with ranges of possible amounts. 12 ‘‘(F) The title and full contact information 13 of each individual submitting the statement. 14 ‘‘(G) If applicable, information on the la- 15 beling required under section 614. 16 ‘‘(H) Such additional information per- 17 taining to the cosmetic product as the Food and 18 Drug Administration may require. 19 ‘‘(3) COSMETIC 20 CERTAIN SMALL BUSINESSES.— 21 smartinez on DSK4TPTVN1PROD with BILLS INGREDIENT STATEMENT FOR ‘‘(A) IN GENERAL.—Notwithstanding 22 other provision of this subsection, the Food and 23 Drug Administration may permit a simplified 24 cosmetic ingredient statement under this sec- 25 tion for a responsible person that— •S 1014 IS VerDate Sep 11 2014 any 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 17 1 ‘‘(i) is a business that meets the appli- 2 cable industry-based small business size 3 standard established by the Administrator 4 of the Small Business Administration 5 under section 3 of the Small Business Act; 6 and 7 ‘‘(ii) has had an average of less than 8 $500,000 in annual domestic cosmetic 9 sales over the previous 3 years. 10 ‘‘(B) CONTENTS.—A responsible person 11 described in subparagraph (A) shall include in 12 each cosmetic ingredient statement under this 13 section, at a minimum, a list of ingredients in 14 the cosmetic product and the applicable cos- 15 metic category for the cosmetic product. 16 17 ‘‘(d) INCOMPLETE GREDIENT smartinez on DSK4TPTVN1PROD with BILLS 18 OR INACCURATE COSMETIC IN- STATEMENT.— ‘‘(1) IN GENERAL.—Not earlier than 10 days 19 after providing notice under paragraph (2), the Food 20 and Drug Administration may nullify a cosmetic in- 21 gredient statement filed under this section if the 22 Food and Drug Administration has reasonable 23 grounds to believe that the cosmetic ingredient state- 24 ment was not completed or updated in accordance •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 18 1 with this section or otherwise contains false, incom- 2 plete, or inaccurate information. 3 ‘‘(2) NOTICE tion under paragraph (1) shall be preceded by notice 5 to the responsible person of the intent to cancel the 6 cosmetic ingredient statement and the basis for such 7 cancellation. ‘‘(3) TIMELY UPDATE OR CORRECTION.—If the 9 cosmetic ingredient statement is appropriately up- 10 dated or corrected not later than 7 days after notice 11 is provided under paragraph (1), the Food and Drug 12 Administration shall not nullify such cosmetic ingre- 13 dient statement. 14 ‘‘(e) ADDITIONAL REQUIREMENTS.— 15 ‘‘(1) SAFETY REQUIREMENTS.—In filing each 16 cosmetic ingredient statement cosmetic product, the 17 responsible person shall include an attestation that 18 the safety of the product, including the individual in- 19 gredients of such product and the product as a 20 whole, has been substantiated in accordance with 21 section 609. In the case of a cosmetic ingredient 22 statement that includes a range of possible amounts 23 (as described in subsection (c)(2)(E)), the respon- 24 sible person shall include an attestation that the •S 1014 IS VerDate Sep 11 2014 nullifica- 4 8 smartinez on DSK4TPTVN1PROD with BILLS OF NULLIFICATION.—A 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 19 1 safety of the full range in the finished product has 2 been substantiated, in accordance with section 609. 3 ‘‘(2) ABBREVIATED Drug Administration shall provide for an abbre- 5 viated renewal process for any such filing with re- 6 spect to which there has been no change since the 7 responsible person submitted the previous filing. ‘‘(3) CHANGES 9 ‘‘(A) IN TO INFORMATION.— GENERAL.—Except as provided in 10 subparagraph (B), the responsible person shall 11 notify the Food and Drug Administration with- 12 in 60 days of any change to the information re- 13 quired to be in a cosmetic ingredient statement, 14 including discontinuation of the manufacture of 15 a cosmetic product, except that notification 16 under this paragraph is not required for a 17 change in— 18 ‘‘(i) the amount of an existing ingre- 19 dient if it is within the range previously re- 20 ported under subsection (c)(2)(E); or 21 ‘‘(ii) the addition or subtraction of a 22 fragrance, flavor, or color, or such other 23 interchangeable ingredients specified by 24 the Food and Drug Administration in reg- 25 ulations or guidance, previously reported •S 1014 IS VerDate Sep 11 2014 Food and 4 8 smartinez on DSK4TPTVN1PROD with BILLS FILING.—The 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 20 1 as a potential ingredient under subsection 2 (c)(2)(E), if, in the case of an addition of 3 such an ingredient, the amount is within 4 the range previously reported. 5 ‘‘(B) SMALL BUSINESS.—The Food and 6 Drug Administration shall allow a responsible 7 person that is a business that meets the appli- 8 cable industry-based small business size stand- 9 ard established by the Administrator of the 10 Small Business Administration under section 3 11 of the Small Business Act to have a period 12 longer than 60 days, but not longer than the 13 next annual registration deadline under section 14 605(a)(1), to submit any change to the infor- 15 mation required to be in a cosmetic ingredient 16 statement as described in subparagraph (A). 17 ‘‘(f) COSMETIC PRODUCTS LIST.—At the time of the 18 initial submission of any cosmetic ingredient statement 19 under this section, the Food and Drug Administration 20 shall assign a unique cosmetic product listing number to 21 the cosmetic ingredient statement. Based on such cosmetic 22 ingredient statements, the Food and Drug Administration smartinez on DSK4TPTVN1PROD with BILLS 23 shall compile and maintain a list of cosmetic products dis24 tributed in the United States, including the ingredients 25 of each such product, and shall make available such list •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 21 1 to any State, upon request. Information disclosed to a 2 State that is exempt from disclosure under section 3 552(b)(4) of title 5, United States Code, shall be treated 4 as a trade secret and confidential information by the 5 State. 6 ‘‘SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC 7 INGREDIENT STATEMENT. 8 9 ‘‘(a) SUSPENSION ITY.—If OF REGISTRATION OF A FACIL- the Food and Drug Administration determines 10 that a cosmetic formulation or cosmetic product manufac11 tured, processed, packed, or held by a registered facility 12 has a reasonable probability of causing serious adverse 13 health consequences or death to humans, and there is rea14 son to believe that other formulations or products manu15 factured, processed, packed, or held by the facility may 16 be similarly affected because of a failure affecting multiple 17 products in that facility, the Food and Drug Administra18 tion may suspend the registration of a facility. 19 20 ‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATEMENT.—If the Food and Drug Administration determines 21 that a cosmetic product manufactured in a registered fa22 cility has a reasonable probability of causing serious ad- smartinez on DSK4TPTVN1PROD with BILLS 23 verse health consequences or death to humans, the Food 24 and Drug Administration may suspend the cosmetic ingre25 dient statement of that product. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 22 1 ‘‘(c) NOTICE OF SUSPENSION.—Before suspending a 2 facility registration or a cosmetic ingredient statement 3 under this section, the Food and Drug Administration 4 shall provide— 5 ‘‘(1) notice to the facility registrant of the cos- 6 metic product or formulation or other responsible 7 person, as appropriate, of the intent to suspend the 8 facility registration or the cosmetic ingredient state- 9 ment, which shall specify the basis of the determina- 10 tion by the Food and Drug Administration that the 11 facility or the cosmetic ingredient should be sus- 12 pended and recommendations for specific actions to 13 avoid suspension; and 14 ‘‘(2) an opportunity, within 2 business days of 15 the notice provided under paragraph (1), for the re- 16 sponsible person to address the reasons for possible 17 suspension of the facility registration or cosmetic in- 18 gredient statement. 19 ‘‘(d) REINSTATEMENT.—Upon a determination by 20 the Food and Drug Administration that adequate grounds 21 do not exist to continue the suspension actions, the Food 22 and Drug Administration shall promptly vacate the sus- smartinez on DSK4TPTVN1PROD with BILLS 23 pension and reinstate the registration of the facility or the 24 cosmetic ingredient statement. 25 ‘‘(e) EFFECT OF SUSPENSION.— •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 23 1 ‘‘(1) REGISTRATION.—If the registration of a 2 facility is suspended under this section, no person 3 shall import or export cosmetics or otherwise dis- 4 tribute cosmetics from such facility. 5 ‘‘(2) COSMETIC INGREDIENT STATEMENT.—If 6 the cosmetic ingredient statement for a cosmetic 7 product is suspended under this section, no person 8 shall import or export such cosmetic product or oth- 9 erwise distribute in the United States such cosmetic 10 product that is the subject of such statement. 11 ‘‘(f) NO DELEGATION.—The authority conferred by 12 this section to issue an order to suspend a registration 13 or vacate an order of suspension shall not be delegated 14 to any officer or employee other than the Commissioner.’’. 15 SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL 16 CONSTITUENTS; SAFETY OF FINISHED PROD- 17 UCTS. 18 (a) AMENDMENTS.—Chapter VI of the Federal Food, 19 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 20 amended by section 101, is further amended by adding 21 at the end the following: 22 ‘‘SEC. 608. REVIEW OF INGREDIENTS AND NON-FUNC- smartinez on DSK4TPTVN1PROD with BILLS 23 TIONAL CONSTITUENTS. 24 25 ‘‘(a) INGREDIENTS STITUENTS AND NON-FUNCTIONAL CON- SUBJECT TO REVIEW.— •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 24 1 ‘‘(1) IN in fiscal year 2 2016, the Food and Drug Administration shall re- 3 view the safety of the cosmetic ingredients and non- 4 functional constituents under paragraph (3), as 5 modified under subsection (c), if applicable, and 6 issue an order under subsection (d) with respect to 7 the use of each such ingredient and presence of each 8 such non-functional constituent. 9 ‘‘(2) PUBLIC NOTICE AND COMMENT.—At initiation of the review of each cosmetic ingredient 11 or non-functional constituent, the Food and Drug 12 Administration shall open a docket for the submis- 13 sion of public comment and additional data relevant 14 to the safety of the ingredient or non-functional con- 15 stituent. The Food and Drug Administration shall 16 provide 60 days for public comment. ‘‘(3) COSMETIC 18 INGREDIENTS.— ‘‘(A) INGREDIENTS TO BE CONSIDERED IN 19 FIRST YEAR.—During 20 Food and Drug Administration shall initiate the 21 review for safety of the following cosmetic in- 22 gredients: fiscal year 2016, the 23 ‘‘(i) Diazolidinyl urea. 24 ‘‘(ii) Lead acetate. •S 1014 IS VerDate Sep 11 2014 the 10 17 smartinez on DSK4TPTVN1PROD with BILLS GENERAL.—Beginning 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 25 1 ‘‘(iii) Methylene glycol/methanediol/ 2 formaldehyde. 3 ‘‘(iv) Propyl paraben. 4 ‘‘(v) Quaternium-15. 5 ‘‘(B) INGREDIENTS 6 SUBSEQUENT YEARS.— 7 smartinez on DSK4TPTVN1PROD with BILLS TO BE CONSIDERED IN ‘‘(i) IN GENERAL.—Beginning 8 cal year 2017, the Food and Drug Admin- 9 istration shall annually select and complete 10 a review of at least 5 cosmetic ingredients 11 or non-functional constituents that were 12 not reviewed in the prior 3 years from a 13 list determined in consultation with indus- 14 try and consumer groups for review of 15 safety. The Food and Drug Administration 16 may modify such list under subsection (c). 17 ‘‘(ii) CONSIDERATIONS.—The deter- 18 mination of which ingredients or functional 19 ingredients will be reviewed in a given year 20 shall be publicized in annual reports to 21 Congress and the public, in accordance 22 with section 618, and subject to consulta- 23 tion as provided for in clause (iii). The re- 24 view of any cosmetic ingredient or non- 25 functional constituent shall commence with •S 1014 IS VerDate Sep 11 2014 in fis- 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 26 1 a public announcement by the Food and 2 Drug Administration and the opening of a 3 docket as required under paragraph (2). 4 ‘‘(iii) CONSULTATION.—The Food and 5 Drug Administration shall establish a Cos- 6 metics Safety Advisory Committee, which 7 shall include equal numbers of individuals 8 from the cosmetics industry and consumer 9 groups, and other individuals, as the Food 10 and Drug Administration determines ap- 11 propriate, including medical practitioners. 12 Such advisory committee shall advise the 13 Food and Drug Administration on cos- 14 metic ingredients and non-functional con- 15 stituents to be considered for review, sum- 16 marize public comments received pursuant 17 to paragraph (4), and recommend 5 cos- 18 metic ingredients or non-functional con- 19 stituents to be reviewed for safety each 20 year, as described in clause (i). The Food 21 and Drug Administration may consult with 22 the Cosmetics Safety Advisory Committee 23 on other matters pertaining to cosmetic 24 safety. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 27 1 ‘‘(4) COMMENT PERIOD.—As part of the annual 2 reporting to Congress and the public under section 3 618, the Food and Drug Administration shall solicit 4 public comment on which cosmetic ingredients or 5 non-functional constituents on the list are of great- 6 est interest to be reviewed next for early review and 7 which additional cosmetic ingredients or non-func- 8 tional constituents should be added to the list. The 9 public may submit comments to the Food and Drug 10 Administration at any time during the year regard- 11 ing which cosmetic ingredients or non-functional 12 constituents of interest that the Food and Drug Ad- 13 ministration may consider during that year or subse- 14 quent years. 15 ‘‘(b) LIST.—The Food and Drug Administration 16 shall maintain a list, posted on the Internet website of the 17 Food and Drug Administration, of the cosmetic ingredi18 ents and non-functional constituents for which final orders 19 have been issued under subsection (d)(3), the finding 20 made for each such ingredient or non-functional con21 stituent under subsection (d)(4), as modified by any order 22 under subsection (f), and, if applicable, compliance dates smartinez on DSK4TPTVN1PROD with BILLS 23 that are the subject of a final order under subsection (e). 24 ‘‘(c) INITIATIVE OF THE FDA.—The Food and Drug 25 Administration may at any time, after consultation with •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 28 1 the Cosmetics Safety Advisory Committee, propose the 2 issuance of an order on the safety of a cosmetic ingredient 3 or non-functional constituent that was not previously list4 ed in subsection (a) or under section 618(a)(3). 5 ‘‘(d) DETERMINATION ON SAFETY.— 6 ‘‘(1) PROPOSED ADMINISTRATIVE 7 ORDER.—Following 8 ments to the public docket and any other informa- 9 tion before the Food and Drug Administration, the 10 Food and Drug Administration shall determine 11 whether there is adequate evidence to make an ini- 12 tial finding on the safety of the ingredient or non- 13 functional constituent. If the Food and Drug Ad- 14 ministration determines that there is adequate evi- 15 dence, the Food and Drug Administration shall issue 16 a proposed administrative order and shall post such 17 order on the Internet website of the Food and Drug 18 Administration, notwithstanding subchapter II of 19 chapter 5 of title 5, United States Code. 20 smartinez on DSK4TPTVN1PROD with BILLS INITIAL ‘‘(2) PUBLIC consideration of data and com- COMMENT.—Upon publication of 21 the proposed administrative order described in para- 22 graph (1), the Food and Drug Administration shall 23 open a docket for the submission of public comment. 24 The Food and Drug Administration shall provide 30 •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 29 1 days for public comment following publication of the 2 proposed administrative order. 3 ‘‘(3) FINAL ORDER.—Fol- 4 lowing the public comment period described in para- 5 graph (2) and consideration of comments to the pub- 6 lic docket and any other information before the Food 7 and Drug Administration, the Food and Drug Ad- 8 ministration shall determine whether there is ade- 9 quate evidence to make a final finding on the safety 10 of the ingredient or non-functional constituent. If 11 the Food and Drug Administration determines that 12 there is adequate evidence, the Food and Drug Ad- 13 ministration shall issue a final administrative order 14 and shall post such order on the Internet website of 15 the Food and Drug Administration, notwithstanding 16 subchapter II of chapter 5 of title 5, United States 17 Code. 18 ‘‘(4) DETERMINATIONS.—In the proposed ad- 19 ministrative order or the final administrative order, 20 as applicable, the Food and Drug Administration 21 shall make a determination that the ingredient or 22 non-functional constituent is— 23 smartinez on DSK4TPTVN1PROD with BILLS ADMINISTRATIVE ‘‘(A) safe in cosmetic products under speci- 24 fied conditions of use or tolerances; •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 30 1 ‘‘(B) safe in cosmetic products without the 2 need for specified conditions of use or toler- 3 ances; or 4 ‘‘(C) not safe in cosmetic products. smartinez on DSK4TPTVN1PROD with BILLS 5 ‘‘(5) CONDITIONS OF USE AND TOLERANCES.— 6 An order under paragraph (4)(A) shall include such 7 conditions on the use of an ingredient or such toler- 8 ances on the presence of a non-functional con- 9 stituent as are necessary for the safety of cosmetic 10 products containing such ingredient or non-func- 11 tional constituent, including— 12 ‘‘(A) limits on the amount or concentration 13 of the ingredient or non-functional constituent 14 that may be present in a cosmetic product, in- 15 cluding limits in products intended for children 16 and other vulnerable populations, and limits on 17 use near the eye or mucosal membranes; 18 ‘‘(B) warnings that are necessary or appro- 19 priate under section 614, including warnings re- 20 lated to use by children, pregnant women, popu- 21 lations with high exposure to the ingredient 22 (such as workers who are exposed through pro- 23 duction practices or handling of final products), 24 or other vulnerable populations, to help ensure •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 31 1 safe use of cosmetic products containing the in- 2 gredient or non-functional constituent; and 3 ‘‘(C) such other conditions as are nec- 4 essary for the safety of cosmetic products con- 5 taining such ingredient or non-functional con- 6 stituent. 7 ‘‘(6) PUBLIC NOTICE.—A final order under this 8 subsection shall set forth the determination of the 9 Food and Drug Administration on safety, any condi- 10 tions of use or tolerances under subparagraph (A) or 11 (B) of paragraph (4) and a summary of the valid 12 scientific evidence supporting the finding. The order 13 shall be effective upon its publication on the Internet 14 website of the Food and Drug Administration and 15 shall be considered final agency action. 16 ‘‘(e) ORDER.—If the Food and Drug Administration 17 issues a final administrative order under subparagraph 18 (A) or (C) of subsection (d)(4), the Food and Drug Ad19 ministration shall, at the same time as publication of the 20 notice under subsection (d)(6), publish a proposed order 21 identifying dates by which use of the ingredient or non22 functional constituent in cosmetic products shall comply smartinez on DSK4TPTVN1PROD with BILLS 23 with the final administrative order, and provide 60 days 24 for public comment, including comment on whether com25 pliance is feasible within the proposed dates. After consid•S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 32 1 ering comments on the proposed order, the Food and 2 Drug Administration shall publish in the Federal Register 3 a final order. 4 ‘‘(f) MODIFICATION OF AN ORDER.—An order issued 5 under subsection (d) or (e) may be modified or revoked 6 by the Food and Drug Administration on the initiative of 7 the Food and Drug Administration or in response to a 8 petition. 9 ‘‘(g) INADEQUATE EVIDENCE.— smartinez on DSK4TPTVN1PROD with BILLS 10 ‘‘(1) NOTICE; EXTENSION.—If the Food and 11 Drug Administration determines that the available 12 data and information are not adequate to make a 13 proposed or final determination regarding safety 14 under subsection (d)(4), with respect to a cosmetic 15 ingredient or non-functional constituent, the Food 16 and Drug Administration shall— 17 ‘‘(A) publish such finding on the Internet 18 website of the Food and Drug Administration 19 not later than 90 days after the close of the rel- 20 evant comment period for the ingredient or 21 non-functional constituent under subsection 22 (a)(2), in the case of a proposed order, or sub- 23 section (d)(2), in the case of a final order; and 24 ‘‘(B)(i) include a notice providing inter- 25 ested persons an additional 30 days from the •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 33 1 notice date to provide additional data and infor- 2 mation; and 3 ‘‘(ii) if, after the 30-day period under 4 clause (i), the Food and Drug Administration 5 determines that additional safety substantiation 6 with respect to such ingredient or non-func- 7 tional constituent is necessary to make a safety 8 determination, include a notice specifying an 9 additional time period, not to exceed 18 months 10 from the notice date, and plan to obtain such 11 data and information. 12 ‘‘(2) DETERMINATION; smartinez on DSK4TPTVN1PROD with BILLS 13 ORDER.— ‘‘(A) INADEQUATE DATA AND INFORMA- 14 TION.—If 15 determines, after considering any additional 16 data and information submitted under para- 17 graph (1)(B), that the available data and infor- 18 mation still are not adequate to make a deter- 19 mination regarding safety under subsection 20 (d)(4), the Food and Drug Administration 21 shall, within 90 days of the close of the addi- 22 tional time period provided under paragraph 23 (1)(B), issue a proposed order or a final admin- 24 istrative order— the Food and Drug Administration •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 34 1 ‘‘(i) making a determination that the 2 ingredient or non-functional constituent 3 has not been shown to be safe in cosmetic 4 products; and 5 ‘‘(ii) explaining why the available data 6 and information are not adequate to assess 7 the safety of the ingredient or non-func- 8 tional constituent. 9 ‘‘(B) ADEQUATE AND TION.—If 11 determines, after considering any additional 12 data and information submitted under para- 13 graph (1)(B), that the available data and infor- 14 mation are adequate to make a determination 15 regarding safety under subsection (d)(4), the 16 Food and Drug Administration shall, within 17 180 days of the close of the comment period, 18 issue a proposed order, followed by a final 19 order, on such cosmetic ingredient or non-func- 20 tional constituent, in accordance with such sub- 21 section. the Food and Drug Administration ‘‘(h) SAFETY ASSESSMENT.— 23 ‘‘(1) IN GENERAL.—In assessing the safety of 24 an ingredient or non-functional constituent, the 25 Food and Drug Administration shall consider wheth- •S 1014 IS VerDate Sep 11 2014 INFORMA- 10 22 smartinez on DSK4TPTVN1PROD with BILLS DATA 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 35 1 er there is adequate evidence to support a reasonable 2 certainty among competent scientists that the ingre- 3 dient is not harmful under the recommended or sug- 4 gested conditions of use or customary or usual use, 5 or that a non-functional constituent is not harmful 6 under the recommended or suggested tolerance levels 7 or the level at which it is customarily or usually 8 present. The Food and Drug Administration may 9 not consider an ingredient or non-functional con- 10 stituent harmful solely because it can cause minor 11 adverse health reactions, such as minor transient al- 12 lergic reactions or minor transient skin irritations, 13 in some users. 14 ‘‘(2) FACTORS.—In assessing the safety of an 15 ingredient or non-functional constituent, the Food 16 and Drug Administration shall consider, among 17 other relevant factors, the following: 18 ‘‘(A) The probable human exposure to the 19 ingredient or non-functional constituent from 20 expected use in cosmetics. 21 ‘‘(B) The probable cumulative and aggre- 22 gate effect in humans of relevant exposure to 23 the ingredient or non-functional constituent or 24 to any chemically or pharmacologically related 25 substances from use in cosmetics or other prod- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 36 1 ucts with similar routes of exposure under rec- 2 ommended or suggested conditions of use or 3 their customary use, to the extent adequate 4 data is available for analysis. In appropriate 5 cases, the Food and Drug Administration may 6 consider available information on the total expo- 7 sure to an ingredient or non-functional con- 8 stituent from all sources. 9 ‘‘(C) Whether warnings or recommenda- 10 tions in a product label, as part of any condi- 11 tions of use or tolerances imposed by the Food 12 and Drug Administration, would be necessary 13 and appropriate to help ensure the safety of the 14 ingredient or non-functional constituent. 15 ‘‘(3) DATA smartinez on DSK4TPTVN1PROD with BILLS 16 AND INFORMATION.— ‘‘(A) REQUIRED INFORMATION.—A 17 mination that an ingredient or non-functional 18 constituent is safe in cosmetics shall be based 19 upon adequate evidence submitted or otherwise 20 known to the Food and Drug Administration, 21 which shall include full reports of all available 22 studies, published or unpublished, that are ade- 23 quately designed to show whether the ingredient 24 or non-functional constituent is safe. Such stud- 25 ies may include in vitro and in silico studies •S 1014 IS VerDate Sep 11 2014 deter- 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 37 1 and epidemiological studies, biomonitoring stud- 2 ies, and studies focused on various points dur- 3 ing the lifespan of the subject, that use scientif- 4 ically valid methodology. 5 ‘‘(B) ADDITIONAL RELEVANT 6 TION.—The 7 shall consider any other relevant information 8 related to the safety of the ingredient or non- 9 functional constituent, including— Food and Drug Administration 10 ‘‘(i) adverse event reports; 11 ‘‘(ii) findings and information from 12 State, Federal, national, and international 13 entities and other bodies composed of sci- 14 entific and medical experts; 15 ‘‘(iii) if the ingredient or non-func- 16 tional constituent is lawfully used or 17 present in other products regulated by the 18 Food and Drug Administration, the sci- 19 entific basis for such use; and 20 ‘‘(iv) experience with the ingredient or 21 non-functional constituent in products that 22 are distributed in the United States or in 23 other countries, if such experience is well- 24 documented and has resulted in substantial •S 1014 IS VerDate Sep 11 2014 INFORMA- 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 38 1 human exposure to the ingredient or non- 2 functional constituent over time.’’. 3 ‘‘SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS. 4 ‘‘(a) DETERMINATION.— 5 ‘‘(1) IN responsible person 6 for a finished cosmetic product shall, before first dis- 7 tributing the product for sale, make a written deter- 8 mination that the product is safe under the condi- 9 tions of use recommended in the labeling of the 10 product. Such determination shall be based on ade- 11 quate evidence that each ingredient in the finished 12 product is safe for the use recommended or sug- 13 gested in the labeling of the product and that the 14 finished product is safe. 15 ‘‘(2) NEW INFORMATION.—If new information 16 relevant to the determination becomes available, the 17 responsible person shall promptly update the deter- 18 mination to address that information. 19 smartinez on DSK4TPTVN1PROD with BILLS GENERAL.—Each ‘‘(3) SAFETY WITH RESPECT TO RANGES OF 20 POSSIBLE AMOUNTS.—In 21 product for which there is a range of possible 22 amounts of cosmetic ingredients included in the cos- 23 metic ingredient statement, as described in section 24 606(c)(2)(E), the safety determination under para- the case of a cosmetic •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 39 1 graph (1) shall include substantiation of the safety 2 of the full range in the finished product. 3 ‘‘(b) PRESUMPTION OF ADEQUATE EVIDENCE.— 4 ‘‘(1) IN as provided in sub- 5 section (c), a determination made under subsection 6 (a) shall be presumed to be based on adequate evi- 7 dence if it is supported by— 8 ‘‘(A) with respect to each ingredient in the 9 finished product— 10 ‘‘(i) references to an official statement 11 by one or more expert medical or scientific 12 bodies that the ingredient is safe under the 13 conditions of use recommended or sug- 14 gested in the product’s labeling; or 15 smartinez on DSK4TPTVN1PROD with BILLS GENERAL.—Except ‘‘(ii) appropriate safety testing of the 16 ingredient; and 17 ‘‘(B) appropriate safety substantiation of 18 the finished product beyond the safety substan- 19 tiation of individual ingredients and consider- 20 ation of the combination of ingredients. 21 ‘‘(2) STATEMENT OF AN EXPERT MEDICAL OR 22 SCIENTIFIC BODY.—For 23 statement of an expert medical or scientific body is 24 an official statement of that body, if— purposes of this section, a •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 40 1 ‘‘(A) the medical or scientific body is a 2 Federal, State, national, or international entity 3 with recognized expertise in chemical or cos- 4 metic safety, or other similarly recognized body 5 composed of scientific and medical experts; 6 ‘‘(B) the statement is based upon adequate 7 data to support the finding of safety, and such 8 data are available to the Food and Drug Ad- 9 ministration; and 10 ‘‘(C) the statement is published and en- 11 dorsed by the medical or scientific body and is 12 not a statement of an employee of such body 13 made in the individual capacity of the employee. 14 ‘‘(c) REBUTTAL OF PRESUMPTION.—Notwith- 15 standing subsection (b), a determination under subsection 16 (a) will not be presumed to be based on adequate evidence 17 if— 18 ‘‘(1) the Food and Drug Administration issues 19 an order under section 608 that an ingredient or 20 non-functional constituent in the finished product is 21 not safe under the product’s conditions of use or 22 customary or usual use; or smartinez on DSK4TPTVN1PROD with BILLS 23 24 ‘‘(2) the Food and Drug Administration has provided the manufacturer with notice that— •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 41 1 ‘‘(A) the manufacturer has not met the cri- 2 teria under subsection (b); or 3 ‘‘(B) the Food and Drug Administration 4 has information that raises significant questions 5 about the safety of the product or any of its in- 6 gredients. 7 ‘‘(d) TIMELY UPDATE.—Upon notice of inadequate 8 evidence under subsection (c), the responsible person shall 9 have 10 days to submit additional evidence to the Food 10 and Drug Administration regarding the safety of an ingre11 dient, non-functional constituent, or the entire cosmetic 12 product, and the Food and Drug Administration shall 13 have 30 days from the date of receipt of such additional 14 evidence to provide the responsible person with notice that 15 the criteria under subsection (b) have been met or not met. 16 ‘‘(e) RECORDS MAINTENANCE.—The responsible per- 17 son shall maintain records documenting the determination 18 required under this section and the information on which 19 it is based until 5 years after the finished product is no 20 longer marketed. 21 ‘‘(f) SUBMISSION OF RECORDS.— smartinez on DSK4TPTVN1PROD with BILLS 22 ‘‘(1) IN GENERAL.—The records required under 23 subsection (e) shall, upon the written request of the 24 Food and Drug Administration to the responsible 25 person, be provided to the Food and Drug Adminis- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 42 1 tration within a reasonable timeframe not to exceed 2 60 days, in either electronic or paper form. 3 ‘‘(2) CRITERIA.—The Food and Drug Adminis- 4 tration may require records under paragraph (1) 5 if— 6 ‘‘(A) the Food and Drug Administration 7 has a reasonable belief, described in written no- 8 tice, that— 9 ‘‘(i) the finished product may be 10 harmful based on adverse event reports or 11 other scientific information; 12 ‘‘(ii) scientific information raises cred- 13 ible and relevant questions about the safe- 14 ty of the product or any of its ingredients; 15 ‘‘(iii) the responsible person has not 16 made the determination required under 17 subsection (a), or such determination is 18 not supported by adequate evidence; or 19 ‘‘(iv) one or more of the criteria to es- 20 tablish a presumption of adequate evidence 21 of safety in subsection (b) has not been 22 satisfied; 23 ‘‘(B) the Food and Drug Administration, 24 an expert regulatory body, or an expert body 25 composed of scientific and medical experts finds •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 43 1 an ingredient in the product to be unsafe under 2 the conditions of use of the product; or 3 ‘‘(C) the Food and Drug Administration 4 concludes that submission of the records will 5 serve the public health or otherwise enable the 6 Food and Drug Administration to fulfill the 7 cosmetic safety purposes of this section. 8 ‘‘(g) GUIDANCE AND REGULATIONS.— 9 ‘‘(1) IN Food and Drug Ad- 10 ministration shall issue guidance describing the evi- 11 dence necessary to support a determination under 12 subsection (a), and may, by regulation, establish ex- 13 emptions to the requirements of this section, if the 14 Food and Drug Administration determines that such 15 exemptions are supported by adequate evidence and 16 would have no adverse effect on public health. 17 smartinez on DSK4TPTVN1PROD with BILLS GENERAL.—The ‘‘(2) SMALL BUSINESSES.—The Food and Drug 18 Administration shall, after consultation with the 19 Small Business Administration and small businesses 20 that manufacture cosmetics, provide additional guid- 21 ance for small businesses on compliance with the re- 22 quirements of this section. Such guidance shall in- 23 clude specific examples of options for compliance 24 that do not place an undue burden on small busi- 25 nesses.’’. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00043 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 44 1 (b) EFFECTIVE DATE.—Section 609 of the Federal 2 Food, Drug, and Cosmetic Act, as added by subsection 3 (a), shall take effect 180 days after the date of enactment 4 of this Act. 5 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS- 6 METICS. 7 (a) IN GENERAL.—Chapter VI of the Federal Food, 8 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 9 amended by section 102, is further amended by adding 10 at the end the following: 11 ‘‘SEC. 610. GOOD MANUFACTURING PRACTICES FOR COS- 12 13 METICS. ‘‘(a) IN GENERAL.—The Food and Drug Administra- 14 tion shall review national and international standards for 15 cosmetic good manufacturing practices that are in exist16 ence on the date of enactment of the Personal Care Prod17 ucts Safety Act and shall develop and implement, through 18 regulations, United States standards consistent, to the ex19 tent the Food and Drug Administration determines prac20 ticable and appropriate, with such national and inter21 national standards for cosmetic good manufacturing prac22 tices to ensure that requirements of this chapter with re- smartinez on DSK4TPTVN1PROD with BILLS 23 spect to the manufacture of cosmetic products are in har24 mony. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 45 1 ‘‘(b) TIMEFRAME.—The Food and Drug Administra- 2 tion shall publish a proposed rule described in subsection 3 (a) not later than 18 months after the date of enactment 4 of the Personal Care Products Safety Act and shall pub5 lish a final such rule not later than 3 years after such 6 date of enactment.’’. 7 8 (b) EFFECTIVE DATE COSMETIC MANUFACTUR- ERS.— 9 (1) LARGE BUSINESSES.—For businesses of a 10 size greater than the Small Business Administra- 11 tion’s standard for a small business, section 610 of 12 the Federal Food, Drug, and Cosmetic Act (as 13 added by subsection (a)) shall take effect beginning 14 180 days after the date on which the Food and 15 Drug Administration makes effective cosmetic good 16 manufacturing practices. 17 smartinez on DSK4TPTVN1PROD with BILLS FOR (2) SMALL BUSINESSES.—For businesses of a 18 size that meets the Small Business Administration’s 19 standard for a small business, section 610 of the 20 Federal Food, Drug, and Cosmetic Act (as added by 21 subsection (a)) shall take effect beginning 2 years 22 after the date the Food and Drug Administration 23 makes effective cosmetic good manufacturing prac- 24 tices. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 46 1 (c) ENFORCEMENT.—Section 601 of Chapter VI of 2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3 361) is amended by adding at the end the following: 4 ‘‘(f) If the methods used in, or the facilities or con- 5 trols used for, its manufacture, processing, packing, or 6 holding do not conform to current good manufacturing 7 practice, as prescribed by the Food and Drug Administra8 tion.’’. 9 SEC. 104. ADVERSE EVENT REPORTS. 10 Chapter VI of the Federal Food, Drug, and Cosmetic 11 Act (21 U.S.C. 361 et seq.), as amended by section 12 103(a), is further amended by adding at the end the fol13 lowing: 14 ‘‘SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS. 15 ‘‘(a) IN GENERAL.—With respect to any cosmetic 16 product distributed in the United States, the responsible 17 person shall submit to the Food and Drug Administration 18 a report of any serious adverse event associated with such 19 cosmetic product, when used in the United States, accom20 panied by a copy of the label on or with the retail pack21 aging of the cosmetic, any new medical information, re22 lated to a submitted serious adverse event report that is smartinez on DSK4TPTVN1PROD with BILLS 23 received by the responsible person, and an annual report 24 for all adverse events received by the responsible person. 25 ‘‘(b) DEFINITIONS.—In this section: •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 47 1 ‘‘(1) An ‘adverse event’ for a cosmetic product 2 is a health-related event associated with the use of 3 this product that is adverse. 4 5 ‘‘(2) A ‘serious adverse event’ for a cosmetic product is an adverse event that— 6 ‘‘(A) results in— 7 ‘‘(i) death; 8 ‘‘(ii) a life-threatening experience; 9 ‘‘(iii) inpatient hospitalization; 10 ‘‘(iv) a persistent or significant dis- 11 ability or incapacity; 12 ‘‘(v) congenital anomaly or birth de- 13 fect; or 14 ‘‘(vi) significant disfigurement, includ- 15 ing serious and persistent rashes and infec- 16 tions; or 17 ‘‘(B) requires, based on appropriate med- 18 ical judgment, a medical or surgical interven- 19 tion to prevent an outcome described in sub- 20 paragraph (A). 21 ‘‘(c) SUBMISSION OF REPORTS.— smartinez on DSK4TPTVN1PROD with BILLS 22 ‘‘(1) SERIOUS ADVERSE EVENT REPORTS.—Ex- 23 cept as provided in paragraph (2), the responsible 24 person shall submit a serious adverse event report to 25 the Food and Drug Administration not later than 15 •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 48 1 business days after information concerning the ad- 2 verse event is received. If a serious adverse event re- 3 port for a cosmetic with drug properties is filed 4 using Form FDA 3500A (or any successor form de- 5 veloped for such purpose) or its electronic equivalent 6 for over-the-counter drugs, the responsible person 7 shall not have to submit a duplicative serious ad- 8 verse event report under this section. smartinez on DSK4TPTVN1PROD with BILLS 9 ‘‘(2) NEW MEDICAL INFORMATION.—The 10 sponsible person shall submit to the Food and Drug 11 Administration any new medical information, related 12 to a submitted serious adverse event report that is 13 received by the responsible person within 1 year of 14 the initial report, and shall submit such information 15 not later than 15 business days after the new infor- 16 mation is received by the responsible person. 17 ‘‘(3) ANNUAL 18 ‘‘(A) IN REPORT.— GENERAL.—Not later than March 19 1 of each year, the responsible person shall sub- 20 mit an electronic report for the prior calendar 21 year for each cosmetic product marketed during 22 that year. 23 ‘‘(B) CONTENTS.—Each report under this 24 paragraph shall contain a summary of all ad- 25 verse events received during the reporting pe- •S 1014 IS VerDate Sep 11 2014 re- 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 49 1 riod, a complete list of individual reports, and 2 an estimate of the total number of product 3 units estimated to have been distributed to con- 4 sumers during such period. The report shall not 5 include consumer complaints that are solely re- 6 garding efficacy and do not contain any infor- 7 mation about an adverse event. The Food and 8 Drug Administration shall further specify the 9 contents of the annual electronic report by reg- 10 ulation or guidance. 11 ‘‘(4) EXEMPTION.—The Food and Drug Ad- 12 ministration may establish by regulation an exemp- 13 tion to any of the requirements under this sub- 14 section if the Food and Drug Administration deter- 15 mines that such exemption is supported by adequate 16 evidence and would have no adverse effect on public 17 health. 18 ‘‘(d) REQUIREMENTS.— smartinez on DSK4TPTVN1PROD with BILLS 19 ‘‘(1) IN GENERAL.—Each serious adverse event 20 report under this section shall be submitted to the 21 Food and Drug Administration using an electronic 22 system of the Food and Drug Administration. The 23 Food and Drug Administration shall make such elec- 24 tronic system available not later than 1 year after •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 50 1 the date of enactment of the Personal Care Products 2 Safety Act. 3 ‘‘(2) MODIFICATION.—The format of the re- 4 porting system may be modified by the Food and 5 Drug Administration and the reports may include 6 additional information. The Food and Drug Admin- 7 istration may, in guidance, further specify the for- 8 mat and contents of required reports. smartinez on DSK4TPTVN1PROD with BILLS 9 ‘‘(3) SCOPE OF SERIOUS ADVERSE EVENT RE- 10 PORT.—A 11 information submitted in the initial report or added 12 later) submitted to the Food and Drug Administra- 13 tion under subsection (a) includes— serious adverse event report (including all 14 ‘‘(A) a report under section 756 with re- 15 spect to safety and related to a specific cos- 16 metic product; 17 ‘‘(B) a record about an individual who suf- 18 fered the serious adverse event under section 19 552a of title 5, United States Code; 20 ‘‘(C) a medical or similar file documenting 21 the serious adverse event, the disclosure of 22 which would constitute a violation of section 23 552(b)(6) of such title 5, and shall not be pub- 24 licly disclosed unless all personally identifiable 25 information is redacted; and •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 51 1 ‘‘(D) contact information for the individual 2 reporting the serious adverse event. 3 ‘‘(4) RESPONSIBILITY TO GATHER INFORMA- 4 TION.—After 5 a serious adverse event, the responsible person for 6 the cosmetic product shall actively gather all of the 7 information to complete and file the report with the 8 Food and Drug Administration. 9 ‘‘(5) NO an individual initiates the reporting of ADVERSE EVENTS TO REPORT.—The 10 Food and Drug Administration shall provide an op- 11 tion as part of the electronic registration process for 12 the responsible person to indicate if such responsible 13 person had no adverse events to report over the pre- 14 vious year. With respect to a responsible person who 15 received no adverse event reports for a year, the an- 16 nual adverse event report requirement may be met 17 by indicating no such events on the annual registra- 18 tion form. 19 ‘‘(e) LIMITATION WITH RESPECT TO ADVERSE 20 EVENT REPORTS.—The submission of an adverse event 21 report in compliance with subsection (a) shall not con22 stitute an admission that the cosmetic involved caused or smartinez on DSK4TPTVN1PROD with BILLS 23 contributed to the adverse event. 24 ‘‘(f) CONTACT INFORMATION.—The label of a cos- 25 metic shall bear the domestic telephone number or elec•S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 52 1 tronic contact information, and it is encouraged that the 2 label include both the telephone number and electronic 3 contact information, through which the responsible person 4 may receive a report of an adverse event. 5 ‘‘(g) MAINTENANCE OF RECORDS.—The responsible 6 person shall maintain records related to each report of an 7 adverse event received by the responsible person for a pe8 riod of 6 years. 9 ‘‘(h) AVAILABILITY TO STATES.—The Food and 10 Drug Administration shall make available records sub11 mitted under this section to any State, upon request. In12 formation disclosed to a State that is exempt from disclo13 sure under section 552(b)(4) of title 5, United States 14 Code, shall be treated as a trade secret and confidential 15 information by the State. 16 17 ‘‘(i) EFFECTIVE DATE SPECT TO OF REQUIREMENT WITH RE- SERIOUS ADVERSE EVENTS.—The requirement 18 under this section to report serious adverse events shall 19 become effective on the date that the Food and Drug Ad20 ministration publicizes the availability of the electronic smartinez on DSK4TPTVN1PROD with BILLS 21 system described in subsection (d)(1).’’. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 53 1 SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU- 2 THORITY. 3 Chapter VI of the Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 361 et seq.), as amended by section 104, 5 is further amended by adding at the end the following: 6 ‘‘SEC. 612. INSPECTION OF COSMETIC RECORDS. 7 ‘‘(a) INSPECTION OF RECORDS.—Each manufac- 8 turer, processor, packer, or holder of a cosmetic shall, at 9 the request of an officer or employee duly designated by 10 the Food and Drug Administration, permit such officer 11 or employee, upon presentation of appropriate credentials 12 and written notice to such person, at reasonable times and 13 within reasonable limits and in a reasonable manner, to 14 have access to and copy— 15 ‘‘(1) all records maintained under section 611 16 and in accordance with the rules promulgated by the 17 Food and Drug Administration under section 610, 18 as applicable; and 19 ‘‘(2) except as provided in subsection (b), all 20 other records, if the Food and Drug Administra- 21 tion— 22 ‘‘(A) has a reasonable belief that the cos- smartinez on DSK4TPTVN1PROD with BILLS 23 metic— 24 ‘‘(i) is adulterated; 25 ‘‘(ii) has caused a reportable serious 26 adverse event; or •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 54 1 ‘‘(iii) contains an ingredient that sub- 2 stantial new scientific information shows 3 may be unsafe when present in a cosmetic; 4 and 5 ‘‘(B) provides written notice of the basis 6 for the Food and Drug Administration’s rea- 7 sonable belief described in subparagraph (A). 8 ‘‘(b) EXCLUSIONS.—No inspection authorized by this 9 section shall extend to financial data, pricing data, per10 sonnel data (other than data as to qualification of tech11 nical and professional personnel performing functions sub12 ject to this Act), research data (other than safety data) 13 or sales data other than shipment data. 14 ‘‘(c) SCOPE.—The requirements under subsection (a) 15 apply to records maintained by or on behalf of such person 16 in any format (including paper and electronic formats) 17 and at any location. 18 ‘‘(d) PROTECTION OF SENSITIVE INFORMATION.— 19 The Food and Drug Administration shall take appropriate 20 measures to ensure that there are effective procedures to 21 prevent the unauthorized disclosure of any trade secret or 22 confidential information that is obtained by the Food and smartinez on DSK4TPTVN1PROD with BILLS 23 Drug Administration pursuant to this section. Information 24 disclosed to a State that is exempt from disclosure under 25 section 552(b)(4) of title 5, United States Code, shall be •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 55 1 treated as a trade secret and confidential information by 2 the State. 3 ‘‘(e) LIMITATIONS.—This section shall not be con- 4 strued— 5 ‘‘(1) to limit the authority of the Food and 6 Drug Administration to inspect records or to require 7 establishment and maintenance of records under any 8 other provision of this Act; or 9 ‘‘(2) to have any legal effect on section 552 of 10 title 5, United States Code, or section 1905 of title 11 18, United States Code.’’. 12 ‘‘SEC. 613. MANDATORY RECALL AUTHORITY. 13 ‘‘(a) VOLUNTARY PROCEDURES.—If the Food and 14 Drug Administration determines that there is a reasonable 15 probability that a cosmetic is adulterated under section 16 601 or misbranded under section 602 and the use of or 17 exposure to such cosmetic is likely to cause serious adverse 18 health consequences or death, the Food and Drug Admin19 istration shall provide the responsible person with an op20 portunity to voluntarily cease distribution and recall such 21 article. 22 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE smartinez on DSK4TPTVN1PROD with BILLS 23 DISTRIBUTION AND GIVE NOTICE.— 24 25 ‘‘(1) IN GENERAL.—If the responsible person refuses to or does not voluntarily cease distribution •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 56 1 or recall such cosmetic within the time and in the 2 manner prescribed by the Food and Drug Adminis- 3 tration, the Food and Drug Administration may 4 order such person to— 5 ‘‘(A) immediately cease distribution of 6 such cosmetic; and 7 ‘‘(B) as applicable, immediately notify all 8 persons— 9 ‘‘(i) manufacturing, processing, pack- 10 ing, transporting, holding, receiving, dis- 11 tributing, or importing and selling such 12 cosmetic; and 13 ‘‘(ii) to which such cosmetic has been 14 distributed, transported, or sold, 15 to immediately cease distribution of such cos- 16 metic. 17 ‘‘(2) REQUIRED smartinez on DSK4TPTVN1PROD with BILLS 18 ‘‘(A) IN ADDITIONAL INFORMATION.— GENERAL.—If a cosmetic covered 19 by a recall order issued under paragraph (1)(B) 20 has been distributed to a warehouse-based third 21 party logistics provider without providing such 22 provider sufficient information to know or rea- 23 sonably determine the precise identity of such 24 cosmetic covered by a recall order that is in its 25 possession, the notice provided by the respon- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 57 1 sible person subject to the order issued under 2 paragraph (1)(B) shall include such information 3 as is necessary for the warehouse-based third 4 party logistics provider to identify the cosmetic. 5 ‘‘(B) RULES 6 in this paragraph shall be construed— 7 ‘‘(i) to exempt a warehouse-based 8 third party logistics provider from the re- 9 quirements of this chapter, including the 10 requirements of this section and section 11 612; or 12 ‘‘(ii) to exempt a warehouse-based 13 third party logistics provider from being 14 the subject of a mandatory recall order. 15 smartinez on DSK4TPTVN1PROD with BILLS OF CONSTRUCTION.—Nothing ‘‘(3) DETERMINATION TO LIMIT AREAS AF- 16 FECTED.—If 17 quires a responsible person to cease distribution 18 under paragraph (1)(A) of a cosmetic, the Food and 19 Drug Administration may limit the size of the geo- 20 graphic area and the markets affected by such ces- 21 sation if such limitation would not compromise the 22 public health. 23 ‘‘(c) HEARING the Food and Drug Administration re- ON ORDER.—The Food and Drug Ad- 24 ministration shall provide the responsible party subject to 25 an order under subsection (b) with an opportunity for an •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00057 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 58 1 informal hearing, to be held as soon as possible, but not 2 later than 2 days after the issuance of the order, on the 3 actions required by the order and on why the cosmetic that 4 is the subject of the order should not be recalled. 5 6 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICATION OF 7 ORDER.— ‘‘(1) AMENDMENT viding opportunity for an informal hearing under 9 subsection (c), the Food and Drug Administration 10 determines that removal of the cosmetic from com- 11 merce is necessary, the Food and Drug Administra- 12 tion shall, as appropriate— ‘‘(A) amend the order to require recall of 14 such cosmetic or other appropriate action; 15 ‘‘(B) specify a timetable in which the recall 16 shall occur; 17 ‘‘(C) require periodic reports to the Food 18 and 19 progress of the recall; and Drug Administration describing the 20 ‘‘(D) provide notice to consumers to whom 21 such cosmetic was, or may have been, distrib- 22 uted. 23 ‘‘(2) VACATING OF ORDER.—If, after such hear- 24 ing, the Food and Drug Administration determines 25 that adequate grounds do not exist to continue the •S 1014 IS VerDate Sep 11 2014 after pro- 8 13 smartinez on DSK4TPTVN1PROD with BILLS OF ORDER.—If, 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 59 1 actions required by the order, or that such actions 2 should be modified, the Food and Drug Administra- 3 tion shall vacate the order or modify the order. 4 ‘‘(e) COOPERATION AND CONSULTATION.—The Food 5 and Drug Administration shall work with State and local 6 public health officials in carrying out this section, as ap7 propriate. 8 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 9 under this section, the Food and Drug Administration 10 shall— 11 ‘‘(1) ensure that a press release is published re- 12 garding the recall, and that alerts and public notices 13 are issued, as appropriate, in order to provide notifi- 14 cation— 15 ‘‘(A) of the recall to consumers and retail- 16 ers to whom such cosmetic was, or may have 17 been, distributed; and 18 ‘‘(B) that includes, at a minimum— 19 ‘‘(i) the name of the cosmetic subject 20 to the recall; 21 ‘‘(ii) a description of the risk associ- smartinez on DSK4TPTVN1PROD with BILLS 22 ated with such article; and 23 ‘‘(iii) to the extent practicable, infor- 24 mation for consumers about similar cos- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 60 1 metics that are not affected by the recall; 2 and 3 ‘‘(2) ensure publication on the Internet website 4 of the Food and Drug Administration an image of 5 the cosmetic that is the subject of the press release 6 described in paragraph (1), if available. 7 ‘‘(g) NO DELEGATION.—The authority conferred by 8 this section to order a recall or vacate a recall order shall 9 not be delegated to any officer or employee other than the 10 Commissioner. 11 ‘‘(h) EFFECT.—Nothing in this section shall affect 12 the authority of the Food and Drug Administration to re13 quest or participate in a voluntary recall, or to issue an 14 order to cease distribution or to recall under any other 15 provision of this chapter or under the Public Health Serv16 ice Act.’’. 17 SEC. 106. LABELING. 18 (a) IN GENERAL.—Chapter VI of the Federal Food, 19 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 20 amended by section 105, is further amended by adding 21 at the end the following: 22 ‘‘SEC. 614. LABELING. smartinez on DSK4TPTVN1PROD with BILLS 23 ‘‘(a) SAFETY REVIEW AND LABELING.—Following a 24 review of cosmetic ingredients that determines that warn25 ings are required to help ensure safe use of cosmetic prod•S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00060 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 61 1 ucts under section 608(d)(5), the Food and Drug Admin2 istration shall require labeling of cosmetics that are not 3 appropriate for use in the entire population, including 4 warnings that vulnerable populations, such as children or 5 pregnant women, should limit or avoid using the product. 6 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL 7 USE.— 8 9 10 ‘‘(1) DEFINITION individual who— 11 ‘‘(A) is licensed by an official State author- 12 ity to practice in the field of cosmetology, nail 13 care, barbering, and or esthetics; ‘‘(B) has complied with all requirements 15 set forth by the State for such licensing; and 16 ‘‘(C) has been granted a license by a State 17 board or legal agency or legal authority. 18 ‘‘(2) LISTING OF INGREDIENTS.—Cosmetic 19 products used and sold by professionals shall list all 20 ingredients, as required for other cosmetic products 21 under this chapter. 22 ‘‘(3) PROFESSIONAL USE LABELING.—In the 23 case of a cosmetic product intended to be used only 24 by a professional on account of a specific ingredient 25 or increased concentration of an ingredient that re- •S 1014 IS VerDate Sep 11 2014 re- spect to cosmetics, the term ‘professional’ means an 14 smartinez on DSK4TPTVN1PROD with BILLS OF PROFESSIONAL.—With 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 62 1 quires safe handling by trained professionals, the 2 product shall bear a statement as follows: ‘To be Ad- 3 ministered Only by Licensed Professionals’. 4 ‘‘(c) DISPLAY.—The warning required under sub- 5 section (a) and the statement required under subsection 6 (b)(3) shall be prominently displayed— 7 8 ‘‘(1) in the primary language used on the label; and 9 ‘‘(2) in conspicuous and legible type in contrast 10 by typography, layout, or color with other material 11 printed or displayed on the label. 12 ‘‘(d) INTERNET SALES.—In the case of Internet sales 13 of cosmetics, each Internet website offering cosmetic prod14 ucts for sale to consumers shall provide the same informa15 tion that is included on the packaging of the cosmetic 16 products as regularly available, and the warnings and 17 statements described in subsection (c) shall be promi18 nently and conspicuously displayed on the website. 19 ‘‘(e) CONTACT INFORMATION.—The label on each 20 cosmetic shall bear the domestic telephone number or elec21 tronic contact information, and it is encouraged that the 22 label include both the telephone number and electronic smartinez on DSK4TPTVN1PROD with BILLS 23 contact information, that consumers may use to contact 24 the responsible person with respect to adverse events. The 25 contact number shall provide a means for consumers to •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 63 1 obtain additional information about ingredients in a cos2 metic, including the ability to ask if a specific ingredient 3 may be present that is not listed on the label, including 4 whether a specific ingredient may be contained in the fra5 grance or flavor used in the cosmetic. The manufacturer 6 of the cosmetic is responsible for providing such informa7 tion, including obtaining the information from suppliers 8 if it is not readily available. Suppliers are required to re9 lease such information upon request of the cosmetic manu10 facturer.’’. 11 (b) EFFECTIVE DATE.—Section 614 of the Federal 12 Food, Drug, and Cosmetic Act, as added by subsection 13 (a), shall take effect on the date that is 1 year after the 14 date of enactment of this Act. 15 SEC. 107. COAL TAR CHEMICALS. 16 Chapter VI of the Federal Food, Drug, and Cosmetic 17 Act (21 U.S.C. 361 et seq.), as amended by section 106, 18 is further amended by adding at the end the following: 19 ‘‘SEC. 615. COAL TAR CHEMICALS. 20 ‘‘(a) IN GENERAL.—Under section 608, the Food and 21 Drug Administration may review any cosmetic ingredient 22 in order to determine if it is safe in cosmetic products smartinez on DSK4TPTVN1PROD with BILLS 23 without the need for specified conditions of use or toler24 ances, safe in cosmetic products under specified conditions 25 of use or tolerances, or not safe in cosmetic products. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 64 1 ‘‘(b) COAL TAR HAIR DYES.—Specific chemicals in 2 coal tar hair dyes may be selected and reviewed under sec3 tion 608(a)(3).’’. 4 SEC. 108. ANIMAL TESTING ALTERNATIVES. 5 Chapter VI of the Federal Food, Drug, and Cosmetic 6 Act (21 U.S.C. 361 et seq.), as amended by section 107, 7 is further amended by adding the following: 8 ‘‘SEC. 616. ANIMAL TESTING ALTERNATIVES. 9 ‘‘(a) IN GENERAL.—To minimize the use of animal 10 testing for safety of cosmetic ingredients, non-functional 11 constituents, and finished cosmetic products, the Food smartinez on DSK4TPTVN1PROD with BILLS 12 and Drug Administration shall— 13 ‘‘(1) encourage the use of alternative testing 14 methods that provide information that is equivalent 15 or superior in scientific quality to the animal testing 16 method to— 17 ‘‘(A) not involve the use of an animal to 18 test a chemical substance for safe use in cos- 19 metics; or 20 ‘‘(B) use fewer animals than conventional 21 animal-based tests for safe use in cosmetics 22 when nonanimal methods are impracticable; and 23 ‘‘(2) encourage— 24 ‘‘(A) the sharing of data across companies 25 and organizations that are testing for safety in •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 65 1 cosmetics, so as to avoid duplication of animal 2 tests; and 3 ‘‘(B) funding for research and validation of 4 alternative testing methods. 5 ‘‘(b) GUIDANCE.—Not later than 3 years after the 6 date of enactment of the Personal Care Products Safety 7 Act, the Food and Drug Administration shall issue guid8 ance on the acceptability of scientifically reliable and rel9 evant alternatives to animal testing for the safety of cos10 metic ingredients, non-functional constituents, and fin11 ished cosmetic products, and encouraging the use of such 12 methods. The Food and Drug Administration shall update 13 such guidance on an annual basis. 14 15 ‘‘(c) RESOURCES REGARDING ANIMAL TESTING ALTERNATIVES.—Not later than 180 days after the date of 16 enactment of the Personal Care Products Safety Act, the 17 Food and Drug Administration shall provide information 18 on the Internet website of the Food and Drug Administra19 tion regarding resources available for information about 20 non-animal methods, and methods that reduce animal 21 usage, in testing for the safety of cosmetic ingredients, 22 non-functional constituents, and finished cosmetic prod- smartinez on DSK4TPTVN1PROD with BILLS 23 ucts.’’. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 66 1 SEC. 109. PREEMPTION. 2 Chapter VI of the Federal Food, Drug, and Cosmetic 3 Act (21 U.S.C. 361 et seq.), as amended by section 108, 4 is further amended by adding the following: 5 ‘‘SEC. 617. PREEMPTION. 6 7 ‘‘(a) REGISTRATION, GOOD MANUFACTURING PRACTICES, RECALLS, ADVERSE EVENT REPORTING.—Except 8 for a State requirement that is in full effect and imple9 mented on the date of enactment of the Personal Care 10 Products Safety Act, no State or political subdivision of 11 a State may establish or continue in effect any require12 ment for cosmetics with respect to registration, good man13 ufacturing practices, mandatory recalls, or adverse event 14 reporting. 15 ‘‘(b) SAFETY OF COSMETIC INGREDIENTS AND NON- 16 FUNCTIONAL CONSTITUENTS.— smartinez on DSK4TPTVN1PROD with BILLS 17 ‘‘(1) IN GENERAL.—Except for a State require- 18 ment that is more restrictive than a final order 19 issued under section 608(d)(3) and that is in full ef- 20 fect and implemented on the date of enactment of 21 the Personal Care Products Safety Act, no State or 22 political subdivision of a State may establish or con- 23 tinue in effect any requirement with respect to the 24 safety of a cosmetic ingredient or non-functional 25 constituent that is the subject of a final order under •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 67 1 section 608(d)(3) that is different from, or in addi- 2 tion to, a final order issued under section 608(d)(3). 3 ‘‘(2) DELAYED 4 QUIREMENTS.—From 5 Drug Administration has made public the final selec- 6 tion of a cosmetic ingredient or non-functional con- 7 stituent to be reviewed in the coming year under sec- 8 tion 608(a)(3)(B), and opened the public comment 9 period under section 608(a)(2), until the date that 10 is one year after the Food and Drug Administration 11 has made public such selection, no State or political 12 subdivision of a State may establish any new re- 13 quirement related to such cosmetic ingredient or 14 non-functional constituent. the date that the Food and 15 ‘‘(3) SCOPE.—This subsection shall not be con- 16 strued to modify or affect the authority of a State 17 or political subdivision of a State with respect to 18 such safety requirements unrelated to the scope of 19 the safety assessment under section 608. 20 smartinez on DSK4TPTVN1PROD with BILLS EFFECT OF NEW STATE RE- ‘‘(4) SENSE OF CONGRESS.—It is the sense of 21 Congress that a State or political subdivision that 22 regulates the safety of cosmetics with respect to the 23 health of humans beyond the scope of section 608 24 should utilize the safety assessment criteria de- 25 scribed in section 608(h). •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 68 1 2 ‘‘(c) STATE REQUIREMENT THAT IS FECT AND 3 IN FULL EF- IMPLEMENTED.—For purposes of this section: ‘‘(1) STATE REQUIREMENT.—A State require- 4 ment includes a State requirement that is adopted 5 by a State public initiative or referendum. 6 ‘‘(2) FULL EFFECT AND IMPLEMENTED.—The 7 term ‘full effect and implemented’ includes require- 8 ments of States that are implemented after the date 9 of enactment of the Personal Care Products Safety 10 Act, if such requirements are under a law that was 11 in effect, or a lawful program that was established 12 and functioning, prior to the date of enactment of 13 the Personal Care Products Safety Act. 14 ‘‘(d) RULE OF CONSTRUCTION REGARDING PRODUCT 15 LIABILITY.—Notwithstanding any other provision of this 16 Act, no provision of this chapter relating to a cosmetic 17 shall be construed to modify or otherwise affect any action 18 or the liability of any person under State or Federal com19 mon law. 20 ‘‘(e) LIMITATION.—The Personal Care Products 21 Safety Act, including the amendments made by such Act, 22 shall not be construed to preempt any State statute, public smartinez on DSK4TPTVN1PROD with BILLS 23 initiative, referendum, or common law, except as expressly 24 provided in this section.’’. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 69 1 SEC. 110. REPORTING. 2 Chapter VI of the Federal Food, Drug, and Cosmetic 3 Act (21 U.S.C. 361 et seq.), as amended by section 109, 4 is further amended by adding at the end the following: 5 ‘‘SEC. 618. REPORTING. 6 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 7 year 2016, and not later than 60 days prior to the end 8 of each fiscal year for which fees are collected under sec9 tion 744L, the Food and Drug Administration shall pre10 pare and submit to Congress a report concerning the 11 progress of the Food and Drug Administration in achiev12 ing the objectives of the Personal Care Products Safety 13 Act during such fiscal year and the future plans of the 14 Food and Drug Administration for meeting the objectives. smartinez on DSK4TPTVN1PROD with BILLS 15 The annual report for a fiscal year shall include— 16 ‘‘(1) the number of registered facilities and cos- 17 metic ingredient statements on file with the Food 18 and Drug Administration; 19 ‘‘(2) identification of the cosmetic ingredients 20 and non-functional constituents that have been fully 21 reviewed for safety by the Food and Drug Adminis- 22 tration in the prior fiscal year and for which a final 23 administrative order has been released; 24 ‘‘(3) identification of at least 5 specific cosmetic 25 ingredients and non-functional constituents that will •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00069 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 70 1 be reviewed by the Food and Drug Administration 2 in the next fiscal year; 3 ‘‘(4) the number of facilities inspected and 4 mandatory recalls that transpired during that fiscal 5 year; 6 ‘‘(5) the number of serious adverse event re- 7 ports received by the Food and Drug Administration 8 during that fiscal year; 9 ‘‘(6) any trends identified by the Food and 10 Drug Administration about adverse event reports re- 11 lated to specific cosmetic ingredients or non-func- 12 tional constituents; and 13 ‘‘(7) efforts of the Food and Drug Administra- 14 tion to reduce animal testing for safety of cosmetic 15 ingredients, non-functional constituents, and cos- 16 metic products. 17 ‘‘(b) PUBLIC AVAILABILITY.—The Food and Drug 18 Administration shall make the reports required under sub19 sections (a) available to the public on the Internet website 20 of the Food and Drug Administration on the date of sub21 mission of such reports to Congress. 22 ‘‘(c) PUBLIC INPUT ON SAFETY REVIEW.—Upon re- smartinez on DSK4TPTVN1PROD with BILLS 23 lease of the report described in subsection (a), the Food 24 and Drug Administration shall provide the public with an 25 opportunity to provide feedback on subsection (a)(3) by— •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 71 1 smartinez on DSK4TPTVN1PROD with BILLS 2 ‘‘(1) providing an electronic portal, upon release of the report, enabling the public to— 3 ‘‘(A) recommend additional cosmetic ingre- 4 dients and non-functional constituents to be 5 considered for review for safety in future years; 6 and 7 ‘‘(B) comment on the priorities for the spe- 8 cific cosmetic ingredients and non-functional 9 constituents that the Food and Drug Adminis- 10 tration anticipates will be reviewed in the next 11 fiscal year; 12 ‘‘(2) announcing on the Internet website of the 13 Food and Drug Administration, within the first 30 14 days of the new fiscal year, any amendments to sub- 15 section (a)(3) based on public input, pursuant to 16 paragraph (1); and 17 ‘‘(3) together with the final announcement of 5 18 specific cosmetic ingredients and non-functional con- 19 stituents that will be reviewed in the coming year 20 under subsection (a)(3), providing a comment period 21 for further public input, pursuant to section 22 608(a)(2).’’. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 72 1 SEC. 111. SMALL BUSINESSES. 2 Chapter VI of the Federal Food, Drug, and Cosmetic 3 Act (21 U.S.C. 361 et seq.), as amended by section 110, 4 is further amended by adding at the end the following: 5 ‘‘SEC. 619. SMALL BUSINESSES. 6 ‘‘The Commissioner, in coordination with the Admin- 7 istrator of the Small Business Administration, shall pro8 vide technical assistance, such as guidance and expertise, 9 to small businesses regarding compliance with the Per10 sonal Care Products Safety Act, including the amend11 ments made by such Act.’’. 12 SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS- 13 METICS. 14 Chapter VI of the Federal Food, Drug, and Cosmetic 15 Act (21 U.S.C. 361 et seq.), as amended by section 111, 16 is further amended by adding at the end the following: 17 ‘‘SEC. 620. APPLICABILITY WITH RESPECT TO CERTAIN 18 19 COSMETICS. ‘‘In the case of a cosmetic product or a facility that 20 is subject to the requirements under this chapter and 21 chapter V, if any requirement under chapter V with re22 spect to such cosmetic or facility is substantially similar smartinez on DSK4TPTVN1PROD with BILLS 23 to a requirement under this chapter, the cosmetic product 24 or facility shall be deemed to be in compliance with the 25 applicable requirement under this chapter if such product 26 or facility is in compliance with such substantially similar •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00072 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 73 1 requirement under chapter V, provided that the product 2 or facility has not obtained a waiver from the requirement 3 under chapter V.’’. 4 SEC. 113. ENFORCEMENT. 5 (a) PROHIBITED ACTS.—Section 301 of the Federal 6 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend7 ed— 8 (1) in subsection (e)— 9 (A) by striking ‘‘504, 564’’ and inserting 10 ‘‘504, 564, 611, or 612’’; and 11 (B) by striking ‘‘519, 564’’ and inserting 12 ‘‘519, 564, 611,’’; 13 (2) in subsection (j) by inserting ‘‘607, 608, 14 610,’’ before ‘‘704’’; 15 (3) in subsection (ii)— 16 (A) by striking ‘‘760 or 761)’’ and insert- 17 ing ‘‘604, 760, or 761)’’; and 18 (B) by striking ‘‘760 or 761) submitted’’ 19 and inserting ‘‘611, 760, or 761) submitted’’; 20 (4) in subsection (xx) by inserting ‘‘or 613’’ 21 after ‘‘423’’; and 22 smartinez on DSK4TPTVN1PROD with BILLS 23 (5) by adding at the end the following: ‘‘(ddd) The failure to register in accordance with sec- 24 tion 605, the failure to submit a cosmetic ingredient state25 ment under section 606, the failure to provide any infor•S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 74 1 mation required by section 605 or 606, or the failure to 2 update the information required by section 605 or 606, 3 as required.’’. 4 (b) ADULTERATION.—Section 601 of the Federal 5 Food, Drug, and Cosmetic Act (21 U.S.C. 361), as 6 amended by section 103, is further amended by adding 7 at the end the following: 8 ‘‘(g) If it contains, after the date prescribed under 9 section 608(e), an ingredient that the Food and Drug Ad10 ministration has determined under section 608(d)(4) to be 11 not safe, or not safe under the conditions of use rec12 ommended or suggested in the label or a non-functional 13 constituent that the Food and Drug Administration has 14 determined under section 608(d)(4) to be not safe or not 15 safe in the amount present in the cosmetic. 16 ‘‘(h) If it is a cosmetic product for which any require- 17 ment of section 609 (relating to safety substantiation) is 18 not met.’’. 19 (c) MISBRANDING.—Section 602 is amended— 20 (1) in subsection (b)— 21 (A) by striking ‘‘and (2)’’ and inserting smartinez on DSK4TPTVN1PROD with BILLS 22 ‘‘(2)’’; and 23 (B) by inserting ‘‘; and (3) a domestic ad- 24 dress or a domestic telephone number, and it is 25 encouraged that the label include both a domes- •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00074 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 75 1 tic address and a domestic telephone number, 2 through which the responsible person may re- 3 ceive a report of an adverse event associated 4 with the use of such cosmetic product’’ after 5 ‘‘numerical count’’; and 6 (2) by adding at the end the following: 7 ‘‘(g) If it has been manufactured, processed, packed, 8 or held in any factory, warehouse, or establishment and 9 the responsible person, operator, or agent of such factory, 10 warehouse, or establishment delays, denies, or limits an 11 inspection, or refuses to permit entry or inspection. 12 ‘‘(h) If its labeling does not conform with a require- 13 ment under section 614.’’. 14 (d) GUIDANCE.—Not later than 1 year after the date 15 of enactment of this Act, the Food and Drug Administra16 tion shall issue guidance that defines the circumstances 17 that would constitute delaying, denying, or limiting inspec18 tion, or refusing to permit entry or inspection, for pur19 poses of section 602(g) of the Federal Food, Drug, and 20 Cosmetic Act, as added by subsection (c)(2). smartinez on DSK4TPTVN1PROD with BILLS 21 (e) IMPORTS.—Section 801(a) is amended— 22 (1) by striking ‘‘section 760 or 761’’ the first, 23 third, and fourth place such term appears and in- 24 serting ‘‘section 611, 760, or 761’’; and •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 76 1 (2) by striking ‘‘760 or 761)’’ and inserting 2 ‘‘604, 760, or 761)’’. 3 (f) FACTORY INSPECTION.—Section 704(a)(1) is 4 amended by inserting after the third sentence the fol5 lowing: ‘‘In the case of any person who manufactures, 6 processes, packs, holds, distributes, or imports a cosmetic 7 product, or distributes a cosmetic product and affixes its 8 name on the cosmetic label, the inspection shall extend 9 to all records and other information described in section 10 612 (regarding inspection of cosmetic records), when the 11 standard for records inspections under paragraph (1) or 12 (2) of subsection (a) of such section applies, subject to 13 the limitations under subsection (d) of such section.’’. 14 SEC. 114. CONSUMER INFORMATION. 15 The Food and Drug Administration shall post on its 16 Internet website information for consumers regarding— 17 (1) final orders regarding the safety of a cos- 18 metic ingredient or non-functional constituent under 19 section 608(d)(3); 20 21 (2) cosmetic product recalls (including voluntary and mandatory recalls); and smartinez on DSK4TPTVN1PROD with BILLS 22 (3) identified counterfeit cosmetic products. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 77 TITLE II—FEES RELATED TO COSMETIC SAFETY 1 2 3 SEC. 201. FINDINGS. 4 Congress finds that the fees authorized by the 5 amendments made by this title will be dedicated to cos6 metic safety activities, as set forth in the goals identified 7 for purposes of part 10 of subchapter C of chapter VII 8 of the Federal Food, Drug, and Cosmetic Act, in the let9 ters from the Secretary of Health and Human Services 10 to the Chairman of the Committee on Health, Education, 11 Labor, and Pensions of the Senate and the Chairman of 12 the Committee on Energy and Commerce of the House 13 of Representatives, as set forth in the Congressional 14 Record. 15 SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFE- 16 TY FEES. 17 Subchapter C of chapter VII of the Federal Food, 18 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 19 amended by adding at the end the following: 20 21 ‘‘PART 10—FEES RELATING TO COSMETICS ‘‘SEC. 744L. REGISTRATION FEE. 22 ‘‘(a) ASSESSMENT AND COLLECTION.— smartinez on DSK4TPTVN1PROD with BILLS 23 ‘‘(1) IN GENERAL.—Beginning in fiscal year 24 2016, the Food and Drug Administration shall as- 25 sess and collect an annual fee from every responsible •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 78 1 person (referred to in this section as a ‘registrant’) 2 who owns or operates any cosmetic facility engaged 3 in manufacturing or processing, or whose name and 4 address appear on the label of a cosmetic product 5 distributed in the United States, except that this 6 subsection shall not apply to entities described in 7 subparagraphs (A) through (H) of section 604(3). 8 ‘‘(2) PAYABLE fee under this section 9 shall be payable during the period of initial registra- 10 tion and on the date of registration each year there- 11 after as prescribed in section 605(a)(1). 12 ‘‘(b) DEFINITIONS.—In this section: 13 smartinez on DSK4TPTVN1PROD with BILLS DATE.—A ‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust- 14 ment factor’ applicable to a fiscal year means the 15 Consumer Price Index for all urban consumers (all 16 items; United States city average) for October of the 17 preceding fiscal year divided by such index for Octo- 18 ber 2015. 19 ‘‘(2) AFFILIATE.—The term ‘affiliate’ means 20 any business entity that has a relationship with a 21 second business entity if, directly or indirectly— 22 ‘‘(A) one business entity controls, or has 23 power to control, the other business entity; or 24 ‘‘(B) a third-party controls, or has the 25 power to control, both of the business entities. •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 79 1 smartinez on DSK4TPTVN1PROD with BILLS 2 ‘‘(3) COSMETIC SAFETY ACTIVITIES.—The ‘cosmetic safety activities’— 3 ‘‘(A) means activities related to compliance 4 by registrants under section 605 with the re- 5 quirements of this Act with respect to cos- 6 metics, including— 7 ‘‘(i) administrative activities, such as 8 information technology support, human re- 9 sources, financial management, the admin- 10 istration and maintenance of the cosmetic 11 registration system and the cosmetic ingre- 12 dient statement system under sections 605 13 and 606, and fee assessment and collection 14 under this section; and 15 ‘‘(ii) implementation and enforcement 16 activities, such as the establishment of 17 good manufacturing practices, the review 18 of adverse event reports, inspection plan- 19 ning and inspections, and use of enforce- 20 ment tools; and 21 ‘‘(B) includes activities related to imple- 22 mentation of section 608, regarding the review 23 of cosmetic ingredients and non-functional con- 24 stituents. •S 1014 IS VerDate Sep 11 2014 term 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00079 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 80 1 ‘‘(4) GROSS term ‘gross 2 annual sales’ means the average United States gross 3 annual sales for the previous 3-year period of cos- 4 metics for a registrant, including the sales of all of 5 its affiliates, as reported in the registration under 6 section 605. 7 ‘‘(c) FEE SETTING AND AMOUNTS.— 8 ‘‘(1) IN GENERAL.—Subject to subsection (d), 9 the Food and Drug Administration shall establish 10 the fees to be collected under this section for each 11 fiscal year after fiscal year 2016, based on the meth- 12 odology described in paragraph (3)(B), and shall 13 publish such fees in a Federal Register notice not 14 later than 60 days before the beginning of each such 15 fiscal year. 16 ‘‘(2) FEE EXEMPTION.—Any registrant whose 17 average gross annual sales of cosmetic products in 18 the 3-year period immediately preceding the fiscal 19 year for which the annual fee will be paid was not 20 more than $500,000, shall be exempt from registra- 21 tion fees under this section for that fiscal year. 22 ‘‘(3) ANNUAL 23 smartinez on DSK4TPTVN1PROD with BILLS ANNUAL SALES.—The FEE SETTING.— ‘‘(A) FISCAL YEAR 2016.—For 24 2016, to generate a total estimated revenue 25 amount of $20,600,000, the amount of the reg- •S 1014 IS VerDate Sep 11 2014 fiscal year 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 81 1 istration fee under subsection (a) shall be as 2 follows: 3 ‘‘(i) TIER I–A.—For a registrant that 4 has gross annual sales of $5,000,000,000 5 or more in 2015, $1,100,000. 6 ‘‘(ii) TIER I–B.—For a registrant that 7 has 8 $4,000,000,000 per annum but less than 9 $5,000,000,000 in 2015, $840,000. 10 annual ‘‘(iii) TIER sales II–A.—For of least a registrant that has gross annual sales of at least 12 $3,000,000,000 per annum but less than 13 $4,000,000,000 in 2015, $720,000. ‘‘(iv) TIER II–B.—For a registrant 15 that has gross annual sales of at least 16 $2,000,000,000 per annum but less than 17 $3,000,000,000 in 2015, $600,000. 18 ‘‘(v) TIER III–A.—For a registrant 19 that has gross annual sales of at least 20 $1,000,000,000 per annum but less than 21 $2,000,000,000 in 2015, $500,000. 22 ‘‘(vi) TIER III–B.—For a registrant 23 that has gross annual sales of at least 24 $500,000,000 per annum but less than 25 $1,000,000,000 in 2015, $395,000. •S 1014 IS VerDate Sep 11 2014 at 11 14 smartinez on DSK4TPTVN1PROD with BILLS gross 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 82 1 ‘‘(vii) TIER a registrant 2 that has gross annual sales of at least 3 $200,000,000 per annum but less than 4 $500,000,000 in 2015, $325,000. 5 ‘‘(viii) TIER IV–B.—For a registrant 6 that has gross annual sales of at least 7 $100,000,000 per annum but less than 8 $200,000,000 in 2015, $275,000. 9 ‘‘(ix) TIER V–A.—For a registrant 10 that has gross annual sales of at least 11 $80,000,000 per annum but less than 12 $100,000,000 in 2015, $185,000. 13 ‘‘(x) TIER V–B.—For a registrant that 14 has 15 $60,000,000 per annum but less than 16 $80,000,000 in 2015, $95,000. 17 gross annual ‘‘(xi) TIER sales of VI–A.—For least a registrant that has gross annual sales of at least 19 $40,000,000 per annum but less than 20 $60,000,000 in 2015, $15,000. ‘‘(xii) TIER IV–B.—For a registrant 22 that has gross annual sales of at least 23 $20,000,000 per annum but less than 24 $40,000,000 in 2015, $12,000. •S 1014 IS VerDate Sep 11 2014 at 18 21 smartinez on DSK4TPTVN1PROD with BILLS IV–A.—For 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00082 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 83 1 ‘‘(xiii) TIER a registrant 2 that has gross annual sales of at least 3 $2,500,000 per annum but less than 4 $20,000,000 in 2015, $500. 5 ‘‘(xiv) TIER VII–B.—For a registrant 6 that has gross annual sales of at least 7 $500,000 8 $2,500,000 in 2015, $250. 9 ‘‘(B) FISCAL per annum but YEARS 2017–2022.—For than fiscal years 2017–2022, fees under subsection (a) 11 shall be established to generate a total esti- 12 mated revenue amount of $20,600,000, as ad- 13 justed by subsection (d). Of that amount: 14 ‘‘(i) TIER I–A.—Registrants that have 15 gross annual sales of $5,000,000,000 or 16 more in the fiscal year immediately pre- 17 ceding the fiscal year in which the annual 18 fee will be paid, shall be responsible, collec- 19 tively, for 10.7 percent. ‘‘(ii) TIER I–B.—Registrants that 21 have gross annual sales of at least 22 $4,000,000,000 per annum but less than 23 $5,000,000,000 in the fiscal year imme- 24 diately preceding the fiscal year in which •S 1014 IS VerDate Sep 11 2014 less 10 20 smartinez on DSK4TPTVN1PROD with BILLS VII–A.—For 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 84 1 the annual fee will be paid, shall be re- 2 sponsible, collectively, for 4.1 percent. 3 ‘‘(iii) TIER have gross annual sales of at least 5 $3,000,000,000 per annum but less than 6 $4,000,000,000 in the fiscal year imme- 7 diately preceding the fiscal year in which 8 the annual fee will be paid, shall be re- 9 sponsible, collectively, for 3.5 percent. ‘‘(iv) TIER II–B.—Registrants that 11 have gross annual sales of at least 12 $2,000,000,000 per annum but less than 13 $3,000,000,000 in the fiscal year imme- 14 diately preceding the fiscal year in which 15 the annual fee will be paid, shall be re- 16 sponsible, collectively, for 2.9 percent. 17 ‘‘(v) TIER III–A.—Registrants that 18 have gross annual sales of at least 19 $1,000,000,000 per annum but less than 20 $2,000,000,000 in the fiscal year imme- 21 diately preceding the fiscal year in which 22 the annual fee will be paid, shall be re- 23 sponsible, collectively, for 7.3 percent. 24 ‘‘(vi) TIER 25 III–B.—Registrants 03:48 Apr 25, 2015 that have gross annual sales of at least •S 1014 IS VerDate Sep 11 2014 that 4 10 smartinez on DSK4TPTVN1PROD with BILLS II–A.—Registrants Jkt 049200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 85 1 $500,000,000 per annum but less than 2 $1,000,000,000 in the fiscal year imme- 3 diately preceding the fiscal year in which 4 the annual fee will be paid, shall be re- 5 sponsible, collectively, for 13.4 percent. 6 ‘‘(vii) TIER have gross annual sales of at least 8 $200,000,000 per annum but less than 9 $500,000,000 in the fiscal year imme- 10 diately preceding the fiscal year in which 11 the annual fee will be paid, shall be re- 12 sponsible, collectively, for 15.8 percent. ‘‘(viii) TIER IV–B.—Registrants that 14 have gross annual sales of at least 15 $100,000,000 per annum but less than 16 $200,000,000 in the fiscal year imme- 17 diately preceding the fiscal year in which 18 the annual fee will be paid, shall be re- 19 sponsible, collectively, for 13.3 percent. 20 ‘‘(ix) TIER V–A.—Registrants that 21 have gross annual sales of at least 22 $80,000,000 per annum but less than 23 $100,000,000 in the fiscal year imme- 24 diately preceding the fiscal year in which •S 1014 IS VerDate Sep 11 2014 that 7 13 smartinez on DSK4TPTVN1PROD with BILLS IV–A.—Registrants 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00085 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 86 1 the annual fee will be paid, shall be re- 2 sponsible, collectively, for 9 percent. 3 ‘‘(x) TIER have gross annual sales of at least 5 $60,000,000 per annum but less than 6 $80,000,000 in the fiscal year immediately 7 preceding the fiscal year in which the an- 8 nual fee will be paid, shall be responsible, 9 collectively, for 6.9 percent. ‘‘(xi) TIER VI–A.—Registrants that 11 have gross annual sales of at least 12 $40,000,000 per annum but less than 13 $60,000,000 in the fiscal year immediately 14 preceding the fiscal year in which the an- 15 nual fee will be paid, shall be responsible, 16 collectively, for 5.1 percent. 17 ‘‘(xii) TIER VI–B.—Registrants that 18 have gross annual sales of at least 19 $20,000,000 per annum but less than 20 $40,000,000 in the fiscal year immediately 21 preceding the fiscal year in which the an- 22 nual fee will be paid, shall be responsible, 23 collectively, for 4.4 percent. 24 ‘‘(xiii) TIER 25 VII–A.—Registrants 03:48 Apr 25, 2015 that have gross annual sales of at least •S 1014 IS VerDate Sep 11 2014 that 4 10 smartinez on DSK4TPTVN1PROD with BILLS V–B.—Registrants Jkt 049200 PO 00000 Frm 00086 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 87 1 $2,500,000 per annum but less than 2 $20,000,000 in the fiscal year immediately 3 preceding the fiscal year in which the an- 4 nual fee will be paid, shall be responsible, 5 collectively, for 1.2 percent. 6 ‘‘(xiv) TIER have gross annual sales of at least 8 $500,000 9 $2,500,000 in the fiscal year immediately 10 preceding the fiscal year in which the an- 11 nual fee will be paid, shall be responsible, 12 collectively, for 2.4 percent, except that no 13 such registrant shall be responsible for 14 more than $250 per fiscal year. per annum but less than ‘‘(d) ADJUSTMENTS.— 16 ‘‘(1) INFLATION 17 ‘‘(A) IN ADJUSTMENT.— GENERAL.—For fiscal year 2017 18 and each subsequent fiscal year, the revenues 19 and fee amounts under subsection (c)(3)(B) 20 shall be adjusted by the Food and Drug Admin- 21 istration in the annual Federal Register notice 22 establishing fees in subsection (c)(1), by an 23 amount equal to the sum of— 24 ‘‘(i) one; •S 1014 IS VerDate Sep 11 2014 that 7 15 smartinez on DSK4TPTVN1PROD with BILLS VII–B.—Registrants 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00087 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 88 smartinez on DSK4TPTVN1PROD with BILLS 1 ‘‘(ii) the average annual 2 change in the cost, per full-time equivalent 3 position of the Food and Drug Administra- 4 tion, of all personnel compensation and 5 benefits paid with respect to such positions 6 for the first 3 of the preceding 4 fiscal 7 years for which data are available, multi- 8 plied by the average proportion of per- 9 sonnel compensation and benefits costs to 10 total Food and Drug Administration costs 11 for the first 3 years of the preceding 4 fis- 12 cal years for which data are available; and 13 ‘‘(iii) the average annual percent 14 change that occurred in the Consumer 15 Price Index for urban consumers (Wash- 16 ington-Baltimore, DC6 MD-VA-WV; not 17 seasonally adjusted; all items less food and 18 energy; annual index) for the first 3 years 19 of the preceding 4 years for which data are 20 available multiplied by the average propor- 21 tion of all costs other than personnel com- 22 pensation and benefits costs to total Food 23 and Drug Administration costs for the 24 first 3 years of the preceding 4 fiscal years 25 for which data are available. •S 1014 IS VerDate Sep 11 2014 percent 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00088 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 89 smartinez on DSK4TPTVN1PROD with BILLS 1 ‘‘(B) COMPOUNDED BASIS.—The 2 ment made each fiscal year under this sub- 3 section shall be added on a compounded basis 4 to the sum of all adjustments made each fiscal 5 year after fiscal year 2016 under this sub- 6 section. 7 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal 8 year 2022, the Food and Drug Administration may, 9 in addition to adjustments under paragraph (1), fur- 10 ther increase the fee revenues and fees established in 11 subsection (c) if such an adjustment is necessary to 12 provide for not more than 3 months of operating re- 13 serves of carryover fees for cosmetic safety activities 14 for the first 3 months of fiscal year 2023. If such 15 an adjustment is necessary, the rationale for the in- 16 crease, shall be contained in the annual Federal 17 Register notice establishing fees, in subsection 18 (c)(1), for fiscal year 2022. If the Food and Drug 19 Administration has carryover balances for such ac- 20 tivities in excess of 3 months of such operating re- 21 serves, the adjustment under this subparagraph 22 shall not be made. 23 ‘‘(3) WORKLOAD 24 ‘‘(A) IN 25 ADJUSTMENT.— GENERAL.—For fiscal year 2017 and each subsequent fiscal year, after fee reve- •S 1014 IS VerDate Sep 11 2014 adjust- 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00089 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 90 1 nues established in subsection (c)(3)(B) are ad- 2 justed for a fiscal year for inflation in accord- 3 ance with paragraph (1), the fee revenues shall 4 be adjusted further for each fiscal year to re- 5 flect changes in the workload of the Food and 6 Drug Administration for actual changes in 7 workload volume due to the process of reviewing 8 cosmetic ingredients or non-functional constitu- 9 ents not listed under section 608(b). 10 ‘‘(B) DETERMINATION 11 The adjustment shall be determined by the 12 Food and Drug Administration based on the 13 workload in the most recent 1-year period for 14 which workload data is available. The Food and 15 Drug Administration shall publish in the Fed- 16 eral Register the fee revenues and fees resulting 17 from the adjustment and the supporting meth- 18 odologies. 19 smartinez on DSK4TPTVN1PROD with BILLS OF ADJUSTMENT.— ‘‘(C) MINIMUM REVENUES.—The 20 ment shall not result in fee revenues for a fiscal 21 year that are less than the sum of the amount 22 under subsection (c)(3)(B), as adjusted for in- 23 flation under subparagraph (1). 24 ‘‘(e) LIMITATIONS.— •S 1014 IS VerDate Sep 11 2014 adjust- 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00090 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 91 1 ‘‘(1) IN respect to the amount 2 that, under the salaries and expenses account of the 3 Food and Drug Administration, is appropriated for 4 a fiscal year for the cosmetics program in the Center 5 for Food Safety and Applied Nutrition and related 6 field activities, fees may not be assessed under sub- 7 section (a) for the fiscal year unless the amount so 8 appropriated for the fiscal year (excluding the 9 amount of fees appropriated for the fiscal year), is 10 equal to or greater than that assessed for fiscal year 11 2015, multiplied by the adjustment factor applicable 12 to the fiscal year involved. 13 ‘‘(2) AUTHORITY.—If the Food and Drug Ad- 14 ministration does not assess fees under subsection 15 (a) during any portion of a fiscal year because of 16 paragraph (1) and if at a later date in such fiscal 17 year the Food and Drug Administration may assess 18 such fees, the Food and Drug Administration may 19 assess and collect such fees, without any modifica- 20 tion in the rate, for registration under section 605 21 at any time in such fiscal year. 22 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 23 smartinez on DSK4TPTVN1PROD with BILLS GENERAL.—With ‘‘(1) IN GENERAL.—Fees authorized under sub- 24 section (a) shall be collected and available for obliga- 25 tion only to the extent and in the amount provided •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00091 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 92 1 in advance in appropriations Acts. Such fees are au- 2 thorized to remain available until expended. Such 3 sums as may be necessary may be transferred from 4 the Food and Drug Administration salaries and ex- 5 penses appropriation account without fiscal year lim- 6 itation to such appropriation account for salaries 7 and expenses with such fiscal year limitation. The 8 sums transferred shall be available solely for cos- 9 metic safety activities. 10 11 ‘‘(2) ACTS.—The 12 AND APPROPRIATIONS fees authorized by this section— ‘‘(A) IN GENERAL.—Subject to subpara- 13 graphs (C) and (D), the fees authorized by this 14 section shall be collected and available in each 15 fiscal year in an amount not to exceed the 16 amount specified in appropriation Acts, or oth- 17 erwise made available for obligation for such 18 fiscal year. 19 ‘‘(B) USE OF FEES AND LIMITATION.— 20 The fees authorized by this section shall be col- 21 lected and available only to defray the costs of 22 cosmetic safety activities. 23 smartinez on DSK4TPTVN1PROD with BILLS COLLECTIONS ‘‘(C) FEE COLLECTIONS DURING 24 PROGRAM YEAR.—Until 25 of an Act making appropriations through Sep- the date of enactment •S 1014 IS VerDate Sep 11 2014 FIRST 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00092 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 93 1 tember 30, 2015, for the salaries and expenses 2 account of the Food and Drug Administration, 3 fees authorized by this section for fiscal year 4 2016 may be collected and shall be credited to 5 such account to remain available until ex- 6 pended. Fees collected under this subparagraph 7 shall be considered discretionary for purposes of 8 the Balanced Budget and Emergency Deficit 9 Control Act of 1985. smartinez on DSK4TPTVN1PROD with BILLS 10 ‘‘(D) REIMBURSEMENT OF 11 AMOUNTS.—Any 12 programs under sections 605 and 606, prior to 13 collection of fees, may be reimbursed through 14 any appropriated fees collected under this sec- 15 tion, in such manner as the Food and Drug Ad- 16 ministration 17 amounts reimbursed under this subparagraph 18 shall be available for the programs and activi- 19 ties for which funds allocated to establish the 20 programs were available, prior to such alloca- 21 tion, until the end of the fiscal year in which 22 the reimbursement occurs, notwithstanding any 23 otherwise applicable limits on amounts for such 24 program or activities for a fiscal year. amounts allocated to establish determines appropriate. •S 1014 IS VerDate Sep 11 2014 START-UP 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00093 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 Any 94 1 ‘‘(3) AUTHORIZATION 2 For each of fiscal years 2016–2022, there are au- 3 thorized to be appropriated for fees under this sec- 4 tion $20,600,000, as adjusted by subsection (d). 5 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY 6 OF COLLECTION SHORTFALLS.— 7 ‘‘(A) OFFSET OF OVERCOLLECTIONS.—If 8 the sum of the cumulative amount of fees col- 9 lected under this section for the fiscal years 10 2016 through 2020 exceeds the cumulative 11 amount appropriated pursuant to paragraph (3) 12 for fiscal years 2016–2021, the excess amount 13 shall be credited to the appropriation account of 14 the Food and Drug Administration as provided 15 in paragraph (1), and shall be subtracted from 16 the amount of fees that would otherwise be au- 17 thorized to be collected under this section pur- 18 suant to appropriation Acts for fiscal year 19 2022. 20 ‘‘(B) RECOVERY 21 smartinez on DSK4TPTVN1PROD with BILLS OF APPROPRIATIONS.— OF COLLECTION SHORT- FALLS.— 22 ‘‘(i) 2018.—For fiscal year 2018, the 23 amount of fees otherwise authorized to be 24 collected under this section shall be in- 25 creased by the amount, if any, by which •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00094 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 smartinez on DSK4TPTVN1PROD with BILLS 95 1 the amount collected under this section 2 and appropriated for fiscal year 2016 falls 3 below the amount of fees authorized for 4 fiscal year 2016 under paragraph (3). 5 ‘‘(ii) 2019.—For fiscal year 2019, the 6 amount of fees otherwise authorized to be 7 collected under this section shall be in- 8 creased by the amount, if any, by which 9 the amount collected under this section 10 and appropriated for fiscal year 2017 falls 11 below the amount of fees authorized for 12 fiscal year 2017 under paragraph (3). 13 ‘‘(iii) 2020.—For fiscal year 2020, 14 the amount of fees otherwise authorized to 15 be collected under this section shall be in- 16 creased by the amount, if any, by which 17 the amount collected under this section 18 and appropriated for fiscal year 2018 falls 19 below the amount of fees authorized for 20 fiscal year 2018 under paragraph (3). 21 ‘‘(iv) 2021.—For fiscal year 2021, the 22 amount of fees otherwise authorized to be 23 collected under this section shall be in- 24 creased by the amount, if any, by which 25 the amount collected under this section •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00095 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 96 1 and appropriated for fiscal year 2019 falls 2 below the amount of fees authorized for 3 fiscal year 2019 under paragraph (3). 4 ‘‘(v) 2022.—For fiscal year 2022, the 5 amount of fees otherwise authorized to be 6 collected under this section shall be in- 7 creased by the amount, if any, by which 8 the amount collected under this section 9 and appropriated for fiscal year 2020 falls 10 below the amount of fees authorized for 11 fiscal year 2020 under paragraph (3). 12 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.—The Food 13 and Drug Administration shall not consider a registration 14 submitted to be complete until such fee under subsection 15 (a) is paid. Until the fee is paid, the registration is incom16 plete and the registrant is deemed to have failed to reg17 ister in accordance with section 605. 18 ‘‘(h) FALSE STATEMENTS.—Any statement or rep- 19 resentation made to the Food and Drug Administration 20 shall be subject to section 1001 of title 18, United States 21 Code. 22 ‘‘(i) COLLECTION OF UNPAID FEES.—In any case smartinez on DSK4TPTVN1PROD with BILLS 23 where the Food and Drug Administration does not receive 24 payment of a fee assessed under subsection (a), such fee 25 shall be treated as a claim of the United States Govern•S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00096 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 97 1 ment subject to subchapter II of chapter 37 of title 31, 2 United States Code. 3 ‘‘(j) CONSTRUCTION.—This section may not be con- 4 strued to require that the number of full-time equivalent 5 positions in the Department of Health and Human Serv6 ices, for officers, employees, and advisory committees not 7 engaged in cosmetic activities, be reduced to offset the 8 number of officers, employees, and advisory committees so 9 engaged. 10 ‘‘(k) RECORDS.—Each facility shall retain all records 11 necessary to demonstrate the facility’s gross annual sales 12 for at least 2 fiscal years after such information is re13 ported in the facility’s registration. Such records shall be 14 made available to the Food and Drug Administration for 15 review and duplication upon request of the Food and Drug 16 Administration.’’. 17 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI- 18 TIES RELATED TO COSMETICS. 19 Part 10 of subchapter C of chapter VII, as added 20 by section 202, is amended by inserting after section 744L 21 the following: 22 ‘‘SEC. 744M. DIRECT HIRING AUTHORITY TO SUPPORT AC- smartinez on DSK4TPTVN1PROD with BILLS 23 24 TIVITIES RELATED TO COSMETICS. ‘‘(a) IN GENERAL.—The Food and Drug Administra- 25 tion shall have direct hiring authority with respect to the •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00097 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014 98 1 appointment of employees into the competitive service or 2 the excepted service to administer the amendments made 3 by title I of the Personal Care Products Safety Act. 4 ‘‘(b) SUNSET.—The authority under subsection (a) 5 shall terminate on the date that is 3 years after the date 6 of enactment of such title.’’. smartinez on DSK4TPTVN1PROD with BILLS Æ •S 1014 IS VerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00098 Fmt 6652 Sfmt 6301 E:\BILLS\S1014.IS S1014