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H.R.4262 - Cosmetics Safety Enhancement Act of 2012
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of cosmetics.
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
SEC. 2. REGISTRATION OF COSMETIC FACILITIES; LISTING OF COSMETIC PRODUCTS; FEES.
(a) Prohibited Act- Section 301(dd) of the Federal Food, Drug, and Cosmetic Act (
‘(f) If it was manufactured, packed, or held in a facility that is not duly registered under section 604(a), or if it is a cosmetic product that is not listed in accordance with section 604(b).’.CommentsClose CommentsPermalink
‘SEC. 604. REGISTRATION OF COSMETIC FACILITIES AND COSMETIC PRODUCT LISTING.
‘(1) IN GENERAL- The Secretary shall by regulation require that any facility engaged in manufacturing, packing, or holding a cosmetic product or a cosmetic formulation be registered annually with the Secretary. To be so registered, any such facility shall pay the registration fee required under section 744.CommentsClose CommentsPermalink
‘(B) FORMAT; CONTENTS- Each registration under paragraph (1) shall be submitted using an electronic format, as specified in regulations or guidance issued by the Secretary, and shall include the following information:CommentsClose CommentsPermalink
‘(vii) In the case of a foreign facility, the name, street address, telephone number, emergency contact information, and, if available, the email address of the United States agent for the facility.CommentsClose CommentsPermalink
‘(ix) Additional information pertaining to the facility or to the cosmetic products or cosmetic formulations manufactured, packed, or held at the facility, as the Secretary may require by regulation.CommentsClose CommentsPermalink
‘(C) CHANGES TO INFORMATION- The registrant shall notify the Secretary of any change to the information described in clauses (i) through (ix) of subparagraph (B) not later than 30 days after the date of such change unless otherwise specified by the Secretary.CommentsClose CommentsPermalink
‘(3) PROCEDURE- Upon receipt of a completed registration under paragraph (1), the Secretary shall notify the registrant of the receipt of such registration. At the time of the initial registration of any cosmetic facility under this section, the Secretary shall assign a unique facility identifier to the facility.CommentsClose CommentsPermalink
‘(C) PUBLIC AVAILABILITY- The list of registered facilities maintained pursuant to subparagraph (A) and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under
section 552 of title 5, United States Code. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5, United States Code, to the extent that such information discloses the identity or location of a specific registered facility.CommentsClose CommentsPermalink
‘(A) IN GENERAL- The Secretary may suspend the registration of any facility under this section for a violation of this Act that could result in serious adverse health consequences or death to humans or animals.CommentsClose CommentsPermalink
‘(C) REINSTATEMENT- A registration that is suspended under this section may be reinstated pursuant to criteria published by the Secretary in the Federal Register and on a public Web site of the Food and Drug Administration.CommentsClose CommentsPermalink
‘(A) IN GENERAL- Not earlier than 10 days after providing notice under subparagraph (B), the Secretary may cancel a registration under this section if the Secretary determines that--CommentsClose CommentsPermalink
‘(C) TIMELY UPDATE OR CORRECTION- If the registration for the facility is updated or corrected and the required registration fee is paid no later than 7 days after notice is provided under subparagraph (B), the Secretary shall not cancel such registration.CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than March 31 of each year, every responsible person shall file with the Secretary a list, in such form as the Secretary may prescribe, of each cosmetic product owned by such person and distributed in the United States.CommentsClose CommentsPermalink
‘(A) The unique facility identifier (assigned under subsection (a)(3)) of the facility where the cosmetic product is manufactured or packed, or, if the same cosmetic product is manufactured or packed in more than one facility, unique facility identifier of each facility where it is manufactured or packed.CommentsClose CommentsPermalink
‘(E) The ingredients in the cosmetic product in descending order of predominance by weight, with each ingredient identified by the name adopted in regulations promulgated by the Secretary, if any, or by the common or usual name of the ingredient.CommentsClose CommentsPermalink
‘(A) CERTIFICATION- The filing for a cosmetic product under paragraph (1) shall include a certification, submitted by the responsible person, that such list includes all cosmetic products owned by such person.CommentsClose CommentsPermalink
‘(5) UP-TO-DATE LIST- The Secretary shall compile and maintain an up-to-date list of cosmetic products distributed in the United States, including the ingredients of each such product.CommentsClose CommentsPermalink
‘(2) COSMETIC PRODUCT- The term ‘cosmetic product’ means a finished cosmetic that has undergone all stages of production, including packaging in its final container for shipment and application of a product label.CommentsClose CommentsPermalink
‘(A)(i) The term ‘facility’ includes any factory, warehouse, or establishment facility (including a factory, warehouse, or establishment of an importer) that manufactures, packs, or holds cosmetic products or cosmetic formulations.CommentsClose CommentsPermalink
‘(C)(i) The term ‘foreign facility’ means a facility that manufactures, packs, or holds cosmetics that are exported to the United States without further processing or packaging outside the United States.CommentsClose CommentsPermalink
‘(ii) A cosmetic may not be considered to have undergone further processing or packaging for purposes of clause (i) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the cosmetic.CommentsClose CommentsPermalink
‘(4) RESPONSIBLE PERSON- The term ‘responsible person’ means a person (as defined in section 201(e)) that is the owner of a cosmetic product intended for introduction into United States commerce.’.CommentsClose CommentsPermalink
‘PART 7--FEES RELATING TO COSMETICS
‘SEC. 744. FACILITY REGISTRATION FEE.
‘(1) ASSESSMENT AND COLLECTION- Beginning in fiscal year 2013, the Secretary shall assess and collect an annual fee for the registration of a facility under section 604(a).CommentsClose CommentsPermalink
‘(2) ANNUAL FEE SETTING- The Secretary shall, not later than 60 days before the start of fiscal year 2014 and each subsequent fiscal year, establish, for the next fiscal year, registration fees under subsection (a), as described in paragraph (1).CommentsClose CommentsPermalink
‘(c) Inflation Adjustment- For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the sum of one plus--CommentsClose CommentsPermalink
‘(1) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of cosmetic safety activities for the first 3 years of the preceding 4 years; andCommentsClose CommentsPermalink
‘(2) the average annual change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of cosmetic safety activities for the first 3 years of the preceding 4 fiscal years.CommentsClose CommentsPermalink
The adjustment made each fiscal year under this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this subsection.CommentsClose CommentsPermalink
‘(1) IN GENERAL- Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2013 unless appropriations for salaries and expenses of the cosmetic products programs of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the cosmetic products programs of the Food and Drug Administration for fiscal year 2012 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.CommentsClose CommentsPermalink
‘(2) AUTHORITY- If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for registration under section 604 at any time in such fiscal year.CommentsClose CommentsPermalink
‘(3) ADJUSTMENT FACTOR- In this subsection, the term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.CommentsClose CommentsPermalink
‘(1) IN GENERAL- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.CommentsClose CommentsPermalink
‘(A) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; andCommentsClose CommentsPermalink
‘(3) AUTHORIZATION OF APPROPRIATIONS- For each of fiscal years 2013 through 2017, there are authorized to be appropriated for fees under this section such sums as may be necessary.CommentsClose CommentsPermalink
‘(f) Collection of Unpaid Fees- In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.CommentsClose CommentsPermalink
‘(g) Construction- This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in cosmetic safety activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.CommentsClose CommentsPermalink
‘(h) Annual Fiscal Reports- Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.CommentsClose CommentsPermalink
‘(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;CommentsClose CommentsPermalink
‘(D) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; andCommentsClose CommentsPermalink
‘(2) The term ‘cosmetic safety activities’ means activities of the Food and Drug Administration related to ensuring the safety of cosmetics sold for use in the United States, as authorized by this Act.’.CommentsClose CommentsPermalink
(1) FEES- The Secretary of Health and Human Services shall first impose the fee established under section 744 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (d), for fiscal years beginning with fiscal year 2013.CommentsClose CommentsPermalink
(2) SUNSET DATE- Section 744 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (d), does not authorize the assessment or collection of a fee for registration under section 604 of such Act occurring after fiscal year 2017.CommentsClose CommentsPermalink
SEC. 3. COSMETIC PRODUCT SAFETY SUBSTANTIATION.
(a) Adulteration- Section 601 of the Federal Food, Drug, and Cosmetic Act (
‘SEC. 605. COSMETIC PRODUCT SAFETY SUBSTANTIATION.
‘(1) before introduction or delivery for introduction into interstate commerce of a cosmetic product, establish a file containing scientific evidence pertaining to such product’s safety; andCommentsClose CommentsPermalink
‘(c) Requests by Secretary; Access to Records- In response to a request by the Secretary, the responsible person shall promptly supply to the Secretary a copy of the file required under subsection (a). Such person shall also permit an officer or employee duly designated by the Secretary, upon presentation of appropriate credentials, to have access at reasonable times to records required to be maintained under this section for the purpose of inspection and copying.CommentsClose CommentsPermalink
‘(2) The term ‘safe’, with respect to a cosmetic product, means that evidence in the file established under subsection (a)(1) demonstrates that there is a reasonable certainty that no harm will result from the use of the cosmetic product under the intended conditions of use for such cosmetic product.CommentsClose CommentsPermalink
SEC. 4. SERIOUS ADVERSE EVENT REPORTS FOR COSMETICS.
‘(f) If it is a cosmetic product that is marketed in the United States, unless the label of such cosmetic product includes a domestic address, including the street address or P.O. box, city, State, and zip code, or a domestic telephone number, including the area code, through which the responsible person (as described in section 606(a)(1)) may receive a report of a serious adverse event associated with the use of such cosmetic product.’.CommentsClose CommentsPermalink
(c) Adverse Event Reporting- Chapter VI of the Federal Food, Drug, and Cosmetic Act (
‘SEC. 606. SERIOUS ADVERSE EVENT REPORTS FOR COSMETICS.
‘(a)(1) In General- The manufacturer, packer, or distributor of a cosmetic product distributed in the United States (referred to in this section as the ‘responsible person’) shall submit to the Secretary under subsection (b) a report containing any information that such responsible person received concerning any serious adverse event that occurs in the United States and that is associated with the use of the cosmetic product in the United States, accompanied by a copy of the label on or within the retail packaging of such cosmetic product.CommentsClose CommentsPermalink
‘(2) Retailer- A retailer whose name appears on the label of a cosmetic product and who is also a distributor of such product may agree in writing that the manufacturer of the cosmetic product shall submit the reports required by paragraph (1) for any cosmetic product so long as the retailer directs to the manufacturer all information relating to each adverse event associated with such cosmetic product that is provided to the retailer.CommentsClose CommentsPermalink
‘(1) IN GENERAL- A report under subsection (a) shall be submitted to the Secretary no later than 15 business days after information concerning the adverse event is received at the place of business that is indicated on the label of the cosmetic, as required under section 602(b)(1).CommentsClose CommentsPermalink
‘(2) CONTENTS- A report under subsection (a) shall be submitted to the Secretary in a format, and shall contain the information, defined by the Secretary in guidance or by regulation, including the following information, to the extent to which such information has been provided to the responsible person:CommentsClose CommentsPermalink
‘(3) ADDITIONAL INFORMATION- The responsible person submitting a report under subsection (a) may include any additional information and shall, within 15 business days of receiving any new information related to the serious adverse event report, submit such new information to the Secretary.CommentsClose CommentsPermalink
‘(1) MAINTENANCE- The responsible person shall maintain records of all information received by such person relating to each serious adverse event for a period of 6 years from initial receipt of such information.CommentsClose CommentsPermalink
‘(2) RECORDS INSPECTION- The responsible person shall permit an officer or employee duly designated by the Secretary, upon presentation of appropriate credentials, to have access, at reasonable times, to records required to be maintained under this subsection for the purpose of inspection and copying.CommentsClose CommentsPermalink
‘(3) a medical or similar file, the disclosure of which would constitute a violation of section 552(b)(6) of such title 5, United States Code, and which shall not be disclosed under section 552 of such title.CommentsClose CommentsPermalink
SEC. 5. MAINTENANCE AND ACCESS TO RECORDS.
‘SEC. 607. MAINTENANCE AND ACCESS TO RECORDS.
‘(A) IN GENERAL- Each person who manufactures, packs, or holds a cosmetic product in the United States or for import into the United States shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials, at reasonable times, within reasonable limits, and in a reasonable manner, to have access to and copy all records relating to whether the cosmetic may be adulterated, misbranded, or otherwise in violation of this Act, including all records collected or developed to comply with section 605 (relating to cosmetic product safety substantiation) or 606 (relating to serious adverse event reports).CommentsClose CommentsPermalink
‘(B) SCOPE OF RECORDS- The requirement under subparagraph (A) applies to all records relating to the manufacture, packing, or holding of such cosmetic product maintained by or on behalf of such person in any format and at any location.CommentsClose CommentsPermalink
‘(C) IMMEDIATE AVAILABILITY WITH NOTICE- Records not required to be made available immediately on commencement of an inspection under subparagraph (A) shall nonetheless be made available immediately on commencement of such an inspection if, a reasonable time before such inspection, the Secretary by letter provides written notice to the person and identifies the records to be made available during such inspection. Nothing in this subparagraph shall be construed as permitting a person to refuse to produce records required under and in accordance with subparagraph (A) due to failure of the Secretary to provide notice under this paragraph.CommentsClose CommentsPermalink
‘(A) REMOTE ACCESS IN EMERGENCIES- If the Secretary has a reasonable belief that a cosmetic product has caused one or more serious adverse events (as such term is used in section 606), the Secretary may require each person who manufactures, packs, or holds such cosmetic product, or any cosmetic product that the Secretary determines may be affected in a similar manner, to submit to the Secretary all records reasonably related to such cosmetic product as soon as is reasonably practicable, after receiving written notice (including by notice served personally and outside normal business hours to an agent identified under clause (vi) or (vii) of section 604(a)(2)(B) of such requirement).CommentsClose CommentsPermalink
‘(B) ELECTRONIC SUBMISSION- If the records required to be submitted to the Secretary under subparagraph (A) are available in electronic format, such records shall be submitted electronically unless the Secretary specifies otherwise in the notice under such subparagraph.CommentsClose CommentsPermalink
‘(b) Regulations Concerning Recordkeeping- The Secretary shall, by regulation, establish requirements regarding the establishment and maintenance, for not longer than 2 years, of records by persons who manufacture, pack, or hold cosmetics in the United States or for import into the United States, which records are needed by the Secretary for inspection to allow the Secretary to determine that the cosmetic is in compliance with applicable laws and regulations; to identify the previous sources and the subsequent recipients of a cosmetic, including its packaging; or for other purposes the Secretary deems necessary to protect public health. The Secretary shall take into account the size of a business in promulgating regulations under this subsection.’.CommentsClose CommentsPermalink
(A) by inserting after the second sentence the following: ‘In the case of any person who manufactures, packs, or holds cosmetics, the inspection shall extend to all records and other information described in or required under section 607 bearing on whether a cosmetic is adulterated, misbranded, or otherwise in violation of this Act.’; andCommentsClose CommentsPermalink
(iii) by inserting after ‘section 505(j))’ the following: ‘, and formulas for a cosmetic, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales) related to a cosmetic’; andCommentsClose CommentsPermalink
(c) No Effect on Other Provisions- This section shall not be construed to limit the authority of the Secretary to require the establishment and maintenance of records under any other provision of this Act.CommentsClose CommentsPermalink
SEC. 6. GOOD MANUFACTURING PRACTICES FOR COSMETICS.
(a) In General- Section 601 of the Federal Food, Drug, and Cosmetic Act (
‘(h) If the methods used in, or the facilities or controls used for, its manufacture, packing, or holding do not conform to current good manufacturing practice, as prescribed by the Secretary in regulations, to ensure that the cosmetic is safe and otherwise in compliance with this Act.’.CommentsClose CommentsPermalink
(1) PROMULGATION- The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate regulations to carry out section 601(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).CommentsClose CommentsPermalink
(2) INTERNATIONAL STANDARDS- In promulgating such regulations, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review international standards for cosmetic product good manufacturing practice that are in existence on the date of enactment of this Act to ensure that such regulations are consistent, to the extent the Secretary determines practicable and appropriate, with such standards.CommentsClose CommentsPermalink
SEC. 7. MANDATORY RECALL AUTHORITY.
(a) Prohibited Act- Section 301(xx) of the Federal Food, Drug, and Cosmetic Act (
‘SEC. 608. MANDATORY RECALL AUTHORITY.
‘(a) Voluntary Procedures- If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 601 and the use of, or exposure to, such cosmetic will cause serious adverse health consequences or death to humans, the Secretary shall provide each responsible person with an opportunity to cease distribution and recall such cosmetic.CommentsClose CommentsPermalink
‘(1) IN GENERAL- If a responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to--CommentsClose CommentsPermalink
‘(2) DETERMINATION TO LIMIT AREAS AFFECTED- If the Secretary requires a responsible person to cease distribution under paragraph (1)(A) of a cosmetic identified in subsection (a), the Secretary may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.CommentsClose CommentsPermalink
‘(c) Hearing on Order- The Secretary shall provide a responsible person subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the cosmetic that is the subject of the order should not be recalled.CommentsClose CommentsPermalink
‘(1) AMENDMENT OF ORDER- If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the cosmetic from commerce is necessary, the Secretary shall, as appropriate--CommentsClose CommentsPermalink
‘(2) VACATING OF ORDER- If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.CommentsClose CommentsPermalink
‘(3) if available, publish on the Internet Web site of the Food and Drug Administration an image of the cosmetic that is the subject of the press release described in (1).CommentsClose CommentsPermalink
‘(g) No Delegation- The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.CommentsClose CommentsPermalink
‘(h) Effect- Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this Act or under the Public Health Service Act.CommentsClose CommentsPermalink