Sec. 5. Registration of cosmetic facilities
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Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.) is amended by adding at the end the following: The Secretary shall by regulation require the manufacturer or distributor whose name appears on the label of a cosmetic marketed in the United States to register all facilities engaged in manufacturing of such cosmetic with the Secretary. To be registered— for a domestic facility, the responsible person, owner, or agent in charge of the facility shall submit a registration to the Secretary; and for a foreign facility, the responsible person, owner, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.
An entity (referred to in this section as the registrant ) shall submit a registration under paragraph
(1)to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all the trade names under which, the registrant conducts business, the e-mail address for the responsible person (as described in section 762(b)) of the facility or, in the case of a foreign facility, the United States agent for the facility. The Secretary shall require— the information submitted under subparagraph
(A)to be maintained and available, at the request of the Secretary, for a period to be determined by the Secretary; and the name and address of each facility with which the registrant contracts related to cosmetic manufacturing, processing, distributing, or other activities, as the Secretary determines appropriate, to be maintained and available at the request of the Secretary, for a period to be determined by the Secretary. The registration shall contain an assurance that— the Secretary will be permitted to inspect the facility at the times and in the manner permitted by this Act; and the registrant will notify the Secretary in a timely manner of changes to the information submitted. A registrant that has submitted a registration under paragraph
(1)shall submit to the Secretary a renewal registration containing the information described in paragraph
(2)every 2 years during a period of time as determined by the Secretary. The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved. Upon receipt of a completed registration described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility. The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list 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 it discloses the identity or location of a specific registered person. If the Secretary determines that cosmetics manufactured or processed by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans, the Secretary may by order suspend the registration of any facility that is responsible for such reasonable probability or that knew of, or had reason to know of, such reasonable probability related to such cosmetics. The Secretary shall provide the registrant subject to an order under paragraph
(1)with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration. If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant. Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate. If the registration of a facility is suspended under this subsection, no person shall import or export cosmetics into the United States from such facility, offer to import or export cosmetics into the United States from such facility, or otherwise introduce cosmetics from such facility into interstate or intrastate commerce in the United States. The Secretary shall promulgate regulations to implement this subsection. The Secretary may require that registration under this section be submitted in an electronic format. Facilities shall not be subject to the requirements of this subsection prior to the date that is 180 days after the date on which the Secretary issues final regulations under paragraph (5). The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner. For purposes of this section: The term facility — includes any factory or other establishment that is engaged in the manufacturing or processing of a cosmetic or cosmetics; and does not include— beauty salons, spas, retailers (including individual sales representatives, wholesale distributors, or pharmacy locations); homes where persons are engaged in making handcrafted soaps or other cosmetics; or any business with less than $1,000,000 in annual net revenue in the previous year, other than any such business that is engaged in the manufacturing or processing of products intended to be injected under the skin, including tattoo ink. The term domestic facility means a facility located in any of the States or Territories. The term foreign facility means a facility located outside of the United States or Territories, but only if the cosmetics from such facility are exported to the United States without further manufacturing outside the United States or Territories. Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b). No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement with respect to the registration of facilities engaged in the manufacturing or processing of a cosmetic or cosmetics that is different from the requirements under this section. .
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Sec. 5
Registration of cosmetic facilities
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