REGISTRATION OF FOOD FACILITIES.

SEC. 102. REGISTRATION OF FOOD FACILITIES.(a) Updating of Food Category Regulations; Biennial Registration Renewal.—Section 415(a) (21 U.S.C. 350d(a)) is amended—(1) in paragraph (2), by—(A) striking “conducts business and” and inserting “conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and”; and(B) inserting “, or any other food categories as determined appropriate by the Secretary, including by guidance” after “Code of Federal Regulations”;(2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and(3) by inserting after paragraph (2) the following:“(3) Biennial registration renewal.—During the period beginning on October 1 and ending on December 31 of each even-numbered year, 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). 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.”.(b) Suspension of Registration.—(1) In general.—Section 415 (21 U.S.C. 350d) is amended—(A) in subsection (a)(2), by inserting after the first sentence the following: “The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.”;(B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and(C) by inserting after subsection (a) the following:“(b) Suspension of Registration.—“(1) In general.—If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility—“(A) that created, caused, or was otherwise responsible for such reasonable probability; or“(B)(i) that knew of, or had reason to know of, such reasonable probability; and“(ii) packed, received, or held such food.124 STAT. 3888“(2) Hearing on suspension.—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 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.“(3) Post-hearing corrective action plan; vacating of order.—“(A) Corrective action plan.—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.“(B) Vacating of order.—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.“(4) Effect of suspension.—If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States.“(5) Regulations.—“(A) In general.—The Secretary shall promulgate regulations to implement this subsection. The Secretary may promulgate such regulations on an interim final basis.“(B) Registration requirement.—The Secretary may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is 5 years after the date of enactment of the FDA Food Safety Modernization Act.“(6) Application date.—Facilities shall be subject to the requirements of this subsection beginning on the earlier of—“(A) the date on which the Secretary issues regulations under paragraph (5); or“(B) 180 days after the date of enactment of the FDA Food Safety Modernization Act.“(7) No delegation.—The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.”.(2) Small entity compliance policy guide.—Not later than 180 days after the issuance of the regulations promulgated 124 STAT. 3889 under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section.(3) Imported food.—Section 801(l) (21 U.S.C. 381(l)) is amended by inserting “(or for which a registration has been suspended under such section)” after “section 415”.(c) Clarification of Intent.—(1) Retail food establishment.—The Secretary shall amend the definition of the term “retail food establishment” in section in 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include—(A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed;(B) the sale and distribution of such food through a community supported agriculture program; and(C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.(2) Definitions.—For purposes of paragraph (1)—(A) the term “community supported agriculture program” has the same meaning given the term “community supported agriculture (CSA) program” in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation); and(B) the term “consumer” does not include a business.(d) Conforming Amendments.—(1) Section 301(d) (21 U.S.C. 331(d)) is amended by inserting “415,” after “404,”.(2) Section 415(d), as redesignated by subsection (b), is amended by adding at the end before the period “for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)”.