21 U.S.C. § 350e — Sanitary transportation practices

Page 137 TITLE 21—FOOD AND DRUGS § 350e ‘‘(2) FINAL REGULATIONS.—Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to— ‘‘(A) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same owner- ship for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act; ‘‘(B) activities that constitute on-farm manufac- turing or processing of food that is not consumed on that farm or on another farm under common owner- ship for purposes of such section 415; and ‘‘(C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g, 350j], as added by this Act, from which the Sec- retary may issue exemptions or modifications of the requirements for certain types of facilities.’’ Pub. L. 107–188, title III, § 305(e), June 12, 2002, 116 Stat. 669, provided that: ‘‘Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate proposed and final regulations for the re- quirement of registration under section 415 of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by subsection (a) of this section). Such require- ment of registration takes effect— ‘‘(1) upon the effective date of such final regula- tions; or ‘‘(2) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compli- ance with the final regulations when the final regula- tions are made effective.’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendments by Pub. L. 111–353 to be con- strued to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title. SMALL ENTITY COMPLIANCE POLICY GUIDE Pub. L. 111–353, title I, § 102(b)(2), Jan. 4, 2011, 124 Stat. 3888, provided that: ‘‘Not later than 180 days after the issuance of the regulations promulgated under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d(b)(5)] (as added by this section), the Sec- retary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in com- plying with registration requirements and other activi- ties required under such section.’’ ELECTRONIC FILING Pub. L. 107–188, title III, § 305(d), June 12, 2002, 116 Stat. 668, provided that: ‘‘For the purpose of reducing paperwork and reporting burdens, the Secretary of Health and Human Services may provide for, and en- courage the use of, electronic methods of submitting to the Secretary registrations required pursuant to this section [enacting this section, amending sections 331 and 381 of this title, and enacting provisions set out as a note under this section]. In providing for the elec- tronic submission of such registrations, the Secretary shall ensure adequate authentication protocols are used to enable identification of the registrant and vali- dation of the data as appropriate.’’ § 350e. Sanitary transportation practices (a) Definitions In this section: (1) Bulk vehicle The term ‘‘bulk vehicle’’ includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle. (2) Transportation The term ‘‘transportation’’ means any move- ment in commerce by motor vehicle or rail ve- hicle. (b) Regulations The Secretary shall by regulation require shippers, carriers by motor vehicle or rail vehi- cle, receivers, and other persons engaged in the transportation of food to use sanitary transpor- tation practices prescribed by the Secretary to ensure that food is not transported under condi- tions that may render the food adulterated. (c) Contents The regulations under subsection (b) shall— (1) prescribe such practices as the Secretary determines to be appropriate relating to— (A) sanitation; (B) packaging, isolation, and other protec- tive measures; (C) limitations on the use of vehicles; (D) information to be disclosed— (i) to a carrier by a person arranging for the transport of food; and (ii) to a manufacturer or other person that— (I) arranges for the transportation of food by a carrier; or (II) furnishes a tank vehicle or bulk ve- hicle for the transportation of food; and (E) recordkeeping; and (2) include— (A) a list of nonfood products that the Sec- retary determines may, if shipped in a bulk vehicle, render adulterated food that is sub- sequently transported in the same vehicle; and (B) a list of nonfood products that the Sec- retary determines may, if shipped in a motor vehicle or rail vehicle (other than a tank ve- hicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle. (d) Waivers (1) In general The Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the waiver— (A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and (B) will not be contrary to the public in- terest. (2) Publication The Secretary shall publish in the Federal Register any waiver and the reasons for the waiver. (e) Preemption (1) In general A requirement of a State or political sub- division of a State that concerns the transpor- tation of food is preempted if— Page 138 TITLE 21—FOOD AND DRUGS § 350f (A) complying with a requirement of the State or political subdivision and a require- ment of this section, or a regulation pre- scribed under this section, is not possible; or (B) the requirement of the State or polit- ical subdivision as applied or enforced is an obstacle to accomplishing and carrying out this section or a regulation prescribed under this section. (2) Applicability This subsection applies to transportation that occurs on or after the effective date of the regulations promulgated under subsection (b). (f) Assistance of other agencies The Secretary of Transportation, the Sec- retary of Agriculture, the Administrator of the Environmental Protection Agency, and the heads of other Federal agencies, as appropriate, shall provide assistance on request, to the ex- tent resources are available, to the Secretary for the purposes of carrying out this section. (June 25, 1938, ch. 675, § 416, as added Pub. L. 109–59, title VII, § 7202(b), Aug. 10, 2005, 119 Stat. 1911.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as an Effective Date of 2005 Amend- ment note under section 331 of this title. REGULATIONS Pub. L. 111–353, title I, § 111(a), Jan. 4, 2011, 124 Stat. 3916, provided that: ‘‘Not later than 18 months after the date of enactment of this Act [Jan. 4, 2011], the Sec- retary shall promulgate regulations described in sec- tion 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)).’’ § 350f. Reportable food registry (a) Definitions In this section: (1) Responsible party The term ‘‘responsible party’’, with respect to an article of food, means a person that sub- mits the registration under section 350d(a) of this title for a food facility that is required to register under section 350d(a) of this title, at which such article of food is manufactured, processed, packed, or held. (2) Reportable food The term ‘‘reportable food’’ means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. (b) Establishment (1) In general Not later than 1 year after September 27, 2007, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of report- able food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from— (A) Federal, State, and local public health officials; or (B) responsible parties. (2) Review by Secretary The Secretary shall promptly review and as- sess the information submitted under para- graph (1) for the purposes of identifying re- portable food, submitting entries to the Re- portable Food Registry, acting under sub- section (c), and exercising other existing food safety authorities under this chapter to pro- tect the public health. (c) Issuance of an alert by the Secretary (1) In general The Secretary shall issue, or cause to be issued, an alert or a notification with respect to a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to protect the public health. (2) Effect Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a notifica- tion under any other provision of this chapter. (d) Reporting and notification (1) In general Except as provided in paragraph (2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall— (A) submit a report to the Food and Drug Administration through the electronic por- tal established under subsection (b) that in- cludes the data elements described in sub- section (e) (except the elements described in paragraphs (8), (9), and (10) of such sub- section); and (B) investigate the cause of the adultera- tion if the adulteration of the article of food may have originated with the responsible party. (2) No report required A responsible party is not required to submit a report under paragraph (1) if— (A) the adulteration originated with the responsible party; (B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and (C) the responsible party— (i) corrected such adulteration; or (ii) destroyed or caused the destruction of such article of food. (3) Reports by public health officials A Federal, State, or local public health offi- cial may submit a report about a reportable food to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) that the official is able to provide. (4) Report number The Secretary shall ensure that, upon sub- mission of a report under paragraph (1) or (3),