21 U.S.C. § 350f — Reportable food registry

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), Page 139 TITLE 21—FOOD AND DRUGS § 350f 1 See References in Text note below. a unique number is issued through the elec- tronic portal established under subsection (b) to the person submitting such report, by which the Secretary is able to link reports about the reportable food submitted and amended under this subsection and identify the supply chain for such reportable food. (5) Review The Secretary shall promptly review a re- port submitted under paragraph (1) or (3). (6) Response to report submitted by a respon- sible party After consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require such respon- sible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, 1 or more of the following: (A) Amend the report submitted by the re- sponsible party under paragraph (1) to in- clude the data element described in sub- section (e)(9). (B) Provide a notification— (i) to the immediate previous source of the article of food, if the Secretary deems necessary; (ii) to the immediate subsequent recipi- ent of the article of food, if the Secretary deems necessary; and (iii) that includes— (I) the data elements described in sub- section (e) that the Secretary deems nec- essary; (II) the actions described under para- graph (7) that the recipient of the notifi- cation shall perform, as required by the Secretary; and (III) any other information that the Secretary may require. (7) Subsequent reports and notifications Except as provided in paragraph (8), the Sec- retary may require a responsible party to per- form, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notifica- tion under subparagraph (C) or paragraph (6)(B), 1 or more of the following: (A) Submit a report to the Food and Drug Administration through the electronic por- tal established under subsection (b) that in- cludes those data elements described in sub- section (e) and other information that the Secretary deems necessary. (B) Investigate the cause of the adultera- tion if the adulteration of the article of food may have originated with the responsible party. (C) Provide a notification— (i) to the immediate previous source of the article of food, if the Secretary deems necessary; (ii) to the immediate subsequent recipi- ent of the article of food, if the Secretary deems necessary; and (iii) that includes— (I) the data elements described in sub- section (e) that the Secretary deems nec- essary; (II) the actions described under this paragraph that the recipient of the noti- fication shall perform, as required by the Secretary; and (III) any other information that the Secretary may require. (8) Amended report If a responsible party receives a notification under paragraph (6)(B) or paragraph (7)(C) with respect to an article of food after the re- sponsible party has submitted a report to the Food and Drug Administration under para- graph (1) with respect to such article of food— (A) the responsible party is not required to submit an additional report or make a noti- fication under paragraph (7); and (B) the responsible party shall amend the report submitted by the responsible party under paragraph (1) to include the data ele- ments described in paragraph (9), and, with respect to both such notification and such report, paragraph (11) of subsection (e). (e) Data elements The data elements described in this subsection are the following: (1) The registration numbers of the respon- sible party under section 350d(a)(3) 1 of this title. (2) The date on which an article of food was determined to be a reportable food. (3) A description of the article of food in- cluding the quantity or amount. (4) The extent and nature of the adultera- tion. (5) If the adulteration of the article of food may have originated with the responsible party, the results of the investigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known. (6) The disposition of the article of food, when known. (7) Product information typically found on packaging including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the arti- cle of food. (8) Contact information for the responsible party. (9) The contact information for parties di- rectly linked in the supply chain and notified under paragraph (6)(B) or (7)(C) of subsection (d), as applicable. (10) The information required by the Sec- retary to be included in a notification pro- vided by the responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under subsection (d)(7)(A). (11) The unique number described in sub- section (d)(4). (f) Critical information Except with respect to fruits and vegetables that are raw agricultural commodities, not more than 18 months after January 4, 2011, the Secretary may require a responsible party to submit to the Secretary consumer-oriented in- formation regarding a reportable food, which shall include— (1) a description of the article of food as pro- vided in subsection (e)(3); Page 140 TITLE 21—FOOD AND DRUGS § 350f 2 So in original. Probably should be followed by ‘‘a’’. 3 So in original. Probably should be ‘‘in section’’. (2) as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food; (3) contact information for the responsible party as provided in subsection (e)(8); and (4) any other information the Secretary de- termines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food. (g) Grocery store notification (1) Action by Secretary The Secretary shall— (A) prepare the critical information de- scribed under subsection (f) for a reportable food as a standardized one-page summary; (B) publish such one-page summary on the Internet website of the Food and Drug Ad- ministration in a format that can be easily printed by a grocery store for purposes of consumer notification. (2) Action by grocery store A notification described under paragraph (1)(B) shall include the date and time such summary was posted on the Internet website of the Food and Drug Administration. (h) Consumer notification (1) In general If a grocery store sold a reportable food that is the subject of the posting and such estab- lishment is part of 2 chain of establishments with 15 or more physical locations, then such establishment shall, not later than 24 hours after a one page summary described in sub- section (g) is published, prominently display such summary or the information from such summary via at least one of the methods iden- tified under paragraph (2) and maintain the display for 14 days. (2) List of conspicuous locations Not more than 1 year after January 4, 2011, the Secretary shall develop and publish a list of acceptable conspicuous locations and man- ners, from which grocery stores shall select at least one, for providing the notification re- quired in paragraph (1). Such list shall in- clude— (A) posting the notification at or near the register; (B) providing the location of the report- able food; (C) providing targeted recall information given to customers upon purchase of a food; and (D) other such prominent and conspicuous locations and manners utilized by grocery stores as of January 4, 2011, to provide notice of such recalls to consumers as considered appropriate by the Secretary. (i) Coordination of Federal, State, and local ef- forts (1) Department of Agriculture In implementing this section, the Secretary shall— (A) share information and coordinate regu- latory efforts with the Department of Agri- culture; and (B) if the Secretary receives a report sub- mitted about a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department of Agriculture. (2) States and localities In implementing this section, the Secretary shall work with the State and local public health officials to share information and co- ordinate regulatory efforts, in order to— (A) help to ensure coverage of the safety of the food supply chain, including those food establishments regulated by the States and localities that are not required to register under section 350d of this title; and (B) reduce duplicative regulatory efforts. (j) Maintenance and inspection of records The responsible party shall maintain records related to each report received, notification made, and report submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall, at the request of the Secretary, permit inspection of such records as provided for section 3 350c of this title. (k) Request for information Except as provided by section 350d(a)(4) 1 of this title, section 552 of title 5 shall apply to any request for information regarding a record in the Reportable Food Registry. (l) Safety report A report or notification under subsection (d) shall be considered to be a safety report under section 379v of this title and may be accom- panied by a statement, which shall be part of any report released for public disclosure, that denies that the report or the notification con- stitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness. (m) Admission A report or notification under this section shall not be considered an admission that the article of food involved is adulterated or caused or contributed to a death, serious injury, or seri- ous illness. (n) Homeland Security notification If, after receiving a report under subsection (d), the Secretary believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry available to the Secretary of Homeland Security. (June 25, 1938, ch. 675, § 417, as added Pub. L. 110–85, title X, § 1005(b), Sept. 27, 2007, 121 Stat. 965; amended Pub. L. 111–353, title II, § 211(a), Jan. 4, 2011, 124 Stat. 3951.) Editorial Notes REFERENCES IN TEXT Section 350d(a)(3), (4) of this title, referred to in sub- secs. (e)(1) and (k), was redesignated section 350d(a)(4), (5), respectively, of this title by Pub. L. 111–353, title I, § 102(a)(2), Jan. 4, 2011, 124 Stat. 3887. Page 141 TITLE 21—FOOD AND DRUGS § 350g AMENDMENTS 2011—Subsecs. (f) to (n). Pub. L. 111–353 added subsecs. (f) to (h) and redesignated former subsecs. (f) to (k) as (i) to (n), respectively. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 110–85, title X, § 1005(e), Sept. 27, 2007, 121 Stat. 969, provided that: ‘‘The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)], as added by subsection (a) [probably should be (b)], shall become effective 1 year after the date of the enactment of this Act [Sept. 27, 2007].’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under cer- tain other Acts, or in a manner inconsistent with inter- national agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. FINDINGS Pub. L. 110–85, title X, § 1005(a), Sept. 27, 2007, 121 Stat. 964, provided that: ‘‘Congress makes the following findings: ‘‘(1) In 1994, Congress passed the Dietary Supple- ment Health and Education Act of 1994 (Public Law 103–417) [see Short Title of 1994 Amendments note set out under section 301 of this title] to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary supplements are safe and properly labeled foods. ‘‘(2) In 2006, Congress passed the Dietary Supple- ment and Nonprescription Drug Consumer Protection Act (Public Law 109–462) [see Short Title of 2006 Amendment note set out under section 301 of this title] to establish a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States. ‘‘(3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act is intended to serve as an early warning system for potential public health issues associated with the use of these products. ‘‘(4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to target limited in- spection resources to protect the public health.’’ GUIDANCE Pub. L. 110–85, title X, § 1005(f), Sept. 27, 2007, 121 Stat. 969, provided that: ‘‘Not later than 9 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary [of Health and Human Services] shall issue a guidance to industry about submitting reports to the electronic portal established under section 417 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f] (as added by this section) and providing notifications to other persons in the supply chain of an article of food under such section 417.’’ § 350g. Hazard analysis and risk-based preven- tive controls (a) In general The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food man- ufactured, processed, packed, or held by such fa- cility, identify and implement preventive con- trols to significantly minimize or prevent the occurrence of such hazards and provide assur- ances that such food is not adulterated under section 342 of this title or misbranded under sec- tion 343(w) of this title, monitor the perform- ance of those controls, and maintain records of this monitoring as a matter of routine practice. (b) Hazard analysis The owner, operator, or agent in charge of a facility shall— (1) identify and evaluate known or reason- ably foreseeable hazards that may be associ- ated with the facility, including— (A) biological, chemical, physical, and ra- diological hazards, natural toxins, pes- ticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and (B) hazards that occur naturally, or may be unintentionally introduced; and (2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and (3) develop a written analysis of the hazards. (c) Preventive controls The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that— (1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be sig- nificantly minimized or prevented; (2) any hazards identified in the hazard anal- ysis conducted under subsection (b)(2) will be significantly minimized or prevented and ad- dressed, consistent with section 350i of this title, as applicable; and (3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 342 of this title or misbranded under section 343(w) of this title. (d) Monitoring of effectiveness The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under sub- section (c) to provide assurances that the out- comes described in subsection (c) shall be achieved. (e) Corrective actions The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly imple- mented or are found to be ineffective— (1) appropriate action is taken to reduce the likelihood of recurrence of the implementa- tion failure; (2) all affected food is evaluated for safety; and (3) all affected food is prevented from enter- ing into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title. (f) Verification The owner, operator, or agent in charge of a facility shall verify that— (1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);