21 U.S.C. § 350l — Mandatory recall authority

Page 152 TITLE 21—FOOD AND DRUGS § 350l niques are followed and reports of analyses are certified as true and accurate; (ii) internal quality systems are estab- lished and maintained; (iii) procedures exist to evaluate and re- spond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and (iv) individuals who conduct the sam- pling and analyses are qualified by train- ing and experience to do so; and (B) any other criteria determined appro- priate by the Secretary. (7) Review of recognition To ensure compliance with the requirements of this section, the Secretary— (A) shall periodically, and in no case less than once every 5 years, reevaluate accredi- tation bodies recognized under paragraph (1) and may accompany auditors from an ac- creditation body to assess whether the ac- creditation body meets the criteria for rec- ognition; and (B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for labora- tories accredited by such body to continue to perform testing as described in this sec- tion. (b) Testing procedures (1) In general Not later than 30 months after January 4, 2011, food testing shall be conducted by Fed- eral laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Sec- retary under subsection (a)(1)(B) whenever such testing is conducted— (A) by or on behalf of an owner or con- signee— (i) in response to a specific testing re- quirement under this chapter or imple- menting regulations, when applied to ad- dress an identified or suspected food safety problem; and (ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety prob- lem; or (B) on behalf of an owner or consignee— (i) in support of admission of an article of food under section 381(a) of this title; and (ii) under an Import Alert that requires successful consecutive tests. (2) Results of testing The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation ex- empt test results from such submission re- quirement if the Secretary determines that such results do not contribute to the protec- tion of public health. Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means. (3) Exception The Secretary may waive requirements under this subsection if— (A) a new methodology or methodologies have been developed and validated but a lab- oratory has not yet been accredited to per- form such methodology or methodologies; and (B) the use of such methodology or meth- odologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak. (c) Review by Secretary If food sampling and testing performed by a laboratory run and operated by a State or local- ity that is accredited by a recognized accredita- tion body on the registry established by the Sec- retary under subsection (a) result in a State re- calling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities. (d) No limit on Secretarial authority Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, includ- ing determining the sufficiency of such informa- tion and testing. (June 25, 1938, ch. 675, § 422, as added Pub. L. 111–353, title II, § 202(a), Jan. 4, 2011, 124 Stat. 3926.) Statutory Notes and Related Subsidiaries CONSTRUCTION Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agree- ments to which the United States is a party, see sec- tions 2206, 2251, and 2252 of this title. § 350l. Mandatory recall authority (a) Voluntary procedures If the Secretary determines, based on informa- tion gathered through the reportable food reg- istry under section 350f of this title or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 342 of this title or misbranded under section 343(w) of this title and the use of or exposure to such article will cause serious adverse health con- sequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 350f of this title) with an op- portunity to cease distribution and recall such article. (b) Prehearing order to cease distribution and give notice (1) In general If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the man- ner prescribed by the Secretary (if so pre- scribed), the Secretary may, by order require, Page 153 TITLE 21—FOOD AND DRUGS § 350l 1 So in original. The words ‘‘to immediately cease distribution of such article.’’ probably should follow cl. (ii). 2 So in original. Probably should be ‘‘paragraph (1).’’ as the Secretary deems necessary, such person to— (A) immediately cease distribution of such article; and (B) as applicable, immediately notify all persons— (i) manufacturing, processing, packing, transporting, distributing, receiving, hold- ing, or importing and selling such article; and (ii) to which such article has been dis- tributed, transported, or sold, to imme- diately cease distribution of such article.1 (2) Required additional information (A) In general If an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics pro- vider to identify the food. (B) Rules of construction Nothing in this paragraph shall be con- strued— (i) to exempt a warehouse-based third party logistics provider from the require- ments of this chapter, including the re- quirements in this section and section 350c of this title; or (ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order. (3) Determination to limit areas affected If the Secretary requires a responsible party to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Secretary may limit the size of the geo- graphic area and the markets affected by such cessation if such limitation would not com- promise the public health. (c) Hearing on order The Secretary shall provide the responsible party 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 ac- tions required by the order and on why the arti- cle that is the subject of the order should not be recalled. (d) Post-hearing recall order and modification of order (1) Amendment of order If, after providing opportunity for an infor- mal hearing under subsection (c), the Sec- retary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate— (A) amend the order to require recall of such article or other appropriate action; (B) specify a timetable in which the recall shall occur; (C) require periodic reports to the Sec- retary describing the progress of the recall; and (D) provide notice to consumers to whom such article was, or may have been, distrib- uted. (2) Vacating of order If, after such hearing, the Secretary deter- mines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Sec- retary shall vacate the order or modify the order. (e) Rule regarding alcoholic beverages The Secretary shall not initiate a mandatory recall or take any other action under this sec- tion with respect to any alcohol beverage until the Secretary has provided the Alcohol and To- bacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall such article under the Alcohol and Tobacco Tax and Trade Bureau authority. (f) Cooperation and consultation The Secretary shall work with State and local public health officials in carrying out this sec- tion, as appropriate. (g) Public notification In conducting a recall under this section, the Secretary shall— (1) ensure that a press release is published regarding the recall, as well as alerts and pub- lic notices, as appropriate, in order to provide notification— (A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and (B) that includes, at a minimum— (i) the name of the article of food subject to the recall; (ii) a description of the risk associated with such article; and (iii) to the extent practicable, informa- tion for consumers about similar articles of food that are not affected by the recall; (2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as deter- mined appropriate by the Secretary; and (3) if available, publish on the Internet Web site of the Food and Drug Administration an image of the article that is the subject of the press release described in (1).2 (h) 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. (i) Effect Nothing in this section shall affect the author- ity of the Secretary to request or participate in Page 154 TITLE 21—FOOD AND DRUGS § 350l–1 1 See References in Text note below. a voluntary recall, or to issue an order to cease distribution or to recall under any other provi- sion of this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.]. (j) Coordinated communication (1) In general To assist in carrying out the requirements of this subsection, the Secretary shall establish an incident command operation or a similar operation within the Department of Health and Human Services that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health con- sequences or death to humans or animals. (2) Requirements To reduce the potential for miscommunication during recalls or regarding investigations of a food borne illness outbreak associated with a food that is subject to a re- call, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Department of Health and Human Services to— (A) ensure timely and coordinated commu- nication within the Department, including enhanced communication and coordination between different agencies and organizations within the Department; (B) ensure timely and coordinated commu- nication from the Department, including public statements, throughout the duration of the investigation and related foodborne illness outbreak; (C) identify a single point of contact with- in the Department for public inquiries re- garding any actions by the Secretary related to a recall; (D) coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak asso- ciated with a food that is subject to the re- call, including notification of the Secretary of Agriculture and the Secretary of Edu- cation in the event such recalled food is a commodity intended for use in a child nutri- tion program (as identified in section 1769f(b) of title 42); and (E) conclude operations at such time as the Secretary determines appropriate. (3) Multiple recalls The Secretary may establish multiple or concurrent incident command operations or similar operations in the event of multiple re- calls or foodborne illness outbreaks necessi- tating such action by the Department of Health and Human Services. (June 25, 1938, ch. 675, § 423, as added Pub. L. 111–353, title II, § 206(a), Jan. 4, 2011, 124 Stat. 3939.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (i), is act July 1, 1944, ch. 373, 58 Stat. 682, which is clas- sified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classi- fication of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. Statutory Notes and Related Subsidiaries CONSTRUCTION Nothing in this section to be construed to alter juris- diction 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. SEARCH ENGINE Pub. L. 111–353, title II, § 206(b), Jan. 4, 2011, 124 Stat. 3942, provided that: ‘‘Not later than 90 days after the date of enactment of this Act [Jan. 4, 2011], the Sec- retary shall modify the Internet Web site of the Food and Drug Administration to include a search engine that— ‘‘(1) is consumer-friendly, as determined by the Sec- retary; and ‘‘(2) provides a means by which an individual may locate relevant information regarding each article of food subject to a recall under section 423 of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 350l] and the status of such recall (such as whether a recall is ongoing or has been completed).’’ § 350l–1. Annual report to Congress (1) In general Not later than 2 years after January 4, 2011, and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives on the use of recall authority under section 350l of this title (as added by subsection (a)) 1 and any public health advisories issued by the Secretary that advise against the consump- tion of an article of food on the ground that the article of food is adulterated and poses an immi- nent danger to health. (2) Content The report under paragraph (1) shall include, with respect to the report year— (A) the identity of each article of food that was the subject of a public health advisory de- scribed in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 350l of this title, or a mandatory recall order under subsection (b) of such sec- tion; (B) the number of responsible parties, as de- fined in section 350f of this title, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 350l(a) of such title; (C) the number of responsible parties de- scribed in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 350l(a) of this title; (D) the number of recall orders issued under section 350l(b) of this title; and (E) a description of any instances in which there was no testing that confirmed adultera-