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21 U.S.C. § 350f — Reportable food registry
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Responsible party** — The term “responsible party”, with respect to an article of food, means a person that submits the registration under [section 350d(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d/a&num=0&edition=prelim) for a food facility that is required to register under [section 350d(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d/a&num=0&edition=prelim), 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 reportable 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 assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this chapter to protect the public health.
**(c) Issuance of an alert by the Secretary**
(1) **In general** — The Secretary shall issue, or cause to be issued, an a
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Stable record: federal_law:legal_authorities:record_usc_4952a021851a3c2436ac2019
Source file: Laws/federal/codes/united-states-code/title-21/section-350f-reportable-food-registry--641737703f.md
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Source location: Title 21, Chapter 9, § 350f; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section:
(1) **Responsible party** — The term “responsible party”, with respect to an article of food, means a person that submits the registration under [section 350d(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d/a&num=0&edition=prelim) for a food facility that is required to register under [section 350d(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d/a&num=0&edition=prelim), 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 reportable 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 assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this chapter to protect 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 notification 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 portal established under subsection (b) that includes the data elements described in subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such subsection); and
(B) investigate the cause of the adulteration 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 official 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 submission of a report under paragraph (1) or (3), a unique number is issued through the electronic 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 report submitted under paragraph (1) or (3).
(6) **Response to report submitted by a responsible party** — After consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require such responsible 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 responsible party under paragraph (1) to include the data element described in subsection (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 recipient of the article of food, if the Secretary deems necessary; and
(iii) that includes—
(I) the data elements described in subsection (e) that the Secretary deems necessary;
(II) the actions described under paragraph (7) that the recipient of the notification 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 Secretary may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notification 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 portal established under subsection (b) that includes those data elements described in subsection (e) and other information that the Secretary deems necessary.
(B) Investigate the cause of the adulteration 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 recipient of the article of food, if the Secretary deems necessary; and
(iii) that includes—
(I) the data elements described in subsection (e) that the Secretary deems necessary;
(II) the actions described under this paragraph that the recipient of the notification 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 responsible party has submitted a report to the Food and Drug Administration under paragraph (1) with respect to such article of food—
(A) the responsible party is not required to submit an additional report or make a notification under paragraph (7); and
(B) the responsible party shall amend the report submitted by the responsible party under paragraph (1) to include the data elements 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 responsible party under section 350d(a)(3) 11 See References in Text note below. 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 including the quantity or amount.
(4) The extent and nature of the adulteration.
(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 article of food.
(8) Contact information for the responsible party.
(9) The contact information for parties directly 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 Secretary to be included in a notification provided 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 subsection (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 information regarding a reportable food, which shall include—
(1) a description of the article of food as provided in subsection (e)(3);
(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 determines 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 described 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 Administration 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 establishment is part of 22 So in original. Probably should be followed by “a”. 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 subsection (g) is published, prominently display such summary or the information from such summary via at least one of the methods identified 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 manners, from which grocery stores shall select at least one, for providing the notification required in paragraph (1). Such list shall include—
(A) posting the notification at or near the register;
(B) providing the location of the reportable 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 efforts**
(1) **Department of Agriculture** — In implementing this section, the Secretary shall—
(A) share information and coordinate regulatory efforts with the Department of Agriculture; and
(B) if the Secretary receives a report submitted 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 coordinate 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim); 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 33 So in original. Probably should be “in section”. 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379v&num=0&edition=prelim) and may be accompanied by a statement, which shall be part of any report released for public disclosure, that denies that the report or the notification constitutes 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 serious 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.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Registration**
(1) **In general** — The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered—
(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and
(B) for a foreign facility, the owner, operator, 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.
(2) **Registration** — 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 trade names under which, the registrant 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, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. 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 chapter. The registrant shall notify the Secretary in a timely manner of changes to such information.
(3) **Biennial registration renewal** — During the period beginning on October 1 and ending on December 31 of each even-numb
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350d
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Federal law — U.S. Code and appendices · legal_authorities
With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379v
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Processing and ingredient standards** Not later than 2 years after September 27, 2007, the Secretary of Health and Human Services (referred to in this chapter as the “Secretary”), in consultation with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by regulation establish—
(1) processing standards for pet food; and
(2) updated standards for the labeling of pet food that include nutritional and ingredient information.
**(b) Early warning surveillance systems and notification during pet food recalls** Not later than 1 year after September 27, 2007, the Secretary shall establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food. In establishing such system, the Secretary shall—
(1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of the Food and Drug Administration and the Department of Agriculture, and the National Animal Health Laboratory Network of the Department of Agriculture;
(2) consult with relevant professional associations and private sector veterinary hospitals;
(3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other notification networks as appropriate to inform veterinarians and relevant stakeholders during any recall of pet food; and
(4) use such information and conduct such other activities as the Secretary deems app
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2102
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Federal law — U.S. Code and appendices · legal_authorities
Nothing in this chapter (or an amendment made by this chapter) shall be construed to affect—
(1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417); or
(2) the adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462).
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2110
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Voluntary procedures** If the Secretary determines, based on information gathered through the reportable food registry under [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or misbranded under [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim)) with an opportunity 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 manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, 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, holding, or importing and selling such article; and
(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such ar
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350l
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Federal law — U.S. Code and appendices · legal_authorities
(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 Representatives on the use of recall authority under section 350l of this title (as added by subsection (a)) 11 See References in Text note below. and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent 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 described 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 section;
(B) the number of responsible parties, as defined in [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim), 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 described 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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350l–1
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Federal law — U.S. Code and appendices · legal_authorities
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 unde
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350f
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.