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21 U.S.C. § 350i — Protection against intentional adulteration
Federal law — U.S. Code and appendices · legal_authorities
**(a) Determinations**
(1) **In general** — The Secretary shall—
(A) conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;
(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and
(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.
(2) **Limited distribution** — In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available.
**(b) Regulations** Not later than 18 months after January 4, 2011, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this chapter. Such regulations shall—
(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and
(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.
**(c) Applicability** Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under su
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Source file: Laws/federal/codes/united-states-code/title-21/section-350i-protection-against-intentional-adulteration--c47e8ee855.md
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Source location: Title 21, Chapter 9, § 350i; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Determinations**
(1) **In general** — The Secretary shall—
(A) conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;
(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and
(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.
(2) **Limited distribution** — In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available.
**(b) Regulations** Not later than 18 months after January 4, 2011, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this chapter. Such regulations shall—
(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and
(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.
**(c) Applicability** Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods—
(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and
(2) in bulk or batch form, prior to being packaged for the final consumer.
**(d) Exception** This section shall not apply to farms, except for those that produce milk.
**(e) Definition** For purposes of this section, the term “farm” has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
**(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 manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not 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), monitor the performance 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 reasonably foreseeable hazards that may be associated with the facility, including—
(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, 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 significantly minimized or prevented;
(2) any hazards identified in the hazard
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350g
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Federal law — U.S. Code and appendices · legal_authorities
Page 149
TITLE 21—FOOD AND DRUGS
§ 350i
guide setting forth in plain language the requirements
of such section 419 and to assist small entities in com-
plying with standards for safe production and har-
vesting and other activities required under such sec-
tion.’’
NO EFFECT ON HACCP AUTHORITIES
Pub. L. 111–353, title I, § 105(d), Jan. 4, 2011, 124 Stat.
3905, provided that: ‘‘Nothing in the amendments made
by this section [enacting this section and amending
section 331 of this title] limits the authority of the Sec-
retary [of Health and Human Services] under the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) or the Public Health Service Act (42 U.S.C. 201 et
seq.) to revise, issue, or enforce product and category-
specific regulations, such as the Seafood Hazard Anal-
ysis Critical Controls Points Program, the Juice Haz-
ard Analysis Critical Control [Points] Program, and the
Thermally Processed Low-Acid Foods Packaged in Her-
metically Sealed Containers standards.’’
§ 350i. Protection against intentional adultera-
tion
(a) Determinations
(1) In general
The Secretary shall—
(A) conduct a vulnerability assessment of
the food system, including by consideration
of the Department of Homeland Security bi-
ological, chemical, radiological, or other
terrorism risk assessments;
(B) consider the best available under-
standing of uncertainties, risks, costs, and
benefits associated with guarding against in-
tentional adulteration of food at vulnerable
points; and
(C) determine the types of science-based
mitigation strategies or measures that are
necessary to protect against the intentional
adulteration of food.
(2) Limited distribution
In the interest of national security, the Sec-
retary, in consultation with the Secretary of
Homeland Se
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350i
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.