21 U.S.C. § 350i — Protection against intentional adultera-

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 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 Sec- retary of Homeland Security and in consulta- tion 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 mitiga- tion strategies or measures intended to pro- tect against the intentional adulteration of food; and (2) specify appropriate science-based mitiga- tion strategies or measures to prepare and pro- tect the food supply chain at specific vulner- able 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 deter- mined by the Secretary, in consultation with the Secretary of Homeland Security, under sub- section (a), that could cause serious adverse health consequences or death to humans or ani- mals 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). (June 25, 1938, ch. 675, § 420, as added Pub. L. 111–353, title I, § 106(a), Jan. 4, 2011, 124 Stat. 3905.) 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. GUIDANCE DOCUMENTS Pub. L. 111–353, title I, § 106(b), Jan. 4, 2011, 124 Stat. 3906, provided that: ‘‘(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i], as added by subsection (a). ‘‘(2) CONTENT.—The guidance documents issued under paragraph (1) shall— ‘‘(A) include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); ‘‘(B) include examples of mitigation strategies or measures described in subsection (b)(2) of such sec- tion; and ‘‘(C) specify situations in which the examples of mitigation strategies or measures described in sub- section (b)(2) of such section are appropriate. ‘‘(3) LIMITED DISTRIBUTION.—In the interest of na- tional security, the Secretary of Health and Human Services, in consultation with the Secretary of Home- land Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences.’’ PERIODIC REVIEW Pub. L. 111–353, title I, § 106(c), Jan. 4, 2011, 124 Stat. 3906, provided that: ‘‘The Secretary of Health and Human Services shall periodically review and, as ap- propriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i(b)], as added by subsection (a), and the guidance documents under subsection (b) [section 106(b) of Pub. L. 111–353, set out above].’’ Page 150 TITLE 21—FOOD AND DRUGS § 350j § 350j. Targeting of inspection resources for do- mestic facilities, foreign facilities, and ports of entry; annual report (a) Identification and inspection of facilities (1) Identification The Secretary shall identify high-risk facili- ties and shall allocate resources to inspect fa- cilities according to the known safety risks of the facilities, which shall be based on the fol- lowing factors: (A) The known safety risks of the food manufactured, processed, packed, or held at the facility. (B) The compliance history of a facility, including with regard to food recalls, out- breaks of foodborne illness, and violations of food safety standards. (C) The rigor and effectiveness of the fa- cility’s hazard analysis and risk-based pre- ventive controls. (D) Whether the food manufactured, proc- essed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title. (E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as de- scribed in section 381(q) or 384b of this title, as appropriate. (F) Any other criteria deemed necessary and appropriate by the Secretary for pur- poses of allocating inspection resources. (2) Inspections (A) In general Beginning on January 4, 2011, the Sec- retary shall increase the frequency of in- spection of all facilities. (B) Domestic high-risk facilities The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected— (i) not less often than once in the 5-year period following January 4, 2011; and (ii) not less often than once every 3 years thereafter. (C) Domestic non-high-risk facilities The Secretary shall ensure that each do- mestic facility that is not identified under paragraph (1) as a high-risk facility is in- spected— (i) not less often than once in the 7-year period following January 4, 2011; and (ii) not less often than once every 5 years thereafter. (D) Foreign facilities (i) Year 1 In the 1-year period following January 4, 2011, the Secretary shall inspect not fewer than 600 foreign facilities. (ii) Subsequent years In each of the 5 years following the 1- year period described in clause (i), the Sec- retary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year. (E) Reliance on Federal, State, or local in- spections In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections con- ducted by other Federal, State, or local agencies under interagency agreement, con- tract, memoranda of understanding, or other obligation. (b) Identification and inspection at ports of entry The Secretary, in consultation with the Sec- retary of Homeland Security, shall allocate re- sources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors: (1) The known safety risks of the food im- ported. (2) The known safety risks of the countries or regions of origin and countries through which such article of food is transported. (3) The compliance history of the importer, including with regard to food recalls, out- breaks of foodborne illness, and violations of food safety standards. (4) The rigor and effectiveness of the activi- ties conducted by the importer of such article of food to satisfy the requirements of the for- eign supplier verification program under sec- tion 384a of this title. (5) Whether the food importer participates in the voluntary qualified importer program under section 384b of this title. (6) Whether the food meets the criteria for priority under section 381(h)(1) of this title. (7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 381(q) or 384b of this title. (8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. (c) Interagency agreements with respect to sea- food (1) In general The Secretary of Health and Human Serv- ices, the Secretary of Commerce, the Sec- retary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or ap- propriate to improve seafood safety. (2) Scope of agreements The agreements under paragraph (1) may in- clude— (A) cooperative arrangements for exam- ining and testing seafood imports that lever- age the resources, capabilities, and authori- ties of each party to the agreement; (B) coordination of inspections of foreign facilities to increase the percentage of im- ported seafood and seafood facilities in- spected; (C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordina- tion;