21 U.S.C. § 2241 — Inspection by the Secretary of Commerce

Page 1019 TITLE 21—FOOD AND DRUGS § 2241 (D) Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of foodborne illness. (E) Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public. (F) Strengthen the capacity of State and local agencies to achieve the goals described in section 2202 of this title. (2) Review In developing of the strategies required by paragraph (1), the Secretary shall, not later than 1 year after January 4, 2011, complete a review of State and local capacities, and needs for enhancement, which may include a survey with respect to— (A) staffing levels and expertise available to perform food safety and defense functions; (B) laboratory capacity to support surveil- lance, outbreak response, inspection, and en- forcement activities; (C) information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Fed- eral level; and (D) other State and local activities and needs as determined appropriate by the Sec- retary. (Pub. L. 111–353, title II, § 205, Jan. 4, 2011, 124 Stat. 3937.) Editorial Notes REFERENCES IN TEXT This Act, referred to in subsec. (a), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables. The Secretary, referred to in subsecs. (b) and (c)(1), (2)(D), probably means the Secretary of Health and Human Services. CODIFICATION Section is comprised of section 205 of Pub. L. 111–353. Subsec. (d) of section 205 of Pub. L. 111–353 amended section 247b–20 of Title 42, The Public Health and Wel- fare. § 2225. Decontamination and disposal standards and plans (a) In general The Administrator of the Environmental Pro- tection Agency (referred to in this section as the ‘‘Administrator’’), in coordination with the Sec- retary of Health and Human Services, Secretary of Homeland Security, and Secretary of Agri- culture, shall provide support for, and technical assistance to, State, local, and tribal govern- ments in preparing for, assessing, decontami- nating, and recovering from an agriculture or food emergency. (b) Development of standards In carrying out subsection (a), the Adminis- trator, in coordination with the Secretary of Health and Human Services, Secretary of Home- land Security, Secretary of Agriculture, and State, local, and tribal governments, shall de- velop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamina- tion and disposal of specific threat agents and foreign animal diseases. (c) Development of model plans In carrying out subsection (a), the Adminis- trator, the Secretary of Health and Human Serv- ices, and the Secretary of Agriculture shall jointly develop and disseminate model plans for— (1) the decontamination of individuals, equipment, and facilities following an inten- tional contamination of agriculture or food; and (2) the disposal of large quantities of ani- mals, plants, or food products that have been infected or contaminated by specific threat agents and foreign animal diseases. (d) Exercises In carrying out subsection (a), the Adminis- trator, in coordination with the entities de- scribed under subsection (b), shall conduct exer- cises at least annually to evaluate and identify weaknesses in the decontamination and disposal model plans described in subsection (c). Such ex- ercises shall be carried out, to the maximum ex- tent practicable, as part of the national exercise program under section 748(b)(1) of title 6. (e) Modifications Based on the exercises described in subsection (d), the Administrator, in coordination with the entities described in subsection (b), shall review and modify as necessary the plans described in subsection (c) not less frequently than bienni- ally. (f) Prioritization The Administrator, in coordination with the entities described in subsection (b), shall de- velop standards and plans under subsections (b) and (c) in an identified order of priority that takes into account— (1) highest-risk biological, chemical, and ra- diological threat agents; (2) agents that could cause the greatest eco- nomic devastation to the agriculture and food system; and (3) agents that are most difficult to clean or remediate. (Pub. L. 111–353, title II, § 208, Jan. 4, 2011, 124 Stat. 3944.) SUBCHAPTER III—IMPROVING THE SAFETY OF IMPORTED FOOD § 2241. Inspection by the Secretary of Commerce (1) In general The Secretary of Commerce, in coordination with the Secretary of Health and Human Serv- Page 1020 TITLE 21—FOOD AND DRUGS § 2242 ices, may send 1 or more inspectors to a country or facility of an exporter from which seafood im- ported into the United States originates. The in- spectors shall assess practices and processes used in connection with the farming, cultiva- tion, harvesting, preparation for market, or transportation of such seafood and may provide technical assistance related to such activities. (2) Inspection report (A) In general The Secretary of Health and Human Serv- ices, in coordination with the Secretary of Commerce, shall— (i) prepare an inspection report for each inspection conducted under paragraph (1); (ii) provide the report to the country or ex- porter that is the subject of the report; and (iii) provide a 30-day period during which the country or exporter may provide a rebut- tal or other comments on the findings of the report to the Secretary of Health and Human Services. (B) Distribution and use of report The Secretary of Health and Human Serv- ices shall consider the inspection reports de- scribed in subparagraph (A) in distributing in- spection resources under section 350j of this title. (Pub. L. 111–353, title III, § 306(b), Jan. 4, 2011, 124 Stat. 3959.) § 2242. Foreign offices of the Food and Drug Ad- ministration (a) In general The Secretary shall establish offices of the Food and Drug Administration in foreign coun- tries selected by the Secretary, to provide as- sistance to the appropriate governmental enti- ties of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the Food and Drug Administration exported by such country to the United States, including by directly conducting risk-based inspections of such articles and sup- porting such inspections by such governmental entity. (b) Consultation In establishing the foreign offices described in subsection (a), the Secretary shall consult with the Secretary of State, the Secretary of Home- land Security, and the United States Trade Rep- resentative. (c) Report Not later than October 1, 2011, the Secretary shall submit to Congress a report on the basis for the selection by the Secretary of the foreign countries in which the Secretary established of- fices, the progress which such offices have made with respect to assisting the governments of such countries in providing for the safety of ar- ticles of food and other products regulated by the Food and Drug Administration exported to the United States, and the plans of the Sec- retary for establishing additional foreign offices of the Food and Drug Administration, as appro- priate. (Pub. L. 111–353, title III, § 308, Jan. 4, 2011, 124 Stat. 3966.) Editorial Notes REFERENCES IN TEXT The Secretary, referred to in text, probably means the Secretary of Health and Human Services. § 2243. Smuggled food (a) In general Not later than 180 days after January 4, 2011, the Secretary shall, in coordination with the Secretary of Homeland Security, develop and implement a strategy to better identify smug- gled food and prevent entry of such food into the United States. (b) Notification to Homeland Security Not later than 10 days after the Secretary identifies a smuggled food that the Secretary believes would cause serious adverse health con- sequences or death to humans or animals, the Secretary shall provide to the Secretary of Homeland Security a notification under section 350f(n) of this title describing the smuggled food and, if available, the names of the individuals or entities that attempted to import such food into the United States. (c) Public notification If the Secretary— (1) identifies a smuggled food; (2) reasonably believes exposure to the food would cause serious adverse health con- sequences or death to humans or animals; and (3) reasonably believes that the food has en- tered domestic commerce and is likely to be consumed, the Secretary shall promptly issue a press re- lease describing that food and shall use other emergency communication or recall networks, as appropriate, to warn consumers and vendors about the potential threat. (d) Effect of section Nothing in this section shall affect the author- ity of the Secretary to issue public notifications under other circumstances. (e) Definition In this subsection, the term ‘‘smuggled food’’ means any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead. (Pub. L. 111–353, title III, § 309, Jan. 4, 2011, 124 Stat. 3966.) Editorial Notes REFERENCES IN TEXT The Secretary, referred to in text, probably means the Secretary of Health and Human Services. SUBCHAPTER IV—MISCELLANEOUS PROVISIONS § 2251. Jurisdiction; authorities Nothing in this Act, or an amendment made by this Act, shall be construed to— (1) alter the jurisdiction between the Sec- retary of Agriculture and the Secretary of Health and Human Services, under applicable statutes, regulations, or agreements regarding