21 U.S.C. § 2224 — Surveillance

Page 1018 TITLE 21—FOOD AND DRUGS § 2224 1 So in original. Probably should be followed by ‘‘of’’. 350g of this title, and was translated as section 350g of this title to reflect the probable intent of Congress be- cause section 350g(n) of this title directs the Secretary of Health and Human Services to define ‘‘small busi- ness’’ and ‘‘very small business’’. CODIFICATION Section is comprised of section 204 of Pub. L. 111–353. Subsec. (j) of section 204 of Pub. L. 111–353 amended sec- tions 331 and 381 of this title. § 2224. Surveillance (a) Definition of foodborne illness outbreak In this Act, the term ‘‘foodborne illness out- break’’ means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a certain food. (b) Foodborne illness surveillance systems (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Preven- tion, shall enhance foodborne illness surveil- lance systems to improve the collection, anal- ysis, reporting, and usefulness of data on foodborne illnesses by— (A) coordinating Federal, State and local foodborne illness surveillance systems, in- cluding complaint systems, and increasing participation in national networks of public health and food regulatory agencies and lab- oratories; (B) facilitating sharing of surveillance in- formation on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, the Department of Homeland Security, and State and local agencies, and with the public; (C) developing improved epidemiological tools for obtaining quality exposure data and microbiological methods for classifying cases; (D) augmenting such systems to improve attribution of a foodborne illness outbreak to a specific food; (E) expanding capacity of such systems, including working toward automatic elec- tronic searches, for implementation of iden- tification practices, including fingerprinting strategies, for foodborne infectious agents, in order to identify new or rarely docu- mented causes of foodborne illness and sub- mit standardized information to a central- ized database; (F) allowing timely public access to aggre- gated, de-identified surveillance data; (G) at least annually, publishing current reports on findings from such systems; (H) establishing a flexible mechanism for rapidly initiating scientific research by aca- demic institutions; (I) integrating foodborne illness surveil- lance systems and data with other bio- surveillance and public health situational awareness capabilities at the Federal, State, and local levels, including by sharing foodborne illness surveillance data with the National Biosurveillance Integration Center; and (J) other activities as determined appro- priate by the Secretary. (2) Working group The Secretary shall support and maintain a diverse working group of experts and stake- holders from Federal, State, and local food safety and health agencies, the food and food testing industries, consumer organizations, and academia. Such working group shall pro- vide the Secretary, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the im- provement of foodborne illness surveillance and implementation of this section, including advice and recommendations on— (A) the priority needs of regulatory agen- cies, the food industry, and consumers for information and analysis on foodborne ill- ness and its causes; (B) opportunities to improve the effective- ness of initiatives at the Federal, State, and local levels, including coordination and inte- gration of activities among Federal agen- cies, and between the Federal, State, and local levels of government; (C) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic re- searchers, and consumers to foodborne ill- ness aggregated, de-identified surveillance data collected by government agencies at all levels, including data compiled by the Cen- ters for Disease Control and Prevention; (D) key barriers at Federal, State, and local levels to improving foodborne illness surveillance and the utility of such surveil- lance for preventing foodborne illness; (E) the capabilities needed for establishing automatic electronic searches of surveil- lance data; and (F) specific actions to reduce barriers to improvement, implement the working group’s recommendations, and achieve the purposes of this section, with measurable ob- jectives and timelines, and identification of resource and staffing needs. (3) Authorization of appropriations To carry out the activities described in para- graph (1), there is authorized to be appro- priated $24,000,000 for each 1 fiscal years 2011 through 2015. (c) Improving food safety and defense capacity at the State and local level (1) In general The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the fol- lowing goals: (A) Improve foodborne illness outbreak re- sponse and containment. (B) Accelerate foodborne illness surveil- lance and outbreak investigation, including rapid shipment of clinical isolates from clin- ical laboratories to appropriate State lab- oratories, and conducting more standardized illness outbreak interviews. (C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards. 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-