21 U.S.C. § 2223 — Enhancing tracking and tracing of food

Page 1014 TITLE 21—FOOD AND DRUGS § 2223 § 2223. Enhancing tracking and tracing of food and recordkeeping (a) Pilot projects (1) In general Not later than 270 days after January 4, 2011, the Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’), taking into account recommenda- tions from the Secretary of Agriculture and representatives of State departments of health and agriculture, shall establish pilot projects in coordination with the food industry to ex- plore and evaluate methods to rapidly and ef- fectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulter- ated under section 342 of this title or mis- branded under section 343(w) of this title. (2) Content The Secretary shall conduct 1 or more pilot projects under paragraph (1) in coordination with the processed food sector and 1 or more such pilot projects in coordination with proc- essors or distributors of fruits and vegetables that are raw agricultural commodities. The Secretary shall ensure that the pilot projects under paragraph (1) reflect the diversity of the food supply and include at least 3 different types of foods that have been the subject of significant outbreaks during the 5-year period preceding January 4, 2011, and are selected in order to— (A) develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for fa- cilities of varying sizes, including small businesses; (B) develop and demonstrate appropriate technologies, including technologies existing on January 4, 2011, that enhance the track- ing and tracing of food; and (C) inform the promulgation of regulations under subsection (d). (3) Report Not later than 18 months after January 4, 2011, the Secretary shall report to Congress on the findings of the pilot projects under this subsection together with recommendations for improving the tracking and tracing of food. (b) Additional data gathering (1) In general The Secretary, in coordination with the Sec- retary of Agriculture and multiple representa- tives of State departments of health and agri- culture, shall assess— (A) the costs and benefits associated with the adoption and use of several product trac- ing technologies, including technologies used in the pilot projects under subsection (a); (B) the feasibility of such technologies for different sectors of the food industry, includ- ing small businesses; and (C) whether such technologies are compat- ible with the requirements of this sub- section. (2) Requirements To the extent practicable, in carrying out paragraph (1), the Secretary shall— (A) evaluate domestic and international product tracing practices in commercial use; (B) consider international efforts, includ- ing an assessment of whether product trac- ing requirements developed under this sec- tion are compatible with global tracing sys- tems, as appropriate; and (C) consult with a diverse and broad range of experts and stakeholders, including rep- resentatives of the food industry, agricul- tural producers, and nongovernmental orga- nizations that represent the interests of con- sumers. (c) Product tracing system The Secretary, in consultation with the Sec- retary of Agriculture, shall, as appropriate, es- tablish within the Food and Drug Administra- tion a product tracing system to receive infor- mation that improves the capacity of the Sec- retary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. Prior to the es- tablishment of such product tracing system, the Secretary shall examine the results of applica- ble pilot projects and shall ensure that the ac- tivities of such system are adequately supported by the results of such pilot projects. (d) Additional recordkeeping requirements for high risk foods (1) In general In order to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health con- sequences or death to humans or animals as a result of such food being adulterated under section 342 of this title or misbranded under section 343(w) of this title, not later than 2 years after January 4, 2011, the Secretary shall publish a notice of proposed rulemaking to es- tablish recordkeeping requirements, in addi- tion to the requirements under section 350c of this title and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations), for facilities that manufacture, process, pack, or hold foods that the Secretary designates under paragraph (2) as high-risk foods. The Secretary shall set an appropriate effective date of such additional requirements for foods designated as high risk that takes into account the length of time necessary to comply with such requirements. Such require- ments shall— (A) relate only to information that is rea- sonably available and appropriate; (B) be science-based; (C) not prescribe specific technologies for the maintenance of records; (D) ensure that the public health benefits of imposing additional recordkeeping re- quirements outweigh the cost of compliance with such requirements; (E) be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping bur- dens, and not require the creation and main- Page 1015 TITLE 21—FOOD AND DRUGS § 2223 1 So in original. The word ‘‘and’’ probably should not appear. tenance of duplicate records where the infor- mation is contained in other company records kept in the normal course of busi- ness; (F) minimize the number of different rec- ordkeeping requirements for facilities that handle more than 1 type of food; (G) to the extent practicable, not require a facility to change business systems to com- ply with such requirements; (H) allow any person subject to this sub- section to maintain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Sec- retary not later than 24 hours after the Sec- retary requests such records; and 1 (I) include a process by which the Sec- retary may issue a waiver of the require- ments under this subsection if the Secretary determines that such requirements would re- sult in an economic hardship for an indi- vidual facility or a type of facility; (J) be commensurate with the known safe- ty risks of the designated food; (K) take into account international trade obligations; (L) not require— (i) a full pedigree, or a record of the com- plete previous distribution history of the food from the point of origin of such food; (ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or (iii) product tracking to the case level by persons subject to such requirements; and (M) include a process by which the Sec- retary may remove a high-risk food designa- tion developed under paragraph (2) for a food or type of food. (2) Designation of high-risk foods (A) In general Not later than 1 year after January 4, 2011, and thereafter as the Secretary determines necessary, the Secretary shall designate high-risk foods for which the additional rec- ordkeeping requirements described in para- graph (1) are appropriate and necessary to protect the public health. Each such des- ignation shall be based on— (i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Preven- tion; (ii) the likelihood that a particular food has a high potential risk for micro- biological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food; (iii) the point in the manufacturing proc- ess of the food where contamination is most likely to occur; (iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of con- tamination; (v) the likelihood that consuming a par- ticular food will result in a foodborne ill- ness due to contamination of the food; and (vi) the likely or known severity, includ- ing health and economic impacts, of a foodborne illness attributed to a particular food. (B) List of high-risk foods At the time the Secretary promulgates the final rules under paragraph (1), the Sec- retary shall publish the list of the foods des- ignated under subparagraph (A) as high-risk foods on the Internet website of the Food and Drug Administration. The Secretary may update the list to designate new high- risk foods and to remove foods that are no longer deemed to be high-risk foods, pro- vided that each such update to the list is consistent with the requirements of this sub- section and notice of such update is pub- lished in the Federal Register. (3) Protection of sensitive information In promulgating regulations under this sub- section, the Secretary shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclo- sure of any trade secret or confidential infor- mation that is obtained by the Secretary pur- suant to this section, including periodic risk assessment and planning to prevent unauthor- ized release and controls to— (A) prevent unauthorized reproduction of trade secret or confidential information; (B) prevent unauthorized access to trade secret or confidential information; and (C) maintain records with respect to access by any person to trade secret or confidential information maintained by the agency. (4) Public input During the comment period in the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment. (5) Retention of records Except as otherwise provided in this sub- section, the Secretary may require that a fa- cility retain records under this subsection for not more than 2 years, taking into consider- ation the risk of spoilage, loss of value, or loss of palatability of the applicable food when de- termining the appropriate timeframes. (6) Limitations (A) Farm to school programs In establishing requirements under this subsection, the Secretary shall, in consulta- tion with the Secretary of Agriculture, con- sider the impact of requirements on farm to school or farm to institution programs of the Department of Agriculture and other farm to school and farm to institution pro- grams outside such agency, and shall modify Page 1016 TITLE 21—FOOD AND DRUGS § 2223 2 See References in Text note below. the requirements under this subsection, as appropriate, with respect to such programs so that the requirements do not place undue burdens on farm to school or farm to institu- tion programs. (B) Identity-preserved labels with respect to farm sales of food that is produced and packaged on a farm The requirements under this subsection shall not apply to a food that is produced and packaged on a farm if— (i) the packaging of the food maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and (ii) the labeling of the food includes the name, complete address (street address, town, State, country, and zip or other postal code), and business phone number of the farm, unless the Secretary waives the requirement to include a business phone number of the farm, as appropriate, in order to accommodate a religious belief of the individual in charge of such farm. (C) Fishing vessels The requirements under this subsection with respect to a food that is produced through the use of a fishing vessel (as de- fined in section 1802(18) of title 16) shall be limited to the requirements under subpara- graph (F) until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel. (D) Commingled raw agricultural commod- ities (i) Limitation on extent of tracing Recordkeeping requirements under this subsection with regard to any commingled raw agricultural commodity shall be lim- ited to the requirements under subpara- graph (F). (ii) Definitions For the purposes of this subparagraph— (I) the term ‘‘commingled raw agricul- tural commodity’’ means any com- modity that is combined or mixed after harvesting, but before processing; (II) the term ‘‘commingled raw agricul- tural commodity’’ shall not include types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that standards promulgated under section 350h of this title (as added by section 105) 2 would minimize the risk of serious adverse health consequences or death; and (III) the term ‘‘processing’’ means op- erations that alter the general state of the commodity, such as canning, cook- ing, freezing, dehydration, milling, grinding, pasteurization, or homogeni- zation. (E) Exemption of other foods The Secretary may, by notice in the Fed- eral Register, modify the requirements under this subsection with respect to, or ex- empt a food or a type of facility from, the requirements of this subsection (other than the requirements under subparagraph (F), if applicable) if the Secretary determines that product tracing requirements for such food (such as bulk or commingled ingredients that are intended to be processed to destroy pathogens) or type of facility is not nec- essary to protect the public health. (F) Recordkeeping regarding previous sources and subsequent recipients In the case of a person or food to which a limitation or exemption under subparagraph (C), (D), or (E) applies, if such person, or a person who manufactures, processes, packs, or holds such food, is required to register with the Secretary under section 350d of this title with respect to the manufacturing, processing, packing, or holding of the appli- cable food, the Secretary shall require such person to maintain records that identify the immediate previous source of such food and the immediate subsequent recipient of such food. (G) Grocery stores With respect to a sale of a food described in subparagraph (H) to a grocery store, the Secretary shall not require such grocery store to maintain records under this sub- section other than records documenting the farm that was the source of such food. The Secretary shall not require that such records be kept for more than 180 days. (H) Farm sales to consumers The Secretary shall not require a farm to maintain any distribution records under this subsection with respect to a sale of a food described in subparagraph (I) (including a sale of a food that is produced and packaged on such farm), if such sale is made by the farm directly to a consumer. (I) Sale of a food A sale of a food described in this subpara- graph is a sale of a food in which— (i) the food is produced on a farm; and (ii) the sale is made by the owner, oper- ator, or agent in charge of such farm di- rectly to a consumer or grocery store. (7) No impact on non-high-risk foods The recordkeeping requirements established under paragraph (1) shall have no effect on foods that are not designated by the Secretary under paragraph (2) as high-risk foods. Foods described in the preceding sentence shall be subject solely to the recordkeeping require- ments under section 350c of this title and sub- part J of part 1 of title 21, Code of Federal Regulations (or any successor regulations). (e) Evaluation and recommendations (1) Report Not later than 1 year after the effective date of the final rule promulgated under subsection (d)(1), the Comptroller General of the United States shall submit to Congress a report, tak- ing into consideration the costs of compliance and other regulatory burdens on small busi- Page 1017 TITLE 21—FOOD AND DRUGS § 2223 3 So in original. Probably should be ‘‘title’’. nesses and Federal, State, and local food safe- ty practices and requirements, that evaluates the public health benefits and risks, if any, of limiting— (A) the product tracing requirements under subsection (d) to foods identified under paragraph (2) of such subsection, in- cluding whether such requirements provide adequate assurance of traceability in the event of intentional adulteration, including by acts of terrorism; and (B) the participation of restaurants in the recordkeeping requirements. (2) Determination and recommendations In conducting the evaluation and report under paragraph (1), if the Comptroller Gen- eral of the United States determines that the limitations described in such paragraph do not adequately protect the public health, the Comptroller General shall submit to Congress recommendations, if appropriate, regarding recordkeeping requirements for restaurants and additional foods, in order to protect the public health. (f) Farms (1) Request for information Notwithstanding subsection (d), during an active investigation of a foodborne illness out- break, or if the Secretary determines it is nec- essary to protect the public health and pre- vent or mitigate a foodborne illness outbreak, the Secretary, in consultation and coordina- tion with State and local agencies responsible for food safety, as appropriate, may request that the owner, operator, or agent of a farm identify potential immediate recipients, other than consumers, of an article of the food that is the subject of such investigation if the Sec- retary reasonably believes such article of food— (A) is adulterated under section 342 of this title; (B) presents a threat of serious adverse health consequences or death to humans or animals; and (C) was adulterated as described in sub- paragraph (A) on a particular farm (as de- fined in section 1.227 of chapter 3 21, Code of Federal Regulations (or any successor regu- lation)). (2) Manner of request In making a request under paragraph (1), the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, shall issue a writ- ten notice to the owner, operator, or agent of the farm to which the article of food has been traced. The individual providing such notice shall present to such owner, operator, or agent appropriate credentials and shall deliver such notice at reasonable times and within reason- able limits and in a reasonable manner. (3) Delivery of information requested The owner, operator, or agent of a farm shall deliver the information requested under para- graph (1) in a prompt and reasonable manner. Such information may consist of records kept in the normal course of business, and may be in electronic or non-electronic format. (4) Limitation A request made under paragraph (1) shall not include a request for information relating to the finances, pricing of commodities produced, personnel, research, sales (other than informa- tion relating to shipping), or other disclosures that may reveal trade secrets or confidential information from the farm to which the arti- cle of food has been traced, other than infor- mation necessary to identify potential imme- diate recipients of such food. Section 331(j) of this title and the Freedom of Information Act [5 U.S.C. 552] shall apply with respect to any confidential commercial information that is disclosed to the Food and Drug Administra- tion in the course of responding to a request under paragraph (1). (5) Records Except with respect to identifying potential immediate recipients in response to a request under this subsection, nothing in this sub- section shall require the establishment or maintenance by farms of new records. (g) No Limitation on commingling of food Nothing in this section shall be construed to authorize the Secretary to impose any limita- tion on the commingling of food. (h) Small entity compliance guide Not later than 180 days after promulgation of a final rule under subsection (d), the Secretary shall issue a small entity compliance guide set- ting forth in plain language the requirements of the regulations under such subsection in order to assist small entities, including farms and small businesses, in complying with the record- keeping requirements under such subsection. (i) Flexibility for small businesses Notwithstanding any other provision of law, the regulations promulgated under subsection (d) shall apply— (1) to small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after January 4, 2011) begin- ning on the date that is 1 year after the effec- tive date of the final regulations promulgated under subsection (d); and (2) to very small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after January 4, 2011) begin- ning on the date that is 2 years after the effec- tive date of the final regulations promulgated under subsection (d). (Pub. L. 111–353, title II, § 204, Jan. 4, 2011, 124 Stat. 3930.) Editorial Notes REFERENCES IN TEXT Section 105, referred to in subsec. (d)(6)(D)(ii)(II), means section 105 of Pub. L. 111–353. Section 350g of this title, referred to in subsec. (i), was in the original ‘‘section 103’’, meaning section 103 of Pub. L. 111–353, which enacted section 350g of this title, amended section 331 of this title, and enacted pro- visions set out as notes under sections 342, 350d, and 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.