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

(a) Pilot projects. Within 270 days of January 4, 2011, the Secretary of Health and Human Services (HHS), taking into account advice from the Secretary of Agriculture and state health and agriculture departments, must set up pilot projects with the food industry to test ways to quickly identify who received a food. The goal is to prevent or reduce a foodborne illness outbreak and to address credible threats of serious illness or death from food that is adulterated or misbranded. At least one pilot must involve the processed food industry, and at least one must involve processors or distributors of raw fruits and vegetables. Taken together, the pilots must reflect the diversity of the food supply and cover at least 3 different kinds of food that caused major outbreaks in the 5 years before January 4, 2011. They're meant to: develop tracking and tracing methods that work for businesses of any size, including small ones; test useful technologies, including ones that already existed; and inform the regulations required under subsection (d). Within 18 months of January 4, 2011, HHS must report to Congress on the pilots' findings and recommend ways to improve food tracking and tracing. (b) Additional data gathering. HHS, working with the Secretary of Agriculture and several state health and agriculture departments, must assess the costs and benefits of various product-tracing technologies (including those used in the pilots), how workable those technologies are for different parts of the food industry, including small businesses, and whether they fit the requirements of this subsection. As far as practical, HHS must also evaluate existing U.S. and foreign tracing practices, consider whether new tracing requirements would work with global tracing systems, and consult a broad range of experts, including food industry representatives, farmers, and consumer groups. (c) Product tracing system. HHS, working with the Secretary of Agriculture, must set up, as appropriate, a system inside the FDA to receive information that helps the agency track and trace food that is in the United States or headed here as an import, more quickly and effectively. Before building this system, HHS must review the results of the pilot projects and make sure the system is grounded in what those pilots showed. (d) Additional recordkeeping for high-risk foods. Within 2 years of January 4, 2011, HHS must propose regulations creating extra recordkeeping rules — on top of existing recordkeeping law — for facilities that make, process, pack, or hold foods HHS designates as "high-risk." HHS must set a fair start date for these new rules, considering how long compliance will take. The rules must: cover only information that is reasonably available and appropriate; be grounded in science; not require any particular recordkeeping technology; ensure the public-health benefit outweighs the cost of compliance; be scaled to a facility's size and not force duplicate recordkeeping of information a company already keeps in the normal course of business; minimize the number of different recordkeeping rules for a facility that handles more than one kind of food; as far as practical, not force a facility to change its business systems; let a facility keep records at one central, reasonably accessible location, as long as it can produce them for HHS within 24 hours of a request; include a process for HHS to waive the requirements for a facility facing economic hardship; match the actual known safety risk of the food; take account of international trade obligations; never require a full "pedigree" — a complete distribution history back to the food's origin — tracking of recipients beyond the very next one in the chain, or tracking down to the level of individual cases; and include a process for HHS to remove a food's high-risk designation later. Designating high-risk foods: within 1 year of January 4, 2011, and as needed after that, HHS must designate high-risk foods that need these extra rules, based on the food's history and severity of past outbreaks (using CDC data), its likelihood of contamination or of supporting the growth of harmful microorganisms, where in the manufacturing process contamination is most likely, existing safeguards against contamination, the likelihood that contamination will actually cause illness, and the likely severity — including health and economic impact — of an outbreak. When HHS finalizes the rules, it must publish the list of designated high-risk foods on the FDA's website, and may later update the list — following this subsection's requirements and announcing updates in the Federal Register. Protection of sensitive information: when writing these regulations, HHS must build in effective safeguards against the unauthorized disclosure of any trade secret or confidential information it collects, including regular risk assessments and controls to prevent unauthorized copying of or access to that information, and to track who accesses it. Public input: during the public comment period on the proposed rule, HHS must hold at least 3 public meetings in different regions of the country. Retention of records: generally, HHS can require a facility to keep records for no more than 2 years, considering how quickly the particular food spoils, loses value, or loses quality. Limitations. In writing these rules, HHS, with the Secretary of Agriculture, must consider the impact on farm-to-school and farm-to-institution programs and adjust the rules so they don't create an undue burden on them. The rules don't apply to food packaged on a farm and sold directly to consumers or grocery stores, if the packaging preserves the product and prevents tampering, and the label lists the farm's name, full address, and phone number — though the phone number can be waived to accommodate a religious belief. For food caught by a fishing vessel, the rules are limited to keeping records of the immediate previous source and immediate next recipient, until the vessel's owner, operator, or agent sells the food. The same limited recordkeeping applies to any "commingled raw agricultural commodity" — a commodity mixed together with others after harvest but before processing — except that this term doesn't include produce for which HHS has set separate standards that already minimize the risk of serious illness; "processing" here means things like canning, cooking, freezing, dehydrating, milling, grinding, pasteurizing, or homogenizing. HHS may also modify the rules for, or exempt, other foods or types of facilities (aside from the previous-source and next-recipient recordkeeping) if it decides tracing isn't needed to protect public health — for example, for bulk or blended ingredients that will be processed to kill pathogens. Anyone covered by one of these limitations or exemptions who is required to register with the FDA must still keep records identifying who they got the food from and who they sent it to next. For a farm-direct sale to a grocery store, HHS can't require the store to keep more than a record of which farm supplied the food, and can't require keeping that record for more than 180 days. HHS can't require a farm to keep any distribution records — even for food it packaged itself — for a sale made directly to a consumer, where the food was grown on that farm and sold by the farm's owner, operator, or agent directly to a consumer or a grocery store. These extra recordkeeping requirements have no effect on foods that HHS has not designated as high-risk; those foods stay under the existing recordkeeping rules. (e) Evaluation and recommendations. Within 1 year after the final rule under (d) takes effect, the Comptroller General must report to Congress, taking into account small-business compliance costs and other regulatory burdens and state and local food-safety practices, evaluating the public-health costs and benefits of limiting the product-tracing requirements to only the designated high-risk foods (including whether that gives adequate protection against intentional contamination, such as terrorism), and of excluding restaurants from these recordkeeping rules. If the Comptroller General finds those limits don't adequately protect public health, the report must recommend to Congress whether restaurants or additional foods should be covered. (f) Farms. During an active outbreak investigation, or whenever HHS decides it's necessary to protect public health and prevent or reduce an outbreak, HHS — working with state and local food-safety agencies as appropriate — may ask a farm's owner, operator, or agent to identify who else, besides consumers, might have received a specific batch of food, if HHS reasonably believes that food is adulterated, poses a threat of serious illness or death, and was contaminated on that particular farm. HHS must make this request in writing, present proper credentials, and deliver the request at a reasonable time and in a reasonable manner. The farm must promptly and reasonably provide the requested information, which may be ordinary business records in any format. HHS cannot use this request to demand financial, pricing, personnel, research, or sales information (other than shipping information) that would reveal trade secrets or confidential data — only what's needed to identify likely recipients. Confidentiality protections under existing law and the Freedom of Information Act apply to any confidential business information the farm gives to the FDA this way. Except for identifying likely recipients in response to a request, this subsection does not require a farm to create or keep any new records. (g) No effect on food commingling. Nothing in this section lets HHS restrict food from being commingled, or mixed together. (h) Small entity compliance guide. Within 180 days after HHS finalizes the rule under (d), it must publish a plain-language guide to help small entities — including farms and small businesses — comply with the new recordkeeping rules. (i) Flexibility for small businesses. The regulations under (d) apply to small businesses, as HHS defines them, starting 1 year after the final rule takes effect, and to very small businesses starting 2 years after the final rule takes effect.

The record indicates that this section was enacted as part of Public Law 111-353, title II, § 204, dated January 4, 2011, and published at 124 Stat. 3930. The source credit reflects a single enactment with no subsequent amendments noted, meaning the text as codified derives directly from the original 2011 statute without later legislative modification. Public Law 111-353 is commonly known as the FDA Food Safety Modernization Act (FSMA). This law is generally understood to represent a major overhaul of federal food safety regulation, shifting the Food and Drug Administration's approach from responding to contamination after it occurs toward preventing it in the first place. The broader legislative effort is commonly associated with a series of high-profile foodborne illness outbreaks in the preceding years, which raised public and congressional concern about the government's ability to quickly trace contaminated food back to its source and prevent widespread harm. Within that broader context, provisions addressing tracking, tracing, and recordkeeping—such as this section—are generally understood to respond to documented difficulties investigators faced in rapidly identifying the origin and distribution path of contaminated food during past outbreaks. The commonly cited purpose of such traceability provisions is to improve the speed and accuracy of outbreak investigations and recalls. Beyond this general understanding of FSMA's purpose, the record does not establish the specific legislative reasoning, debates, or drafting history behind this particular section's detailed requirements; the text itself should be consulted for its precise operative effect.