Enhancing tracking and tracing of food and recordkeeping
Pilot projects
In general
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 processors 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
develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses;
develop and demonstrate appropriate technologies, including technologies existing on
inform the promulgation of regulations under subsection (d).
Report
Additional data gathering
In general
The Secretary, in coordination with the Secretary of Agriculture and multiple representatives of State departments of health and agriculture, shall assess—
the costs and benefits associated with the adoption and use of several product tracing technologies, including technologies used in the pilot projects under subsection (a);
the feasibility of such technologies for different sectors of the food industry, including small businesses; and
whether such technologies are compatible with the requirements of this subsection.
Requirements
To the extent practicable, in carrying out paragraph (1), the Secretary shall—
evaluate domestic and international product tracing practices in commercial use;
consider international efforts, including an assessment of whether product tracing requirements developed under this section are compatible with global tracing systems, as appropriate; and
consult with a diverse and broad range of experts and stakeholders, including representatives of the food industry, agricultural producers, and nongovernmental organizations that represent the interests of consumers.
Product tracing system
Additional recordkeeping requirements for high risk foods
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 consequences 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
relate only to information that is reasonably available and appropriate;
be science-based;
not prescribe specific technologies for the maintenance of records;
ensure that the public health benefits of imposing additional recordkeeping requirements outweigh the cost of compliance with such requirements;
be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping burdens, and not require the creation and maintenance of duplicate records where the information is contained in other company records kept in the normal course of business;
minimize the number of different recordkeeping requirements for facilities that handle more than 1 type of food;
to the extent practicable, not require a facility to change business systems to comply with such requirements;
allow any person subject to this subsection to maintain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Secretary not later than 24 hours after the Secretary requests such records; and 1
include a process by which the Secretary may issue a waiver of the requirements under this subsection if the Secretary determines that such requirements would result in an economic hardship for an individual facility or a type of facility;
be commensurate with the known safety risks of the designated food;
take into account international trade obligations;
not require—
a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food;
records of recipients of a food beyond the immediate subsequent recipient of such food; or
product tracking to the case level by persons subject to such requirements; and
include a process by which the Secretary may remove a high-risk food designation developed under paragraph (2) for a food or type of food.
Designation of high-risk foods
In general
Not later than 1 year after
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 Prevention;
the likelihood that a particular food has a high potential risk for microbiological 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;
the point in the manufacturing process of the food where contamination is most likely to occur;
the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
List of high-risk foods
Protection of sensitive information
In promulgating regulations under this subsection, the Secretary shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section, including periodic risk assessment and planning to prevent unauthorized release and controls to—
prevent unauthorized reproduction of trade secret or confidential information;
prevent unauthorized access to trade secret or confidential information; and
maintain records with respect to access by any person to trade secret or confidential information maintained by the agency.
Public input
Retention of records
Limitations
Farm to school programs
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—
the packaging of the food maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and
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.
Fishing vessels
Commingled raw agricultural commodities
Limitation on extent of tracing
Definitions
For the purposes of this subparagraph—
the term “commingled raw agricultural commodity” means any commodity that is combined or mixed after harvesting, but before processing;
the term “commingled raw agricultural 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
the term “processing” means operations that alter the general state of the commodity, such as canning, cooking, freezing, dehydration, milling, grinding, pasteurization, or homogenization.
Exemption of other foods
Recordkeeping regarding previous sources and subsequent recipients
Grocery stores
Farm sales to consumers
Sale of a food
A sale of a food described in this subparagraph is a sale of a food in which—
the food is produced on a farm; and
the sale is made by the owner, operator, or agent in charge of such farm directly to a consumer or grocery store.
No impact on non-high-risk foods
Evaluation and recommendations
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, taking into consideration the costs of compliance and other regulatory burdens on small businesses and Federal, State, and local food safety practices and requirements, that evaluates the public health benefits and risks, if any, of limiting—
the product tracing requirements under subsection (d) to foods identified under paragraph (2) of such subsection, including whether such requirements provide adequate assurance of traceability in the event of intentional adulteration, including by acts of terrorism; and
the participation of restaurants in the recordkeeping requirements.
Determination and recommendations
Farms
Request for information
Notwithstanding subsection (d), during an active investigation of a foodborne illness outbreak, or if the Secretary determines it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak, the Secretary, in consultation and coordination 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 Secretary reasonably believes such article of food—
is adulterated under section 342 of this title;
presents a threat of serious adverse health consequences or death to humans or animals; and
was adulterated as described in subparagraph (A) on a particular farm (as defined in section 1.227 of chapter 3
Manner of request
Delivery of information requested
Limitation
Records
No Limitation on commingling of food
Small entity compliance guide
Flexibility for small businesses
Notwithstanding any other provision of law, the regulations promulgated under subsection (d) shall apply—
to small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after
to very small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after