Requirements for Additional Traceability Records for Certain Foods

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0053]

RIN 0910-AI44

Requirements for Additional Traceability Records for Certain Foods

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).

DATES:

Submit either electronic or written comments on the proposed rule by January 21, 2021. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 23, 2020.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The

https://www.regulations.gov

electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 21, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal:

https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand Delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2014-N-0053 for “Requirements for Additional Traceability Records for Certain Foods.” Received comments, those filed in a timely manner (see

ADDRESSES

), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

https://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit comments on the information collection under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) to

https://www.reginfo.gov/public/do/PRAMain.

Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Requirements for Additional Traceability Records for Certain Foods.”

FOR FURTHER INFORMATION CONTACT:

Regarding the proposed rule:

Brian Pendleton, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4614,

Brian.Pendleton@fda.hhs.gov.

Regarding the information collection:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,

PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

A. Purpose and Coverage of the Proposed Rule

B. Summary of the Major Provisions of the Proposed Rule

C. Legal Authority

D. Costs and Benefits

II. Table of Abbreviations and Commonly Used Acronyms in This Document

III. Background

A. Introduction

B. Need for the Regulation

C. FDA's Current Regulatory Framework

D. History of the Rulemaking

E. Improving Traceability for All Foods

IV. Legal Authority

A. Designation of High-Risk Foods

B. Additional Recordkeeping Requirements

V. Description of the Proposed Rule

A. Scope/Applicability (Proposed § 1.1300)

B. Exemptions (Proposed § 1.1305)

C. Definitions (Proposed § 1.1310)

D. Traceability Program Records (Proposed §§ 1.1315 to 1.1320)

E. Records of Growing, Receiving, Transforming, Creating, and Shipping Food (Proposed §§ 1.1325 to 1.1350)

F. Special Requirements for Foods Subjected to a Kill Step (Proposed § 1.1355)

G. Procedures for Modified Requirements and Exemptions (Proposed §§ 1.1360 to 1.1400)

H. Waivers (Proposed §§ 1.1405-1.1450)

I. Records Maintenance and Availability (Proposed § 1.1455)

J. Consequences of Failure To Comply (Proposed § 1.1460)

K. Updating the Food Traceability List (Proposed § 1.1465)

VI. Proposed Effective and Compliance Dates

VII. Economic Analysis of Impacts

VIII. Analysis of Environmental Impact

IX. Paperwork Reduction Act of 1995

X. Federalism

XI. Consultation and Coordination With Indian Tribal Governments

XII. References

I. Executive Summary

A. Purpose and Coverage of the Proposed Rule

In accordance with section 204(d) of FSMA, this proposed rule would establish traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods that FDA has designated as foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health. The requirements are intended to help us rapidly and effectively identify recipients of these foods to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death as a result of such foods being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). The proposed requirements would reduce the harm to public health caused by foodborne illness outbreaks and limit adverse impacts on industry sectors affected by these outbreaks by improving the ability to quickly and efficiently trace the movement through the supply chain of foods identified as causing illness, identify and remove contaminated food from the marketplace, and develop mitigation strategies to prevent future contamination.

We are issuing the proposed rule because Congress directed us, in section 204(d)(1) of FSMA, to establish recordkeeping requirements for these foods that would be additional to the traceability recordkeeping requirements in section 414 of the FD&C Act (21 U.S.C. 350c) and FDA regulations in 21 CFR part 1, subpart J (subpart J). The existing requirements in subpart J are designed to enable FDA to identify the immediate previous sources and immediate subsequent recipients of foods to address credible threats of serious adverse health consequences or death to humans or animals. The proposed rule would adopt additional recordkeeping requirements beyond those in subpart J for foods we designate as high-risk foods (including foods that contain foods designated as high risk) in accordance with factors specified by Congress in section 204(d)(2)(A) of FSMA. We will list these designated foods on a “Food Traceability List,” a draft of which is available for comments. We will publish a final version of the Food Traceability List on our website when we issue the final rule, and we will update the list as appropriate under the procedures set forth in section 204(d)(2)(B) of FSMA and the proposed rule.

B. Summary of the Major Provisions of the Proposed Rule

We are proposing recordkeeping requirements for foods on the Food Traceability List (“listed foods”) designed to improve the traceability information available for these foods during foodborne illness outbreaks and to increase the speed and precision of traceforward investigations for recall events. The proposed requirements are informed by the challenges we have faced in obtaining critical tracing information and the advancements in traceability approaches that industry has already begun to implement.

The proposed rule would require persons who manufacture, process, pack, or hold foods on the Food Traceability List (including foods that contain foods on the list as ingredients) to keep certain records describing their traceability operations and the listed foods they handle to help FDA investigators understand their traceability procedures and records when reviewing them during a foodborne illness outbreak or a routine inspection. These traceability program records include a description of the reference records (

e.g.,

bills of lading, purchase orders) in which they keep required tracing information, a list of foods on the Food Traceability List they ship, a description of how they assign traceability lot codes, and other information needed to understand their traceability programs.

The core components of the proposed rule are the requirements to establish and maintain records containing key data elements (KDEs) associated with different critical tracking events (CTEs) in a listed food's supply chain, including the growing, receiving, transforming, creating, and shipping of listed foods. The recordkeeping requirements we propose emphasize the importance of documenting the applicable traceability lot codes and linking these codes to other KDEs at critical points in the supply chain of a food to aid product tracing during an investigation of a foodborne illness outbreak or during a recall.

The proposed rule includes several proposed full and partial exemptions from the additional recordkeeping requirements, including some specified by Congress and some we are proposing on our own initiative. Proposed full exemptions include those for small retail food establishments (under one option of a “co-proposal” regarding such establishments), small farms, farms selling food directly to consumers, certain food produced and packaged on a farm, food that receives certain types of processing, and transporters of food. Partial exemptions would apply to certain commingled raw agricultural commodities (not including fruits and vegetables subject to the produce safety regulations), fishing vessels, retail food establishments that receive a listed food directly from a farm, and farm to school and farm to institution programs.

The proposed rule also includes special requirements for foods on the Food Traceability List that are subjected to a kill step.

In accordance with section 204 of FSMA, we are proposing to establish procedures under which persons subject to the proposed rule (when finalized) could request modified requirements or an exemption from these recordkeeping regulations for a specific food or a type of entity on the grounds that application of the requirements to that food or type of entity is not necessary to protect public health. In addition, the proposed rule includes procedures for requesting a waiver of one or more of the requirements for an individual entity or a type of entity on the grounds that

having to meet the requirements would impose an economic hardship.

The proposed rule also includes procedures for future updating of the Food Traceability List in accordance with section 204(d)(2)(B) of FSMA.

C. Legal Authority

Section 204(d)(1) of FSMA directs FDA to publish a notice of proposed rulemaking to establish recordkeeping requirements, in addition to the requirements under section 414 of the FD&C Act and the subpart J regulations, for facilities that manufacture, process, pack, or hold foods that FDA designates as foods for which additional recordkeeping requirements are needed under section 204(d)(2) of FSMA. Section 204(d)(2)(A) of FSMA directs FDA to designate foods for which the additional recordkeeping requirements described in section 204(d)(1) of FSMA are appropriate and necessary to protect the public health.

D. Costs and Benefits

This proposed rule, if finalized, would impose compliance costs on affected entities to establish and maintain traceability records for foods on the Food Traceability List and costs to read and understand the rule. Some entities may also incur initial capital investment and training costs. We estimate that the present value of costs of the rule over 10 years, if Option 1 of the co-proposal for retail food establishments with 10 or fewer full-time equivalent employees (full exemption from the rule) were selected, would range from $238 million to $17 billion, with a primary estimate of $2.9 billion in 2018 dollars at a seven percent discount rate, and from $285 million to $20.1 billion, with a primary estimate of $3.4 billion at a three percent discount rate. At a seven percent discount rate, annualized costs of the rule under proposed Option 1 would range from approximately $34 million to $2.4 billion per year in 2018 dollars, with a primary estimate of $411 million per year. At a three percent discount rate, annualized costs under proposed Option 1 would range from approximately $33 million to $2.4 billion per year, with a primary estimate of $400 million per year.

We estimate that the present value of costs of the rule over 10 years, if Option 2 of the co-proposal for retail food establishments with 10 or fewer full-time equivalent employees (exemption from the requirement to make available to FDA, in certain circumstances, an electronic sortable spreadsheet containing requested traceability information) were selected, would range from $301 million to $22.5 billion, with a primary estimate of $3.8 billion in 2018 dollars at a seven percent discount rate, and from $356 million to $26.1 billion, with a primary estimate of $4.4 billion at a three percent discount rate. At a seven percent discount rate, annualized costs of the rule under proposed Option 2 would range from approximately $43 million to $3.2 million per year in 2018 dollars, with a primary estimate of $535 million per year. At a three percent discount rate, annualized costs under proposed Option 2 would range from approximately $42 million to $3.1 billion per year, with a primary estimate of $513 million per year.

The proposed rule, if finalized, would result in public health benefits if it averts foodborne illnesses related to outbreaks linked to foods on the Food Traceability List. It would also improve the likelihood of conducting more targeted recalls and reduce the cost of conducting recalls by avoiding overly broad recalls and market withdrawals. Additional benefits may include increased food supply system efficiencies, such as improvements in supply chain management and inventory control; more expedient initiation and completion of recalls; avoidance of costs due to unnecessary preventive actions by consumers; and other benefits due to a standardized approach to traceability, including an increase in transparency and trust and potential deterrence of fraud.

We estimate public health benefits using several case studies of outbreak tracebacks for four pathogens associated with illnesses caused by foods on the Food Traceability List. These benefits have a tendency toward underestimation of the total public health benefits because these four pathogens do not represent the total burden of all illnesses associated with listed foods. However, adjustments made for undiagnosed and unattributed illnesses may have the opposite tendency of overstating both illnesses and benefits associated with listed foods. We calculate these monetized benefits from illnesses averted per year based on an estimated 84 percent reduction of traceback time resulting from the requirements of this rule.

Under Option 1 of the co-proposal, for an estimated 84 percent traceback improvement, the annualized monetized benefits range from $33 million to $1.4 billion with a primary estimate of $567 million, discounted at seven percent over ten years. At a three percent discount rate over ten years, the annualized monetized benefits range from $33 million to $1.4 billion with a primary estimate of $580 million. Under Option 2 of the co-proposal, for an estimated 84 percent traceback improvement, the annualized monetized benefits range from $36 million to $1.5 billion with a primary estimate of $626 million, discounted at a seven percent over ten years, and from $37 million to $1.5 billion with a primary estimate of $640 million, discounted at three percent over ten years. Using examples from three recalls, additional (non-health) benefits for both Options 1 and 2 of avoiding overly broad recalls could range from $1.7 billion to $5.6 billion per year at a seven percent discount rate and from $1.7 billion to $5.8 billion using a three percent discount rate. We lack complete information on other benefits described above and discuss them qualitatively.

Table 1—Costs and Benefits

[In 2018 dollars annualized over 10 years at 7 percent discount rate]

Option 1

Option 2

Total Costs

$411 million

$535 million.

Total Benefits

$567 million in public health benefits for an estimated scenario of 84 percent traceback time improvement. Additional potential benefits that we describe qualitatively include increased food supply system efficiencies; more expedient initiation and completion of recalls; avoidance of costs due to unnecessary preventive actions; and other efficiencies from a standardized approach to traceability. However, if retail food establishments with 10 or fewer full-time equivalent employees are exempt from subpart S requirements, the timeliness, precision, and accuracy of traceability efforts can be impacted, and qualitative benefits, such as the ability to narrow the number of lots in a recall and the ability for retail food establishments with 10 or fewer full-time equivalent employees to have the data necessary to quickly identify and remove contaminated products from shelves, will be lessened in comparison to Option 2

$626 million in public health benefits for an estimated scenario of 84 percent traceback time improvement. Additional potential benefits that we describe qualitatively include increased food supply system efficiencies; more expedient initiation and completion of recalls; avoidance of costs due to unnecessary preventive actions; and other efficiencies from a standardized approach to traceability.

II. Table of Abbreviations and Commonly Used Acronyms in This Document

Abbreviation or

acronym

What it means

ASN

Advance shipping notice.

BOL

Bill of lading.

CDC

Centers for Disease Control and Prevention.

CSA

Community supported agriculture.

CTE

Critical tracking event.

FDA

Food and Drug Administration.

FD&C Act

Federal Food, Drug, and Cosmetic Act.

FSIS

Food Safety and Inspection Service.

FSMA

FDA Food Safety Modernization Act.

FOIA

Freedom of Information Act.

GAP

Good agricultural practices.

GPS

Global positioning system.

KDE

Key data element.

LACF

Low-acid canned foods.

OMB

Office of Management and Budget.

RAC

Raw agricultural commodity.

USDA

U.S. Department of Agriculture.

III. Background

A. Introduction

On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) into law. As a component of FSMA's overhaul of U.S. food safety law to better ensure the safety and security of the nation's food supply, section 204(d) of FSMA requires that FDA establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that the Agency designates as high-risk to facilitate the rapid and effective traceability of such foods. These recordkeeping requirements will be additional to the food traceability requirements under section 414 of the FD&C Act (added to the FD&C Act in title III, subtitle A, section 306, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188)) and the implementing regulations in subpart J of part 1 of title 21 of the Code of Federal Regulations (§§ 1.326 to 1.368) (the subpart J regulations). Congress directed FDA to adopt the subpart J recordkeeping requirements to allow the Agency to identify the immediate previous sources and immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping) to address credible threats of serious adverse health consequences or death to humans or animals. In section 204(d)(1) of FSMA, Congress directed FDA to adopt additional recordkeeping requirements to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death to humans or animals resulting from foods being adulterated under section 402 of the FD&C Act or misbranded with respect to allergen labeling under section 403(w) of the FD&C Act.

The proposed additional recordkeeping requirements, when finalized, will help FDA follow the movement of listed food products and ingredients both backward and forward throughout the supply chain. Documenting the movement of foods through the supply chain is called product tracing or traceability. In the case of a foodborne illness outbreak or evidence of contaminated food, product tracing helps government agencies identify the points in the food supply chain, including the source of the product, where contamination may have occurred and, working in partnership with industry, subsequently remove the food from the marketplace. It also helps those who sell food to notify those in the distribution chain that they may have received the product. Efficient traceability enables the government and the food industry to take action more quickly, thus preventing illnesses and reducing economic harm.

Traceability includes traceback and traceforward investigations. Traceback begins at the end of the supply chain at the point of purchase or point of service (

e.g.,

grocery stores and restaurants) and follows the food product back through the points of distribution, processing, and production to determine the source of the product and its ingredients. Traceforward follows the movement of a food in the opposite direction, from the source (

e.g.,

a farm or manufacturer) forward to the retail shelf, to determine the scope of a potential recall and the impact of the contaminated product on the public health.

Even before the enactment of FSMA, FDA had been considering ways to improve food product traceability and increase the speed and accuracy of our traceback and traceforward investigations. For example, in 2008 we held two public meetings to discuss mechanisms to enhance product tracing systems for fresh produce and to improve our ability to identify the source of contamination associated with fresh produce-related outbreaks of foodborne illnesses (see 73 FR 55115, September 24, 2008). In the spring of 2009, we engaged in a pilot project with the Institute of Food Technologists (IFT) to conduct a mock traceback scenario on tomatoes with representatives of the

industry, academia, States, and two technology companies (Ref. 1). In December 2009, we conducted a public meeting, in collaboration with the United States Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS), regarding product tracing systems for human food and animal food (see 74 FR 56843, November 3, 2009).

After FSMA was enacted, FDA sought public comment, scientific data, and information in February 2014 to inform our draft approach to identifying high-risk foods (see 79 FR 6596, February 4, 2014). Section 204(d)(2)(A) of FSMA requires FDA to designate high-risk foods for which the proposed additional recordkeeping requirements are appropriate and necessary to protect the public health. The high-risk food designation must be based on the following factors:

• 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 (CDC);

• 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 the 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.

Section 204(d)(2)(B) of FSMA requires the Agency to publish the list of high-risk foods on our website when we issue the final rule establishing the additional recordkeeping requirements for high-risk foods.

B. Need for the Regulation

Each day that a foodborne illness outbreak remains unresolved, the health of consumers remains at risk. We recognize that to fully realize the public health benefits envisioned by FSMA, we need to improve our ability to rapidly identify and trace foods that may be causing illness. While industry has generally adopted the requirements for one-up, one-back tracing required under the subpart J regulations, the complexity and level of implementation of tracing systems that exceed those requirements vary. From our traceback investigations and discussions with food industry companies and organizations, we recognize that many firms have developed traceability procedures for internal use to help ensure the safety of their products and the security of their supply chains. A smaller number of firms employ tracing systems that are more robust and allow linking of incoming and outgoing products throughout the supply chain, primarily through reference to applicable lot codes in records documenting the production, processing, and distribution of the foods. The proposed recordkeeping requirements, which go beyond subpart J, including by mandating such linking information, would reduce the harm to public health caused by foodborne illness outbreaks and limit adverse impacts on industry sectors affected by these outbreaks. The requirements would achieve this by improving the ability to (1) quickly and efficiently trace the movement of listed foods through the supply chain and (2) identify and remove contaminated food from the marketplace during an outbreak.

This proposed rule is intended to establish the framework of information needed to be maintained in traceability records to accurately and efficiently trace contaminated foods (both domestic and imported) across the U.S. food supply chain to protect the health of all consumers. The rule would establish a consistent approach for product tracing for the different types of products and firms subject to this regulation. The rule also specifies the data elements and information firms must establish and maintain, along with information they must send, in certain circumstances, to the next entity in the supply chain. The rule also would help establish a foundation for the use of consistent food tracing terminology, a transition from paper-based recordkeeping to electronic records, and a universal understanding of the critical information needed for a standardized and efficient system for traceability.

Tracing a food back in the supply chain from the point of sale or service to a common source is important for identifying contaminated foods or ingredients and removing those products from the marketplace to prevent additional illnesses. Tracing foods forward can help FDA understand how the distribution of a food product relates to illnesses or illness clusters, especially for outbreaks that are challenging to resolve, such as those involving multiple foods and foods with multiple ingredients.

The Agency has sometimes been unable to determine links between illnesses and specific product distribution due to inconsistent, unstandardized recordkeeping, lack of a deliberate method to connect records, and the frequent lack of lot tracing regarding distribution to specific retail locations. The retail food establishment is the first point in the supply chain where an investigation is initiated to collect traceback data to identify the source of a product. The more accurate and detailed the data available on the product of interest at the retail food establishment, the more refined record collection can be throughout the remainder of the supply chain. In 2018, FDA investigated a cluster of illnesses caused by

Cyclospora cayetanensis

at small restaurants. We were unable to obtain enough information to identify specific farms/growers (from among several suppliers) as the source of the products suspected of contamination (

e.g.,

basil, cilantro, vegetable trays) due to the restaurants' lack of records indicating lot numbers received and lack of linking to information throughout the supply chain. In the absence of more specific data at the retail food establishment, we had to conduct a broader record collection involving numerous suppliers to ensure that we had sufficient tracing information to accurately determine what lots likely would have been available for consumption or purchase at the establishments by the sickened persons. One benefit of the proposed requirements is that they would allow us to conduct comparative analyses on supply chains of multiple commodities to rule in or out specific ingredients in outbreaks in which ill persons have reported concerns about mixed-ingredient foods.

When a foodborne illness outbreak occurs, a firm with an effective traceability program can lessen the potential adverse economic impact of the event. This is possible when the firm can quickly and precisely provide specific traceability information on a suspected product to regulatory agencies. This information can enable the confirmation of common foods and ingredients associated with illnesses and also help determine which foods and ingredients can be potentially eliminated from further consideration as possible sources of contamination. As a result, regulatory agencies can narrow the scope of necessary recall actions, public health alerts, and countrywide import alerts. Furthermore, being able to

identify the source of a contaminated product quickly enables FDA to conduct more timely root-cause analysis, which could provide important information to help in understanding how contamination may have occurred and prevent future outbreaks.

Lack of traceability has led to delays in product recalls and notification to the public, allowing potentially contaminated foods to remain on the market longer. In 2017, the manufacturer of a soy nut butter product recalled the product after it was found to be the source of a multistate outbreak of Shiga toxin-producing

Escherichia coli

(

E. coli

) that sickened 32 people (81 percent of whom were younger than 18) in 12 states (Refs. 2 to 4). Weeks later, another company announced a recall of its products because they were made with soy nut butter supplied by the original company (Ref. 5). Inadequate traceability significantly impeded product actions for potentially contaminated product associated with this outbreak investigation.

Inadequate traceability can affect both traceback and traceforward investigations. In 2015, FDA, CDC, and multiple states investigated a multistate outbreak of

Salmonella

associated with imported cucumbers that ultimately sickened 907 people (Ref. 6). While the traceback was able to identify a single grower of the cucumbers resulting in product recalls, the CDC reported additional sporadic cases of

Salmonella

6 months after the recall. Having more robust traceforward information could have helped ensure a more complete recall by identifying more locations that received the contaminated product and may have helped assess whether there were other contaminated products on the market subject to the same conditions that led to contamination of cucumbers.

During an outbreak of

Salmonella

Typhimurium in 2008, almost 4,000 peanut butter-containing products were recalled over a period of three and a half months. Cases of illness were first seen in patients residing in a long-term care facility and other institutional settings. Records at these locations identified a common brand of peanut butter, which led to a common manufacturer, and a recall of the brand was initiated. But illnesses continued to be reported across the United States, and further case interviews indicated that the illnesses could not be explained by consumption of the recalled brand of peanut butter. An extensive traceback and traceforward investigation led to expanded recalls over several months, during which many potentially contaminated peanut butter products remained available in the marketplace. This outbreak illustrates the challenges posed by ingredient-based outbreaks and lack of standardized records documenting a product's distribution chain. Manual review of a variety of records was necessary to determine the subsequent commercial recipients of the peanut butter and the inclusion of the peanut butter as an ingredient in other food products. This time-consuming review resulted in a delay in the identification of the many products ultimately recalled in this outbreak (Ref. 7).

Poor traceability records also can lead to an inability to appropriately narrow the scope of a recall. In 2018, a leafy greens mix was linked to an outbreak of Shiga toxin-producing

E. coli.

FDA identified numerous farms that could potentially have produced leafy greens linked to the outbreak. Traceback data gathered during the investigation led to issuance of a public advisory to not consume chopped romaine lettuce from the identified growing region. However, lack of traceability records hindered our ability to identify specific lots and growers of contaminated product. After the initial advisory was issued, we identified an additional cluster of illnesses in people who consumed whole-head romaine lettuce from the same region. As a result, we expanded the initial public advisory to include all romaine lettuce from the identified growing region. Because we were unable to identify a point of origin for the food that made people ill, we were unable to narrow the scope of the advisory but instead had to expand it (Ref. 8).

Lack of specific lot-level tracing data can impact FDA's ability to perform root-cause analyses to determine the point of contamination once the source(s) is identified, which can lead to recurring outbreaks. For example, in 2013, 2014, and 2015, the CDC and state public health officials identified annually recurring outbreaks of

Cyclospora cayetanensis

infections in the United States associated with fresh cilantro from the state of Puebla, Mexico. Although not confirmed by epidemiological means, FDA reviewed a cluster of cyclosporiasis illnesses from 2012 in which the state of Texas had previously identified cilantro as one of multiple possible suspect vehicles. FDA determined that cilantro from Puebla was supplied to the point of service implicated in that outbreak and was one potential source of the outbreak. After the outbreak investigation in 2015, FDA implemented an import alert for shipments of fresh cilantro from Puebla during April through August to align with the seasonality of previous cyclosporiasis outbreaks (Ref. 9). There were numerous traceback challenges during all three of the investigations due to commingling of product, recordkeeping issues, and inconsistencies in documented firm names that hindered our ability to identify the suppliers of the contaminated cilantro. Poor traceability delayed us from taking product actions to ensure contaminated product was removed from the market and conducting environmental assessments that could have identified routes of contamination to reduce future illnesses.

Poor traceability can affect not only outbreaks caused by infectious pathogens but also illnesses associated with fish poisonings. For example, in 2019, FDA investigated a cluster of 50 illnesses that were attributed to Scombrotoxin fish poisoning. In cases of fish toxin poisonings, the illness onset can occur within minutes of consuming fish products, making it even more vital to have specific tracing data available at the point of sale. Because cases reported a variety of frozen tuna products due to inconsistent product descriptions, FDA's traceback investigation traced all cuts of tuna supplied by two firms rather than narrowing the focus to one specific cut of tuna (Ref. 10). The traceback investigation was unable to confirm that the most recent shipments to the points of sale contained the actual product used to prepare meals reported by the cases, due to the extended 2-year shelf life of the frozen product and lack of recordkeeping for this product. Additionally, the traceback investigation could not identify/implicate lot codes at the point of sale because at least two distributors reboxed product into different packaging, and there was potential commingling of product at least one point of sale. Given the extended shelf life and lack of lot codes available at the point of sale, the traceback investigation could not determine relevant lot codes for the implicated products. Due to these traceability limitations, the Agency was only able to place one of the importers of the contaminated tuna products on an import alert, and multiple recalls were required to ensure that importers removed all contaminated products.

Inconsistent product descriptions and commingling of product can also affect traceability efforts. In June 2017, FDA investigated an outbreak of multiple serotypes of

Salmonella

that caused 220 cases of illnesses associated with contaminated papayas (Ref. 11). Tracing the contaminated papayas was delayed by inconsistent descriptions of the papayas, making it difficult to link the

product with the records. Ultimately, the traceback investigation was not able to implicate the shipments of the contaminated papayas due to product commingling, resulting in an inability to differentiate suppliers of the papayas.

As these examples show, while some elements of internal product tracing information are kept by many food producers, manufacturers, distributors, and retailers, the types of information recorded and maintained, the format in which information is kept, the length of time information is retained, and the amount of information shared between trading partners varies among firms. These challenges are further compounded when looking at the traceability of a product moving through multiple entities in a supply chain. Standardization of data elements is needed to help ensure successful traceability throughout the supply chain.

Recognizing the need for improvement in food traceability, when Congress enacted FSMA in 2011 it included provisions, in section 204, intended to enhance tracking and tracing of food. As noted, section 204(d) of FSMA directed FDA to establish additional recordkeeping requirements for certain foods. Under section 204(a) of FSMA, Congress directed us to establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated or misbranded. At FDA's request, the IFT conducted two product tracing pilots (involving mock tracebacks and traceforwards) of foods that had been implicated in foodborne illness outbreaks between 2005 and 2010, assessed the costs and benefits of efficient and effective methods for tracking the foods, and evaluated the feasibility of such methodologies being adopted by different sectors of the food industry. In its 2012 final report to FDA on the pilot studies, the IFT found that pilot participants appeared to have many tools and procedures needed to capture and communicate key traceability information at critical points of product transfer and transformation. However, the IFT identified several problems with current tracing systems, including inconsistencies in terminology and the production of information in formats that cannot be electronically manipulated (Ref. 12).

C. FDA's Current Regulatory Framework

The subpart J traceability recordkeeping requirements stemming from the 2002 Bioterrorism Act require firms to know and record the immediate previous sources of their food products and ingredients and the immediate subsequent recipients of the products they make and/or distribute. The regulations, which we adopted in a final rule issued in 2004 (see 69 FR 71562, December 9, 2004), specify information that “non-transporters” of food (persons who own food or who hold, manufacture, process, pack, import, receive, or distribute food for purposes other than transportation) must maintain regarding their receipt and release of food, with more limited requirements for transporters of food. In accordance with section 414(b) of the FD&C Act, the subpart J regulations exempt farms and restaurants from the requirements. Also exempt are retail food establishments that employ ten or fewer full-time equivalent employees.

Since implementation of the subpart J regulations more than 10 years ago, FDA has learned that these one-up, one-back recordkeeping requirements do not capture all the data elements necessary to effectively and rapidly link shipments of food through each point in the supply chain. In many outbreak investigations, we typically request additional information not explicitly required to be maintained under subpart J to help us conduct traceback and traceforward investigations. This additional information often is available because many firms maintain it for business (other than tracing) purposes. However, piecing together information from several types of documents to extract useful tracing data at each point in the supply chain is laborious and time-consuming, significantly slowing the tracing process and potentially putting more consumers at risk.

Among the most significant gaps in the subpart J recordkeeping requirements are the following:

• Lack of coverage of all sectors involved in food production, distribution, and sale (

e.g.,

exemptions for farms and restaurants).

• Lack of uniform data collection (

e.g.,

regarding the source of food ingredients used in each lot of finished product; the requirement to record a lot code or other identifier only “to the extent this information exists” (see §§ 1.337(a)(4) and 1.345(a)(4)); and

• Inability to link incoming with outgoing product within a firm and from one point in the supply chain to the next (Ref. 13).

When FDA faces challenges during a traceback investigation, it is often due to one or more of the above-listed gaps in the subpart J requirements. The exemptions for point-of-service firms (foodservice and retail) affect almost every investigation because consumer data often is used to initiate a traceback event. During the investigation of an outbreak of

E. coli

O26 in 2015 at a restaurant, the available consumer data could not identify a single ingredient for tracing because customers who became ill had consumed a variety of dishes with multiple common ingredients. This problem was magnified by the lack of information linking the distribution center to the point of sale.

In the last few years, numerous outbreaks associated with leafy greens have resulted in expansive recalls due to, among other reasons, a lack of uniform data collection across the supply chain. While our traceback activities identified farms that could have supplied affected product during the timeframe of interest for those outbreaks, a lack of data about the source of individual lots restricted our ability to identify which farms actually supplied the contaminated product.

These limitations in the existing tracing recordkeeping requirements have been evident in FDA investigations of foodborne illness outbreaks since the adoption of the subpart J requirements. By including section 204 in FSMA, Congress recognized the need for improvement of food tracking and tracing generally and traceability recordkeeping requirements in particular. In not excluding farms and restaurants from the scope of the additional requirements for high-risk foods, Congress also recognized the importance of ensuring traceability to both ends of the supply chain. The requirements of this proposed rule, when finalized, will help ensure that the food industry maintains the traceability information we have determined is needed to enable us to respond quickly and effectively to foodborne illness outbreaks and recall events.

D. History of the Rulemaking

On February 4, 2014, FDA issued a notice in the

Federal Register

(79 FR 6596) announcing the opening of a docket (FDA-2014-N-0053) to obtain comments and scientific data and information to help us implement section 204(d)(2) of FSMA, which requires us to designate high-risk foods (2014 Notice). The 2014 Notice summarized our tentative draft approach for the review and evaluation of data to designate high-risk foods. We

included as a reference to the notice a draft approach document in which we described the process and methodology we were considering using to designate high-risk foods. We invited interested parties to submit comments, scientific data, and information that would help us refine the draft approach to identifying these foods. In addition to requesting comment and information related to the draft approach to high-risk food designation, we sought information on the following:

• Scientific data and methods that can be used to assess the public health impact of acute or chronic exposures to pathogens and chemical contaminants in food; and

• For representative foods in each food category or commodity group, a list of pathogens and chemical contaminants likely to be found in the food, the percentage prevalence of contaminants in the food, the levels of contaminants in the food, the point in the manufacturing process where contaminants are likely to be introduced, and the typical steps and control measures taken in the manufacturing process to reduce the possibility of contamination of the food with the pathogen or chemical contaminant (79 FR 6596 at 6597).

1. Risk-Ranking Model and Food Traceability List

FDA received many comments in response to the 2014 Notice. Taking into consideration the comments and other information submitted, we developed a draft risk-ranking model and collected data to populate the model for chemical and microbiological hazards associated with specific foods, with technical assistance from external expert panels. We conducted an extensive internal review of the draft model and data with Agency subject-matter experts. Two separate peer-review panels of independent external experts reviewed the draft model and the data used to generate risk scores with the model. Taking into consideration comments from these peer reviews (Refs. 14 and 15), we revised the model and updated the data.

As discussed more fully in FDA's “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C. 2223)” (Ref. 16), which is available in the public docket for this rulemaking and on our website, the risk-ranking model uses a semiquantitative, multicriteria decision analysis risk-ranking approach. The approach is consistent with the factors set forth in section 204(d)(2) of FSMA and is operationalized with data relevant to those factors, enabling the Agency to rank, on the basis of public health risk criteria, commodity-hazard pairs and, ultimately, foods we regulate.

Although section 204(d) of FSMA does not exclude food for animals, we have not included animal foods in our risk-ranking model. The current risk-ranking model was designed to account only for humans and cannot accommodate applicability to other animal species. A principal reason for this is that one of the criteria used in the risk model is illness data. While human illnesses related to food are tracked by the CDC, there is no Federal agency with the authority or capability to track foodborne illness outbreaks in animals. Although FDA and state animal food regulatory programs have begun efforts to collect data on animal food-related illnesses, there are no requirements for reporting such illnesses, which has led to significant gaps in the data.

Although animal foods are not included in FDA's risk-ranking model, we may revisit the issue of animal foods when we conduct any future reassessments of the model. We welcome comments on whether and how we should consider incorporating animal foods or animal food-related illness into this or a separate model.

Using the results of the risk-ranking model, we tentatively identified foods for which additional traceability records will be required in accordance with section 204 of FSMA (see “Designation of the Food Traceability List Using the Risk-Ranking Model for Food Tracing” (Ref. 17). Based on that analysis, and in accordance with section 204(d)(2) of FSMA, following is the tentative list of foods for which additional traceability records would be required under the proposed rule (the Food Traceability List) (Ref. 18):

Table 2—Tentative Food Traceability List

Food traceability list

Description

Cheeses, other than hard cheeses

Includes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk.

Shell eggs

Shell egg means the egg of the domesticated chicken.

Nut butter

Includes all types of tree nut and peanut butters; does not include soy or seed butters.

Cucumbers

Includes all varieties of cucumbers.

Herbs (fresh)

Includes all types of herbs, such as parsley, cilantro, basil.

Leafy greens, including fresh-cut leafy greens

Includes all types of leafy greens, such as lettuce, (

e.g.,

iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive.

Melons

Includes all types of melons, such as cantaloupe, honeydew, and watermelon.

Peppers

Includes all varieties of peppers.

Sprouts

Includes all varieties of sprouts.

Tomatoes

Includes all varieties of tomatoes.

Tropical tree fruits

Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit.

Fruits and Vegetables (fresh-cut)

Includes all types of fresh-cut fruits and vegetables.

Finfish, including smoked finfish

Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish.

Crustaceans

Includes all crustacean species, such as shrimp, crab, lobster, and crayfish.

Mollusks, bivalves

Includes all species of bivalve mollusks, such as oysters, clams, and mussels; does not include scallop adductor muscle.

Ready-to-eat deli salads

Includes all types of ready-to-eat deli salads, such as egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads.

We note that, as discussed in section V.A, the proposed traceability recordkeeping requirements would apply not only to foods specifically appearing on the Food Traceability List

but also to foods that contain foods on the list as ingredients.

A proposed Food Traceability List, including descriptions of the foods on the list (referred to in this document as “listed foods”), is available in the public docket for this rulemaking and on FDA's website. In accordance with section 204(d)(2)(B) of FSMA, when we issue the final rule, we will publish a finalized Food Traceability List on our website. That list might differ from the list we are publishing with this proposed rule. We also note that, as discussed in section V.K, we anticipate periodically conducting a review to determine whether it is appropriate to revise the Food Traceability List in accordance with the procedures set forth in the proposed rule.

2. Proposed Recordkeeping Requirements for Foods on the Food Traceability List

To help us develop appropriate traceability recordkeeping requirements under section 204(d) of FSMA, we have met with stakeholders and reviewed the current state of food traceability standards, systems, and technologies. We considered a broad range of domestic and international tracing standards and approaches, including those of the IFT, the business global standards organization GS1, the Produce Traceability Initiative, the International Standards Organization, the Global Food Safety Initiative, and others. We researched standards and systems for traceability in effect in several regions and countries, including the European Union, Canada, Australia, Japan, and China. We also discussed traceability approaches and concerns with food industry and consumer groups (Ref. 19). In addition, we have taken into account our experiences and challenges in conducting investigations in response to outbreaks of foodborne illness and recall events.

From our traceback investigations and discussions with food industry companies and organizations, we recognize that most firms have developed and use some traceability procedures. For those firms that have traceability processes, it appears that an increasingly common approach to traceability involves the identification of CTEs for which KDEs are recorded and maintained. One of the IFT's recommendations in its 2012 final report was that FDA require firms to identify and maintain records of CTEs and KDEs as determined by the Agency (Ref. 12). While not all firms at all points in the supply chain employ KDE/CTE-specific tracing tools and procedures, those that do are recognizing the benefits both to their businesses and to public health of adopting such an approach to product tracing recordkeeping (Ref. 20). However, the KDEs/CTEs the food industry uses are not consistently implemented across supply chains. Further, many firms have not adopted updated traceability approaches and are awaiting further agreement on standard KDEs and CTEs to be used throughout the food industry.

As discussed in more detail in section V.E, the proposed rule adopts an approach to recordkeeping for foods on the Food Traceability List focused on maintaining and sharing specific KDEs for certain CTEs in a food's supply chain, which aligns with consensus standards for traceability currently used by industry. The information required to be kept would vary depending on the type of supply chain activity, such as the growing, receiving, transforming, creating, and shipping of listed foods. We believe that the proposed rule will align the tracing information for foods on the Food Traceability List with our need to quickly and effectively respond to foodborne illness outbreaks and other contamination events associated with these foods.

E. Improving Traceability for All Foods

Ideally, a robust traceability system would provide for traceability of all foods, not just foods on the Food Traceability List. Regardless of the type of food that is the subject of a foodborne illness outbreak investigation, sufficient traceability information is needed to identify the source of an outbreak, expedite the removal of contaminated food from the marketplace, and prevent additional consumer exposures. Although section 204 of FSMA limits recordkeeping requirements to foods on the Food Traceability List, the types of records required to be maintained under the proposed rule could be used by entities in the supply chains of all foods to improve traceability.

The tracing information required to be kept under the proposed rule is consistent with information FDA typically requests during an outbreak investigation, regardless of the food commodity. Firms that maintain records containing this information can help FDA more quickly trace the movement of products through the supply chain, identify the source of contamination, and reduce harm to consumers posed by tainted food. By facilitating faster and more accurate identification of contaminated foods, the availability of such records can help narrow the scope of an outbreak investigation and limit the adverse impact of an outbreak on affected sectors of the food industry. In addition, maintaining records in accordance with the proposed requirements would help ensure that a firm is well-prepared if a food the firm produces or distributes is added to the Food Traceability List as a result of a future reassessment of the list.

Of particular importance to an effective food traceability system under the proposed rule is the use of lot codes in documenting CTEs. Tracebacks are most efficient when point-of-service entities can provide investigators with as much information as possible about the origination of the food. If a point-of-service entity can provide lot codes and other relevant information for suspect foods, including the originating farm or firm, FDA investigators can more quickly identify the potential common source of an outbreak and take regulatory action. Tracing the lot information associated with suspect products can narrow the scope of an investigation, provide FDA with information to quickly go directly to the person that created the lot, and limit further illnesses by enabling more rapid removal of contaminated food from the marketplace. Lot code information can also allow investigators to more quickly determine which products are outside the scope of the investigation, reducing the likelihood of unnecessary category-wide recalls.

Although the proposed rule does not require the use of electronic records and electronic communications for traceability (except to aid FDA's review of records during investigations of foodborne illness outbreaks), we encourage all segments of the food industry to incorporate electronic recordkeeping and communication procedures into their traceability programs. Keeping records of KDEs in electronic, rather than paper, form and sharing tracing information electronically with others in the supply chain can greatly facilitate the analysis of information during investigations into foodborne illness outbreaks and speed the completion of traceback and traceforward operations. Sharing of standard KDEs electronically allows all entities in the supply chain access to reliable information on the traceability of a product.

Further, while this proposed rule would not require retail establishments to maintain KDEs for consumer purchases, we support efforts by retailers to identify and provide anonymized consumer purchase data for outbreak investigations. Presently, we rely on date ranges to identify potentially contaminated products purchased by consumers. Access to

traceability lot codes and product identifiers at the consumer level would further enhance our ability to focus on specific products purchased and narrow the scope of implicated shipments.

To realize the full benefits of end-to-end traceability, although the proposed rule applies only to foods on the Food Traceability List, we encourage all firms involved in food production, distribution, and sale to consumers to adopt the recordkeeping practices set forth in the proposed rule for all the foods they manufacture, process, pack, and hold. Consistent with FDA's “New Era of Smarter Food Safety” initiative (Ref. 21), we will pursue ways to help all supply chain entities adopt practices and technologies that will promote rapid and effective tracking and tracing of foods to prevent or mitigate foodborne illness outbreaks. The New Era of Smarter Food Safety is FDA's FSMA-based, technology-enabled, strategic initiative for modernizing food safety. Comments provided during and after the October 29, 2019, public meeting on the New Era initiative indicated a strong desire for FDA to specify required CTEs and KDEs to enable interoperability of tracing procedures among all stakeholders. The proposed rule defines the minimum CTEs and KDEs necessary for achieving the goal of improving food safety and will provide the food industry with the framework and language for communicating tracing information throughout the supply chain.

IV. Legal Authority

Under section 204(d) of FSMA, 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 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act, FDA is required to issue regulations to establish recordkeeping requirements, in addition to the requirements under section 414 of the FD&C Act and the subpart J regulations (or any successor regulations), for facilities that manufacture, process, pack, or hold foods that FDA designates under section 204(d)(2) of FSMA as high-risk foods.

We are proposing these regulations under the following authorities:

• Section 204 of FSMA, the specific provisions of which are discussed in the remainder of this section;

• section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which provides FDA with the authority to promulgate regulations for the efficient enforcement of the FD&C Act; and

• sections 311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C. 243, 264, and 271), which relate to communicable disease, including by providing FDA with authority to make and enforce such regulations as in FDA's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession (see section 361(a) of the PHS Act).

A. Designation of High-Risk Foods

Section 204(d)(2) of FSMA directs FDA to designate high-risk foods for which the additional recordkeeping requirements promulgated under the authority of FSMA section 204(d)(1) are appropriate and necessary to protect the public health. Each such designation is to be based on the factors enumerated in section 204(d)(2)(A), which are listed in section III.A of this document.

To assist with the fulfillment of this requirement, we developed a semi-quantitative risk-ranking model that utilizes multiple data sources to score commodity-hazard pairs according to a set of criteria that address the factors set out in section 204(d)(2)(A) of FSMA. This model is explained in greater detail in Reference 16 of this document. Foods were included on the list of foods FDA has tentatively designated as high-risk (the “Food Traceability List”) based on the strength of the criteria scores that the model produced (Ref. 16).

FSMA section 204(d)(2)(B) provides that the list of foods designated under section 204(d)(2)(A) (

i.e.,

the Food Traceability List) shall be published on FDA's website at the time of publication of the final rule that creates the recordkeeping requirements described in section 204(d)(1). Proposed § 1.1300 would provide for such publication. FSMA section 204(d)(2)(B) further states that FDA may update the list to designate new foods or to remove foods that are no longer deemed necessary for inclusion, provided that each such update to the list is consistent with the requirements of FSMA section 204(d) and provided that notice of the update is published in the

Federal Register

. The procedures for updating the list that are set forth in proposed § 1.1465 would address this requirement.

B. Additional Recordkeeping Requirements

Section 204(d)(1)(A)-(M) of FSMA provides both general and specific guidelines that FDA must follow in creating the additional recordkeeping requirements that are mandated by section 204(d)(1). These include the following:

• The requirement that these proposed regulations 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 (section 204(d)(1)(E)), which is addressed in proposed § 1.1455(e);

• the requirement that persons subject to these regulations be allowed to maintain the required records at a central or reasonably accessible location provided that such records can be made available to FDA not later than 24 hours after we request them (section 204(d)(1)(H)), which is addressed in proposed § 1.1455(b)(2);

• the requirement to include a process by which FDA may issue a waiver of the recordkeeping requirements if we determine that such requirements would result in an economic hardship for an individual facility or a type of facility (section 204(d)(1)(I)), which is addressed in proposed §§ 1.1405 through 1.1450; and

• the requirement to include a process by which FDA may remove a high-risk food designation developed under section 204(d)(2) for a food or type of food (section 204(d)(1)(M)), which is addressed in proposed § 1.1465.

Furthermore, section 204(d)(5) of FSMA provides that FDA may require that a facility retain records for not more than 2 years, taking into consideration the risk of spoilage, loss of value, or loss of palatability of the applicable food when determining the appropriate timeframes; this is addressed in proposed § 1.1455(c).

Section 204(d)(6) of FSMA places a number of limitations on the requirements that FDA can impose, including limitations relating to the following:

• Farm to school or farm to institution programs (section 204(d)(6)(A)), which are addressed in proposed § 1.1305(i);

• identity-preserved labels with respect to farm sales of food that is produced and packaged on a farm (section 204(d)(6)(B)), which are addressed in proposed § 1.1305(c);

• fishing vessels (section 204(d)(6)(C)), which are addressed in proposed § 1.1305(j);

• commingled raw agricultural commodities (RACs) (section 204(d)(6)(D)), which are addressed in proposed § 1.1305(e); and

• the sale of a food directly from the farm that produced it to a grocery store

or consumer (sections 204(d)(6)(G)-(I)), which are addressed in proposed § 1.1305(h) and (b), respectively.

In addition, section 204(d)(6)(E) of FSMA states the conditions under which FDA may modify the additional recordkeeping requirements or exempt a food or type of facility from those requirements. This process is addressed in proposed §§ 1.1360 through 1.1400. Section 204(d)(6)(F) of FSMA sets forth limited requirements for a person or food who receives such a modification or exemption, as well as limited requirements for any person or food to which a limitation or exemption applies under the provisions relating to fishing vessels and commingled RACs. These limited requirements are included in the proposed provisions that would implement FSMA sections 204(d)(6)(C) through (E).

In addition to the limitations prescribed by Congress, we have identified certain persons or foods that we have tentatively concluded should not be covered by the rule. These include the following:

• Certain small originators of food, as described in proposed § 1.1305(a);

• foods that receive certain types of processing, as described in proposed § 1.1305(d);

• produce that is rarely consumed raw, as described in proposed § 1.1305(e);

• transporters of food, as described in proposed § 1.1305(k);

• nonprofit food establishments, as described in proposed § 1.1305(l);

• persons who manufacture, process, pack, or hold food for personal consumption, as described in proposed § 1.1305(m); and

• certain persons who hold food on behalf of individual consumers, as described in proposed § 1.1305(n).

In addition, we are proposing (in § 1.1305(h)) to extend section 204(d)(6)(G) of FSMA's partial exemption for grocery stores (with respect to food they purchase directly from a farm) to all retail food establishments.

To effectuate and efficiently enforce section 204 of FSMA, we are proposing several requirements for entities that are covered by the proposed rule. In accordance with FSMA section 204(d)(1), proposed § 1.1300 provides that, except as specified otherwise, these requirements would apply to persons who manufacture, process, pack, or hold foods on the Food Traceability List. The proposed requirements are as follows:

• Proposed requirements to establish and maintain certain traceability program records (proposed § 1.1315); proposed requirements related to the establishment of traceability lot codes (proposed § 1.1320); proposed requirements for those who grow, receive, transform, create, or ship foods on the Food Traceability List (proposed §§ 1.1325 through 1.1350); proposed special requirements related to the application of a kill step (proposed § 1.1355); and proposed requirements relating to records maintenance and availability (proposed § 1.1455). These proposed requirements would address Congress's directive to create additional recordkeeping requirements for foods of the Food Traceability List.

• proposed requirements for when a traceability lot code must be established and when it cannot be established (proposed §§ 1.1320 and 1.1330(c)), which would help ensure that this key data element serves its intended function with respect to traceability, as discussed in sections V.D.1 to V.D.2.

• proposed requirements for those who ship a food on the Food Traceability List to send records containing certain information to the immediate subsequent recipient (other than a transporter) of the food (proposed § 1.1350(b)), which would help ensure that the recipient of the food has the information they would be required to maintain under the proposed rule.

• proposed requirements related to record availability (proposed § 1.1455(b)), which would help ensure that FDA has access to the required records in the event of an outbreak or other threat to the public health, and which would also assist FDA in ensuring compliance with these regulations and in identifying any violations.

The definitions we are proposing in proposed § 1.1310 would provide a common terminology, which would help all parties as they implement the proposed recordkeeping requirements. The consequences of a failure to comply with the recordkeeping requirements established under section 204 of FSMA were set forth by Congress in section 204(j)(1) and (2), which amended sections 301(e) and 801(a) of the FD&C Act (21 U.S.C. 331(e) and 381(a)), respectively. These consequences are reiterated in proposed § 1.1460.

V. Description of the Proposed Rule

We are proposing to establish additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods we have designated as requiring additional traceability records under section 204(d) of FSMA. Because we propose to establish these new requirements in a new subpart S to part 1 of the FDA regulations, we refer to the proposed requirements as “the subpart S regulations.”

A. Scope/Applicability (Proposed § 1.1300)

Proposed § 1.1300 answers the question, “Who is subject to this subpart?” Proposed § 1.1300 would provide that, except as specified otherwise in subpart S, the proposed regulations would apply to persons who manufacture, process, pack, or hold foods that appear on the list of foods for which additional traceability records are required in accordance with section 204(d)(2) of FSMA (the “Food Traceability List”). Proposed § 1.1300 also states that we will publish the Food Traceability List on our website in accordance with section 204(d)(2)(B) of FSMA.

Although section 204(d)(1) of FSMA refers to “facilities” that manufacture, process, pack, or hold food, we propose that the rule would apply to “persons” that manufacture, process, pack, or hold food to avoid possible confusion with other uses of the term “facilities” in other FDA food regulations. For example, regulations such as those on preventive controls for human food (21 CFR part 117), preventive controls for animal food (21 CFR part 507), and foreign supplier verification programs (21 CFR part 1, subpart L) define “facility” in part as a domestic or foreign entity that is required to register with FDA under section 415 of the FD&C Act (21 U.S.C. 350d). It is clear that Congress intended that these proposed recordkeeping requirements would apply to some persons that are not required to register with FDA, such as grocery stores (see section 204(d)(6)(G) of FSMA), which do not have to register with FDA under section 415 of the FD&C Act due to the exemption for retail food establishments in § 1.226(c). Consequently, we propose that these regulations apply to “persons” who manufacture, process, pack, or hold food, rather than “facilities,” to avoid possible confusion with other uses of the term “facility.” The term “person,” as defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) and proposed § 1.1310, includes an individual, partnership, corporation, and association.

In accordance with section 204(d)(1) of FSMA, the proposed recordkeeping requirements would apply to persons that “manufacture, process, pack, or hold” foods on the Food Traceability List. We note that this differs from the scope of section 414(b) of the FD&C Act and the subpart J requirements, which apply to persons (excluding farms and

restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. Unlike section 414 of the FD&C Act, section 204 of FSMA does not explicitly apply to persons who transport, distribute, receive, or import food. However, with respect to importation, section 204(j)(2) of FSMA (codified in section 801(a)(4) of the FD&C Act) authorizes FDA to refuse admission to foods for which the recordkeeping requirements under section 204 of FSMA have not been complied with. As discussed more fully in section V.C., we believe that many, but not all, persons who transport, distribute, receive, or import food also “hold” food, as we propose to define holding.

We propose that the additional recordkeeping requirements in subpart S would apply not only to persons who manufacture, process, pack, or hold foods specified on the Food Traceability List, but also to persons who manufacture, process, pack, or hold foods that contain foods on that list as ingredients. We identified foods on the Food Traceability List based on the factors that Congress provided in section 204(d)(2) of FSMA. The potential risk associated with these foods are not diminished when the foods are used as ingredients in other food products (absent application of a kill step). However, it would be unwieldy and impractical for the Food Traceability List to specify every food product of this sort,

i.e.,

food products whose risk derives from their having a listed food as an ingredient. Nonetheless, foods that contain foods on the Food Traceability List as ingredients would be considered part of the list, as stated in the definition of the list in proposed § 1.1310. If the proposed recordkeeping requirements did not apply to foods containing an ingredient that is on the Food Traceability List, it would be much more difficult for the Agency to quickly identify and remove common lots of such an ingredient when investigating a foodborne illness outbreak believed to be linked to the ingredient. A multi-ingredient food that contains a food on the Food Traceability List as an ingredient (

e.g.,

a pre-made sandwich containing leafy greens) may be a signal triggering an outbreak investigation that ultimately leads to identification of the contaminated ingredient. For these reasons, the proposed recordkeeping requirements would apply not only to specifically listed foods but also to foods that contain listed foods as ingredients. In proposed § 1.1310, we propose to define “Food Traceability List” to include both the foods specifically listed and foods that contain foods on the list as ingredients. We use the term in this way for the remainder of this preamble.

B. Exemptions (Proposed § 1.1305)

Proposed § 1.1305 answers the question, “What foods and persons are exempt from this subpart?” We propose to create exemptions from the traceability recordkeeping requirements in proposed subpart S for certain types of food and certain types of persons who manufacture, process, pack, or hold foods on the Food Traceability List. Some of the proposed exemptions are specified in section 204 of FSMA, while others reflect our thinking that applying the proposed requirements to certain persons or foods is not appropriate at this time for the reasons discussed later in this document.

1. Exemption for Certain Types of Small Originators (Proposed § 1.1305(a))

On our own initiative, we propose to exempt from the proposed traceability recordkeeping requirements certain types of small or very small farms and other originators of food (

i.e.,

persons who grow, raise, or catch food or who harvest a non-produce commodity). These firms include very small produce farms, small producers of shell eggs, and other small originators of food. Given the relatively low volume of food produced by these entities, and the fact that subsequent parties in the supply chain will be required to maintain records regarding the food produced by these entities, covering these small originators would produce little measurable public health benefit.

a. Farms That Have No More Than $25,000 in Annual Sales of Produce

Proposed § 1.1305(a)(1) would provide that subpart S would not apply to farms or the farm activities of farm mixed-type facilities with respect to the produce (as defined in 21 CFR 112.3 (§ 112.3) in the produce safety regulations) (21 CFR part 112) they grow, when the farm is not a covered farm under the produce safety regulations in accordance with § 112.4(a). The farms addressed in § 112.4(a) have no more than $25,000 in annual sales of produce.

b. Certain Producers of Shell Eggs

Proposed § 1.1305(a)(2) would provide that subpart S would not apply to shell egg producers with fewer than 3,000 laying hens at a particular farm, with respect to the shell eggs produced at that farm. This designation of small shell egg producers as those with fewer than 3,000 laying hens is consistent with the regulations on shell egg production, storage, and transportation (see 21 CFR 118.1(a) (§ 118.1(a))) and other FDA food safety regulations (

e.g.,

foreign supplier verification program regulations (see 21 CFR 1.512(a)(2)(iii))).

c. Certain Other Originators of Food

Proposed § 1.1305(a)(3) would provide that subpart S would not apply to originators of food with an average annual monetary value of food sold during the previous 3-year period of no more than $25,000 (on a rolling basis), adjusted for inflation using 2019 as the baseline year for calculating the adjustment. This exemption would apply to, for example, small aquaculture farms and small farms that grow non-produce foods that may be on the Food Traceability List in the future.

2. Exemption for Farms Regarding Food Sold Directly to Consumers (Proposed § 1.1305(b))

Consistent with section 204(d)(6)(H) and (I) of FSMA, we propose to exempt farms from the proposed traceability recordkeeping requirements with respect to food produced on the farm (including food that is also packaged on the farm) when the owner, operator, or agent in charge of the farm sells the food directly to a consumer (proposed § 1.1305(b)). This means that if the owner, operator, or agent in charge of a farm sells food that is produced (or both produced and packaged) on the farm directly to a consumer, the farm would not be subject to the proposed subpart S requirements with respect to that food (

e.g.,

recordkeeping requirements applicable to food growers). These direct-to-consumer sales by farms would include applicable sales at farmers' markets, roadside stands, over the internet, and through community-supported agriculture programs.

3. Inapplicability to Certain Food Produced and Packaged on a Farm (Proposed § 1.1305(c))

In addition to the farm-related exemptions in proposed § 1.1305(a) and (b), proposed § 1.1305(c) would provide, consistent with section 204(d)(6)(B) of FSMA, that the proposed traceability recordkeeping requirements would not apply to food produced and packaged on a farm, provided that:

• The packaging of the food remains in place until the food reaches the consumer, and such packaging maintains the integrity of the product and prevents subsequent contamination or alteration of the product (proposed § 1.1305(c)(1)); and

• the labeling of the food that reaches the consumer includes the name,

complete address (street address, town, State, country, and zip or other postal code for a domestic farm and comparable information for a foreign farm), and business phone number of the farm on which the food was produced and packaged (proposed § 1.1305(c)(2)).

In accordance with section 204(d)(6)(B) of FSMA, upon request we would waive the requirement for the farm to include a business phone number, as appropriate, to accommodate a religious belief of the individual in charge of the farm (proposed § 1.1305(c)(2)).

Examples of foods that might be exempt under proposed § 1.1305(c), provided the specified packaging and labeling requirements were met, include the following:

• Iceberg whole head lettuce that is harvested and packaged for the consumer in the field with individual non-vented cellophane wrapping that maintains the integrity of the lettuce and prevents subsequent contamination or alteration; and

• English cucumbers individually wrapped for the consumer by a farm in sealed plastic that maintains the integrity of the cucumbers and prevents subsequent contamination or alteration.

However, produce packed or packaged in containers such as clamshells with holes, cardboard boxes, vented crates, plastic bags with holes, or netted bags would not be eligible for this exemption from the subpart S requirements because such packaging does not necessarily maintain the product's integrity and prevent subsequent contamination and alteration.

We note that, consistent with section 204(d)(6)(B) of FSMA, the exemption in proposed § 1.1305(c) would only apply if, among other things, the labeling of the food that reaches the consumer includes the farm's complete address, including the street address, town, State, country, and zip or other postal code for a domestic farm and comparable information for a foreign farm. However, we recognize that not all farms have a street address. In the event that a farm without a street address wanted to rely on this proposed exemption for certain food produced and packaged on that farm, the farm could substitute its geographical coordinates for a traditional street address in the labeling of the food that reaches the consumer.

While the statute requires this exemption, we encourage retail food establishments to keep records on foods covered under the exemption as a best practice because packaging is often discarded by consumers, resulting in loss of information identifying the farm. We recommend that retail food establishments maintain records on the receipt of the produce including the date of receipt and the name, complete address (street address, town, State, country, and zip or other postal code), and business phone number of the farm on which the food was produced and packaged.

4. Inapplicability to Foods That Receive Certain Types of Processing (Proposed § 1.1305(d))

On our own initiative, we propose to exempt from the proposed traceability recordkeeping requirements produce and shell eggs that receive certain types of processing. Under proposed § 1.1305(d)(1), subpart S would not apply to produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, provided the conditions set forth in § 112.2(b) in the produce safety regulations are met for the produce. We believe that because of the lesser risk to public health posed by this produce (as reflected in its being exempt from almost all of the requirements of the produce safety regulations), it is not necessary to apply the additional recordkeeping requirements to this food. This proposed exemption would apply to all persons who manufacture, process, pack, or hold such produce, not just the farms that grow it. This means that no persons handling produce that receives the commercial processing exemption in accordance with § 112.2(b) would be required to keep subpart S records for the produce.

Similarly, subpart S would not apply to shell eggs when all the eggs produced at a particular farm receive a treatment (as defined in 21 CFR 118.3 (§ 118.3)) in accordance with § 118.1(a)(2). Section 118.3 of the shell egg regulations (21 CFR part 118) defines “treatment” as a technology or process that achieves at least a 5-log destruction of

Salmonella

Enteritidis for shell eggs, or the processing of egg products in accordance with the Egg Products Inspection Act. Under § 118.1(a)(2), if all shell eggs produced at a particular farm receive a treatment, the producer must comply only with the refrigeration requirements in § 118.4(e) for production of eggs on that farm and with the registration requirements in § 118.11. We believe that the lesser risk to public health posed by shell eggs that have received this treatment in accordance with § 118.1(a)(2) makes it unnecessary to apply the subpart S requirements to these eggs.

5. Exemption for Produce That Is Rarely Consumed Raw (Proposed § 1.1305(e))

On our own initiative, we propose to exempt from the proposed traceability recordkeeping requirements produce that is listed as “rarely consumed raw” in § 112.2(a)(1) in the produce safety regulations. We believe that because of the lesser risk to public health posed by this produce (as reflected in its being exempt from the produce safety regulations), it is not necessary to apply the additional recordkeeping requirements to these foods.

6. Partial Exemption of Commingled Raw Agricultural Commodities (Proposed § 1.1305(f))

Proposed § 1.1305(f)(1) would provide that, except as specified in proposed § 1.1305(f)(2), subpart S would not apply to commingled RACs, in accordance with section 204(d)(6)(D) of FSMA. Consistent with section 204(d)(6)(D) of FSMA, we propose to define “commingled raw agricultural commodity” for the purposes of this exemption as any commodity that is combined or mixed after harvesting but before processing, except that the term “commingled raw agricultural commodity” would not include types of fruits and vegetables that are RACs to which the standards for the growing, harvesting, packing, and holding of produce for human consumption in part 112 apply (proposed § 1.305(e)(1)). As a result, the proposed exemption would

not

apply to produce subject to the produce safety regulations.

For the purpose of the definition of “commingled raw agricultural commodity,” a commodity would be regarded as “combined or mixed . . . before processing” only when the combination or mixing involves food from different farms (proposed § 1.1305(f)(1)). We believe this clarification is appropriate because most of the traceability challenges associated with commingling of food from different farms are less present (or entirely absent) when food from different parts of a single farm is commingled.

In keeping with section 204(d)(6)(D)(ii)(III) of FSMA, the term “processing” as used in the definition of commingled RAC would mean operations that alter the general state of the commodity, such as canning, cooking, freezing, dehydration, milling, grinding, pasteurization, or homogenization (proposed § 1.1305(f)(1)).

An example of a RAC that would be exempt from the proposed traceability recordkeeping requirements when they are commingled is shell eggs. For the

purposes of this rule, we would consider commingled shell eggs to be eggs from separate farms under different company management that are physically mixed before packing. Packed eggs that are from a single farm or from separate farms under the same management would not be considered commingled shell eggs. Shell eggs are the only commingled RAC (as defined in proposed § 1.1305(f)(1)) on the current proposed Food Traceability List. Although the limited exemption for commingled RACs in § 1.1305(f) applies to commingled shell eggs, we nevertheless encourage shell egg producers to keep records on the commingling of eggs as a transformation event to help ensure that we are able to determine the source of contaminated eggs in a foodborne illness outbreak or recall event.

Notwithstanding this proposed exemption from the subpart S requirements for commingled RACs, and in accordance with section 204(d)(6)(D) and (F) of FSMA, proposed § 1.1305(f)(2) would specify that, with respect to a commingled RAC that receives the exemption in proposed § 1.1305(f)(1), if a person manufactures, processes, packs, or holds a commingled RAC and is required to register with FDA under section 415 of the FD&C Act in accordance with 21 CFR part 1, subpart H (subpart H), such person must maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food in accordance with the subpart J traceability requirements in §§ 1.337 and 1.345 (which apply to the receipt and release of foods by nontransporters of food). Thus, although certain commingled RACs (as defined in proposed § 1.1305(f)(1)) generally would be exempt from the proposed rule, persons who manufacture, process, pack, or hold these RACs who are required to register with FDA as a food facility would have to comply with the existing food traceability recordkeeping requirements in §§ 1.337 and 1.345. While we recognize that many firms are already required to comply with §§ 1.337 and 1.345 because they are subject to the subpart J recordkeeping requirements, this provision creates an independent obligation to comply with these provisions with respect to foods on the Food Traceability List, including for firms that are not subject to subpart J.

Proposed § 1.1305(f)(2) would further specify that such records identifying immediate previous sources and immediate subsequent recipients of these commingled RACs would have to be maintained for 2 years, consistent with the retention requirement for other records maintained in accordance with subpart S. We discuss the proposed retention requirements for subpart S records in more detail in section V.H.3.

7. Exemption or Partial Exemption for Small Retail Food Establishments (Proposed § 1.1305(g))

On our own initiative, we are co-proposing either a full exemption or a partial exemption from the proposed subpart S requirements for retail food establishments that employ 10 or fewer full-time equivalent employees. Such retail food establishments are exempt from the subpart J requirements under § 1.327(f), except that they are subject to §§ 1.361 and 1.363, which relate to record availability. Although we are considering adopting a full exemption from the proposed subpart S recordkeeping requirements for small retail food establishments, we also are considering whether a more limited exemption for these firms would be appropriate. Therefore, in proposed § 1.1305(g), we are co-proposing two options for full or partial exemption for small retail food establishments, as discussed in the following paragraphs.

a. Option 1: Full Exemption for Small Retail Food Establishments

Option 1 of the co-proposal would specify that subpart S does not apply to retail food establishments that employ 10 or fewer full-time equivalent employees. Option 1 would further state that the number of full-time equivalent employees is based on the number of such employees at each retail food establishment and not the entire business, which may own numerous retail stores. Because these smaller retail food establishments might handle a lesser volume of food than larger establishments, it is possible that requiring the smaller establishments to comply with subpart S would impose costs that would outweigh the benefits of such compliance. In addition, because many of the foods sold at small retail food establishments are nationally distributed and are also sold at larger retail food establishments, we may be able to obtain relevant information about the source of a foodborne illness outbreak from a larger establishment that sold the same food using the same distributor.

On the other hand, because these smaller firms might also be more likely to have less robust traceability records and procedures, fully exempting these firms from the proposed recordkeeping requirements would make it more difficult for FDA to obtain needed tracing information from these firms when investigating a foodborne illness outbreak. There would likely be significant delays in obtaining pertinent tracing data due to the variability of information maintained by these small establishments. The need to rely on the supplier of these small establishments for the tracing data that would be required under this rule would likely result in at least a 24- to 48-hour delay in the traceback. In addition, small retail food establishments can make a particularly important contribution to tracebacks by serving to narrow the scope of products implicated during an investigation. Key data elements, such as lot codes, are not required at the consumer level, requiring traceback investigations to implicate all lot codes available for purchase on a given purchase date identified by the consumer. Retail food establishments, especially larger ones, often receive the same product from multiple distributors, which makes it difficult to narrow the suppliers of interest in an investigation. On the other hand, small establishments often receive product from limited sources, which can make them particularly valuable during an outbreak in narrowing the suppliers of interest and focusing the traceback investigation. The inability to narrow the suppliers of interest and focus the information relevant to the potential source of contamination not only prolongs a traceback effort but might also result in conducting a broader recall than would otherwise be necessary had the firms maintained records required under subpart S (Ref. 22).

b. Option 2: Partial Exemption for Small Retail Food Establishments

Option 2 for proposed § 1.1305(g) would specify that the requirement in proposed § 1.1455(b)(3) to make available to FDA under specified circumstances an electronic sortable spreadsheet containing the information required to be maintained under this subpart (for the foods and date ranges specified in FDA's request) does not apply to retail food establishments that employ 10 or fewer full-time equivalent employees. (The above-stated text regarding determination of the number of full-time equivalent employees also would be included.) As discussed in section V.I.2, we propose to require that, when necessary to help FDA prevent or mitigate a foodborne illness outbreak, or to assist in the implementation of a recall, or to otherwise address a threat to the public health, persons subject to the subpart S requirements must make available, within 24 hours of request by an authorized FDA representative, an

electronic sortable spreadsheet containing the information in the records they are required to maintain under subpart S, for the foods and date ranges specified in the request. We believe that having access to a firm's required traceability information in such electronic form would help us more quickly identify the source of potentially contaminated food on the Food Traceability List and remove the food from the marketplace. Nevertheless, we recognize that smaller firms might be less likely to have the resources to readily produce their traceability information in such a format. Exempting small retail food establishments from this requirement could reduce their burden of complying with the subpart S requirements, while still providing us with access to relevant and specific tracing information when investigating foodborne illness outbreaks involving listed foods received by such establishments.

We request comment on whether we should adopt Option 1 of the co-proposal for § 1.1305(g), which would fully exempt small retail food establishments from subpart S, or Option 2, which would exempt these firms from the requirement to provide to FDA, under certain circumstances, an electronic sortable spreadsheet containing required traceability information. Of course, you may also comment on whether any full or partial exemption for small retail food establishments from the proposed traceability recordkeeping requirements is appropriate. We also request comment on whether having 10 or fewer full-time equivalent employees is an appropriate size limit for a “small” retail food establishment under these proposed options and, if not, what an appropriate limit would be.

8. Partial Exemption for Retail Food Establishments (Proposed § 1.1305(h))

In addition to the proposed full or partial exemption for small retail food establishments in proposed § 1.1305(g), in accordance with section 204(d)(6)(G) of FSMA, we propose to adopt a partial exemption from the subpart S requirements for all retail food establishments when they receive foods on the Food Traceability List directly from a farm. Proposed § 1.1305(h)(1) would provide that subpart S would not apply to a retail food establishment with respect to foods on the Food Traceability List that are produced on a farm (including foods produced and packaged on the farm) and sold directly to the retail food establishment by the owner, operator, or agent in charge of that farm, except as specified in proposed § 1.1305(h)(2). Under proposed § 1.1305(h)(2), when a retail food establishment purchases a food on the Food Traceability List directly from the owner, operator, or agent in charge of a farm, the retail food establishment would be required to establish and maintain a record documenting the name and address of the farm that was the source of the food. Consistent with section 204(d)(6)(G) of FSMA, retail food establishments would be required to maintain these farm identification records for 180 days.

Although section 204(d)(6)(G) of FSMA specifies that this limited tracing requirement to document the farm that was the source of the food applies to grocery stores, we propose to broaden the application of this partial exemption to include all retail food establishments purchasing food directly from farms. We believe it is appropriate to apply this partial exemption to all retail food establishments because we think there is no meaningful or easy way to distinguish grocery stores from other retail food establishments such as convenience stores and vending machine locations.

9. Partial Exemption for Farm to School and Farm to Institution Programs (Proposed § 1.1305(i))

Having consulted with the USDA in accordance with section 204(d)(6)(A) of FSMA, we believe it is appropriate to establish, in proposed § 1.1305(i), a partial exemption from the subpart S requirements for farm to school and farm to institution programs operated under the auspices of the USDA, State agencies, or local jurisdictions to avoid placing undue burdens on these programs. Farm to school programs include, but are not limited to, programs in which farms sell food such as fruits, vegetables, eggs, beans, and meat to: (1) Schools under competitive procurement; (2) competitively procured food distributors; and (3) Child Nutrition Programs, including the USDA DoD Fresh Fruit and Vegetable Program, that provide USDA-purchased domestic agricultural products (USDA Foods). Proposed § 1.1305(i)(1) would provide that, except as specified in § 1.1305(i)(2), the subpart S requirements would not apply to an institution operating a child nutrition program authorized under the Richard B. Russell National School Lunch Act or Section 4 of the Child Nutrition Act of 1966, or any other entity conducting a farm to school or farm to institution program, with respect to a food on the Food Traceability List that is produced on a farm (including food produced and packaged on the farm) and sold directly to the school or institution. Under proposed § 1.1305(i)(2), when a school or institution conducting farm to school or farm to institution activities purchases a food on the Food Traceability List directly from a farm, the school food authority or relevant food procurement entity must establish and maintain a record documenting the name and address of the farm that was the source of the food. Proposed § 1.1305(i)(2) specifies that the school food authority or relevant food procurement entity must maintain the records identifying the farm for 180 days, the same retention period that we propose for records maintained under the partial exemption for retail food establishments in proposed § 1.1305(g).

10. Partial Exemption for Fishing Vessels (Proposed § 1.1305(j))

In accordance with section 204(d)(6)(C) of FSMA, we propose to adopt a partial exemption from the proposed traceability recordkeeping requirements for fishing vessels. Proposed § 1.1305(j)(1) would provide that, except as specified in proposed § 1.1305(j)(2), with respect to a food produced through the use of a fishing vessel, subpart S would not apply to the owner, operator, or agent in charge of the fishing vessel. In accordance with section 204(d)(6)(C) of FSMA, “fishing vessel” would be defined (in proposed § 1.1310) as that term is defined in section 3(18) of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1802(18)),

i.e.,

as any vessel, boat, ship, or other craft which is used for, equipped to be used for, or of a type which is normally used for: (1) Fishing or (2) aiding or assisting one or more vessels at sea in the performance of any activity relating to fishing, including, but not limited to, preparation, supply, storage, refrigeration, transportation, or processing. Under this partial exemption, activities of fishing vessels such as harvesting, transporting, heading, eviscerating, and freezing fish would generally not be subject to the proposed recordkeeping requirements.

Under this exemption, the owner, operator, or agent in charge of a fishing vessel also would not have to keep tracing records on the sale and shipment of food produced through the use of the vessel, except as provided in proposed § 1.1305(j)(2) (discussed in the following paragraph). Section 204(d)(6)(C) of FSMA somewhat ambiguously states that the section 204(d) requirements applicable to fishing vessels would be limited to certain requirements for vessels that are required to register with FDA (set forth in proposed

§ 1.1305(j)(2)) “until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel.” Although the phrase “until such time” could be interpreted as meaning that the owner, operator, or agent in charge of the fishing vessel could be subject to requirements relating to the sale of the relevant food, we believe it is appropriate to exempt the owner, operator, or agent in charge of the fishing vessel from all requirements relating to the relevant food (except as specified in proposed § 1.1305(j)(2)).

In accordance with section 204(d)(6)(C) and (F) of FSMA, proposed § 1.1305(j)(2) would specify that if the owner, operator, or agent in charge of the fishing vessel who receives the exemption in proposed § 1.1305(j)(1) is required to register with FDA under section 415 of the FD&C Act with respect to the manufacturing, processing, packing, or holding of the applicable food, in accordance with subpart H, that person would be required to maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food in accordance with §§ 1.337 and 1.345. This means that fishing vessels that must register with FDA because they process fish on the vessel would be required to comply with the existing subpart J traceability recordkeeping requirements in §§ 1.337 and 1.345, even though many such fishing vessels are currently exempt from those requirements under § 1.327(c). Affected fishing vessels would be required to maintain such records for 2 years (proposed § 1.1305(j)(2)), the retention period for subpart S records specified in proposed § 1.1460(c) (see section V.H.3).

11. Exemption for Transporters (Proposed § 1.1305(k))

On our own initiative, we propose to exempt transporters of food from the proposed traceability recordkeeping requirements (proposed § 1.1305(k)). We propose to define a “transporter” as a person who has possession, custody, or control of an article of food for the sole purpose of transporting the food, whether by road, rail, water, or air (proposed § 1.1310). We believe that transporters should be exempt from the proposed rule because we find that in most of our investigations of potential foodborne illness outbreaks, it is not necessary to inspect records maintained by food transporters because we generally are able to obtain the tracing information we need from other persons in the food's supply chain. If necessary, we could review records maintained by transporters of the food in the usual course of business or, when applicable, in accordance with the subpart J regulations.

12. Exemption for Nonprofit Food Establishments (Proposed § 1.1305(l))

Proposed § 1.1305(l) would provide that subpart S would not apply to nonprofit food establishments, consistent with their exclusion from the subpart J regulations (see § 1.327(l)). We propose to define a nonprofit food establishment as in subpart J (§ 1.328),

i.e.,

as a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States (proposed § 1.1310). The term would include central food banks, soup kitchens, and nonprofit food delivery services. In addition, to be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).

13. Exemption for Persons Who Manufacture, Process, Pack, or Hold Food for Personal Consumption (Proposed § 1.1305(m))

Proposed § 1.1305(m) would provide that subpart S would not apply to persons who manufacture, process, pack, or hold food for personal consumption. Such persons are excluded from the subpart J requirements under § 1.327(m). As discussed in the preamble to the final rule adopting the subpart J requirements (69 FR 71562 at 71579), whether a food is for personal consumption depends on many factors, but we would consider food prepared in a private home and transported for other than business purposes (

e.g.,

to a “pot luck” dinner with friends) to qualify for this exemption.

14. Exemption for Persons Who Hold Food for Individual Consumers (Proposed § 1.1305(n))

Proposed § 1.1305(n) would provide that subpart S would not apply to persons who hold food on behalf of specific individual consumers, provided that such persons: (1) Are not parties to the transaction involving the food they hold and (2) are not in the business of distributing food. This would mirror the exemption for such persons from the subpart J requirements (see § 1.327(n)). This exemption would cover persons such as a hotel concierge, reception desk staff in an apartment building, and staff at an office complex who receive and store a food on the Food Traceability List on behalf of the consumer but are not parties to the purchase of the food they hold and are not in the business of distributing food (see 69 FR 71562 at 71570 to 71571).

C. Definitions (Proposed § 1.1310)

Proposed § 1.1310 sets forth the meaning of several terms we propose to use in the regulations on additional traceability recordkeeping. Some of the definitions are self-explanatory or are being used for consistency with the existing traceability recordkeeping requirements in subpart J and/or other food safety regulations. In the following paragraphs we discuss definitions of terms used in the proposed rule.

1. Category

We propose to define “category” as a code or term used to classify a food product in accordance with a recognized industry or regulatory classification scheme, or a classification scheme a person develops for their own use. Examples of industry or regulatory classification schemes include the GS1 Global Product Classification standard, the United Nations Standard Products and Services Code, the Food and Agriculture Organization of the United Nations 3-Alpha Seafood Species Code, and the European Union Common Procurement Vocabulary. Rather than use a recognized product classification scheme, a firm might choose to develop its own classification scheme to meet its unique product, customer, or other business needs.

2. Cooling

We propose to define “cooling” as active temperature reduction of a food using hydrocooling, icing, forced air cooling, vacuum cooling, or a similar process, either before or after packing. We discuss proposed recordkeeping requirements related to the cooling of listed foods beginning in section V.E.2.

3. Creating

We propose to define “creating” as making or producing a food on the Food Traceability List (

e.g.,

through manufacturing or processing) using only ingredient(s) that are not on the Food Traceability List. The definition further states that creating does not include originating or transforming a food. We discuss proposed recordkeeping requirements related to the creation of listed foods in sections V.D and V.E.4.

4. Critical Tracking Event

We propose to define “critical tracking event” as an event in the supply chain of a food involving the growing, receiving (including receipt by a first receiver), transforming, creating, or shipping of the food. We discuss

proposed recordkeeping requirements for particular critical tracking events in section V.E.

5. Farm

The proposed rule would define “farm” as it is defined in § 1.328 of the subpart J traceability regulations (and other FDA food safety regulations). The definition further states that, for producers of shell eggs, “farm” means all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program (matching the definition of farm under § 118.3 in the shell egg production regulations).

6. First Receiver

We propose to define “first receiver” as the first person (other than a farm) who purchases and takes physical possession of a food on the Food Traceability List that has been grown, raised, caught, or (in the case of a non-produce commodity) harvested. A first receiver of a food might be a manufacturer/processor, distributor, or other non-farm entity who receives a food that has been originated. As discussed in section V.E.2, we believe it is appropriate to require first receivers of listed foods to maintain records containing information about the production of the foods (including information on the harvesting, cooling, and packing of the foods, if applicable) and, for first receivers of seafood, information related to the harvest date range and locations for the trip during which the seafood was caught.

However, an entity that receives a listed food after it has been created (

e.g.,

the first purchaser of a nut butter product) would not be a first receiver under the proposed rule. It would not be appropriate to require the first purchaser of a created food to establish and maintain the first receiver KDEs because those KDEs focus on on-farm practices and other originating events, while created foods have already undergone some form of manufacturing or processing.

7. Fishing Vessel

We propose to define “fishing vessel” as any vessel, boat, ship, or other craft which is used for, equipped to be used for, or of a type which is normally used for: (a) Fishing; or (b) aiding or assisting one or more vessels at sea in the performance of any activity relating to fishing, including, but not limited to, preparation, supply, storage, refrigeration, transportation, or processing. In accordance with section 204(d)(6)(C) of FSMA, this matches the definition of “fishing vessel” in section 3(18) of the Magnuson-Stevens Fishery Conservation and Management Act.

8. Food Traceability List

We propose to define the “Food Traceability List” as the list of foods for which additional traceability records are required to be maintained, as designated in accordance with section 204(d)(2) of FSMA. The definition further states that the term “Food Traceability List” includes both the foods specifically listed and foods that contain specifically listed foods as ingredients.

9. Growing Area Coordinates

We propose to define “growing area coordinates” as the geographical coordinates (under the global positioning system (GPS) or latitude/longitude) for the entry point of the physical location where the food was grown and harvested. We discuss the importance for traceability of requiring growers of food to maintain information on the growing area coordinates for the food in section V.E.1.

10. Harvesting

We propose to define “harvesting” as it is defined in the subpart J regulations and other FDA food safety regulations, with some minor differences. Thus, “harvesting” applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the FD&C Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (

e.g.,

foliage, husks, roots, or stems). Examples of harvesting also include collecting eggs, taking of fish and other seafood in aquaculture operations, milking, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm. Although egg collection and taking of fish and other seafood in aquaculture operations are not included among the examples of harvesting in the definition in subpart J, we want to make clear that we consider these activities to be harvesting. We propose not to include “cooling” as an example of harvesting activities under subpart S, even though it is included in the subpart J definition, because for traceability purposes we wish to distinguish cooling from harvesting.

11. Holding

We propose to define “holding” as storage of food, and to also include activities performed incidental to storage of a food (

e.g.,

activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding would also include activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets) but would not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the FD&C Act. The proposed definition specifies that holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

We believe that persons who do not physically possess food are not engaged in holding of food within the meaning of the proposed rule. This means, for example, that a person who coordinates the import of a listed food but never takes physical possession of the food would not be subject to the rule, while a person who imports a listed food they physically possess would be subject to the rule unless an exemption applied. For example, some firms buy food produced in foreign countries, arrange for the importation of the food into the United States, and sell the food to other U.S. firms without ever taking physical possession of the food; such firms would not be subject to the rule. Similarly, food brokers who negotiate sales of food from producers to wholesalers, retail stores, and others but never physically possess the food would not be subject to the rule.

We are aware that such importers and brokers often maintain tracing information on the food, while some firms that would be subject to the rule because they hold food (such as distributors) might not currently maintain tracing information. For example, a cold storage facility that receives imported produce might not keep tracing records on such produce because the importer of record, broker,

or other firm has the relevant information on the produce. As discussed in section V.D.1, we propose to allow persons subject to the proposed rule to designate an individual or firm who will establish and maintain tracing records on behalf of the person, although the person subject to the rule would remain responsible for meeting the subpart S requirements. This would enable firms who hold imported foods to enter into agreements with importers of record, brokers, and others to keep required tracing records for the foods on their behalf.

We also recognize that the headquarters for retail food establishments typically provide centralized information technology resources for their stores, distribution centers, and, in most cases, franchisee locations. For example, even though a firm's headquarters location may not hold food, the firm may decide that headquarters will maintain the records for each of the firm's retail food establishment locations. In addition, retail food establishments may designate third parties to maintain their traceability records on their behalf (although the establishment would remain responsible for ensuring the subpart S requirements are met for the foods the firm holds).

12. Key Data Element

We proposed to define “key data element” as information associated with a CTE for which a record must be established and maintained in accordance with subpart S. We discuss proposed requirements for records containing KDEs associated with CTEs in section V.E.

13. Kill Step

We propose to define “kill step” as processing that significantly minimizes pathogens in a food. Examples of kill steps include cooking, pasteurization, heat treatment, high-pressure processing, and irradiation, as long as those processes are conducted in a manner that significantly minimizes pathogens in the food. We discuss proposed requirements for foods on the Food Traceability List that are subjected to a kill step in section V.F.

14. Location Description

We propose to define “location description” as a complete physical address and other key contact information, specifically the business name, physical location name, primary phone number, physical location street address (or geographical coordinates), city, state, and zip code for domestic facilities and comparable information for foreign facilities, including country; except that for fishing vessels, “location description” would mean the name of the fishing vessel that caught the seafood, the country in which the fishing vessel's license (if any) was issued, and a point of contact for the fishing vessel.

Location descriptions are typically stored in business systems used for purchasing, manufacturing, and selling goods and services. Table 3 provides an example of the data attributes in a location description for a food processor.

Table 3—Example of Data Attributes for Location Description

KDE

Data attributes

Example

Location Description

Business name

Fin-to-Tail Processing Co.

Physical location name

Facility #345.

primary phone number

222.222.2222.

Physical location street address

456 Blue Water Way.

City

Sarasota.

State

FL.

ZIP code

98765.

15. Location Identifier

We propose to define “location identifier” as a unique identification code that an entity assigns to the physical location name identified in the corresponding location description; except that for fishing vessels, “location identifier” would mean the vessel identification number or license number (both if available) for the fishing vessel. Location identifiers are typically stored with location descriptions in business systems used for purchasing, manufacturing, and selling goods and services.

Along with location descriptions, firms could keep all the location identifiers for their suppliers, customers, and other supply chain partners in an electronic master file. Many firms maintain “master data” containing information on products, companies, and locations, as well as other key commercial information. Trading partners often share certain master data information with each other to simplify business transactions. Persons subject to the proposed rule could meet their requirements to keep records on different location descriptions and identifiers (

e.g.,

for firms from which they receive foods and firms to which they ship food) in electronic master data files. Table 4 illustrates how a firm might maintain relevant information identifying the locations of its supply chain partners using location identifier and location description KDEs.

Table 4—Example of Location Master Data Listing

Location identifier

Location description

Business Name

Physical Location Name

Primary Phone

Street

City

State

Zip code

ALPHA-01

Alpha Eggs

Bldg. 3

999.999.9999

101 Birch

Springfield

MO

111111

GG-CA-01

Gary Greens

Field 21

888.888.8888

818 Elm

Salinas

CA

222222

GG-AZ-02

Gary Greens

Cooler #1

777.777.7777

789 Maple

Yuma

AZ

333333

16. Lot

We propose to define “lot” as the food produced during a period of time at a single physical location and identified by a specific code, noting that a lot may also be referred to as a “batch” or “production run.” While each firm determines the size or quantity of a lot, we recommend that lots consist of product produced under uniform conditions, be as small as possible, and generally not exceed 24 hours of production. Limiting the size of a lot allows for more precise traceability of a product and helps narrow the scope of potentially recalled product.

17. Manufacturing/Processing

We propose to define “manufacturing/processing” as it is defined in subpart J and other FDA food safety regulations,

i.e.,

making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. The definition further provides that examples of manufacturing/processing activities include the following: baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. The definition also states that for farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.

18. Mixed-Type Facility

We propose to define “mixed-type facility” as it is defined in subpart J,

i.e.,

an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. The proposed definition further states that an example of a mixed-type facility is a farm mixed-type facility, which is an establishment that is a farm but also conducts activities outside the farm definition that require the establishment to be registered.

19. Nonprofit Food Establishment

We propose to define “nonprofit food establishment” as it is defined in subpart J,

i.e.,

a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States. The term would include central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment would be required to meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code.

20. Originating

We propose to define “originating” as an event in a food's supply chain involving the growing, raising, or catching of a food (typically on a farm, a ranch, or at sea), or the harvesting of a non-produce commodity. Section V.E.2 discusses a proposed requirement that the first receiver of a listed food keep information on the originator of the food, such as a farm.

21. Originator

We propose to define “originator” as a person who grows, raises, or catches a food, or harvests a non-produce commodity.

22. Packing

We propose to define “packing” as it is defined in subpart J and other food safety regulations,

i.e.,

placing food into a container other than packaging the food. “Packing” also includes re-packing and activities performed incidental to packing or re-packing a food (

e.g.,

activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but would not include activities that transform a raw agricultural commodity (as defined in section 201(r) of the FD&C Act) into a processed food as defined in section 201(gg) of the FD&C Act.

23. Person

We propose to define “person” as including an individual, partnership, corporation, and association. This matches the definition of “person” in section 201(e) of the FD&C Act.

24. Physical Location Name

We propose to define “physical location name” as the word(s) used to identify the specific physical site of a business entity where a particular CTE occurs. Examples could be “Packing Shed 2,” “Store #7228,” or “Warehouse A.” The definition further states that a physical location name might be the same as an entity's business name if the entity has only one physical location. Tables 3 and 4 provide additional examples of physical location names.

25. Point of Contact

We propose to define “point of contact” as an individual having familiarity with an entity's procedures for traceability, including their name, telephone number, and, if available, their email address and fax number. As discussed, beginning in section V.E.2, the proposed rule would require certain first receivers, receivers, and shippers of listed foods to maintain information on points of contact for certain entities in a food's supply chain.

26. Produce

We propose to define “produce” to mean produce as defined in § 112.3 in the produce safety regulations.

27. Receiving

We propose to define “receiving” as an event in a food's supply chain in which a food is received by a customer (other than a consumer) at a defined location after being transported (

e.g.,

by truck or ship) from another defined location. We discuss the traceability records we propose to require for receipt of foods on the Food Traceability List in section V.E.3.

28. Reference Record

We propose to define “reference record” as a record used to identify an event in the supply chain of a food, such as a shipping, receiving, growing, creating, or transformation event. The proposed definition states that types of reference records include, but are not limited to, bills of lading (BOL), purchase orders, advance shipping notices (ASNs), work orders, invoices, batch logs, production logs, and receipts. We discuss the use of reference records in product tracing beginning in section V.D.1.

29. Reference Record Number

We propose to define “reference record number” as the identification number assigned to a reference record, such as a purchase order number, bill of lading number, or work order number.

30. Retail Food Establishment

We propose to define “retail food establishment” as it is defined in the food facility registration regulations (§ 1.227)),

i.e.,

as an establishment that sells food products directly to consumers as its primary function. The definition further specifies the following:

• The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that

it manufactures, processes, packs, or holds, directly to consumers;

• a retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers;

• the term “consumers” in the definition does not include businesses; and

• retail food establishments include, but are not limited to, grocery stores, convenient stores, and vending machine locations.

The definition of “retail food establishment” also includes certain farm-operated businesses selling food directly to consumers as their primary function. The definition further specifies that the sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers in the following circumstances:

• At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);

• through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and

• at other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and internet order, including online farmers' markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.

The definition further states that the sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers in the same circumstances just specified with respect to sale of food directly to consumers from an establishment located on a farm.

Although not specified in this definition of “retail food establishment,” we regard restaurants, online food retailers, and meal kit delivery companies as other examples of such establishments.

31. Shipping

We propose to define “shipping” as an event in a food's supply chain in which a food is arranged for transport (

e.g.,

by truck or ship) from a defined location to another defined location at a different farm, a first receiver, or a subsequent receiver. This would mean that, for example, shipping would not include arranging for transport of a food between different locations of a single farm. The definition further specifies that shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food.

As with the subpart J regulations, the proposed traceability recordkeeping requirements would not apply to the sale of food to consumers by retail food establishments, such as grocery stores, convenience stores, and restaurants. We have tentatively concluded that to require retail facilities to keep records of each individual recipient consumer would be too burdensome and not necessary to address credible threats of serious adverse health consequences or death to humans or animals. However, we acknowledge that some retail food establishments are able to use their consumer loyalty cards to provide consumer-level data (see 68 FR 25188 at 25192, May 9, 2003). We discuss the traceability records we propose to require for shipment of foods on the Food Traceability List in section V.E.5.

32. Traceability Lot

We propose to define “traceability lot” as a lot of food that has been originated, transformed, or created.

33. Traceability Lot Code

We propose to define “traceability lot code” to mean a descriptor, often alphanumeric, used to identify a traceability lot. As with location descriptions and location identifiers, traceability lot codes are typically stored in business systems and printed in human readable and machine-readable format on food product packaging. We discuss the generation and use of traceability lot codes in product tracing in section V.D.1.

34. Traceability Lot Code Generator

We propose to define “traceability lot code generator” to mean the person who assigns a traceability lot code to a product.

35. Traceability Product Description

We propose to define “traceability product description” to mean a description of a food product typically used commercially for purchasing, stocking, or selling, and includes the category code or term, category name, and trade description. As with traceability lot codes, traceability product descriptions are typically stored in business systems and printed in human readable format on food product packaging.

The definition of “traceability product description” further states that for single-ingredient products, the trade description includes the brand name, commodity, variety, packaging size, and packaging style; for multiple-ingredient food products, the trade description includes the brand name, product name, packaging size, and packaging style.

The same term might be used for different components of the traceability product description of a food. For example, “cucumber” may be used as both the category and the commodity.

36. Traceability Product Identifier

We propose to define “traceability product identifier” as a unique identification code (such as an alphanumeric code) that an entity assigns to designate a specific type of food product. As with traceability lot codes and traceability product descriptions, traceability product identifiers are typically stored in business systems and printed in human and machine-readable format on food product packaging. We discuss the use of traceability product identifiers in section V.E.3.

Table 5 illustrates how information in traceability product identifiers and descriptions could be maintained.

Table 5—Example of Data Attributes for Traceability Product Descriptions and Traceability Product Identifiers

Traceability product identifier

Traceability product description data attributes

Category

Category code or term

Category name

Trade Description

Brand name

Commodity

Variety

Product name

Packaging size

Packaging style

614141007349

10006162

1

Cherry Tomatoes—Round

1

Brand ABC

Tomatoes

Cherry

n/a

25 LB

Carton.

183859303020

10006260

1

Sprouts (Fresh)

1

Brand ABC

n/a

n/a

Sprout Mix

4 oz

Clamshell.

20614141004366

BFT

2

Blue Fin Tuna

2

Brand 123

Tuna

Atlantic Bluefin

n/a

10 KG

Bin.

498265800732

Soft Cheese

3

Soft Cheese

3

Brand XYZ

N/A

N/A

Queso Fresco

12 × 8 Ounce

Vac Pack.

5 1462872318 2

Fresh Cut Produce

3

Fresh Cut Produce

3

Brand 999

N/A

N/A

Small Vegetable Tray w/dip

6 oz

Tray.

7483945748383

10000161

1

Biscuits/Cookies (Shelf Stable)

1

Brand CDE

N/A

N/A

Peanut Butter Sandwich Cracker

12 oz

Box.

1

Example of a category that is assigned using the GS1 Global Product Classification Scheme.

2

Example of a category that is assigned using the United Nations Food and Agriculture Organization's Aquatic Sciences and Fisheries Information System (ASFIS) List of Species for Fishery Statistics Purposes, 3A code.

3

Example of a category that is self-assigned by a firm.

37. Transformation

We propose to define “transformation” as an event in a food's supply chain that involves changing a food on the Food Traceability List, its package, and/or its label (regarding the traceability lot code or traceability product identifier), such as by combining ingredients or processing a food (

e.g.,

by cutting, cooking, commingling, repacking, or repackaging). The definition would further specify that transformation does not include initial packing of a single-ingredient food or creating a food. We understand that this definition of “transformation” might differ from the way the term is defined in other traceability systems and approaches; however, we believe this definition is appropriate for use with traceability records for foods on the Food Traceability List, as discussed in section V.E.4.

38. Transporter

We propose to define “transporter” as a person who has possession, custody, or control of an article of food for the sole purpose of transporting the food, whether by road, rail, water, or air. This definition of “transporter” is the same as in subpart J except that it omits language differentiating foreign from domestic transporters, which is not necessary under subpart S. As discussed in section V.B.9, we propose to exempt transporters from the subpart S requirements.

39. Vessel Identification Number

We propose to define “vessel identification number” to mean the number assigned to a fishing vessel by the International Maritime Organization, or by any entity or organization, for the purpose of uniquely identifying the vessel. We request comment on whether the proposed definition provides appropriate flexibility regarding the manner in which fishing vessels are uniquely identified.

D. Traceability Program Records (Proposed §§ 1.1315 Through 1.1320)

We propose to require persons who manufacture, process, pack, or hold foods on the Food Traceability List to create and maintain certain records related to their internal traceability program. As described further below, these “traceability program records” concern the use of reference records, maintaining a list of foods on the Food Traceability List that are shipped, the assignment of traceability lot codes to listed foods, and information on the classification schemes a firm uses for traceability.

We encourage firms to maintain required traceability information in electronic form. Because electronic recordkeeping itself has not yet been universally adopted, it is especially important that firms be able to provide information on how they conduct their required traceability operations to help us more quickly review and understand the information we need to conduct an investigation into a foodborne illness outbreak involving a listed food.

1. Traceability Program Records (Proposed § 1.1315)

Proposed § 1.1315 answers the question, “What traceability program records must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?” Proposed § 1.1315(a) would require persons subject to subpart S to establish and maintain certain traceability program records. We note that, for these and all other records required under subpart S, persons subject to these requirements may enter into agreements with individuals or firms to create and keep the records required under this rule on their behalf. As discussed later in this document, this could include records documenting KDEs for CTEs such as growing, receiving, shipping, transforming, and creating listed foods. Firms could, for example, retain consultants or other outside entities to perform some or all of their subpart S responsibilities, or rely on their supply chain partners, such as their brokers or suppliers, to establish and maintain required records on their behalf. We believe that allowing firms to enter into such agreements will allow for flexibility and accommodate current business practices while ensuring that persons subject to the rule remain responsible for ensuring that these recordkeeping requirements are met.

a. Description of Reference Records (Proposed § 1.1315(a)(1))

Proposed § 1.1315(a)(1) would require persons subject to subpart S to establish and maintain a description of the reference records in which they

maintain the information required under subpart S, an explanation of where on the records the required information appears, and, if applicable, a description of how reference records for different tracing events for a food (

e.g.,

receipt, transformation, shipment) are linked. We encourage firms to maintain required traceability information in a single electronic system; however, we recognize there are firms that currently do not have product tracing systems that enable them to do this. We therefore propose to require firms to describe the particular types of reference records in which they keep the required tracing information to help expedite the firm's production of records and facilitate our review of those records during a foodborne illness outbreak investigation. In some recent foodborne illness outbreaks, some firms' inability to quickly identify and make available to us pertinent information on such matters as production, receipt, and shipment of a possibly contaminated food has significantly delayed completion of our investigation, resulting in greater harm to consumers. Furthermore, even when a firm produces the relevant records, additional delays can occur when it is difficult for us to find the relevant information on those records.

Proposed § 1.1315(a)(1) also would require documentation, if applicable, of how the reference records used for different tracing events for a food are linked. The ability to link incoming with outgoing products within a firm and from one point in the supply chain to the next is critical for traceability. Rarely are there identifiers that link a product as it moves from firm to firm through the supply chain, and often identifiers are lacking within a single firm. One firm may assign a lot code to a product shipment, and the firm receiving the product may assign a new lot code or other identifying code to the product that is not connected by records to the incoming product. Additionally, the incoming product may be processed and used as an ingredient in many different products without any documentation of the link between the ingredient and the finished products, thus compounding the challenge of linking incoming products within a firm to outgoing products.

Another challenge associated with linking of traceability records is that a food product may not always retain the same description as it moves through the supply chain. For example, an FDA traceback of iceberg lettuce during a cyclosporiasis outbreak in 2013 revealed that the lettuce was referred to as “iceberg lettuce” by some firms and as “lettuce liner size 24” by others. In a 2012 outbreak of

Salmonella

Bareilly in tuna, the tuna was identified as “tuna ground meat AAA” by one supplier and “frozen yellow fin tuna CO treated” by the next firm in the supply chain. Use of different descriptions for the same product can make it very difficult or impossible to determine whether two records refer to the same products or shipments.

Having information on how a firm links its records of incoming and outgoing food products, including records of any transformation that may occur at the firm, can help verify movement of a received product through the firm regardless of any changes made to the product or its naming convention. For example, a distributor may use invoices and BOLs as reference records for their traceability information. Knowing which pieces of information are kept within each type of reference record and how those records can be used to show the movement of products within the firm would help FDA understand the products a firm received and what the firm did with them. For example, if a distributor's BOL records contain the necessary information on products received and its invoice records contain the information on products shipped, the distributor could indicate in its traceability program records that an invoice sent to the next point in the supply chain contains the BOL number for the distributor's receipt of the product. This information would help FDA understand the distributor's recordkeeping system and verify movement of incoming and outgoing products at the firm.

b. List of Foods on the Food Traceability List Shipped (Proposed § 1.1315(a)(2))

Proposed § 1.1315(a)(2) would require persons subject to subpart S to establish and maintain a list of foods on the Food Traceability List that they ship, including the traceability product identifier and traceability product description for each food. Depending on the volume of product that a firm handles, if they did not maintain the list required under proposed § 1.1315(a)(2), during an outbreak investigation we might not be able to quickly and easily determine all of the foods on the Food Traceability List that the firm manufactures, processes, packs, or holds, which could delay completion of product tracing or recall. In addition, reviewing a firm's list would help us more quickly analyze information for traceforward purposes during an outbreak, such as when a firm has received and used a recalled ingredient in manufacturing other listed foods of which we were unaware. For example, in a 2008 outbreak involving peanut butter, numerous recalls spanning several months were conducted due to the use of the contaminated peanut butter in other products. Even though we were able to identify the firm that was the source of the peanut butter, having access to a comprehensive list of peanut butter products produced and shipped from the source may have avoided multiple expanded recalls by the same firm over several weeks. In addition, review of a complete list of peanut butter products may have led to efficient and quick traceforward activities to determine additional recipients of potentially contaminated products, which might have enabled faster identification of products produced with potentially contaminated peanut butter by other firms, leading to earlier notification to consumers to avoid such products. In addition, reviewing a firm's list of all foods on the Food Traceability List the firm manufactures, processes, packs, or holds also would help us evaluate the firm's compliance with the subpart S requirements, and we anticipate it will also help firms with their own internal compliance programs.

Although proposed § 1.1315(a)(2) would only require maintenance of a list of foods on the Food Traceability List that a firm ships, best practice would be for a firm to maintain a list of all foods it ships. Firms following that practice could satisfy the requirements of § 1.1315(a)(2) by denoting the foods that are on the Food Traceability List (

e.g.,

with an asterisk).

We realize that a firm's list of foods on the Food Traceability List that they ship may not be accurate in real time if the firm is temporarily out of a commodity or only handles certain products seasonally. The list of foods would indicate which foods on the Food Traceability List a firm generally ships, even if there are gaps in those shipments.

c. Description of How Traceability Lot Codes Are Established and Assigned (Proposed § 1.1315(a)(3))

Proposed § 1.1315(a)(3) would require persons subject to subpart S to establish and maintain a description of how they establish and assign traceability lot codes to foods on the Food Traceability List that they originate, transform, or create, if applicable. Assignment of a lot code allows a food product to be uniquely identified and provides information needed to link shipments of a food between different entities in the supply chain. We believe that tracking

foods to the lot level provides adequate information for traceability operations. (Although some firms conduct product tracing to the case level, the proposed rule would not require that, in accordance with section 204(d)(1)(L)(iii) of FSMA.) During a tracing or recall event, FDA routinely requests lot code information from firms to effectively link movement of foods within a firm and shipments throughout the supply chain. The availability of lot codes along an entire supply chain can facilitate identifying the specific food involved in a contamination event and limiting the scope of a recall event. Lot codes can contain data such as the production line used, plant location, or harvest date. Because of the significance of lot codes in food tracing, understanding how a firm creates and assigns traceability lot codes would provide us with information about the relevance of a code to a particular outbreak investigation and insight on how the code can help us appropriately narrow or broaden the investigation.

d. Other Information Needed To Understand Data (Proposed § 1.1315(a)(4))

Proposed § 1.1315(a)(4) would require persons subject to subpart S to establish and maintain records containing any other information needed to understand the data provided within any required subpart S records, such as internal or external coding systems, glossaries, and abbreviations. We need this information to be able to adequately understand the terminology, methods, and systems a firm uses in its traceability operations. For example, many firms use classification schemes developed by industry (such as the GS1 Global Product Classification standard and the Food and Agriculture Organization of the United Nations Fisheries and Aquaculture and Information Branch List of Species for Fishery Statistics Purposes) or regulatory agency schemes (such as the United Nations Standard Products and Services Code and the European Union Common Procurement Vocabulary) to categorize foods for traceability purposes. Use of standardized product classification schemes, lookup tables, and abbreviations can streamline a firm's internal records and promote interoperability throughout the supply chain, which can speed outbreak investigations. When the records kept in accordance with subpart S make use of such classification schemes, abbreviations, or similar methods, it is important that firms be able to provide us with the information we need to understand those records.

e. Retention Requirement for Traceability Program Records (Proposed § 1.1315(b))

Although we are proposing that most subpart S records be retained for 2 years from the date of creation (see section V.I.3), proposed § 1.1315(b) would require firms to retain the records required under proposed § 1.1315(a) for 2 years after their use is discontinued (

e.g.,

because the firm changes the records in which the required information is maintained, updates the list of foods on the Food Traceability List it ships, or changes its procedures for establishing and assigning traceability lot codes). We believe that a different retention period is appropriate because the records in § 1.1315(a) involve procedures and processes, rather than documentation of the production and handling of particular lots of food products. For example, proposed § 1.1315(b) would ensure that even if a firm uses the same procedures to establish and assign traceability lot codes for many years, a record of these procedures will remain available for FDA review for 2 years after the procedures are discontinued.

2. When Traceability Lot Codes Must Be Assigned (Proposed § 1.1320)

Proposed § 1.1320 answers the question, “When must I establish and assign traceability lot codes to foods on the Food Traceability List?” Proposed § 1.1320(a) would require a person subject to subpart S to establish and assign a traceability lot code when they originate, transform, or create a food on the Food Traceability List. Proposed § 1.1320(b) would specify that, except as otherwise specified in the subpart S regulations, a person may not establish a new traceability lot code when conducting other activities (

e.g.,

shipping, receiving) in the supply chain for a food on the Food Traceability List.

Typically, persons who grow or otherwise originate food assign a lot code to the food; the same is true when a food is transformed (

e.g.,

processed in some way) or “created” by combining several different ingredients. As previously discussed, lot codes provide important tracing information for a food product. Therefore, we propose to require the assignment of a traceability lot code when a firm originates, transforms, or creates a food on the Food Traceability List. However, some firms assign lot codes to foods they receive even though they do not transform the food or use the food to create a new food product. We believe that assignment of new lot codes to foods in such circumstances can create confusion that can hinder traceback and traceforward efforts during investigation of foodborne illness outbreaks. Therefore, the proposed rule generally would prohibit establishment of a traceability lot code (for the purpose of meeting the proposed subpart S requirements) for a listed food except when originating, transforming, or creating a listed food. However, under proposed § 1.1330(c) (discussed in section V.F.2), if a first receiver receives a listed food to which the originator has not assigned a traceability lot code, the first receiver would be required to establish (and maintain a record of) a traceability lot code for the food.

E. Records of Growing, Receiving, Transforming, Creating, and Shipping Food (Proposed §§ 1.1325 to 1.1350)

As discussed in section III.D.2, we are proposing to require persons who manufacture, process, pack, or hold foods on the Food Traceability List to establish and maintain records containing KDEs related to CTEs in the production and transfer of such foods. Under the proposed rule, the CTEs for which records must be kept are growing a listed food, receiving a listed food (including receipt by a first receiver of a listed food), transforming a listed food, creating a listed food, and shipping a listed food. In addition, the proposed rule includes KDE requirements concerning activities such as harvesting, cooling, and packing food that are included in the CTE requirements just noted. The proposed rule also includes requirements concerning KDEs that shippers of foods on the Food Traceability List must provide to their customers.

As discussed in more detail in the following paragraphs, the KDEs required to be kept would vary depending on the type of supply chain activity. In developing the recordkeeping requirements, we identified which KDEs would be necessary to effectively trace a product based on the CTEs a firm performs (

e.g.,

receiving, transformation, shipping). Not all KDEs are relevant for each CTE; however, firms that perform multiple CTEs would be required to maintain all the KDEs that pertain to the CTEs they perform. For example, a firm that receives a food on the Food Traceability List and then transforms and ships it would be required to keep records of KDEs relevant to the receiving, transforming, and shipping events.

The proposed KDE/CTE recordkeeping requirements would require the person performing the relevant CTE to establish and maintain records containing and linking the

food's traceability lot code to the KDEs that must be kept. As discussed in sections III.B a

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