Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 16, and 112

[Docket No. FDA-2011-N-0921]

RIN 0910-AG35

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce.

DATES:

This rule is effective January 26, 2016. The effective date of §§ 117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), and 117.475(c)(13) published September 17, 2015 (80 FR 55908), is January 26, 2016. The effective date of §§ 507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 507.175(c)(13) published September 17, 2015 (80 FR 56170), is January 26, 2016. See section XXIV of this document for the compliance dates. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of January 26, 2016.

FOR FURTHER INFORMATION CONTACT:

Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

I. Background

A. FDA Food Safety Modernization Act

B. 2013 Proposed Produce Safety Rule

C. Draft Qualitative Assessment of Risk

D. Produce Safety Supplemental Notice

E. List of

Federal Register

Publications Regarding the Proposed Produce Safety Rule

F. Public Comments

II. Legal Authority

A. Relevant Statutory Authorities Other Than Section 419 of the FD&C Act and Section 105 of FSMA

B. Legal Authority for Records Requirements

C. Intrastate Activities

D. Application of Section 112.2(b)(6) to Entities Other Than Covered Farms

III. General Comments on the 2013 Proposed Rule

A. General Comments

B. Intentional Adulteration

C. Registration

D. Consistency With USDA's National Organic Program

E. Consideration of Environmental Standards

F. Product Testing as a Strategy To Control Pathogens

G. Aquaponic and Hydroponic Operations

IV. Comments on the Regulatory Approach

A. Commodity-Specific Versus Integrated Approach

B. Use of Quantitative Metrics

C. Scientific Support for the Rule

D. Market Channels

E. Guidance in Lieu of the Produce Safety Regulation

F. Existing Industry Guidelines and Certification Programs

G. Reducing Burden on Small Farms

H. Estimated Produce Outbreaks and Associated Illnesses

I. Impact on Traditional Farming Methods

J. Other Comments

V. Final Qualitative Assessment of Risk

VI. Comments on Non-Biological Hazards

VII. Comments on Farm-Specific Food Safety Plans

VIII. Comments Related to Foreign Farms

IX. Subpart A—Comments on Definitions and General Provisions

A. Food That Is Covered and That Is Not Covered (§§ 112.1 and 112.2, and Definition of “Produce” in § 112.3(c))

B. Definitions Other Than Small Business, Very Small Business, Produce (§ 112.3(c))

C. Small Businesses, Very Small Businesses, and Farms That Are Not Covered or Are Eligible for a Qualified Exemption

X. Subpart B—Comments on General Requirements

A. General Requirement in § 112.11

B. General Comments About Alternatives in § 112.12

C. Alternatives for Additional or All Requirements

D. Additional Clarification

E. Prior Approval of Alternatives

XI. Subpart C—Comments on Personnel Qualifications and Training

A. General Comments

B. Qualification and Training for Personnel Who Handle (Contact) Covered Produce or Food-Contact Surfaces (§ 112.21)

C. Training Personnel Who Conduct a Covered Activity (§ 112.22)

D. Records Related to Personnel Qualifications and Training (§ 112.30)

XII. Subpart D—Comments on Health and Hygiene

A. General Comments

B. Ill or Infected Persons (§ 112.31)

C. Personnel Hygienic Practices (§ 112.32)

D. Visitors (§ 112.33)

XIII. Subpart E—Comments on Agricultural Water

A. General Comments

B. General Agricultural Water Quality Requirement (§ 112.41) and Corresponding Corrective Measures (§ 112.45(a))

C. Agricultural Water Sources, Water Distribution Systems, and Pooling of Water (§ 112.42)

D. Treatment of Agricultural Water (§ 112.43)

E. Microbial Quality Criterion for Agricultural Water Used for Certain Specified Purposes (§ 112.44(a)) and Corresponding Corrective Measures (§ 112.45(a))

F. Microbial Quality Criteria for Agricultural Water Used for Direct Application During Growing Activities of Produce (Other Than Sprouts) (§ 112.44(b)) and Corresponding Corrective Measures (§ 112.45(b))

G. Testing of Agricultural Water (§ 112.46)

H. Sharing of Water Testing Data (§ 112.47(a))

I. Agricultural Water Used During Harvest, Packing, and Holding Activities (§ 112.48)

J. Records Related to Agricultural Water (§ 112.50)

K. Compliance Periods Related to Agricultural Water

XIV. Subpart F—Comments on Biological Soil Amendments of Animal Origin and Human Waste

A. General Comments

B. Determining the Status of a Biological Soil Amendment of Animal Origin (§ 112.51)

C. Handling, Conveying, and Storing Biological Soil Amendments of Animal Origin (§ 112.52)

D. Prohibitions Regarding Use of Human Waste (§ 112.53)

E. Treatment Processes (§ 112.54)

F. Microbial Standards Applicable to the Treatment Processes in § 112.54 (§ 112.55)

G. Application Requirements and Minimum Application Intervals (§ 112.56)

H. Records Related to Biological Soil Amendments of Animal Origin (§ 112.60)

I. Other Comments

XV. Subpart I—Comments on Domesticated and Wild Animals

A. Subpart I and Prevention of Contamination

B. Limited Scope of Applicability of Subpart I (§ 112.81)

C. Grazing and Working Animals (§ 112.83)

D. Animal Intrusion (§ 112.83)

E. List of “Animals of Concern”

XVI. Subpart K—Comments on Growing, Harvesting, Packing, and Holding Activities

A. Growing, Harvesting, Packing, or Holding Both Covered and Excluded Produce (§ 112.111)

B. Harvesting Covered Produce (§ 112.112)

C. Handling Harvested Covered Produce (§ 112.113)

D. Dropped Covered Produce (§ 112.114)

E. Packaging Covered Produce (§ 112.115)

F. Food-Packing (Including Food Packaging) Material (§ 112.116)

XVII. Subpart L—Comments on Equipment, Tools, Buildings, and Sanitation

A. Types of Buildings That Are Subject to the Requirements of Subpart L (§ 112.122)

B. Equipment and Tools (§ 112.123)

C. Instruments and Controls Used To Measure, Regulate, or Record (§ 112.124)

D. Equipment Used in the Transport of Covered Produce (§ 112.125)

E. Buildings (§ 112.126)

F. Toilet Facilities (§ 112.129) and Hand-Washing Facilities (§ 112.130)

G. Controlling Animal Excreta and Litter From Domesticated Animals (§ 112.134)

XVIII. Subpart M—Comments on Sprouts

A. General Comments

B. Seeds or Beans Used To Grow Sprouts (§ 112.142)

C. Growing, Harvesting, Packing, and Holding Sprouts (§ 112.143)

D. Testing During Growing, Harvesting, Packing, and Holding Sprouts (§ 112.144)

E. Environmental Testing for

Listeria

Species or

L. monocytogenes

(§ 112.145)

F. Follow-Up Actions for Positive Environmental Testing Results (§ 112.146)

G. Collection and Testing of Samples of Spent Sprout irrigation Water or Sprouts (§ 112.147)

H. Actions if Spent Sprout Irrigation Water or Sprouts Test Positive for a Pathogen (§ 112.148)

I. Records Related to Sprouts (§ 112.150)

J. Compliance Periods for Covered Activities Involving Sprouts

K. Other Comments

XIX. Subpart N—Comments on Analytical Methods

A. Responses to Comments

B. Other Revisions

C. Incorporation by Reference

XX. Subpart O—Comments on Records

A. General Comments

B. General Requirements Applicable to Records Required Under Part 112 (§ 112.161)

C. Storage of Records (§ 112.162)

D. Use of Existing Records (§ 112.163)

E. Length of Records Retention (§ 112.164)

F. Acceptable Formats for Records (§ 112.165)

G. Disclosure of Records Submitted to FDA (§ 112.167)

XXI. Subpart P—Comments on Variances

A. Requesting a Variance (§§ 112.171 and 112.172)

B. The Statement of Grounds in a Variance Petition (§ 112.173)

C. Process for Requesting a Variance (§ 112.176)

D. Permissible Types of Variances (§ 112.182)

E. Other Comments

XXII. Subpart Q—Comments on Compliance and Enforcement

A. General Comments on Compliance and Enforcement Strategy

B. FDA Enforcement Decisions

C. Coordination of Education and Enforcement (§ 112.193)

D. On-Farm Inspections

E. Third-Party Audits, Inspections, and Other Arrangements

XXIII. Subpart R—Comments on Withdrawal of Qualified Exemption

A. Circumstances That May Lead FDA To Withdraw a Farm's Qualified Exemption (§ 112.201)

B. Contents of an Order To Withdraw a Qualified Exemption (§ 112.203)

C. Compliance With, or Appeal of, an Order To Withdraw a Qualified Exemption (§§ 112.204, 112.205, and 112.206)

D. Procedure for Requesting an Informal Hearing (§ 112.207)

E. Informal Hearing (§ 112.208)

F. Circumstances Related To Reinstatement of a Qualified Exemption That Is Withdrawn (§ 112.213)

G. Other Comments

H. Conforming Amendment to 21 CFR Part 16

XXIV. Comments on Effective and Compliance Dates

A. Effective and Compliance Dates for Part 112

B. Effective Dates for Conforming Changes

C. Effective Date for Certain Provisions in the PCHF Regulation

D. Effective Date for Certain Provisions in the PCAF Regulation

XXV. Executive Order 13175

XXVI. Economic Analysis of Impacts

XXVII. Analysis of Environmental Impact

XXVIII. Paperwork Reduction Act of 1995

XXIX. Federalism

XXX. References

Executive Summary

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) requires FDA to conduct a rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities (RACs) for which we have determined such standards minimize the risk of serious adverse health consequences or death. Further, FSMA requires FDA to adopt a final regulation based on known safety risks, setting forth procedures, processes, and practices that we determine to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA published a proposed rule entitled, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption (78 FR 3504, January 16, 2013). The comment period for the proposed rule closed on November 22, 2013. In response to information we heard at public meetings, and based on a preliminary review of written comments submitted to the docket for the 2013 proposed rule, information available at that time, and our subsequent analysis of the proposed provisions in light of such information, FDA issued a supplemental notice of proposed rulemaking and reopened the comment period to seek public comment on specific issues and amended and new proposed provisions (79 FR 58434; September 29, 2014). The comment period for the supplemental notice of proposed rulemaking closed on December 15, 2014. We are now finalizing this rule entitled, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”

The final rule focuses on biological hazards related to produce growing, harvesting, packing, and holding. We conducted a “Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce” and considered the findings of this assessment in finalizing this rule. While we acknowledge the potential for non-biological (physical or chemical (including radiological)) hazards in produce, we are not addressing such hazards in this rule.

Scope of Coverage of the Rule

The final rule applies to both domestic and imported produce. However, as explained in the remainder of this document, the rule contains several exemptions and limitations:

The rule does not apply to certain specified produce commodities that are rarely consumed raw.

The rule also does not apply to produce that is used for personal or on-farm consumption, or that is not a RAC.

The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (

e.g. via

a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.

The rule does not cover farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less.

The rule provides a qualified exemption and modified requirements for farms that meet two requirements: (1) The farm must have food sales averaging less than $500,000 per year during the previous 3 years; and (2) the farm's sales to qualified end-users must exceed sales to others. A qualified end-user is either: (1) The consumer of the food or (2) a restaurant or retail food establishment that is located in the same State or the same Indian reservation as the farm or not more than 275 miles away. Instead, these farms are required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or to display the same information at the point-of-purchase. These farms are also required to establish and keep certain documentation. This exemption may be withdrawn in the event of an active investigation of an outbreak that is directly linked to the farm, or if it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce.

The rule also permits States, tribes, or foreign countries to submit a petition, along with supporting information, to FDA requesting a variance(s) from the requirements of this rule.

Summary of the Major Provisions of the Rule

The final rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. Based on the findings of the Qualitative Assessment of Risk, we are focusing the provisions of this rule on five major routes of contamination. We are finalizing requirements in the following major areas:

Worker Training and Health and Hygiene

○ Establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors (§§ 112.21, 112.22, and 112.23);

○ Require documentation of required training and corrective actions (§ 112.30); and

○ Establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance (§§ 112.31, 112.32, and 112.33).

Agricultural Water

○ Require that all agricultural water must be safe and of adequate sanitary quality for its intended use (§ 112.41). Agricultural water is defined in part as water that is intended to, or is likely to, contact the harvestable portion of covered produce or food-contact surfaces (§ 112.3(c));

○ Establish requirements for inspection, maintenance, and certain other actions related to the use of agricultural water, water sources, and water distribution systems associated with growing, harvesting, packing, and holding of covered produce (§§ 112.42 and 112.48);

○ If a farm chooses to treat agricultural water to meet relevant requirements for its intended use, establish requirements related to methods of treatment and monitoring such treatment (§ 112.43);

○ Establish specific requirements for the microbial quality of agricultural water that is used for certain specified purposes, including provisions requiring periodic analytical testing of such water (with exemptions provided for use of public water supplies, under certain specified conditions, and treated water), and requiring certain actions to be taken when such water is not safe or of adequate sanitary quality for its intended use and/or does not meet the microbial quality requirements (§§ 112.44, 112.45, 112.46, and 112.47); and provide for the use of alternative requirements for certain provisions under certain conditions (§§ 112.12 and 112.49); and

○ Require certain records, including documentation of inspection findings, water testing results, scientific data or information relied on to support the adequacy of water treatment methods, treatment monitoring results, scientific data or information relied on to support microbial die-off or removal rates or any permitted alternatives to requirements, time intervals or log reductions applied, and corrective actions (§ 112.50).

Biological Soil Amendments

○ Establish requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying, and storing (§§ 112.51 and 112.52);

○ Prohibit the use of human waste for growing covered produce except in compliance with U.S. Environmental Protection Agency (EPA) regulations for such uses or equivalent regulatory requirements (§ 112.53);

○ Establish requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, biological, physical and/or chemical processes that satisfy certain specific microbial standards (§§ 112.54 and 112.55), including examples of such processes;

○ Establish application requirements and minimum application intervals for untreated and treated biological soil amendments of animal origin (§ 112.56); and

○ Require certain records, including documentation from suppliers of treated biological soil amendments of animal origin, documentation that process controls were achieved, and corrective actions (§ 112.60).

Domesticated and Wild Animals

○ If there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce, require measures to assess as needed relevant areas during growing and, if significant evidence of potential contamination is found, take measures reasonably necessary to assist later during harvest when the farm must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard (§§ 112.83 and 112.112).

Equipment, Tools, and Buildings

○ Establish requirements related to equipment and tools that contact covered produce and instruments and controls (including equipment used in transport), buildings, domesticated animals in and around fully-enclosed buildings, pest control, hand-washing and toilet facilities, sewage, trash, plumbing, and animal excreta (§§ 112.121-134); and

○ Require certain records related to the date and method of cleaning or sanitizing equipment used in growing operations for sprouts, and in covered harvesting, packing, or holding activities, and corrective actions (§ 112.140).

Sprouts

○ Establish scope of applicability of sprout provisions (§ 112.141);

○ Establish measures that must be taken related to seeds or beans for sprouting (§ 112.142);

○ Establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts (§ 112.143);

○ Require testing the growing environment for

Listeria

species (

Listeria

spp.) or

Listeria monocytogenes

(

L. monocytogenes

) and testing each production batch of spent sprout irrigation water or sprouts for

Escherichia coli

(

E. coli

) O157:H7,

Salmonella

species (

Salmonella

spp.) and, under certain conditions, other pathogen(s), and taking appropriate follow-up actions (§§ 112.144-112.148); and

○ Require certain records, including documentation of treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, certain test methods used, and corrective actions (§ 112.150).

The effective date of this rule is 60 days after its publication in the

Federal Register

. As shown in the following table, we are establishing three sets of compliance dates, all of which vary based on size of the farm: (1) For covered activities involving sprouts subject to subpart M, which are also subject to all of part 112 as applicable; (2) for covered activities involving all other produce, which are subject to all of part 112 as applicable except subpart M; and (3) for farms eligible for a qualified exemption and related modified requirements. In the second set of compliance dates, we are also providing extended compliance dates for certain specified requirements related to agricultural water. In the compliance dates relating to the qualified exemption, the compliance date for the records that a farm is required by § 112.7(b) to maintain to support its eligibility for a qualified exemption is the effective date of this rule,

i.e.,

January 26, 2016. Farms need not comply with the requirement for a written record reflecting that the farm has performed an annual review and verification of continued eligibility for the qualified exemption until the farm's general compliance date, however. In addition, we are establishing January 1, 2020, as the compliance date for the modified requirement in § 112.6(b)(1).

Compliance Dates

Size of covered farm

Covered activities involving sprouts covered under subpart M (i.e., subject to all

requirements of

part 112)

Covered activities involving all other covered produce (i.e., subject to part 112, except subpart M)

Compliance date for certain

specified

agricultural

water

requirements

Compliance date for all other

requirements

Farms eligible for a qualified exemption (if applicable)

Compliance date for retention of records supporting eligibility in § 112.7(b)

Compliance date for modified

requirement in § 112.6(b)(1)

Compliance date for all other

requirements in

§§ 112.6 and 112.7

Time periods starting from the effective date of this rule

Very small business

3 years

6 years

4 years

Effective date of rule

January 1, 2020

4 years.

Small business

2 years

5 years

3 years

3 years.

All other businesses

1 year

4 years

2 years

N/A.

Costs and Benefits

The primary benefits of the provisions in this final rule are an expected decrease in the incidence of illnesses related to microbial contamination of produce. Annualizing benefits over the first ten years after the effective date of the rule at seven percent, benefits are expected to derive from averting approximately 331,964 illnesses per year (362,059 at 3 percent), valued at $925 million annually ($976 million at 3 percent). Similarly, annualized costs, estimated at 7 percent, are expected to be approximately $366 million annually ($387 million at 3 percent). Additionally, annualized costs for foreign farms are estimated to be approximately $138 million annualized at 7 percent ($146 million at 3 percent).

I. Background

A. FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities. A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food. To that end, we proposed the seven foundational rules listed in Table 1 and requested comments on all aspects of these proposed rules.

Table 1—Published Foundational Rules for Implementation of FSMA

Title

Abbreviation

Publication

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

2013 proposed produce safety rule or simply “2013 proposed rule”

78 FR 3504, January 16, 2013.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

2013 proposed human preventive controls rule

78 FR 3646, January 16, 2013.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

2013 proposed animal preventive controls rule

78 FR 64736, October 29, 2013.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

2013 proposed FSVP rule

78 FR 45730, July 29, 2013.

Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications

2013 proposed third-party certification rule

78 FR 45782, July 29, 2013.

Focused Mitigation Strategies To Protect Food Against Intentional Adulteration

2013 proposed intentional adulteration rule

78 FR 78014, December 24, 2013.

Sanitary Transportation of Human and Animal Food

2014 proposed sanitary transportation rule

79 FR 7006, February 5, 2014.

We also issued supplemental notices of proposed rulemaking for the rules listed in table 2 and requested comments on specific issues identified in each supplemental notice of proposed rulemaking.

Table 2—Published Supplemental Notices of Proposed Rulemaking for the Foundational Rules for Implementation of FSMA

Title

Abbreviation

Publication

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

2014 supplemental produce safety notice or simply “supplemental notice”

79 FR 58434, September 29, 2014.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

2014 supplemental human preventive controls notice

79 FR 58524, September 29, 2014.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

2014 supplemental animal preventive controls notice

79 FR 58476, September 29, 2014.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

2014 supplemental FSVP notice

79 FR 58574, September 29, 2014.

As FDA finalizes these seven foundational rulemakings, we are putting in place a framework for food safety that is modern and brings to bear the most recent science on provisions to enhance food safety, that is risk-based and focuses effort where the hazards are reasonably likely to occur, and that is flexible and practical given our current knowledge of food safety practices. To achieve this, FDA has engaged in a great deal of outreach to the stakeholder community to find the right balance in these regulations of flexibility and accountability.

Since FSMA was enacted in 2011, we have been involved in approximately 600 engagements on FSMA and the proposed rules, including public meetings, webinars, listening sessions, farm tours, and extensive presentations and meetings with various stakeholder groups (Ref. 1). As a result of this stakeholder dialogue, FDA decided to issue the four supplemental notices of proposed rulemaking to share our current thinking on key issues and get additional stakeholder input on those issues. As we move forward into the next phase of FSMA implementation, we intend to continue this dialogue and collaboration with our stakeholders, through guidance, education, training, and assistance, to ensure that everyone understands and engages in their role in food safety. FDA believes these seven foundational final rules, when implemented, will fulfill the paradigm shift toward prevention that was envisioned in FSMA and be a major step forward for food safety that will protect consumers into the future.

B. 2013 Proposed Produce Safety Rule

Eating fruits and vegetables is an important part of a healthy diet. FDA is responsible for ensuring the safety of all domestic and imported fruits and vegetables. We place a high priority on identifying and implementing measures that can reduce the incidence of foodborne illness associated with produce and maintain a high level of consumer confidence in this important food category. Produce is vulnerable to contamination with microorganisms of public health significance (

e.g.,

bacteria and viruses that can cause disease), as well as physical and chemical (including radiological) contaminants. Contamination of produce can occur on-farm during growing (either in an open environment or in a fully- or partially-enclosed building), harvesting, packing, or holding; or elsewhere along the farm-to-table continuum.

Section 105 of FSMA adds section 419 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350h) requiring FDA to adopt a final regulation to provide for minimum science-based standards for fruits and vegetables that are RACs based on known safety risks, and directing FDA to set forth in the final regulation those procedures, processes, and practices that we determine to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act. On January 16, 2013, FDA issued the produce safety proposed rule to propose such standards, as well as certain exemptions from the standards, consistent with section 419 of the FD&C Act (78 FR 3504; hereafter referred to as “the 2013 proposed produce safety rule” or simply “the 2013 proposed rule”). Specifically, we proposed, among other provisions, to:

Establish, in 21 Code of Federal Regulations (CFR) proposed part 112, science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms, focusing on the areas of worker training and health and hygiene; agricultural water; biological soil amendments; domesticated and wild animals;

equipment, tools, and buildings; and sprouts;

Focus the rule on microbiological hazards related to produce growing, harvesting, packing, and holding;

Apply proposed part 112 to both domestic and imported produce, with several exemptions, including that the rule would not apply to certain specified produce commodities that are rarely consumed raw; produce that is used for personal or on-farm consumption; or produce that is not a RAC;

Provide an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms (

e.g.,

“kill step”) as long as certain documentation is kept;

Not cover farms that have an average annual value of food sold during the previous 3-year period of $25,000 or less;

Provide a qualified exemption and modified requirements for farms that meet certain requirements, as well as establish circumstances and procedures under which this exemption may be withdrawn; and

Require compliance within time periods ranging from 2 to 4 years based on the size of farm, with an additional 2 years to comply with some of the proposed water provisions.

We extended the comment period for the 2013 proposed produce safety rule in response to requests that we do so (78 FR 11611, February 19, 2013; and 78 FR 24692, April 26, 2013). We later extended the comment period to allow interested persons an opportunity to consider the interrelationships between the 2013 proposed produce safety rule and the 2013 proposed FSVP and third-party certification rules (78 FR 48637, August 9, 2013). We also issued a notice correcting several typographical, stylistic, and reference numbering errors (78 FR 17155, March 20, 2013). At the time of that correction notice, we also made publicly available, in its entirety, the proposed produce safety rule with all errors corrected. The comment period for the 2013 proposed rule closed on November 22, 2013.

C. Draft Qualitative Assessment of Risk

We conducted a “Draft Qualitative Assessment of Risk to Public health from On-Farm Contamination of Produce” (hereafter referred to as “the draft QAR”) to evaluate hazards related to produce production and harvesting. We published the findings of our assessment, and asked for public comment on our assessment and findings (78 FR 3504, January 16, 2013). The tentative conclusions of this assessment informed our proposed science-based minimum standards for the safe production and harvesting of produce commodities.

D. Produce Safety Supplemental Notice

Taking into account information we heard at public meetings, and based on a preliminary review of written comments submitted to the docket, then-currently available information, and our subsequent analysis of the proposed provisions in light of this information, on September 29, 2014, we proposed certain new provisions and certain amendments to our provisions proposed in the 2013 proposed rule (79 FR 58434; hereafter referred to as “the 2014 supplemental produce safety notice” or simply “the supplemental notice”). Specifically, we proposed among other provisions:

Amendment to not cover farms that have an average annual value of produce sold during the previous three year period of $25,000 or less;

Amendment to the definition of “farm” such that establishments that pack or hold produce that is grown or harvested on another farm would be subject to the produce safety standards of proposed part 112 regardless of whether or not that farm is under the same ownership;

Amendments to update the microbial quality standard for water that is used during growing of produce (other than sprouts) using a direct application method; and to incorporate additional flexibility and provide means to achieve this standard,

i.e.,

by applying a time interval between last irrigation and harvest and/or between harvest and end of storage to account for post-application microbial die-off or removal;

Amendment to provide tiered-approaches for specific testing frequency requirements to test untreated surface water as well as untreated ground water, which would enable testing at a reduced frequency;

Amendment to remove the 9-month minimum application interval for use of raw manure and other untreated biological soil amendments of animal origin, and defer FDA's decision on an appropriate time interval until FDA takes certain specified actions;

New provision to explicitly state that part 112 would not authorize or require covered farms to take actions that would constitute the “taking” of threatened or endangered species in violation of the Endangered Species Act (ESA), or require covered farms to take measures to exclude animals from outdoor growing areas, or destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages; and

New provisions to establish that, before FDA issues an order to withdraw a qualified exemption, FDA may consider one or more other actions to protect the public health and prevent or mitigate a foodborne illness outbreak; and to list the circumstances under which FDA would reinstate a farm's qualified exemption that is withdrawn.

In the 2014 supplemental produce safety notice, we reopened the comment period only with respect to the specific issues covered in the supplemental notice. In addition, we emphasized that the new and amended proposed provisions we included in the regulatory text were based on a preliminary review of the comments. We also noted the 2013 proposed produce safety rule and the new and amended proposed provisions published in the 2014 supplemental produce safety notice, taken together, constitute the entirety of the proposed rule on “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The comment period for the supplemental notice closed on December 15, 2014.

In this document, we use the broad term “proposed produce safety rule” to refer to the complete proposed regulatory text, including both the proposed provisions we published in the 2013 proposed produce safety rule and the new and amended proposed provisions we published in the 2014 supplemental produce safety notice.

E. List of Federal Register Publications Regarding the Proposed Produce Safety Rule

Table 3 lists

Federal Register

publications regarding the proposed produce safety rule. This list does not include the

Federal Register

publications regarding the Environmental Impact Statement (EIS) related to this rule; the EIS and related publications are addressed in section XXVII of this document.

Table 3—List of Federal Register Publications Regarding the Proposed Produce Safety Rule

Description

Publication

2013 proposed produce safety rule, requesting comments by May 16, 2013

78 FR 3504, January 16, 2013.

Notice of public meeting (held in Washington D.C. on February 28, 2013) on the 2013 proposed preventive controls rule and the 2013 proposed produce safety rule

78 FR 6762, January 31, 2013.

Notice of public meetings (held in Chicago, IL on March 11, 2013 and in Portland, OR on March 27, 2013) on the 2013 proposed preventive controls rule and the 2013 proposed produce safety rule

78 FR 10107, February 13, 2013.

Notice extending comment period, until May 16, 2013, for the information collection provisions of the 2013 proposed produce safety rule

78 FR 11611, February 19, 2013.

Notice of correction for the 2013 proposed produce safety rule

78 FR 17155, March 20, 2013.

Notice extending the comment period, until September 16, 2013, for the 2013 proposed produce safety rule and its information collection provisions

78 FR 24692, April 26, 2013.

Notice extending the comment period, until November 15, 2013, for the 2013 proposed produce safety rule and its information collection provisions

78 FR 48637, August 9, 2013.

Notice extending the comment period, until November 22, 2013, for the 2013 proposed produce safety rule and its information collection provisions

78 FR 69605, November 20, 2013.

Produce safety supplemental notice, requesting comments by December 15, 2014

79 FR 58434, September 29, 2014.

Notice of public meeting (held in College Park, MD on November 13, 2014) on the human preventive controls supplemental notice, produce safety supplemental notice, animal preventive controls supplemental notice, and FSVP supplemental notice

79 FR 63346, October 23, 2014.

F. Public Comments

Since issuing the 2013 proposed rule, we conducted numerous outreach activities. For example, we held four public meetings to solicit oral stakeholder and public comments on the 2013 proposed rule and the supplemental notice, inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and respond to questions about the 2013 proposed rule and the supplemental notice (see Table 3) (Ref. 2) (Ref. 3) (Ref. 4) (Ref. 5) (Ref. 6) (Ref. 7). We also traveled across the country and around the world to discuss the 2013 proposed rule, as well as the other foundational FSMA proposed rules listed in section I.A of this document, with persons who would be affected by them (Ref. 8) (Ref. 9) (Ref. 10) .

We received a total of about 36,000 submissions (representing approximately 15,000 unique comments) on the proposed produce safety rule by the close of the comment period, each containing one or more comments. We received submissions from diverse members of the public, including produce farms; facilities co-located on a farm; cooperatives; coalitions; trade organizations; consulting firms; law firms; academia; public health organizations; public advocacy groups; consumers; consumer groups; Congress; federal, State, local, and tribal government agencies; and other organizations. Some submissions included signatures and statements from multiple individuals. Comments addressed virtually every provision of the proposed produce safety rule, including our requests for comment on various topics.

In sections III through XXIV of this document, we describe these comments, respond to them, and explain any changes we made to the proposed produce safety rule. We discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. Our responses to the comments include our reasons for determining whether to modify any of the proposed requirements. The remainder of this document establishes a final rule (“the final rule,” this final rule,” “the rule,” or “this rule”) based on the proposed produce safety rule.

Some comments address issues that are outside of the scope of this rule. We do not discuss such comments in this document. We also received comments that solely address topics, such as preventive controls applicable to food for humans or animals, traceability, foreign supplier verification programs, and third-party accreditation or certification, which are outside of the scope of this final produce safety rule, and will be appropriately addressed in other relevant FSMA rulemaking documents.

II. Legal Authority

The 2013 proposed rule contained an explanation of its legal basis under authorities in FSMA, the FD&C Act, and the Public Health Service Act (PHS Act). After considering comments received in response to the 2013 proposed rule and supplemental notice, FDA made changes in the final rule. The legal authorities relied on for the final rule are the same as in the 2013 proposed rule unless otherwise described in the paragraphs that follow.

A. Relevant Statutory Authorities Other Than Section 419 of the FD&C Act and Section 105 of FSMA

The final rule requires that, to rely on the exemption in § 112.2(b) for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health concern, a covered farm must disclose in documents accompanying the produce that the food is “not processed to adequately reduce the presence of microorganisms of public health significance” (§ 112.2(b)(2)). This requirement is authorized by sections 419 and 701(a) of the FD&C Act (21 U.S.C. 371(a)).

Section 112.2(b) exempts from most requirements in the rule produce that is low risk because it receives commercial processing that will adequately reduce the biological hazards that are the focus of this rule. It is important to ensure that such produce does indeed receive such commercial processing because such processing is the reason the produce is considered sufficiently low risk to be exempt from the other requirements in this rule. A food may pass through multiple entities in the distribution chain before the control is applied. Further, it may not be apparent from visual examination of the food whether a control has been applied. Consequently, without labeling, an entity in the distribution chain might not know whether a control has been applied. Therefore, FDA concludes that information that food has not been processed to adequately reduce the presence of microorganisms of public health significance must be provided in accompanying documentation when a farm is relying on this exemption from the rule. FDA also concludes that such labeling is necessary for the efficient

enforcement of the FD&C Act to help ensure that food receives the required processing. Further, because the relevant hazards can cause communicable disease, FDA concludes that the requirement is necessary to prevent the spread of communicable disease from one State into another State and relies on sections 311, 361, and 368 of the PHS Act (42 U.S.C. 243, 264, and 271).

B. Legal Authority for Records Requirements

We are using our authority under the FD&C Act and the PHS Act to institute certain records requirements. In addition to those requirements we proposed in the 2013 proposed rule and the supplemental notice, we are adding the following new record requirement: For farms eligible for a qualified exemption and modified requirements, adequate records necessary to demonstrate that you satisfy the criteria for a qualified exemption, including a written record reflecting that you performed an annual review and verification of your farm's continued eligibility for the qualified exemption (§ 112.7).

We have also revised some of the records requirements in our 2013 proposed rule and the supplemental notice. We note in particular that the record requirement proposed as § 112.161(b) relating to documentation of corrective actions taken under subparts C, E, F, L, and M is now eliminated and, instead, we added specific provisions in two relevant subparts (E and M), at §§ 112.50(b)(6) and 112.150(b)(6). Moreover, in § 112.50(b)(6), we are also establishing specific requirements for documentation of any time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) and/or (b)(1)(ii), including the specific time interval or log reduction applied, how the time interval or log reduction was determined, and the dates of corresponding activities such as the dates of last irrigation and harvest, the dates of harvest and end of storage, and/or the dates of activities such as commercial washing.

In addition, we note that the revised records requirements in § 112.2(b) include: (1) For farms relying on the exemption in § 112.2(b), documentation of disclosures required under § 112.2(b)(2) and annual written assurances obtained from customers under § 112.2(b)(3) (§ 112.2(b)(4)); and (2) For entities that provide a written assurance under § 112.2(b)(3), documenting actions taken to satisfy the written assurance (§ 112.2(b)(6)).

As discussed further in the 2013 proposed rule and in sections XI, XIII, XIV, XVII, and XVIII of this document, these records requirements are necessary for regulated industry to ensure their own compliance with these aspects of the rule and for FDA to ensure that industry is complying with the same aspects of the rule. Therefore, these requirements are necessary for the efficient enforcement of the FD&C Act because they will aid both regulated industry and FDA in ensuring that food is not adulterated, and are necessary to prevent the spread of communicable disease because they will aid both regulated industry and FDA in ensuring that food does not become contaminated with human pathogens. In addition to having the authority under the FD&C Act and the PHS Act to require this recordkeeping, we also have the authority to require access to the records. Because the underlying requirements are necessary to minimize the likelihood of adulteration and the spread of communicable disease, access to records that demonstrate that regulated industry has followed those requirements is essential to confirm compliance and achieve the full benefits of the rule. We also have the authority to copy the records when necessary. We may consider it necessary to copy records when, for example, our investigator may need assistance in reviewing a certain record from relevant experts in headquarters. If we are unable to copy the records, we would have to rely solely on our investigators' notes and reports when drawing conclusions. In addition, copying records will facilitate follow up regulatory actions. Therefore, we conclude that the ability to access and copy records is necessary to enforce the rule and prevent adulteration and the spread of communicable disease. In other sections of this document, we explain in more detail the recordkeeping provisions that we believe are necessary, and because they are limited to what is necessary, that we believe do not create an unreasonable recordkeeping burden.

C. Intrastate Activities

(Comment 1) One comment argues that FDA should not apply this rule to activities that are intrastate in character, citing the lack of an explicit reference to intrastate activities in relevant sections of the FD&C Act, and asserting that the greatest risk of foodborne illness comes from food in interstate distribution networks. This comment argues that the rule as applied to intrastate commerce is beyond the federal government's power under the commerce clause of the Constitution.

(Response) FDA disagrees. We conclude that the rule should be applicable to activities that are intrastate in character. The plain language of section 419 of the FD&C Act directs FDA to establish science-based minimum standards for the safe production and harvesting of fruit and vegetable RACs to minimize the risk of serious adverse health consequences or death. Section 419 does not include a limitation to interstate commerce. In addition, the exemption provided in section 419(f) of the FD&C Act, based in part on the proportion of a farm's sales made to restaurants or retail food establishments intrastate or within 275 miles, suggests that Congress intended the rule issued under section 419 to apply to intrastate commerce because otherwise there would be no need to provide an exemption for farms whose sales are intrastate in character. In addition, section 301(vv) of the FD&C Act provides that “[t]he failure to comply with the requirements under section 419”, or the causing thereof, is a prohibited act. Section 301(vv) does not require an interstate commerce nexus. Notably, other subsections in section 301 of the FD&C Act, and section 304 of the FD&C Act (21 U.S.C. 334) demonstrate that Congress has included a specific interstate commerce nexus in the provisions of the FD&C Act when that is its intent. Accordingly, it is reasonable to interpret sections 419 and 301(vv) of the FD&C Act as not limiting the application of the rule only to those farms with a direct connection to interstate commerce.

FDA is mindful that its interpretation of FSMA and the FD&C Act should not cast doubt on their constitutionality. (See

Solid Waste Agency of Northern Cook County

v.

U.S.,

531 U.S. 159 (2001)). FDA has considered the relevant provisions of FSMA and the FD&C Act, FDA's responsibilities in implementing those laws, and the law interpreting the commerce clause of the Constitution (Article I, section 8). Congress's power to legislate under the commerce clause is very broad. However, such power is not without limits, see

United States

v.

Lopez,

514 U.S. 549, 567 (1995);

U.S.

v.

Morrison,

529 U.S. 598, 618 (2000), and these limits have been construed in light of relevant and enduring precedents. In particular, in

Lopez,

supra, the Supreme Court acknowledged the continuing vitality of

Wickard

v.

Filburn,

317 U.S. 111 (1942), noting that “although Filburn's own contribution to the demand for wheat may have been trivial by itself, that was not `enough to remove him from the scope of federal regulation

where, as here, his contribution, taken together with that of many others similarly situated, is far from trivial.' ” (514 U.S. at 556.) See also

Gonzales

v.

Raich,

545 U.S. 1, 17-25 (2005). This principle applies to the application of sections 419 and 301(vv) of the FD&C Act, as added by section 105 of FSMA. Accordingly, given the collective impact on commerce of farms that grow, harvest, pack, or hold food that is sold in “intrastate” commerce, FDA concludes that such farms should be subject to the rule unless an exemption from the rule applies (for example, if the farm is eligible for the qualified exemption in § 112.5, or if the farm only grows produce exempt from the regulation under one of the exemptions in § 112.2). This outcome regarding intrastate commerce is consistent with section 709 of the FD&C Act (21 U.S.C. 379a), which states that in any action to enforce the FD&C Act's requirements respecting foods, drugs, devices, and cosmetics, any necessary connection with interstate commerce is presumed. Likewise, this outcome is consistent with FSMA's risk-based, preventive approach to food safety because the risk presented by unsafe food can be significant, whether or not the food moves from one state to another.

D. Application of Section 112.2(b)(6) to Entities Other Than Covered Farms

As discussed in IX.A.4 of this document, we are specifying in § 112.2(b)(6) that the entities that provide written assurances described in § 112.2(b)(3) must act consistently with the assurances and document the actions taken to satisfy the assurance. Section 112.2(b)(6) applies not just to covered farms, but to other entities that voluntarily agree to provide the written assurances described in § 112.2(b)(3). The application of this requirement to facilities subject to section 418 of the FD&C Act is consistent with section 419(h) of the FD&C Act. Providing, complying with, and documenting compliance with the written assurances described in § 112.2(b)(3) are not activities that are subject to section 418 of the FD&C Act. As discussed in section II.A of this document, in addition to sections 419 and 701(a) of the FD&C Act, this requirement is supported by sections 311, 361, and 368 of the PHS Act.

III. General Comments on the 2013 Proposed Rule

A. General Comments

(Comment 2) Some comments ask us to make the various rules we are establishing to implement FSMA consistent with each other.

(Response) We have aligned the provisions of the various rules to the extent practicable. For example, we use the same definitions of “farm” and the terms used in the definition of “farm” (

i.e.,

harvesting, packing, holding, and manufacturing/processing) in this rule, the final human preventive controls rule (80 FR 55908; Ref. 11) that established part 117 (the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation; hereafter referred to as “the PCHF regulation”), and the final animal preventive controls rule (80 FR 56170) that established part 507 (the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulation; hereafter referred to as “the PCAF regulation”). However, the statutory requirements are not the same for all the rules, and the purposes and contents of the rules differ from each other. For example, section 419(f) of the FD&C Act (which relates to this rule) and section 418(l) of the FD&C Act (which relates to the final human preventive controls rule) both create qualified exemptions with modified requirements for certain entities based in part on business size and/or certain specific sales criteria. However, these two sections provide different criteria for eligibility for exemption from the two rules, and different modified requirements for farms and facilities eligible for the relevant exemptions.

(Comment 3) Several comments ask us to develop guidance to accompany this rule to help covered farms to understand and implement this rule, particularly in the areas of agricultural water, personnel training, domesticated and wild animals, sprout production, and biological soil amendments of animal origin. Some of these comments also ask that drafts of such guidance first be made available for public comment. Comments ask us to take into consideration existing public and private food safety programs as we develop our guidance. Comments also recommend that guidance documents should be easily understood, available in multiple formats (including simple checklists), and issued in a timely manner.

Other comments emphasize the importance of education and outreach and ask us to provide support for ongoing education and outreach, including taking an active role in providing needed instructional examples and lessons learned from current investigations and foodborne outbreaks.

(Response) We are developing guidance documents, including general guidance on the implementation of this rule, as well as a Small Entity Compliance Guide (SECG) in accordance with section 105(b) of FSMA (21 U.S.C. 350h note) and section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). A SECG is a guidance that explains the actions a small entity must take to comply with a rule. We also intend to develop guidance specific to commodities, as needed. We agree that we should take into consideration existing public and private food safety programs as we develop our recommendations. We will develop and issue our guidances in accordance with our good guidance practices regulation, 21 CFR 10.115, which establishes criteria for when we issue a guidance document as an initial draft, invite public comment, and prepare a final version of the guidance document that incorporates suggested changes, when appropriate. The public may submit comments on any guidance document at any time (§ 10.115(g)(5)).

We agree with comments that stress the importance of education and outreach. Supporting efforts to help covered farms get the education and technical assistance they need to understand and implement the requirements is a central element of FDA's strategy to gain compliance with this rule (Ref. 12) (Ref. 13). Within FDA, we are establishing a Food Safety Technical Assistance Network and seeking funding to increase FDA staffing to provide a central source of information to support industry understanding and implementation of FSMA standards (Ref. 12). This will allow us to respond in a timely and consistent way to questions from covered farms related to this rule.

We continue to work with other government agencies, academia, and industry groups, as appropriate, to facilitate the successful implementation of this rule. For example, FDA, in collaboration with the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) and others, has established the Produce Safety Alliance (PSA). FDA and others also established the Sprouts Safety Alliance (SSA). Both PSA and SSA will develop and disseminate science- and risk-based training and education programs to provide produce farms with fundamental, on-farm food safety knowledge and equip them to comply with the produce safety regulation. FDA is working to ensure

that the PSA and SSA training materials (which we refer to collectively as “the Alliance courses”) are consistent with the requirements of this rule.

We are also partnering with USDA's National Institute of Food and Agriculture (NIFA). FDA and NIFA are funding a grant program that will provide funding for food safety training, education and technical assistance to small farm owners and food processors to help them comply with food safety standards to be established under FSMA. The purpose of the grant program is to train owners and operators of small businesses, including small- and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers, and farms that lack access to food safety training and other educational opportunities.

We also plan to work with cooperative extension units, land grant universities, trade associations, foreign partners, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), and other stakeholders to develop a network of institutions that can provide technical assistance to the farming community, especially small and very small farms, as they endeavor to comply with the provisions of the final rule. FDA has entered into a cooperative agreement with National Association of State Departments of Agriculture (NASDA) to help with the implementation of the produce safety regulation. Such efforts will help ensure widespread compliance.

(Comment 4) Some comments ask us to establish and annually convene a scientific workgroup that includes experts in produce production, public health, and testing and laboratory science to advise us on pathogens that should be addressed in produce safety standards. Some other comments recommend that FDA establish a national advisory committee or a stakeholder advisory committee to provide ongoing input to FDA as FSMA implementation begins, and suggests that such committee include members from States, industry, and other stakeholders, as well as NASDA. These comments recommend that such advisory body should assist FDA in updating regulations or guidance as science evolves and new information becomes available. One commenter also believes such an established advisory body could function in a manner similar to the National Conference on Interstate Milk Shipments or the Interstate Shellfish Sanitation Conference and provide a formal and effective mechanism for dialogue between FDA, States, NASDA, and the regulated community.

(Response) We disagree with the suggestion to establish an advisory group for the purpose of assisting FDA in updating regulations or guidance as science evolves and new information becomes available. FDA's rulemaking and guidance development processes allow for future amendments, and also provide ample opportunity for public input when warranted. We will consider the need for such amendments in light of evolving scientific information and, as warranted, take appropriate actions.

(Comment 5) Some comments express the need for FDA to review and update the provisions in the produce safety regulation as new scientific information becomes available. One commenter requests that FDA establish a process for such review and update.

(Response) FDA may, on its own initiative or in response to a petition from an interested person, initiate administrative proceedings to amend existing regulations, including the produce safety regulation. See 21 CFR part 10 for our administrative practices and procedures.

(Comment 6) Some comments assert that the rule should be more concise, and that the average person without a team of experts should be able to understand the rule and manage the application of the rule.

(Response) We agree the rule needs to be understandable. We have incorporated plain language techniques—

e.g.,

by framing the regulation in the form of questions and answers, and using active voice in the requirements. We also have established definitions that enable us to improve readability (

e.g.,

“monitor,” “raw agricultural commodity,” and “you”). We have used examples in the codified, where appropriate, and provided examples throughout the preamble to assist with understanding the requirements. We will be issuing guidance documents that will be helpful in understanding the rule (See Comment 3). We anticipate that these various educational and outreach efforts will involve development of checklists, templates, protocols, and other tools that will facilitate compliance with the produce safety regulation.

(Comment 7) Some comments assert that the rule incorrectly assumes that all bacteria are harmful.

(Response) We have long recognized that some bacteria have a role in food production, such as the lactic-acid producing bacteria that our regulations explicitly acknowledge as being added to yogurt (see

e.g.,

the standards of identity for yogurt, low fat yogurt, and nonfat yogurt, in 21 CFR 131.200, 131.203, and 131.206, respectively). This rule defines the term “microorganism,” which explains that the term “undesirable microorganism” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. The produce safety standards established in this rule focus on minimizing the risk of contamination of produce with microorganisms that can cause serious adverse health consequences or death, and are consistent with our “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (the GAPs Guide) (Ref. 14).

(Comment 8) One comment suggests covering school-garden programs under the produce safety regulation. According to this comment, the current requirements for food safety assurance at these farms are variable, and practices such as improper manure or compost use could present a significant risk to high-risk consumers served by such farms.

(Response) We expect most school-garden programs would likely fall below the monetary threshold for coverage in § 112.4 and, therefore, would not be subject to this rule. We have determined the scope and coverage of this rule to establish only those requirements that are reasonably necessary to meet the public health objectives of the regulation. Note, however, that farms that are not subject to this rule are and will continue to be covered under the adulteration and other applicable provisions of the FD&C Act and applicable implementing regulations, irrespective of whether they are included within the scope of this rule. We recommend that farms that are not covered under part 112 follow good agricultural practices to ensure that the produce they grow, harvest, pack or hold does not serve as a vehicle for foodborne illness.

(Comment 9) Some comments express concern that current tests for pathogens such as

E. coli

and

Salmonella

are expensive and time-consuming, and could lead to holding up perishable produce in the food chain. Comments also highlight the need for affordable, on-site, and fast test methods, particularly for testing agricultural water.

(Response) We are not requiring final product testing of produce, except as in subpart M under certain circumstances for sprouts, for reasons explained in section III.F of this document. In prescribing certain analytical methods

for testing the quality of agricultural water, for testing the growing environment of sprouts for

Listeria

spp. or

L. monocytogenes,

and for testing spent sprout irrigation water (or sprouts) for certain pathogens (in subpart N of part 112), we also provided flexibility for covered farms to use any other method that is at least equivalent to the prescribed analytical methods in accuracy, precision, and sensitivity in detecting the relevant organism. We are aware that there are numerous scientific testing and diagnostic development companies that have invented rapid tests and systems, and that many of these products undergo internal quality control and performance testing, as well as receive additional third-party approvals. In addition, we are aware of programs such as the AOAC International Research Institute's Performance Tested Methods Program that provides an independent third-party review of proprietary test method performance, and that test methods demonstrated to meet acceptable performance criteria are granted Performance Tested Methods (PTM) status. Such methods, including test kit methods, may be acceptable for testing for generic

E. coli

in agricultural water to satisfy the requirements of § 112.46, for testing for

Listeria

spp. or

L. monocytogenes

to satisfy the requirements of § 112.144(a), and for testing for certain pathogens to satisfy the requirements of § 112.144(b) and (c), provided they meet certain conditions in accordance with §§ 112.151(b), 112.152(b), and 112.153(a)(2) and (b), respectively. FDA will consider providing guidance on testing methods, specifically on rapid and low-cost test kits that might be useful for farms.

(Comment 10) Some comments ask us to address model laboratory standards and accreditation to ensure that laboratories are using sound and reliable test methods and practices for detecting and identifying microorganisms of public health significance. These comments argue that if there are no criteria for training and appropriate use of testing devices or interpretation, test results may not be reliable. These comments also suggest posting a list of accredited laboratories on FDA's Web site for use by farms.

(Response) We are currently working on a proposed rule to implement section 202 of FSMA (section 422 of the FD&C Act), which addresses “Laboratory Accreditation for Analyses of Foods.” Neither model laboratory standards nor laboratory accreditation are within the scope of the produce safety regulation in part 112.

(Comment 11) In the 2013 proposed rule, we requested comment on whether we should require, in a final rule, any or all covered farms that wash and pack produce, or that only pack produce, to perform environmental testing for

L. monocytogenes

or

Listeria

spp., and any criteria that should be employed to determine which farms should be subjected to such a requirement (78 FR 3504 at 3619). Some comments respond by noting that not all produce operations will be vulnerable to harborage and contamination by pathogens such as

L. monocytogenes.

These comments argue that mandatory environmental monitoring for such operations would not yield a food safety benefit and, instead, would impose a wasteful economic burden. These comments recommend that environmental monitoring or assessment for produce (other than sprouts) should be addressed in guidance and can be a part of food safety plans for operations vulnerable to relevant routes of contamination. On the other hand, some comments, suggest the environmental monitoring requirements we proposed for sprouts should be expanded to other high-risk produce.

(Response) We are not requiring environmental testing for

L. monocytogenes

or

Listeria

spp. for covered produce other than sprouts. See discussion in the 2013 proposed rule (78 FR 3504 at 3619). Farms may consider voluntarily performing environmental testing for

L. monocytogenes

or

Listeria

spp. as appropriate for their operations. See also section VII of this document where we discuss farm-specific food safety plans.

B. Intentional Adulteration

(Comment 12) Several comments address intentional adulteration of produce. One comment contends that small farms are inherently more resilient to terrorism or other forms of intentionally introduced hazards than large farms due to their diversity, independence, and geographic decentralization. According to the comment, if the proposed produce safety rule negatively affects the viability of diverse small farms, in favor of large, centralized farms, then the net result may be an increase in the American food system's vulnerability to terrorism. With regards to economically motivated intentional adulteration, one comment states that this type of adulteration is difficult to prevent and should not be addressed in this rule.

(Response) FDA is implementing the intentional adulteration provisions in sections 418, 419, and 420 of the FD&C Act in a separate rulemaking. As such, neither intentional adulteration nor economically motivated adulteration in the context of fruits and vegetables that are RACs, during activities that occur on produce farms, are within the scope of the produce safety regulation in part 112. On December 24, 2013, FDA published a proposed rule to implement the intentional adulteration provisions for facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (per section 418 of the FD&C Act); for fruits and vegetables that are RACs (per section 419 of the FD&C Act); and for high risk foods, exempting farms except for farms that produce milk (per section 420 of the FD&C Act) (78 FR 78014).

C. Registration

In the 2013 proposed produce safety rule, we requested comment on whether we should require that covered farms, as described in proposed § 112.4(a), register with FDA. We acknowledged that we are not aware of a nationwide database of farms, nor an accumulation of statewide databases, that would enable us to identify the names and locations of all entities subject to the produce safety regulation, which, in turn, would enable us to better provide outreach and technical assistance to covered entities and to allocate our inspection resources. We also requested information about the existence of databases that could help us identify covered farms in the absence of a registration system, and the appropriate data elements that should be collected in a registration system, should we decide to set up such a system.

(Comment 13) Several comments support requiring registration of covered farms with FDA, and state that registration would be most helpful during response activities associated with illness outbreaks and recalls. These comments contend that any registration requirement should be kept simple, occur once annually, and apply to every farm no matter their size, sales volume, or method of trade. According to these comments, registration would provide FDA with key information to monitor each crop industry by knowing the size and scope of the regulated community, with a secondary advantage for that crop's association/board to be able to conduct industry outreach and education to assist with compliance with the final rule. Conversely, several other comments oppose a requirement for farms to register with FDA, stating that such a requirement would be unreasonable and inconsistent with FSMA. These comments argue that

FSMA does not authorize FDA to require farms to register with FDA, and that FDA fails to establish how requiring farms to register would contribute to improved food safety outcomes in produce production. Other comments suggest that FDA has many State and federal partners to assist in reaching out to the produce production community, and that there are existing industry resources, which include lists of producers. Some comments state that local and State agencies or extension agencies, not FDA, should maintain a database of farms. Still other comments argue that registration would be economically burdensome for farmers.

(Response) At this time, we are not establishing a requirement for farms to register with FDA. However, we believe that an inventory of farms would enable us to better provide outreach and technical assistance to covered farms and to allocate our inspection resources, so we intend to pursue other avenues for identifying farms. Historically, when we have needed a list of farms, such as for field assignments involving inspections, or for conducting education and outreach activities, FDA has worked with our district offices, State and local departments of health and agriculture, and local university extension services to identify farm operations. Doing this on an as needed, case-by-case basis can be resource intensive and may, or may not, result in a list of operations sufficient for our needs. FDA has entered into a cooperative agreement with NASDA to help with the implementation of the produce safety regulation, and will explore whether and how an inventory of farms located in the United States may be developed and may enhance these efforts.

D. Consistency With USDA's National Organic Program (NOP)

(Comment 14) Several comments state that the regulation may be interpreted to conflict with the requirements of the NOP. In this context, some comments specifically cited NOP's regulations in 7 CFR 205.200, 205.205, and 205.2. Another comment expresses concern that the regulation would discourage farms from becoming organic certified.

(Response) We disagree that the final produce safety regulation (or specifically any provisions in subparts E, F, or I) conflicts with, or discourages farms from following NOP standards, including the provisions in NOP's regulations at 7 CFR 205.200, 205.205, and 205.2. The provisions in 7 CFR 205.200 require, in relevant part, that production practices implemented in accordance with the NOP must maintain or improve the natural resources of the operation, including soil and water quality. The provisions in 7 CFR 205.205 require an organic producer to implement a crop rotation including but not limited to sod, cover crops, green manure crops, and catch crops that provide the following functions that are applicable to the operation: (1) Maintain or improve soil organic matter content; (2) provide for pest management in annual and perennial crops; (3) manage deficient or excess plant nutrients; and (4) provide erosion control. The provisions in 7 CFR 205.2 provide definitions of various terms for purposes of the NOP, including “crop rotation,” “natural resources of the operation,” and “organic production.”

Part 112, including subparts E, F, and I, does not establish any specific requirements that conflict with, or discourage compliance with, these or other NOP requirements. As noted in the 2013 proposed rule and the supplemental notice, consistent with sections 419(a)(1)(A), (a)(3)(E), and (a)(3)(D) of the FD&C Act, we consulted with the NOP, USDA's Natural Resources Conservation Service (NRCS), U.S. Fish and Wildlife Service (FWS), and the EPA to ensure that environmental and conservation standards and policies established by those agencies were appropriately considered in developing the requirements of this rule. See also sections XIII, XIV, and XV of this document where we discuss the requirements related to water, biological soil amendments of animal origin, and animals, respectively.

E. Consideration of Environmental Standards

(Comment 15) Several comments ask that FDA do more to support on-farm conservation efforts and ensure that farmers can continue to use sustainable practices that enhance conservation and food safety. Some comments request that FDA codify into the regulation specific conservation requirements, including requirements to train farm personnel in conservation practices, not to destroy wild animal habitats, to promote natural barriers, to use sustainable conservation practices, and to use co-management of conservation and food safety. Some comments request that FDA recognize conservation practices intended to protect water quality; train enforcement officials on co-management principles; and/or define the term “co-management” in relation to such requirements.

(Response) As required by section 419 of the FD&C Act, the produce safety regulation establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce for human consumption, and sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. As discussed in the 2013 proposed rule and the supplemental notice, consistent with sections 419(a)(1)(A), (a)(3)(E), and (a)(3)(D) of the FD&C Act, we consulted with the NOP, NRCS, FWS, and EPA to ensure that environmental and conservation standards and policies established by those agencies are appropriately considered in developing the requirements established in this rule.

As discussed in the 2013 proposed rule and reiterated in the supplemental notice, we encourage the application of practices that can enhance food safety and that are also consistent with sustainable conservation. We believe that the provisions of part 112 are consistent with existing conservation and environmental practice standards and policies and are not in conflict with federal or State programs. In addition, by including § 112.84, as proposed in the supplemental notice, we are finalizing a codified statement in the produce safety regulation that the requirements of part 112 do not require or permit the use of practices in violation of the ESA, and that the regulation does not require the use of practices that may adversely affect wildlife, such as removal of habitat or wild animals from land adjacent to produce fields.

We continue to encourage the co-management of food safety, conservation, and environmental protection. We consider it important to take into account the environmental practice standards and policies of other relevant agencies in the context of food safety. However, the commenters identified no reason that it would be necessary for FDA to go beyond the statements we have included in § 112.84 and create affirmative conservation-related requirements in this rule. Therefore, we are taking no further action in response to these comments.

F. Product Testing as a Strategy To Control Pathogens

(Comment 16) Some comments agree with FDA's tentative conclusion that product testing would be impracticable as a component of this rule, except as proposed in subpart M under certain

circumstances for sprouts. One comment notes that sporadic contamination of produce cannot be detected reliably by product testing. One comment states that maintaining robust records of testing results will allow both farms and FDA to monitor for trends, correct imbalances or inaccuracies, and make adjustments to the system to best protect public health.

(Response) As discussed in section IV.I of the 2013 proposed rule, microbiological product testing for process control purposes presents several challenges that make it impracticable to be included within the framework of mandatory, science-based minimum standards established in part 112, with the exception of certain testing for sprouts described in subpart M (see section XVIII of this document). Among other issues, there are challenges associated with sampling plans, indicator organisms, and pathogen detection such that product testing is not appropriate as a generally applicable strategy to control pathogens across all produce commodities. The final human preventive controls rule also notes that product testing and environmental monitoring are unlikely to be common in facilities complying with that rule that process, pack, or hold produce RACs. We agree that, when testing is conducted (either voluntarily or in compliance with this rule for sprouts), records are important and useful.

G. Aquaponic and Hydroponic Operations

(Comment 17) Several comments request that FDA exempt aquaponic farming (raising produce and fish together in an integrated system) from the produce safety regulation, including specifically from the standards directed to agricultural water in subpart E, the standards directed to biological soil amendments of animal origin and human waste in subpart F, and the standards directed to domesticated and wild animals in subpart I. These comments argue the proposed produce safety rule does not address the nature of aquaponic farming. Some other comments suggest making it clear that the produce safety regulation is not intended to prohibit aquaponic practices.

Some comments requested that the standards related to agricultural water not be applied to aquaponic water containing fish waste fertilizer that is not intended or likely to come into contact with the harvestable portion of the plants; aquaponic water that is drawn from potable sources; or to hydroponics using effluent from domestic fish or crustaceans that is kept under what commenters describe as closed, hygienic conditions (in accordance with the Aquaponic Association's GAPs). Other comments state that fish waste does not contain

E. coli

and, therefore, the water microbial quality and testing requirements in proposed §§ 112.44 and 112.45 should not apply to water used in aquaponic systems. With respect to subpart F, some comments suggest the water and fish waste used in aquaponic and hydroponic systems should not be considered a biological soil amendment of animal origin. With respect to subpart I, some comments contend fish (including shellfish) are an inherently different reservoir for microorganisms than mammalian or avian species and, while fish may become temporary carriers of human pathogens, they do not act as hosts, and it is unlikely that they will come into contact with the harvestable portions of produce.

(Response) We acknowledge that aquaponic farming systems present a particular set of circumstances that differ in important ways from non-aquaponic farming. However, we do not agree that aquaponic farms should be excluded from the rule. We do not intend to prohibit using aquaponic farming systems to grow covered produce. The routes of contamination we considered for covered produce under this rule are applicable to aquaponic farming and covered produce grown in aquaponic systems is subject to the same potential for contamination from agricultural water, biological soil amendments of animal origin, and animals as covered produce grown using non-aquaponic systems.

With regard to subpart E of this rule, when covered produce is grown in an aquaponic system in which the water is not intended or likely to contact the harvestable portion of the produce, that water is not agricultural water for purposes of this rule. On the other hand, when covered produce is grown in an aquaponic system in which water is intended or likely to contact the harvestable portion of the produce, that water is agricultural water for purposes of this rule and must meet the applicable standards of subpart E, including the relevant microbial quality requirements in § 112.44 and the relevant water testing requirements in § 112.46. Also, as discussed further in Comment 222, the § 112.46(a) exception from water testing requirements applies only when water received from a public water system (as in § 112.46(a)(1)) or a public water supply (as in § 112.46(a)(2)) is not held under your control in a way that meets the definitions of “ground water” or “surface water” before you use it as agricultural water. For example, where under the circumstances the water used in the aquaponic system is “agricultural water” (because it is intended to, or likely to, contact covered produce), if that water is from a surface water source (or held in a surface water capacity), it must meet the surface water testing requirements in § 112.46. For example, the testing requirements in § 112.46(b) for untreated surface water apply to an aquaponic system that is established in an outdoor stream or pond, if under the circumstances the water meets the definition of “agricultural water.” With regard to the comments that asserted that fish do not carry

E. coli,

we note that information submitted or otherwise available to us demonstrates that fish can become carriers of human pathogens, including

E. coli

and

Salmonella,

if they are exposed to contaminated feed (Ref. 15), waters or sediment (Ref. 16) (Ref. 17). Studies show that fish have natural defenses against bacterial colonization of human pathogens, but as the population of the pathogen is elevated the fish become stressed and are no longer able to mitigate harboring the pathogens, becoming more susceptible to carrying human pathogens and becoming infected with other fish pathogens (Ref. 18). Fish are also natural carriers of

Vibrio

spp. (Ref. 19), a zoonotic pathogen.

With regard to subpart F of this rule, we consider growth media to include solid or semi-solid matrices in which plants are grown; we do not consider liquid-only matrices to be growth media. If a liquid matrix in which covered produce is grown is intended to or is likely to contact the harvestable portion of the crop, the water is agricultural water subject to all applicable requirements in subpart E.

Subpart I of this rule applies only in outdoor areas and partially-enclosed buildings. As revised in this final rule, subpart I is not intended to address potential contamination from fish used as part of an aquaculturing system. We conclude that the risks presented by fish used in aquaculture are better suited to regulation via the requirements for agricultural water in subpart E (when the water meets the definition of agricultural water) and the requirements related to harvesting in § 112.112 (for example, if covered produce is reasonably likely to have become contaminated by water containing fish waste that is not managed in compliance with subpart E's requirements for agricultural water). Thus, we are revising § 112.81 to specify

that subpart I does not apply to fish used in aquaculture operations. We note that subpart I does apply to aquaculture operations conducted in outdoor areas or partially-enclosed buildings when, under the circumstances, there is a reasonable probability that animals other than the fish used in the aquaculture operation will contaminate covered produce. We will consider issuing additional guidance related to the application of this rule to aquaculture operations, as appropriate.

(Comment 18) One comment presents various arguments in support of a position that aquaponic or hydroponic farming of produce other than sprouts should not be subject to the proposed requirements in subpart M, including asserting that there are no documented instances of

Salmonella

or

E. coli

transmission via aquaponic or hydroponic produce (other than sprouts), and that the growth conditions in aquaponic or hydroponic systems for produce (other than sprouts) are different and safer than those used to germinate sprouts. This comment also requests that FDA clarify that “water used for growing sprouts” does not cover water used in aquaponic or hydroponic systems for produce (other than sprouts) and, likewise, that the definition of “spent sprout irrigation water,” does not include water used for irrigation in aquaponic or hydroponic systems for produce (other than sprouts).

(Response) We have added new § 112.141 to clarify the scope of subpart M. Therefore, an aquaponic or hydroponic system used to grow covered produce other than sprouts is not subject to the requirements in subpart M. Likewise, “spent sprout irrigation water” is defined as “water that has been used in the growing of sprouts”; thus, the term spent sprout irrigation water, and the requirements for testing spent sprout irrigation water in subpart M, only apply to the water used for growing sprouts, and not to water used in an aquaponic or hydroponic operation growing produce other than sprouts. However, to the extent the specific aquaponic or hydroponic production systems used to grow produce other than sprouts may present risks similar to those associated with sprouts, we encourage aquaponic and hydroponic operations to consider voluntarily implementing the standards in subpart M.

(Comment 19) Some comments ask FDA to consider establishing additional regulations specifically applicable to aquaponics operations, as well as to hydroponic production of crops other than sprouts. According to one comment, this is especially important for high-risk crops such as leafy greens because the use of growth media in hydroponic production can increase the growth of pathogens.

(Response) At this time, we are not establishing additional standards specifically applicable to aquaponic or hydroponic production of crops other than sprouts. As noted in section V.M of the 2013 proposed rule, sprouts present a special concern with respect to human pathogens compared to other covered produce because of the warm, moist, and nutrient-rich conditions required to produce sprouts, the same conditions that are also ideal for the proliferation of pathogens if present (Ref. 20) (Ref. 21). Sprouts also have been frequently associated with foodborne illness outbreaks and, as a result, we issued our first commodity-specific guidance for sprouts. Likewise, the Codex Alimentarius Commission (or “the Codex”) supplemented the Codex Code of Practice for Fresh Fruits and Vegetables (the Codex Guide) (Ref. 22) with a Sprout Annex (Ref. 23). Therefore, we believe it is necessary to incorporate additional subpart M establishing standards specific to sprouts (including soil- or substrate-grown sprouts harvested with roots). Unlike sprouts, we believe that the production methods and safety considerations associated with aquaponics, generally, as well as with hydroponic production of crops other than sprouts, are sufficiently addressed through the provisions of the rule that are generally applicable to covered produce, including the provisions for water in subpart E, for soil amendments of animal origin in subpart F (which include growth media that serve as the entire substrate during the growth of covered produce), and for harvesting in § 112.112. We will consider issuing guidance on these topics in the future, as appropriate. Aquaponic and/or hydroponic operations growing produce other than sprouts may also voluntarily choose to follow the standards in subpart M.

IV. Comments on the Regulatory Approach

In the 2013 proposed rule, in section IV of that document, we explained in detail our tentative conclusion that we should establish a regulatory framework based on practices, procedures, and processes associated with growing, harvesting, packing, and holding of all covered produce. We considered and rejected a framework that (based solely on a history of outbreaks or illnesses associated with the commodity) would be applicable to individual commodities or classes of commodities. As discussed in the 2013 proposed rule, foodborne illness outbreaks have regularly been associated with commodities that have previously not been linked to outbreaks. Moreover, as discussed in the QAR, some commodities (

e.g.,

leafy greens) have been consistently associated with outbreaks while others (

e.g.,

grapes, jalapeno peppers) have only rarely been associated with outbreaks. In addition, because only a small percentage of outbreaks are both reported and assigned to a food vehicle, outbreak data may not provide a complete picture of the commodities upon which we need to focus to minimize current and future risk of illness. See also discussion at 78 FR 3504 at 3524-3528. We proposed an integrated approach to prescribe standards for on-farm routes of contamination that we tentatively determined are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act. Importantly, this integrated approach does take into account differences in commodities in that it takes into account differences in practices associated with the growing, harvesting, packing, and holding of produce commodities. We believe this integrated approach that focuses on the likelihood of contamination of produce posed by the agricultural practices applied to the crop, while exempting the lowest-risk produce, provides the most appropriate balance between public health protection, flexibility, and appropriate management of different levels of risk. The requirements of this regulation are based on identified routes of contamination and the associated practices that affect the likelihood that produce becomes contaminated. Agricultural practices that are more likely to contaminate produce require more stringent measures to ensure that the likelihood of contamination is sufficiently minimized. For example, as discussed in section XIII of this document, we are establishing the most stringent microbial quality standard for water that is used in direct contact with the harvestable portion of covered produce during or after harvest activities (when there is little further opportunity for pathogen die-off) and in certain other uses that present significant safety risk for the safety of the produce (such as irrigation of sprouts); less stringent criteria for water that directly contacts the harvestable portion of covered produce (other than sprouts) during growing activities (when

the opportunity for pathogen die-off is greater); and no requirements when water is used during growing, but does not contact the harvestable portion of covered produce (other than sprouts). In addition, we recognized the need for, and proposed, additional standards specifically tailored to the growing, harvesting, packing, and holding of sprouts.

We requested comment on our tentative conclusions related to our proposed regulatory approach. We asked for comment on various issues, as discussed in section IV.C of the 2013 proposed rule.

A. Commodity-Specific Versus Integrated Approach

(Comment 20) Several comments generally support our proposed integrated approach for various reasons, including that: (1) An integrated approach focuses on practices of highest risk and provides a whole farm approach rather than commodity-specific measures, which would be challenging for farms that grow multiple crops; (2) an approach that relies on outbreak data to make determinations about which produce should be covered would be inconsistent with the prevention-based approach mandated by FSMA; (3) relying on outbreak data would be insufficient to protect the public because many foodborne illnesses are not linked to an outbreak and the patterns of outbreaks associated with produce commodities change over time; (4) relying on pathogen surveillance data would not provide sufficient information to make risk determinations because FDA collects few data on produce and data collected are typically targeted to produce that is already known to be risky, which is not a preventive approach.

In contrast, several other comments request that we develop a commodity-specific approach, arguing that the proposed integrated approach is not sufficiently based on risk or science and does not sufficiently align with the intent of Congress that FDA establish a rule that considers differences in risk among various commodities. Several comments contend that, with the exception of exemptions for produce rarely consumed raw and produce that receives commercial processing, FDA has proposed a generic, one-size-fits-all approach. Some comments maintain that, by focusing on agricultural practices, FDA has ignored relevant commodity-specific factors, such as adhesion and infiltration. Some comments also express concern that FDA did not consider past association with outbreaks a major determinant for coverage of produce commodities, contending that doing so would result in more cost-effective and targeted risk reduction. Still other comments state that there is a known and significant variation in risk profiles, practices, and regional differences across produce commodities, and ask FDA and USDA to fund research to determine the relative risk of microbial contamination.

Some comments suggest FDA should analyze each commodity separately and develop commodity-specific requirements, and establish a level of regulation commensurate to the level of risk of causing foodborne illness presented by a specific commodity, focusing on commodities presenting the highest risk. Some comments point to commodities such as tree fruits, produce with an inedible peel, and nuts as “low risk,” and argue that such commodities should not be regulated the same way as other commodities that present a greater risk profile. Some comments state that citrus fruit is grown off the ground, the peel is generally not consumed, the fruit is acidic, and irrigation water generally does not touch the fruit and, therefore, citrus fruits should be considered low risk. Other comments suggest FDA should start by regulating only commodities that have been associated with an outbreak and consider expanding to include other commodities only after evaluating the public health benefits of the initial rulemaking. Some comments also ask FDA to consider the crop grouping strategies employed by other organizations, such as the grouping used by Codex Alimentarius (in Codex classification of foods); the USDA (in IR-4 project); and the EPA (in EPA's Crop Group listings).

(Response) We agree with comments that indicated the integrated approach proposed by FDA is appropriate for a variety of reasons. We recognize the diversity of produce operations and agree with comments that pointed out that multiple, crop-specific standards could be confusing and burdensome both in their implementation and in assessing compliance, especially for diversified operations. As discussed in the 2013 proposed rule and the QAR, we agree that an approach that relies on outbreak data, or certain commodity characteristics, to make determinations about which produce should be covered would be inconsistent with the prevention-based approach mandated by FSMA and that relying on outbreak data would be insufficient to protect the public because many foodborne illnesses are not linked to an outbreak and the patterns of outbreaks associated with produce commodities change over time. For example, cucumbers are frequently (although not always) peeled prior to consumption and, until recently, did not have a history of association with outbreaks. In 2009, based on literature indicating the potential for cucumbers to be contaminated with

Salmonella

(Ref. 24) (Ref. 25), we added cucumbers to our routine surveillance sampling assignments and, in fact, detected an outbreak linked to cucumbers that year (Ref. 26) (Ref. 27). Between 2011 and 2014, we have identified cucumbers as the food vehicle in three additional outbreaks (Ref. 28).

FDA based its proposal of a practices-based approach in part on the results of our draft QAR. We received public comment on the QAR and also had it peer reviewed and have now issued a final QAR (or the QAR), which incorporates revisions based on public comments and the peer review (Ref. 29). While we have made some revisions, the conclusions of the QAR are unchanged. We conclude that, while different commodities may have different risk profiles at different stages of production, all commodities have the potential to become contaminated through one or more of the routes identified, especially if practices are poor and/or conditions are insanitary. Commenters did not provide information affecting this conclusion. We also conclude that commodity characteristics, such as an inedible peel or the fact that it is grown off the ground, may be relevant to relative likelihood of contamination during growing, but are not good indicators of an association, or lack thereof, with outbreaks. Commenters also did not provide information affecting this conclusion. The QAR looked at likelihood of contamination during growing, harvest, and postharvest activities for 47 commodities and found that commodity characteristics, including microbial adhesion and infiltration considerations, were not reliably protective against contamination, as evidenced by past association with an outbreak for a range of commodities with variable characteristics. For example, if a pathogen is present on the surface of the peel or rind of a piece of fruit, cutting the fruit with a knife can carry the pathogen into the edible portion of the fruit (Ref. 30). Indeed, produce commodities with a peel or removable outer layer, such as honeydew, cantaloupe, papaya, and mango, have previously been associated with outbreaks of foodborne illness. From 1997 to 2014, there have been a total of 20 outbreaks in the United States

associated with produce commodities sold whole (not fresh-cut) where the commodity has an outer peel that is removed prior to consumption, with a range of pathogens (

Salmonella, Shigella,

and

Listeria

) implicated in the outbreak (Ref. 28) (Ref. 29). The public health consequences of these outbreaks have been significant. For example, the 2011

L. monocytogenes

outbreak in the United States associated with cantaloupe resulted in 147 reported cases of illness, 143 reported hospitalizations, and 33 reported deaths (Ref. 28).

With regard to comments asking that we start by regulating only commodities that have been associated with an outbreak, we note in the QAR that “new” commodities are associated with outbreaks on a regular basis, which means that a history of outbreaks is not appropriate as a basis for determining the regulatory status of various commodities. Many comments asked that we consider factors such as commodity characteristics or past association with an outbreak to define a subset of low risk commodities that would be exempt from the requirements of part 112. However, these comments did not provide data that affected the findings of the QAR, and in finalizing this rulemaking we continue to conclude that the integrated approach is the appropriate regulatory framework to ensure the safety of produce.

In considering options for the regulatory framework for the produce rule, we considered the crop groupings used by Codex Alimentarius, the IR-4 project, and EPA's crop grouping designations (Ref. 31) (Ref. 32) (Ref. 33), which were suggested by comments. These programs categorize commodities based on commodity characteristics, production practices, or pest pressures. They were not created for the purposes of characterizing relative risk of causing serious adverse health consequences or death, or to determine what procedures, processes, and practices should apply to such commodities to minimize the risk of serious adverse health consequences or death. Thus, we did not find these groupings appropriate for purposes of this regulation. As demonstrated by the QAR, even within a commodity group, physical characteristics (such as texture of the fruit) of the commodity that could alter the potential for contamination and, therefore, association with an outbreak, do not always appear to do so.

In the 2013 proposed rule, we specifically sought comment on various possible strategies for developing a commodity-specific approach, including covering only commodities/commodity groups that had been associated with outbreaks during a specified time period; covering only commodities/commodity groups that had ever been associated with an outbreak; and combining outbreak-based commodity classification with other information, such as commodity characteristics, or pathogen surveillance data. We noted specific problems with each of these approaches. In summary, commenters did not provide data or information suggesting that the problems we identified could be adequately addressed to allow development of a commodity-specific approach that would be sufficiently protective of public health. As a result, we are finalizing our conclusion that the integrated approach is the most appropriate, risk-based, and scientifically sound approach, and we are adopting such an approach.

We also asked specific questions in the 2013 proposed rule regarding whether we might additionally exclude commodities beyond those we identified as the lowest risk (

i.e.,

those that are rarely consumed raw and those that receive commercial processing that adequately reduces pathogens). We asked if produce, such as bananas and coconuts, that are peeled or shelled before consumption in a manner that can be expected not to transfer contamination onto the interior, edible portion of the commodity should be covered by the rule or subject to a less stringent set of requirements (78 FR 3504 at 3528). We received several comments indicating that bananas should not be covered because they have an inedible peel, which according to commenters means that it is unlikely that contamination will contact the edible portion. In response to our questions in the preamble, no comments identified any unique characteristics, in addition to the ones we identified, of bananas and coconuts that would justify their exemption. We indicated with our question a characteristic of bananas and coconuts that might put them in a lower risk category than other commodities. However, there is no evidence that bananas and coconuts are lower risk than other low-risk commodities or that the method of peeling or opening these commodities generally precludes transfer of contamination on the exterior to the edible portion. As noted in the QAR, there are limited data on the effect of cutting and peeling on the levels of pathogens across the range of produce commodities (Ref. 29). In addition, in the final QAR, while both bananas and coconuts have low `route scores' in the assessment of potential routes of contamination and likelihood of contamination on-farm, other commodities have lower scores. As noted previously, we continue to conclude that commodity characteristics, such as an inedible peel or the fact that produce is grown off the ground, may be relevant to relative likelihood of contamination during growing, but are not good indicators of an association, or lack thereof, with outbreaks. Therefore, we conclude that they should be subject to part 112.

We also asked about certain commodities that are ranked in the QAR as presenting a relatively lower likelihood of exposure, in part because they have fewer potential routes of contamination and/or lower potential for contamination and have not previously been associated with an outbreak. We asked if commodities that meet both these criteria should be subject to the rule or subject to a less stringent set of requirements (78 FR 3504 at 3528). We specifically mentioned pears, grapefruit, oranges and lemons as examples. As noted earlier, we received a comment arguing that citrus fruits should be considered low risk commodities due to the fact that they are acidic, have a rarely consumed peel, are grown in trees, irrigation water generally does not touch the fruit, and citrus fruits have not been associated with outbreaks. However, the comment did not ask for citrus to be exempt, but to be deemed in compliance with the rule if farms are in compliance with the Citrus industry's good agricultural practices (the Citrus GAPs) (Ref. 34). However, while different commodities may have different risk profiles at different stages of production, all commodities have the potential to become contaminated through one or more of the routes identified, especially if practices are poor and/or conditions are insanitary. In addition, commodity characteristics, such as an inedible peel or the fact that it is grown off the ground, may be relevant to relative likelihood of contamination during growing, but are not good indicators of an association, or lack thereof, with outbreaks. For these reasons, and because comments provided no other information to suggest that citrus fruits or pears should not be covered by the rule, we conclude that they should be subject to part 112. With regard to compliance with the Citrus GAPs, see Comment 143.

(Comment 21) One comment suggests that, as an alternative to developing a commodity-specific regulatory approach, FDA should provide for a notification process by which industry can voluntarily notify FDA about a particular commodity that should be

characterized as low risk and, therefore, exempt from the produce safety regulation.

(Response) We believe the alternative and variance provisions, in subparts B and P, respectively, provide adequate flexibility to address particular situations, and the rule otherwise provides exemptions for certain types of low-risk produce (§§ 112.2(a)(1) and (b)). We are not establishing an additional process or exemptions.

(Comment 22) We received numerous comments stating that we have adopted a “one-size-fits-all,” rigid and prescriptive approach. These comments argue that our proposed approach is not flexible or scale appropriate.

(Response) Under our regulatory approach, the scope and stringency of the requirements are based on risk, and depend in several cases on the types of practices employed within operations, such that producers of different commodities who use different practices will not necessarily be subject to all of the same requirements. We note that § 112.4(a) requires that “[i]f you are a covered farm subject to this part, you must comply with all

applicable

requirements of this part when you conduct a covered activity on covered produce” (emphasis added). As discussed in the 2013 proposed rule, given various considerations, we proposed an integrated approach that draws on our past experiences and appropriately reflects the need to tailor requirements to specific on-farm routes of contamination. In some cases, our standards are similar to current good manufacturing practices-type provisions, especially where the routes of contamination are well-understood and appropriate measures are well-established and generally applicable across covered produce commodities (

e.g.,

personnel qualifications, training, health, and hygiene; harvesting, packing, and holding activities; equipment, tools, buildings, and sanitation). In other cases, our standards require the farm to inspect or monitor an on-farm route of contamination and take appropriate measures if conditions warrant. We rely on such a monitoring approach where the diversity of conditions that can be expected relative to an on-farm route of contamination is very high and it would be impractical and unduly restrictive to set out a standard that specifies the appropriate measures for each possible circumstance (

e.g.,

requirements for visual assessment for working or grazing animals or animal intrusion in § 112.83 and inspection of agricultural water system in § 112.42). In still other cases (

e.g.,

sprouts), our standards require the farm to develop a written plan, committing itself to specific measures (

e.g.,

sprout environmental testing and spent sprout irrigation water testing). Finally, on a limited basis, we are establishing specific numerical standards against which the effectiveness of a farm's measures would be compared and actions that would be taken to bring the operation into conformance, as necessary (

e.g.,

microbial quality criteria for agricultural water in subpart E). We rely on the numerical standards approach where our evaluation of current scientific information to determine reasonable measures allows us to establish numerical criteria that are broadly applicable across a wide range of conditions, while acknowledging that such criteria may be tailored, as appropriate, when applied specifically to a commodity (or group of commodities) or under a set of farm practices.

We incorporated flexibility into the standards, where appropriate, so covered farms are able comply with the requirements while taking into account their specific commodities and conditions in their operations, and risk profile associated with them. For example, we define “agricultural water,” in relevant part, to mean water that is intended to, or likely to, contact the harvestable portion of the crop or food-contact surfaces, thus allowing consideration of commodity-specific characteristics and/or practices. For example, if irrigation water does not contact the produce (

e.g.,

drip or furrow irrigation of tree fruit), the microbial quality criteria for agricultural water applied during growing using a direct water application method (for produce other than sprouts) do not apply because the water is not “agricultural water” as we have defined that term. We also incorporated additional flexibility to accommodate future changes in science and technology and the particularities of local growing conditions and commodities. Under § 112.12, we list the specific numerical standards established in this rule for which we allow alternatives to be established and used in appropriate circumstances. This provision provides significant flexibility by allowing individual farms to develop alternative standards suitable to their operations with appropriate scientific support (for example, under §§ 112.12(a) and 112.49(a), alternatives are permitted to the microbial quality criteria in § 112.44(b) related to agricultural water used in a direct application method during growing of produce (other than sprouts)). In addition, in subpart P, we provide for a mechanism by which a State, tribe, or a foreign country from which food is imported into the United States may request a variance from one or more requirements of part 112, where such variance, among other conditions, is demonstrated to provide the same level of public health protection as the relevant requirement(s) of part 112.

Taking into account comments in response to the 2013 proposed rule and as proposed in the supplemental notice, we incorporated further flexibility in certain key areas such as the standards for agricultural water. For example, § 112.45(b)(1) provides additional means by which to satisfy the microbial quality criteria for agricultural water that is used in a direct application method during the growing of produce (other than sprouts). Allowing for microbial die-off between last irrigation and harvest and/or microbial reduction or removal resulting from postharvest practices provides covered farms viable options to meet the microbial quality criteria without needing to, for example, treat water or switch to a ground water source. This additional flexibility recognizes the diversity of commodities and production practices. It may also be useful for other postharvest activities, for example, commercial washing and controlled atmosphere storage of apples, with adequate supporting data and documentation.

We believe the coverage threshold, qualified exemption, and extended compliance periods adequately address concerns related to scale-appropriate regulation of farms. We have provided as much flexibility as is appropriate while maintaining the overall public health goal of this produce safety regulation. This regulation does not apply to those businesses with $25,000 or less in sales of produce, as described in § 112.4(a), because such farms do not contribute significantly to the produce market and, therefore, to the volume of production that could become contaminated. In addition, for farms that fit our criteria for very small business or small business, we are providing extended compliance periods ranging from two to three years for covered activities involving sprouts; and ranging from three to four years for most provisions coupled with more time for certain water-related requirements for covered activities involving all other covered produce (see section XXIV of this document), so they are given sufficient time to make any necessary adjustments to their current practices. There are also provisions for qualified exemption for certain farms based on monetary value and direct-to-consumer sales, and associated modified

requirements, as described in §§ 112.5, 112.6, and 112.7.

In addition, the provisions in subpart A provide risk-based exemptions for certain types of produce based on our determination that the manner in which the produce is consumed does not require that produce to be subject to the requirements in part 112. We are exempting produce commodities that are rarely consumed raw (§ 112.2(a)(1)). Produce that receives commercial processing that adequately reduces the presence of pathogens is also eligible for exemption under certain conditions (§ 112.2(b)).

(Comment 23) One comment asks whether covering all commodities in the rule is compliant with the provisions of the WTO-SPS agreement about the appropriate level of protection. This commenter expresses concern specifically with respect to covering under this rule those fruits and vegetables that have an inedible peel and that are peeled before consumption.

(Response) We believe that the regulatory framework underlying the science-based minimum standards established in part 112 is supported by currently available scientific information, as explained throughout the 2013 proposed rule and in this rule and, as such, satisfies our obligations under the WTO-SPS agreement. We also note that not all produce commodities are subject to the rule. Section 112.2(a)(1) specifies certain commodities that are not covered based on our conclusion that they are rarely consumed raw. See Comment 20 for our consideration of produce with inedible peel.

B. Use of Quantitative Metrics

(Comment 24) Several comments express concern with the use of quantitative metrics in the rule. For example, one comment indicates the proposed requirements in subpart I to “monitor . . . for evidence of animal intrusion” and “evaluate whether the covered produce can be harvested”, allows for regional and commodity diversity and provides sufficient flexibility to be applicable to any operation, whereas the quantitative metrics, such as in proposed §§ 112.44, 112.45, 112.55 and 112.56, are too prescriptive and inflexible to be codified in the regulation. Several comments argue the current status of produce safety research is inadequate to establish the quantitative metrics as applicable to all commodities and regions and all situations. Another comment asks us to limit the metrics to those for which sufficient scientific evidence exists that such standards will protect public health and reduce risk. Some comments argue that guidance would be a more appropriate vehicle to convey quantitative metrics, as recommendations rather than requirements, because there is such variation in region, operations, and commodities, and because guidance is easier to amend than a regulation.

(Response) The standards that FDA is issuing in part 112 are based in science. Taking into account comments received in response to the 2013 proposed rule we proposed revisions to some provisions in the supplemental notice and explained our rationale, including scientific support for those new and amended proposed provisions. Among proposed §§ 112.44, 112.45, 112.55, and 112.56, which included quantitative criteria, there was one, the minimum application interval for an untreated biological soil amendment of animal origin in proposed § 112.56, for which we indicated that we would conduct further research and a risk assessment. FDA has committed to pursuing this work before revisiting the interval. We conclude we have an adequate basis on which to finalize the metrics in this rule, including in final §§ 112.44, 112.45, 112.46, and 112.55. For a discussion of the final provisions, and comments received in response to the supplemental notice, we refer you to sections XIII and XIV of this document. We disagree with comments that suggest eliminating all quantitative metrics from this rule in favor of recommending such numerical criteria in guidance. We believe it is clearer to regulated industry to establish these metrics in the rule, and important for public health that these metrics be binding requirements rather than recommendations.

C. Scientific Support for the Rule

(Comment 25) Some comments state the record of proven on-farm causation of outbreaks is thin. One comment acknowledges our estimates of produce-related reported outbreaks, outbreak-related illnesses, hospitalizations, and deaths, and argues that, although these adverse impacts are regrettable, the number of deaths pale in comparison to the 2.5 million total deaths in the country, including about 35,000 caused by motor vehicle accidents.

(Response) In the 2013 proposed rule, FDA outlined the history of contamination associated with produce, predominantly during growing, harvesting, packing, and holding (78 FR 3504 at 3507), from 1996 to 2010. On-farm contamination of produce is well documented. We also developed and finalized the QAR which evaluates likely routes of contamination for 47 produce commodities, including pre-harvest and postharvest activities on farms. We have updated our outbreak data since the 2013 proposed rule issued, and between January 2011 and 2014, there were 44 outbreaks, 3120 illnesses, 735 hospitalizations, and 42 deaths associated with produce (including sprouts) (Ref. 28). We continue to conclude that there is an ample history of microbiological contamination of produce on farms to justify establishing the provisions of part 112 to help prevent contamination and illness. This rule is also consistent with our statutory mandate to develop standards for the safe production and harvesting of produce to minimize the risk of serious adverse health consequences or death.

(Comment 26) One comment questions FDA's interpretation of the term “scientifically valid,” which, according to the commenter, relies too much on peer review for validation.

(Response) We use the term “scientifically valid” to mean an approach that is based on scientific information, data, or results published in, for example, scientific journals, references, text books, or proprietary research. Use of peer-reviewed literature is just one component of what we mean by the term “scientifically valid;” however, we continue to believe that peer-reviewed literature may be an important source of validation of, for example, a procedure, process, or practice allowed as an alternative to a specific requirement of this rule under § 112.12.

(Comment 27) Some comments suggest we should revise the regulation to align with what the commenters identify as the modern microbial ecology paradigm, stating that achieving public health goals is more complex than eliminating pathogens and that exposure to diverse microbes may be necessary for health.

(Response) We do not expect or intend for this rule to bring about a “microbe-free” food production system. We acknowledge that eliminating all pathogens would not be a realistic expectation, especially in an open field environment. However, foodborne illness associated with consumption of contaminated produce can carry high public health and financial costs. Many produce contamination events are preventable, and we will work with industry and other stakeholders to achieve successful implementation of this rule and, ultimately, protect public health. This rule is also consistent with our statutory mandate to develop standards for the safe production and harvesting of produce to minimize the

risk of serious adverse health consequences or death.

D. Market Channels

(Comment 28) We received several comments in response to our question about whether and how we could use market channels as a factor in the rule beyond inclusion of the qualified exemption that already takes market channels into account. One commenter states that local food is less risky because there is less time between harvest and consumption (and, therefore, less time for pathogen growth and multiplication) as well as less centralized processing with potential for cross contamination. This comment argues that FDA's analysis confuses data on hazards that occur on-farm, with hazards that occur off-farm, including hazards that occur later in the chain of production. In addition, one comment suggests that FDA should support research and data collection to compare the risks of different types of supply chains, including direct-to-consumer and multiple “touch-points” supply chains. One comment recommends establishing a three-tiered structure for the regulation of produce safety, reflecting current produce production and marketing systems. As recommended, the three tiers would be: (1) “Farm-direct,” which would include farm stands, farmers' markets, community supported agriculture (CSA) programs (

e.g.

subscription farms) and other strategies where the relationship between individual farmers and consumers is “immediate and understood;” (2) “identity-preserved,” which would include distribution on a regional scale where the farmer and consumer do not necessarily meet, but the identity of the farm is displayed or otherwise preserved on products all the way through the system; and (3) “commodity-stream,” which would include other distribution systems besides “farm-direct” and “identity-preserved.”

(Response) FDA disagrees with the commenter who argues that we are using off-farm food safety data to justify control of farming practices. We recognize that contamination can happen at any point in the supply chain. In a review of outbreaks in the United States attributed to fresh leafy vegetables between 1973 and 2012, Herman and colleagues noted that most (85 percent) fresh leafy vegetable outbreaks during the study period were attributed to food prepared in a restaurant or catering facility (Ref. 35). According to Herman et al., the large number of fresh leafy vegetable outbreaks in which the food was prepared in a restaurant and contaminated with norovirus, often by an ill food worker, underscores the need to enforce safe handling practices for food workers for these types of foods. The authors also noted, however, that contamination of leafy vegetables early in production by bacterial pathogens such as Shiga-toxin producing

E. coli

(STEC) and

Salmonella

caused nearly all multistate outbreaks associated with those commodities, including some of the largest leafy vegetable outbreaks:

Shigella

and fresh parsley in 1998, Hepatitis A and green onions in 2003,

E. coli

O157:H7 and spinach in 2006. Furthermore, leafy green vegetables used in ready-to-eat pre-packaged salads retain much of their indigenous microflora after minimal processing, including pathogens, if present (Ref. 36).

The focus of the produce rule on contamination on-farm, the earliest point in the supply chain, is consistent with FSMA's focus on prevention of food safety problems. On-farm routes of contamination have been well documented. However, this does not mean that FDA is singling out farms as the only source of contamination for produce; other efforts are directed to potential contamination at later stages of manufacturing and processing. For example, the PCHF regulation addresses manufacturing/processing operations for food, including produce commodities; the FDA Model Food Code (Ref. 37) addresses practices at the retail level; and educational campaigns, such as consumer advice for safe handling of raw produce and juice (Ref. 38) (Ref. 39), are designed to enhance safe handling practices by consumers.

We decline to establish the three-tiered system advocated for by a comment. The comment described potential categorizations that relate to traceability of produce. Tracing may be easier when only selling through the types of arrangements described in the commenter's “farm-direct” category, or in a manner described in the commenter's “identity-preserved” category; however, the goal of this regulation is the prevention of foodborne illness. The commenter did not provide data or information from which we can conclude that the “farm-direct” or “identity-preserved” market channels described represent lower risk of foodborne illness, only that such market channels may better facilitate traceback after illness occurs.

As discussed in the 2013 proposed rule, we acknowledge that the number of opportunities for contamination during packing and holding may be greater for produce in market channels involving greater numbers of handlers and touch points. At the same time, we concluded that produce in both direct market channels and other commercial channels are subject to the same routes of contamination, and we indicated that we were not aware of any data that would allow us to compare the likelihood of contamination for produce in more or less direct market channels. This rule includes the statutory qualified exemption which addresses market channels (see section 419(f) of the FD&C Act, and § 112.5). We identified no data that would allow us to otherwise use market channels as a basis of risk categorization under this rule. Nor did commenters provide any data or factual information that would allow us to do so. We believe that the commenter who advocated the three tiered system described previously is arguing that it is most important from a public health standpoint to focus our efforts on large farms that sell produce through attenuated supply chains. We agree that we should prioritize our enforcement and compliance efforts in an efficient way that is based on risk. See our discussion in section XXII of this document. We also note that the proposed revised definition of “retail food establishment” (80 FR 19160; April 9, 2015) may affect the number of farms that are subject to the requirements of part 112.

E. Guidance in Lieu of the Produce Safety Regulation

(Comment 29) Several comments recommend that FDA consider issuing guidance, or otherwise providing information and advice to farms, in lieu of establishing the produce safety regulation. These comments note there is a tremendous amount of research being done to address known produce safety issues and enhance produce safety, and use of guidance rather than a regulation would allow FDA to readily and easily incorporate new science and preventive controls as they become available. Some comments state FDA has not explained why we determined not to adopt a voluntary approach and request that any guidance documents consider industry-developed recommendations. Some commenters ask FDA to consider the number of other regulations with which farms must currently comply, suggesting that further regulation is unnecessary.

(Response) Under section 419 of the FD&C Act (created by section 105 of FSMA), Congress explicitly requires the issuance of regulations establishing science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of

fruits and vegetables, that are RACs for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. Adopting a voluntary approach, in lieu of regulatory requirements, does not fulfill this statutory mandate nor does it achieve the public health objectives intended by the produce safety regulation. Rather, this rule implements the statutory mandate described in section 419 of the FD&C Act. We also recognize that there are many requirements with which produce farms must comply, including environmental and worker safety regulations. However, such regulations do not minimize the risk of severe adverse health consequences or death from produce for consumers, which is the goal of part 112.

FDA recognizes that there are many growing situations across the country and abroad, each of which is unique to a particular growing region and site location, and that there may be different measures a farmer can take to prevent and/or minimize food safety risks in compliance with the regulation. In this regard, we note that part 112 gives farm operators sufficient flexibility to tailor their practices as appropriate to achieve compliance with the applicable produce safety standards. Moreover, guidance will play an important role in providing recommendations to assist farms in tailoring their activities to the conditions, practices and commodities specific to their farm. As discussed throughout this document, we intend to issue guidance to help covered farms comply with the requirements of this rule, including a SECG specifically intended for small and very small businesses.

F. Existing Industry Guidelines and Certification Programs

(Comment 30) Several comments request FDA approve or recognize existing industry voluntary programs, and accept participation in such programs as a means to meet the requirements of the produce safety rule. Some comments believe such programs are as protective, or more protective, of public health than the proposed produce safety rule. Some comments note that many farms currently use and understand voluntary auditing and other food safety programs such as the USDA Good Agricultural Practices (GAP) and Good Handling Practices (GHP) programs, the Global Food Safety Initiative's (GFSI) food safety program, the California Leafy Greens Marketing Agreement (CA LGMA) (Ref. 40), the California Cantaloupe Marketing Order, the Arizona Leafy Greens Products Shipper Marketing Agreement (AZ LGMA) (Ref. 41), the Florida Tomato Good Agricultural and Best Management Practices programs, the Citrus GAPs, and the Massachusetts GAP and Commonwealth Quality programs. Some comments argue that it would not be efficient to create a separate inspection framework under the produce safety regulation without taking steps to provide integration with such existing programs, and integrating inspections would allow FDA to focus its resources on operations that are not part of an existing system. Some comments state that the internal and external audit components of these programs would serve as an additional check to ensure food safety practices are being implemented effectively at farms. Some comments suggest that FDA should grant an exemption or an alternative or variance for GAP-certified farms, those participating in the CA LGMA or AZ LGMA, or those complying with other certification programs.

(Response) FDA appreciates the efforts of commodity groups and industry segments that have proactively developed food safety programs. We also appreciate that farms currently implementing these programs may have developed an understanding and comfort level with the provisions in these programs. Such farms will likely be well-positioned to comply with this rule.

To the extent that certification schemes or food safety programs are consistent with the produce safety regulation, then compliance with those schemes or programs could be relevant to compliance with the requirements of part 112. We reviewed widely used food safety schemes and programs in developing this rule and note that there are consistencies with several of the provisions of this rule. We understand that, as of the publication of this document, many of the widely used food safety schemes and programs will be considering whether and how to revise their provisions in light of the requirements of FDA regulations, including this produce safety regulation and our other new FSMA regulations. Over time, we expect that certification programs and food safety programs will develop tools to demonstrate the alignment of their provisions with FDA requirements. FDA believes there is value in such efforts and will consider the possible implications for FDA's work if and when such information on alignment is available. With respect to the comment about alternatives or variances, see our response to Comment 143.

G. Reducing Burden on Small Farms

(Comment 31) Some comments request a range of options designed for small and mid-sized agricultural operations, and express concern about the burden of the rule on small farms and their ability to stay in business. Some comments state the rule should be established in a manner that does not create a burden on new farm startup enterprises. Comments also request the rule minimize burden on smaller operations by streamlining and reducing unnecessary paperwork. Several comments agree problems with food safety need to be addressed, but request FDA's emphasis should be on “industrial agriculture,” which they contend is the primary source of food safety problems, rather than on small farms. One comment suggests costs of compliance will be more burdensome to small farms than to large farms because certain costs, such as those associated with water testing, paperwork, and documentation, remain relatively constant regardless of the size of the operation.

(Response) FDA appreciates that this rule will establish, for the first time, regulatory requirements for on-farm growing, harvesting, packing, and holding of produce. We also appreciate that implementing the requirements of this rule will come with a cost, both in time and resources. As discussed in section IX of this document, we have incorporated a coverage threshold (§ 112.4(a)) and a qualified exemption and corresponding modified requirements (§§ 112.5, 112.6, and 112.7), as well as extended compliance periods (see section XXIV of this document) each based, in part, on the size of the farm. We conclude that these provisions adequately address the concerns of small farms and are in compliance with our statutory mandate under section 419 of the FD&C Act. This rule also provides sufficient flexibility to allow individual operations to tailor their practices as appropriate. Our recordkeeping requirements established in subpart O of part 112 allow farms to use existing records, and do not require duplication provided such records satisfy all of the applicable requirements of part 112. FDA agrees that education, training, and technical assistance to farmers is important. As mentioned throughout this document, FDA will be issuing guidance, including SECG, specifically aimed at assisting small and very small farms to comply with the requirements of this rule. See also Comment 3 and sections XI and XXII of this document.

(Comment 32) Some comments assert the rule will disproportionately affect New England farmers, with negative impacts on New England's food supply because New England farms are small and production costs are higher compared to elsewhere in the country. Other comments assert this rule will force small farmers out of business, forcing the United States to rely on foreign suppliers who these commenters assert are under very little FDA oversight. These comments argue the requirements of this rule should be reduced in various ways as a means of supporting small, local farmers. Other comments express concern that this rule will discourage farmers from supplying the “Farm to School” market.

(Response) We believe that the “farm” definition that we have established in the PCHF regulation, and which we are adopting into part 112 through this rule, reduces the impact of the FSMA rulemakings on farms of all sizes, because several types of operations that were required to register as food facilities under the section 415 registration regulations as established in 2003 (68 FR 58894, October 10, 2003) will no longer be required to do so by virtue of the changes we are making to the definition of “farm.” (See the discussion of the changes to the “farm” definition in section IV of the final human preventive controls rule (80 FR 55908).) In addition, a farm that has annual sales of produce below the monetary threshold in § 112.4(a) is not covered under this rule. Moreover, under § 112.5, a farm is eligible for a qualified exemption (and subject to certain modified requirements) if it satisfies certain criteria. We are also establishing delayed compliance dates for small and very small businesses as discussed in section XXIV of this document. All of these factors will reduce the burden of this rule on small farms.

H. Estimated Produce Outbreaks and Associated Illnesses

(Comment 33) Several comments question our analysis and estimates of produce-related outbreak illnesses. According to these comments, the number of outbreaks and health consequences should be reduced by removing known foreign-sourced outbreaks. Some comments point out limitations of the CDC dataset, including that the data do not differentiate between illnesses caused by contamination in the production of produce and contamination due to improper handling by the consumer, and that the data do not include illnesses caused by “unspecified agents”. Finally, some comments contend that FDA should limit its consideration of past outbreak data on which it relies in the proposed regulation; for example, if previous outbreaks are related to activities that would be covered by the proposed Preventive Controls for Human Food rule, then these comments argue that FDA should not consider those outbreaks when determining the risk of activities covered by the produce safety regulation.

(Response) FDA acknowledges that there are a number of limitations associated with available outbreak data. For example, the data do not include illnesses that were not reported, sporadic cases of illness, or illnesses transmitted person-to-person (secondary transmission). The data also do not include a large number of reported illnesses/outbreaks where the contaminated food vehicle cannot be determined. The data do not include illnesses/outbreaks where the point of contamination is determined to be the home, retail, or institutional setting. We thus conclude that, if anything, our dataset likely undercounts the number of outbreaks associated with the production of produce. We disagree with comments that suggest illnesses and outbreaks attributed to foreign sources should be excluded from data considered in support of this rule. Our goal is to minimize illnesses and deaths associated with the consumption of contaminated produce. Imported produce, like domestically-grown produce, contributes to the risk of foodborne illness from contaminated produce and is therefore relevant to this rulemaking.

Finally, while we are not counting these illnesses for purposes of the Regulatory Impact Analysis (RIA) for this rule, we are otherwise considering them in our assessment in the QAR and in establishing this rule. We have determined that it is most appropriate to attribute the benefits of avoiding fresh-cut produce related illnesses to the PCHF regulation for purpose of economic analysis to avoid double counting such benefits; however, we note that it appears that in several cases, the most likely point of original contamination for the fresh-cut-related outbreaks occurred on the farm rather than at the fresh-cut facility. Both farms and fresh-cut manufacturing/processing operations provide routes of contamination that may contribute to adulteration of fresh-cut produce, and the integrated system of preventive controls we are establishing under FSMA is intended to address these risks at multiple stages in the farm-to-table continuum. Thus, illnesses attributable to fresh-cut produce are relevant to both this rule and the PCHF regulation even though the economic benefits of avoiding illnesses attributable to such products are being estimated only in the RIA for the PCHF regulation.

I. Impact on Traditional Farming Methods

(Comment 34) Several comments express concern that the proposed produce safety rule would impose undue restrictions on traditional farming methods. Comments indicate concern with our proposed approach as applied to diversified livestock-crop farms, the use of working animals, and the use of biological soil amendments of animal origin. These comments urge FDA to remove restrictions applicable to these methods of farming, absent data showing an actual, verified increased rate of foodborne illness associated with use of such. In addition, these comments argue that FDA is inappropriately placing the burden on farmers to prove that their methods are safe.

(Response) We disagree the produce safety regulation would impose undue restrictions on traditional farming methods, such as diversified livestock-crop farms, the use of working animals, or the use of biological soil amendments. These issues are further discussed in sections XIV (standards directed to biological soil amendments) and XV (standards directed to animals) of this document. We have made changes in those subparts that we expect will address at least some of these commenters' concerns. See also section III.E of this document. Farms have a responsibility to produce food that complies with the FD&C Act, and FDA disagrees that we are inappropriately placing burden on farmers to prove that their methods are safe. We are establishing requirements in this rule that will minimize the risk of serious adverse health consequences or death from produce. We are also establishing a rule with significant flexibility for farms to tailor their practices to their operations while remaining in compliance with the rule. We intend to commit significant resources to education, training, and technical assistance to help farms comply with the rule—see section XXII of this document. Also, as discussed in section X of this document, although we expect farms that establish and use an alternative approach (where permitted) to have the necessary scientific data or other information in support of that alternative, such data or information may be developed by you, available in

the scientific literature, or available to you through a third party. We anticipate that the necessary scientific support for an alternative could be developed with broad efforts across the produce community, involving academia, extension services, industry associations, and federal, State, tribal, and local government agencies. FDA is collaborating with partners on research that may provide scientific support for specific alternatives, and we intend to disseminate useful scientific information, when available, and issue commodity- and region-specific guidance as appropriate, such that farmers would be able to consider our recommendations and apply the new scientific information to their operations, as appropriate.

J. Other Comments

(Comment 35) Comments strongly encourage FDA to interact with the retail community to promote the adoption of the final produce rule as a uniform public/private standard. Citing concerns that farms are suffering from “audit fatigue” due to the multitude of requirements already in place from handlers, retailers, and state authorities, these comments urge FDA to facilitate standardization of produce safety requirements and third-party audits.

(Response) FDA is aware of the multitude of audit programs with varying requirements and the associated burden that this places on farms. The produce safety regulation represents science-based minimum standards for the safe production and harvesting of produce to minimize the risk of serious adverse health consequences or death. We understand that, as of the publication of this document, many of the widely used food safety schemes and programs will be considering whether and how to revise their provisions in light of the requirements of FDA regulations, including this produce safety regulation and our other new FSMA regulations. We expect to continue to work in collaboration with stakeholders, including the buyer community, as we move forward in implementing this rule.

(Comment 36) One comment requests FDA to provide a safe harbor exemption for contracts and from torts when produce is not delivered due to demonstrated food safety concerns.

(Response) We are not establishing requirements of the type suggested by this commenter. We do not believe it would be appropriate for FDA to dictate, or to invalidate, the specific aspects of contract terms between private parties that the commenter asks us to regulate in this rule. We do not discourage private parties from including “safe harbor” provisions such as those described by the commenter in their agreements, but we decline to require or otherwise establish them. In addition, we note that section 301(a) of the FD&C Act already prohibits the introduction or delivery for introduction of adulterated food into interstate commerce. Tort law duties are outside the scope of this rulemaking.

V. Final Qualitative Assessment of Risk

In the 2013 proposed produce safety rule, we discussed the findings of a draft qualitative assessment of risk (“the draft QAR”) of hazards related to produce production and harvesting that we conducted to inform the development of our proposed regulatory approach. The draft QAR addressed various questions related to produce safety, including: (1) What are the biological hazards of concern in produce that can lead to serious adverse health consequences or death? (2) How does produce become contaminated (

i.e.,

routes of contamination) during on-farm growth, harvesting, and postharvest operations? (3) Does the likelihood of contamination vary among produce commodity types? (4) Does the likelihood of illness attributable to produce consumption vary among produce commodity types? (5) What is the impact of postharvest practices on the level of contamination at consumption? (6) What on-farm interventions are available to reduce the likelihood of contamination?

As indicated in the 2013 proposed produce safety rule, the draft QAR was peer reviewed in April, 2013. We considered peer reviewers' comments as well as public comments received in response to the proposed produce safety rule, and finalized the QAR. We consider changes made from the draft QAR to the final QAR, such as adding a sensitivity analysis regarding the scoring system used in the draft QAR and updating the datasets for outbreaks and farm investigations to include data through 2014, to have improved the robustness of the QAR. We provide a brief summary of conclusions of the QAR in the paragraphs that follow. For the complete QAR and our responses to comments received, see (Ref. 29) (Ref. 42), respectively. Key conclusions from this assessment are: (1) Produce can be contaminated with biological hazards, and the vast majority of produce-related illnesses are associated with biological hazards; (2) the known routes of contamination from growing, harvesting, and on-farm postharvest activities are associated with seed (for sprouts), water, soil amendments, animals, worker health and hygiene, and buildings/equipment; (3) although some types of produce have been repeatedly associated with outbreaks, all types of produce commodities have the potential to become contaminated through one or more of these potential routes of contamination; (4) the specific growing, harvesting, and on-farm postharvest conditions and practices associated with a produce commodity influence the potential routes of contamination and the likelihood that the given route could lead to contamination and illness. Use of poor agricultural practices could lead to contamination and illness, even where the potential for contamination is relatively low; and (5) postharvest practices such as cooking (and possibly certain peeling) before consumption may have an impact on the likelihood of contamination of the edible portion and, thus, may decrease the likelihood of exposure of consumers to contamination.

Hazards of concern in produce

—The scientific evidence from outbreaks, surveys and published literature establishes that human pathogens (

e.g., Salmonella,

pathogenic

E.coli, Shigella,

and

Cyclospora

) constitute a biological hazard with the potential to cause serious adverse health consequences or death and result in the vast majority of foodborne illness known to be associated with produce consumption.

Potential routes of contamination

—Based on our observations during inspections, investigations, and surveillance activities and other available information, we have grouped the possible routes of contamination into five major pathways: Water, Soil amendments, Animals, Worker health and hygiene, and Equipment and buildings. Seed is an additional route of contamination for sprouts.

Likelihood of contamination

—All produce commodities can be contaminated before, during, and/or after harvest through one or more of the potential routes of contamination. Although the likelihood of contamination varies by commodity, it appears to be dependent on the practices employed and, to a lesser extent, on the characteristics of the commodity. There appears to be greater variability in the likelihood of contamination among commodities during growing than during harvest or after harvest.

Likelihood of exposure

—Subsequent to any contamination on-farm, consumer and retail handling practices and produce consumption rates affect the likelihood that consumers will be exposed to contamination (see also section IX.A.3 of this document).

Postharvest practices such as cooking (and possibly certain peeling) before consumption may have an impact on the likelihood of exposure if indeed the produce is contaminated.

Risk of illness

—Contaminated produce has the potential to cause illness. However, there are differences among commodities in the risk of illness, primarily based on the routes of contamination associated with the commodity.

Produce commodities that are ranked as “higher” risk of illness and those ranked as “lower” risk of illness share some of the same characteristics. Both categories include:

Crops where the harvestable portion grows in the ground;

Row crops where the harvestable portion grows on or near the ground;

Crops where the harvestable portion grows above the ground;

Crops where the harvestable portion grows on trees, high above the ground; and

Crops that are generally grown without soil.

Such diversity suggests that sorting commodities for risk based only on the manner in which commodities grow would be inappropriate. This diversity also characterizes commodities associated with outbreaks. Even within a commodity group, physical characteristics (such as texture of the fruit) of the commodity that could alter the potential for contamination and, therefore, association with an outbreak, do not always appear to do so.

In summary, some produce types are repeatedly associated with reported foodborne illness whereas other produce types are only intermittently associated with foodborne illness. Still other produce commodities have not been associated with reported foodborne illness. Likely factors contributing to the likelihood of contamination, exposure, and illness include: agricultural practices used during growing, harvesting, and postharvest; physical characteristics of the crop; consumer and retail handling practices (such as cooking and peeling); and rates of consumption. However, use of poor agricultural practices could lead to contamination and illness, even where the potential for contamination is relatively low.

The QAR also identifies certain data gaps and research needs that would reduce our uncertainty in understanding how produce becomes contaminated and how that contamination contributes to risk during growing, harvesting, and postharvest activities. Areas for research needs identified in the QAR are origins of pathogens in the farm environment; survival and distribution of pathogens in the farm environment, specifically in animals, soils, water; transfer of pathogens to produce; survival and growth of pathogens on produce; and prevalence and levels of pathogens in produce that cause illness.

We conclude the QAR advances our ability to describe, in a systematic manner, the current state of our knowledge about the likelihood of illness associated with produce and the likely routes of contamination from on-farm activities. It provides a framework for integrating and evaluating the scientific knowledge related

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