DEPARTMENT OF AGRICULTURE RULES PERTAINING TO THE ADMINISTRATION AND ENFORCEMENT OF THE PRODUCE SAFETY ACT 8 CCR 1202-17 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] Pursuant to the provisions and requirements of the Produce Safety Act, Title 35, Article 77, C.R.S., the following rules are hereby promulgated to enforce under Colorado law the federal Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, 21 CFR § 112.

Part 1 DEFINITIONS

1.1 “Act” means the Produce Safety Act, Title 35, Article 77, C.R.S.

1.2 “Adulterated’ has the same meaning as defined in section 402 of the Federal

1. Food, Drug, and Cosmetic Act.

1.3 “Commissioner” means the Colorado Commissioner of Agriculture or any

1. employee designated by the Commissioner.

1.4 “Covered Activity” has the same meaning as set forth in 21 CFR 112.3.

1.5 “Covered Farm” has the same meaning as set forth in 21 CFR 112.4

1.6 “Covered Produce” has the same meaning as set forth in 21 CFR 112.3.

1.7 “Department” means the Colorado Department of Agriculture.

1.8 “Farm” has the same meaning as set forth in 21 CFR 112.3 and includes all

1. buildings or areas where covered activity occurs or covered produce is grown, stored, handled or kept. It includes farms incorporated into other businesses.

1.9 “Farm Records” means any record that identifies a farm's ownership, or contains trade secrets, privileged information, or confidential commercial, financial, geological, or geophysical data. Such records can be in written, printed, photographic, electronic or digital format and can include, but are not required to include: crop information, financial information, purchase and sale information, operational protocols, or account numbers or unique identifiers issued by government or private entities.

1.10 “FDA” means the United States Food and Drug Administration.

1. 1.11 “Imminent Threat to Public Health” means a significant threat or danger to
   1. health is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that is substantially likely to pose a significant danger considering the number of potential injuries and the nature, severity, and duration of the anticipated injury to human health that:
2. (1) should be corrected immediately to prevent injury and, (2) should not be permitted to continue while an investigation, hearing, or other formal process is being held.
   1. The imminent threat may be declared at any point in the chain of events which ultimately result in harm to the public. The occurrence of the final anticipated injury is not essential to establish that an imminent threat of such occurrence exists.

1.12 “Mixed-Type Facility” has the same meaning as set forth in 21 CFR 112.3.

1.13 “Produce” has the same meaning as set forth in 21 CFR 112.3.

1.14 “Produce Safety Act” means the Colorado Produce Safety Act, Title 35, Article 77, C.R.S.

1.15 “Program” means the Produce Safety Program within the Colorado Department

1. of Agriculture.

1.16 “Registrant” means a covered farm that is required to register pursuant to the

1.17 “Registration” means the annual submission of a registration form to the

1. Commissioner identifying a covered farm and complying with the requirements of Title 35, Article 77, C.R.S.

1.18 “Registration Period” means the time when submission of required information to the Program occurs.

1.19 “Regulated Person” means a grower, grower-shipper, harvester, packer, cooler or holder that is a farm, as defined in 21 CFR 112.3 and is subject to any of the requirements of the Act and these Rules.

1.20 “Routine Regulatory Inspection” means an inspection of a Regulated Person’s farm to monitor for compliance with these Produce Safety Rules. Part 2 ADOPTION OF FEDERAL CODE

2.1 Material incorporated by reference does not include any later amendments or

1. editions of the incorporated material. Copies of material incorporated by reference in these Rules is available for public inspection during regular business hours. This incorporated material may be obtained at a reasonable charge or examined by contacting the Department of Agriculture, 305 Interlocken Parkway, Broomfield, CO 80021 or at the offices of the US. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Further, the incorporated material may be examined at no cost on the Internet at: 21 CFR § 112, Subpart A, B, C, D, F, I, K, L, N, O, Q, and R, (2015): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFR Part=112 21 CFR § 112, Subpart E (2024):

   https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFR Part=112 21 USC § 342 (2024):

   https://uscode.house.gov/view.xhtml?req=(title:21%20section:342%20edition:prel im)%20OR%20(granuleid:USC-prelim-title21- section342)&f=treesort&edition=prelim&num=0&jumpTo=true Part 3 REGISTRATION REQUIREMENT

3.1 A farm or mixed type facility, that conducts Covered Activity of any Covered Produce at any primary production farm or secondary activities farm location, and which the average annual monetary value of produce sold during the previous three-year period is more than average monetary value determined in Part 3.5 of this Rule, must register and is subject to the General Provisions in Subpart A of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published November 27, 2015.

3.2 A farm that is eligible for a qualified exemption, as defined in Subpart A of 21 CFR § 112.5, must register with the Department and is only subject to sections of Subpart A of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”, stated in 21 CFR § 112.6 and

1. 112.7

3.3 Registration and the General Provisions of Subpart A of 21 CFR § 112 do not

1. apply to a farm or mixed-type facility that has an annual monetary value of produce sold during the previous three year period that is less than the monetary value determined in Part 3.5 of this Rule, even if that farm or mixed-type facility conducts Covered Activity.

3.4 Each farm, or mixed type facility, required to register shall do so annually during the registration period of November 1 to December 31. Such registration shall be completed by the submission of a form in the manner required by the Commissioner. All such information shall be complete and accurate.

3.5 For the 2026 registration year of January 1, 2026, to December 31, 2026, a farm that sold an average monetary value of produce during 2022, 2023, and 2024 with more than $33,297 must register with the Department. Part 4 GENERAL PROVISIONS 4.1 These Rules incorporate by reference the General Provisions in Subpart A of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”, published November 27, 2015. Such incorporation excludes any later amendments or editions. Part 5 RESERVED Part 6 CONFIDENTIALITY OF RECORDS 6.1 Farm records are confidential pursuant to §35-77-107, C.R.S. and §24-72-204, C.R.S.

6.2 Complaints of record, investigations, and inspection reports may, at the

1. discretion of the Commissioner, be closed to public inspection except to the person of interest, as defined in §24-72-202, C.R.S., or as provided by court order.

Part 7 GENERAL REQUIREMENTS 7.1 These Rules incorporate by reference the General Requirements in Subpart B of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”, published November 27, 2015. Such incorporation excludes any later amendments or editions.

7.2 Each Regulated Person must take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated, on account of such hazards.

Part 8 PERSONNEL QUALIFICATIONS AND TRAINING

8.1 These Rules incorporate by reference all the Personnel Qualifications and

1. Training requirements found in Subpart C of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” Part 9 HEALTH AND HYGIENE

9.1 These Rules incorporate by reference all the Health and Hygiene requirements found in Subpart D of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published November 27, 2015. Such incorporation excludes any later amendments or editions. Part 10 AGRICULTURAL WATER 10.1 These Rules incorporate by reference all the Agricultural Water requirements found in Subpart E of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published May 6, 2024. Such incorporation excludes any later amendments or editions. Part 11 BIOLOGICAL SOIL AMENDMENTS OF ANIMAL ORIGIN AND HUMAN WASTE

11.1 These Rules incorporate by reference all the Biological Soil Amendments of

1. Animal Origin and Human Waste requirements found in Subpart F of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published November 27, 2015. Such incorporation excludes any later amendments or editions.

Part 12 RESERVED Part 13 RESERVED Part 14 DOMESTICATED AND WILD ANIMALS

14.1 These Rules incorporate by reference all the Domesticated and Wild Animals

1. requirements found in Subpart I of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” Part 15 RESERVED Part 16 GROWING, HARVESTING, PACKING and HOLDING ACTIVITIES

16.1 These Rules incorporate by reference all the Growing, Harvesting, Packing and Holding Activity requirements found in Subpart K of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published November 27, 2015. Such incorporation excludes any later amendments or editions.

Part 17 EQUIPMENT, TOOLS, BUILDINGS, AND SANITATION 17.1 These Rules incorporate by reference all the Equipment, Tools, Buildings and Sanitation requirements found in Subpart L of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” Part 18 RESERVED Part 19 ANALYTICAL METHODS 19.1 These Rules incorporate by reference all the Analytical Methods requirements found in Subpart N of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published November 27, 2015. Such incorporation excludes any later amendments or editions. Part 20 RECORDS

20.1 These Rules incorporate by reference all the Records requirements found in

1. Subpart O of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published November 27, 2015. Such incorporation excludes any later amendments or editions. Part 21 RESERVED Part 22 COMPLIANCE AND ENFORCEMENT

22.1 These Rules incorporate by reference all the Compliance and Enforcement

1. requirements found in Subpart Q of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” Part 23 WITHDRAWAL OF QUALIFIED EXEMPTIONS

23.1 These Rules incorporate by reference all the Withdrawal of Qualified Exemption requirements found in Subpart R of 21 CFR § 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” Part 24 UNLAWFUL ACTS 24.1 In addition to the Unlawful Acts in section §35-77-109, C.R.S., any Regulated Person or Registered entity will be subject to a civil penalty up to $2500 per violation for:

1. 24.1.1 Failing to timely register with the Program;
2. 24.1.2 Providing false, inaccurate or misleading information to the Commissioner or Department of Agriculture; or 24.1.3 Failing to comply with any of the requirements in Part 3, 4, 7, 8, 9, 10, 11, 14, 16, 17, 19, 20, 22, 23, 24 or 25 of these Rules.

Part 25 STOP SALE, RECALL, EMBARGO, QUARANTINE 25.1 In addition to the requirements for inspection under Part 26, the Commissioner or the Commissioner’s designee may take the following as the result of an inspection or during an investigation:

1. 25.1.1 Require a corrective action plan for violations that pose either some risk to human health or an imminent threat to human health;
2. 25.1.2 Examine and collect environmental, water or covered produce samples for
   1. laboratory analysis;
3. 25.1.3 Initiate a stop sale, recall, embargo or quarantine for violations that pose an imminent threat to public health or adulteration;
   1. 25.1.3.1 The reason for the stop sale, recall, embargo or quarantine
      1. shall be documented on the Order.
   2. 25.1.3.2 The affected produce shall not be sold, used or removed
      1. until the violation is corrected, if possible.
   3. 25.1.3.3 The Regulated Person is responsible for the storage and, if
      1. necessary, the destruction of the affected produce.
      2. 25.1.3.3.1 If storage facilities are not available, the Regulated
         1. Person is responsible for any costs incurred to store the affected produce.
      3. 25.1.3.3.2 The Regulated Person is responsible for any
         1. additional fees associated with the affected produce.
   4. 25.1.3.4 If the produce subject to a stop sale, recall, embargo or
      1. quarantine is found not to be adulterated or associated with a violation that poses an imminent threat to public health, it shall be released.
   5. 25.1.3.5 Failure to comply with the conditions of a stop sale, recall,
      1. embargo or quarantine may result in administrative penalties pursuant to section 35-77-110, C.R.S.
4. 25.1.4 Require follow-up inspections to ensure compliance with the corrective
   1. action plan and these Rules or the Act;
5. 25.1.5 Refer violations for further enforcement action, if necessary.

25.2 Nothing in this section shall be construed to limit the Department’s authority to issue cease-and-desist orders to respond to a condition that may present a public health hazard, or to issue orders necessary to effectuate the purpose of the Act and these Rules.

Part 26 INSPECTIONS 26.1 For each registration period and prior to any Routine Regulatory Inspection, a Regulated Person or authorized representative, must attest that the Regulated Person understands that the Regulated Person has specific rights regarding a Routine Regulatory Inspection. A Regulated Person’s attestation shall be completed in a form established by the Commissioner, referred to as the Notice of Inspection Rights. The form must include attestations that the Regulated Person understands the Regulated Person has the right to:

1. 26.1.1 Receive notification at least five (5) days in advance of a Routine
   1. Regulatory Inspection of their farm.
2. 26.1.2 Meet with the Commissioner prior to the start of a Routine Regulatory
   1. Inspection to explain ongoing operations and to ask questions about the inspection process.
3. 26.1.3 Escort the Commissioner at all times while observing the Regulated
   1. Person’s operations.
4. 26.1.4 Discuss any observations of these Produce Safety Rules with the
   1. Commissioner away from the production area of the Registered Person’s operations. The provisions of this section shall not limit the Commissioner’s ability to issue a cease-and-desist Order, assess an administrative penalty, or otherwise enforce regulatory provisions at a later date pursuant to C.R.S. § 35-77-108 or C.R.S. § 35-77-110.

26.2 The Commissioner reserves the right to conduct an inspection without the notice specified in 26.1.1 under the following conditions:

1. 26.2.1 The Regulated Person cannot be reached at the contact information
   1. provided at the time of Registration;
2. 26.2.2 The Commissioner wishes to ascertain whether corrections have been
   1. made to address a previous violation of these Produce Safety Rules;
3. 26.2.3 The Commissioner has a reasonable belief that the Registrant is in
   1. violation of these Produce Safety Rules resulting in a risk to public health.

26.3 Regulated Persons who meet the criteria for a qualified exemption pursuant to Part 3.2 shall not be subject to Routine Regulatory Inspection, but may be subject to limited records inspections to confirm compliance. Part 27 STATEMENT OF BASIS, SPECIFIC STATUTORY AUTHORITY AND

27.1 Adopted September 9, 2020. Effective Oct 30, 2020

The Commissioner of Agriculture adopts these rules pursuant to §35-77-106(1), C.R.S. The Purpose of this rulemaking is to define the administration and enforcement of the Colorado Produce Safety Act, §§35-77-101 through 111, C.R.S. These rules incorporate 21 CFR 112, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” define Colorado registration requirements and timelines, and establish confidentiality protections for farm records and registrants. House Bill 19-1114, Colorado’s Produce Safety Act, was passed by the General Assembly and signed into law by Governor Polis in 2019. The Act, codified in §§35-77- 101 through 111, C.R.S., authorized the creation of a program within the Department, in lieu of the FDA, to regulate the safe production, handling, packing and storage of produce as defined in 21 CFR Part 112. This rulemaking provides definitions, references and rules to assist in the administration and enforcement of Colorado’s Produce Safety Act.

27.2 Adopted September 8, 2021 - Effective October 30, 2021

The Commissioner of Agriculture adopts these rules pursuant to §35-77-106(1), C.R.S. The purpose of this rule change is to increase the threshold limit for farms Exempt from the rule.

Increased limits allowed for Exempt status are consistent with FDA’s annual adjusted for inflation calculations.

27.3 Adopted October 12, 2022 – Effective December 15, 2022

The Commissioner of Agriculture adopts these rules pursuant to §35-77-106(1), C.R.S. The purpose of this rule change is to increase the threshold limit for farms Exempt from the rule.

Increased limits allowed for Exempt status are consistent with FDA’s annual adjusted for inflation calculations.

27.4 Adopted July 12, 2023 – Effective October 30, 2023

Adoption authority for these rules pursuant to §35-77-106(1), C.R.S. The purpose of this rule change is to increase the threshold limit for farms Exempt from the rule.

Increased limits allowed for Exempt status are consistent with FDA’s annual adjusted for inflation calculations.

27.5 Adopted July 10, 2024 – Effective September 15, 2024

Adoption authority for these rules pursuant to §§ 35-77-104(2) and 106(1), C.R.S. The purpose of this rule change is to increase the threshold limit for farms Exempt from the rule.

Increased limits allowed for Exempt status are consistent with FDA’s annual adjusted for inflation calculations.

27.6 Adopted November 19, 2024 – Effective January 14, 2025

These rules are pursuant to the Commissioner of Agriculture’s authority under §35-77- 105 C.R.S.

The purpose of this rule change is to incorporate by reference revisions to 21 C.F.R Part 112 Subpart E, published May 6, 2024, which replaces the previous version, published on March 18, 2019.

In 2024, the Food and Drug Administration (FDA) set out to revise Subpart E of 21 C.F.R. Part 112, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” FDA’s revisions replace annual water testing with a more current, water-systems-based assessment. The Department has incorporated this revised subpart to maintain its consistency with FDA’s safety and testing requirements related to how produce for human consumption is grown, harvested, packed, and held in Colorado.

27.7 Adopted September 17, 2025 – Effective November 14, 2025

These rules are pursuant to the Commissioner of Agriculture’s authority under § 35-77- 105 and 106(a), C.R.S., to adopt any rules necessary to implement the Produce Safety The purpose of this rule change is to define “Adulterated,” “Imminent Threat to Human Health,” and “Regulated Person”; to increase the threshold limit for farms exempt from the rule; and to authorize the Commissioner to issue corrective action plans and orders to stop sale, recall, embargo, or quarantine when necessary to protect human health. The definitions were added to provide clear meaning for produce that may not be suitable for human consumption and clarify that a regulated person includes both those who have registered and those who have not registered but who are subject to the provisions of the Act. Increasing the threshold limits allowed for exempt status to be consistent with FDA’s annual, adjusted-for-inflation calculations. Because protecting human health from food-borne illness is critical, these rules are necessary to prevent covered produce that may pose a threat to human health from entering or remaining in commerce. Increasing the Commissioner’s remedial actions to include corrective action plans and orders to stop sale, recall, embargo, and quarantine will increase the Commissioner’s ability to meet the over-arching goals of the Produce Safety Act.

27.8 Adopted January 21, 2026 – Effective March 17, 2026

These rules are pursuant to the Commissioner of Agriculture’s authority under § 35-77- 105 and 106(a), C.R.S., to adopt any rules necessary to implement the Produce Safety The purpose of this rule change is to remove the incorporation by reference of the United States Code in the definition of "adulterated.”

Because the State Administrative Procedure Act (§ 24-4-103, C.R.S.) does not permit incorporation by reference of the United States Code, the reviewers propose amending the definition of “adulterated” to remove the incorporation by reference and to, instead, refer to the section of the United States Code (the Federal Food, Drug, and Cosmetic Act) where the definition of “adulterated” is located.

______________________________________________________________________ Editor’s Notes History New rule eff. 10/30/2020.

Rules 3.5, 27.2 eff. 10/30/2021.

Rules 3.5, 27.3 eff. 12/15/2022.

Rules 3.5, 27.4 eff. 10/30/2023.

Rules 3.5, 27.5 eff. 09/15/2024.

Rules 2.1, 10.1, 27.6 eff. 01/14/2025.

Rules 1-2, 3.5, 7.2, 24.1, 25-26, 27.7 eff. 11/14/2025. Rule 1.2, 27.8 eff. 03/17/2026.