TITLE 4. AGRICULTURE

PART 1. TEXAS DEPARTMENT OF AGRICULTURE

CHAPTER 11. TEXAS OFFICE OF PRODUCE SAFETY

The Texas Department of Agriculture (TDA or the Department) proposes new Title 1, Part 4, Chapter 11, Texas Office of Produce Safety, Subchapter A, General Provisions, §§11.1-11.4, relating to General Provisions; Subchapter B, Coverage and Exemptions, §§11.20-11.22; and Subchapter C, Compliance and Enforcement, §§11.40-11.43. The proposed new rules are for TDA's administration of the Food Safety Modernization Act (FSMA), P.L. 111-353, and the rules established by the United States Food and Drug Administration (FDA) to comply with FSMA for produce, titled "Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption," 21 CFR Part 112, commonly referred to as the Produce Safety Rule. By working cooperatively with producers, the Produce Safety Rule helps shift the food safety regulations from a reactive system that focuses on responding to contamination to a proactive one that focuses on preventing them. The proposed rules establish definitions; clarify persons covered by the Produce Safety Rule; and set forth the compliance and enforcement framework.

Through a cooperative agreement with the FDA, the Department is administering the Produce Safety Rule to advance efforts for a nationally integrated food safety system. As part of the cooperative agreement, the Department established the Texas Office of Produce Safety (TOPS) within TDA to administer the Produce Safety Rule. As part of its duties, TOPS will enhance current produce programs within the Department to support the safe production of fresh fruits and vegetables. Additionally, TOPS offers additional outreach programs to educate producers and promote understanding and compliance with the requirements of the Produce Safety Rule.

The proposal is necessary for the administration of the Produce Safety Rule, and to protect Texas consumers and producers by ensuring that food grown, harvested, and packed for human consumption meets the requirements of the rule. The proposed rules are designed to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce. Additionally, the proposal establishes recordkeeping requirements that, in the event of a foodborne illness outbreak, enable TOPS to review producer records and work with FDA to track the potential sources of contamination. TDA will implement the proposed rules while working in cooperation with the fresh fruit and vegetable industries in Texas, to reassure consumers in Texas and nationwide that Texas produce meets national standards designed to protect individuals and families from foodborne illness.

Prior to filing this proposal, the Department held stakeholder meetings across the state to take input on TDA's implementation of the standards contained in the FDA's Produce Safety Rule. The attendees, which included local producers, industry representatives and food retailers, provided valuable feedback regarding the administration of the national produce safety program in Texas. Stakeholder recommendations were taken under consideration in the development of the proposed rules.

Stakeholders and the public recognize that a foodborne outbreak could cause wide-spread illness in humans and have a significant negative impact on the state's economy, as well as that of local communities. Additionally, all businesses in the produce continuum such as producers, processors, transporters, and restaurants that could potentially serve contaminated produce, may suffer economic damages associated with possible recalls and litigation. Other organizations that grow, distribute, or sell the same type of produce may see decreased demand resulting in a reduction in sales volume and market share throughout the nation. Thus, these proposed regulations protect public health, welfare and safety in addition to furthering the state and industry's economic interests.

Industry and the public are generally aware that the Produce Safety Rule includes national standards established by the FDA to comply with FSMA, and that covered farms within the State of Texas are required to follow these standards. Since the inception of the produce safety program, TDA has worked, and continues to work, to protect the public interest while minimizing the impact and cost of this program on producers.

Richard De Los Santos, Director of the Texas Office of Produce Safety, has determined that there will be no fiscal impact to state government as a result of implementing the proposed rules. The program and all associated direct and indirect costs are fully funded by the FDA. There will be no fiscal impact to local governments as a result of the implementation of this proposal.

Mr. De Los Santos has also determined that for each year of the first five years the proposed rules are in effect, the anticipated public benefit as a result of administering the proposed rules will be to safeguard consumers and provide them with reasonable assurance that produce and farms in Texas covered by the Produce Safety Rule meet national standards intended to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce. As with many federal regulations, affected producers and industry will be required to absorb compliance costs associated with the Produce Safety Rule. However, TDA lacks sufficient data to quantify the effect on small and micro-businesses at this time. The cost of compliance with the Produce Safety Rule for affected producers will depend on various factors, including the size of the operation and whether it currently utilizes documentation and other tools necessary for compliance. TDA does not anticipate that there will be an adverse fiscal impact on rural communities related to the implementation of this proposal. Any potential increases in the cost of doing business will be offset by the marketing and sales opportunities for Texas producers due to increased consumer confidence in products as a result of the implemented safety standards.

Mr. De Los Santos has provided the following information related to the government growth impact statement, as required pursuant to Texas Government Code, §2001.021. As a result of implementing the proposal, for the first five years the proposed rules are in effect:

(1) the Texas Office of Produce Safety was created;

(2) an additional 10 employee positions will be created over the course of 5 years, and no existing Department staff positions will be eliminated; and

(3) there will be an increase in future legislative appropriations to the Department.

Additionally, Mr. De Los Santos has determined that for the first five years the proposed rules are in effect:

(1) there will be no increase or decrease in fees paid to the Department, as this program is funded by the FDA, and TDA is not required to assess license or inspection fees in order to implement or finance this program;

(2) new regulations will be created by the proposal;

(3) there will be an increase to the number of individuals subject to the proposal, as this is a new program; however, many farms may claim a qualified exemption from the requirements of this proposal; and

(4) the proposal will positively affect the Texas economy by protecting the public health and Texas fruit and vegetable industry by helping prevent foodborne illness outbreaks, shifting food safety regulations from a system that focuses on responding to contaminations to one that focuses on preventing them.

Written comments on the proposal may be submitted to Richard De Los Santos, Director of the Texas Office of Produce Safety, Texas Department of Agriculture, P.O. Box 12847, Austin, Texas, 78711; or by email to Richard.DeLosSantos@TexasAgriculture.gov. Comments must be received no later than July 12, 2019.

SUBCHAPTER A. GENERAL PROVISIONS

4 TAC §§11.1 - 11.4

The proposal is made under §91.009 of the Texas Agriculture Code (the Code), which designates the Department as the lead agency for the administration, implementation, and enforcement of the Produce Safety Rule, and authorizes the Department to adopt rules to coordinate, implement and enforce the Produce Safety program; and, §12.020 of the Code, which authorizes the Department to assess penalties for violations of rules adopted by the Department.

Chapters 12 and 91 of the Texas Agriculture Code are affected by the proposal.

§11.1.Definitions.

In addition to the definitions set forth in 21 CFR Part 112, the following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Anniversary Date--The last day following two years from the issuance of a Qualified Exemption.

(2) CFR--Code of Federal Regulations.

(3) Department--The Texas Department of Agriculture.

(4) Egregious condition--A practice, condition, or situation on a covered farm or in a packing facility that is undertaken as part of a covered activity that is reasonably likely to lead to:

(A) serious adverse health consequences or death from the consumption of or exposure to covered produce; or

(B) an imminent public health hazard.

(5) FDA--United States Food and Drug Administration.

(6) Inspection--An initial or follow up inspection conducted by TOPS for the purpose of inspecting covered produce, a covered farm, or records related to the Produce Safety Rule.

(7) Produce Safety Rule--21 CFR Part 112: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, including any additions, amendments or revisions thereto.

(8) Raw agricultural commodity (RAC)--The term "raw agricultural commodity" is defined in Section 201(r) of the Federal Food, Drug and Cosmetic Act and means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. See 21 U.S.C. §321(4) and 21 CFR §112.3.

(9) TOPS--Texas Office of Produce Safety.

§11.2.Covered Produce.

(a) Covered produce. Covered produce includes produce listed in 21 CFR §112.1.

(b) Produce that is not covered.

(1) The following produce is "not covered" by the Produce Safety Rule under 21 CFR §112.2(a):

(A) produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same management;

(B) produce that is not a RAC; and

(C) produce that is rarely consumed raw, specifically the produce on the following exhaustive list: Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts.

(2) A farm which solely produces produce that is "not covered" is not subject to the Produce Safety Rule or this chapter.

(3) Produce is eligible for exemption from the requirements of this part if the produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance.

§11.3.Covered Farms.

Per 21 CFR §112.4, the following farms are covered by the Produce Safety Rule and this chapter:

(1) a farm which produces covered produce sold during the previous 3-year period in an amount more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as the baseline year for calculating the adjustment;

(2) a farm which has its primary production that is devoted to growing, harvesting (such as hulling or shelling), packing, and/or holding of RAC; or

(3) a farm which performs covered activities, including manufacturing/processing of covered produce on a farm, but only to the extent that such activities are performed on RAC.

§11.4.FDA Coordinated Outbreak Response and Evaluation ("CORE") Network.

(a) Subject to its cooperation agreement with FDA, TOPS will work in coordination with the FDA's Coordinated Outbreak Response and Evaluation ("CORE") Network to respond to an outbreak which has been identified by CORE.

(b) FDA will be the lead agency conducting on-site visits and inspections related to an outbreak.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 3, 2019.

TRD-201901642

Jessica Escobar

Assistant General Counsel

Texas Department of Agriculture

Earliest possible date of adoption: July 14, 2019

For further information, please call: (512) 463-4075


SUBCHAPTER B. COVERAGE AND EXEMPTIONS

4 TAC §§11.20 - 11.22

The proposal is made under §91.009 of the Texas Agriculture Code (the Code), which designates the Department as the lead agency for the administration, implementation, and enforcement of the Produce Safety Rule, and authorizes the Department to adopt rules to coordinate, implement and enforce the Produce Safety program; and, §12.020 of the Code, which authorizes the Department to assess penalties for violations of rules adopted by the Department.

Chapters 12 and 91 of the Texas Agriculture Code are affected by the proposal.

§11.20.Qualified Exemption.

(a) TOPS may conduct a pre-assessment review to determine whether a farm is covered by the Produce Safety Rule and/or eligible for a Qualified Exemption.

(1) A covered farm is eligible for a Qualified Exemption if it meets the requirements of 21 CFR §112.5.

(2) A covered farm which is eligible for a Qualified Exemption under 21 CFR §112.5, must establish and maintain adequate records demonstrating compliance with criteria necessary for Qualified Exemption as required by 21 CFR §112.7(b).

(3) A covered farm eligible for a Qualified Exemption is subject to the modified requirements set forth in 21 CFR §112.6, and this chapter.

(b) Federal law determines whether or not a farm is subject to the Produce Safety Rule. Failure to permit TOPS to conduct a pre-assessment review does not exclude a farm from being subject to this chapter or the Produce Safety Rule.

§11.21.Verification of Exemption.

(a) A covered farm shall be required to reaffirm eligibility for a Qualified Exemption upon its Anniversary Date. Qualified Exemption determinations for covered farms shall be valid for two years from the date of verification by TOPS.

(b) TDA will provide notice of the required reaffirmation and renewal of a Qualified Exemption by sending a Qualified Exemption Verification Form to the producer's last known address, as reflected in TDA's records, at least 30 days prior to the Anniversary Date.

(c) Failure to return a Qualified Exemption Verification Form within 45 days after the Anniversary Date shall result in a required on-site visit by TOPS to reevaluate exemption, coverage, or eligibility for a qualified exemption. Failure to return a Qualified Exemption Verification Form within 60 days of the Anniversary Date shall result in the presumption by TOPS that the farm is subject to all requirements of the Produce Safety Rule and this chapter.

(d) TOPS reserves the right to schedule, at any time, an on-site visit to verify whether a farm is exempt, covered, or eligible for a Qualified Exemption.

§11.22.Change in Eligibility.

If a farm's qualification for an exemption or eligibility for a Qualified Exemption changes, or if its Qualified Exemption is withdrawn by the FDA as outlined in 21 CFR Part 112, Subpart R, the farm will be considered "Covered" and will be subject to all requirements of the Produce Safety Rule and this chapter.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 3, 2019.

TRD-201901643

Jessica Escobar

Assistant General Counsel

Texas Department of Agriculture

Earliest possible date of adoption: July 14, 2019

For further information, please call: (512) 463-4075


SUBCHAPTER C. COMPLIANCE AND ENFORCEMENT

4 TAC §§11.40 - 11.43

The proposal is made under §91.009 of the Texas Agriculture Code (the Code), which designates the Department as the lead agency for the administration, implementation, and enforcement of the Produce Safety Rule, and authorizes the Department to adopt rules to coordinate, implement and enforce the Produce Safety program; and, §12.020 of the Code, which authorizes the Department to assess penalties for violations of rules adopted by the Department.

Chapters 12 and 91 of the Texas Agriculture Code are affected by the proposal.

§11.40.Right of Entry.

(a) Right of Entry to Determine Coverage or Verify Exceptions. TOPS may enter the premises of a farm growing produce during normal business hours to determine coverage and/or verify exceptions to the Produce Safety Rule.

(b) Right of Entry to Conduct Inspections. TOPS may enter all locations or areas of a covered farm or Qualified Exempt farm during operating hours where there are activities, conditions, produce, and equipment, or at any other location where covered activities occur, to conduct inspections.

(c) Egregious Condition. TOPS may enter the premises of a covered and exempt/or Qualified Exempt farm at any time to conduct an inspection in response to an egregious condition at all locations or areas where there are activities, conditions, produce, and equipment, or at any other location where covered activities occur.

(d) Failure to Comply. Refusal to allow a TOPS inspection, or interfering with TOPS' ability to perform its duties under this section, shall result in a violation, as stated in §11.41 of this chapter, relating to Enforcement and Penalties.

§11.41.Enforcement and Penalties.

(a) The following actions may be taken, and penalties may be assessed in response to findings of violations of the Produce Safety Rule.

Figure: 4 TAC §11.41(a) (.pdf)

(b) A corrective action plan must be developed by the producer and approved by TOPS in response to one or more findings by TOPS of a violation of the Produce Safety Rule. The producer must implement the corrective action plan and demonstrate, upon a follow up inspection by TOPS, that it has fully and permanently corrected the violations of the Produce Safety Rule made the subject of the findings by TOPS in its previous inspection.

§11.42.Stop Sale.

(a) TOPS may issue a stop sale order upon a finding of an egregious condition or for repeated failure to comply with one or more corrective action plans which may result in risk to public health.

(b) A stop sale order shall apply to all covered produce, lots, batches, or bins that are determined to be non-compliant, at-risk, or affected by an egregious condition. A stop sale order may also include covered produce that is stored or in transit.

§11.43. Complaint Investigation.

(a) Any person with reasonable cause to believe that a producer has violated the Produce Safety Rule or this chapter may file a complaint with TOPS.

(b) TOPS may, in its sole discretion, investigate the complaint and make a full written report.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 3, 2019.

TRD-201901644

Jessica Escobar

Assistant General Counsel

Texas Department of Agriculture

Earliest possible date of adoption: July 14, 2019

For further information, please call: (512) 463-4075