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 - 11.23; 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 that encourage 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 an 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 potential 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 all federal regulations, affected producers and industry will absorb costs associated with compliance 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.

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, 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 contamination to one that focuses on preventing it.

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 RuleComments@TexasAgriculture.gov. Comments must be received no later than January 31, 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) CFR--Code of Federal Regulations.

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

(3) FDA--Food and Drug Administration.

(4) Produce Safety Rule--21 CFR Part 112: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.

(5) Raw agricultural commodity--Food as defined in section 201 of the Federal Food, Drug, and Cosmetic Act.

(6) 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 raw agricultural commodity; 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.

The following is a covered farm under 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 raw agricultural commodities; or

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

§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 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 November 30, 2018.

TRD-201805123

Jessica Escobar

Assistant General Counsel

Texas Department of Agriculture

Earliest possible date of adoption: January 13, 2019

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


SUBCHAPTER B. COVERAGE AND EXEMPTIONS

4 TAC §§11.20 - 11.23

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.Farm Inventory Survey.

A farm in Texas which grows covered produce is required to submit a Farm Inventory Survey to determine whether it is exempt, covered, or eligible for a qualified exemption from the requirements of the Produce Safety Rule.

§11.21.Qualified Exemption.

TOPS shall 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.

§11.22.Verification of Eligibility.

(a) Qualified Exemption determinations for covered farms shall be calculated on a yearly basis, valid until their anniversary date, which is one (1) year from the date of issuance by TOPS. A covered farm shall be required to reaffirm eligibility for a Qualified Exemption status upon its anniversary date.

(b) TDA will provide notice of the required reaffirmation and renewal of a Qualified Exemption by sending a Qualified Exemption Verification Form to the farm'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 its 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) At any time, TOPS reserves the right to schedule an on-site visit to verify whether a farm is exempt, covered, or eligible for a Qualified Exemption.

§11.23.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 Food and Drug Administration 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 November 30, 2018.

TRD-201805124

Jessica Escobar

Assistant General Counsel

Texas Department of Agriculture

Earliest possible date of adoption: January 13, 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. During normal business hours, TOPS may enter the premises of a covered or Qualified Exempt farm, and all locations or areas where there are activities, conditions, produce, and equipment on covered and qualified exempt farms, or at any other location where covered activities occur:

(1) to examine records; or

(2) to conduct inspections.

(b) TOPS may enter the premises of a covered and exempt/or Qualified Exempt farm, and all locations or areas where there are activities, conditions, produce, and equipment on covered and qualified exempt farms, or at any other location where covered activities occur, to respond to any emergency involving an egregious condition, as defined in §11.42 of this title (relating to a Stop Sale), at any time.

(c) Failure to comply with a TOPS examination or 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 title (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 may be developed by the producer and approved by TOPS in response to one or more findings by TOPS that result in a violation during an inspection. Implementation of the Corrective Action Plan must fully and permanently correct the deficiency upon re-inspection.

§11.42.Stop Sale.

(a) A Stop Sale Order may be issued upon a finding of an egregious condition, which is a practice, condition or situation on a farm or in a covered location that is reasonably likely to lead to:

(1) serious adverse health consequences to, or death of, a human from the consumption or exposure to covered produce; or

(2) an imminent public health hazard if corrective action is not taken immediately.

(b) A Stop Sale Order shall apply to all commodities, lots, batches, or bins that are determined to be non-compliant, at-risk, or affected by the 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 any provision of the Produce Safety Rule or this chapter has been violated may file a complaint with TOPS.

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

(c) A final and complete inspection report will be made available upon written request by concerned parties or the public to the extent authorized under Chapter 552 of the Texas Government Code.

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 November 30, 2018.

TRD-201805125

Jessica Escobar

Assistant General Counsel

Texas Department of Agriculture

Earliest possible date of adoption: January 13, 2019

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