TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 100. IMMUNIZATION REGISTRY

25 TAC §§100.1 - 100.8, 100.10

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts amendments to §§100.1 - 100.8 and 100.10, concerning the Texas Immunization Registry (registry).

The amendments to §§100.1 - 100.8 and 100.10 are adopted without changes to the proposed text as published in the October 11, 2019, issue of the Texas Register (44 TexReg 5867), and therefore will not be republished.

BACKGROUND AND JUSTIFICATION

DSHS offers the registry at no cost to all Texans. The registry is secure and confidential and safely consolidates and stores immunization records from multiple sources in one centralized system.

Texas law requires written consent by individuals to participate in the registry. Access to the registry records is for those who have authorization. Authorized organizations include health care providers, schools, and public health departments. The registry is part of an initiative to increase vaccine coverage across Texas.

The amendments are necessary to comply with H.B. 1256, 86th Legislature, Regular Session, 2019, which amended Texas Health and Safety Code, Chapter 161. The new law requires DSHS to establish a process to provide an employer of a first responder with direct access in the registry for verification of the first responder's immunization history. This process requires the prior written or electronic consent of the first responder. H.B. 1256 addresses concerns that some first responders may be unaware of their vaccination status and lack access to their immunization information, which could delay their ability to render aid during a declared disaster quickly and effectively.

COMMENTS

The 31-day comment period ended November 12, 2019. During this period, DSHS did not receive any comments regarding the proposed rules.

STATUTORY AUTHORITY

The amendments are authorized by Texas Health and Safety Code, Chapter 161; Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters within DSHS jurisdiction.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 9, 2019.

TRD-201904643

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: January 1, 2020

Proposal publication date: October 11, 2019

For further information, please call: (800) 252-9152


CHAPTER 229. FOOD AND DRUG

SUBCHAPTER EE. COTTAGE FOOD PRODUCTION OPERATIONS

25 TAC §229.661

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts an amendment to §229.661, concerning Cottage Food Production Operations. The amendment to §229.661 is adopted with changes to the proposed text as published in the October 18, 2019, issue of the Texas Register (44 TexReg 5993) and will be republished.

BACKGROUND AND JUSTIFICATION

The adopted amendment to §229.661 complies with Senate Bill (S.B.) 572, 86th Legislature, Regular Session, 2019, which amended Texas Health and Safety Code, Chapter 437, relating to Cottage Food Production Operations. The legislation expands and clarifies the list of foods allowable as cottage food products to include frozen raw and uncut fruit or vegetables, pickled fruit or vegetables, fermented vegetable products, plant-based acidified canned foods, and any other food that is not a time and temperature control for safety food. The legislation sets forth specific requirements for cottage foods production of fermented and acidified canned foods and requirements for DSHS to implement procedures for recipe source approval and to maintain lists of laboratories and process authorities on DSHS' website. The legislation expands the methods by which cottage food products may be marketed and sold through the internet and by mail-order.

COMMENTS

The 31-day comment period ended November 18, 2019.

During this period, DSHS received three (two from the same source) comments by email and one comment by telephone regarding the proposed rule from San Angelo-Tom Green County Health Department, Harris County Public Health, and Texas Environmental Health Association. A summary of comments relating to the amended rule and DSHS's responses follows.

Comment: The representative from Harris County Public Health noted an error in rule references to the definition for "time and temperature control for safety foods." The reference should be revised to paragraph (13) instead of paragraph (14).

Response: DSHS agrees and the rule references to paragraph (13) have been revised in §229.661(b)(3)(A)(i) and (b)(3)(A)(xx).

Comment: The representative from Harris County Public Health objected to the change in definition of a "farmers' market" at §229.661(b)(7) for the following reasons: (i) The changed definition no longer matches the definition of "farmers' market" in Texas Health and Safety Code, §437.020(a)(1). (ii) The change in definition conceivably allows any event to be called a "farmers' market," thus changing the way local regulatory agencies must regulate certain activities and hindering them in their mission. (iii) The changed definition essentially removes the special character intended for farmers' markets as an event "primarily" for farmers and their food and wares. This was not the original intent of a farmers' market.

Response: DSHS agrees with (i) and (iii) and revised the rule to the original definition of "farmers' market" as suggested and per Texas Health and Safety Code, §437.020(a)(1).

Comment: The representative from San Angelo-Tom Green County Health Department requested clarification, either in rule or guidance, regarding the meaning of §229.661(b)(3)(C) and (D) regarding where cottage food operators are now allowed to sell their products. For example, are cottage food operators able to occupy "kiosks at the mall" or "mobile trailers?" The commenter does not agree with either scenario and suggests that, if the scenarios are allowed, there will be pushback from permitted establishments.

Response: DSHS disagrees and declines to revise the rule based on this comment. The wording of the passage in question is directly from Texas Health and Safety Code, §437.001(2-b)(C) and (D). S.B. 572 removed the previous restrictions on location of sale from the statute and did not add language to prevent a cottage food operator from selling cottage food products from a kiosk at the mall, from a mobile unit, or from another retail location not prohibited by local zoning ordinances.

Comment: The representative from Texas Environmental Health Association pointed to wording at §229.661(e)(2)(A) that states that the operator must deliver products to the consumer "person-to-person" does not match the wording from Texas Health and Safety Code, §437.0194(b)(1), which states that the operator must "personally deliver" products to the consumer. This potentially changes the meaning and the intent of the language in the bill and statute.

Response: DSHS agrees and revises the rule as suggested.

Due to a DSHS staff comment, the name of the subchapter is changed to Cottage Food Production Operations.

STATUTORY AUTHORITY

The amendment is adopted under Texas Health and Safety Code, §437.0056, which provides the Executive Commissioner of HHSC with authority to adopt rules necessary to care out Chapter 437, including rules governing cottage food operations; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

§229.661.Cottage Food Production Operations.

(a) Purpose. The purpose of this section is to implement Health and Safety Code, Chapter 437, related to cottage food production operations, which requires the department to adopt rules for labeling and production of foods by cottage food production operations.

(b) Definitions. The following words and terms when used in this subchapter shall have the following meanings unless the context clearly indicates otherwise.

(1) Acidified canned goods--Food with a finished equilibrium pH value of 4.6 or less that is thermally processed before being placed in an airtight container.

(2) Baked good--A food item prepared by baking the item in an oven, which includes cookies, cakes, breads, Danishes, donuts, pastries, pies, and other items that are prepared by baking.

(3) Cottage food production operation (operator)--An individual, operating out of the individual's home, who:

(A) produces at the individual's home:

(i) a baked good that is not a time and temperature control for safety food (TCS food), as defined in paragraph (13) of this subsection;

(ii) candy;

(iii) coated and uncoated nuts;

(iv) unroasted nut butters;

(v) fruit butters;

(vi) a canned jam or jelly;

(vii) a fruit pie;

(viii) dehydrated fruit or vegetables, including dried beans;

(ix) popcorn and popcorn snacks;

(x) cereal, including granola;

(xi) dry mix;

(xii) vinegar;

(xiii) pickled fruit or vegetables, including beets and carrots, that are preserved in vinegar, brine, or a similar solution at an equilibrium pH value of 4.6 or less;

(xiv) mustard;

(xv) roasted coffee or dry tea;

(xvi) a dried herb or dried-herb mix;

(xvii) plant-based acidified canned goods;

(xviii) fermented vegetable products, including products that are refrigerated to preserve quality;

(xix) frozen raw and uncut fruit or vegetables; or

(xx) any other food that is not a TCS food, as defined in paragraph (13) of this subsection.

(B) has an annual gross income of $50,000 or less from the sale of food described by subparagraph (A) of this paragraph;

(C) sells foods produced under subparagraph (A) of this paragraph only directly to consumers; and

(D) delivers products to the consumer at the point of sale or another location designated by the consumer.

(4) Department--The Department of State Health Services.

(5) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.

(6) Farm stand--A premises owned and operated by a producer of agricultural food products at which the producer or other persons may offer for sale produce or foods described in paragraph (3) of this subsection.

(7) Farmers' market--A designated location used primarily for the distribution and sale directly to consumers of food by farmers or other producers.

(8) Fermented vegetable product--A low-acid vegetable food product subjected to the action of certain microorganisms that produce acid during their growth and reduce the pH value of the food to 4.6 or less.

(9) Food establishment--

(A) Food establishment means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:

(i) such as a restaurant; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and

(ii) that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.

(B) Food establishment includes:

(i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and

(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.

(C) Food establishment does not include:

(i) an establishment that offers only prepackaged foods that are not TCS foods;

(ii) a produce stand that only offers whole, uncut fresh fruits and vegetables;

(iii) a food processing plant including those that are located on the premises of a food establishment;

(iv) a kitchen in a private home if only food that is not TCS food is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;

(v) an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption;

(vi) a Bed and Breakfast Limited establishment as defined in §228.2 of this title (relating to Definitions) concerning food establishments;

(vii) a private home that receives catered or home-delivered food; or

(viii) a cottage food production operation.

(10) Herbs--The leafy green parts of a plant (either fresh or dried) used for culinary purposes and not for medicinal uses.

(11) Home--A primary residence that contains a kitchen and appliances designed for common residential usage.

(12) Process authority--A person who has expert knowledge acquired through appropriate training and experience in the pickling, fermenting, or acidification and processing of pickled, fermented, or acidified foods.

(13) Time and temperature control for safety food (TCS food)--A food that requires time and temperature control for safety to limit pathogen growth or toxin production. The term includes a food that must be held under proper temperature controls, such as refrigeration, to prevent the growth of bacteria that may cause human illness. A TCS food may include a food that contains protein and moisture and is neutral or slightly acidic, such as meat, poultry, fish, and shellfish products, pasteurized and unpasteurized milk and dairy products, raw seed sprouts, baked goods that require refrigeration, including cream or custard pies or cakes, and ice products. The term does not include a food that uses TCS food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production.

(c) Complaints. The department shall maintain a record of a complaint made by a person against an operator.

(d) Packaging and labeling requirements for cottage food production operations. All foods prepared by an operator shall be packaged and labeled in a manner that prevents product contamination.

(1) The label information shall include:

(A) the name and physical address of the cottage food production operation;

(B) the common or usual name of the product;

(C) disclosure of any major food allergens, such as eggs, nuts, soy, peanuts, milk, wheat, fish, or shellfish used in the product; and

(D) the following statement: "This food is made in a home kitchen and is not inspected by the Department of State Health Services or a local health department."

(2) Labels must be legible.

(3) A food item is not required to be packaged if it is too large or bulky for conventional packaging. For these food items, the information required under paragraph (1) of this subsection shall be provided to the consumer on an invoice or receipt.

(4) A label for frozen raw and uncut fruit or vegetables must include the following statement in at least 12-point font when sold: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria, keep this food frozen until preparing for consumption" on the label or on an invoice or receipt provided with the frozen fruit or vegetables.

(5) Advertising media of cottage food products for health, disease, or other claims must be consistent with those claims allowed by the Code of Federal Regulations Title 21, Part 101, Subparts D and E.

(e) Certain sales by cottage food production operations prohibited or restricted.

(1) An operator may not sell any of the foods described in this section at wholesale.

(2) An operator may sell a food described in this section in this state through the internet or by mail-order only if:

(A) the consumer purchases the food through the internet or by mail-order from the operator and the operator personally delivers the food to the consumer; and

(B) subject to paragraph (3) of this subsection, before the operator accepts payment for the food, the operator provides all labeling information required by subsection (d) of this section to the consumer by:

(i) posting a legible statement on the cottage food production operation's internet website;

(ii) publishing the information in a catalog; or

(iii) otherwise communicating the information to the consumer.

(3) The operator that sells a food described by subsection (b)(3)(A) of this section in this state in the manner described by paragraph (2) of this subsection:

(A) is not required to include the address of the cottage food production operation in the labeling information required under subsection (d)(1)(A) of this section before the operator accepts payment for the food; and

(B) shall provide the address of the cottage food production operation on the label of the food in the manner required by subsection (d)(1)(A) of this section after the operator accepts payment for the food.

(f) Requirements for sale of certain cottage food products.

(1) An operator that sells to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods shall:

(A) use a recipe that:

(i) is from a source approved by the department under paragraph (4) of this subsection;

(ii) has been tested by an appropriately certified laboratory that confirmed the finished fruit or vegetable product, or plant-based acidified canned good has an equilibrium pH value of 4.6 or less; or

(iii) is approved by a qualified process authority; or

(B) if the operation does not use a recipe described by subparagraph (A) of this paragraph, test each batch of the recipe with a calibrated pH meter to confirm the finished fruit or vegetable, product, or plant-based acidified canned good has an equilibrium pH value of 4.6 or less.

(2) An operator may not sell to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods before the operator complies with paragraph (1) of this subsection.

(3) For each batch of pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods, an operator must:

(A) label the batch with a unique number; and

(B) for a period of at least 12 months, keep a record that includes:

(i) the batch number;

(ii) the recipe used by the producer;

(iii) the source of the recipe or testing results as applicable; and

(iv) the date the batch was prepared.

(4) The department shall:

(A) approve sources for recipes that an operator may use to produce pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods; and

(B) semiannually post on the department's internet website a list of the approved sources for recipes, appropriately certified laboratories, and qualified process authorities.

(5) This subsection does not apply to a pickled cucumber preserved in vinegar, brine, or similar solution.

(g) Requirements for the sale of frozen raw and uncut fruit or vegetables. An operator that sells to consumers frozen raw and uncut fruit or vegetables shall:

(1) store and deliver the frozen raw and uncut fruit or vegetables at an air temperature of not more than 32 degrees Fahrenheit; and

(2) label the frozen raw and uncut fruit or vegetables in accordance with subsection (d)(4) of this section.

(h) A cottage food production operation is not exempt from meeting the application of Health and Safety Code, §431.045, Emergency Order; §431.0495, Recall Orders; and §431.247, Delegation of Powers or Duties. The department or local health authority may act to prevent an immediate and serious threat to human life or health.

(i) Prohibition for Cottage Food Production Operations. A cottage food production operation may not sell TCS foods to customers.

(j) Production of Cottage Food Products - Basic Food Safety Education or Training Requirements.

(1) An individual who operates a cottage food production operation must have successfully completed a basic food safety education or training program for food handlers accredited under Health and Safety Code, Chapter 438, Subchapter D.

(2) An individual may not process, prepare, package, or handle cottage food products unless the individual:

(A) meets the requirements of paragraph (1) of this subsection;

(B) is directly supervised by an individual described by paragraph (1) of this subsection; or

(C) is a member of the household in which the cottage food products are produced.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 9, 2019.

TRD-201904639

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: January 1, 2020

Proposal publication date: October 18, 2019

For further information, please call: (512) 231-5653