Texas Register

TITLE 25 HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER EECOTTAGE FOOD PRODUCTION OPERATION
RULE §229.661Cottage Food Production Operations
ISSUE 02/07/2014
ACTION Proposed
Preamble Texas Admin Code Rule

(a)(No change.)

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

  (1)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. [A baked good does not include a potentially hazardous food (time/temperature control for safety foods).]

  (2)Cottage food production operation--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 potentially hazardous food, as defined in paragraph (11) of this subsection; [ ,]

       (ii)candy;

       (iii)coated and uncoated nuts;

       (iv)unroasted nut butters;

       (v)fruit butters;

      (vi)a canned jam or jelly; [, or]

       (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)pickles, as defined in paragraph (10) of this subsection;

       (xiv)mustard;

       (xv)roasted coffee or dry tea; or

      (xvi)a dried herb or dried herb mix [for sale at the person's home];

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

    (C)sells foods produced under subparagraph (A) of this paragraph only directly to consumers at the individual's home; a farmers' market; a farm stand; a municipal, fair, festival, or event; a county fair, festival, or event; or a nonprofit fair, festival, or event; and[.]

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

  (3) - (4)(No change.)

   (5)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 (2) of this subsection.

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

  (7)[(5)] 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 potentially hazardous (time/temperature control for safety) 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 potentially hazardous (time/temperature control for safety) 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 §229.162 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.

  (8)[(6)] Herbs--Herbs are from the leafy green parts of a plant (either fresh or dried) used for culinary purposes and not for medicinal uses.

  (9)[(7)] Home--A primary residence that contains a kitchen and appliances designed for common residential usage.

   (10)Pickle--A cucumber preserved in vinegar, brine, or similar solution, and excluding all other pickled vegetables.

   (11)Potentially hazardous food (PHF)--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 potentially hazardous 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 potentially hazardous food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production.

   [(8)Potentially hazardous food (PHF) (time/temperature control for safety food (TCS))--]

    [(A)Potentially hazardous food (time/temperature control for safety food) means a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation.]

    [(B)Potentially hazardous food (time/temperature control for safety food) includes:]

      [(i)an animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and]

      [(ii)except as specified in subparagraph (C)(iv) of this paragraph, a food that because of the interaction of it's aw and pH values is designated as Product Assessment required (PA) in Table A or B of this clause.]

        [(I)Table A. Interaction of pH and aw for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged.]

[Figure: 25 TAC §229.661(b)(8)(B)(ii)(I)]

        [(II)Table B. Interaction of pH and aw for control of vegetative cells and spores in food not heat-treated or heat-treated but not packaged.]

[Figure: 25 TAC §229.661(b)(8)(B)(ii)(II)]

    [(C)Potentially hazardous food (time/temperature control for safety food) does not include:]

      [(i)an air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae;]

      [(ii)a food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;]

      [(iii)a food that because of its pH or aw value, or interaction of aw and pH values, is designated as a non-PHF/non-TCS food in Table A or B in subparagraph (B)(ii)(I) and (II) of this paragraph;]

      [(iv)a food that is designated as PA in Table A or B in subparagraph (B)(ii)(I) and (II) of this paragraph and has undergone a Product Assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:]

        [(I)intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;]

        [(II)extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use; or]

        [(III)a combination of intrinsic and extrinsic factors; or]

      [(v)a food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the clauses (i) - (iv) of this subparagraph even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.]

(c)(No change.)

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

  (1) - (2)(No change.)

   (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.

(e)Certain sales [Sales] by cottage food production operations [through Internet] prohibited. A cottage food production operation may not sell any of the foods described in this section [these rules] through the Internet , by mail order, or at wholesale. No health claims may be made on any of the advertising media [medium ] of the finished products because they are conventional foods.

(f)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.

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

(h)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 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 January 27, 2014

TRD-201400299

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: March 9, 2014

For further information, please call: (512) 776-6972



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