|(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
of foods produced 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) 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 a baked good, a canned jam or jelly, or
a dried herb or herb mix for sale at the person's home;
(B) has an annual gross income of $50,000 or less from
the sale of this food described by subparagraph (A) of this paragraph;
(C) sells foods produced under subparagraph (A) of
this paragraph only directly to consumers.
(3) Department--The Department of State Health Services.
(4) Executive Commissioner--The Executive Commissioner
of the Health and Human Services Commission.
(5) Food establishment--
(A) Food establishment means an operation that stores,
prepares, packages, serves, vends, or otherwise provides food for
(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)
(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
(vii) a private home that receives catered or home-delivered
(viii) a cottage food production operation.
(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.
(7) Home--A primary residence that contains a kitchen
and appliances designed for common residential usage.
(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 its 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 a
w for control of spores in food heat-treated to destroy vegetative
cells and subsequently packaged.
(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.
(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 a
w 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,
(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;
(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) Complaints. The department shall maintain a record
of a complaint made by a person against a cottage food production
(d) Labeling requirements for cottage food production
operations. All foods prepared by a cottage food production operation
must be labeled.
(1) The label information shall include:
(A) the name and physical address of the cottage food
(B) the common or usual name of the product;
(C) if a food is made with a major food allergen, such
as eggs, nuts, soy, peanuts, milk or wheat that ingredient must be
listed on the label; 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.
(e) Sales by cottage food production operations through
Internet prohibited. A cottage food production operation may not sell
any of the foods described in these rules through the Internet. No
health claims may be made on any of the advertising medium of the
finished products because they are conventional foods.