(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 [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)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)[(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.
(3)[(2)] 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) [potentially hazardous
food], as defined in paragraph (14) [(11)]
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; [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;
(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 (14) 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 [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.
(4)[(3)] Department--The Department
of State Health Services.
(5)[(4)] Executive Commissioner--The
Executive Commissioner of the Health and Human Services Commission.
(6)[(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 (3)[(2)] of this
subsection.
(7)[(6)] Farmers' market--A
designated location typically used [primarily]
for the [distribution and] sale [directly to consumers]
of food by farmers or other vendors [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)[(7)] 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 [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 TCS [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 §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)[(8)] Herbs--The [
Herbs are from the] leafy green parts of a plant (either fresh
or dried) used for culinary purposes and not for medicinal uses.
(11)[(9)] 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.]
(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)[(11)] Time and temperature
control for safety food (TCS food) [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 TCS [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 TCS [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.
(c)Complaints. The department shall maintain a record
of a complaint made by a person against an operator [a
cottage food production operation].
(d)Packaging and labeling requirements for cottage
food production operations. All foods prepared by an operator [
a cottage food production operation] 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 [if a food is
made with a] major food allergens [allergen],
such as eggs, nuts, soy, peanuts, milk, [or]
wheat, fish, or shellfish used in the product [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.
(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. [A cottage food production
operation may not sell any of the foods described in this section
through the Internet, by mail order, or at wholesale. No health claims
may be made on any of the advertising media of the finished products
because they are conventional foods.]
(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 delivers the food
to the consumer person-to-person; 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)[(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.
(i)[(g)] Prohibition for Cottage
Food Production Operations. A cottage food production operation may
not sell TCS [potentially hazardous] foods to
customers.
(j)[(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 October 2, 2019
TRD-201903579 Barbara L. Klein
General Counsel
Department of State Health Services
Earliest possible date of adoption: November 17, 2019
For further information, please call: (512) 231-5653
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