Current through Reg. 49, No. 38; September 20, 2024
(a)
License/registration required.
(1) A person
who manufactures food must obtain a food manufacturer's license for each place
of business as described in subsection (b)(1) or (2) of this section; also, a
food manufacturer who distributes its own food, and/or food from another
manufacturer must only obtain a food manufacturer's license. When calculating
the amount of the licensing fee, the manufacturer must include the total for
all food manufactured and wholesaled from the place of business.
(2) A person who distributes food, but who
does not manufacture food, must obtain a food wholesaler's license for each
place of business as described in subsection (b)(3) or (4) of this
section.
(3) A person who
distributes food, but who does not manufacture food, and who chooses to store
that food with a warehouse operator licensed under subsection (b)(8) or (9) of
this section, must register as a food wholesaler under subsection (b)(7) of
this section.
(4) A person who
distributes food and drugs, food and medical devices, or food and drugs and
medical devices, must obtain a wholesaler with combination products license, as
described in subsection (b)(5) or (6) of this section, for each place of
business; this license is required even if the products are stored in a
separate warehouse or with a warehouse operator licensed under subsection
(b)(8) or (9) of this section.
(5)
A warehouse operator storing food for a registered food wholesaler must obtain
a warehouse operator license as described in subsection (b)(8) or (9) of this
section for each such warehouse. A warehouse operator who distributes only food
is required to obtain only a warehouse operator license. A warehouse operator
who distributes combination products (food and drugs, food and medical devices,
or food, drugs, and medical devices) and is also required to obtain a
wholesaler's license under subsection (b)(5) or (6) of this section will be
issued only one license. The license fee to be paid will be the higher of the
two applicable fees.
(6) A
warehouse operated by a food manufacturer which is totally separate from any
manufacturing location, including locations from which foods are held for
limited periods of time for distribution, must obtain a warehouse operator
license as described in subsection (b)(8) or (9) of this section for each such
warehouse.
(7) A retail food store
that also manufactures food and is required to be permitted by the Department
of State Health Services (department) pursuant to Health and Safety Code,
Chapter 437, and the Texas Food Establishment Regulations, §
229.370 and
§
229.371 of
this title (relating to Permitting Retail Food Establishments), will be issued
only one license or permit. The license or permit fee to be paid will be the
higher of the two applicable fees.
(8) A wholesaler who distributes combination
products and who is also required to be licensed as a warehouse operator under
this section will be issued only one license. The license fee to be paid will
be the higher of the two applicable fees.
(9) A food manufacturer required to be
licensed exclusively pursuant to Health and Safety Code, Chapter 432, relating
to Food, Drug, Device and Cosmetic Salvage, Chapter 433, relating to Meat and
Poultry Inspection, Chapter 435, relating to Dairy Products, Chapter 436,
relating to Aquatic Life, or Chapter 440, relating to Frozen Desserts, is not
required to license pursuant to this chapter.
(b) Licensing and registration fees.
(1) Food manufacturer. No person may operate
or conduct business as a food manufacturer in this state without first
obtaining a license from the department. Licenses issued under this subsection
expire two years from the start date of the regulated activity. All applicants
for a new or renewal food manufacturer's license shall pay a license fee.
(A) For each place of business having gross
annual manufactured food sales of $0.00 - $9,999.99, the fees are:
(i) $100 for a two-year license;
(ii) $100 for a two-year license that is
amended due to a change of ownership; and
(iii) $50 for a two-year license that is
amended during the current licensure period due to minor changes.
(B) For each place of business
having gross annual manufactured food sales of $10,000 - $24,999.99, the fees
are:
(i) $150 for a two-year
license;
(ii) $150 for a two-year
license that is amended due to a change of ownership; and
(iii) $75 for a two-year license that is
amended during the current licensure period due to minor changes.
(C) For each place of business
having gross annual manufactured food sales of $25,000 - $99,999.99, the fees
are:
(i) $250 for a two-year
license;
(ii) $250 for a two-year
license that is amended due to a change of ownership; and
(iii) $125 for a two-year license that is
amended during the current licensure period due to minor changes.
(D) For each place of business
having gross annual manufactured food sales of $100,000 - $199,999.99, the fees
are:
(i) $560 for a two-year
license;
(ii) $560 for a two-year
license that is amended due to a change of ownership; and
(iii) $280 for a two-year license that is
amended during the current licensure period due to minor changes.
(E) For each place of business
having gross annual manufactured food sales of $200,000 - $999,999.99, the fees
are:
(i) $900 for a two-year
license;
(ii) $900 for a two-year
license that is amended due to a change of ownership; and
(iii) $450 for a two-year license that is
amended during the current licensure period due to minor changes.
(F) For each place of business
having gross annual manufactured food sales of $1 million - $9,999,999.99, the
fees are:
(i) $1,120 for a two-year
license;
(ii) $1,120 for a two-year
license that is amended due to a change of ownership; and
(iii) $560 for a two-year license that is
amended during the current licensure period due to minor changes.
(G) For each place of business
having gross annual manufactured food sales greater than or equal to $10
million, the fees are:
(i) $1,680 for a
two-year license;
(ii) $1,680 for a
two-year license that is amended due to a change of ownership; and
(iii) $840 for a two-year license that is
amended during the current licensure period due to minor changes.
(2) Food wholesaler. No
person may operate or conduct business as a food wholesaler in this state
without first obtaining a food wholesaler's license from the department.
Licenses issued under this subsection expire two years from the start date of
the regulated activity. Except as provided for in paragraph (4) of this
subsection, all food wholesalers shall pay a license fee.
(A) For each place of business having gross
annual food sales of $0.00 - $199,999.99, the fees are:
(i) $250 for a two-year license;
(ii) $250 for a two-year license that is
amended due to a change of ownership; and
(iii) $125 for a two-year license that is
amended during the current licensure period due to minor changes.
(B) For each place of business
having gross annual food sales of $200,000 - $499,999.99, the fees are:
(i) $450 for a two-year license;
(ii) $450 for a two-year license that is
amended due to a change of ownership; and
(iii) $225 for a two-year license that is
amended during the current licensure period due to minor changes.
(C) For each place of business
having gross annual food sales of $500,000 - $999,999.99, the fees are:
(i) $680 for a two-year license;
(ii) $680 for a two-year license that is
amended due to a change of ownership; and
(iii) $340 for a two-year license that is
amended during the current licensure period due to minor changes.
(D) For each place of business
having gross annual food sales of $1 million - $9,999,999.99, the fees are:
(i) $900 for a two-year license;
(ii) $900 for a two-year license that is
amended due to a change of ownership; and
(iii) $450 for a two-year license that is
amended during the current licensure period due to minor changes.
(E) For each place of business
having gross annual food sales of greater than or equal to $10 million, the
fees are:
(i) $1,350 for a two-year
license;
(ii) $1,350 for a two-year
license that is amended due to a change of ownership; and
(iii) $675 for a two-year license that is
amended during the current licensure period due to minor changes.
(3) Wholesaler with
combination products. A person who is required to be licensed as a food
wholesaler under this section and who is also required to be licensed as a
wholesale distributor of drugs under §
229.249(a)
of this title (relating to Licensure Fees) or as a device distributor under
§
229.439(a)(1)
of this title (relating to Licensure Fees) shall pay a combined licensure fee
for each place of business. The licensure fee shall be based on the combined
gross annual sales of these regulated products (foods, drugs, and/or devices).
(A) For each place of business having
combined gross annual sales of $0.00 - $199,999.99, the fees are:
(i) $520 for a two-year license;
(ii) $520 for a two-year license that is
amended due to a change of ownership; and
(iii) $260 for a license that is amended
during the current licensure period due to minor changes.
(B) For each place of business having
combined gross annual sales of $200,000 - $499,999.99, the fees are:
(i) $780 for a two-year license;
(ii) $780 for a two-year license that is
amended due to a change of ownership; and
(iii) $390 for a license that is amended
during the current licensure period due to minor changes.
(C) For each place of business having
combined gross annual sales of $500,000 - $999,999.99, the fees are:
(i) $1,040 for a two-year license;
(ii) $1,040 for a two-year license that is
amended due to a change of ownership; and
(iii) $520 for a license that is amended
during the current licensure period due to minor changes.
(D) For each place of business having
combined gross annual sales of $1 million - $9,999,999.99, the fees are:
(i) $1,300 for a two-year license;
(ii) $1,300 for a two-year license that is
amended due to a change of ownership; and
(iii) $650 for a license that is amended
during the current licensure period due to minor changes.
(E) For each place of business having
combined gross annual sales greater than or equal to $10 million, the fees are:
(i) $1,950 for a two-year license;
(ii) $1,950 for a two-year license that is
amended due to a change of ownership; and
(iii) $975 for a license that is amended
during the current licensure period due to minor changes.
(4) Food wholesaler registration.
Except as provided in paragraph (3) of this subsection, a food wholesaler is
not required to obtain a license under this section for a place of business if
all of the food distributed from that place of business will be stored in a
warehouse licensed under this section. A food wholesaler that is not required
to obtain a license for a place of business under this section shall register
each place of business with the department pursuant to subsection (d)(2) of
this section, but only one registration fee must be paid by each such food
wholesaler. A food wholesaler who meets this subsection's requirements shall
pay a registration fee of $100. A registration issued under this subsection
expires two years from the start date of the regulated activity.
(5) Warehouse operator. No person may operate
or conduct business as a warehouse operator in this state without first
obtaining a license from the department. Licenses issued under this subsection
expire two years from the start date of the regulated activity. License fees
are based on the maximum amount of square feet dedicated to food storage during
the licensing period. A warehouse operator shall pay a license fee.
(A) For each place of business having food
storage of 0 - 6,000 square feet, the fees are:
(i) $350 for a two-year license;
(ii) $350 for a two-year license that is
amended due to a change of ownership; and
(iii) $175 for a two-year license that is
amended during the current licensure period due to minor changes.
(B) For each place of business
having food storage of 6,001 - 24,000 square feet, the fees are:
(i) $700 for a two-year license;
(ii) $700 for a two-year license that is
amended due to a change of ownership; and
(iii) $350 for a two-year license that is
amended during the current licensure period due to minor changes.
(C) For each place of business
having food storage of 24,001 - 75,000 square feet, the fees are:
(i) $1,050 for a two-year license;
(ii) $1,050 for a two-year license that is
amended due to a change of ownership; and
(iii) $525 for a two-year license that is
amended during the current licensure period due to minor changes.
(D) For each place of business
having food storage of 75,001 - 250,000 square feet, the fees are:
(i) $1,400 for a two-year license;
(ii) $1,400 for a two-year license that is
amended due to a change of ownership; and
(iii) $700 for a two-year license that is
amended during the current licensure period due to minor changes.
(E) For each place of business
having food storage of 250,001 or more square feet, the fees are:
(i) $2,000 for a two-year license;
(ii) $2,000 for a two-year license that is
amended due to a change of ownership; and
(iii) $1,000 for a two-year license that is
amended during the current licensure period due to minor changes.
(6) A firm that has
more than one business location may request a one-time proration of fees when
applying for a license for each new location. Upon approval by the department,
the expiration date of the license for the new location will be established the
same as the firm's previously licensed locations.
(7) For all applications and renewal
applications, the department is authorized to collect subscription and
convenience fees, in amounts determined by the Department of Information
Resources, to recover costs associated with application and renewal application
processing through tex.gov.
(8) All
license/registration fees paid under this section are non-refundable.
(9) If the license/registration category
changes during the license period, the license shall be renewed in the proper
category at the time of renewal.
(c) License/registration forms.
License/registration forms may be obtained from the department, located at 1100
West 49th Street, Austin, Texas 78756-3182, or from the website at
www.dshs.state.tx.us/fdlicense/apps.shtm.
(d) License/registration application. All
food manufacturers, food wholesalers, and warehouse operators shall file a
license application on a form authorized by the department.
(1) The application form shall be signed and
verified, and shall contain the following information:
(A) the name of the legal entity to be
licensed, including the name under which the business is conducted;
(B) the physical address of the place of
business;
(C) the mailing address
of the place of business;
(D) if a
sole proprietorship, the name of the proprietor; if a partnership, the names of
all partners; if a corporation, the name of the corporation, the date and place
of incorporation and name and address of its registered agent in the state; or
if any other type of association, the names of the principals of such
association;
(E) the names of those
individuals in an actual administrative capacity which, in the case of a sole
proprietorship shall be the managing proprietor; in a partnership, the managing
partner; in a corporation, the officers and directors; in any other
association, those in a managerial capacity; and
(F) a list of categories of gross annual
sales or square footage as applicable, which must be marked and adhered to by
the licensee in the determination and paying of the license fee.
(2) Food wholesalers who meet the
requirements to register under subsection (b)(7) of this section, must submit a
registration form authorized by the department which shall be signed and
verified, and contain the following information:
(A) the name of the legal entity to be
registered, including the name under which the business is conducted;
(B) the name, telephone number, and physical
addresses of the licensed warehouses where the food wholesaler's food products
are or will be stored;
(C) the
physical address where the food wholesaler's distribution records are located
and available for review upon inspection;
(D) the mailing address and telephone number
where the food wholesaler may be contacted; and
(E) a description of the type of food
products being distributed by the food wholesaler.
(e) Two or more establishments. If
the food manufacturer, food wholesaler, or warehouse operator operates more
than one place of business, each place of business shall be licensed separately
by listing the name and address of each place of business on the license
application.
(f) Issuance of
license/registration. The department may license/register a manufacturer, food
wholesaler, or warehouse operator who meets the requirements of this section
and §
229.183
of this title (relating to Minimum Standards for Licensure/Registration).
(1) The initial license/registration shall be
valid for two years from the date the license/registration was
issued.
(2) The renewal
license/registration shall be valid for two years from the date the
license/registration was issued.
(3) A current license/registration shall only
be issued when all past due fees and late fees are paid.
(g) Renewal of license/registration.
(1) For each licensing/registration period,
the food manufacturer, food wholesaler, or warehouse operator shall renew its
license/registration as applicable following the requirements of this section
and §
229.183
of this title.
(2) A person who
holds a license/registration issued by the department under the Health and
Safety Code shall renew the license/registration by filing an application for
renewal on a form authorized by the department accompanied by the appropriate
licensing/registration fee. A licensee/registrant must file for renewal before
the expiration date of the current license. A person who files a renewal
application after the expiration date must pay an additional $100 as a
delinquency fee.
(3) Failure to
submit the renewal during the licensing/registration period may subject the
food manufacturer, food wholesaler, or warehouse operator to the offense
provisions under the Health and Safety Code, Chapter 431, to the provision of
§
229.184
of this title (relating to the Refusal, Revocation, or Suspension of
License/Registration), and to the provisions of §
229.222
of this title (relating to Enforcement).
(h) Amendment of license/registration.
(1) Fees. A license or registration that is
amended during the licensing or registration period, including a change of
name, ownership (change in legal entity), or a notification of a change in the
location of a licensed or registered place of business required under the
Health and Safety Code, §
431.2251,
will require a new application and submission of license or registration fees
as outlined in subsection (b) of this section.
(2) Change in name, ownership, status, or
location of business.
(A) Not later than the
31st day before the date of the change in the name, status, or location of a
licensed/registered place of business, the license/registration holder shall
provide written notice to the department of the intended change. The notice
shall include, as applicable:
(i) The new
name of the legal entity to be licensed or registered, including the name under
which the business is conducted;
(ii) The physical and mailing address of the
new location;
(iii) The name and
physical address of the licensed warehouse where the food wholesaler's food
products will be stored;
(iv) The
physical address where the food wholesaler's distribution records are located
and available for review upon inspection; and
(v) The mailing address and telephone number
where the food wholesaler may be contacted.
(B) Not later than the 10th day after
completion of the change of location, the licensee or registrant shall forward
to the department the name and residence address of the individual in charge of
the new place of business.
(C)
Notice is considered adequate if the licensee or registrant provides the intent
and verification notices to the department by certified mail, return receipt
requested, mailed to the department at Regulatory Licensing Unit, Food and Drug
Licensing Group, Mail Code 2835, P.O. Box 149347, Austin, Texas
78714-9347.
(i) This section does not apply to:
(1) a person, firm, or corporation that
harvests, packages, or washes raw fruits or vegetables for shipment at the
location of harvest;
(2) a direct
seller who is not otherwise engaged in manufacturing;
(3) a person engaged solely in the
distribution of alcoholic beverages in sealed containers by holders of licenses
or permits issued under the Alcoholic Beverage Code, Chapters 19, 20, 21, 23,
64, or 65;
(4) a food service
establishment or a commissary which distributes food primarily intended for
immediate consumption on the premises of a retail outlet under common ownership
unless the business regularly engages in the labeling, combining, and purifying
of food which is either sold for resale or packaged for sale in other than
individual portions; or
(5) a
restaurant that provides food for immediate human consumption to a political
subdivision or to a licensed nonprofit organization if the restaurant would not
otherwise be considered a food wholesaler.