(1) Any person applying to operate a
wholesale food establishment must complete and submit a written application for
a license on a form provided by the department. License application forms are
available through the local health authority in the county where the activity
is being proposed.
(2) A license
applicant or legal licensee must submit to the regulatory authority properly
prepared plans and specifications for review and approval before:
(a) construction of a new food
establishment;
(b) conversion of an
existing structure for use as a food establishment;
(c) significant remodeling of an existing
food establishment, as determined by the regulatory authority;
(d) significant change in licensing subtype
from low-risk food processing to high-risk food processing, as determined by
the regulatory authority; or
(e) a
proposed change in legal ownership of an existing food establishment, as
determined by the regulatory authority.
(3) Establishment plans and specifications
must include, as required by the regulatory authority, the following
information to demonstrate conformance with this subchapter:
(a) intended ingredients, recipes, or
products;
(b) anticipated volume of
food to be stored, processed, and sold or served;
(c) proposed layout, mechanical schematics,
construction materials, and finish schedules;
(d) proposed equipment types, manufacturers,
model numbers, locations, dimensions, performance capacities, and installation
specifications;
(e) evidence that
standard procedures ensuring compliance with the requirements of this rule are
developed or are being developed; and
(f) other information that may be required by
the regulatory authority for the proper review of the proposed construction,
conversion, or modification, and procedures for operating a food
establishment.
(4)
Proposed mobile food establishments, engaged in food processing, especially
high-risk processing, must adequately demonstrate to both the department and
the local regulatory authority that the business plan can control at least the
following factors, prior to issuance of a license for each and every
anticipated food-processing site:
(a) access
to sufficient quantity and quality of potable water;
(b) provision for numbers and location of
handwashing stations;
(c) provision
for numbers and location of food worker toilets;
(d) access to sufficient quantity and quality
of wastewater disposal systems;
(e) control over possible airborne
contaminants;
(f) control over
possible ground-based contaminants;
(g) control over possible vermin access;
(h) control over proper plumbing
for water and wastewater;
(i)
control over operations to prevent water and wastewater freezing; and
(j) other relevant control items deemed
appropriate by the department or local regulatory authority.
(5) A proposed food manufacturing
establishment bottling drinking water in Montana must submit the following to
the department and/or local health authority for review and approval:
(a) written test results of the most recent
inorganic, volatile organic, organic chemical, and radiological analyses of the
water serving the establishment;
(b) written test results for pesticides and
synthetic organic chemicals, if the department or local health authority
determines such tests are necessary, or if random testing has shown there is or
may be contaminants present at levels which may adversely affect public health;
(c) a written description of the
water source, water treatment systems, all substances added to the water, and
any other documentation required by the department or local health authority to
verify that labels and terminology used on product labels conform with
applicable law; and
(d) for
products labeled "mineral water" or for a label containing the term "mineral
water" copies of laboratory testing results of mineral content and total
dissolved solids (TDS) of the product, obtained during the last 12 months
preceding the license year from an agency approved by the department or another
public health agency, to test drinking water.
(6) License applicants and license holders
must ensure uniform application of food safety standards and compliant product
labels.
(a) Prior to approval of an
application for a license, or change in certain license subtypes, the local
regulatory authority will require the license applicant to submit to the
department, and/or the local regulatory authority, food processing plans and
food package labeling examples on a form provided by the department for
assessment of compliance with this subchapter, and food standards in applicable
subsections of ARM
37.110.101. The
assessment will be conducted by either the local regulatory authority or the
department, or both.
(b) Pursuant
to the requirement in (6), this section addresses who is qualified to conduct
food safety evaluations and scientific food studies:
(i) Food processes or packaging methods and
scientific challenge studies that need a written safety evaluation must be
conducted by a process authority currently listed with the Association of Food
and Drug Officials at the time of the compliance assessment stated in
(6)(a).
(ii) When a challenge study
is proposed, in addition to the requirement in (b)(i), the study must be
designed and evaluated by an expert food microbiologist, and the laboratory in
which the study is conducted must be able to demonstrate prior experience in
conducting valid scientific challenge studies.
(c) At the conclusion of the pre-licensing
assessment done by the department, the department will submit in a timely
manner to the local regulatory authority, and license applicant, a written
report regarding findings of the pre-licensing assessment, which may be used by
the local regulatory authority as a basis for approval or denial of an
application for a license. The written report will also suggest to the local
regulatory authority to which license subtype the business should be
assigned.
(7) All
wholesale food establishments must comply with all appropriate building
construction standards in
50-60-101,
MCA, and all applicable administrative rules as adopted by the Department of
Labor and Industry in ARM Title 24, chapter 301 before issuance of a department
wholesale food license.
(8) The
regulatory authority must conduct one or more pre-licensing inspections to
verify that the food establishment is constructed and equipped in accordance
with the approved plans and approved modifications of those plans, and is in
compliance with law and this subchapter. No license will be issued or
permission granted to operate a proposed establishment if any violations of
this rule are observed by the regulatory authority during the final onsite
pre-licensing inspection. The department will issue a license to the applicant
if the final pre-licensing inspection by the regulatory authority reveals that
the proposed wholesale food establishment complies with requirements in this
subchapter.
(9) No person may
operate a wholesale food establishment who does not have a valid license issued
by the department. Only a person who complies with the requirements of this
subchapter will be entitled to receive or retain such a license. A valid
license must be posted in a conspicuous place for viewing at every wholesale
food establishment. Food establishments, under this subchapter that also sell
or serve to consumers must procure a separate retail food establishment
license, unless specifically exempted from licensure under law in Title 50,
chapter 50, MCA.
(10) A license
issued by the department must be validated by the local health officer of the
local board of health with jurisdiction where the establishment is located in
accordance with
50-57-208,
MCA. Upon refusal to validate a license, the applicant may appeal the decision
in accordance with
50-57-209,
MCA.
(11) The department may deny
or cancel a license, in accordance with
50-57-210,
MCA. Prior to license cancellation, the applicant or licensee may submit a
correction plan, in accordance with
50-57-211,
MCA. A written notice to the applicant or licensee and hearing are required in
cases involving license denials or cancellations, in accordance with
50-57-212,
MCA.
(12) Whenever a cancellation
of a license has become final, the holder of the cancelled license may make
written application for a new license.
(13) Obtaining the license referred to in (9)
does not relieve the applicant from satisfying applicable requirements from
other federal, state, or local agencies. These may include:
(a) building rule permits and
inspections;
(b) fire and life
safety inspections;
(c) private or
public water supply system or sewage treatment systems permits or inspections;
and
(d) occupational health and
safety requirements.
(14) The local regulatory authority will
assign a food establishment to a license type and subtype by assessing food
processing procedures, food service, and utilizing the definitions in this
subchapter.
(15) At the time of
initial licensing and updated as needed, but no less than each licensing year,
the regulatory authority will correctly assign a food establishment to one of
four categories by evaluating the food processing and service procedures of the
food establishment based on the criteria specified in Table 1.
Table 1: Food Establishment Categories
Category A: a food establishment whose point value is less
than two must be included in this category.
Category B: a food establishment whose point value is at
least two, but not greater than four, must be included in this category.
Category C: a food establishment whose point value equals or
exceeds five must be included in this category.
Category D: a food establishment that has been ordered
closed by the regulatory authority, or caused a documented foodborne illness
outbreak within the previous licensing year must be included in this
category.
Food Establishment Point Assignments
|
Assignment Factors
|
Points
|
Food is not processed at the facility
|
0
|
Establishment has annual gross sales in excess of $1
million
|
1
|
Establishment distributes food to other states or
nations
|
1
|
Establishment provides delivery of ready-to-eat food
to consumers
|
1
|
Potentially hazardous food (condition control food)
are held at the facility for any period of time
|
1
|
Establishment provides wild mushrooms or wild
plants
|
1
|
Establishment distributes food directly to schools,
hospitals, elderly care facilities, or to other facilities that serve highly
susceptible populations to foodborne illness
|
4
|
Food is processed before being distributed, involving
activities such as baking, blanching, boiling, chopping, cooking, cutting,
dicing, heating, reheating, or slicing, back-sweetening, and the finished food
product is considered ready-to-eat
|
5
|
Food processed at the facility is classified as an
acidified food, fish, or fishery product, low-acid canned food, or juice
product
|
5
|
Establishment is engaged in sprouting seeds or making
ice for human consumption
|
5
|
Establishment infuses vegetables or herbs in
oil
|
5
|
Establishment packages potentially hazardous foods in
reduced oxygen packaging or modified atmospheric packaging
|
5
|
(16)
Botanical substances are those substances not classified in law as food,
dietary supplements, drugs, or cosmetics but its use is commonly or usually
known by reasonable persons to be an edible product available in commerce.
(a) Botanical substances as determined by the
department that are in commerce, such as kratum (
Mitragnya
speciosa), will not be classified as foods, dietary supplements,
drugs, or cosmetics if the following conditions apply to product labeling,
promotional materials, and advertising:
(i)
the information makes no reference to the product being edible; and
(ii) the information makes no health or
health-related claims that would render the products unapproved drugs, dietary
supplements, or food.
(b) This rule does not waive detainment and
condemnation powers given in
50-31-509
and
50-31-510,
MCA, for public health and safety purposes regarding adulteration and
misbranding.