(1) The department adopts by reference the following federal regulations establishing food definitions and standards promulgated by the United States Food and Drug Administration that are found in the corresponding parts of Title 21 of the Code of Federal Regulations (CFR) as of April 1, 2017 and 2018. These standards apply to all food as the term is defined in 50-31-103(15), MCA.

(2) Copies of the federal regulations which were adopted and incorporated by reference under (1) may be obtained from the Department of Public Health and Human Services, Food and Consumer Safety Section, 1400 Broadway, P.O. Box 202951, Helena, Montana 59620-2951, phone: (406) 444-2408.

(1) This is a subchapter regulating retail food establishments that serve food to the public, as provided in Title 50, chapter 50, MCA.

(2) All retail food establishments must comply with all appropriate building construction standards as set forth by 50-60-101, MCA and all applicable administrative rules as adopted by the Department of Labor and Industry in ARM Title 24.

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(1) No person may operate a 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 every retail food establishment.

(2) Any person desiring to operate a retail food establishment must make written application for a license on forms provided by the department.

(3) Except for temporary food establishment permit fees set by the local health authority in accordance with 50-50-205(6), MCA, license fees are:

(a) $85 for each license issued to an establishment that does not have more than two employees working at any one time; and

(b) $115 for establishments with more than two employees.

(4) Prior to approval of an application for a license, the regulatory authority must inspect the proposed retail food establishment to determine compliance with the requirements of this subchapter.

(5) The department will issue a license to the applicant if an inspection by the regulatory authority reveals that the proposed retail food establishment complies with all applicable requirements of this subchapter.

(6) The department may, after providing opportunity for hearing, cancel a license for serious or repeated violations of any of the requirements of this subchapter or for interference with the department or other authorized persons in the performance of duty.

(7) Prior to cancellation, the department will notify, in writing, the licensee of the specific reason(s) for which the license is to be cancelled. The notice will further provide for the licensee the opportunity to request an administrative hearing in front of the department within ten business days after the receipt of the notice. If no request for hearing is filed within the ten-day period, the cancellation of the license becomes final.

(8) The licensee may submit to the department an acceptable plan of correction within ten business days after receiving the department's notice of cancellation. Such an acceptable plan of correction will be a bar to canceling the license.

(9) A notice provided for in this rule is properly served when it is delivered to the holder of the license, or the person in charge, or when it is sent by registered or certified mail, return receipt requested, to the last known address of the holder of the license. A copy of the notice will be filed in the records of the department.

(10) The hearing provided for in this rule will be conducted by the department pursuant to Title 2, chapter 4, subchapter 6, MCA of the Montana Administrative Procedure Act regarding contested cases and ARM 37.5.117. The department will make a final finding based upon the complete hearing record and will sustain, modify, or rescind any notice or order considered in the hearing. The department will furnish a written report of the hearing decision to the licensee.

(11) Whenever a cancellation of a license has become final, the holder of the cancelled license may make written application for a new license.

(12) Obtaining the license referred to in (1) does not relieve the applicant from satisfying applicable requirements from other federal, state, or local agencies. These may include:

(a) building code permits and inspections;

(b) fire and life safety inspections;

(c) private or public water supply system or sewage treatment systems permits or inspections; or

(d) occupational health and safety requirements.

(13) The 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 these rules.

(14) 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 Complexity Categories

Category	Establishment Complexity
(1)	(i) only heat commercially processed time/temperature control for safety foods (TCS/potentially hazardous foods) for hot holding; (ii) process only non-TCS foods; (iii) no cooling TCS foods; (iv) establishments otherwise grouped in Category 2, but have shown through documentation to have achieved managerial control of foodborne illness risk factors; and (v) examples include: convenience stores, hot dog carts, coffee shops, and establishments that serve or sell only prepackaged, non-TCS foods.
(2)	(i) establishment has a limited menu; (ii) processed foods are immediately served or made-to-order; (iii) food operations may involve hot and cold holding of TCS foods, after processing or cooking; (iv) limited processing of TCS foods that require cooking, cooling, reheating, and the limited service of a few TCS foods; (v) establishments that would otherwise be grouped in Category 3, but have shown through historical documentation to have achieved managerial control of foodborne illness risk factors; (vi) newly licensed establishments that would otherwise be grouped in Category 1 are categorized here, until a history of managerial control of foodborne illness risk factors is documented; (vii) examples include: retail food stores, schools not serving a highly susceptible population, and quick-service operations.
(3)	(i) establishment has extensive menu and handling of raw ingredients; (ii) complex preparation including cooking, cooling, and reheating for hot holding involving many TCS foods; (iii) variety of processes require hot and cold holding of TCS food; (iv) establishments that would otherwise be grouped in Category 4, but have shown through historical documentation to have achieved managerial control of foodborne illness risk factors; (v) newly licensed establishments that would otherwise be grouped in Category 2 are categorized here, until a history of managerial control of foodborne illness risk factors is documented; (vi) examples include: full-service restaurant.
(4)	(i) establishments serving a highly susceptible population; (ii) engage in specialized processes, such as smoking, curing, reduced oxygen packaging, etc.; (iii) examples include: preschools, hospitals, nursing homes, and special processing requiring a variance.

(1) No person may operate a 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 every retail food establishment.

(2) Any person desiring to operate a retail food establishment must make written application for a license on forms provided by the department.

(3) Except for temporary food establishment permit fees set by the local health authority in accordance with 50-50-205(6), MCA, license fees are:

(a) $85 for each license issued to an establishment that does not have more than two employees working at any one time; and

(b) $115 for establishments with more than two employees.

(4) Prior to approval of an application for a license, the regulatory authority must inspect the proposed retail food establishment to determine compliance with the requirements of this subchapter.

(5) The department will issue a license to the applicant if an inspection by the regulatory authority reveals that the proposed retail food establishment complies with all applicable requirements of this subchapter.

(6) The department may, after providing opportunity for hearing, cancel a license for serious or repeated violations of any of the requirements of this subchapter or for interference with the department or other authorized persons in the performance of duty.

(7) Prior to cancellation, the department will notify, in writing, the licensee of the specific reason(s) for which the license is to be cancelled. The notice will further provide for the licensee the opportunity to request an administrative hearing in front of the department within ten business days after the receipt of the notice. If no request for hearing is filed within the ten-day period, the cancellation of the license becomes final.

(8) The licensee may submit to the department an acceptable plan of correction within ten business days after receiving the department's notice of cancellation. Such an acceptable plan of correction will be a bar to canceling the license.

(9) A notice provided for in this rule is properly served when it is delivered to the holder of the license, or the person in charge, or when it is sent by registered or certified mail, return receipt requested, to the last known address of the holder of the license. A copy of the notice will be filed in the records of the department.

(10) The hearing provided for in this rule will be conducted by the department pursuant to Title 2, chapter 4, subchapter 6, MCA of the Montana Administrative Procedure Act regarding contested cases and ARM 37.5.117. The department will make a final finding based upon the complete hearing record and will sustain, modify, or rescind any notice or order considered in the hearing. The department will furnish a written report of the hearing decision to the licensee.

(11) Whenever a cancellation of a license has become final, the holder of the cancelled license may make written application for a new license.

(12) Obtaining the license referred to in (1) does not relieve the applicant from satisfying applicable requirements from other federal, state, or local agencies. These may include:

(a) building code permits and inspections;

(b) fire and life safety inspections;

(c) private or public water supply system or sewage treatment systems permits or inspections; or

(d) occupational health and safety requirements.

(13) The 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 these rules.

(14) 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 Complexity Categories

Category	Establishment Complexity
(1)	(i) only heat commercially processed time/temperature control for safety foods (TCS/potentially hazardous foods) for hot holding; (ii) process only non-TCS foods; (iii) no cooling TCS foods; (iv) establishments otherwise grouped in Category 2, but have shown through documentation to have achieved managerial control of foodborne illness risk factors; and (v) examples include: convenience stores, hot dog carts, coffee shops, and establishments that serve or sell only prepackaged, non-TCS foods.
(2)	(i) establishment has a limited menu; (ii) processed foods are immediately served or made-to-order; (iii) food operations may involve hot and cold holding of TCS foods, after processing or cooking; (iv) limited processing of TCS foods that require cooking, cooling, reheating, and the limited service of a few TCS foods; (v) establishments that would otherwise be grouped in Category 3, but have shown through historical documentation to have achieved managerial control of foodborne illness risk factors; (vi) newly licensed establishments that would otherwise be grouped in Category 1 are categorized here, until a history of managerial control of foodborne illness risk factors is documented; (vii) examples include: retail food stores, schools not serving a highly susceptible population, and quick-service operations.
(3)	(i) establishment has extensive menu and handling of raw ingredients; (ii) complex preparation including cooking, cooling, and reheating for hot holding involving many TCS foods; (iii) variety of processes require hot and cold holding of TCS food; (iv) establishments that would otherwise be grouped in Category 4, but have shown through historical documentation to have achieved managerial control of foodborne illness risk factors; (v) newly licensed establishments that would otherwise be grouped in Category 2 are categorized here, until a history of managerial control of foodborne illness risk factors is documented; (vi) examples include: full-service restaurant.
(4)	(i) establishments serving a highly susceptible population; (ii) engage in specialized processes, such as smoking, curing, reduced oxygen packaging, etc.; (iii) examples include: preschools, hospitals, nursing homes, and special processing requiring a variance.

(1) The local health officer, registered sanitarian, or sanitarian-in-training employed by or contracted with the local board of health shall perform an inspection of each retail food establishment within the jurisdiction of the local board of health at least once every 12 months. Additional inspections of the food service establishment must be performed as often as necessary for the enforcement of this subchapter.

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(1) To qualify for reimbursement under 50-50-305, MCA, a local board of health will perform inspections as specified in this subchapter or enter into a written, signed cooperative agreement with the department that establishes the duties and responsibilities of the local board of health and the department consistent with this subchapter.

(3) All local boards of health must meet the following criteria:

(a) At least one sanitarian working with or for the local board of health must receive training from the department in standardized food inspections. The department is responsible for making training and standardization available on a periodic basis.

(b) Reporting of inspection dates must be documented in a manner and frequency approved by the department.

(c) All documentation of enforcement of this subchapter including inspection reports, consumer complaints, illness investigations, plans of correction, and enforcement actions is retained for five years and copies of the documentation are submitted or otherwise made available to the department upon request.

(4) A failure by the local board of health to meet all of its responsibilities under (3)(a), (b), and (c) may result in the withholding of funds from the local board reimbursement fund in an amount to be determined by the department.

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(1) The Department of Public Health and Human Services (department), except as otherwise provided in this chapter, adopts and incorporates by reference the following publication: "Food Code, 2013, Recommendations of the United States Public Health Service, Food and Drug Administration" published by National Technical Information Service, Publication PB2013-110462, ISBN 978-1-935239-02-4, November 3, 2013. This publication may be reviewed online at: http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm374275.htm; or by contacting DPHHS-FCSS, 1400 Broadway Street, Helena, MT 59620. This publication is being adopted with modifications and additions as described in ARM 37.110.260 through 37.110.272.

(a) Chapter 1: Purpose and Definitions. Additions and modifications have been made to this chapter as described in ARM 37.110.261.

(b) Chapter 2: Management and Personnel. Additions have been made to this chapter as described in ARM 37.110.262.

(c) Chapter 3: Food. Modifications have been made to this chapter as described in ARM 37.110.265.

(d) Chapter 4: Chapter 4: Equipment, Utensils, and Linens. An addition has been made to this chapter as described in ARM 37.110.266.

(e) Chapter 5: Water, Plumbing, and Waste. Additions have been made to this chapter as described in ARM 37.110.267.

(f) Chapter 6: Physical Facilities. An addition has been made to this chapter as described in ARM 37.110.268.

(g) Chapter 7: Poisonous or Toxic Materials. This chapter has been adopted with no modifications.

(h) Chapter 8: Compliance and Enforcement. Additions and modifications have been made to this chapter as described in ARM 37.110.272.

(i) Annexes 1 through 7 of the "Food Code, 2013, Recommendations of the United States Public Health Service, Food and Drug Administration" are excluded. These sections have not been adopted, but may be used as reference information for public health purposes.

(2) The department, except as otherwise provided in this chapter, adopts and incorporates by reference the following publication: "Food and Consumer Safety (FCS) Circular 1-2012" for nonpublic water systems serving food establishments, including temporary food establishments. A copy of FCS Circular 1-2012 may be obtained from the Department of Public Health and Human Services, Food & Consumer Safety Section, P.O. Box 202951, Helena, MT 59620-2951. The FCS Circular 1-2012 is also available on the department's web site at www.fcss.mt.gov.

The terms defined in this section are modifications or additions to the definitions described in this chapter of the 2013 Food Code:

(1) "Adulterated" means the same as determined in 50-31-202, MCA instead of the "Adulterated" definition in section 1-201.10 of the November 3, 2013 model document of food regulations promulgated by the United States Food and Drug Administration (Food Code).

(2) "Bakery" means processing or packaging of baked goods described in 50-50-102(1), MCA for sales or service directly to consumers.

(3) "Catering kitchen" means the activity of providing food wholly or in part owned by the caterer for a specific event at a location other than the food establishment, as defined in 50-50-102 (4)(a), MCA, on a contractual, prearranged basis to a specific subset of the public, such as invited guests to a wedding or similar celebration, or to participants in an organized group or activity. A catering kitchen is not the same activity as a contract cook.

(4) "Certified Food Protection Manager" (CFPM) means an individual who operates a food establishment or manages a food establishment who has successfully completed a test through an accredited program required under section 2-102.12 (A) of the Food Code.

(5) "Department" means the Montana Department of Public Health and Human Services.

(6) "Food Code" means the November 3, 2013 model document of food regulations promulgated by the United States Food and Drug Administration.

(7) "Food establishment" means the following:

(a) includes in section 1-201.10(B) of the Food Code, any and all licensable establishments stated in Title 50, chapter 50, MCA;

(b) does not include in section 1-201.10(B) of the Food Code, any and all food provider exclusions stated in Title 50, chapter 50, MCA;

(c) in section 1-201.10(B) of the Food Code, the term "small family day-care provider" actually means a day-care provider not required to be licensed by the department as a day-care center, under 52-2-721(1)(a), MCA; and

(d) in section 1-201.10(B) of the Food Code; a bed-and-breakfast operation actually means a bed-and-breakfast establishment that meets the definition in 50-51-102(1), MCA. Bed-and-breakfast establishments must meet food safety rules required in ARM 37.111.312 through 37.111.334.

(8) "Food manufacturing" means the same as 50-50-102(19), MCA, but for the purposes of license subtypes, should be on-site food processing for sales or service to the public, which includes drinking water vending machines and beverage ice production, packaging, or both.

(9) "Food service" means the same as 50-50-102(7), MCA, but for the purposes of license subtypes, should only be the sales or service of food to the public that is not processed on-site.

(10) "Legal licensee" means the same as "permit holder."

(11) "License" means the same as "permit."

(12) "License subtype" means one or more of the following food establishments: bakery, catering kitchen, food service, food manufacturing, meat shop, mobile food establishment, perishable food dealer, produce, school, tavern, or water hauler.

(13) "License type" means a food establishment at a fixed (nonmobile or permanent) location, mobile food establishment, or temporary food establishment.

(14) "Meat market" means the same as 50-50-102(10), MCA, but is the processing or packaging of meat or poultry for sales or service to the public.

(15) "Mobile food establishment" means:

(a) A food establishment where food is served or sold from a motor vehicle, nonmotorized cart, movable vehicle such as a push cart, trailer, or boat that periodically or continuously changes location and requires a servicing area to accommodate the unit for cleaning, inspection, and maintenance, as specified in sections 5-402.14, 6-101.11, and 6-202.18.

(b) Mobile food establishment does not include a motor vehicle used solely to transport or deliver food by a motorized carrier regulated by the state or federal government or a concession stand designed to operate as a temporary food establishment.

(16) "Perishable food" means foods that require time/temperature control for safety (formerly known as potentially hazardous foods).

(17) "Perishable food dealer" means the same as 50-50-102(12), MCA, which is an operation that is in the business of purchasing and selling foods that require time/temperature control for safety (formerly known as potentially hazardous foods).

(18) "Potentially hazardous food" means time/temperature control for safety food.

(19) "Processing" means the same as "preparation" of food through one or more methods including: assembling, baking, bottling, brewing, canning, coating, cooking, cutting, dicing, distilling, drying, extracting, fermenting, freezing, grinding, heating, infusing, mixing, packaging, reheating, repackaging, pickling, slicing, smoking, stuffing, or other food treatment or food preservation method.

(20) "Produce" means fruits, vegetables, or grains sold directly to consumers in their natural or unprocessed states.

(21) "Regulatory authority" means the department, the local board of health, the local health officer, or the local sanitarian, instead of the "regulatory authority" definition in section 1-201.10 of the Food Code.

(22) "School" means a building or structure or portion thereof occupied or used at least 180 days per year for the teaching of individuals, the curriculum of which satisfies the basic instructional program approved by the board of public education for pupils in any combination of kindergarten through grade 12. This term does not include home schools. For purposes of this licensing subtype, in general, a school is also a learning institution that participates in the federal National School Lunch Program, under 7 CFR 210 of the Code of Federal Regulations.

(23) "Tavern, bar, brewery, winery, distillery, or saloon" means the sale or service of alcoholic beverages with or without beverage ice. This licensing subtype does not include on-site food manufacturing or food service, as defined in this section of the rules.

(24) "Temporary food establishment" means a food establishment that operates at a fixed location for a period of no more than 21 days in a licensing year in conjunction with a single event or celebration, instead of the "Temporary food establishment" definition in section 1-201.10 of the Food Code.

(25) "Water hauler" means the same as 50-50-102(20), MCA.

(1) The following additions have been made to section 2-102.12 of Chapter 2.

(a) A one-year, phase-in period will apply to affected establishments to have a Certified Food Protection Manager, and the one-year period will begin from the date new rules are adopted.

(b) After the one-year, phase-in period, new legal licensees required to have a Certified Food Protection Manager must have a Certified Food Protection Manager within 90 days of issuance of a new license.

(c) After the one-year, phase-in period, existing legal licensees required to have a Certified Food Protection Manager must have a Certified Food Protection Manager within 45 days of losing their Certified Food Protection Manager.

(2) The following additions have been made to 2-102.12(B) of Chapter 2.

(a) Temporary food establishments engaged in the following activities are exempt from having a certified food protection manager:

(i) serving non-TCS (time/temperature controlled for safety) foods;

(ii) serving nonalcoholic or alcoholic beverages with or without beverage ice;

(iii) serving commercially pre-cooked, pre-packaged ready-to-eat, TCS foods, such as hot dogs, sausages, FDA and United States Department of Agriculture (USDA) registered canned food products, frozen pizzas;

(3) The regulatory authority may require or exempt additional food safety training for temporary food establishments under the authority granted in 8-102.10 of Chapter 8.

(4) The following additions have been made to subpart 2-201 Responsibilities of Permit Holder, Person in Charge, Food Employees, and Conditional Employees of Chapter 2.

(5) Specific communicable disease control measures, outlined in the Food Code, should be followed unless more stringent rules are provided in ARM 37.114.501.

(1) This chapter has been adopted with the following modifications:

(a) section 3-201.17(A2) will not be adopted;

(b) section 3-201.17(A3) will not be adopted;

(c) section 3-201.17(A4) will not be adopted; and

(d) section 3-201.17(A1cii) will be replaced with the requirements of 81-9-230, 87-4-702, and 87-6-106(1), MCA.

(1) This chapter has been adopted with the addition of the following paragraph: 4-301.12(F) A food preparation sink must be provided if food is placed into a sink or sink compartment for the purposes of thawing or cleaning. A food preparation sink must meet the requirements specified in Sections 4-205.10, 5-202.13, and 5-402.11 of the Food Code.

(1) Additions have been made to paragraph 5-101.11(B) through section 5-103.12 of this chapter for public and nonpublic water systems.

(2) A nonpublic water supply system must meet the requirements of Food and Consumer Safety (FCS) Circular 1-2012 when:

(a) the water supply is constructed after the effective date of this rule;

(b) significant modifications are made to the water system; or

(c) the local regulatory authority determines compliance with FCS Circular 1-2012 is necessary to meet the requirements of this subchapter.

(3) An establishment using a nonpublic water supply system must have drinking water samples analyzed for coliform bacteria as follows:

(a) Sampling for coliform bacteria must be done before initial licensing, and at least in two separate months of each calendar year that the establishment operates.

(b) The sampling schedule must include collection when the water source is most likely to be contaminated, such as during April through June, September through October, during high, ground-water season, or as directed by the local regulatory authority.

(c) The local regulatory authority may require the establishment to sample:

(i) monthly;

(ii) in months the establishment operates; or

(iii) if an inspection, sampling results, or an event indicates the water source is at high risk of contamination.

(d) The local regulatory authority may return the establishment to the sampling frequency stated in (3)(a), if an examination of the drinking water system by the local regulatory authority indicates the system is no longer at high risk of contamination.

(4) An establishment using a nonpublic water supply system must have a water sample analyzed for total nitrates before initial licensing and at least every three years the establishment is operating.

(5) After shock disinfection of the system, a sample for coliform bacteria must be collected for analysis three to five days after the disinfectant is no longer detected in the system.

(6) Water samples must be analyzed by a laboratory licensed and certified for drinking water analysis by the state of Montana.

(7) The establishment must report water sampling test results to the local regulatory authority in a format acceptable to the local regulatory authority within five days of receiving the results, except as required in (9)(c) and (11)(d).

(8) The establishment must keep test results readily available for inspection purposes on the premises of the licensed establishment for at least five years.

(9) If coliform bacteria are detected in a nonpublic water system routine sample, the establishment must:

(a) collect at least four additional or repeat samples within 24 hours of notification of the contamination at the following system locations:

(i) site of the original contaminated routine sample;

(ii) upstream from the contaminated routine sample;

(iii) downstream from the contaminated routine sample; and

(iv) at the source of the drinking water supply system, before the distribution plumbing; or

(v) as directed by the local regulatory authority.

(b) collect at least five samples during the month following a detection of coliform bacteria in any routine sample; and

(c) notify the local regulatory authority of the test results within 48 hours of receiving them.

(10) If coliform bacteria are detected in a repeat sample, the establishment must:

(a) take appropriate corrective action to eliminate the condition causing the positive test results; and

(b) post an advisory sign or placard regarding the test results in a conspicuous place for public viewing at each point of entry, or as directed by the local regulatory authority.

(11) If fecal coliform bacteria, Escherichia coli, or both are detected in a routine sample or repeat sample, the establishment must:

(a) immediately stop using the water source;

(b) provide a temporary source of safe water in accordance with (17);

(c) implement appropriate corrective actions; and

(d) notify the local regulatory authority of the test results within 24 hours of receiving them.

(12) If an establishment with a public or nonpublic water supply fails to take the required samples following the detection of coliform bacteria, or the laboratory fails to test for fecal coliform bacteria or Escherichia coli in coliform positive samples, the establishment must follow corrective actions as specified in (13).

(13) For nonpublic water systems, appropriate corrective actions must be implemented in a timely manner to eliminate the condition or conditions that resulted in the positive test result(s), which may include shock disinfection of the entire water system and replacement or repair of the water system by a date set by the local regulatory authority when:

(a) a water sample exceeds a maximum contaminant level as specified in ARM Title 17, chapter 38, subchapter 2;

(b) the water system does not have the capacity to provide the quantity needed for drinking, food processing, personal hygiene, or cleaning;

(c) after examination of the water system, the local regulatory authority provides a written report to the operator or person-in-charge that the water system is at high risk of contamination;

(d) a pathogenic microorganism is detected in a sample; or

(e) a confirmed disease outbreak is linked with the water system.

(14) When a water system is replaced or repaired, the water system must be shock disinfected before the system is placed into service.

(15) The local regulatory authority will issue a restricted-use order to an establishment using a nonpublic water supply when:

(a) fecal coliform or Escherichia coli is detected in a nonpublic water system sample;

(b) total nitrate level is greater than 10 milligrams per liter in a nonpublic water system sample;

(c) maximum contaminant levels exceed parameters specified in ARM Title 17, chapter 38, subchapter 2;

(d) a pathogenic microorganism is detected; or

(e) a confirmed disease outbreak is linked with the water system.

(16) An establishment with a public or nonpublic water supply subject to a restricted-use order must provide and use a temporary source of potable water as described in (17) for consumers and staff for drinking, food processing, personal hygiene and cleaning, or immediately discontinue operations.

(17) With approval from the local regulatory authority, an establishment with a public or nonpublic water supply may provide potable water on a temporary basis using one or more of the following:

(a) bottled or packaged potable water from a department-licensed wholesale or retail food establishment, if the water is dispensed directly from the original container;

(b) water from a Department of Environmental Quality (DEQ)-approved public water supply that meets the requirements of ARM Title 17, chapter 38, subchapters 1, 2, 3, and 5, stored in a clean, sanitized, and covered potable water container or holding tank;

(c) water delivered by a department-licensed potable water hauler;

(d) if the water is contaminated with fecal coliform bacteria or Escherichia coli, water that has been boiled for at least one minute, and stored and served from a clean, sanitized, and covered container; or

(e) other source approved by the local regulatory authority.

(18) If the local regulatory authority determines that boiling water will not provide adequate potable water, it may require an establishment with a public or nonpublic water supply to use another approved method for supplying water.

(19) An establishment with a public or nonpublic water supply that is subject to a restricted-use order must post an advisory sign or placard regarding the restricted-use order in a conspicuous place for public viewing at each point of entry, or as directed by the local regulatory authority.

(20) A public or nonpublic water supply under a restricted-use order may not be used to make ice for food or beverages.

(21) An establishment with a public or nonpublic water supply that is subject to a restricted-use order may wash, rinse, and sanitize dishes, utensils, and equipment using the affected water system, if using an approved chemical disinfectant or dish machine that reaches 180 degrees Fahrenheit (82 degrees Celsius) during the final rinse cycle, or as directed by the local regulatory authority.

(22) A restricted-use order on a public or nonpublic water supply may be cancelled by the local regulatory authority after:

(a) Laboratory sampling demonstrates that the water supply is safe;

(b) Water system plumbing is completely flushed with cold water for at least five minutes; and

(c) Food-contact surfaces and equipment directly and indirectly connected to the water system must be cleaned and sanitized prior to use including, but not limited to: post-mix carbonated beverage machines, spray misters, coffee makers, tea urns, ice machines, glass washers, and dish machines.

(23) Additions have been made to section 5-303 of this chapter that may apply to public or nonpublic water supplies.

(24) Every mobile food establishment must be equipped with a gravity or pressurized water storage tank.

(25) The water storage tank, or tanks, in a mobile food establishment must be of adequate capacity, as required in section 5-103.11 (A), but no smaller than the following:

(a) a mobile food establishment that serves beverages or food or reheats processed foods must have a water storage tank, or tanks, with a capacity of at least 38 liters (10 gallons) for food employee handwashing;

(b) a food pushcart must have a water storage tank, or tanks, with a minimum capacity of 19 liters (5 gallons) for handwashing; and

(c) a mobile food establishment that processes food or beverages must have a water storage tank, or tanks, with a capacity of at least 151 liters (40 gallons) for handwashing, utensil washing, and sanitizing purposes.

(1) The following addition has been made to section 6-301.14 of this chapter.

(a) Food establishment operators may create and post their own signs or posters for the posting requirement.

(1) This chapter has been adopted with no modifications.

(1) Additions and modifications have been made to this chapter.

(2) In section 8-201.11, the regulatory authority may require properly prepared plans and specifications for review and approval before issuance of a new license to a new legal licensee at the change in ownership of an existing food establishment.

(3) Section 8-301.11 has not been adopted.

(4) Section 8-302.11 has not been adopted.

(5) Section 8-302.12 has not been adopted.

(6) Section 8-302.13 has not been adopted.

(7) Section 8-302.14 has not been adopted.

(8) Section 8-303.30 has not been adopted.

(9) Section 8-304.10 has not been adopted.

(10) Section 8-304.20 has not been adopted.

(11) Section 8-401.10 has not been adopted.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

(1) This subchapter regulates wholesale food establishments, as stated in Title 50, chapter 57, MCA. These rules reflect the most recent scientific information, align the regulations with other states, and correspond to the extent feasible with the retail food rules. 

(1) The Department of Public Health and Human Services (department) adopts and incorporates by reference the Food and Consumer Safety (FCS) Circular 2-2019 for wholesale food establishments. This publication may be reviewed online at: https://dphhs.mt.gov/publichealth/FCSS/WholesaleFoodEstablishments, or by contacting DPHHS-FCSS, 1400 Broadway Street, Helena, MT 59620. The circular is modeled after the 2015 Montana retail food rule, 2013 U.S. Food and Drug Administration "Food Code," and Montana food standards contained in ARM Title 37, chapter 110, subchapter 1. 

(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.

(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.

(1) The local health officer, registered sanitarian, or sanitarian-in-training employed by or contracted with the local board of health must perform an inspection of each wholesale food establishment within the jurisdiction of the local board of health at least once every 12 months. Additional inspections of the food service establishment must be performed as often as necessary for the enforcement of this subchapter.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

(1) To qualify for reimbursement under 50-57-305, MCA, a local board of health will perform inspections as specified in this subchapter or enter into a written, signed cooperative agreement with the department that establishes the duties and responsibilities of the local board of health and the department consistent with this subchapter. 

(2) All local boards of health must meet the following criteria:

(a) At least one sanitarian working with or for the local board of health must receive training from the department in standardized food inspections. The department is responsible for making training and standardization available on a periodic basis.

(b) Reporting of inspection dates must be documented in a manner and frequency approved by the department.

(c) All documentation of enforcement of this subchapter including inspection reports, consumer complaints, illness investigations, plans of correction, issuances of variances, and enforcement actions must be retained for five years and be submitted or otherwise made available to the department upon request.

(3) A failure by the local board of health to meet any or all of its responsibilities under this rule may result in the withholding of funds from the local board reimbursement fund in an amount to be determined by the department.

(1) Requirements for issuance of a Certificate of Free Sale (CFS) by the department or local regulatory authority are:

(a) all certificate applicants must possess a valid wholesale food license;

(b) a CFS will be issued only for license subtypes listed on the issued license;

(c) a CFS will only be issued for compliance with general good food manufacturing practices regulated in this subchapter, and not for the specific food manufacturing regulations stated in ARM 37.110.101;

(d) products for certification must not be under or pending any known embargo, detainment, or litigation by the regulatory authority, U.S. Food and Drug Administration (USFDA), or other enforcement action by health or safety authorities recognized by the department, including local, state, or federal judicial orders;

(e) prior to issuing a CFS, the certificate applicant will provide to the department or local regulatory authority a signed statement that certifies to the best of their knowledge the products are not pending any known embargo, detainment, or litigation by a local regulatory authority, the department, or USFDA, or local, state, or federal judicial orders;

(f) certificate applicants that request a CFS must have been inspected by the regulatory authority within the inspection frequency stated in ARM 37.110.307;

(g) certificate applicants must be in substantial compliance, and not have any uncorrected critical or priority violations of applicable food safety laws and rules;

(h) a CFS will be issued in a format approved by the department that specifies:

(i) plant location where the products were processed;

(ii) date the plant was inspected, and found in substantial compliance, without any uncorrected critical or priority violations of applicable food safety laws and rules;

(iii) only known facts about the products, and conditions found during the inspection;

(iv) the inspection was not conducted to assess compliance with federal good manufacturing practices, only for compliance with Montana wholesale food rules;

(v) the issued document is clearly titled ″Certificate of Free Sale″; and

(vi) the certificate does not imply or express any testimonials regarding product warranty;

(i) the applicant must provide the department or local regulatory authority with information for a CFS on a form provided and approved by the department;

(j) certificate applicant must currently be registered with USFDA, if products are shipped out of state, or outside the United States;

(k) the CFS will be issued in the order the requests are received, and provided in accordance with department or local regulatory authority resources in the timeliest manner possible; and

(l) the department or local regulatory authority will deliver CFSs by the U.S. Postal Service.

(2) The department or local regulatory authority will not charge a fee for the CFS, unless allowed by law.

(3) The decision by the department or local regulatory authority to deny a CFS may be appealed by the applicant by filing a written notice of appeal to the department or local regulatory authority within 30 days of the date on the written denial. Upon the filing of the notice of appeal, the applicant is entitled to a hearing before the department or local regulatory authority held pursuant to the contested case procedure detailed in the Montana Administrative Procedure Act. If the department or local regulatory authority finds the applicant is entitled to a CFS, the presiding officer of the department will issue written directions about how and when the certificate will be issued.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

(1) The purpose of this subchapter is to provide rules in addition to the provisions stated in 50-50-102, 50-50-116, 50-50-117, and 50-50-121, MCA, so that cottage food products may be safely produced for the public in approved home kitchens.

In addition to the definitions contained in 50-50-102, MCA, the following definitions apply to this subchapter:

(1) "Baked goods" means breads, candies, cookies, pastries, and pies that are non-potentially hazardous because they are non-time temperature controlled for safety.

(2) "Cottage food operator" means a person registered with the regulatory authority to operate a cottage food operation.

(3) "Approved" means acceptable to the regulatory authority based on their determination of conformity with principles, practices, and generally recognized standards that protect public health.

(1) Only those products approved by the department and listed in the registration may be produced by a cottage food operation. A cottage food operation is allowed to produce the following food items as long as they are a non-potentially hazardous food:

(a) products that may be cooked in an oven including:

(i) loaf breads, rolls, biscuits, quick breads, and muffins;

(ii) cakes including celebration cakes such as birthday, anniversary, and wedding cakes;

(iii) pastries and scones;

(iv) cookies and bars;

(v) crackers;

(vi) cereals, trail mixes, and granola;

(vii) pies, except that custard style pies, pies with fresh fruit that is unbaked, or pies that require refrigeration after baking are not approved;

(viii) nuts and nut mixes; and

(ix) snack mixes;

(b) standardized jams, jellies, preserves, and fruit butters as identified under 21 CFR, Part 150, subject to the following:

(i) fresh picked or harvested fruits from noncommercial sources are allowed for use;

(ii) fresh fruits may be frozen in a household freezer and used at a later time;

(iii) all recipes must have a cook step included such as a hot fill or hot water bath, and freezer or refrigerator-style products are not approved;

(iv) all jams, jellies, preserves and fruit butters must be sealed in containers that are sterilized prior to filling; and

(v) paraffin wax is not allowed for sealing;

(c) repackaged, commercially dried fruit or vegetables from an approved source as described in ARM 37.110.510(2), or fresh fruits that:

(i) have a natural pH below 4.6, specifically: apples, apricots, grapefruit, lemons, limes, mangos, nectarines, oranges, peaches, plums, pomegranates, tangerines, blackberries, blueberries, cherries, cranberries, currants, gooseberries, grapes, raspberries, strawberries, and huckleberries; and

(ii) are dried by cottage food operators with the following methods:

(A) during the fruit drying process the fruit must reach 160^o Fahrenheit within an hour of processing the fruit;

(B) the fruit must then maintain 140^o Fahrenheit for the remainder of the drying process;

(C) dried fruit may not be packaged using any method of reduced oxygen packaging, including vacuum packaging.

(d) dry herb combining and packaging, and seasoning and mixture combining; examples of which are dry bean soup mixes, dry teas and coffees, and spice seasonings;

(e) popcorn, popcorn balls, cotton candy;

(f) fudge, candies, and confections that require a cook step;

(g) molded chocolate using commercial chocolate melts; and

(h) honey.

(2) The following provisions apply to the production of cottage food products:

(a) fresh picked or harvested fruits from noncommercial sources are allowed in baked good products;

(b) fresh fruits can be frozen and used at a later time as long as there is a cook step in the recipe; and

(c) all frostings or glazes must have a cook step or be made with ingredients (such as a large amount of sugar) that when combined are stable at room temperature.

(3) Other products may be approved on a case-by-case basis by the department in consultation with the local health department of the county in which the cottage food operator is registered.

(1) Cottage food operations must adhere to the labeling requirements outlined in 50-50-116, MCA.

(2) The following is representative of a label meeting the requirements of (1):

MADE IN A HOME KITCHEN THAT IS NOT SUBJECT TO RETAIL FOOD ESTABLISHMENT REGULATIONS OR INSPECTIONS   Chocolate Chip Cookies   Net Wt. 8oz (227g)   Ingredients: Enriched flour (Wheat flour, niacin, reduced iron, thiamine, mononitrate, riboflavin and folic acid), butter (milk, salt), chocolate chips (sugar, chocolate liquor, cocoa butter, butterfat (milk), soy lecithin as an emulsifier), walnuts, sugar, eggs, salt, artificial vanilla extract, baking soda. Contains: Wheat, eggs, milk, soy, walnuts.   Ashley Bryant 2550 Helena Lane Helena, MT 59620

(3) The department may allow large cakes or a container of bulk products to be handled and labeled in the following manner:

(a) be protected from contamination during transportation to the consumer; and

(b) have a product label sheet with all the required information as listed in (1) that is provided to the consumer.

(1) Cottage food operators must not manufacture cottage food products (for example, working with exposed food; working with cleaning equipment, utensils, and linens; or working with unwrapped single-service or single-use articles) while experiencing the following symptoms:

(a) vomiting;

(b) diarrhea;

(c) jaundice;

(d) sore throat with fever;

(e) a lesion containing pus such as a boil or infected wound that is open or draining and is:

(i) on the hands or wrists, unless an impermeable cover such as a finger cot or stall protects the lesion and a single-use glove is worn over the impermeable cover;

(ii) on exposed portions of the arms, unless the lesion is protected by an impermeable cover; or

(iii) on other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage;

(f) symptoms of any of the following illnesses as diagnosed by a health practitioner:

(i) norovirus;

(ii) hepatitis A virus;

(iii) shigella spp.;

(iv) shiga toxin-producing escherichia coli;

(v) salmonella typhi; or

(vi) nontyphoidal salmonella.

(2) A cottage food operator experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth must not work with exposed food; clean equipment, utensils, and linens; or unwrapped single-service or single-use articles.

(1) Cottage food operators must keep their hands and exposed portions of their arms clean.

(2) Cottage food operators must use the following procedure in order to keep their hands and exposed portions of their arms clean:

(a) rinse under clean, running warm water;

(b) apply an amount of soap;

(c) rub together vigorously for at least 10 to 15 seconds while:

(i) paying particular attention to removing soil from underneath the fingernails during the cleaning procedure; and

(ii) creating friction on the surfaces of the hands and arms or surrogate prosthetic devices for hands and arms, finger tips, and areas between the fingers;

(d) thoroughly rinse under clean, running warm water; and

(e) immediately follow the cleaning procedure with thorough drying using a single use towel.

(3) Cottage food operators must clean their hands and exposed portions of their arms immediately before engaging in food preparation, which includes working with exposed food, clean equipment and utensils, and unwrapped single-service and single-use articles, and:

(a) after touching bare human body parts other than clean hands and clean, exposed portions of arms;

(b) after using the toilet room;

(c) after caring for or handling service animals, household pets, or aquatic animals;

(d) after coughing, sneezing, using a handkerchief or disposable tissue, using tobacco, eating, or drinking;

(e) after handling soiled equipment or utensils;

(f) during food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks;

(g) when switching between working with raw food and working with ready-to-eat food;

(h) before donning gloves to initiate a task that involves working with food; or

(i) after engaging in other activities that contaminate the hands.

(4) Cottage food operators must keep their fingernails trimmed, filed, and maintained so the edges and surfaces are cleanable and not rough. Unless wearing intact gloves in good repair, a cottage food operator may not wear fingernail polish or artificial fingernails when working with unpackaged food.

(5) Except for a plain ring such as a wedding band, cottage food operators may not wear jewelry on their arms and hands while preparing food, including medical information jewelry.

(6) Cottage food operators must wear clean outer clothing to prevent contamination of food, equipment, utensils, linens, and single-service and single-use articles.

(1) A cottage food operator must not eat, drink, or use any form of tobacco in the registered area of the domestic residence while preparing a cottage food, or where the contamination of exposed food, clean equipment, utensils, and linens, unwrapped single-service and single-use articles, or other items needing protection can result.

(2) Cottage food operators must provide a barrier between the registered area of their domestic residence and all pets while preparing and packaging cottage food items.

(1) Cottage food products must be safe, unadulterated, honestly presented, and:

(a) must be offered for human consumption in a way that does not mislead or misinform the consumer;

(b) food or color additives and colored overwraps may not be used to misrepresent the true quality of a cottage food product, although dying cookies or other similar products and/or wrapping them for a theme such as a green cookie for St. Patrick's Day or a popcorn ball wrapped in red plastic for Christmas is allowed.

(2) Food must be obtained from approved sources, including:

(a) retail and wholesale establishments licensed by the state of Montana;

(b) fluid and dry milk products must:

(i) be obtained pasteurized; and

(ii) comply with grade A standards.

(c) In many cases local farm products are considered approved sources; consult with your local health authority to make determinations on a case-by-case basis.

(3) Eggs and dairy ingredients must be stored under refrigeration.

(4) Upon receiving food packages from an approved source, food packages must be maintained in good condition and protect the integrity of the contents so the food is not exposed to adulteration or potential contaminants.

(5) Cottage food operators must minimize bare hand and arm contact with exposed food that is not in a ready-to-eat form.

(6) Cottage food operators may not contact exposed, ready-to-eat food with their bare hands, and must use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment.

(7) A cottage food operator may not use a utensil more than once to taste cottage food products or ingredients that are to be sold or served.

(8) Food contact surfaces must be easily cleanable.

(9) Food must only contact surfaces of equipment and utensils that are cleaned and sanitized as specified:

(a) equipment food-contact surfaces and utensils must be clean to sight and touch;

(b) food-contact surfaces of cooking equipment and pans must be kept free of encrusted grease deposits and other soil accumulations.

(c) To the extent practicable, cottage food manufacturers should either dip utensils, dishes, and equipment in a 100 ppm chlorine bleach solution (or other approved sanitizer) and allow to air dry, or use the sanitizing cycle of a dishwasher.

(10) Toxic chemicals such as household cleaners, concentrated bleach, and pesticides must be stored in a way that will not contaminate food, food-preparation areas, and food-contact surfaces.

(1) Registration must follow the requirements provided in 50-50-117, MCA.

(2) The registrant must provide their name, mailing address, phone number, and e-mail address.

(3) The registrant must provide a detailed description of cottage food product manufacturing process including equipment and utensils to be used.

(4) The registrant must dispose of sewage through an approved facility that is:

(a) a public sewage treatment plant; or

(b) an individual sewage disposal system that is operated according to law.

(5) The recipe for each product must be submitted with the application for review and kept on file at the cottage food operation location. Ingredient lists are subject to public disclosure, but recipes are proprietary and are not subject to public disclosure.

(6) At the time of registration, the registrant must demonstrate that the water for the cottage food operation is either:

(a) from an approved public water system; or

(b) meets minimum drinking water standards from a certified laboratory by providing results for total coliform and nitrates from the private well serving the domestic residence that is being registered for the cottage food operation;

(i) nitrates must be below 10 mg/L from a sample within the last 12 months;

(ii) total coliforms must be absent from a sample within the last 6 months;

(iii) failure to meet minimum drinking water standards will result in registration being withheld until samples are provided that meet the minimum nitrate and total coliform standards in this rule.

(c) Water sampling may also be required by the state or local health authority when cottage food is suspected of being associated with an illness or outbreak.

(7) A registration fee of $40.00 must be paid to the county in which the cottage food operation is registered. Once registered, a cottage food operator may sell their registered products anywhere in the state of Montana. The cottage food operation must register again with the local health authority and pay the registration fee if it wishes to change the location of its cottage food operation or produce new products. Recipe changes to an existing approved product that necessitate redetermination as to whether that product constitutes a non-potentially hazardous food or contains a major allergen are new products for the purposes of this rule. While not exhaustive, the following are examples of when a new fee must be paid:

(a) when a cottage food operator moves to a new house;

(b) when a cottage food operator changes a recipe in a way that may make the recipe potentially hazardous or adds an allergen, such as switching from a traditional frosting to one that contains cream cheese or adding walnuts to chocolate chip cookies; and

(c) when a cottage food operator wishes to make a completely new product, such as dried fruit when they had previously registered chocolate chip cookies.

(8) A department-approved certificate of registration will be provided to each new registrant. A certificate of registration must be made available to a local health authority upon request when a cottage food operator is vending to the public.

(1) Cottage food operations will be inspected according to the requirements of 50-50-301(3), MCA.

(2) Cottage food operators in violation of this subchapter are subject to enforcement action in accordance with Title 50, chapter 50, part 1, MCA.

(1) A cottage food operator must furnish cottage food product or ingredient samples for analysis upon request of the regulatory authority when the food is suspected of being associated with an illness or outbreak.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.