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| Montana Administrative Register Notice 37-847 | No. 22 11/22/2019 | |
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BEFORE THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES OF THE STATE OF MONTANA
TO: All Concerned Persons
1. On May 24, 2019, the Department of Public Health and Human Services published MAR Notice No. 37-847 pertaining to the public hearing on the proposed adoption, amendment, and repeal of the above-stated rules at page 598 of the 2019 Montana Administrative Register, Issue Number 10.
2. The department has adopted the following rules as proposed: New Rules I (37.110.304), II (37.110.305), III (37.110.306), IV (37.110.307), V (37.110.313), and VI (37.110.315).
The department has repealed the following rules as proposed: ARM 37.110.301, 37.110.302, 37.110.303, 37.110.310, 37.110.311, 37.110.312, 37.110.318, 37.110.319, 37.110.320, 37.110.321, 37.110.323, 37.110.330, 37.110.331, 37.110.332, 37.110.333, 37.110.340, 37.110.341, 37.110.342, 37.110.347, 37.110.348, 37.110.350, 37.110.351, 37.110.352, 37.110.353, 37.110.354, 37.110.355, 37.110.360, 37.110.361, 37.110.362, 37.110.363, 37.110.364, 37.110.370, 37.110.371, 37.110.801, 37.110.802, 37.110.805, and 37.110.810.
3. The department has amended the following rule as proposed, but with the following changes from the original proposal, and has corrected a statutory citation of authority, that was typed incorrectly in the Notice of Public Hearing on Proposed Adoption, Amendment, and Repeal, new matter underlined, deleted matter interlined:
37.110.101 FOOD STANDARDS (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
(2) remains as proposed.
AUTH: 50-31-104, 50-31-108, IMP: 50-31-101, 50-31-104, 50-31-203, MCA
4. The department has thoroughly considered the comments and testimony received. A summary of the comments received and the department's responses are as follows:
COMMENT #1: A commenter asked whether training provided to local sanitarians under New Rule V(2)(a) will be different from retail food standardized field training.
RESPONSE #1: Since nearly all routine inspections conducted by local sanitarians entail checking compliance with conventional risk factors and good manufacturing practices, training should be identical, or nearly identical, to retail food standardized field training. Training is dependent on time and resources available for both state and local staff but was placed in rule to emphasize the importance of making training a priority for both parties and to establish obligations that ultimately help ensure food products are safe for consumers.
COMMENT #2: A commenter asked the department to explain why alternative livestock as defined in 87-6-106(1), MCA, is relevant to the wild game section of the circular.
RESPONSE #2: Because wild game meats in specifically small percentages fall under jurisdictional authority of the department, section 3-201.11 of the circular clarifies that alternative livestock could be used as an approved food source.
COMMENT #3: A commenter asked if a rule should be created to require out-of-state exotic and game meat processing plants to meet the same legal standards as Montana facilities, if the product enters commerce in Montana.
RESPONSE #3: In the opinion of the department, no additional rule is needed since section 3-201.11 of the circular requires Montana establishments to obtain food "from sources that comply with law," which is broad in scope and scale in the food supply chain network. This means Montana, like other states, relies on federal and other state agencies to enforce regulations that apply to harvesting, processing, storage, and sanitary transport of wild and exotic game meats. If findings show there was a violation of law regarding sourcing, Montana has current regulations to render the product adulterated or misbranded to not only protect consumers from unsafe or questionable food under the Montana Food, Drug, and Cosmetic Act, but stop illegally harvested game from entering or continuing further into interstate or intrastate commerce.
COMMENT #4: A commenter asked if section 3-403.11 "reheating for hot holding" food is needed in the wholesale food circular. The commenter states a manufacturer most likely will not package hot-held foods to be supplied to a retailer.
RESPONSE #4: While the department agrees with the commenter, this situation will likely not be encountered during most inspections or investigations. The situation may occur in rare circumstances, such as offering offsite food samples as the commenter mentioned. This same rationale applies to why section 5-101.14, regarding natural snow and ice, was added as a regulation, as well as section 8-102.10. These rare and unique circumstances need to be addressed to ensure safe food for consumers.
COMMENT #5: A commenter requests the department clarify the apparent conflict between sections 4-301.12 and 4-501.16 regarding food preparation sinks and warewashing sinks used for washing or thawing foods.
RESPONSE #5: The department is of the opinion there is no conflict. The department believes newly licensed establishments will be required to have separate food preparation sinks when needed, unless a variance is warranted in the opinion of the local authority under section 8-103.10. In such cases, and for current and continuing licensees absent an existing and separate food preparation sink, the sanitizing compartment of a multiple-compartment warewashing sink may continue to be used under section 4-501.16, unless the local authority finds conditions that require an immediate or phased-in upgrade. This might be the case if the absence of a food preparation sink was significantly linked to an outbreak, recall, major allergen cross-contact condition, or other observed adverse conditions.
COMMENT #6: A commenter stated the terms "regulatory authority" and "local regulatory authority" used in the circular and rule should be reviewed for clarity.
RESPONSE #6: The department has reviewed the circular to ensure the terms are properly used.
COMMENT #7: A commenter requests the department review and remove all retail references from the circular, such as "temporary food establishments."
RESPONSE #7: The department has reviewed the circular and removed extraneous and irrelevant retail food references that inadvertently remained, such as "temporary" and "vending."
COMMENT #8: A commenter suggested the "f" in "federal" on page one of the circular be capitalized.
RESPONSE #8: The department has reviewed the circular and believes use of the noncapitalized letters is correct.
COMMENT #9: A commenter stated the department should consider removing the terms "critical" and "non-critical" violations in favor of "priority," "priority-foundation," and "core" inspection items.
RESPONSE #9: The department has long been in favor of using the terms "high," "medium," and "low" or alternatively "critical," "major," and "minor" to describe inspection findings to assign regulatory significance to the violation. These terms are carefully defined by the FDA for internal use to assist officers in establishing priorities and communicating findings to operators. However, assigning some observation to a specific severity category in all situations is not always possible or even advisable, and is best left to the professional judgment of the sanitarian. For example, a leaky roof in an establishment warehouse where all the food is packaged and sealed might be a minor violation, but a leaky roof above the production line in a manufacturing plant where there is exposed food might be a critical violation. The department has reviewed and revised the circular to better use terminology to categorize findings with the hope it will facilitate increased communications between regulators and operators.
COMMENT #10: A commenter suggests the department recheck the circular for spelling errors such as "potential hazardous food" in the preface table.
RESPONSE #10: The department agrees and has corrected all spelling errors identified.
COMMENT #11: A commenter states one term should be used to describe food that needs to be controlled for safety reasons (i.e., potentially hazardous food, time-temperature for safety food, condition control food). The commenter likes the concept of condition control food.
RESPONSE #11: The department partially agrees and plans to phase-in "condition control food" in the state and at the national retail food conference for consideration by all parties.
COMMENT #12: A commenter asked the department to define the term "honey" in rule.
RESPONSE #12: The department has revised the circular to define "honey" in the same manner as it is defined under 50-31-103(20), MCA.
COMMENT #13: A commenter asks the department to include "warehouse" in rule definitions regarding license subtypes.
RESPONSE #13: The department partially agrees, but believes the issue is better addressed when an updated licensing database is procured and implemented. However, the department has included in the circular a warehouse subtype.
COMMENT #14: A commenter stated the term "regulated carrier" is not defined and needs to be regarding transport of food.
RESPONSE #14: The department partially agrees and plans, through future rulemaking, to formally adopt applicable sections of 21 CFR 1.900-934 for the sanitary transport of human foods, which are currently in effect for vehicles engaged in transporting food in commerce. Specifically, the term "Carrier" is defined in 21 CFR 1.904, and has many exemptions and waivers. Also, use of the term as proposed in the circular is consistent with 21 CFR 1.227 regarding FDA registration of food facilities. In addition to using section 3-202.11 of the circular, and until a future circular update is adopted, departmental policy and guidance will resemble applicable portions of 21 CFR 1.900-934 for the sanitary transport of human foods.
COMMENT #15: A commenter suggests revising the definition of "packaged" under section 1-201.10(73) of the circular by removing language the commenter believes is not relevant to wholesale food.
RESPONSE #15: The department disagrees because the language provides clarity about what the term does not include.
COMMENT #16: A commenter suggests removing from the definition of "Potentially hazardous food" duplicative abbreviations already in the preface for the table of the circular.
RESPONSE #16: The department disagrees because the abbreviations provide clarity about the terms.
COMMENT #17: A commenter suggests defining the term "process authority."
RESPONSE #17: The department disagrees. New Rule III(6), now ARM 37.110.306(6) addresses who is qualified as a process authority to perform assessments and studies.
COMMENT #18: A commenter suggests changing the definition of "Sealed" in the circular to match the model retail code.
RESPONSE #18: The department agrees, and the current definition matches the current model retail code.
COMMENT #19: A commenter suggests exempting certain specialized processors from the certified food management training requirement, such as juice and acidified processors, who are required to take specialized training. The commenter also asks which administrative rule contains the establishment categories.
RESPONSE #19: The department agrees and has revised the circular accordingly. Establishment categories are contained in Table 1 of New Rule III and section 2-102.12 of the circular.
COMMENT #20: A commenter suggests changing the title of section 2-201.11 to read "Responsibility to report illness" for section clarification.
RESPONSE #20: The department partially agrees and has revised the title to read "RESPONSIBILITY, ILLNESS."
COMMENT #21: A commenter suggests removing paragraph 2 from section 2-402.11, since this applies to retail establishments.
RESPONSE #21: The department disagrees because the paragraph provides detail about when hair restraints are not required at retail establishments, which has logical application to wholesale establishments while adhering to the legal requirements in 50-57-103(2), MCA.
COMMENT #22: A commenter requests the department denote which parts of section 3-201.16 regarding wild plants and mushrooms are priority and priority foundation items.
RESPONSE #22: The department agrees and has revised the circular to include the recommendations.
COMMENT #23: A commenter suggests revising section 3-201.16 of the circular regarding wild plants and wild mushrooms to remove "or other persons involved in providing food directly to consumers."
RESPONSE #23: The department partially agrees and has revised the circular to clarify this section and to more closely correspond with the statutory definition of "wholesale."
COMMENT #24: A commenter asks if an online course would qualify as academic coursework for identifying wild mushrooms.
RESPONSE #24: An online course could qualify depending upon the institution and coursework content, but this determination is best decided on a case-by-case basis by local and state officials.
COMMENT #25: A commenter states the reference to paragraph (4)(h) in section 3-201.16(6)(l) needs clarification.
RESPONSE #25: The department agrees and has revised the section so that it now references (5)(a) through (h).
COMMENT #26: A commenter suggests the title of 3-202.11 be changed to "Food transport and receipt."
RESPONSE #26: The department partially agrees and has revised the title to read: "FOOD TRANSPORT, RECEIPT."
COMMENT #27: A commenter asks what would happen if a local jurisdiction disagreed with the requirement to transport certain foods under mechanical refrigeration in section 3-202.11.
RESPONSE #27: Variances can be granted under section 8-103.10, and other legal disputes between regulatory authorities can be settled under differing sections of state law.
COMMENT #28: A commenter suggests changing "will" to "must" in section 3-202.11 of the circular.
RESPONSE #28: The department believes this part of the circular is sufficiently written.
COMMENT #29: A commenter states that section 3-202.110 contains a reference to 3-404.11(3)(a), but that no such section exists in the circular.
RESPONSE #29: The department believes this part of the circular is sufficiently written because the circular does contain section 3-404.11(3)(a).
COMMENT #30: A commenter states decisions about whether to allow bare-hand contact with ready-to-eat foods should be up to local jurisdictions in section 3-301.11.
RESPONSE #30: The department agrees but no wording change is needed for this section because the term "regulatory authority" includes a local authority.
COMMENT #31: A commenter states that section 3-302.110 of the circular regarding major food allergen cross-contact issues is unworkable as written and suggests the department revise the section.
RESPONSE #31: The department has revised the section to better correspond with 21 CFR 117 Subpart B.
COMMENT #32: A commenter requests clarification of section 3-304.17 regarding when refillable containers may be reused that are returned to the manufacturer by the retailer/consumer.
RESPONSE #32: The department has revised the section to provide greater clarity.
COMMENT #33: A commenter asks whether the state or local regulatory authority is the party responsible for approving food reuse under section 3-306.14 regarding food returned to the wholesaler.
RESPONSE #33: The state and local regulatory authority share joint responsibility in making such decisions.
COMMENT #34: A commenter requests clarification as to plant treatment processes for fruit and vegetables in section 3-401.13 to provide more specificity in the rule.
RESPONSE #34: The department partially agrees and has made revisions to the circular.
COMMENT #35: A commenter suggests section 3-404.11 "specialized processing" be revised to include fermentations, using additives to get around time-temperature control and curing. The commenter also asks whether the section should be revised so all processors should simply comply with all applicable sections of ARM 37.110.101.
RESPONSE #35: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #36: A commenter seeks clarification of the use-by dates in section 3-501.17 of the circular.
RESPONSE #36: The department believes this part of the circular is sufficiently written to address this topic. A primary purpose of this section is to ensure that leftover ingredients dispensed from opened containers are used within the prescribed time period.
COMMENT #37: A commenter suggests section 3-502.12 be revised to clarify use-by dates for reduced oxygen packaging, especially for sous vide and cook-chill techniques.
RESPONSE #37: The department has revised the circular to clarify actions, such as "consumed" and "discarded." In certain processes, required specialized training is a substitute for a Hazard Analysis of Critical Control Points (HACCP) plan. At the retail level, specialized food safety training is not a requirement; hence the HACCP plan regulation for some processes and packaging.
COMMENT #38: A commenter stated section 3-502.12 for fish in reduced oxygen packaging is not consistent with section 3-501.13.
RESPONSE #38: The department believes both these sections of the circular are sufficiently written to address these two separate topics regarding proper thawing and processing/packaging.
COMMENT #39: A commenter suggests section 3-601.11 regarding the new standard of identity for sandwiches and fishery products be revised to provide greater clarity.
RESPONSE #39: The department believes this part of the circular is sufficiently written to address this topic and is consistent with wording in other federal standards of identity. This part of the circular will likely be addressed during the pre-licensing stage by the department and was prompted by the absence of a federal standard of identity.
COMMENT #40: A commenter suggests section 3-601.13 regarding offsite food sampling be revised to provide simplification and clarity.
RESPONSE #40: The department believes this part of the circular is sufficiently written to address this topic, but has added the statutory citation.
COMMENT #41: A commenter suggests language in section 3-601.13 regarding customer bulk food dispensing be removed.
RESPONSE #41: The department believes this part of the circular is sufficiently written to address this topic. A customer is not necessarily a consumer.
COMMENT #42: A commenter states the warning language in section 3-602.11(6) needs to be more flexible.
RESPONSE #42: The department believes this part of the circular is sufficiently written to address this topic. This entire subsection is voluntary.
COMMENT #43: A commenter suggests adding warning language to section 3-602.11 to include products such as sushi and shellfish.
RESPONSE #43: The department believes this part of the circular is sufficiently written to address this topic. For example, raw fish included in certain types of sushi must be treated for parasite destruction as indicated in their HACCP plan during the pre-licensing process.
COMMENT #44: A commenter notes "bowels" in the section 4-101.13 chart should read "bowls."
RESPONSE #44: The department has revised the circular to correct this typographical error.
COMMENT #45: A commenter states stronger language is needed in section 4-201.11 regarding food equipment and utensils to support the requirement for commercial equipment designed for the intended use.
RESPONSE #45: The department believes this part of the circular is sufficiently written to address this topic and has revised the language in the circular to refer the reader to section 4-205.10 to specifically address the topic of commercial-grade equipment.
COMMENT #46: A commenter states section 4-301.12 is wordy and confusing, especially if a wholesale facility is using detergent-sanitizers.
RESPONSE #46: The department believes this part of the circular is sufficiently written to address this topic. For example, detergent-sanitizers that have an EPA registration number are effective in sanitizing if used in accordance with written product label instructions.
COMMENT #47: A commenter suggests changing the title of section 4-501.14.
RESPONSE #47: The department believes the title is sufficiently written to describe the content of this section.
COMMENT #48: A commenter seeks clarification of section 4-501.16(2) and states the language is confusing.
RESPONSE #48: The department believes this part of the circular is sufficiently written to address the topic.
COMMENT #49: A commenter seeks removal of extra commas in section 4-501.114.
RESPONSE #49: The department agrees and has revised the circular accordingly.
COMMENT #50: A commenter suggests deleting section 4-501.115 because detergent-sanitizers will not meet the needs of wholesalers.
REPSONSE #50: The department believes this part of the circular is sufficiently written to address this topic. For example, detergent-sanitizers that have an EPA registration number are effective in sanitizing if used in accordance with written product label instructions. In the past, states like Wisconsin had their own sanitizer verification programs, but this service is now conducted by the EPA.
COMMENT #51: A commenter states they are unclear on why sections 3-503.12, 4-401.11, and 4-903.12 repeat the same storage conditions in three separate sections of the circular.
RESPONSE #51: There is no section 3-503.12 in the circular or model Food Code. The department believes these parts of the circular are sufficiently written to address this topic.
COMMENT #52: A commenter states section 4-904.11 as written only applies to retail food for single-use and multiple-use article and utensils. The commenter suggests the section be removed or revised.
RESPONSE #52: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #53: A commenter seeks correction of the numbering system relating to section 5-101.11.01.
RESPONSE #53: The department agrees and has revised the section to correct the numbering errors.
COMMENT #54: A commenter requests section 5-101.12 be revised to include water flushing for seasonable establishments using public and non-public water systems.
RESPONSE #54: The department agrees and has revised the circular accordingly. Seasonable establishment water flushing is also addressed in the non-public water circular.
COMMENT #55: A commenter states section 5-102.12 should be revised to remove awkward wording and require labeling of pipes.
RESPONSE #55: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #56: A commenter states section 5-102.14 regarding records retention conflicts with Nonpublic Water Supply Circular FCS 1-2016.
RESPONSE #56: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #57: A commenter states section 5-103.11(3)(a) and (b) should be removed for retail mobile units.
RESPONSE #57: The department agrees and has revised the circular accordingly.
COMMENT #58: A commenter states section 5-103.12 regarding food sampling sites should be revised to reference food sampling establishments.
RESPONSE #58: The department agrees and has revised the circular accordingly.
COMMENT #59: A commenter asks why the mobile establishment water capacity determination in section 5-103.11 is a joint function of both the department and the local regulatory authority.
RESPONSE #59: The wording of this section was clarified to be a joint decision between the local authority and department and likely will be addressed during the pre-licensing stage.
COMMENT #60: A commenter suggests changing the reference to "water transport vehicles" in section 5-104.11(2)(b) to read: "water hauler licensed in the state of Montana or regulated as part of a public water supply as provided in Title 75, Chapter 6."
RESPONSE #60: The department partially agrees and has revised the language to include a water hauler.
COMMENT #61: A commenter suggests changing the reference to "temporary" in section 5-104.12 to read "wholesale food sampling site" or similar language.
RESPONSE #61: The department agrees and has revised the language to read "food sampling establishment."
COMMENT #62: A commenter suggests section 5-203.11 be revised to remove reference to "temporary" and "vending."
RESPONSE #62: The department agrees and has revised the circular to remove extraneous and irrelevant retail food references, such as "temporary" and "vending."
COMMENT #63: A commenter suggests section 5-402.14 be revised to clarify who is authorized to haul wastewater.
RESPONSE #63: The department agrees and has revised this section to provide greater clarity.
COMMENT #64: A commenter suggests changing the reference to "temporary" in section 6-101.11 to read "wholesale food sampling site" or similar language.
RESPONSE #64: The department agrees and has revised the language to read "food sampling establishment."
COMMENT #65: A commenter suggests changing the reference to "temporary" in section 6-202.15 to read "wholesale food sampling site" or similar language.
RESPONSE #65: The department agrees and has revised the language to read "food sampling establishment."
COMMENT #66: A commenter suggests the word "flowing" in section 6-501.115 be changed to "running."
RESPONSE #66: The department agrees and has revised the section to remove the term "flowing."
COMMENT #67: A commenter suggests the department review whether section 6-501.115(3) applies to wholesale.
RESPONSE #67: The department has reviewed the section and believes it is sufficiently written to address the topic.
COMMENT #68: A commenter suggests revising the language of section 7-207.11 to eliminate the retail reference.
RESPONSE #68: The department believes this part of the circular is sufficiently written to address this topic. For example, some wholesale operations also offer retail sales of medicines.
COMMENT #69: A commenter suggests revising the language of section 7-207.12 to eliminate the retail and childcare references.
RESPONSE #69: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #70: A commenter suggests revising the language of section 7-301.11 to eliminate retail reference.
RESPONSE #70: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #71: A commenter states section 8-101.10 should be revised to replace "7" with "g."
RESPONSE #71: The department agrees and has revised the circular accordingly.
COMMENT #72: A commenter suggests the department revise section 8-102.10 to provide more clarity and flexibility.
RESPONSE #72: The department believes this part of the circular is sufficiently written to address this topic.
COMMENT #73: A commenter suggests section 8-401.20 be revised to clarify inspection frequency.
RESPONSE #73: The department agrees and has revised the section to provide greater clarity.
COMMENT #74: A commenter suggests revising section 8-402.10 to include sanitarians in-training.
RESPONSE #74: The department agrees and has revised the circular accordingly.
COMMENT #75: A commenter suggests changing the number for section 8-402.11 to end in .10 or .20.
RESPONSE #75: The department believes this section is numbered appropriately, but has added terms to clarify the requirements and has added the new rule number.
COMMENT #76: A commenter suggests changing numbering for sections 8-402.15 through 8-402.40 to match convention.
RESPONSE #76: The department believes these sections are appropriately numbered.
COMMENT #77: A commenter suggests revising section 8-501.20 regarding license suspensions to remove language allowing licenses to be summarily suspended. The commenter states that law does not allow for suspending a license and suspension would need to be done through the health officer's authority.
RESPONSE #77: The department believes this part of the circular is sufficiently written to address this topic and complies with Montana law.
COMMENT #78: A commenter suggests all definitions from the circular be moved to administrative rule.
RESPONSE #78: The circular is adopted and incorporated by reference under New Rule II, now ARM 37.110.305. The definitions apply to both the circular and the administrative rules.
COMMENT #79: A commenter states New Rule III(8), now ARM 37.110.306(8), is too stringent and suggests it be revised to allow a local regulatory authority to waive the no-violation requirement regarding final pre-licensing inspections.
RESPONSE #79: The department believes this part of the rule is sufficiently written to address this topic. An establishment must not commence operations in a state of non-compliance. Obtaining compliance after issuance of a license may be difficult, if not realistically impossible.
COMMENT #80: A commenter suggests New Rule IV, now ARM 37.110.307, be revised to allow more inspection flexibility.
RESPONSE #80: The department believes this part of the rule is sufficiently written to address this topic. This rule corresponds with existing retail food rule in ARM 37.110.239.
COMMENT #81: A commenter suggests revising ARM 37.110.101(1)(af) so that the term "fours" reads "flours."
RESPONSE #81: The department agrees and has revised the rule accordingly.
COMMENT #82: A commenter states all references to "sewage" in the circular should be changed to "wastewater" to fit terminology used in applicable regulations across the state. Alternatively, the commenter suggests the definition of sewage be revised to include wastewater.
RESPONSE #82: The department believes the terms are used correctly in the circular, since both terms are used in the model Food Code.
COMMENT #83: A commenter indicates the term "regulatory authority" defined in the circular is inconsistent with the definition provided for under 50-57-102(8), MCA.
RESPONSE #83: The department has revised the definition to conform with 50-57-102(8), MCA.
5. The department intends these rules to be effective January 1, 2020.
/s/ Robert Lishman /s/ Sheila Hogan Robert Lishman Sheila Hogan, Director Rule Reviewer Public Health and Human Services
Certified to the Secretary of State November 12, 2019.
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