9-1900-10927-1

10. The Agencies met all of the procedural requirements established by statute and rule.

Nature of the Proposed Rules

11. This rulemaking proceeding involves a joint proposal by the Minnesota Department of Health and the Minnesota Department of Agriculture to adopt new rules governing the handling, storage, and preparation of food by food service establishments, retail food stores, and other “food establishments” as defined in the rules. The proposed Minnesota Food Code, to be set forth in Chapter 4626 of the Minnesota Rules, would replace the food sanitation and safety standards currently set forth in chapters 1547, 1550, and 4625 of the Minnesota Rules. The proposed rules are based on the 1995 Model Food Code issued by the United States Food and Drug Administration. The 1995 Model Food Code continued the approach first taken by the FDA in 1993 of combining the previously separate model codes used for restaurants, grocery stores, and vending machines.

12. A state task force convened in 1994 at the direction of the Minnesota Legislature to examine the current system of regulating and inspecting grocery stores and food, beverage, and lodging establishments. The report eventually issued by the task force recommended that the Departments of Health and Agriculture jointly adopt rules governing food service establishments and retail food stores and consider whether the FDA food code could be used as the basis for a uniform Minnesota rule. The proposed rules, which were drafted with the assistance and input of an advisory committee, reflect the Agencies’ belief that changes in the food industry have blurred the former distinctions between grocery stores and restaurants, duplicative rule requirements should be eliminated in favor of a uniform food code, and the focus of such a code should be on the prevention of foodborne disease.[7] The food code would replace existing standards that govern restaurants, food and beverage establishments, retail grocery stores, retail bakeries, vending machines, and food carts.[8]

Statutory Authority

13. The Department of Health cites Minn. Stat. §§ 144.05, 144.08, 144.12, and 157.011, as the source of its authority to adopt these rules.[9] These statutory provisions require the Commissioner of Health to “adopt rules establishing standards for food and beverage service establishments, hotels, motels, lodging establishments, and resorts”; direct the Commissioner to be responsible for the “development and maintenance of an organized system of programs and services for protecting, maintaining, and improving the health of the citizens,” including the planning of the “organization of services for the prevention and control of illness and disease” and the coordination and integration of “local, state and federal programs and services affecting the public’s health”; authorize inspections of food products in hotels; permit the adoption of reasonable rules “for the preservation of the public health”; and empower the Commissioner to “regulate the general sanitation of mass gatherings by adoption of rules . . . .” The Department of Agriculture cites Minn. Stat. §§ 31.11 and 31.101 as the source of its authority to adopt these rules. Minn. Stat. § 31.101, subd. 1, gives the Commissioner of Agriculture authority to “promulgate and amend rules “for the efficient administration and enforcement of the Minnesota food law.” That statute further requires that the rules adopted “when applicable shall conform, insofar as practicable and consistent with state law, with those promulgated under the federal law.” Minn. Stat. § 31.11, subd. 1, imposes upon the Commissioner of Agriculture the duty “to make and publish uniform rules, not inconsistent with law, for carrying out and enforcing the provisions of law now or hereafter enacted relating to food” for the “purpose of protecting and preserving the public health.”

14. The primary purpose of the proposed rules is to ensure the fitness of food for consumption by the public. The Administrative Law Judge finds that the Agencies have the statutory authority jointly to adopt the proposed rules.

Rulemaking Legal Standards

15. Under Minn. Stat. § 14.14, subd, 2, and Minn. Rule 1400.2100, one of the determinations which must be made in a rulemaking proceeding is whether the agency has established the need for and reasonableness of the proposed rule by an affirmative presentation of facts. In support of a rule, the Agencies may rely on legislative facts, namely general facts concerning questions of law, policy and discretion, or they may simply rely on interpretation of a statute, or stated policy preferences.[10] The Agencies prepared a Statement of Need and Reasonableness ("SONAR") in support of the proposed rules. At the hearing, the Agencies primarily relied upon the SONAR as its affirmative presentation of need and reasonableness for the proposed amendments. The SONAR was supplemented by comments made by Agency staff members and a representative of the FDA at the public hearing and in written post-hearing submissions.

16. The question of whether a rule has been shown to be reasonable focuses on whether it has been shown to have a rational basis, or whether it is arbitrary, based upon the rulemaking record. Minnesota case law has equated an unreasonable rule with an arbitrary rule.[11] Arbitrary or unreasonable agency action is action without consideration and in disregard of the facts and circumstances of the case.[12] A rule is generally found to be reasonable if it is rationally related to the end sought to be achieved by the governing statute.[13] The Minnesota Supreme Court has further defined an agency’s burden in adopting rules by requiring it to "explain on what evidence it is relying and how the evidence connects rationally with the agency's choice of action to be taken."[14] An agency is entitled to make choices between possible approaches as long as the choice made is rational. Generally, it is not the proper role of the Administrative Law Judge to determine which policy alternative presents the "best" approach since this would invade the policy-making discretion of the agency. The question is rather whether the choice made by the agency is one a rational person could have made.[15]

17. In addition to need and reasonableness, the Administrative Law Judge must also assess whether the rule adoption procedure was complied with, whether the rule grants undue discretion, whether the Agencies have statutory authority to adopt the rule, whether the rule is unconstitutional or illegal, whether the rule constitutes an undue delegation of authority to another entity, or whether the proposed language is not a rule.[16] In this matter, the Agencies have proposed changes to the rule after publication of the rule language in the State Register. Because of this circumstance, the Administrative Law Judge must determine if the new language is substantially different from that which was originally proposed.[17] The standards to determine if the new language is substantially different are found in Minn. Stat. § 14.05, subd. 2 (1996). The statute specifies that a modification does not make a proposed rule substantially different if “the differences are within the scope of the matter announced . . . in the notice of hearing and are in character with the issues raised in that notice,” the differences “are a logical outgrowth of the contents of the . . . notice of hearing and the comments submitted in response to the notice,” and the notice of hearing “provided fair warning that the outcome of that rulemaking proceeding could be the rule in question.” In reaching a determination regarding whether modifications are substantially different, the Administrative Law Judge is to consider whether “persons who will be affected by the rule should have understood that the rulemaking proceeding . . . could affect their interests,” whether “the subject matter of the rule or issues determined by the rule are different from the subject matter or issues contained in the . . . notice of hearing,” and whether “the effects of the rule differ from the effects of the proposed rule contained in the . . . notice of hearing.”[18]

Impact on Farming Operations

18. Minn. Stat. § 14.111, (1996), imposes an additional notice requirement when rules are proposed that affect farming operations. In essence, the statute requires that an agency must provide a copy of any such proposed rule change to the Commissioner of Agriculture at least thirty days prior to publishing the proposed rule in the State Register. The Agencies indicated that the proposed rules will not have any direct or substantial adverse impact on agricultural land or farming operations.[19] The Agencies also pointed out that this rulemaking is a joint endeavor between Health and Agriculture.[20]

19. The proposed rules do not impose restrictions or have a direct impact on fundamental aspects of farming operations. The Administrative Law Judge finds that the proposed rule change will not affect farming operations in Minnesota, and thus finds that no additional notice is required. Were additional notice to be required, the participation of Agriculture in this rulemaking proceeding constitutes full compliance with Minn. Stat. § 14.111.

Cost and Alternative Assessments in the SONAR

20. Minn. Stat. § 14.131 requires an agency adopting rules to include in its SONAR:

(1) a description of the classes of persons who probably will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule;

(2) the probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues;

(3) a determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule;

(4) a description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule;

(5) the probable costs of complying with the proposed rule; and

(6) an assessment of any differences between the proposed rule and existing federal regulations and a specific analysis of the need for and reasonableness of each difference.

21. The SONAR includes a discussion of the analysis that was performed by the Agencies to meet the requirements of this statute.[21] With respect to the first requirement, the Agencies noted that “everyone eats food; therefore everyone benefits from a safe food supply.”[22] In actuality, the rule protects the health of persons who eat in food establishments covered by the rules or buy food that is supplied by such establishments. That class of persons amounts to most persons living in Minnesota and many who are passing through. The anticipated costs will be incurred by food establishments that are not explicitly exempted from the rules, and thus will generally be borne by operations that store, prepare, package, serve, vend, or otherwise provide food for human consumption. The exemptions include private homes receiving catered meals, hospitals, nursing homes, boarding care homes, intermediate care facilities for the mentally retarded, federally-regulated food processing plants, interstate carriers, churches, day care homes, bake sales, pot luck events, certain pharmacies, certain farm products and farm animals, apiaries, manufacturers of prepackaged ice or other nonperishable items, and certain farmer’s market vendors.

22. With respect to the second requirement, the Agencies emphasized that food inspection programs are supported by fees and that there are no additional fees associated with the proposed rules. The primary new requirement imposed by the proposed rules on state regulatory agencies will be the requirement that they review Hazard Analysis Critical Control Point (“HACCP”) plans for new and existing establishments under certain circumstances. HACCP is a food safety system that “involves identifying and monitoring the critical points in food preparation where the risks of food-borne hazards (microbial, chemical and physical) are the greatest.”[23] It is anticipated that review of HACCP plans for existing establishments at the time of inspection will require an additional one hour of staff time and that the review of HACCP plans for new establishments will require an additional two hours of staff time per plan. The Agencies estimated that the costs associated with licensure should remain unchanged if the proposed rules are adopted because there are no significant new inspection requirements in the proposed rules other than the review of HACCP plans. The Agencies indicated in the SONAR that the use of consistent standards such as uniform inspection forms and standardized sanitarian training might even result in some efficiencies. The Agencies thus anticipate that the additional time and cost associated with HACCP plan review over the next two years will be absorbed by the Agencies’ existing staffing levels and will be offset by efficiencies resulting from the adoption of a statewide food code.[24]

23. Forty-three counties and eighteen cities currently administer the food, beverage, and lodging standards of the state under delegation agreements with the Department of Health.[25] The Agencies expect that such local units of government will incur costs totaling approximately $61,000 as a result of the proposed rules. These costs will stem from the need to amend local ordinances to conform to the statewide food code. It is anticipated that the amendment process will not be time-consuming because local governments may simply cross-reference the revised state rules. To reduce the expense to local governments, the Agencies will prepare a model ordinance to be used by local jurisdictions.[26]

24. The third requirement imposed by Minn. Stat. § 14.131 asks the Agencies to determine whether there are less costly or less intrusive methods to achieve the purposes of the proposed rules. In the SONAR, the Agencies discussed comments on drafts of the proposed rules provided by Dr. O. Peter Snyder, President of the Hospitality Institute of Technology and Management (“HITM”), in which it was recommended that the Agencies consider a HACCP-based approach to regulation of the state food industry. The food code advisory work group considered this recommendation, but did not recommend it for every food establishment. Moreover, the work group did not believe it should be a substitute for the inspection-based system that is currently set forth in state law for establishments licensed by the Department of Health and the Department of Agriculture. The Agencies emphasized that the U.S. Food and Drug Administration recommends in the federal model code that food establishments be inspected by government inspectors on an even more frequent basis than current practice in Minnesota, and that the National Conference for Food Protection supports an inspection-based program. The Agencies also pointed out that fees supporting the inspection-based program range between $130 and $355 per year per establishment; the cost for custom meat processors to develop a HACCP plan has been estimated to be from $50 to $300 per establishment; the cost for meat processors with less than ten employees to develop a HACCP plan has been estimated to be from $400 to $1,000 per product; and it would not be efficient or feasible for temporary establishments to have HACCP plans. While the Agencies have not yet made any determination as to whether a HACCP plan-based system would be less costly or intrusive than the current inspection-based system, the Agencies indicated in the SONAR that they would be closely monitoring areas where HACCP is being required and would undertake pilot projects in the next two years in selected establishments using HACCP plans as a mechanism to control foodborne illness. The Agencies also pointed out that the cost of foodborne illness to the public is very great, the investigation of outbreaks and the potential exclusion of employees can be very intrusive, and investigations of foodborne illness would occur regardless of whether the state had an inspection or HACCP-based system in place.[27]

25. The fourth provision of Minn. Stat. § 14.131 requires the Agencies to describe any alternative methods that were considered and the reasons they were rejected. In the SONAR, the Agencies noted that alternatives considered with respect to specific rule parts are discussed in the SONAR in conjunction with that particular rule part. In general, the Agencies noted that the overall alternative considered by the Agencies was the requirement of HACCP plans for all food establishments in lieu of inspections. The Agencies noted that this alternative was rejected because state and federal laws governing the food programs administered by the Departments of Health and Agriculture require inspection; the advisory workgroup agreed that the HACCP plan requirement should be limited to certain high risk situations; and the food industry is not yet trained to develop HACCP plans, although rules under development for food service operation manager certification will likely include HACCP planning. In the Agencies’ estimation, there is insufficient knowledge of HACCP methods throughout the food industry to ensure compliance. Under these circumstances, the Agencies decided that they “must abide by the statutory requirements to administer an inspection-based regulatory program.”[28] Other alternatives were considered by the Agencies, such as imposing more stringent building, material, and equipment requirements. With three exceptions (and then only for new or extensively remodeled facilities), the suggestions for more stringent building, material, and equipment standards were rejected based upon the Agencies’ judgment that behavior factors such as handwashing and the exclusion of ill workers are more critical and should receive greater emphasis.[29]

26. The fifth factor required to be considered under Minn. Stat. § 14.131 is the probable cost of complying with the proposed rules. The SONAR indicates that costs to food establishments covered by the rules will be minimal because, for the most part, the proposed rules do not impose new requirements. Many of the requirements seen to be new by the regulated industry are, in fact, existing requirements of which the commentators were unaware.[30] Costs during new construction or remodeling are the only additional building and equipment costs that will be required of the majority of food establishments. Food establishments using preparation methods that present a greater than normal risk (such as those that choose to serve raw or undercooked fish or meat dishes) are required to develop a HACCP plan that could cost as much as $1,000 for a single product. Since the foods being consumed carry a greater than normal risk of transmitting food-borne illnesses, the imposition of the additional cost is justified.

27. The Agencies did not consider the additional costs that arise from the need to train employees in the requirements of the rules. Since the proposed rules for the most part retain existing standards for safe food-handling practices, such retraining is no more costly than a food establishment’s current obligation to train employees in such practices. In addition, the Agencies have prepared summaries of information for use by food service workers and others in controlling the transmission of food-borne illnesses. Any additional costs required for retraining are justified.

28. The sixth factor set forth in Minn. Stat. § 14.131 requires an assessment of differences between the proposed rule and existing federal regulations. As noted above, the 1995 model food code developed by the U.S. Food and Drug Administration was followed by the Agencies in developing the proposed rules.[31] The model food code is not binding federal law, but is an attempt to achieve uniform standards in the nation. In the SONAR, the Agencies indicated that Minnesota has chosen to use federal models as a basis for regulation of food safety and sanitation since 1950. The Agencies described the differences between the FDA model code and the proposed rules in the SONAR. None of these differences results in a rule that conflicts with an applicable federal requirement. In areas where there are applicable or preemptive federal laws or rules, the proposed rules are consistent with the federal standard and in many instances refer directly to that standard.[32]

29. The Administrative Law Judge concludes that the Agencies have met the requirements set forth in Minn. Stat. § 14.131 for assessing the impact of the proposed rules.

Analysis of the Proposed Rules

General

30. Numerous comments were received in writing and through testimony at the public hearing. The commentators in this matter have paid close attention to detail in the rules and have made suggestions that encompass matters of both substance and form. This Report is generally limited to the discussion of the portions of the proposed rules that received significant critical comment or otherwise need to be examined. Accordingly, the Report will not discuss each comment or rule part. Persons or groups who do not find their particular comments referenced in this Report should know that each and every suggestion has been carefully read and considered. Moreover, because some sections of the proposed rules were not opposed and were adequately supported by the SONAR, a detailed discussion of each section of the proposed rules is unnecessary. For these reasons, it is unnecessary to engage in a detailed discussion of each part and subpart of the proposed rules in this Report. The Administrative Law Judge specifically finds that the Agencies have demonstrated the need for and reasonableness of all rule provisions not specifically discussed in this Report by an affirmative presentation of facts. She also finds that all provisions not specifically discussed are authorized by statute and there are no other problems that would prevent the adoption of the rules.

31. Where changes were made to the rules after publication in the State Register, the Administrative Law Judge must determine if the new language is substantially different from that which was originally proposed.[33] The standards to determine if the new language is substantially different from that which was originally proposed by the Board are found in Minn. Stat. § 14.05, subd. 2. In this rulemaking proceeding, members of the public urged the Agencies to make several non-substantive changes in the language of the rules as originally published in the State Register. For example, Steve Olson of the City of St. Paul’s Office of Licensing, Inspection and Environmental Protection submitted 102 suggestions for corrections in numerous subparts of the rules. In response, the Agencies amended the rules throughout to cure grammatical errors and eliminate improper citations. These suggestions and amendments will not be discussed individually. The Administrative Law Judge finds that modifications made by the Agencies in punctuation or to correct a cross-reference or a typographical error are needed and reasonable, and that these changes do not result in a substantially different rule.

Structure, Format, and Overall Content of the Rules

32. Several objections were made to the format, structure, and overall content of the proposed rules. Some commentators, such as Steven Olson (Public Health Sanitarian for the City of St. Paul), Petrona Lee (Environmental Health Manager of the City of Bloomington), and Roger Carlson (Principal Planner/Analyst for the Hennepin County Public Health Department), felt that the proposed rules were repetitive and/or covered similar topics in several different areas of the code. Several of these individuals and others, such as Dr. Snyder, Tom Newman (Corporate Foodservice Manager, SuperValu, Inc.), L.P. Juba (Chairman, Juba’s, Inc.), and Douglas Downs (Minnesota Association of Meat Processors Committee Member) felt that the proposed food code was too lengthy, legalistic, and complex to be utilized by employees of food establishments or to be effectively enforced. They also objected to what they see as an emphasis in the proposed rules on inspections and building requirements and an asserted lack of a scientific basis for the requirements imposed by the proposed rules. They recommended that the proposed rules be placed on hold until a revised version is produced that emphasizes education of food handlers and assures the safety of food. D. Thomas Day (Government Affairs Manager, Hospitality Minnesota) agreed that the proposed code was confusing and difficult to follow, but supported the proposed rules as “a legal document first, and a user’s document second.” Hospitality Minnesota indicated its willingness to assist in drafting a guidebook that will discuss the most important features of the proposed rules.

33. The Agencies responded to these concerns in their post-hearing comments. They explained that the structure of the proposed rules was derived from the structure of the FDA model code, and emphasized that the Legislature directed the Agencies to adopt uniform rules that were consistent with federal requirements to the greatest extent possible. In addition, the Agencies noted that the fact that the state code is similar in format and content to the federal model code would enable food establishments operating in different jurisdictions to more efficiently train their employees and implement food safety and sanitation requirements and would allow for a national discussion on food safety and sanitation. Although the Agencies acknowedged that the format of the proposed rules is more difficult to understand than the federal model code, the Revisor of Statutes requires that rules follow a particular format. A detailed table of contents that will be published with the rules may be of assistance in understanding the basic structure of the rules. The Agencies indicated that, while the proposed rules are intended to be readable by the general public, they were not intended to serve as a training document but rather as the basis for training documents. The Agencies are in the process of drafting training materials and fact sheets pertaining to the food code. Accordingly, the Agencies did not propose any change in the format and structure of the proposed rules in response to the comments, other than developing a detailed table of contents for publication with the rule.[34] In addition, the Agencies indicated that references in the proposed rule to “floors, walls, and ceilings” are very limited and do not permeate the proposed code. The Agencies pointed out that the majority of the building requirements included in the proposed rules have to do with preventing the accumulation of dirt or the harboring of vermin, and thus are necessary to address food safety and sanitation.

34. The Administrative Law Judge concludes that the Agencies have shown that the format, structure, and overall content of the proposed rule is needed and reasonable to ensure consistency between the state food code and the federal model code and regulate food safety and sanitation matters.

Rule by Rule Discussion

4626.0015 – Food Safety

35. Proposed rule 4626.0015 sets out the general requirement that food offered by food establishments “not be adulterated, misbranded or falsely advertised.“ Dr. Snyder objected to the rule language as insufficient to address problems customers have when allergic to some of the ingredients in food. The Agencies responded that a separate rule provision requires that food be correctly identified and thus would require that food establishments give customers needed information on the content of food.[35] The Agencies also acknowledged that “more work needs to be done in this area” and indicated that the FDA was currently considering different regulatory approaches to address this concern.[36] The Agencies indicated that “future revisions to the federal model code will include provisions addressing allergies and Minnesota will consider adopting the federal provisions at that time.”[37]

36. The rule language proposed has been shown to be needed and reasonable to prevent covered food establishments from offering food that has not been properly identified. No commentator has suggested a method to adequately protect customers with allergies that can accommodate the myriad ways food is presented. The lack of language to address food allergies does not render the proposed rule unreasonable, particularly where the Agencies are awaiting further federal guidance in this area.

4626.0020 – Statement of Application and Listing of Terms

37. A wide variety of terms, acronyms, and notations used in throughout the rules are defined in proposed rule 4626.0020. Most of the terms are taken directly from the FDA model code. Some modifications were made to conform the definitions to those in existing Minnesota statutes and some definitions were added for clarity. The majority of the definitions received no critical comments. Those definitions not specifically discussed below are found to be needed and reasonable.

“Clean”

38. Mr. Olson suggested that a definition of “clean” be included in the proposed rules. In its post-hearing comments, the Agencies amended the proposed rules to include such a definition. A new subparagraph would be added to rule part 4626.0020 to define “clean” to mean “free from insects, vermin, and debris and free from physical, chemical, and microbial substances discernible by ordinary sight or touch, by ultraviolet light, or by artificial light.” This definition is similar to the definition of “clean” contained in existing rule part 4625.2401, except that references in the existing rule to the safranine-o dye test and microscopic or microbiological examination have been deleted based upon the Agencies’ assessment that these methods of testing are not practical in the field. The definition of “clean” has been added in response to public comment. The modification to include the definition does not render the final version of the rule substantially different from the rule as originally proposed, since it is similar to the existing rule and is a logical outgrowth of the contents of the notice of hearing and comments.

“Noncritical Item”

39. Subpart 20 defines “critical item” to mean those areas of the food code where a failure to comply is more likely than other violations to contribute to food contamination, illness, or environmental degradation. These rule parts are marked with an asterisk and are deemed to be critical for enforcement purposes. Mr. Carlson suggested at the hearing and in his written post-hearing comments that a definition of “noncritical item” be added. Although the Agencies indicated that they did not consider such a definition important since any part of the rule not designated as a critical item was, in effect, a noncritical item, they accepted the commentator’s suggestion and added a subpart defining “noncritical item.” The proposed definition notes that noncritical item means “a part of the Code that, if in noncompliance, is less likely than other violations to contribute to food contamination, illness, or environmental degradation.” Two other items were added to explain that parts set forth in the proposed food code without an asterisk after the headnote are noncritical items, and provisions within critical items that are marked with a superscripted letter ^N are noncritical items.[38] In addition, a new subpart was added explaining when the asterisk and superscripted ^N designate.[39]

40. The new subparts are needed and reasonable to clarify the proposed rules. The modifications were prompted by a comment received during the rulemaking proceeding and does not result in a rule that is substantially different that the rule as originally proposed.

“Fish”

41. Proposed subpart 29 defines “fish” to include a wide variety of aquatic, amphibious, and reptilian creatures, “if the animal life is intended for human consumption.” Mr. Carlson objected to the proposed definition as lumping together as “fish” species that are in no way similar and questioned the “intended for human consumption” language. The Agencies responded that the definition “usefully defines a category of aquatic animal life” for the purposes of the rules.[40] The Agencies added a further definition of shellfish, to assist persons who need clarification on the issue.[41]

42. The Administrative Law Judge finds that the Agencies have demonstrated that the definition of “fish” is needed and reasonable, as proposed. Although the definition selected does not coincide with biological or common use, it is not required to do so. The rule definition provides a clear delineation of the meaning of the term as used in the rules. There is no difficulty in defining an alligator, for example, as a fish, so long as any use of the term distinguishes between alligators and animals more commonly thought of as fish (such as trout or tuna) when the food items must be treated differently. The “intended for human consumption” language merely distinguishes between the handling requirements for fish that people intend to serve as food to other people and any other fish (for example, fish used in an aquarium for display purposes).

“Food Establishment”

43. “Food establishment” is defined in subpart 35 to include a variety of entities that prepare and serve food to customers. As originally proposed, the rule exempted boarding care homes that provide services to residents and are licensed under Minn. Stat. §§ 144.50-144.56 (in subitem (5)) as well as residential facilities that are federally certified as intermediate care facilities for persons with mental retardation (“ICFs/MR”) serving 18 or fewer persons (in subitem (6)). Laura Lund, Associate Director of the Association of Residential Resources in Minnesota (“ARRM”), objected to the definition to the extent that it appeared that the Agencies intended that ICFs/MR serving more than eighteen people were to be governed by the rules. Ms. Lund asserted that all ICFs/MR were, in fact, exempt from application of the rules by virtue of being licensed as supervised living facilities under Minn. Stat. §§ 144.50-144.56, and contended that the inclusion of both exemption clauses in the proposed rule was confusing. Ms. Lund pointed out that the vast majority of ICFs/MR licensed by the Department of Human Services are small in size. She emphasized that these facilities provide a home-like atmosphere for persons requiring supervised living and contended that requiring ICFs/MR to meet these rules would interfere with the beneficial atmosphere of these facilities. Ms. Lund also maintained that regulation of such facilities under the food rules was unnecessary, since ICFs/MR are already closely regulated for food storage, preparation, and service by federal surveyors. She further indicated that the statutory scheme for licensure of ICFs/MR includes a provision that specifies that “[n]o institution of any kind licensed pursuant to the provisions of sections 144.50 to 144.56 shall be required to be licensed or inspected under the laws of this state relating to hotels, restaurants, lodging houses, boarding houses, and places of refreshment.” Minn. Stat. § 144.54. Ms. Lund recommended that the language of the proposed rule be changed to simply exempt all facilities that are federally certified as ICFs/MR.

44. The Agencies acknowledged that supervised living facilities are licensed under Minn. Stat. § 144.50 and thus are encompassed within the statutory provision quoted above that prohibits regulation under state food regulations. They also pointed out that certain data set forth in the SONAR about the size of ICFs/MR in Minnesota was inaccurate, and provided corrected data in their post-hearing comments.[42] The Agencies proposed to amend the definition of food establishment by including supervised living facilities in the list of exempt establishments set forth in subitem (5). The Agencies also proposed deletion of the reference to federally certified ICFs/MR in former subitem (6), since it is clearer to use only terms that apply to state licensing.

45. Ms. Lee, Mr. Day, and other commentators suggested that the rules should apply to food services serving patients in hospitals and nursing homes, and objected to the exemptions for such establishments set forth in item (C)(5) of subpart 35. The Agencies responded that the exemptions in the rule reflect exemptions in Minnesota statutes and emphasized that any changes in the coverage of food laws must be sought from the Legislature.[43]

46. The Agencies have demonstrated that the proposed definition of “food establishment” in subpart 35 is needed and reasonable, as amended. The modifications proposed by the Agencies in their post-hearing comments conform the rule to statutory exemptions and do not result in a rule that is substantially different than the rule as originally published in the State Register.

“Special Event Food Stand or Special Event Food Stand - Limited”

47. As originally proposed, subpart 85 defined the terms “special event food stand” and “special event food stand-limited” to have the meanings given them in Minn. Stat. § 157.15, subdivisions 14 and 15. During the rule adoption process, the Legislature amended Minn. Stat. § 157.15 to eliminate the “special event food stand-limited” category.[44] Establishments that were previously included in the “limited” category are not included in the “special event food stand” category. The Agencies took note of the statutory change in their post-hearing comments and amended the rule to delete the reference to the “limited” category.[45] Similar changes were made to rule parts 4626.1830, 4626.1835, 4626.1845, and 4626.1855.[46] The subpart has been shown to be needed and reasonable, as amended. The amendment conforms the rule to a recent statutory change and the final version of the rule is not substantially different from the rule as originally published.

4626.0025 – Assignment

48. Proposed rule 4626.0025 requires a food establishment to have a person in charge present during all hours of operation. The duties of the person in charge in relation to the food code are set out in proposed rule 4626.0035-4626.0045. The requirement of a person in charge is intended to ensure that an individual knowledgeable about the food code and standards for safe food preparation is present and available to direct operations. No commentator objected to having such a person designated. Joseph Labalestra, President of the Minnesota Restaurant Operators Association and owner of the Lido Café, suggested that the person in charge be authorized to fine employees for not complying with the food rules. The Agencies lack the authority to implement that suggestion and they properly declined to make the requested modification. The rule is needed and reasonable to provide continual assurance that safe food handling practices are followed.

4626.0045 – Exclusions and Restrictions and 4626.0050 – Removal of Restriction

49. Proposed rule 4626.0045 requires the person in charge to exclude or restrict employees from certain work when the employee is ill or presents a risk for transmission of foodborne disease. The standards for removing the restriction on an employee after an investigation of a confirmed disease outbreak are set out in proposed rule 4626.0050. Ms. Lee and Sherry Engelman, President of the Local Environmental Health Association (“LEHA”), noted that local authorities also exercise the investigatory authority described in these rule parts, even though the rules as originally proposed only identified the Department of Health as the investigating authority.

50. In their post-hearing comments, the Agencies acknowledged that both the Department of Health and the licensing regulatory authority played a part in managing potential transmission of foodborne disease, and agreed that the rules needed clarification. The Agencies added the phrase “and the licensing regulatory authority” to each of these rule part to acknowledge the manner in which these investigations are currently carried out. Proposed rules 4626.0045 and 4626.0050, as amended, are needed and reasonable to accurately reflect the shared regulatory authority in these instances. The modifications stem from comments made during the rulemaking proceeding and do not render the rules substantially different from the original version.

4626.0065 – Clean Condition, 4626.0070 – Cleaning Procedure, and

4626.0075 - When to Wash

51. Personal cleanliness of food employees is addressed in proposed rule parts 4626.0065 through 4626.0100. Handwashing procedures, fingernail maintenance, and clothing standards are set forth in this portion of the food code. Handwashing is a critical procedure in the proposed food code. The rule provisions were derived from the FDA 1995 food code, with modifications to maintain the current state practice of using a nail brush to clean under the fingernails and between the fingers, and to clarify that, after using toilet facilities, handwashing takes place once in the area of toileting and again in the food preparation area before handling food, in a sink designated for handwashing (not the food preparation sink).

52. In the SONAR, the Agencies point out that the hands are particularly important in transmitting foodborne pathogens and stress that any activity that may contaminate the hands must be followed by thorough handwashing according to the procedures set forth in the proposed rules. The proposed rules require food employees to keep hands and exposed parts of arms clean. “by vigorously rubbing together the surfaces of the lathered hands and arms for at least twenty seconds and thoroughly rinsing with clean water” and must “pay particular attention to the areas underneath the fingernails and between the fingers by scrubbing thoroughly with a nail brush.”[47] Under the rules, employees must use a cleaning compound, clean water, and a fingernail brush and continue handwashing for a minimum of twenty seconds. The proposed rules specify that handwashing must be done at a handwash sink in the toilet room immediately after using the toilet and, again, in the food preparation area before handling food. As noted in the SONAR, this rule provision “ensures that a double handwash will occur--once in the toileting area, again in the food preparation area.”[48]

53. Dr. Snyder criticized the rules relating to handwashing on the grounds that they were not based on science and were likely to be counterproductive. He contends that the hand washing procedure in the proposed food code has not been validated and that the rule should contain step by step, specific instruction. He asserts that the rules should focus on fingertip washing because fecal pathogens are more predominant on the fingertips than on other parts of the hand. He alleges that, for the most part, inadequate fingertip washing causes foodborne illness in Minnesota, and believes that it is unlikely that pathogens will be spread within the food preparation area by the hands or arms.[49] A study conducted by Dr. Snyder indicates that food workers should concentrate on fingertip cleaning using a nail brush and flowing water, with a second hand wash required for workers who have just returned from using toilet facilities. Dr. Snyder indicates that a single hand wash could take only five seconds, and a double hand wash would take less than 15 seconds.[50] He further asserted that the 20 seconds was “wrong,” and that “[i]t is the soap, nail brush friction, and volume of water that is important.”[51] Comments filed by Thomas L. Schwarz, who is the Director of the Division of Cooperative Programs, Office of Field Programs, Center for Food Safety and Applied Nutrition, FDA, indicate that the guidance provided in the model code and the Minnesota proposal is a “practical compromise” which gives employees direction about when and where to wash and how long to lather while also setting a performance standard requiring that food employees keep their hands clean. He further notes that the FDA model code represents “the best current recommendations of the [FDA] and its ‘partners’ in the Food Code development process including - physicians, microbiologists, chemists, epidemiologists, health scientists, entomologists - professionals who understand the science!” (Emphasis in original.)

54. The proposed rules in fact require a double wash after using toilet facilities and also mandate the use of a nail brush, consistent with Dr. Snyder’s recommendations. The crux of the disagreement between Dr. Snyder and the Agencies here apparently has to do with the length of the handwashing, whether exposed portions of the arms should be included, whether the rules must specify that the handwashing must occur under flowing water, and whether the rules should emphasize the importance of fingertip cleaning to a greater extent. The Agencies have taken the conservative approach of requiring that handwashing include the arms and continue for a period longer than Dr. Snyder apparently believes is necessary. Since Dr. Snyder has not presented definitive evidence that his handwashing procedure results in bacteriological contamination ceasing to be a problem,[52] it appears that the choice of handwashing methods is a matter of policy for the Agencies to consider.

55. As noted above, it is generally not the proper role of the Administrative Law Judge to determine which policy alternative presents the “best” approach since this would invade the policy-making discretion of the Agencies. The Agencies have shown that that the proposed rule’s requirement that food employees vigorously rub their lathered hands and exposed portions of the arms for twenty seconds and rinse with clean water, paying particular attention to the areas underneath the nails and between the fingers by scrubbing with a nail brush, is both needed and reasonable and represents a rational choice by the Agencies between possible standards. The Agencies may, if they wish, further amend the proposed rule to express a need to focus on the need to clean fingertips and use flowing water. However, the proposed rule will not be rendered unreasonable by a failure to include these provisions. Food establishments are, of course, free to establish more stringent handwashing requirements as a condition of employment.

4626.0130 – Compliance with Food Law

56. Chapter 3 of the FDA model code and the corresponding provisions of the proposed rules set forth in parts 4626.0125 through 4626.0445 establish standards for food itself. Proposed rule 4626.0130 contains a list of citations to the federal and state laws and rules that relate to the standards with which food sources must comply. A number of commentators objected to the list of citations as being too complicated for the regulated public to follow. The Agencies indicated that the intent of the rule is to provide one location in which citations to all of the requirements are listed. They further stated that persons affected by this rule are already required to handle food in conformance with those standards. The citation list is needed and reasonable to inform the public of the location of various standards pertaining to food which are already in effect. The listing of these citations in the rules does not constitute a defect in the proposed rules.

4626.0155 – Wild Mushrooms

57. A specific type of food with special handling requirements is wild mushrooms. These requirements are based on the known toxicity of at least 115 species of mushroom.[53] Fifteen of those species are deadly.[54] The Agencies concluded that the FDA model code provisions on wild mushrooms did not provide sufficient information about what criteria would be used in order to gain approval as a mushroom identification expert.[55] The Agencies indicated in the SONAR that the past practice of the Department of Agriculture has been to recognize an individual as a wild mushroom expert if he or she had successfully completed a course from an accredited college or university on wild mushroom identification. The rule advisory work group reviewed the criteria used by the Department of Agriculture and recommended its inclusion in the proposed rules.

58. Proposed rule 4626.0155 generally requires “mushroom identification experts” to individually inspect and find to be safe each mushroom picked from the wild, if that mushroom will be sold or consumed in a food establishment. The proposed rule further provides that the expertise of “mushroom identification experts” must be “verified and approved by the regulatory authority through the successful completion of a wild mushroom identification course provided by an accredited college or university.” An individual who wishes to gain such approval must “have on file with the regulatory authority a letter from an accredited college or university certifying successful completion of a wild mushroom identification course . . . .” The rule part does not apply to cultivated wild mushroom species that are grown, harvested, and processed in an operation regulated by a food regulatory agency or to wild mushroom species that are in packaged form and are produced by a regulated food processing plant.

59. Mr. Carlson and William Jaspers III, Food Safety Consultant, expressed concern over what constituted "successful completion" of a course. Mr. Jaspers suggested extensive modification to and expansion of the proposed rule based upon a concern that persons would be at risk of consuming toxic mushrooms without more stringent standards. He stressed that, while passing a college course is highly desirable, it is not necessarily the best or only way to learn to accurately identify mushrooms. He recommended that the term “knowledgeable mushroom hunter” replace “mushroom identification expert” and that the rules allow persons to be so designated based upon a self-declaration that the individual is “able to accurately distinguish edible mushrooms from poisonous mushrooms” (rather than completion of a course) and an agreement that he or she will provide evidence of ability to correctly identify and name edible and poisonous species if asked to do so by a regulatory authority. Mr. Jaspers warned that packaging of wild mushrooms does not mean that they come from an approved source. He suggested that documentation of the source of wild mushrooms be retained for twelve months and that the documentation include a certification signed by the “knowledgeable mushroom hunter” that particular mushrooms are wholesome, in good condition, and edible. He also recommended that the proposed rules define “commercial mushroom provider,” “cultivated mushroom,” “edible mushrooms,” “edible mushroom list,” “knowledgeable mushroom hunter,” “mushroom,” “poisonous mushroom,” “professional mycologist,” “uniform declaration of mushroom identification,” and “wild mushroom.”

60. The Agencies declined to make any changes to this subpart of the proposed rule and continued to rely upon the SONAR to support the need for and reasonableness of the rule. The Agencies emphasized that the Conference for Food Protection has formally recommended that a committee be assigned to study issues relating to the safety of wild mushrooms and report back to the Conference in two years, and indicated that Mr. Jaspers’ proposal would be considered during this committee process.[56]

61. It is within the Agencies’ discretion to await further federal guidance before modifying the proposed rule. The Agencies have chosen in the proposed rule to rely upon the standards of accredited organizations to ensure that adequate instruction in mushroom identification has been given to a particular individual. The rule thus has a rational basis. It is evident, however, that some useful knowledge in mushroom identification is excluded under an approach that is restricted to those who successfully complete courses offered by accredited institutions. The Agencies noted in the SONAR that at least one governmental agency, university, mycological society, or other organization exists in most parts of the country to aid in proper mushroom identification and program design.[57] The Agencies may wish to consider allowing those who have successfully completed courses offered by mycological societies approved by the regulatory authority to be approved as mushroom identification experts in order to include a group explicitly mentioned in the SONAR and absent from the proposed rule. The need for such societies to obtain approval of the regulatory body would assure that appropriate standards would be maintained. Should the Agencies make this change, the new language would not constitute substantially different language from the rule as originally published.

4626.0160 – Game Animals and

4626.0415 - Specialized Processing HACCP Requirements

62. A substantial number of people consume meat from game animals taken through hunting. A common practice exists whereby the meat is donated to charitable organizations for consumption or use in fundraising dinners.[58] Typically, an animal carcass is brought from the hunt to a commercial meat processor for butchering. The Agencies noted that such animals may be the source of a number of food-borne illnesses.[59] To address this potential for harm, the Agencies proposed a number of standards in rule part 4626.0160(C) for the processing of wild game animals donated to charity. In addition, the rules as originally drafted included a requirement in part 4626.0415 that HACCP plans be prepared prior to custom processing field-harvested wild game that is for personal use as food and not for sale or service in a food establishment. Mr. Downs of MAMP objected to the requirement that custom processing have a HACCP plan. MAMP asserted that the complete lack of control a processor has over wild game before that animal arrives at the processor's facility renders it almost impossible to implement a valid HACCP plan. The Association suggested that a written sanitation procedure be required rather than a HACCP.

63. The Agencies, after consultation with the University of Minnesota, agreed with MAMP that the inclusion of a written sanitation standard operation procedure (“SSOP”) would provide a sufficient level of protection against cross contamination. SSOPs include detailed procedures for equipment cleaning and sanitizing, but are less restrictive than HACCP plans.[60] Accordingly, the Agencies added a new subitem (5) to part 4626.0160(C) which provides that a written SSOP including the entire process used to eliminate the possibility of cross-contamination from wild game processing to retail products must be implemented and available for inspection. The Agencies deleted from part 4626.0415 the requirement that a HACCP plan be developed before custom processing field-harvested game for personal use.

64. The proposed rule, as modified, has been shown to be needed and reasonable to guard against cross-contamination. The requirement of an SSOP meets the objection of a commentator. The modification does not make the rule substantially different from the rule as originally proposed because the modification is within the scope of the matter announced in the notice of hearing and is a logical outgrowth of the contents of the Notice of Hearing and the comments received during the rulemaking proceeding.

4626.0165 – Temperature

65. It is well established that temperature is a very important consideration in maintaining the wholesomeness of food. If cold foods are allowed to warm, or hot cooked foods are allowed to cool, favorable environments will be provided for the growth of bacteria, including varieties known to cause illness and death. These facts are not in dispute. There is, however, an active controversy over what are appropriate temperatures for holding cold foods and hot foods safely.

66. Items A and B of proposed rule 4626.0165 require that potentially hazardous food be at a temperature of 41°F or below when received, unless a different temperature is specified in law governing its distribution (such as for eggs, shellfish, and readily perishable, frozen and hot food). Item C requires that potentially hazardous food that is cooked and received hot shall be at a temperature of 140°F or above. Item D requires that a food that is labeled and shipped frozen shall also be received frozen. Finally, item E requires that potentially hazardous food shall be free of evidence of “temperature abuse” upon receipt.

67. The existing rule requires that potentially hazardous foods must be maintained at 40°F or below, or at 150°F or above, except during preparation. Minn. R. 4625.3401, subp. 1. Proposed rule 4626.0165, item C, would change the hot holding temperature of such foods to 140°F or above, and change the cold holding temperature of such foods to 41°F or below, unless another temperature is specified by law for the particular type of food involved.

68. Ms. Lee and Ms. Engelman objected to reducing the hot holding temperature from the 150°F standard. Ms. Lee asserted that studies have shown that some organisms will grow at temperatures of 137°F and contended that the proposed rules do not have a sufficient margin of safety. Ms. Engelman indicated that the food industry had accepted the 150°F standard and urged that it be retained in order to provide a safety margin. Dr. Snyder suggested that setting one temperature for all hot foods was not reasonable, because foods with different pH factors provide different media for bacterial growth.[61] He asserted that 130°F has been shown to be a safe temperature and urged adoption of that standard. Mr. Olson supported the lowering of the hot holding temperature to 140°F.

69. John Labalestra, owner of Lido’s Restaurant, objected to the 41°F standard as impossible to meet with current equipment. He pointed out that temperatures will inevitably rise in a reach-in cooler as a result of employees opening and closing it, and related his experience with holding food in a cold rail while using the food for preparation of pizza. Due to the difficulty of maintaining food at 41°F, it was urged that the proposed rule be found to be unreasonable. Mr. Olson objected to the 41°F standard as not being necessary or prudent. He maintained that there is evidence to support a reduction of the cold holding temperature to 38°F, but did not explain the basis for this assertion.[62]

70. The Agencies declined to change the proposed rule. They indicated in their post-hearing comments that temperature controls are a critical item because micro-organisms that cause foodborne illness may grow rapidly if food remains in the temperature danger zone of 41°F to 140°F too long. Although the Agencies acknowledged that the scientific data differs with respect to the precise identification of the range of the temperature danger zone, they indicated that 41°F to 140°F was being used based on FDA scientific research. That range was also supported by the Conference for Food Protection in its 1998 meeting, and by food scientists from the University of Minnesota. The Agencies emphasized that the 41-140°F range was selected to allow a safety margin to account for the fact that temperatures fluctuate in a single item of food.[63] It was also pointed out that Dr. Snyder’s proposal to the Conference for Food Protection to lower the hot holding temperature to 130°F food was not successful.

71. Dr. Snyder has shown that for some foods, lower holding temperatures do not result in unsafe food. But the standards are being set by the Agencies with the ability of all food establishments to comply in mind. To safely use lower temperatures, food workers must be sophisticated enough to measure pH in food and accurately determine the minimum allowable holding temperature from that measurement. Further, the food workers must be diligent in the use of equipment to ensure that the settings for one food are changed if a different food is held in that equipment. There is nothing in the record to support a conclusion that such sophistication and diligence is the norm in food establishments. By contrast, setting a single standard eliminates erroneous use of equipment and requires one measurement (temperature) to meet a single standard. The simplicity of the proposed standard is a consideration in the reasonableness of the proposed rule. There has been no showing that the 140°F temperature itself would allow bacterial growth. The objections to the temperature standard focus on the amount of margin between the standard and the temperature at which some organisms have been demonstrated to grow. The amount of margin to be required is a matter for the Agencies to decide, subject to the requirement that the decision be based on facts in the record. Because groups knowledgeable in food safety support setting 140°F as the minimum hot holding temperature, the Agencies have met their burden to show that they have a rational basis for the proposed rule. The proposed rule has been shown to be needed and reasonable.

72. If the only manner of keeping food cold was to use cold rails, the impossibility of keeping food items at 41°F could render the proposed cold holding temperature unreasonable. But the proposed rules allow several different means of controlling bacterial growth. Time alone may be used, so long as the food is served by the appropriate point or discarded.[64] In addition, food may be maintained at 41°F by alternating a working supply of the food between the cold rail and a walk-in cooler. Since the reason for the requirement is the inhibition of bacterial growth, and 41°F has been shown to be an appropriate level to accomplish this end, the imposition of some additional burden on operators of food establishments is not unreasonable. The 41°F cold holding standard has been shown to be needed and reasonable.

4626.0285 – Wiping Cloths; Used for One Purpose

73. Proposed rule 4626.0285 was criticized by Mr. Labalestra as requiring the use of dry cloths for wiping surfaces. He indicated that dry cloths do not clean as well as moist cloths. The Agencies pointed out that the next subitem in the proposed rule allows the use of moist cloths.[65] The language connecting the subitems is the word "or" which allows the operator to choose either dry or moist cloths. The rule is needed and reasonable, as proposed.

4626.0340 – Raw Animal Foods

74. The Agencies proposed rule 4626.0340 in an attempt to prevent transmission of food-borne illnesses when raw animal foods are cooked. Item A of the rule establishes various temperatures and times for cooking such foods in order to eliminate or inhibit disease-causing toxins contained in the foods when raw. Mr. Olson recommended that the phrase “or above" be added after the temperature specifications in subitems (2) and (3). In addition, a mistake in one of the temperature charts set forth in the proposed rule was identified at the hearing.

75. The Agencies agreed that the language recommended by Mr. Olson would clarify the intent of the rule and proposed to amend the rule part in their post-hearing comments. The new language makes it clear that the temperatures listed in subitems (2) and (3) are minimum temperatures. The Agencies also modified item (B)(1) to refer to a standard of 121°C (250°F) or more for roasts weighing 10 pounds or more cooked in convection ovens. The modifications made to items A and B have been shown to be needed and reasonable. They are an outgrowth of the comments submitted in response to the original version of the proposed rule, and do not render the final version of the rule substantially different from the rule as originally proposed.

76. As originally proposed, item C, subitem 1, exempted the food establishment from the temperature requirement when the food is a raw animal food that is served or offered for sale in a ready-to-eat form and the consumer is informed that, to ensure its safety, the food should be cooked as specified in item A. Annette Henkel of the Minnesota Retail Merchants Association and Tom Day of Hospitality Minnesota indicated that item C did not contain language that had been agreed upon in the rule advisory work group. Mr. Day asserted that the work group had agreed that language would be incorporated indicating that the customer in such instances had to request that the food be prepared to a temperature below that set in the rule.[66] The Agencies agreed that consumer request was intended and altered the rule, noting that the revision was consistent with the SONAR. The Agencies have shown that the proposed rule is needed and reasonable. The change in language made by the Agencies does not result in a rule that is substantially different from the original proposal.

77. The new language proposed for item C is problematic, because it does not express the intended meaning in an intelligible fashion. As amended, item C reads (in pertinent part): “Items A and B do not apply if the food is a raw animal food . . . that is served or offered for sale in a ready-to-eat form, at the request of the consumer, the food should be cooked as specified in item A . . . .” The SONAR indicates that the rule was intended to address situations in which “consumers may demand raw or partially cooked foods” and “some establishments want to provide food products in a raw or undercooked state.”[67] Unfortunately, the rule item as modified, which sets out to exempt raw animal food from the item A temperature standard, ends by vaguely indicating the food should be cooked to that standard. This internal contradiction is a defect in the proposed rule. Two alternatives are available to the Agencies. One alternative is to clarify the consumer request language to show that only a consumer request is required for food establishments to be allowed to serve food that is prepared at lower temperatures and for lesser times than otherwise allowed . The other alternative is to require both a consumer request and a warning from the food establishment as to the hazard of the food preparation method requested before the food establishment is permitted to serve food that does not comply with the time and temperature specifications. Although the discussion is somewhat unclear, the SONAR suggests that the Agencies decided “not [to] take the consumer advisory approach.”[68] It may be the case that the Agencies intended that the rule follow the first approach outlined above. However, either of the two alternatives set forth above is permissible and would be needed and reasonable to clearly delineate the circumstances under which food establishments will be exempted from the time and temperature requirements. Neither alternative would result in a rule that would be substantially different from the rule as originally published.

78. To achieve the first alternative, the Agencies may alter item C(1) to read as follows: “Items A and B do not apply if: the food is a raw animal food . . . that is served or offered for sale in a ready-to-eat form, when the food item is prepared in that fashion at the request of the consumer; . . . .” The Agencies may use alternative language to achieve the same purpose.

79. To achieve the second alternative, the Agencies may alter item C(1) to read as follows: “Items A and B do not apply if: the food is a raw animal food . . . that is served or offered for sale in a ready-to-eat form, when the food item is prepared in that fashion at the request of the consumer and the consumer has been advised of the hazard inherent in consuming food that has not been cooked as specified in item A; . . . .” The Agencies may use alternative language to achieve the same purpose.

80. The Agencies are not required to use the language set out in the foregoing findings. Whatever change is made to the rule must clearly state what is required of a food establishment in order to be exempt from the temperature and time requirements set forth in item A of the rule.

4626.0385 – Cooling

81. Proposed rule 4626.0385(A) requires cooked food that is potentially hazardous to be cooled from 140°F to 70°F within two hours and further cooled from 70°F to 41°F or below within an additional four hours. The proposed rule contains the further requirement that potentially hazardous food prepared from ingredients at ambient temperature, including reconstituted foods and canned tuna, shall be cooled to 41°F or below within four hours, and that potentially hazardous food received under laws allowing a temperature above 41°F during shipment from the supplier shall be cooled to 41°F or below within four hours.

82. A substantive dispute was aired at the hearing and in written comments regarding the proposed cooling standards. Ms. Engelman urged the Agencies to retain the current Minnesota cooling standard of four hours or less.[69] Dr. Snyder maintained that the cooling periods required under proposed rule 4626.0385(A) were not based on scientific procedures.[70] Specifically, he indicated that five gallon bags of milk at 45°F cannot be cooled to 41°F in four hours and that cooling an eighteen pound roast from 140°F to 41°F takes about twenty-four hours in an NSF-approved refrigerator.[71] Dr. Snyder asserted that ordinary refrigerators will not cool viscous foods such as casseroles and roasts to 41°F in six hours. He contended that “virtually every restaurant” will have to buy a $10,000-to-$20,000 blast cooler in order to cool casseroles in pans, roasts, turkeys, or solid foods in six hours.[72] Dr. Snyder also indicated that a particular bacterium did not exhibit growth to potentially hazardous levels in cooked ground beef within fifteen hours.[73] He recommended that the cooling time be extended to at least 12 hours, or that a range of temperatures and times be adopted in an effort to simplify the code and base it on "actual science."[74] Mr. Labalestra asserted that the proposed cooling standard was unreasonable.

83. In the SONAR, the Agencies indicated that “[e]xcessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness” and that, “[d]uring extended cooling, potentially hazardous foods are subject to the growth of a variety of pathogenic microorganisms.”[75] The Agencies maintain that such standards are needed and reasonable to bring food through the "ideal bacterial incubation temperatures" (120°F to 70°F) in a short enough period to inhibit growth of such pathogens.[76] The cooling provision is equivalent to the standard contained in the FDA’s 1995 food code. The Standards are based on the growth patterns of organisms that grow rapidly under temperature abuse conditions. The Agencies indicated that, if food is not cooled in compliance with these standards, sufficient numbers of pathogens may grow to cause foodborne illness.

84. In their post-hearing comments, the Agencies indicated that they had considered the comments and suggestions, but declined to modify the proposed rule. They stressed that the rule was based upon FDA advice, which is scientifically based and represents a significant degree of national consensus. The Agencies indicated that the primary purpose of the proposed rule is the prevention of illness and the provision of a uniform system of regulatory policy. The Agencies rejected the suggestion to extend the cooling time for potentially hazardous foods to 12 or more hours because such an approach would not control the microorganisms capable of rapidly growing under temperature abuse conditions. The Agencies pointed out that Dr. Snyder’s data was based on the ability of a single pathogen to grow in one type of food item, and indicated that another bacterium has been shown to grow to harmful levels at approximately 70°F after six hours.[77] Although the Agencies acknowledged that commercial refrigeration equipment is not designed to cool large masses of food and alternative methods may be required to achieve rapid cooling, they pointed out that, “[b]ased on the type of food being cooled, there are several rapid cooling methods in lieu of ‘blast coolers’ which can be used to meet the cooling requirements. Part 4626.0390 (3-501.15) provides examples of such methods.”[78] The referenced rule provision refers to such methods as placing the food in shallow pans, separating the food into smaller or thinner portions, using rapid cooling equipment, stirring the food in a container placed in an ice water bath, using containers that facilitate heat transfer, and adding ice. The Agencies also noted that the rules permit the regulatory authority to waive or modify the cooling requirements in appropriate circumstances.[79]

85. The Agencies indicated that the time restrictions set forth in the proposed rule “are conservative and based on worse case scenario.”[80] The Agencies also noted that the cooling times and temperature requirements were based upon information showing that cooked foods may become contaminated with a variety of pathogens under poorly monitored conditions, improper cooling is a major factor in foodborne illness, rapid cooling is necessary to control significant growth of pathogens, especially between 120°F and 70°F, and proper cooling may be the only control point where the hazard may be prevented before the customer consumes the food.[81]

86. The scientific data set forth by the Agencies in the SONAR and post-hearing submissions supports the need for and reasonableness of the Agencies’ admittedly conservative approach in setting the cooling standard contained in the proposed rule. The cooling methods identified in part 4626.0390 directly address concerns that were expressed about the capacity of typical refrigerators. The use of a uniform standards for the cooling of various broad categories of potentially hazardous foods provides protection against mistakes by food employees as to what is the appropriate cooling period and temperature for a particular food. The Agencies have demonstrated that rule 4626.0385 is needed and reasonable, as proposed.

4626.0395 – Potentially Hazardous Food; Hot and Cold Holding

87. This issue of hot and cold holding temperature of food was addressed above at Findings 65-72. The issues and resolution of those issues are identical to those involving this rule part. The rule has been shown to be needed and reasonable, as proposed.

4626.0410 – Time as a Public Health Control

88. Proposed rule 4626.0410 sets out the standards by which time can be used by a food establishment as a means of inhibiting the growth of pathogens. In essence, the proposed rule permits an approach under which ready-to-eat potentially hazardous food or a working supply of potentially hazardous food before cooking may be removed from temperature control. If the food is not consumed within four hours from the point in time when it is removed from temperature control, it must be discarded. Thus, when time is used as a control, food must be either served or discarded within four hours. The proposed rule requires that the food must be marked or otherwise identified with the time within which it shall be cooked, served, or discarded. The proposed rule also specifies that written procedures must be maintained in the food establishment to ensure compliance with the rule provision and with the cooling requirements set forth in part 4626.0385.

89. Ms. Lee, Ms. Engelman, and Elliot Marston, Environmental Health Sanitarian for the City of Edina objected to allowing the use of time to assure food safety. Ms. Lee indicated that E. coli is capable of increasing to potentially hazardous levels within four hours under optimum conditions.[82] She and Ms. Engelman suggested that the rule include more stringent language concerning when the "clock" starts running for food controlled only by time and clarification that the food must be discarded at the end of four hours, not returned to temperature control.[83] Ms. Lee recommended that the rule be deleted or that a HACCP plan be required, the time period limited to two hours, and service limited to 50 people. Ms. Engelman also commented that the requirements were too vague and would lead to enforcement problems. Mr. Marston suggested that the rule be modified to require that food establishments obtain approval from the local regulatory authority before time as a control may be used.[84]

90. The Agencies declined to make most of the modifications suggested by the commentators. They indicated in post-hearing comments that there was no need to require approval by the local regulatory authority since, if the procedures were inadequate or not being followed, the regulatory authority could in any event proceed to correct the problem under its existing authority. The Agencies did, however, decided to clarify item B of the proposed rule by adding an explicit statement that food cannot be removed from time control and returned for use at a later time.

91. The SONAR indicates that the provision was derived from the FDA’s 1995 food code and that the Agencies have determined that no significant growth or toxin production is possible in the limited time period of four hours. The Agencies have shown that time is an adequate control, when the conditions in the proposed rule are followed. The proposed rule, as amended, has been demonstrated to be needed and reasonable. The amendment to item B is consistent with other provisions of the proposed rules relating to temperature and cooling standards and will ensure that no confusion will arise with respect to the proper treatment of potentially hazardous foods that are removed from temperature control. The modification is in character with the issues raised in the Notice of Hearing and within the scope of the matters announced in that Notice, and is responsive to comments made during the rulemaking process. The amendment thus does not result in a rule that is substantially different from the rule as published in the State Register.

92. Although the Agencies have demonstrated the need for and reasonableness of the rule, as modified, they did not specifically address several of the suggestions made by the above commentators in their post-hearing comments. The Agencies are urged to consider these comments prior to rule adoption. If they desire to make the requested modifications, it does not appear that such changes will result in a substantially different rule.

4626.0415 – Specialized Processing HACCP Requirements*

93. Rule 4626.0415, as originally proposed, required that food establishments prepare a HACCP plan before “smoking or curing food,” using food additives or additional components (such as vinegar), using reduced oxygen methods of packaging food, or “custom processing field-harvested wild game that is for personal use as food and not for sale or service in a food establishment.” In the SONAR, the Agencies relied upon the history of food-borne illnesses resulting from the use of specific, non-standard food processes as support for the requirement for a HACCP.[85] As discussed in Findings 62-64 above in conjunction with the rule change to proposed rule 4626.0160, the Agencies have deleted item D from the proposed rule. A HACCP plan thus is no longer required before a food establishment engages in the custom processing of field-harvested wild game.

94. Tom Johnson, President of Johnson Commercial Agents, suggested that the rule differentiate between food service smoker ovens that cook meats while imparting a smoke flavor and the more hazardous traditional smoking and curing approaches common in retail meat departments. The Agencies agreed that there was no need for the extra protection of a HACCP plan where the food products were being smoked only to impart flavor and not as a cooking method.[86] Accordingly, the Agencies amended item A to specify that HACCP plans must be prepared before smoking or curing food, “except for smoking done for the purpose of imparting flavor only and not as a part of the cooking process.” The rule, as amended, has been shown to be needed and reasonable. The new language arises out of concerns expressed during the rulemaking proceeding and is not substantially different from the language contained in the rule as originally published.

4626.0505 – Equipment and Utensils

95. Chapter 4 of the proposed food code relates to equipment, utensils, and linens. Proposed rule 4626.0505 as originally proposed provided, in pertinent part, that “[f]ood equipment installed or placed in service after June 6, 1989, shall meet the applicable NSF [National Sanitation Foundation] International food service equipment standards specified in this item.” The rule goes on to specify in item H that, if an NSF International, NAMA, or BISSC standard is not available, “the equipment shall be designed for commercial use, smooth, easily cleanable, and readily accessible for cleaning.”

96. Dr. Snyder of HITM objected to the practices of some local regulatory authorities with regard to the approval of equipment for use by food establishments. As an example, the difficulties of a food cart hot dog vendor in obtaining approval were cited.[87] The difficulty, as related by HITM, was the lack of NSF certification of the vendor's equipment. Ms. Lee and Ms. Engelman requested that the proposed rule be amended to require that non-certified equipment meet performance standards for toxicity.

97. The Agencies agreed with the suggestions and modified item H to specify that the equipment “have contact surfaces that are not toxic.” While this rule language does not ensure that non-certified equipment will be approved by a local regulatory authority, the rule does establish a standard for guidance. The rule, as amended, has been shown to be needed and reasonable to provide the regulated public with information concerning the proper features non-certified equipment should have. The new language is not substantially different from that published in the State Register.

4626.0760 – Warewashing Sinks; Use Limitation and

4626.0780 – Food Preparation Sinks; New or Extensively Remodeled Establishment

98. Mr. Carlson and Mr. Olson criticized the language in these proposed rule parts. Proposed rule 4626.0760 indicates that food establishments licensed before the effective date of the food code may use a warewashing sink to wash wiping cloths, wash produce, or thaw food if the sink is cleaned before and after each such use. Proposed rule 4626.0780 requires the addition of a separate food preparation sink when a food establishment is extensively remodeled or newly licensed, or a food item requiring washing or thawing in a sink is added to the menu. Mr. Carlson and Mr. Olson objected to these rules based on their belief that food preparation sinks have been required in the metropolitan area during the past several years, food preparation should not be allowed in warewashing sinks, and food establishments should not be permitted to wait to install food preparation sinks until they undergo extensive remodeling or add an item to the menu requiring sink preparation. They pointed out that the rule advisory work group recommended that a separate sink be required.

99. The Agencies responded that the requirement for separate food preparation and warewashing sinks is not currently in state law but may be in local code. They emphasized that the provisions were intended as a compromise, to accommodate existing licensed establishments that have not yet initiated the use of separate sinks and permit a graduated implementation of the requirement to have separate sinks. Although the Agencies acknowledged in the SONAR that the likelihood of cross-contamination increased where a single sink is used, the Agencies stressed that, If unsafe practices exist at a food establishment, local regulatory authorities are able to intervene. The effect of the rule is to accept existing food preparation practices at an existing establishment until such time as matters change by virtue of the addition of a new menu item or extensive remodeling. The approach taken in the proposed rules reduces the cost to food establishments of compliance with the rules without increasing the risk of food-borne illnesses. Proposed rules 4626.0760 and 4626.0780 have been shown to be needed and reasonable.

4626.1025 – Hot Water

100. Proposed rule 4626.1025 requires that hot water generation and distribution systems in food establishments “shall be sufficient to meet the peak hot water demands . . . ." Mr. Carlson objected to the standard as vague and requested that it be defined. The Agencies responded that peak demand was "synonymous with maximum capacity" as that term is used in plumbing design and construction. The Agencies also indicated that mathematical formulae exist to determine the amount of water required at maximum capacity based on fixture unit values and the peak hot water demand.[88] The Agencies did not add a definition of “peak demand” to the rules.

101. It is needed and reasonable to require that hot water needed to wash equipment, utensils, and employees’ hands be available in sufficient quantities to meet demand during peak periods of water usage. If the volume of water is insufficient, the establishment will not be able to reach the required temperatures for sanitation. Although the Agencies may wish to consider whether they should add a definition of the term to the proposed rules or cross-reference an existing definition, the proposed rules are not rendered unreasonable by their failure to do so.

4626.1050 – Handwashing Lavatory; Water Temperature and Flow

102. The proposed rule specifies in part 4626.1050 that handwashing lavatories must be able to provide water at a temperature of at least 110ºF through a mixing valve or combination faucet, along with certain other requirements. Several commentators, including Mr. Olson, Mr. Carlson, Mr. Marston, and Joseph Hibberd, Supervisor of the Community Environmental Health Program of the St. Paul - Ramsey County Department of Public Health, suggested that the standard for handwashing lavatories include a maximum water temperature to prevent injuries to children, elderly persons, and persons with disabilities. Mr. Marston suggested that the maximum be set at 120ºF or 130ºF. Mr. Carlson noted that 120ºF is recommended as a maximum for home use and questioned the selection of 110ºF. Mr. Hibberd recommended a maximum temperature of 130ºF, with an exception allowing a 140ºF maximum in food establishments utilizing a hot water sanitizing dishwashing machine installed prior to the effective date of the code.

103. The Agencies responded that, after serious consideration, it was decided that the rule would not be amended to include a maximum handwashing temperature at this time. The Agencies noted that the U.S. Department of Labor and the Minnesota Department of Labor and Industry both have authority over the safety of employees in the workplace and would have authority regarding burns and scalding.[89] The Agencies have been informed that the temperature considered to be safe under OSHA is less than 112ºF. The Agencies indicated that they were concerned that setting a maximum of either 130ºF or 140ºF would result in a conflict with OSHA. Although the Agencies admitted that there was a tenuous link to food sanitation based on the possibility that employees may not wash their hands when the water is too hot, they emphasized that the rules mandate thorough handwashing and point out that employers are responsible under existing OSHA law for protecting employees against burns.

104. The Agencies have provided a rational reason for their decision to retain the proposed rule without modification. It appears that the proper place for such restrictions is in the Plumbing Code or in occupational safety and health regulations. Absent a stronger showing that food safety is affected, there is no basis for requiring the inclusion of a maximum water temperature provision in these rules. The rule as proposed has been shown to be needed and reasonable.

4626.1350 – Floor Carpeting; Restrictions and Installation

105. Chapter 6 of the proposed food code addresses construction materials in physical facilities. Proposed rule 4626.1350 prohibits the use of carpeting in food preparation areas and other areas where moisture-based cleaning methods are used. Where carpeting is not prohibited, the rule sets out standards for installation of the carpet. Mr. Olson commented that installation of carpet in the dining room is "not a public health concern” and should not be included in the code.[90] Dr. Snyder generally commented that the proposed rule should focus on food safety and sanitation issues, not building code issues.

106. The Agencies responded that carpeting must be securely attached to the floor and installed tightly against walls, and that edges must be secured by metal stripping or other means. The rule governs installation of carpeting in retail areas of grocery stores as well as dining rooms. Rules regarding carpet installation are included in order to ensure that "regular and effective cleaning" is possible and the presence of insects may be minimized.[91].

107. With respect to Dr. Snyder’s objection that this entire part of the proposed rules amounts to "floors, walls, and ceilings" regulation that has nothing to do with food safety,[92] the Agencies responded that the provisions in the proposed rules relating to requirements for physical facilities focus on food safety and sanitation, and thus differ from the provisions found in state and local building codes emphasizing structural safety.[93] Traditional building codes have never included food safety and sanitation issues, and those issuing such codes do not have expertise in those areas. The Agencies contend that the Legislature has given the Departments of Health and Agriculture authority to regulate the building of sanitary, easy to clean, food facilities, and that these rules are a proper exercise of that authority.

108. As the record of this proceeding amply demonstrates, providing adequate protection from food-borne illnesses can only be accomplished by adherence to food handling protocols, use of properly functioning equipment, and the existence of properly designed facilities. The existence of uncleaned walls, floors, and ceilings increases the risk of food being adulterated by nonfood contaminants. All of these concerns are properly within the statutory authority of the Agencies when addressing the operations of food establishments. The Agencies have shown that rules governing building standards, including the installation of carpeting, are needed and reasonable.

4626.1470 – Lighting Intensity

109. Food establishments rely on many features to create an atmosphere pleasing to their customers. Many of these features are conventions for the dining experience the food establishment intends to convey. Lighting forms an important part of this atmosphere. Family-oriented food establishments often use bright lights. Fine dining establishments often diminish the light in the dining area. Proposed rule 4626.1470 establishes different minimum lighting levels for the various areas in food establishments. The lowest light levels (at least ten foot candles) are required in walk-in coolers, dry food storage areas or other areas while cleaning. Food establishments often turn off the main lights in the dining area upon closing to avoid confusing customers. The proposed rule reflects this custom. Higher levels (at least 20 foot candles) are required at self-service counters and in equipment and utensil storage areas, and the highest levels (at least 50 foot candles) are required at food preparation surfaces and in areas used for warewashing.

110. In written pre-hearing comments, Mr. Olson commented that ten foot candles was inadequate in walk-in coolers and suggested that the requirement be increased to 20 foot candles. At the hearing, Mr. Carlson indicated that 50 foot candles was "still pretty low" and urged that the specification of 10 or 20 foot candles be increased. Hospitality Minnesota strongly supported the lighting standard, as proposed, and opposed any effort to increase the requirement.[94]

111. In response, the Agencies indicated that the foot candle standards contained in the FDA model code (from which the proposed rule is derived) are consistent with OSHA requirements and with other standards in the food industry. In setting the light intensity levels, the FDA considered existing industry standards and documentation on lighting adequacy. Because adequate lighting is needed to ensure that employees are able to properly prepare food and observe adulteration or other defects that render the food unfit for consumption, it is appropriate for the proposed rules to address lighting intensity. Because the proposed rule sets minimum lighting levels only, food establishments remain free to use higher levels if they wish. The proposed rule properly requires higher levels of lighting where customers select food and employees are working with food. The Agencies have established that the lighting levels proposed are both needed and reasonable.

4626.1525 – Cleaning Floors; Dustless Methods and

4626.1545 – Absorbent Materials on Floors; Use Limitation

112. Proposed rule 4626.1525 generally requires that dustless methods of cleaning must be used to clean floors, with a few exceptions. One exception permits the application of a small amount of sawdust to liquid spills or drippage on floors that occur between normal floor cleaning times, followed by spot cleaning. Proposed rule 4626.1545 provides that, except as specified in 4626.1525, sawdust shall not be used on floors.

113. Mr. Carlson objected to allowing sawdust to be used as a cleaning material. The Agencies pointed out that rule parts 4626.1525 and 4626.1545 place stringent limitations on the use of sawdust or other listed materials in cleaning spills.[95] The rules make it clear that only a small amount of sawdust may be applied immediately before spot cleaning liquid spills. The Agencies indicated that sawdust practical and useful as an absorbent in limited situations. Because sawdust cannot be used continuously as a floor absorbent, it should not increase the level of dust over time. The Agencies have shown that the rule parts are needed and reasonable to provide a useful method for cleaning up certain spills while requiring dustless methods when conducting more extensive cleaning.

4626.1660 – Restriction and Storage*

114. As originally proposed, rule 4626.1600 specified that only medicines in a food establishment for an employee’s use and necessary for the employee’s health would be allowed in a food establishment, in a location that would prevent contamination of food, equipment, and other items. Don Lawrence, Director of Environmental Health for the City of Moorhead, pointed out that the rule language could cause problems for persons storing medications for others in boarding care facilities.

115. In response, the Agencies noted that the existing rule permits the storage of personal medications in day care settings and board and care facilities.[96] The Agencies agreed that it is necessary for the proposed rules to allow the storage of personal medications for non-employees and that adequate precautions could be included in the rules to ensure that these substances do not contaminate food or food supplies. Accordingly, the Agencies modified item B of the proposed rule to permit medicine “belong to employees, individuals in a day care setting, or residents of a board and lodging facility which require refrigeration or storage . . . .” Proposed rule 4626.1660 has been shown to be needed and reasonable, as amended. The new language does not render the rule substantially different from the rule as published.

4626.1730 – When a HACCP Plan is Required

116. Chapter 8 of the proposed food code addresses compliance and enforcement matters. As originally proposed, part 4626.1730 required those food establishments that must prepare HACCP plans to have such plans available for review by the regulatory authority by July 1, 1999. MAMP pointed out that the Food Safety and Inspection Service of the U.S. Department of Agriculture set January 26, 2000, as the implementation date for small plants, and requested that the proposed rule be modified to adopt the same date.

117. The Agencies agreed that making the two dates coincide was reasonable and changed the due date in the proposed rule accordingly. No commentator objected to the delay in making such plans available for review by regulatory authorities. Conforming the state rule to existing federal standards is consistent with the legislative intent expressed in Minn. Stat. § 14.131(6), which requires an agency to demonstrate the reasonableness of standards that differ from federal requirements. Proposed rule 4626.1730, as modified, has been demonstrated to be needed and reasonable. The new language is not substantially different from the rules as published in the State Register.

4626.1795 – Emergency Reporting

118. As originally proposed, rule 4626.1795 required that licensees notify the regulatory authority of imminent health hazards or other emergency situation that may endanger public health “within 24 hours.” Ms. Lee expressed a concern that “within 24 hours” was not immediate enough, and suggested that the language from the 1997 FDA model food code be incorporated in the rule.

119. The Agencies agreed that it is reasonable for a licensee to provide immediate notification of regulatory authorities in order to reduce the possible risk of harm to the public. The Agencies noted that emergencies such as the outbreak of food-borne illness, require an immediate response from the authorities. While local regulatory authorities may not be available at all hours, the Agencies noted that the Minnesota Duty Officer is available at all hours of the day, every day, to receive such notification. The Agencies thus modified the rule to delete the “within 24 hours” language and mandate immediate notification. The Agencies declined to include the remainder of the language contained in the 1997 FDA model code specifying that licensees must also immediately discontinue operations because the authority to require an establishment to cease operation is already available to the Agencies under state law.

120. Since the Minnesota Duty Officer is under the authority of the Minnesota Pollution Control Agency (MPCA), it is the Agencies' responsibility to coordinate the relay of food-related reports. In addition, the Agencies should widely publicize the metropolitan area telephone number and toll-free telephone number of the Minnesota Duty Officer, because that number can be difficult to find by those unaware that the MPCA is the agency sponsoring the position. The proposed rule, as modified, has been shown to be needed and reasonable to ensure that the proper authorities receive prompt notification of emergency situations that may endanger public health. The new language is a logical outgrowth of the contents of the Notice of Hearing and the comments submitted during the rulemaking process, and is not substantially different from the rule as originally published in the State Register.

Based on the foregoing Findings of Fact, the Administrative Law Judge makes the following:

CONCLUSIONS

1. The Minnesota Departments of Agriculture and Health gave proper notice in this matter.

2. The Agencies have fulfilled the procedural requirements of Minn. Stat. § 14.14 (1996) and all other procedural requirements of law or rule.

3. The Agencies have demonstrated their statutory authority to adopt the proposed rules, and have fulfilled all other substantive requirements of law or rule within the meaning of Minn. Stat §§ 14.05, subd. 1, 14.15, subd. 3, and 14.50 (i) and (ii) (1996).

4. The Agencies have demonstrated the need for and reasonableness of the proposed rules by an affirmative presentation of facts in the record within the meaning of Minn. Stat. §§ 14.14, subd. 4 and 14.50 (iii) (1996), except as noted at Findings 77-80.

5. The additions and amendments to the proposed rules suggested by the Agencies after publication of the proposed rules in the State Register are not substantially different from the proposed rules as published in the State Register within the meaning of Minnesota Stat. §§ 14.05, subd. 2, and 14.15, subd. 3 (1996).

6. Any Findings that might properly be termed Conclusions and any Conclusions that might properly be termed Findings are hereby adopted as such.

7. A Finding or Conclusion of need and reasonableness in regard to any particular rule subsection does not preclude and should not discourage the Agencies from further modification of the proposed rules based upon an examination of the public comments, provided that the rule finally adopted is based upon facts as appearing in this rule hearing record.

Based upon the foregoing Conclusions, the Administrative Law Judge makes the following:

RECOMMENDATION

IT IS HEREBY RECOMMENDED that the proposed amended rules be adopted, except where otherwise noted.

Dated this 13th day of July, 1998.

_____________________________________

BARBARA L. NEILSON

Administrative Law Judge

[1] Minn. Stat. §§ 14.131 through 14.20 (1996).

[2] Minn. Stat. § 14.15, subd. 1 (1996).

[3] Minn. Stat. § 14.15, subds. 3-4 (1996).

[4] Minn. R. 1400.2240, subp. 5 (1997).

[6] Minn. Stat. § 14.131 and Minn. R. 1400.2220, subp. 1(E).

[7] See Statement of Need and Reasonableness at 1-4.

[10] Mammenga v. Department of Human Services, 442 N.W.2d 786 (Minn. 1989); Manufactured Housing

Institute v. Pettersen, 347 N.W.2d 238, 244 (Minn. 1984).

[11] In re Hanson, 275 N.W.2d 790 (Minn. 1978); Hurley v. Chaffee, 231 Minn. 362, 367, 43 N.W.2d 281,

284 (1950).

[12] Greenhill v. Bailey, 519 F.2d 5, 19 (8th Cir. 1975).

[13] Mammenga, 442 N.W.2d at 789-90; Broen Memorial Home v. Minnesota Department of Human

Services, 364 N.W.2d 436, 444 (Minn. Ct. App. 1985).

[14] Manufactured Housing Institute, 347 N.W.2d at 244.

[15] Federal Security Administrator v. Quaker Oats Co., 318 U.S. 218, 233 (1943).

[17] Minn. Stat. § 14.15, subd. 3 (1996).

[18] Minn. Stat. § 14.05, subd. 2 (1996).

[23] Written Version of Karen Holmes’ Remarks at the Rulemaking Hearing at 3.

[34] Agencies’ May 26, 1998, Comment at 2.

[35] See rule part 4626.0015; Agencies’ May 26, 1998, Comment at 3.

[44] Laws of Minnesota 1998, Chapter 407, Article 2, Sections 87- 92 and 109.

[45] Agencies’ May 26, 1998, Comment at 8.

[47] Proposed Rule part 4626.0070.

[50] See April 22, 1998, comment (also included in Agency Ex. 10) at 9-10.

[51] See attachment to May 26, 1998, comment.

[52] See Letter of April 22, 1998, Attachment 18, at 14 ("This confirms findings of previous hand wash studies of the past 50 years that it is virtually impossible to remove all microorganisms from the skin.")

[56] Agencies’ May 26, 1998, Comment at 14.

[60] Agencies’ May 26, 1998, Comment at 15.

[61] HITM May 26, 1998, Comment at 8.

[62] April 21, 1998, Letter (Exhibit 10 (11)).

[63] Agencies’ May 26, 1998, Comment at 16.

[65] Agencies’ May 26, 1998, Comment at 19.

[66] April 22, 1998, Letter (Exhibit 10 (7)).

[69] See Minn. R. 4625.3401, subp. 1.

[70] April 22, 1998, Letter (Exhibit 10 (12)).

[72] HITM Quality Assurance Report, April 1998, appended to May 1, 1998, letter; see also June 2, 1998,

Letter at 2.

[73] April 22, 1998, Letter, Attachment 25.

[74] April 22, 1998, Letter (Exhibit 10 (12)).

[76] Agencies’ May 26, 1998, Comment at 22; see also SONAR at 65..

[77] Agencies’ May 26, 1998, Comment at 22.

[80] Agencies’ May 26, 1998, Comment at 22.

[82] April 22, 1998, Letter (Exhibit 10 (8)).

[83] Id.; and April 20, 1998, Letter (Exhibit 10 (10)).

[84] See April 14, 1998, Letter (Ex. 10 (5)).

[86] Agencies’ May 26, 1998, Comment at 25.

[90] April 21, 1998, Letter (Exhibit 10 (11)) at 5.

[91] Agencies’ May 26, 1998, Comment at 29.

[93] Agencies’ May 26, 1998, Comment at 28.

[94] April 22, 1998, Letter (Exhibit 10 (7)).

[96] See Minn. R. 4625.4601, subp. 5.