Ch. 331: State of Maine Food Code 2001 (a joint chapter with 10-144 Ch. 200)

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1. Foodborne Illness Estimates, Risk Factors, and Interventions

Foodborne illness in the United States is a major cause of personal distress, preventable illness and death, and avoidable economic burden. Scallan et al. (2011a,b) estimated that foodborne diseases cause approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths in the United States each year. The occurrence of approximately 1,000 reported disease outbreaks (local, regional, and national) each year highlights the challenges of preventing these infections.

Most foodborne illnesses occur in persons who are not part of recognized outbreaks. For many victims, foodborne illness results only in discomfort or lost time from the job. For some, especially preschool age children, older adults in health care facilities, and those with impaired immune systems, foodborne illness is more serious and may be life threatening.

The annual cost of foodborne illness in terms of pain and suffering, reduced productivity, and medical costs are estimated to be $10 - $83 billion. As stated by Scallion et. al., the nature of food and foodborne illness has changed dramatically in the United States over the last century. While technological advances such as pasteurization and proper canning have all but eliminated some disease, new causes of foodborne illness have been identified. Surveillance of foodborne illness is complicated by several factors. The first is underreporting. Although foodborne illnesses can be severe or even fatal, milder cases are often not detected through routine surveillance. Second, many pathogens transmitted through food are also spread through water or from person to person, thus obscuring the role of foodborne transmission. Finally, pathogens or agents that have not yet been identified and thus cannot be diagnosed cause some proportion of foodborne illness

borne illnesses can be severe or even fatal, milder cases are often not detected through routine surveillance. Second, many pathogens transmitted through food are also spread through water or from person to person, thus obscuring the role of foodborne transmission. Finally, pathogens or agents that have not yet been identified and thus cannot be diagnosed cause some proportion of foodborne illness.

Epidemiological outbreak data repeatedly identify five major risk factors related to employee behaviors and preparation practices in retail and food service establishments as contributing to foodborne illness:

Improper holding temperatures,

Inadequate cooking, such as undercooking raw eggs,

Contaminated equipment,

Food from unsafe sources, and

Poor personal hygiene

The Food Code addresses controls for risk factors and further establishes 5 key public health interventions to protect consumer health. Specifically, these interventions are: demonstration of knowledge, employee health controls, controlling hands as a vehicle of contamination, time and temperature parameters for controlling pathogens, and the consumer advisory. The first two interventions are found in Chapter 2 and the last three in Chapter 3.

Healthy People 2010 and Healthy People 2020 are national initiatives that work through the cooperative federal-state-private sector and which establish 10-year objectives to improve the health of all Americans through prevention. Food Safety Objective 10-6 in Healthy People 2010 is: Improve food employee behaviors and food preparation practices that directly relate to foodborne illness in retail food establishments. This includes food operations such as retail food stores, food service establishments, health care facilities, schools and other "food establishments" as defined in the Food Code. In 2010, the Healthy People 2020 objectives will be released along with guidance for achieving the new 10-year targets

d food preparation practices that directly relate to foodborne illness in retail food establishments. This includes food operations such as retail food stores, food service establishments, health care facilities, schools and other "food establishments" as defined in the Food Code. In 2010, the Healthy People 2020 objectives will be released along with guidance for achieving the new 10-year targets.

The Food and Drug Administration (FDA) endeavors to assist the approximately 75 state and territorial agencies and more than 3,000 local departments that assume primary responsibility for preventing foodborne illness and for licensing and inspecting establishments within the retail segment of the food industry. This industry segment consists of more than one million establishments and employs a work force of over 16 million.

2. PHS Model Codes History, Purpose, and Authority

(A) History and Purpose

U.S. Public Health Service (PHS) activities in the area of food protection began at the turn of the 20th century with studies on the role of milk in the spread of disease. These studies led to the conclusion that effective disease prevention requires the application of comprehensive food sanitation measures from production to consumption. Additional studies identified and evaluated measures which would most effectively control disease, including work which led to improved processes for pasteurization.

Next, model codes were developed to assist state and local governments in initiating and maintaining effective programs for prevention of foodborne illness. The first of these, which is now titled Grade A Pasteurized Milk Ordinance – Recommendations of the PHS/FDA, was initially published in 1924. Subsequently, the PHS published recommended model food codes that address the various components of the retail segment of the food industry. Through the years all states, hundreds of local jurisdictions, and many federal agencies have adopted some edition of model food codes recommended by the PHS

Grade A Pasteurized Milk Ordinance – Recommendations of the PHS/FDA, was initially published in 1924. Subsequently, the PHS published recommended model food codes that address the various components of the retail segment of the food industry. Through the years all states, hundreds of local jurisdictions, and many federal agencies have adopted some edition of model food codes recommended by the PHS.

Today, FDA's purpose in maintaining an updated model food code is to assist food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail segment of the food industry. The retail segment includes those establishments or locations in the food distribution chain where the consumer takes possession of the food.

The model Food Code is neither federal law nor federal regulation and is not preemptive. Rather, it represents FDA's best advice for a uniform system of regulation to ensure that food at retail is safe and properly protected and presented. Although not federal requirements (until adopted by federal bodies for use within federal jurisdictions), the model Food Code provisions are designed to be consistent with federal food laws and regulations, and are written for ease of legal adoption at all levels of government.

A list of jurisdictions that have reported to FDA their status in adopting the Food Code is available on the FDA CFSAN web site. The list is self-reported and FDA has not yet evaluated whether all the

adopted codes are equivalent to the model Food Code.

Providing model food codes and model code interpretations and opinions is the mechanism through which FDA, as a lead federal food control agency, promotes uniform implementation of national food regulatory policy among the several thousand federal, state, and local agencies and tribes that have primary responsibility for the regulation or oversight of retail level food operations

model Food Code.

(B) Authority

PHS authority for providing assistance to state and local governments is derived from the Public Health Service Act [42 USC 243]. Section 311(a) states in part:

"... The Secretary shall ... assist states and their political subdivisions in the prevention and suppression of communicable diseases, and with respect to other public health matters, shall cooperate with and aid state and local authorities in the enforcement of their ... health regulations and shall advise the several states on matters relating to the preservation and improvement of the public health." Responsibility for carrying out the provisions of the Act relative to food protection was delegated within the PHS to the Commissioner of Food and Drugs in 1968 [21 CFR 5.10(a)(2) and (3)].

Assistance provided to local, state, and federal governmental bodies is also based on FDA's authorities and responsibilities under the Federal Food, Drug, and Cosmetic Act [21 USC 301].

3. Public Health and Consumer Expectations

It is a shared responsibility of the food industry and the government to ensure that food provided to the consumer is safe and does not become a vehicle in a disease outbreak or in the transmission of communicable disease. This shared responsibility extends to ensuring that consumer expectations are met and that food is unadulterated, prepared in a clean environment, and honestly presented

tations

Under FDA's 2009 Mission Statement the agency is responsible for:

Protecting the public health by assuring the safety and security of our nation’s food supply… and for advancing the public health by helping to make foods safer and more affordable; and helping the public get the accurate, science-based information they need about foods to improve their health.

Accordingly, the provisions of the Food Code provide a system of prevention and overlapping safeguards designed to minimize foodborne illness; ensure employee health, industry manager knowledge, safe food, nontoxic and cleanable equipment, and acceptable levels of sanitation on food establishment premises; and promote fair dealings with the consumer.

4. Advantage of Uniform Standards

The advantages of well-written, scientifically sound, and up-to-date model codes have long been recognized by industry and government officials.

Industry conformance with acceptable procedures and practices is far more likely where regulatory officials "speak with one voice" about what is required to protect the public health, why it is important, and which alternatives for compliance may be accepted.

Model codes provide a guide for use in establishing what is required. They are useful to business in that they provide accepted standards that can be applied in training and quality assurance programs. They are helpful to local, state, and federal governmental bodies that are developing or updating their own codes.

The model Food Code provides guidance on food safety, sanitation, and fair dealing that can be uniformly adopted for the retail segment of the food industry

y are useful to business in that they provide accepted standards that can be applied in training and quality assurance programs. They are helpful to local, state, and federal governmental bodies that are developing or updating their own codes.

The model Food Code provides guidance on food safety, sanitation, and fair dealing that can be uniformly adopted for the retail segment of the food industry. The document is the cumulative result of the efforts and recommendations of many contributing individuals, agencies, and organizations with years of experience using earlier model code editions. It embraces the concept that our quality of life, state of health, and the public welfare are directly affected by how we collectively provide and protect our food.

The model Food Code provisions are consistent with, and where appropriate incorporate, federal performance standards for the same products and processes. Federal performance standards in effect define public food safety expectations for the product, usually in terms of lethality to a pathogenic microorganism of particular concern. Use of performance standards as the measure of regulatory compliance means establishments are free to use innovative approaches in producing safe products, in lieu of adherence to traditional processing approaches, such as specified cooking times and temperatures, that achieve the same end. Federally inspected establishments demonstrate compliance with performance standards by showing that their process adheres to an appropriately designed, validated HACCP plan.

P plan.

Retail processors may be given the same opportunity as federally-regulated establishments to use innovative techniques in the production of safe foods. Retail establishments may apply to the regulatory authority for a variance to use a specific federal food safety performance standard for a product or a process in lieu of compliance with otherwise applicable specifications in the Food Code. However, to show compliance with the federal performance standard, the retail processor must, like a federally inspected establishment, show that processing controls are in place to ensure that the standard is being met. Thus, a request for a variance based on a federal performance standard must be supported by a validated HACCP plan with record keeping and documented verification being made available to the regulatory authority.

5. Information to Assist the User

Food Code provisions address essentially four areas: personnel (Chapter 2), food (Chapter 3), equipment/facilities/supplies (Chapters 4, 5, 6, 7), and compliance and enforcement (Chapter 8). The structural nomenclature of the document is as follows:

Code provisions are either appropriate for citing and debiting on an inspection report or they are not. Those not intended for citing/debiting are identified by the digits following the decimal point in the numbering system. These "nondebitable" provisions fall into two categories, those that end with two digits after the decimal point and the last digit is a zero, e.g., § 1-201.10; and those that end with three digits after the decimal point and the last 2 digits are zeros, e.g., § 8-805.100.

Two types of internal cross referencing are widely used throughout the Code to eliminate the need for restating provisions

em. These "nondebitable" provisions fall into two categories, those that end with two digits after the decimal point and the last digit is a zero, e.g., § 1-201.10; and those that end with three digits after the decimal point and the last 2 digits are zeros, e.g., § 8-805.100.

Two types of internal cross referencing are widely used throughout the Code to eliminate the need for restating provisions.

The first type of cross reference uses phrases that contain the word "under", e.g., "as specified under … (followed by the relevant portion of the Code)."

The purpose of this type of cross reference is to:

Alert the reader to relevant information, and

Provide a system by which each violation is recorded under the one most appropriate provision. This type of cross reference signals to the reader the provision of the Code under which a certain violation is properly cited/debited.

The second type of cross reference uses phrases that contain the word "in," e.g., "as specified in... (followed by the relevant portion of the Code)."

The purpose of this type of cross reference is to:

1) Indicate the specific provisions of a separate document such as a federal regulation that are being incorporated by reference in the requirement of the Code, e.g., ¶ 3-201.11(C); or

2) Refer the reader to a nondebitable provision of the Code which provides further information for consideration, such as provision for an exception or for an allowance to comply via an alternative method.

For example, ¶ 3-201.16 (A) begins with "Except as specified in ¶ (B)…" and ¶ (B) states the relevant exceptions to ¶ (A). Paragraph 3-201.11(E) states in part, "… as specified in ¶ 3-401.11(C)" and ¶ 3-401.11(C) provides for an allowance to serve or sell raw or undercooked, whole-meat, intact beef steaks in a ready-to-eat form

an exception or for an allowance to comply via an alternative method.

If you review the exception in ¶ 3-201.16(B) and the allowance in ¶ 3-401.11(C), you will see that exceptions and allowances often contain conditions of compliance, i.e., conditions that must be met in order for the exception or allowance to convey.

Based on the violation being cited, the substance of the text being referred to, and the context in which the reference is made, users of the Code must infer the intent of the cross reference. That is, the user must determine if the cross reference simply alerts the user to additional information about the requirement or if the cross reference:

sends (via the word "under") the citing/debiting to another Code provision;

incorporates (via the word "in") the referenced requirements into the Code provision.

The Food Code presents requirements by principle rather than by subject. For example, equipment requirements are presented under headings such as Materials, Design and Construction, Numbers and Capacities, Location and Installation, and Maintenance and Operation rather than by refrigerators, sinks, and thermometers. In this way provisions need be stated only once rather than repeated for each piece or category of equipment. Where there are special requirements for certain equipment, the requirement is delineated under the appropriate principle (e.g., Design and Construction) and listed separately in the index.

Requirements contained in the Food Code are presented as being in one of 2 categories of importance: critical and noncritical

d be stated only once rather than repeated for each piece or category of equipment. Where there are special requirements for certain equipment, the requirement is delineated under the appropriate principle (e.g., Design and Construction) and listed separately in the index.

Requirements contained in the Food Code are presented as being in one of 2 categories of importance: critical and noncritical. An asterisk * after a tagline (which is the language immediately following a section number that introduces the subject of the section) indicates that all of the provisions within that section are critical unless otherwise indicated, as follows:

Any unmarked provisions within a section that has an asterisked tagline are critical. All provisions following a tagline that is not marked with an asterisk are noncritical.

The following conventions are used in the Food Code. "Shall" means the act is imperative, i.e., "shall" constitutes a command. "May not" means absolute prohibition. "May" is permissive and means the act is allowed. The term "means" is followed by a declared fact.

CHAPTER 1

PURPOSE AND DEFINITION

1-1 TITLE, INTENT, SCOPE

1-101 Title

1-101.10 Food Code: These provisions shall be known as the Food Code, hereinafter referred to as “this Code.”

1-102 Intent

1-102.10 Food Safety, Illness Prevention, and Honest Presentation.

The purpose of this Code is to safeguard public health and provide to consumers Food that is safe, unadulterated, and honestly presented.

1-103 Scope

1-103.10 Statement: This Code establishes definitions; sets standards for management and personnel, Food operations, and Equipment and facilities; and provides for Food or Eating Establishment plan review, Permit issuance, inspection, Employee restriction, and Permit suspension.

1-2 DEFINITIONS

1-201 Applicability and Terms Defined

1-201.10 Statement of Application and Listing of Terms.

(A) The following definitions apply in the interpretation and application of this Code.

(B) Terms Defined

Food operations, and Equipment and facilities; and provides for Food or Eating Establishment plan review, Permit issuance, inspection, Employee restriction, and Permit suspension.

1-2 DEFINITIONS

1-201 Applicability and Terms Defined

1-201.10 Statement of Application and Listing of Terms.

(A) The following definitions apply in the interpretation and application of this Code.

(B) Terms Defined. As used in this Code, each of the terms listed in Section 1-201.10(B) shall have the meaning stated below.

(1) Accredited program.

(a) "Accredited program" means a food protection manager certification program that has been evaluated and listed by an accrediting agency as conforming to national standards for organizations that certify individuals.

(b) "Accredited program" refers to the certification process and is a designation based upon an independent evaluation of factors such as the sponsor's mission; organizational structure; staff resources; revenue sources; policies; public information regarding program scope, eligibility requirements, re-certification, discipline and grievance procedures; and test development and administration.

(2) Additive.

(a) "Food additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, §201(s) (2006 Edition, Supplement 3 current through January 5, 2010) and 21 CFR §170.3(e)(1) (April 1, 2012 ed.).

re-certification, discipline and grievance procedures; and test development and administration.

(2) Additive.

(b) "Color additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, §201(t) ((2006 Edition, Supplement 3 current through January 5, 2010)) and 21 CFR §70.3(f) (April 1, 2012 ed.).

(3) "Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, §402 (2006 Edition, Supplement 3 current through January 5, 2010) and as provided in 22 M.R.S.§2156 (Amended2009)).

(4) "Approved" means acceptable to the Regulatory Authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

(5) "aw" means water activity which is a measure of the free moisture in a Food, is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature, and is indicated by the symbol aw.

(6) “Balut” means an embryo inside a fertile egg that has been incubated for a period sufficient for the embryo to reach a specific stage of development after which it is removed from incubation before hatching.

(7) "Bed and Breakfast" is a unique Eating Establishment where the general public can stay overnight, and are provided with a "limited menu," serving only a breakfast meal. This meal can be either a full or continental breakfast. Unlike other Eating Establishments, the meal is prepared in the private home. Notwithstanding 22 M.R.S. §2501 (Amended 2011), all Bed and Breakfasts, regardless of the number of rooms rented, are subject to Departmental licensing requirements by these Rules.

(8) "Beverage" means a liquid for drinking, including water.

only a breakfast meal. This meal can be either a full or continental breakfast. Unlike other Eating Establishments, the meal is prepared in the private home. Notwithstanding 22 M.R.S. §2501 (Amended 2011), all Bed and Breakfasts, regardless of the number of rooms rented, are subject to Departmental licensing requirements by these Rules.

(8) "Beverage" means a liquid for drinking, including water.

(9) "Bottled drinking water" means water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

(10) “Bulk Food” Processed or unprocessed food in aggregate containers from which quantities desired by the consumer are withdrawn.

(11) “Casing” means a tubular container for sausage products made of either natural or artificial (synthetic) material.

(12) "Certification number" means a unique combination of letters and numbers assigned by a Fish Control Authority to a Molluscan Fish Dealer according to the provisions of the National Shellfish Sanitation Program.

(13) “Certified Food Protection Manager” means a person who is employed or engaged by the management of that Establishment with the authority to implement food protection measures, and who meets the certification requirements of Maine’s Rules Relating to the Administration and Enforcement of Establishments Licensed by the Health Inspection Program, 10-144 CMR 201, Section 2(A) (Amended October 7, 2012).

(14) "CFR" means Code of Federal Regulations. Citations in this Code to the CFR refer sequentially to the Title, Part, and Section numbers, such as 40 CFR 180.194 refers to Title 40, Part 180, Section 194. "Code of Federal Regulations" means the compilation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government which:

(a) Is published annually by the U.S. Government Printing Office; and

e CFR refer sequentially to the Title, Part, and Section numbers, such as 40 CFR 180.194 refers to Title 40, Part 180, Section 194. "Code of Federal Regulations" means the compilation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government which:

(a) Is published annually by the U.S. Government Printing Office; and

(b) Contains FDA rules in 21 CFR, USDA rules in 7 CFR and 9 CFR, EPA rules in 40 CFR, and Wildlife and Fisheries rules in 50 CFR.

(c) If the CFR citations in this Code do not have a date, or has a date earlier than 2012, then the version incorporated by reference in this Food Code is the 2012 version. The CFR is available free on the internet at a number of websites by searching the citation.

(15) CIP

(a) "CIP" means cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method used, in part, to clean and sanitize a frozen dessert machine.

(b) "CIP" does not include the cleaning of equipment, such as band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system.

(16) “Commingle” means

(a) To combine Stock harvested on different days or from different growing areas as identified on the tag or label, or

(b) To combine shucked fish from containers with different container codes or different shucking dates.

(17) Comminuted.

(a) "Comminuted" means reduced in size by methods including chopping, flaking, grinding, or mincing.

ithout the use of a CIP system.

(16) “Commingle” means

(a) To combine Stock harvested on different days or from different growing areas as identified on the tag or label, or

(b) To combine shucked fish from containers with different container codes or different shucking dates.

(17) Comminuted.

(a) "Comminuted" means reduced in size by methods including chopping, flaking, grinding, or mincing.

(b) "Comminuted" includes fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef, and sausage; and a mixture of 2 or more types of meat that have been reduced in size and combined, such as sausages made from 2 or more meats.

(18) “Conditional Employee” means a potential Food Employee to whom a job offer is made, conditional on responses to subsequent medical questions or examinations designed to identify potential Food Employees who may be suffering from a disease that can be

transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990 (Amended January 1, 2009).

(19) "Confirmed disease outbreak" means a Foodborne Disease Outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness.

(20) "Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a Food or Eating Establishment or Food Processing Plant, and does not offer the food for resale.

(21) "Corrosion-resistant material" means a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

(22) "Counter-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf.

nt material" means a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

(22) "Counter-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf.

(23) "Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.

(24) "Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a Critical Control Point to minimize the risk that the identified food safety hazard may occur.

(25) Critical Item.

(a) "Critical item" means a provision of this Code, that, if in noncompliance, is more likely than other violations to contribute to Food contamination, illness, or environmental health Hazard.

(b) "Critical item" is an item that is denoted in this Code with an asterisk *.

"Cut leafy greens" means fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or torn. The term "leafy greens" includes iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula and chard. The term "leafy greens" does not include herbs such as cilantro or parsley.

"Dealer" means a Person who is authorized by a Fish Control Authority for the activities of stock shipper, shucker-packer, repacker, reshipper, or depuration processor of molluscan fish according to the provisions of the National Fish Sanitation Program

carole, endive, spring mix, spinach, cabbage, kale, arugula and chard. The term "leafy greens" does not include herbs such as cilantro or parsley.

"Disclosure" means a written statement that clearly identifies the animal-derived

foods which are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

(29) Drinking Water.

"Drinking water" means water that meets criteria as specified in 40 CFR 141 National Primary Drinking Water Regulations (Amended July 1, 2012), 10-144 CMR Chapter 231 State of Maine Rules Relating to Drinking Water (Amended Feb 27, 2012), and Maine’s Water for Human Consumption Act, 22 M.R.S., Chapter 601 (1975, Amended 2011).

(b) "Drinking water" is traditionally known as "potable water."

(c) "Drinking water" includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking" water.

(30) "Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not Potentially Hazardous (Time/Temperature Control For Safety Food) and dry goods such as Single-Service items.

(31) Easily Cleanable.

(a) "Easily cleanable" means a characteristic of a surface that:

Allows effective removal of soil by normal cleaning methods;

Is dependent on the material, design, construction, and installation of the surface; and

(iii) Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into Food based on the surface's approved placement, purpose, and use.

y cleanable" means a characteristic of a surface that:

Allows effective removal of soil by normal cleaning methods;

Is dependent on the material, design, construction, and installation of the surface; and

(iii) Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into Food based on the surface's approved placement, purpose, and use.

(b) "Easily cleanable" includes a tiered application of the criteria that qualify the surface as Easily Cleanable as specified under Subparagraph (a) of this definition to different situations in which varying degrees of cleanability are required such as:

The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining; or

The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area.

(32) "Easily movable" means:

(a) Portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to safely tilt a unit of equipment for cleaning; and

(b) Having no utility connection, a utility connection that disconnects quickly, or a

flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.

(33) Eating Establishment means:

Any place where food or drink is prepared and served, or served to the public for consumption on the premises, or catering establishments or establishments dispensing food from vending machines, or establishments preparing food for vending machines dispensing foods other than in original sealed packages, such as hotels, motels, boarding homes, restaurants, mobile eating places, coffee shops, cafeterias, short order cafes, luncheonettes, grills, tearooms, sandwich shops, soda fountains, bars, cocktail lounges, night clubs, roadside stands, industrial feeding establishments, privat

achines, or establishments preparing food for vending machines dispensing foods other than in original sealed packages, such as hotels, motels, boarding homes, restaurants, mobile eating places, coffee shops, cafeterias, short order cafes, luncheonettes, grills, tearooms, sandwich shops, soda fountains, bars, cocktail lounges, night clubs, roadside stands, industrial feeding establishments, private or public institutions routinely serving foods, retail frozen dairy product establishments, airports, parks, theaters, take-outs, or any other catering or non-alcoholic drinking establishments or operations where food is prepared and served or served for consumption on the premises, or catering establishments where food is prepared.

(34) Egg.

(a) "Egg" means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites or turkey.

(b) "Egg" does not include:

A Balut;

The egg of reptile species such as alligator; or

An egg product

(35) Egg Product.

"Egg Product" means all, or a portion of, the contents found inside eggs separated from the shell and pasteurized in a Food Processing Plant, with or without added ingredients, intended for human consumption, such as dried, frozen or liquid eggs.

"Egg Product" does not include Food which contains Eggs only in a relatively small proportion, such as cake mixes.

(36) "Employee" means the Permit Holder, Person in Charge, Food Employee, Person,

having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person

working in a Food or Eating Establishment. Volunteers providing services in a Food or Eating Establishment are subject to the same standards as other Employees.

6) "Employee" means the Permit Holder, Person in Charge, Food Employee, Person,

having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person

working in a Food or Eating Establishment. Volunteers providing services in a Food or Eating Establishment are subject to the same standards as other Employees.

(37)"Enterohemorrhagic Escherichia coli" (EHEC) means E. coli which cause hemorrhagic colitis, meaning bleeding enterically or bleeding from the intestine. The term is typically used in association with E. coli that have the capacity to produce Shiga toxins and to cause attaching and effacing lesions in the intestine. EHEC is a subset of STEC, whose members produce additional virulence factors. Infections with EHEC may be asymptomatic but are classically associated with bloody diarrhea (hemorrhagiccolitis) and hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). Examples of serotypes of EHEC include: E. coli O157:H7; E. coli O157:NM; E. coli O26:H11; E. coli O145:NM; E. coli O103:H2; or E. coli O111:NM. Also see Shiga Toxin- Producing E. coli

(38) "EPA" means the U.S. Environmental Protection Agency.

(39) Equipment.

(a) "Equipment" means an article that is used in the operation of a Food or Eating Establishment, such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or warewashing machine.

E. coli

(38) "EPA" means the U.S. Environmental Protection Agency.

(39) Equipment.

(b) "Equipment" does not include apparatuses or items used for handling or storing large quantities of Packaged Foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids.

"Exclude" means to prevent a person from working as an Employee in a Food or Eating Establishment or entering a Food or Eating Establishment as an Employee.

"FDA" means the United States Food and Drug Administration.

(42) Fish.

(a) "Fish" means fresh or saltwater finfish, crustaceans and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, if such animal life is intended for human consumption.

(b) "Fish" includes an edible human Food product derived in whole or in part from Fish, including Fish that have been processed in any manner.

(43) "Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

(44) "Foodborne Disease Outbreak" means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

(45) "Food-contact surface" means:

(a) A surface of equipment or a Utensil with which Food normally comes into contact; or

e, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

(44) "Foodborne Disease Outbreak" means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

(45) "Food-contact surface" means:

(a) A surface of equipment or a Utensil with which Food normally comes into contact; or

(b) A surface of Equipment or a Utensil from which Food may drain, drip, or splash:

Into a Food, or

(ii) Onto a surface normally in contact with Food.

(46) "Food Employee" means an individual working with unpackaged Food, Food Equipment or Utensils, or Food-Contact Surfaces.

(47) “Food Establishment” means a factory, plant, warehouse or store in which food and food products are manufactured, processed, packed, held for introduction into commerce or sold. “Food establishment” includes a primary caregiver, as defined in 22 M.R.S. §2422 (8-A) (New 2011) and a registered dispensary, as defined in 22 M.R.S. §2422(6) (New 2011), that prepare food containing marijuana for medical use by a qualifying patient pursuant to 22 M.R.S., Chapter 558-C (New 2009). The following establishments are not considered food establishments required to be licensed under 22 M.R.S. § 2167 (Amended 2011):

(a) Eating establishments, as defined in 22 M.R.S. §2491(7) (Amended 2011) and within this Code;

Fish and shellfish processing establishments inspected under 12 M.R.S. §§6101 (Amended 2011), 6102 (Amended 1981) or 6856 (Amended 2011);

M.R.S., Chapter 558-C (New 2009). The following establishments are not considered food establishments required to be licensed under 22 M.R.S. § 2167 (Amended 2011):

(a) Eating establishments, as defined in 22 M.R.S. §2491(7) (Amended 2011) and within this Code;

Fish and shellfish processing establishments inspected under 12 M.R.S. §§6101 (Amended 2011), 6102 (Amended 1981) or 6856 (Amended 2011);

Establishments such as farm stands and farmers’ markets primarily selling fresh produce not including dairy and meat products;

Establishments engaged in the washing, cleaning or sorting of whole produce, provided the produce remains in essentially the same condition as when harvested. The whole produce may be packaged for sale, provided that packaging is not by a vacuum packaging process or a modified atmosphere packaging process;

Establishments that are engaged in the drying of single herbs that are generally recognized as safe under 21 CFR §§182-189 (Amended September 2011). The single herbs may be packaged for sale, provided that packaging is not by a vacuum packaging process or a modified atmosphere packaging process; and

A primary caregiver, as defined in 22 M.R.S. §2422(8-A) (New 2011), conducting an activity allowed in 22 M.R.S. §2423-A (New 2011) for a

qualifying patient who is a member of the family, as defined in 22 M.R.S.§2422 (5-A) (New 2011), or member of the household, as defined in 22 M.R.S.§2422(5-B) (New 2011), of the primary caregiver.

(48) Food Processing Plant.

"Food processing plant" means a commercial operation that manufactures, packages, labels, or stores Food for human consumption and provides food for sale or

distribution to other business entities such as Food Processing Plants or Food Establishments and does not provide Food directly to a Consumer.

(b) "Food processing plant" does not include a Food Establishment as defined under Subparagraph 1-201.10(B).

(49) Game Animal

a commercial operation that manufactures, packages, labels, or stores Food for human consumption and provides food for sale or

distribution to other business entities such as Food Processing Plants or Food Establishments and does not provide Food directly to a Consumer.

(b) "Food processing plant" does not include a Food Establishment as defined under Subparagraph 1-201.10(B).

(49) Game Animal

(a) "Game animal" means an animal, the products of which are Food, that is not classified as livestock, cattle, sheep, swine, goat, horse, mule, or other equine in 9 CFR 301.2 Definitions, Subchapter A - Mandatory Meat Inspection (January 1, 2013 ed.), as Poultry in 9 CFR 381, Subchapter C - Mandatory Poultry Products Inspection, or as fish, defined under Subparagraph 1-201.10(B) (January 1, 2013 ed.).

(b) "Game animal" includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat, and nonaquatic reptiles such as land snakes.

(50) "General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175 (Revised July 2011).

(51) "Grade A standards" means the requirements of the United States Public Health Service/FDA “Grade A Pasteurized Milk Ordinance” with which certain fluid and dry milk and milk products comply.

(52) Group Residence.

(a) "Group residence" means a private or public housing corporation or institutional facility that provides living quarters and meals.

fied in 40 CFR 152.175 (Revised July 2011).

(51) "Grade A standards" means the requirements of the United States Public Health Service/FDA “Grade A Pasteurized Milk Ordinance” with which certain fluid and dry milk and milk products comply.

(52) Group Residence.

(a) "Group residence" means a private or public housing corporation or institutional facility that provides living quarters and meals.

(b) "Group residence" includes a domicile for unrelated Persons such as a retirement home or a long-term health care facility.

(53) “Hazard Analysis Critical Control Point (HACCP)” means a systematic evaluation of food preparation procedures to identify opportunities for bacterial contamination and growth. From this perspective, a public health inspector may then determine those circumstances which could result in the development of food-borne diseases.

(54) "HACCP plan" means a written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by The National Advisory Committee on Microbiological Criteria for Foods.

(55) Handwashing Sink.

"Handwashing sink" means a lavatory, a basin or vessel for washing, a wash

basin, or a Plumbing Fixture especially placed for use in personal hygiene and designed for the washing of the hands.

(b) "Handwashing sink" includes an automatic handwashing facility.

(56) "Hazard" means a biological, chemical, or physical property that may cause an unacceptable Consumer health risk.

(57) “Health Inspector” means a person whose education and experience in the biological and sanitary sciences qualify him/her to engage in the promotion and protection of the public health. A health inspector applies technical knowledge to solve problems of a sanitary nature and develops methods and carries out procedures for those factors of man's environment which affect health, safety and the well-being of others.

or” means a person whose education and experience in the biological and sanitary sciences qualify him/her to engage in the promotion and protection of the public health. A health inspector applies technical knowledge to solve problems of a sanitary nature and develops methods and carries out procedures for those factors of man's environment which affect health, safety and the well-being of others.

(58) "Health practitioner" means a physician licensed to practice medicine, or if allowed by Law, a nurse practitioner, physician assistant, or similar medical professional.

(59) "Hermetically sealed container" means a container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned Foods, to maintain the commercial sterility of its contents after processing.

(60) "Highly susceptible population" means a group of Persons who are more likely than other people in the general population to experience foodborne disease because they are:

(a) Immunocompromised; preschool age children, or older adults; and

Obtaining Food at a facility that provides services such as custodial care, or older adults and in a facility that provides health care or assisted living services, such

as a child or adult day care center, kidney dialysis center, hospital or nursing home; or nutritional or socialization services, such as a senior center.

(61) "Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on:

(a) The number of potential injuries, and

r socialization services, such as a senior center.

(a) The number of potential injuries, and

(b) The nature, severity, and duration of the anticipated injury.

Imminent Health Hazard includes, but is not limited to, the following:

(1) an extended loss of water supply,

(2) an extended power outage,

(3) flood water or sewer back-up into the establishment,

(4) fire, or

(5) any other violation(s) that has/have the potential to pose an imminent threat to public health.

Failure to include other violations in this definition shall not be construed as a determination that other violations may not, in light of the circumstances, be found to pose an imminent health hazard.

(62) "Injected" means manipulating a Meat to which a solution has been introduced into its interior by processes that are referred to as "injecting," “pump marinating” "pinning," or "stitch pumping.”

(63) Juice

(a) “Juice”, when used in the context of Food safety, means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purées of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or purée.

been introduced into its interior by processes that are referred to as "injecting," “pump marinating” "pinning," or "stitch pumping.”

(63) Juice

(b) “Juice” does not include, for purposes of HACCP, liquids, purees, or

concentrates that are not used as Beverages or ingredients of Beverages.

(64) "Kitchenware" means food preparation and storage Utensils.

(65) "Law" means applicable local, state, and federal statutes, regulations, and ordinances.

(66) "Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments including cloth gloves.

(67) Major Food Allergen.

"Major food allergen" means:

Milk, Egg, Fish (such as bass, flounder, cod, and including crustacean fish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or

A Food ingredient that contains protein derived from a Food, as specified in Subparagraph (a)(i) of this definition.

"Major food allergen" does not include:

Any highly refined oil derived from a Food specified in Subparagraph (a)(i) of this definition and any ingredient derived from such highly refined oil; or

Any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labeling and Consumer Protection Act of 2004 at 21 U.S.C. § 31 et. seq.

ph (a)(i) of this definition.

"Major food allergen" does not include:

Any highly refined oil derived from a Food specified in Subparagraph (a)(i) of this definition and any ingredient derived from such highly refined oil; or

Any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labeling and Consumer Protection Act of 2004 at 21 U.S.C. § 31 et. seq.

(68) "Meat" means the flesh of animals used as Food including the dressed flesh of cattle,

swine, sheep, or goats and other edible animals, except fish, poultry, and wild game animals, as specified under Subparagraphs 3-201.17.

Mechanically Tenderized.

"Mechanically tenderized" means manipulating meat with deep penetration by processes which may be referred to as "blade tenderizing," "jaccarding," "pinning," "needling," or using blades, pins, needles or any mechanical device.

(b) "Mechanically tenderized" does not include processes by which solutions are injected into meat.

(70) "mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).

"Molluscan Shellfish" means any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle.

Non-Continuous Cooking.

"Non-continuous cooking" means the cooking of Food in a Food or Eating Establishment, using a process in which the initial heating of the Food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or service.

"Non-continuous cooking" does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process.

Packaged.

"Packaged" means bottled, canned, cartoned, securely bagged, or securely wrapped, whether packaged in a Food Establishment or a Food Processing Plant.

be cooled and held for complete cooking at a later time prior to sale or service.

"Non-continuous cooking" does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process.

Packaged.

"Packaged" means bottled, canned, cartoned, securely bagged, or securely wrapped, whether packaged in a Food Establishment or a Food Processing Plant.

(b) "Packaged" does not include a wrapper, carry-out box, or other nondurable container used to containerize Food with the purpose of facilitating Food protection during service and receipt of the Food by the Consumer.

(74) "Permit" means the license issued by the Regulatory Authority that authorizes a Person to operate a Food Establishment.

(75) "Permit holder" means the entity that:

(a) Is legally responsible for the operation of the Food or Eating Establishment such as the owner, the owner's agent, or other Person; and

(b) Possesses a valid Permit to operate a Food or Eating Establishment.

(76) "Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

(77) "Person in charge" means the individual present at a Food or Eating Establishment

who is responsible for the operation at the time of inspection.

(78) Personal Care Items.

(a) "Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination and are used to maintain or enhance a Person’s health, hygiene, or appearance.

ental subdivision or agency.

(77) "Person in charge" means the individual present at a Food or Eating Establishment

who is responsible for the operation at the time of inspection.

(78) Personal Care Items.

(a) "Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination and are used to maintain or enhance a Person’s health, hygiene, or appearance.

(b) "Personal care items" include items such as medicines; first aid supplies; and

other items such as cosmetics, and toiletries such as toothpaste and mouthwash.

(79) "pH" means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between 0 and 7 indicate acidity and values between 7 and 14 indicate alkalinity. The value for pure distilled water is 7, which is considered neutral.

(80) "Physical facilities" means the structure and interior surfaces of a Food or Eating Establishment, including accessories, such as soap and towel dispensers, and attachments such as light fixtures and heating or air conditioning system vents.

(81) "Plumbing fixture" means a receptacle or device that:

(a) Is permanently or temporarily connected to the water distribution system of the Premises and demands a supply of water from the system; or

(b) Discharges used water, waste materials, or Sewage directly or indirectly to the drainage system of the Premises.

(82) "Plumbing system" means the water supply and distribution pipes; Plumbing Fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the Premises; and water-treating Equipment.

(83) "Poisonous or toxic materials" means substances that are not intended for ingestion and are included in 4 categories:

(a) Cleaners and Sanitizers, which include cleaning and Sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

s, including their respective connections, devices, and appurtenances within the Premises; and water-treating Equipment.

(83) "Poisonous or toxic materials" means substances that are not intended for ingestion and are included in 4 categories:

(a) Cleaners and Sanitizers, which include cleaning and Sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

(b) Pesticides, except Sanitizers, which include substances such as insecticides and rodenticides;

(c) Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants and Personal Care Items that may be deleterious to health; and

(d) Substances that are not necessary for the operation and maintenance of the establishment and are on the Premises for retail sale, such as petroleum products and paints.

(84) Potentially Hazardous Food. (Time/Temperature Control for Safety Food)

(a) "Potentially hazardous food (time/temperature control for safety food)” means a Food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.

(b) "Potentially hazardous food (Time/Temperature Control for Safety Food) includes:

An animal Food or any food that consists in whole, or in part, of milk or milk products, eggs, meat, poultry, shellfish, fish, edible crustacea, or their ingredients, including synthetic ingredients that is raw or heat-treated; a plant Food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation;

Except as specified in Subparagraph (c)(iv) of this definition, a Food that because of the interaction of its aw and pH values is designated as Product Assessment Required (PA) in Table A or B of this

ort pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation;

An air-cooled hard-boiled egg with shell intact or an Egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae;

A Food, in an unopened Hermetically Sealed Container, that is commercially processed to achieve and maintain commercial sterility under conditions of

nonrefrigerated storage and distribution;

A Food that because of its pH or aw value, or interaction of aw and pH values, is designated as a non-PHF/non-TCS Food in Table A or B of this definition;

A Food that is designated as Product Assessment Required (PA) in Table A or B of this definition and has undergone a Product Assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that Food is precluded due to:

Intrinsic factors including added or natural characteristics of the Food such as preservatives, antimicrobials, humectants, acidulants, or nutrients,

Extrinsic factors including environmental or operational factors that affect the Food such as packaging, modified atmosphere such as Reduced Oxygen Packaging, shelf life and use, or temperature range of storage and use, or

A combination of intrinsic and extrinsic factors; or

ng added or natural characteristics of the Food such as preservatives, antimicrobials, humectants, acidulants, or nutrients,

A combination of intrinsic and extrinsic factors; or

(v) A Food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the Subparagraphs (c)(i)-(iv)

of this definition even though the Food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

(85) "Poultry" means:

Any domesticated bird (chickens, turkeys, ducks, geese, or guineas, ratites

or squabs), whether live or dead, as defined in 9 CFR 381.1 (Poultry Products Inspection Regulations Definitions, Poultry)( January 1, 2013 ed.); and

Any migratory waterfowl or game bird, or squab, pheasant, partridge,

quail, grouse, pigeon, or guinea, whether live or dead, as defined in 9 CFR 362.1 (Voluntary Poultry Inspection Regulations, Definitions) (January 1, 2013 ed.).

(86) "Premises" means:

(a) The physical facility, its contents, and the contiguous land or property under the control of the Permit Holder; or

(b) The physical facility, its contents, and the land or property not described

under Subparagraph (a) of this definition if its facilities and contents are under

the control of the Permit Holder and may impact Food or Eating Establishment personnel, facilities, or operations, and a Food or Eating Establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.

(87) "Primal cut" means a basic major cut into which carcasses and sides of Meat are separated, such as a beef round, pork loin, lamb flank, or veal breast.

nd may impact Food or Eating Establishment personnel, facilities, or operations, and a Food or Eating Establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.

(87) "Primal cut" means a basic major cut into which carcasses and sides of Meat are separated, such as a beef round, pork loin, lamb flank, or veal breast.

(88) "Public water system" has the meaning stated in 40 CFR 141 National Primary Drinking Water Regulations (June 2012 ed.). Specifically, a Public Water System means any publicly or privately owned system of pipes or other constructed conveyances, structures and facilities through which water is obtained for or sold, furnished or distributed to the public for human consumption if such a system has at least 15 service connections, regularly serves an average of at least 25 individuals daily at least 60 days out of the year or bottles water for sale. Any publicly or privately owned system that only stores and distributes water without treating or collecting it; obtains all its water from, but is not owned or operated by, a public water system; and does not sell water or bottled water to any person is not a "public water system." The term "public water system" includes any collection, treatment, storage or distribution pipes or other constructed conveyances, structures or facilities under the control of the supplier of water and used primarily in connection with such a system, and any collection or pretreatment storage facilities not under that control that are used primarily in connection with such a system. The system does not include the portion of service pipe owned and maintained by a customer of the public water system.

(89) “Ratite” means a flightless bird such as an emu, ostrich, or rhea.

(90) Ready-to-Eat Food.

(a) “Ready-to-Eat Food” means Food that:

d any collection or pretreatment storage facilities not under that control that are used primarily in connection with such a system. The system does not include the portion of service pipe owned and maintained by a customer of the public water system.

(89) “Ratite” means a flightless bird such as an emu, ostrich, or rhea.

(90) Ready-to-Eat Food.

(a) “Ready-to-Eat Food” means Food that:

(i) Is in a form that is edible without additional preparation to achieve food safety, as specified under one of the following: ¶ 3-401.11(A) or (B),

§ 3-401.12, or § 3-402.11, or as specified in ¶ 3-401.11(C);

(ii) Is a raw or partially cooked animal food and the consumer is advised as specified in Subparagraphs 3-401.11(D)(1) and (3); or

(iii) Is prepared in accordance with a variance that is granted as specified in Subparagraph 3-401.11(D) (4); and

(iv) May receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes.

"Ready-to-Eat Food" includes:

Raw animal food that is cooked as specified under§ 3-401.11 or 3401.12, or frozen as specified under § 3-402.11;

Raw fruits and vegetables that are washed as specified under § 3-302.15;

Fruits and vegetables that are cooked for hot holding, as specified under § 3-401.13;

All Potentially Hazardous Food (Time/Temperature Control For Safety Food) that is cooked to the temperature and time required for the specific Food under Subpart 3-401 and cooled as specified under § 3-501.14;

Plant Food for which further washing, cooking, or other processing is not required for Food safety, and from which rinds, peels, husks, or shells, if naturally present are removed;

Substances derived from plants such as spices, seasonings, and sugar;

A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not required for Food safety;

The following products that are produced in accordance with USDA guidelines and that have received a lethality treatment for pathogens: dry, fermented sausages, such as dry salami or

lly present are removed;

Substances derived from plants such as spices, seasonings, and sugar;

A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not required for Food safety;

The following products that are produced in accordance with USDA guidelines and that have received a lethality treatment for pathogens: dry, fermented sausages, such as dry salami or pepperoni; salt-cured Meat and Poultry products, such as prosciutto ham, country cured ham, and Parma ham; and dried Meat and Poultry products, such as jerky or beef sticks; and

Foods manufactured as specified in 21 CFR Part 113, (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) (April 2013 ed.) .

(91) Reduced Oxygen Packaging.

(a) "Reduced oxygen packaging" means:

The reduction of the amount of oxygen in a Package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a

level below that normally found in the atmosphere, (approximately 21% at sea level); and

(ii) A process as specified in Subparagraph (a)(i) of this definition that involves a Food for which the hazards Clostridium botulinum and Listeria monocytogenes require control in the final Packaged form.

(b) "Reduced oxygen packaging" includes:

Vacuum Packaging, in which air is removed from a Package of Food and the Package is Hermetically Sealed so that a vacuum remains inside the Package;

Modified atmosphere Packaging, in which the atmosphere of a Package of Food is modified so that its composition is different from

air but the atmosphere may change over time due to the permeability

of the Packaging material or the respiration of the Food

uum Packaging, in which air is removed from a Package of Food and the Package is Hermetically Sealed so that a vacuum remains inside the Package;

Modified atmosphere Packaging, in which the atmosphere of a Package of Food is modified so that its composition is different from

air but the atmosphere may change over time due to the permeability

of the Packaging material or the respiration of the Food. Modified atmosphere Packaging includes: reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen;

Controlled atmosphere Packaging, in which the atmosphere of a Package of Food is modified so that until the Package is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable packaging material.

Cook chill Packaging, in which cooked Food is hot filled into impermeable bags which have the air expelled and are then sealed or crimped closed. The bagged Food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens; or

Sous vide Packaging, in which raw or partially cooked Food is placed in a hermetically sealed, impermeable bag, cooked in the bag, rapidly

chilled, and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens.

(92) "Refuse" means solid waste not carried by water through the Sewage system.

(93) "Regulatory authority" means the local, state, or federal enforcement body or authorized representative having jurisdiction over the Eating or Food Establishment. The state Regulatory Authority means the Maine Department of Health and Human Services or the

Maine Department of Agriculture, Conservation and Forestry.

(94) "Reminder" means a written statement concerning the health Risk of consuming animal Foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

presentative having jurisdiction over the Eating or Food Establishment. The state Regulatory Authority means the Maine Department of Health and Human Services or the

Maine Department of Agriculture, Conservation and Forestry.

(94) "Reminder" means a written statement concerning the health Risk of consuming animal Foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

(95) "Re-service" means the transfer of Food that is unused and returned by a Consumer

after being served or sold and in the possession of the Consumer, to another Person.

(96) "Restrict" means to limit the activities of a Food Employee so that there is no Risk of transmitting a disease that is transmissible through Food and the Food Employee does not work with exposed Food, clean Equipment, Utensils, Linens, or unwrapped Single-Service or Single-Use Articles.

(97) "Restricted egg" means any check, dirty Egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR 590 (January 1, 2013 ed.)

(98) "Restricted use pesticide" means a pesticide product that contains the active ingredients specified in 40 CFR 152.175 (Sept 2011 ed.). Pesticides classified for restricted use, and that is limited to use by or under the direct supervision of a certified applicator; and also includes pesticides added by 22 M.R.S. §1471-C (23) (Amended 2011).

(99) "Risk" means the likelihood that an adverse health effect will occur within a population as a result of a Hazard in a Food.

(100) "Safe material" means:

(a) An article manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any Food;

(b) An additive that is used as specified in §§ 409 or 706 of the Federal Food, Drug, and Cosmetic Act (2006 Edition, 21 USC §§348, 379(e); or

in a Food.

(100) "Safe material" means:

(b) An additive that is used as specified in §§ 409 or 706 of the Federal Food, Drug, and Cosmetic Act (2006 Edition, 21 USC §§348, 379(e); or

(c) Other materials that are not Additives and that are used in conformity with applicable regulations of the Food and Drug Administration.

(101) "Sanitization" means the application of cumulative heat or chemicals on cleaned

Food-Contact Surfaces that, when evaluated for efficacy, is sufficient to yield a

reduction of 5 logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.

(102) "Sealed" means free of cracks or other openings that allow the entry or passage of moisture.

(103) "Service animal" means an animal such as a guide dog or signal dog, in accordance with 5 M.R.S. §4553(9-E)(Amended 2011), that has been individually trained to do work or perform tasks for the benefit of an individual with a physical or mental disability. Service animals are permitted on the premises of Food or Eating Establishments, in accordance with 17 M.R.S. §3966 (Amended 2011).

(104) "Servicing area" means an operating base location to which a mobile Food

Establishment or transportation vehicle returns regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding Food.

(105) "Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.

(106) "Shellfish control authority" means a state, federal, foreign, tribal, or other government entity legally responsible for administering a program that includes certification of Molluscan Shellfish harvesters and dealers for interstate commerce.

"Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.

(107) "Shellstock" means raw, in-shell Molluscan Shellfish.

(108) "Shiga toxin-producing Escherichia coli" (STEC) means any E. coli capable of producing Shiga toxins (also called verocytotoxins or "Shiga-like" toxins). Examples of serotypes of STEC include both O157 and non-O157 E. coli. Also see Enterohemorrhagic Escherichia Coli.

(109) "Shucked Shellfish" means Molluscan Shellfish that have one or both shells removed.

(110) "Single-service articles" means Tableware, carry-out Utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one time, one Person use after which they are intended for discard.

(111) Single-Use Articles.

(a) "Single-use articles" means Utensils and bulk Food containers designed and constructed to be used once and discarded.

(b) "Single-use articles" includes items such as wax paper, butcher paper, plastic wrap, formed aluminum Food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number 10 cans which do not meet the materials, durability, strength, and cleanability specifications under §§4-101.11, 4-201.11, and 4-202.11 for multiuse Utensils.

(112) "Slacking" means the process of moderating the temperature of a Food such as allowing a Food to gradually increase from a temperature of -23oC (-10oF) to -4o C

(25oF) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen Food such as shrimp.

(113) "Smooth" means:

nder §§4-101.11, 4-201.11, and 4-202.11 for multiuse Utensils.

(112) "Slacking" means the process of moderating the temperature of a Food such as allowing a Food to gradually increase from a temperature of -23oC (-10oF) to -4o C

(25oF) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen Food such as shrimp.

(113) "Smooth" means:

(a) A Food-Contact Surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (100 grit) number 3 stainless steel;

(b) A non-Food-Contact Surface of Equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale; and

(c) A floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.

(114) “Sporting -Recreational Camp” means a building or group of buildings devoted primarily to the offering of eating and primitive lodging facilities to guests only, and not to the general public, primarily in pursuit of primitive recreation, hunting, fishing, snowmobiling or

similar activities. Sporting-Recreational camps generally do not include summer sports programs overseen by employees or volunteers of municipalities and educational institutions, when the activities generally take place at the municipal or institution property and buildings.

(115) "Tableware" means eating, drinking, and serving Utensils for table use such as flatware including forks, knives, and spoons; hollowware including bowls, cups, serving dishes, and tumblers; and plates.

(116) "Temperature measuring device" means a thermometer, thermocouple, thermistor,

or other device that indicates the temperature of Food, air, or water.

(117) "Temporary Eating Establishment" means an Eating Establishment that operates for a period of no more than 14 consecutive days in conjunction with a single event or celebration.

(118) "USDA" means the U.S. Department of Agriculture.

(116) "Temperature measuring device" means a thermometer, thermocouple, thermistor,

or other device that indicates the temperature of Food, air, or water.

(117) "Temporary Eating Establishment" means an Eating Establishment that operates for a period of no more than 14 consecutive days in conjunction with a single event or celebration.

(118) "USDA" means the U.S. Department of Agriculture.

(119) "Utensil" means a Food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of Food, such as Kitchenware or Tableware that is multiuse, Single-Service, or Single-Use; gloves used in contact with Food; Food Temperature Measuring Devices; and probe-type price or identification tags used in contact with Food.

(120) "Variance" means a written document issued by the Regulatory Authority that authorizes a modification or waiver of one or more requirements of this Code if, in

the opinion of the Regulatory Authority, a health Hazard or nuisance will not result from the modification or waiver.

(121) "Vending Machine" means a self-service device that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses unit servings of Food in bulk or in packages without the necessity of replenishing the device between each vending operation.

(122) "Vending machine location" means the room, enclosure, space, or area where one or more Vending Machines are installed and operated and includes the storage areas and areas on the Premises that are used to service and maintain the Vending Machines.

(123) "Warewashing" means the cleaning and Sanitizing of Utensils and Food-Contact Surfaces of Equipment.

e device between each vending operation.

(123) "Warewashing" means the cleaning and Sanitizing of Utensils and Food-Contact Surfaces of Equipment.

(124) "Whole-muscle, intact beef" means whole muscle beef that is not injected,

mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

CHAPTER 2

MANAGEMENT AND PERSONNEL

2-1 SUPERVISION

2-101 Responsibility

2-101.11 Assignment.*

Except as specified in ¶ (B) of this section, the Permit Holder shall be the Person in Charge or shall designate a Person in Charge and shall ensure that a Person in Charge is present at the Food or Eating Establishment during all hours of operation.

In a Food or Eating Establishment with two or more separately permitted departments that are the legal responsibility of the same Permit Holder and that are located on the same Premises, the Permit Holder may, during specific time periods when food is not being prepared, packaged, or served, designate a single Person in Charge who is present on the Premises during all hours of operation, and who is responsible for each separately Permitted Food or Eating Establishment on the Premises.

2-102 Knowledge

2-102.11 Demonstration.*

Based on the risks inherent to the Food operation, during inspections and upon request, the Person in Charge shall demonstrate to the Regulatory Authority knowledge of foodborne disease prevention, application of the Hazard Analysis Critical Control Point principles, and the requirements of this Code

rmitted Food or Eating Establishment on the Premises.

2-102 Knowledge

2-102.11 Demonstration.*

Complying with this Code, by having no violations of critical items during the current inspection;

Being a Certified Food Protection Manager who has shown proficiency of required information through passing a test that is part of an Accredited Program;

Responding correctly to the inspector's questions as they relate to the specific Food operation. The areas of knowledge include:

Describing the relationship between the prevention of foodborne disease and the personal hygiene of a Food Employee;

Explaining the responsibility of the Person in Charge for preventing the transmission of foodborne disease by a Food Employee who has a disease or medical condition that may cause foodborne disease;

Describing the symptoms associated with the diseases that are transmissible through Food;

Explaining the significance of the relationship between maintaining the time and temperature of Potentially Hazardous Food (Time/Temperature Control for Safety Food) and the prevention of foodborne illness;

Explaining the Hazards involved in the consumption of raw or undercooked Meat, Poultry, Eggs and Fish.

Stating the required Food temperatures and times for safe cooking of Potentially Hazardous Food (Time/Temperature Control for Safety Food) including Meat, Poultry, Eggs, and Fish

ure of Potentially Hazardous Food (Time/Temperature Control for Safety Food) and the prevention of foodborne illness;

Explaining the Hazards involved in the consumption of raw or undercooked Meat, Poultry, Eggs and Fish.

Stating the required Food temperatures and times for safe cooking of Potentially Hazardous Food (Time/Temperature Control for Safety Food) including Meat, Poultry, Eggs, and Fish.

Stating the required temperatures and times for the safe refrigerated storage, hot holding, cooling, and reheating of Potentially Hazardous Food (Time / Temperature Control for Safety Food);

Describing the relationship between the prevention of foodborne illness and the management and control of the following:

(1) Cross contamination

(2) Hand contact with Ready-To-Eat Foods,

(3) Handwashing, and

(4) Maintaining the Food Establishment in a clean condition and in good repair;

Describing Foods identified as Major Food Allergens and the symptoms that a Major Food Allergen could cause in a sensitive individual who has an allergic reaction.

Explaining the relationship between Food safety and providing Equipment that is:

(1) Sufficient in number and capacity, and

(2) Properly designed, constructed, located, installed, operated, maintained, and cleaned;

Explaining correct procedures for cleaning and Sanitizing Utensils and Food-Contact Surfaces of Equipment;

Identifying the source of water used and measures taken to ensure that it remains protected from contamination such as providing protection from backflow and precluding the creation of cross connections;

Identifying Poisonous or Toxic Materials in the Food Establishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to Law;

Identifying Critical Control Points in the operation from purchasing through sale or service that, when not controlled, may contribute to the transmission of foodborne illness and explaining steps taken to ensure that the points are controlled in accordance with the req

ablishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to Law;

Explaining the details of how the Person in Charge and Food Employees comply with the HACCP Plan if a plan is required by Law, this Code, or an agreement between the Regulatory Authority and the Food Establishment;

Explaining the responsibilities, rights, and authorities assigned by this Code to the: Food Employee, Conditional Employee, Person in Charge, and Regulatory Authority.

17. Explaining how the Person in Charge, Food Employees, and Conditional Employees comply with reporting responsibilities and Exclusion or Restriction of Food Employees.

2-102.12 Certified Food Protection Manager

(A) At least one Employee that has supervisory and management responsibility and the authority to direct and control food preparation and service shall be a Certified Food Protection Manager who has shown proficiency and required information through passing a test that is part of an Accredited Program. The Regulatory Authority reserves the right to approve another food consultant as the CFPM, in place of an employee, in certain limited circumstances.

(B) This section does not apply to certain types of Food or Eating Establishments deemed by the Regulatory Authority to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and extent of food preparation

gulatory Authority reserves the right to approve another food consultant as the CFPM, in place of an employee, in certain limited circumstances.

Bed and breakfast establishments with 5 rooms or less;

Bed and breakfast and lodging establishments that serve a continental breakfast consisting of non-potentially hazardous baked goods, whole fruit or fruit sliced for same-day service, cereal, milk, juice, portion- controlled cream cheese, portioned-controlled peanut butter, and portion-controlled jam or jelly.

Temporary eating establishments that operate fewer than 14 days;

Establishments that serve or sell non-potentially hazardous pre-packaged foods (non-time/temperature control for safety (TCS) foods);

Establishments that prepare only non-potentially hazardous foods (non-TCS foods);

Establishments that heat only commercially processed, potentially hazardous foods (TCS foods) for hot holding. No cooling of potentially hazardous foods (TCS foods);

Sporting/ Recreational Camps operating 90 days or less and serving only their own residential guests; and

Eating establishments which pose minimal risk of causing, or contributing to, foodborne illness, based on the nature of the operation and the extent of food preparation.

2-102.20 Food Protection Manager Certification

(A) A Certified Food Protection Manager must be a Person in Charge who has demonstrated knowledge of the duties and responsibilities of a food protection manager

sidential guests; and

Eating establishments which pose minimal risk of causing, or contributing to, foodborne illness, based on the nature of the operation and the extent of food preparation.

2-102.20 Food Protection Manager Certification

(A) A Certified Food Protection Manager must be a Person in Charge who has demonstrated knowledge of the duties and responsibilities of a food protection manager. To qualify as a certified food protection manager, a person must attain certification by a program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs. These standards are deemed to comply with ¶ 2-102.11(B).

(B) A Food or Eating Establishment that has an Employee that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs is deemed to comply with §2-102.12.

2-103 Duties

2-103.11 Person in Charge. The Person in Charge shall ensure that:

(A) Food or Eating Establishment operations are not conducted in a private home or in a room used as living or sleeping quarters as specified under §6-202.111; unless such establishment is a Bed and Breakfast licensed by the Maine Department of Health and

Human Services or a home business licensed by the Maine Department of Agriculture Conservation and Forestry, or any other establishment specifically exempted by Law

tablishment operations are not conducted in a private home or in a room used as living or sleeping quarters as specified under §6-202.111; unless such establishment is a Bed and Breakfast licensed by the Maine Department of Health and

Human Services or a home business licensed by the Maine Department of Agriculture Conservation and Forestry, or any other establishment specifically exempted by Law.

(B) Persons unnecessary to the Food or Eating Establishment operation are not allowed in the Food preparation, Food storage, or Warewashing areas, except that brief visits and tours may be authorized by the Person in Charge, if steps are taken to ensure that exposed Food, clean Equipment, Utensils, and Linens, and unwrapped Single-Service and Single-Use Articles are protected from contamination;

(C) Employees and other Persons such as delivery and maintenance Persons and pesticide applicators entering the Food preparation, Food storage, and Warewashing areas comply with this Code;

Employees are effectively cleaning their hands, by routinely monitoring the Employees’ handwashing;

Employees are visibly observing Foods as they are received to determine that they are from Approved sources, delivered at the required temperatures, protected from contamination, unadulterated, and accurately presented, by routinely monitoring the

Employees’ observations and periodically evaluating Foods upon their receipt;

Employees are verifying that Foods delivered to the Food or Eating Establishment during non-operating hours are from approved sources, and are placed into appropriate storage locations, such that they are maintained at the required temperatures, protected from contamination, unadulterated, and accurately presented

the

Employees’ observations and periodically evaluating Foods upon their receipt;

Employees are properly cooking Potentially Hazardous Food (Time/Temperature Control for Safety Food), being particularly careful in cooking those Foods known to cause severe foodborne illness and death, such as eggs and Comminuted Meats, through daily oversight of the Employees’ routine monitoring of the cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated as specified under §4-203.11 and ¶ 4-502.11(B);

Employees are using proper methods to rapidly cool Potentially Hazardous Food (Time/Temperature Control for Safety Food) that are not held hot or are not for consumption within 4 hours, through daily oversight of the Employees’ routine monitoring of Food temperatures during cooling;

Consumers who order raw, or partially cooked Ready-to-Eat Foods of animal origin are informed, as specified under §3-603.11, that the Food is not cooked sufficiently to ensure its safety;

Employees are properly Sanitizing cleaned multiuse Equipment and Utensils before they are reused, through routine monitoring of solution temperature and exposure time for hot water Sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical Sanitizing;

Consumers are notified that clean Tableware is to be used when they return to self-service areas such as salad bars and buffets as specified under §3-304.16;

Except when Approval is obtained from the Regulatory Authority as specified in ¶ 3-301.11(D), Employees are preventing cross-contamination of Ready-to-Eat Food with bare hands by properly using suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensin

ware is to be used when they return to self-service areas such as salad bars and buffets as specified under §3-304.16;

Employees are properly trained in Food safety including food allergy awareness as it relates to their assigned duties;

Food Employees and Conditional Employees are informed of their responsibility to report in accordance with Law, to the Person in Charge, information about their health and activities as they relate to diseases that are transmissible through Food, as specified under ¶ 2-201.11(A); and

Written procedures and plans, where specified by this Code and as developed by the Food or Eating Establishment are maintained and implemented as required.

2-2 EMPLOYEE HEALTH

2-201 Responsibilities and Reporting Symptoms and Diagnosis

2-201.11 Responsibility of Permit Holder, Person in Charge, Food Employees, and Conditional Employees*

(A) The Permit Holder shall require Food Employees and Conditional Employees to report to the Person in Charge information about their health and activities, as they relate to diseases that are transmissible through Food. A Food Employee or Conditional Employee shall report the information in a manner that allows the Person in Charge to reduces the risk of foodborne disease transmission, including providing necessary additional information, such as the date of onset of symptoms and an illness, or of a diagnosis without symptoms, if the Food Employee or Conditional Employee:

(1) Has any of the following symptoms:

(a) Vomiting,

(b) Diarrhea,

(d) Sore throat with fever,

in a manner that allows the Person in Charge to reduces the risk of foodborne disease transmission, including providing necessary additional information, such as the date of onset of symptoms and an illness, or of a diagnosis without symptoms, if the Food Employee or Conditional Employee:

(1) Has any of the following symptoms:

(a) Vomiting,

(b) Diarrhea,

(d) Sore throat with fever,

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

On the hands or wrists, unless an impermeable cover such as a finger cot or stall protects the lesion and a Single-Use glove is worn over the impermeable cover,

On exposed portions of the arms, unless the lesion is protected by an impermeable cover, or

On other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage;

(2) Has an illness diagnosed by a Health Practitioner due to:

(a) Norovirus,

(b) Hepatitus A Virus,

(d) Enterohemorrhagic or Shiga Toxin-Producing Eschericia Coli,;

(e) Salmonella Typhi,

(3) Had a previous illness, diagnosed by a Health Practitioner, within the past 3 months due to Salmonella Typhi, without having received antibiotic therapy, as determined by a Health Practitioner;

(4) Has been exposed to, or is the suspected source of, a Confirmed Disease Outbreak, because the Food Employee or Conditional Employee consumed or prepared Food implicated in the outbreak, or consumed food at an event prepared by a Person who is infected or ill with*:

(a) Norovirus within the past 48 hours of the last exposure,

(b) Enterohemorrhagic of Shiga Toxin-Producing Escherichia Coli or Shigella

spp. within the past 3 days of the last exposure,

Employee consumed or prepared Food implicated in the outbreak, or consumed food at an event prepared by a Person who is infected or ill with*:

(a) Norovirus within the past 48 hours of the last exposure,

(b) Enterohemorrhagic of Shiga Toxin-Producing Escherichia Coli or Shigella

spp. within the past 3 days of the last exposure,

(d) Hepatitis A virus within the past 30 days of the last exposure; or

(5) Has been exposed by attending or working in a setting where there is a Confirmed Disease Outbreak, or living in the same household as, and has knowledge about, an individual who works or attends a setting where there is a Confirmed Disease Outbreak, or living in the same household as, and has knowledge about, an individual diagnosed with an illness caused by*:

(a) Norovirus within the past 48 hours of the last exposure,

(b) Enterohemorrhagic or Shiga Toxin-Producing Escherichia Coli or Shigella spp. within the past 3 days of the last exposure,

(d) Hepatitis A virus within the past 30 days of the last exposure.

(B) The Person in Charge shall notify the Regulatory Authority when a Food Employee is:

(1) Jaundiced, or

(2) Diagnosed with an illness due to a pathogen as specified under Subparagraphs (A)(2)(a) - (e) of this section.

(1) Who exhibits or reports a symptom, or who reports a diagnosed illness as specified under Subparagraphs (A)(1) - (3) of this section, is prohibited from becoming a Food Employee until the Conditional Employee meets the criteria for the specific symptoms or diagnosed illness as specified under § 2-201.13; and

e) of this section.

(2) Who will work as a Food Employee in a Food or Eating Establishment that serves as a Highly Susceptible Population and reports a history of exposure as specified under Subparagraphs (A)(4) – (5), is prohibited from becoming a Food Employee until the Conditional Employee meets the criteria as specified under ¶ 2-201.13(I).

(D) The Person in Charge shall ensure that a Food Employee who exhibits or reports a symptom, or who reports a diagnosed illness or a history of exposure as specified under Subparagraphs (A)(1) - (5) of this section is:

(1) Excluded as specified under ¶¶ 2-201.12 (A) - (C), and Subparagraphs (D)(1), (E)(1), (F)(1), or (G)(1) and in compliance with the provisions specified under ¶¶ 2-201.13(A) - (G) *; or

(2) Restricted as specified under Subparagraphs 2-201.12 (D)(2), (E)(2), (F)(2), (G)(2), or ¶¶ 2-201.12(H) or (I) and in compliance with the provisions specified under ¶¶ 2-201.13(D) - (I) *.

(E) A Food Employee or Conditional Employee shall report to the Person in Charge the information as specified under ¶ (A) of this section.

(F) A Food Employee shall*:

(1) Comply with an Exclusion, as specified under ¶¶ 2-201.12(A) - (C) and Subparagraphs 2-201.12(D)(1), (E)(1), (F)(1), or (G)(1) and with the provisions specified under ¶¶ 2-201.13(A) - (G); or

ecified under ¶¶ 2-201.13(D) - (I) *.

(E) A Food Employee or Conditional Employee shall report to the Person in Charge the information as specified under ¶ (A) of this section.

(F) A Food Employee shall*:

(1) Comply with an Exclusion, as specified under ¶¶ 2-201.12(A) - (C) and Subparagraphs 2-201.12(D)(1), (E)(1), (F)(1), or (G)(1) and with the provisions specified under ¶¶ 2-201.13(A) - (G); or

(2) Comply with a Restriction as specified under Subparagraphs 2-201.12(D)(2), (E)(2), (F)(2), (G)(2), or ¶¶ 2-201.12 (H) or (I) and comply with the provisions specified under ¶¶ 2-201.13(D) - (I).

2-201.12 Exclusions and Restrictions.*

The Person in Charge shall Exclude or Restrict a Food Employee from a Food or Eating Establishment in accordance with the following:

(A) Except when the symptom is from a noninfectious condition, Exclude a Food Employee if the Food Employee is*:

(1) Symptomatic with vomiting or diarrhea; or

(2) Symptomatic with vomiting or diarrhea and diagnosed with an infection from Norovirus, Shigella spp., or Enterohemorrhagic or Shiga Toxin-Producing E. coli.

(B) Exclude a Food Employee who is*:

(1) Jaundiced and the onset of jaundice occurred within the last 7 calendar days, unless the Food Employee provides to the Person in Charge written medical documentation from a Health Practitioner specifying that the jaundice is not caused by hepatitis A virus or other fecal-orally transmitted infection;

(2) Diagnosed with an infection from hepatitis A virus within 14 calendar days from the onset of any illness symptoms, or within 7 calendar days of the onset of jaundice; or

(3) Diagnosed with an infection from hepatitis A virus without developing symptoms.

(C) Exclude a Food Employee who is diagnosed with an infection from Salmonella Typhi, or reports a previous infection with Salmonella Typhi within the past 3 months as specified under Subparagraph 2-201.11(A)(3). *

(D) If a Food Employee is diagnosed with an infection from Norovirus and is Asymtomatic*:

aundice; or

(3) Diagnosed with an infection from hepatitis A virus without developing symptoms.

(D) If a Food Employee is diagnosed with an infection from Norovirus and is Asymtomatic*:

(1) Exclude the Food Employee who works in a Food or Eating Establishment serving a Highly Susceptible Population; or