CR 17-073 Rule Text

(2)

“Approved sanitizing solution" means a substance or compound approved by the department for the sanitizing of equipment or utensils under s. ATCP 70.28 (5).

(3)

“Bakery" means any place where bread, cookies, crackers, pasta, or pies, or any other food product for which flour or ground meal is the principal ingredient, are baked, cooked, or dried, or prepared or mixed for baking, cooking, or drying, for sale as food.

(4)

“Bottle" means the immediate package or container in which bottled drinking water, soda water beverage, or alcohol beverage is sold or distributed for consumption. “Bottle" includes a bottle cap or other seal for a bottle.

(5)

“Bottled drinking water" means all water packaged in bottles or similar containers and sold or distributed for drinking purposes. “Bottled drinking water" includes distilled water, artesian water, spring water, and mineral water, whether carbonated or uncarbonated.

(6)

“Bottling establishment" means any place where drinking water, soda water beverage, or alcohol beverage is manufactured or bottled for sale. “Bottling establishment" does not include a retail establishment either engaged in the preparation and sale of beverages, under a license issued under s. 125.26 or 125.51, Stats., or licensed under s. 97.30 or s. 97.605, Stats.

(7)

“C-I-P system" means equipment which is designed, constructed, and installed to be cleaned in place by the internal circulation of cleaning and sanitizing solutions onto product contact surfaces. “C-I-P System” includes separate equipment used to store or deliver cleaning and sanitizing solutions to the food contact surfaces.

(8)

“Canning" means the preservation and packaging in hermetically sealed containers of low-acid or acidified foods.

(9)

“Cold-process smoked fish" or “cold-process smoke flavored fish" means fish which is treated with smoke or smoke flavoring to give it a smoked flavor, but which is not fully cooked or heat treated to coagulate protein in fish loin muscle. “Cold-process smoked fish” or “cold-process smoke flavored fish” may not be heated above 90° F. during processing because the safety of the treatment is partially dependent on the survival of harmless microorganisms indigenous to the fish.

(10)

“Confectionary" means any place where candy, fruit, nut meats, or any other food product is manufactured, coated, or filled with saccharine substances for sale as food.

(11)

“Continuous operation” means operating without interruption beyond 24 hours, with no interruptions after 24 hours longer than a period approved by the department.

(12)

“Critical control point" means a step in food processing at which a failure to monitor a food safety parameter such as pH, temperature, time, or water activity (aw), or a failure to control any food safety parameter within critical limits or according to specific criteria, may result in the unacceptable risk of a potentially adverse impact on human health.

(13)

“Department" means the state of Wisconsin department of agriculture, trade and consumer protection.

(14)

“Equipment" means an implement, vessel, machine, or apparatus, other than a utensil, which has one or more food contact surfaces and is used in the handling or processing of food at a food processing plant. “Equipment" includes C-I-P systems.

(15)

“Facility” as used in s. ATCP 70.04 has the meaning given in 21 CFR 117.3.

(16)

“Fish" means fresh or saltwater finfish; crustaceans; forms of aquatic life other than birds or mammals including alligators, frogs, aquatic turtles, jellyfish, sea cucumber, sea urchin, and their roe; and all mollusks, if intended for human consumption.

(17)

“Fish processing plant" means a food processing plant which produces processed fish or fishery products.

(18)

“Fishery product” means any human food product in which fish is a characterizing ingredient.

(19)

“Food" means:

(a)

Articles ingested as food or drink by persons.

(b)

Chewing gum.

(c)

Components of articles specified in pars. (a) and (b).

(20)

“Food contact surface" means any surface of equipment, utensils, or food packages with which food normally comes in direct contact, or from which materials may drain, drip, or otherwise be drawn into or onto food.

(21)

“Food package" means the immediate container in which food is sold or shipped from a food processing plant. “Food package" includes a bulk container or shipping container which has one or more food contact surfaces.

(22)

“Food processing" means the manufacture or preparation of food for sale through the process of canning, extracting, fermenting, distilling, pickling, freezing, baking, drying, smoking, grinding, cutting, mixing, coating, stuffing, packing, bottling or packaging, or through any other treatment or preservation process. “Food processing" includes the activities of a bakery, confectionary, vending machine commissary licensed under s. 97.605, Stats., or bottling establishment, and also includes the receipt and salvaging of distressed food for sale or use as food. It also includes the packaging of seeds that have been harvested, and dried after the harvest for sale as food. These seeds include unpopped popcorn whether shelled or on the cob, black beans, wild rice, sunflower seeds, pumpkin seeds, and soybeans. “Food processing" does not include any of the following:

(a)

Activities performed under a dairy plant license issued under s. 97.20, Stats.

(b)

Activities performed under a meat establishment license issued under s. 97.42, Stats.

(c)

The retail preparation and processing of meals for sale directly to consumers or through vending machines if the preparation and processing is covered under a retail food establishment license issued under s. 97.30, Stats., or other license issued under s. 97.605, Stats.

(d)

Activities inspected by the United States department of agriculture under 21 USC 601 et seq. or 21 USC 451 et seq.

(e)

The extraction of honey from the comb, or the production and sale of raw honey or raw bee products by a beekeeper from their own apiaries.

(f)

The washing and packaging of fresh fruits and vegetables if the fruits and vegetables are not otherwise processed at the packaging establishment.

(g)

The receipt and salvaging of distressed food for sale or use as food if the food is received, salvaged, and used solely by a charitable organization, and if contributions to the charitable organization are deductible by corporations in computing net income under s. 71.26 (2) (a), Stats.

(h)

The collection, packing, and storage of eggs from a flock of not more than 150 laying birds by an egg producer who only sells the eggs directly to consumers at the premises where the eggs were laid, at a farmers’ market, or on an egg-sales route as defined in s. ATCP 88.01.

(i)

The collection, packaging, and storage of nest-run eggs, as defined in s. ATCP 88.01, from a flock of laying birds by an egg producer who is registered with the department in accordance with s. ATCP 88.02 and who sells the nest-run eggs to an egg handler.

(j)

Seeds that have not been harvested until they have dried naturally in the field and are only handled by harvesting, storing, and packaging for sale as food.

(23)

“Food processing plant" means any place used primarily for food processing, where the processed food is not intended to be sold or distributed directly to a consumer. “Food processing plant" does not include any mobile establishment, retail food establishment subject to the requirements of s. 97.30, Stats., or any restaurant or other establishment holding a license under s. 97.605, Stats., to the extent that the activities of that establishment are covered by s. 97.30, Stats., or the license under s. 97.605, Stats.

(24)

“Hazard analysis and critical control point plan" or “HACCP plan" means a food processing plan under which a food processing plant operator effectively identifies, and prevents, controls, or eliminates food safety hazards by monitoring food safety parameters at critical control points, and by controlling those parameters within critical limits.

(25)

“Hot-process smoked fish" or “hot-process smoke flavored fish" means fish that is either of the following:

(a)

Fully cooked or heat treated, or sold or represented as being fully cooked or heat treated, so that the internal temperature of the fish has been maintained for at least 30 minutes at not less than 145° F (62.8° C) or an equivalent process validated for lethality against pathogenic organisms.

(b)

Fully cooked or heated in accordance with par. (a) and treated with smoke or smoke flavoring to give it a smoked flavor.

(26)

“Ingredient water" means water used by a food processing plant as an ingredient for food.

(27)

“Juice" means aqueous liquids expressed or extracted from fruits or vegetables, purées of the edible portions of fruits or vegetables, or combinations or concentrates of those liquids or purées, which are used as whole beverages or beverage ingredients.

(28)

“Loin muscle" means the longitudinal quarter of the great lateral muscle of a fish, freed from skin, scales, visible blood clots, bones, gills, and viscera, and from the non-striated part of such muscle, which part is known anatomically as the median superficial muscle.

(29)

“Major food allergen" includes any food or food ingredient, other than highly refined oil or an ingredient derived from highly refined oil, which contains protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, or soybeans. “Major food allergen" does not include a food that is exempted by the secretary of the United States department of health and human services pursuant to 21 USC 321(qq)(2).

(30)

“Official Methods of Analysis" means the Official Methods of AOAC International, eighteenth edition revision 2 (2007).

Note: Those portions of the “Official Methods of Analysis" cited in this chapter are on file with the

department and the legislative reference bureau. The Official Methods of Analysis of AOAC International may be obtained from the AOAC International, 2275 Research Blvd., Rockville, MD 20850.

(31)

“Operations water" means water used by a food processing plant for cleaning equipment and utensils, transporting food, handwashing, or other cleaning or sanitizing purposes.

(32)

“Organoleptic quality" means quality as assessed by means of sight, smell, touch, or taste.

(33)

“Potentially hazardous food" also means “TCS (time/temperature controlled for safety) Food”, and has the meaning given in ch. ATCP 75 Appendix (Wisconsin Food Code), part 1201.10 (B).

(34)

“Processed fish" means fish that is preserved for human consumption by means of hot or cold smoking, curing, salting, drying, marinating, pickling, fermenting, or related processes.

“Processed fish" does not include fish processed in accordance with ss. ATCP 70.36 or 70.38.

(35)

“Qualified facility” as used in s. ATCP 70.04 has the meaning given in 21 CFR 117.3.

(36)

“Ready-to-eat food" has the meaning given in ch. ATCP 75 Appendix (Wisconsin Food Code), part 1-201.10 (B).

(37)

“Reduced oxygen packaging" has the meaning given in ch. ATCP 75 Appendix (Wisconsin Food Code), part 1-201.10 (B).

(38)

“Retail” means selling food or food products directly to any consumer only for consumption by the consumer or the consumer’s immediate family or non-paying guests.

(39)

“Roe" as used in s. ATCP 70.48 means fish eggs, including fish eggs that are still enclosed in the ovarian membrane.

(40)

“Safe temperatures" for the holding or storage of potentially hazardous foods means one of the following as appropriate:

(a)

Temperatures at or above 135° F (57° C.) for heated foods.

(b)

Temperatures at or below 41° F (5° C) for refrigerated foods, except as provided in par. (c).

(c)

Temperatures at or below 38° F (3.4° C) for refrigerated, raw fish, cold smoked fish, or raw fish products that are vacuum packed, and have only refrigeration as a critical control point.

(d)

Temperatures that maintain frozen food in a constantly frozen condition.

(41)

“Salt content" means the percent salt (sodium chloride) as determined by the method described in sections 18.034 and 18.035 of the Official Methods of Analysis, multiplied by 100 and divided by the sum of the percent salt (sodium chloride) and the percent moisture in the finished product as determined by the method described in section 24.002 of the Official Methods of Analysis.

(42)

“Sanitize" means the application of cumulative heat or chemicals 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-causing microorganisms of public health importance on a food contact surface that has been previously cleaned of all soil, residue, and visible contaminants.

(43)

“Single-service" means any utensil, container, or package, or any part of a utensil, container, or package, which is designed to be used only once.

(44)

“Smoked fish" means any food obtained by subjecting fresh fish, frozen fish, dried fish, or cured fish to the direct action of smoke or smoke flavor, whether by burning wood or a similar burning material, or by applying a smoke-flavored solution, for the primary purpose of imparting the flavor and color of smoke to fish. This includes both cold-process smoked and hot-process smoked fish, and is considered “fish processing”.

(45)

“Soda water beverage" means all beverages commonly known as soft drinks or soda water, whether carbonated, uncarbonated, sweetened, or flavored. “Soda water beverage" does not include alcohol beverages.

(46)

“Utensil" means a hand-held or similarly portable container or device, such as a set of tongs, spatula, strainer, or scoop, which has one or more food contact surfaces and is used in the processing or handling of food at a food processing plant. “Utensil" does not include a food package.

(47)

“Wholesale” means the sale of any food to a person or commercial entity who will either re-sell it, distribute it for re-sale, or use it as an ingredient in a product that will be then offered for sale. Wholesale includes those activities in which the processor relinquishes control of the food. Wholesale does not include the movement of food between two food processing plants or retail food establishments licensed to the same licensee, except for the movement of dairy products as specified in s. ATCP 65.04.

SUBCHAPTER II

GENERAL REQUIREMENTS

ATCP 70.04 Federal and record keeping requirements. (1) Facilities and qualified facilities. A food processing plant that is also a facility or a qualified facility shall comply with the requirements of this chapter and applicable requirements of 21 CFR 117.

(2) RECORD REQUIREMENTS AND RETENTION. (a) The operator of a food processing plant that is a facility shall create all records to meet the requirements for records in 21 CFR 117.305, unless otherwise specified in this chapter or in 21 CFR 120 or 21 CFR 123.

(b) All records generated under par. (a) shall be retained and made available to the department, in accordance with the provisions set forth in 21 CFR 117.315, unless otherwise specified in this chapter or in 21 CFR 120 or 21 CFR 123.

(c) The license holder shall maintain on site at the food processing plant, and make available to the department or its agent when requested, all applicable approvals, variances, waivers, plans, and licenses pertaining to the operation and maintenance of the plant.

ATCP 70.06 Food processing plants; licensing; fees. (1) LICENSE REQUIRED. Except as provided under sub. (11), no person may operate a food processing plant without a valid license issued by the department for that food processing plant under s. 97.29, Stats. A food processing plant license expires on March 31 annually. A license is not transferable between persons or food processing plants.

(2)

LICENSE APPLICATION. Application for an annual license to operate a food processing plant shall be made on a form provided by the department. The application shall include applicable fees required under this section.

(3)

ANNUAL LICENSE FEE. An applicant for a license to operate a food processing plant shall pay an annual license fee. Except as provided in sub. (4), the fee amount is as follows:

(a)

For operating a food processing plant that has an annual production of at least $25,000 but less than $250,000, and the operator is engaged in processing potentially hazardous food or in canning, an annual license fee of $400.

(b)

For operating a food processing plant that has an annual production of at least $250,000, and the operator is engaged in processing potentially hazardous food or in canning, an annual license fee of $835.

(c)

For operating a food processing plant that has an annual production of at least $25,000 but less than $250,000, and the operator is not engaged in processing potentially hazardous food or in canning, an annual license fee of $160.

(d)

For operating a food processing plant that has an annual production of at least $250,000, and the operator is not engaged in processing potentially hazardous food or in canning, an annual license fee of $520.

(e)

For operating a food processing plant that has an annual production of less than $25,000, an annual license fee of $95.

(4)

CANNING OPERATIONS; LICENSE FEE SURCHARGE. If an operator of a food processing plant is engaged in canning operations and has annual food sales of more than $25,000, the operator shall pay an annual license fee surcharge of $320, which shall be added to the license fee under sub. (3).

(5)

SURCHARGE FOR OPERATING WITHOUT A LICENSE. An applicant for a license under sub. (1) shall pay a license fee surcharge of $100 if the department determines that, within one year prior to submitting the license application, the applicant operated the food processing plant without a license in violation of sub. (1). Payment of this license fee surcharge does not relieve the applicant of any other civil or criminal liability which results from the unlicensed operation of the food processing plant, but does not constitute evidence of a violation of any law.

(6)

REINSPECTION FEE. (a) If the department reinspects a food processing plant because the department has found a violation of ch. 97, Stats., or this chapter, on a regular inspection, the department shall charge the licensee the reinspection fee specified under par. (b). A reinspection fee is payable when the reinspection is completed, and is due upon written demand from the department. The department may issue a demand for payment when it issues a license renewal application form to a licensee.

(b) The reinspection fee required under par. (a) is as follows:

1.

For a license holder of a food processing plant that has an annual production of less than $250,000, and the license holder is engaged in processing potentially hazardous food or in canning, the reinspection fee is $255.

2.

For a license holder of a food processing plant that has an annual production of at least $250,000, and the license holder is engaged in processing potentially hazardous food or in canning, the reinspection fee is $525.