Food packages shall be of sanitary design and construction, so as to protect food contents from reasonably foreseeable risks of contamination. Food packages shall be clean, sanitary, and free of any extraneous or deleterious substance. Food shall not be sold or distributed in packages which are damaged to the extent that food contents may be adulterated as a result of the damage. A sealed food package is damaged within the meaning of this subsection if the package or seal is broken or bulged.
Cleaning and sanitizing returnable food packages.
Returnable or multi-use food packages, including returnable bottles, shall be effectively cleaned and sanitized before being reused. Cleaning and sanitizing processes shall remove all extraneous matter and potential adulterants from a food package before the food package is reused. Sanitizing methods shall comply with s. ATCP 70.28
. No food package may be reused unless it is specifically designed and constructed for that purpose.
Inspection of returnable food packages.
Returnable or multi-use packages, after being cleaned and sanitized, shall be inspected before being reused. Inspection shall be adequate to detect extraneous material and visible adulterants, and any damage to product contact surfaces. Inspection shall be performed on surfaces lighted in compliance with s. ATCP 70.08 (5) (b)
Single-service food packages.
Single-service food packages, including bottle caps and other single-service articles used to package food, shall be made from clean, sanitary materials. Single-service food packages shall be clean and sanitary at the time of use. Single-service food packages shall be protected from contamination prior to use, and shall be handled in a sanitary manner. Single-service food packages, including single-service bottles and bottle caps, shall not be re-used.
Food package labeling.
Packaged food shall be packaged and labeled according to all of the following, as applicable:
If the packaged food contains a major food allergen, the ingredient statement on the package shall disclose the common name of the major food allergen. The disclosure shall be equivalent in size and prominence to the rest of the ingredient statement. If an allergen originates from finfish, crustacean shellfish, or tree nuts, the disclosure shall include the common name of the source species.
ATCP 70.26 Note
Note: For example, if a food product includes an allergen that originates from finfish, the ingredient statement must disclose the common name such as bass, flounder, or cod. If the allergen originates from crustacean shellfish, the ingredient statement must disclose the common name such as crab, lobster, or shrimp. If the allergen originates from tree nuts, the ingredient statement must disclose the common name such as almond, pecan, walnut, or coconut.
Egg packaging and labeling.
The packaging and labeling of eggs shall be done in compliance with the requirements of ss. ATCP 88.32
, and 88.38
Alcohol restrictions and labeling.
If a product contains more than 1.0% but less than 7.0% alcohol it is regulated by the labeling provisions of this subsection and the alcohol would be declared as an ingredient in normal descending order of predominance. If the alcohol is part of other ingredients such as a flavoring, and it is less than 0.5% of the finished product by volume, then it is considered an incidental ingredient.
ATCP 70.26 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; corrections in (5) (a) to (e) made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.28
Sanitizers and sanitizing methods. ATCP 70.28(1)(1)
All returnable or multi-use food packages, and all food contact surfaces of equipment and utensils used to handle foods, shall be effectively sanitized prior to each use.
(2) Chemical sanitizers; requirements.
The operator shall use only chemical sanitizers that are specified as acceptable for use in 21 CFR 178.1010
, are registered with the U.S. environmental protection agency, are applied according to manufacturer's instructions, are labeled for use in food processing plants on food contact surfaces, and do not leave an unacceptable residue on the food contact surface when used appropriately.
Baking and cooking containers; exemption.
does not apply to baking and cooking containers if heating time and temperature combinations meet industry standards and are adequate to destroy pathogenic microorganisms, provided that the containers are cleaned, stored, and used in a manner which prevents contamination of food.
Sanitizers; maximum concentrations.
The operator shall use sanitizers and cleaning compounds so no toxic or otherwise unacceptable residue is left on any food contact surface. Sanitizing solutions shall not exceed the maximum concentrations established by the food and drug administration, United States department of health and human services, under 21 CFR 178.1010
. A test kit or other device that measures the concentration of sanitizing solutions in parts per million shall be used as necessary to ensure compliance with this subsection.
Sanitizers approved by the U.S. environmental protection agency and labeled for use on food contact surfaces are also accepted by the department for use according to their labels. The department may approve other sanitizers and sanitizing methods that it finds to be safe and effective for the purpose used.
The department may deny or withdraw approval of any sanitizer or sanitizing method if the department determines that the sanitizer or sanitizing method is not safe or effective for the purpose or under the conditions used, or that it adversely affects the sanitary characteristics of equipment, utensils, or food packages.
ATCP 70.28 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction in (2), (3) made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.30
Ready-to-eat foods; reporting pathogens and toxins. ATCP 70.30(1)(1)
Except as provided under sub. (2)
, an operator shall report to the department the results of any microbiological test or laboratory analysis which indicates that any ready-to-eat food produced by that operator contains pathogenic organisms, toxins resulting from the growth of pathogenic organisms, or any other adulterant capable of causing disease or injury if ingested. The operator shall report to the department within 24 hours after the operator obtains the test results. The operator may report orally, electronically, or in writing.
ATCP 70.30 Note
Note: The State of Wisconsin's Emergency Management phone number is (800) 943-0003. The general number of the Division of Food and Recreational Safety is (608) 224-4700, and its FAX number is (608) 224-4710.
An operator is not required to report test results under sub. (1)
if all of the following apply:
The ready-to eat-food is identified by a product code or production lot number.
The operator has not yet sold or distributed any of the ready-to-eat food represented by the product code or production lot number under par. (a)
, but retains direct control over all of that ready-to-eat food.
ATCP 70.30 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20. ATCP 70.32(1)(1)
An operator shall have a written plan for identifying and recalling food produced at that plant, should a food recall become necessary. The operator shall update the plan as necessary, and shall make it available to the department for inspection and copying upon request.
A plan, under sub. (1)
, shall do all of the following:
Identify key individuals or positions that are responsible for planning, approving, and implementing recalls on behalf of the operator.
Identify key individuals or entities to be contacted or consulted in connection with a recall.
Include procedures for the routine identification, dating, and tracking of food production lots, so that affected lots can be identified and distinguished from unaffected lots in the event of a recall.
Include procedures to enable routine identification, dating, and tracking of food shipments from the food processing plant. Tracking shall identify shipment recipients and contents, cross-referenced to production lots, so that recipients of affected lots may be contacted in the event of a recall.
Include procedures for determining the nature and scope of a recall, including affected food production lots, shipments, and shipment recipients.
Include procedures for identifying and communicating with affected persons, including suppliers, food shipment recipients, down-line buyers, consumers, government agencies, and others.
Identify potential target audiences for recall information, including consumers, distributors, and government agencies.
Identify potential methods for communicating with target audiences under par. (g)
Identify key information, including the identity of the affected food, the reason for the recall, and suggested actions to be taken by affected persons, which may need to be communicated in the event of a recall.
Deviations from plan.
Actual recall procedures may deviate from the recall plan under sub. (1)
, as circumstances warrant.
ATCP 70.32 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20. ATCP 70.34(1)(1)
Operators engaged in canning operations shall comply with applicable provisions of subch. II
. Operators engaged in canning operations shall also comply with this subchapter and shall file processes, as required, with the U.S. food and drug administration according to the provisions in 21 CFR part 108
Restrictions on sale, distribution, and donation of home-canned foods.
Home-canned low-acid or acidified foods may not be donated to charitable organizations, food banks, food pantries, or other non-profit organizations that will distribute or sell the home-canned foods. The individual canning processor may not sell the home-canned foods at a food bank or food pantry, or on behalf of a charitable or non-profit organization, unless exempted by statute or rule.
ATCP 70.34 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction in (1) made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.36
Low-acid foods packaged in hermetically sealed containers.
The operator of a food processing plant that processes and packages low-acid foods in hermetically sealed containers shall comply with applicable federal regulations under 21 CFR 108.35
(c) and 21 CFR part 113
ATCP 70.36 Note
Section ATCP 70.36
applies to all low-acid foods processed and packaged in hermetically sealed containers, including thermally processed and aseptically processed low-acid foods.
ATCP 70.36 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.38 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.40
Facilities and equipment; cleaning. ATCP 70.40(1)(1)
Equipment design, construction, and accessibility.
The operator of a food processing plant facility handling raw agricultural commodities to prepare the commodities for canning shall use product-handling equipment that is kept clean and in good repair and is designed and constructed in a way that allows easy accessibility for maintenance and cleaning.
Equipment, water, and supplies used for cleaning.
The operator of a food processing plant conducting canning operations shall use cleaning equipment that is adequate and in good repair, and shall provide ample supplies of water and steam or other approved cleaning and sanitizing materials for cleaning purposes at the facility.
Cleaning requirements for equipment used to process food before thermal processing.
The operator at a canning facility shall clean equipment used to process food before thermal processing, in accordance with a written plan kept at the canning facility and made available to the department for review upon request. The written plan shall include:
A clear and complete description of the affected food processing equipment and utensils, including any continuously-operated equipment. The description shall identify sanitary design features that are relevant to the proposed cleaning and, if deemed appropriate, sanitizing procedures.
The types of food produced with the affected equipment or utensils, the purposes for which the food will be used, and the thermal processing conditions to which the food will be subjected.
A clear and complete description of the alternative procedures used to clean and, if deemed appropriate, sanitize the equipment, including equipment used to conduct these procedures, frequency, methods, materials, and relevant process parameters such as time and temperature. The description shall include a flow diagram of the alternative procedures.
A written statement, by the operator, that the alternative cleaning and sanitizing procedures have been determined by competent authority, such as a process authority, or validated by a published or unpublished, peer-reviewed article, challenge studies, or regulatory standards, to be effective in preventing finished food product contamination and ensuring the microbiological safety of food.
Identification of foreseeable hazards, critical control points, critical safety parameters and limits, and monitoring procedures and controls to ensure that the procedure is effective and appropriately implemented.
ATCP 70.40 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction in (1), (3) (d) made under s. 35.17, Stats., Register January 2020 NO. 769. ATCP 70.42
Handling raw agricultural commodities and by-products. ATCP 70.42(1)(1)
Raw agricultural commodities shall be washed, sorted, trimmed as necessary, and inspected before being canned. This requirement does not apply to the washing of cabbage being prepared to make sauerkraut.
Waste and by-products from canning operations shall be stored and handled in a sanitary manner.
ATCP 70.42 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20. ATCP 70.44(1)(1)
A fish processing plant operator shall comply with subch. II
and 21 CFR part 123
. The operator shall have and operate in accordance with HACCP plans that comply with 21 CFR part 123
and address food safety hazards that may occur in fish processing. If a fish processing plant produces smoked fish products or smoke-flavored fish products, the HACCP plan for that fish processing plant shall address potential botulism risks as provided in 21 CFR part 123
(2) Restriction on use of cold-process smoked fish.
Cold-process smoked fish may not be used as an ingredient in any other ready-to-eat, potentially hazardous food.
ATCP 70.44 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction in (1) made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.46
Labeling and sale of smoked fish. ATCP 70.46(1)(1)
Mandatory label information.
Every package containing smoked fish shall be clearly and conspicuously labeled, on the principal display panel of that package, with all of the following information:
The name and address, including the zip code, of the smoked fish processor or distributor.
The name of the product, including the common name of the fish from which the product is derived as found in Table 3-2 of the Fourth Edition of Fish and Fishery Products Hazards and Controls Guidance
If cold-smoked fish is contained in reduced-oxygen packaging and sold or distributed in an unfrozen state, the words “PERISHABLE – KEEP REFRIGERATED AT OR BELOW 38°
F” in conspicuous letters at least the size of those used in the food name.
If smoked fish contained in the package are sold or distributed in a frozen state, the words “PERISHABLE — KEEP FROZEN PRIOR TO USE" in conspicuous letters at least the size of those used in the food name.
The processing date or processing date code of the smoked fish.
Prohibition against commingling.
Smoked fish processed on different dates or codes may not be commingled in the same container, either at the processing plant or while the fish are being stored, distributed, or offered for sale at wholesale or retail.
Misrepresentation of processing date or processing date code prohibited.
No person may misrepresent a smoked fish processing date or processing date code, or sell or distribute smoked fish labeled with any processing date or processing date code other than the original date or code affixed by the processor.
Removal of mislabeled or mishandled smoked fish.
Food consisting of or containing smoked fish shall be immediately removed from sale, and shall be destroyed or treated to render it unattractive and unfit for human consumption, if any of the following occurs:
The food package is not labeled with a processing date or processing date code.
Vacuum-packaged, cold-smoked fish is held, other than for brief periods during distribution, at a temperature above 38°
C) prior to retail sale. This paragraph does not apply to a food which the department specifically exempts in writing because it is not subject to spoilage and does not support pathogen growth.
Applicability of smoked fish regulations in Wisconsin.
No smoked fish may be sold, distributed, or offered or exposed for sale in this state unless the smoked fish have been processed, labeled, and handled in compliance with this subchapter. This subsection applies to every person engaged in the sale or distribution of smoked fish in this state, regardless of whether the person processes smoked fish in this state.
ATCP 70.46 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20.