Roe and any attached entrails harvested from a fish shall be refrigerated at a temperature of not more than 38°
C). Processing of dry salted roe or salted roe product shall be done in accordance with 21 CFR part 123
Harvesting and handling.
Roe and attached entrails, if any, shall be harvested, stored, and transported for processing in covered food grade containers. Each container shall be conspicuously labeled to indicate when each of the following operations was performed, if that operation has been performed:
The roe and attached entrails, if any, were harvested from the fish.
The roe sacks were separated from attached entrails, if any. Roe sacks shall be separated from attached entrails within 48 hours after the roe sacks and entrails are harvested from the fish.
The roe was separated from the roe sacks. Roe shall be separated from roe sacks within 72 hours after the roe sacks are harvested from the fish, unless the roe is processed and packed in roe sacks. Roe processed and packed without being separated from roe sacks shall be processed and packed within 72 hours after the roe sacks are harvested from the fish.
Receipt for processing.
A fish processing plant operator may not accept for processing any roe that has been held, transported, or processed in violation of sub. (1)
Processed roe shall contain a minimum of 2.5% salt by weight, as determined by quantitative analysis for total salt content.
No fish processing plant personnel may have direct hand contact with finished, ready-to-eat roe.
No roe product may be labeled or represented as “caviar" unless one of the following applies:
The product consists only of the eggs of sturgeon prepared by a salting and separation process traditionally associated with the term “caviar."
The product consists of roe prepared by a salting and separation process traditionally associated with the term “caviar," and the name of the fish species is clearly disclosed with the term “caviar" whenever that term is used.
ATCP 70.48 Note
For example, a caviar-type product made from whitefish eggs, using the traditional caviar process, may not be labeled as “caviar" unless it is labeled as “whitefish caviar." All packaged food product labels, including “caviar" labels, must also include a statement of ingredients listed by their common or usual names in descending order of prominence (see s. ATCP 70.26
No person may misrepresent the identity or value of any roe product by adding a color additive to the roe product. This paragraph does not prohibit the use of color additives in roe products if all of the following apply:
The color additive is approved by the United States food and drug administration.
The product includes a conspicuous label disclosure, such as “artificially colored" or “color added," which clearly indicates that the product includes a color additive. The disclosure shall appear on the product label directly below the product name in type at least one-third the size of the type used in the product name.
The color additive is included in the ingredient statement on the product label.
ATCP 70.48 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 70.50
Marine molluscan shellfish processing. ATCP 70.50(1)(1)
Applicable federal regulations.
Shellfish processing and shipping operations shall comply with subch. II
, the U.S. food and drug administration's Guide for the Control of Molluscan Shellfish, The Model Ordinance,
and applicable sections of 21 CFR part 123
. Shellfish processing plant operators shall have HACCP plans that comply with 21 CFR part 123
and address food safety hazards that may occur in shellfish processing. If a shellfish processing plant produces smoked shellfish products or smoke-flavored shellfish products, the HACCP plan for that fish processing plant shall address potential botulism risks as provided in 21 CFR part 123
If at any time shellfish are potentially implicated in an illness outbreak involving at least 2 persons not from the same household, or at least one person in the case of shellfish toxicity poisoning associated with marine biotoxins, the department shall determine whether an epidemiological association exists between the illness and the shellfish consumption by reviewing each consumer's food intake history and the shellfish handling practices of the consumer and retailer.
When the department has determined an epidemiological association exists between an illness outbreak and shellfish consumption, the department shall conduct an investigation of the outbreak to determine whether the illness is related to the shellfish growing area or to post-harvest contamination or mishandling.
Upon completion of the investigation, the department shall notify receiving states and the U.S. food and drug administration of the findings, and take appropriate steps in cooperation with the licensee dealer to recall the affected product and, if necessary, inform consumers about the outbreak and associated product.
Documents associated with shellfish processing.
Any documents generated by the facility in the course of its operation shall be available to the department within 24 hours of request by the department or its agent.
ATCP 70.50 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction in (1), (2) (a), (c) made under s. 35.17, Stats., Register January 2020 No. 769. ATCP 70.52
Bottling establishments; general.
Bottling establishments shall comply with subch. II
and this subchapter. Bottling establishments producing bottled water shall comply with 21 CFR part129
ATCP 70.52 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 70.54
Returnable and single-service bottles.
Bottles shall comply with food package requirements under s. ATCP 70.26 (1)
. Returnable bottles shall be cleaned, sanitized, and inspected in compliance with s. ATCP 70.26 (2)
. Single service bottles shall comply with s. ATCP 70.26 (4)
ATCP 70.54 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 70.56
Bottled water product sampling; record keeping; reports. ATCP 70.56(1)(1)
Sampling and analysis.
The operator of a bottled water plant shall collect and analyze samples of bottled product for the following contaminants at the following minimum frequency, and more frequently if necessary, to provide reasonable assurance of compliance with this subsection:
A weekly total coliform analysis. Pursuant to 21 CFR 129.80
(g) (1), a positive total coliform analysis requires follow-up testing for E. coli
and, pursuant to 21 CFR 165.110
(b) (2) (B), if E. coli
is present the bottled water will be deemed adulterated.
Reporting of analytical results.
A processor of bottled water shall report the results of all required analyses, under sub. (1)
, to the department, for each license year upon request. If the result of any individual analysis exceeds the established enforcement standard, the bottled water processor shall submit a copy of that analytical report to the department within 7 days of the completion of the analysis.
ATCP 70.56 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20. ATCP 70.58
Labeling bottled products.
Bottled products shall be labeled according to s. ATCP 70.26 (5)
. Bottled water shall also be labeled according to 21 CFR 165.110
. Juice shall be labeled according to 21 CFR part 120
, and any applicable regulations found in this chapter.
ATCP 70.58 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 70.60(1)(1)
Food processing plants producing and packaging or bottling juice shall comply with subch. II
and this subchapter. Food processing plants engaged in juice processing and packaging or bottling shall comply with 21 CFR part 120
A juice label may not misrepresent that juice has been pasteurized or has undergone a process equivalent to pasteurization. A juice label may not represent as “fresh" any juice that has been treated with ultra-violet light.
ATCP 70.60 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 70.62
Effect of rules on local ordinances. ATCP 70.62(1)(1)
Non-conflicting local ordinances permitted.
This chapter does not prohibit or nullify any local government ordinance with which it is not in direct conflict as provided in sub. (2)
Preemption of conflicting local ordinances.
If this chapter conflicts directly with any local government ordinance, so that it is impossible to comply with one except by violating the other, this chapter controls.
Duty to comply.
Compliance with local government ordinances does not relieve any person from the duty of complying with this chapter.
ATCP 70.62 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20. ATCP 70.64(1)(1)
The department may issue a written waiver granting a variance from a construction, equipment, utensils, processing or procedure standard under this chapter if the department finds that the variance is reasonable and necessary under the circumstances, and that it will not compromise the purpose served by the construction, equipment, or processing standards. The administrator of the department's division of food and recreational safety may issue a waiver on behalf of the department. The department shall keep a copy of the waiver on file for as long as the waiver remains in effect.
Submission of request for a variance.
A variance request shall be submitted to the department through the sanitarian assigned by the department to inspect the food processing plant, and shall include all validation documents as well as a HACCP plan required under 21 CFR part 120
, if applicable; or food safety preventive controls plan as required under 21 CFR 117
, Subpart C, if it is for a waiver of accepted processing protocols.
Department decision on request for a variance.
The department shall grant or deny a request under sub. (2)
within 60 days after it receives a complete request, except that the department may give written notice extending the action deadline for reasons stated in the notice.
Waivers to construction and maintenance standards under s. ATCP 70.08
shall remain in effect as long as no material changes to construction or maintenance of the food processing plant result in failure to meet the standard in s. ATCP 70.08 (1)
. All waivers to standards under ss. ATCP 70.10
granted under this section shall expire five years from the date of issuance.
A license holder who wishes to continue a variance to standards under ss. ATCP 70.10
after the expiration of the waiver shall file a request with the department for reissuance of the waiver at least 180 days prior to its expiration, unless permission for a later date has been granted by the department.
When a license holder has made timely and sufficient application for the reissuance of a waiver or a new variance request with reference to any activity of a continuing nature, the existing waiver does not expire until the application has been finally acted upon by the department, and, if the application is denied or the terms of the new request are limited, until the last day for seeking review of the agency decision or a later date fixed by order of the reviewing court.
A waiver shall be reissued by the department if the equipment, utensils, processes, or procedures described in it continue to meet the criteria in sub. (1)
or if the food processing plant operator updates the original variance request to ensure compliance with the criteria in sub. (1)
ATCP 70.64 History
History: CR 17-073: cr. Register January 2020 No. 769, eff. 2-1-20; correction in (2), (3), (4) (a) made under s. 35.17, Stats., Register January 2020 No. 769.