Section 97.28, Stats., requires DATCP to exempt small-scale egg producers who sell eggs directly to consumers on the premises where the eggs are laid, on egg sales routes, and at farmers’ markets from the requirement of holding a food processing plant license. Section 97.29 Stats., also authorizes DATCP to exempt certain food processing activities by rule. Section 97.10, Stats., prohibits the sale of adulterated or misbranded food as defined in ss. 97.02 and 97.03, Stats., including food for which the identity is misrepresented. Section 100.183, Stats., prohibits deceptive advertising of food. Plain Language Analysis
This rulemaking action repeals the existing ATCP 88, Egg Grading, Handling and Labeling, and creates a new rule, ATCP 88, Eggs, to consolidate licensing, egg handling, grading, packing, and retail sale requirements into one rule. Specifically, the rule addresses the following:
Food Processing Plant and Retail Establishment Rules
The rule revises ATCP 70, Food Processing Plants, to clarify that egg producers, with flocks of not more than 150 laying birds, are exempt from food processing plant licensing requirements, provided they only sell eggs directly to consumers on the premises where the eggs are laid, at a farmers’ market, or on an egg-sales route.
The rule revises ATCP 70, Food Processing Plants, to clarify that egg producers who only collect nest-run eggs to sell to licensed egg handlers, are exempt from food processing plant licensing requirements, provided they register with the department.
The rule revises ATCP 70, Food Processing Plants, to refer egg handlers who hold a food processing plant license to specific sections of ATCP 88 that relate to construction, maintenance, sanitation, packaging and labeling requirements for egg handling. The rule also revises the Wisconsin Food Code found in the appendix of ATCP 75, Retail Food Establishments, to clarify that eggs sold by egg handlers holding a food processing plant license issued by another state, or who are selling eggs directly to the consumer and exempted under s. ATCP 88.02, are allowed to sell eggs at retail. The rule also updates the cited location of restricted egg tolerances from s. ATCP 88.06 to s. ATCP 88.26. Title and Organization
The rule retitles ATCP 88 from “Egg Grading, Handling, and Labeling” to “Eggs,” reflecting the broader scope of the rule. The revised rule organizes provisions into six subchapters to improve ease of use, reorganizes and renumbers existing provisions that are retained from the current rule, and creates new provisions throughout the rule.
General Provisions
ATCP 88.01-Definitions. The rule adds definitions to ATCP 88 for “ambient temperature,” “balut,” “check,” “community-supported agriculture business,” “consumer,” “egg handler,” “egg producer,” “egg sales route,” “farmers’ market,” “incubator reject,” “leaker,” “loss,” “nest-run,” “official egg products plant,” “restricted egg,” “storage,” and “U.S. Consumer Grade B.” The rule also expands the definition of “egg,” now limited to chicken eggs, to include turkey, duck, goose, guinea or other avian species whose eggs are used for human consumption. The rule also separates each federal regulation related to eggs into a discrete definition. These changes provide additional support and clarity to the rule.
ATCP 88.02-Licensing and registration. The rule creates a provision describing food processing plant, food warehouse, and retail food establishment licensing and registration requirements for egg producers and egg handlers. The rule continues to require anyone who conducts egg handling activities to acquire a food processing plant license, but specifies two exemptions: 1) Egg producers who collect, pack, and store eggs, from a flock of not more than 150 laying birds, and only sell eggs directly to the consumer at the premises where the eggs are laid, a farmers’ market, or on an egg sales route. The rule requires those exempted producers to label packages of eggs, sold under this exemption, as ungraded and uninspected, and include the seller’s name, address, and pack date. 2) Egg producers who collect nest-run eggs, register with DATCP, and sell the nest-run eggs to a licensed egg handler. The revision clarifies that a retail food establishment license is required to sell eggs directly to consumers at sites other than the premises where the eggs were laid, including sales at farmers’ markets or on egg sales routes. A retail food establishment license is not required for eggs sold directly to consumers at the egg producer’s premises or as part of a community-supported agriculture business.
ATCP 88.04-Federal registrations and records. Under federal law, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require registration for certain egg producers and handlers, so these agencies may identify those egg producers and handlers required by federal law to meet federal regulations designed to reduce the risk of Salmonella Enteritidis (SE) contamination. ATCP 88 now requires egg producers to register with the FDA if they are required to do so under 21 CFR 118.11 of the federal egg safety rule. Generally, egg producers with flocks of 3,000 laying birds or more are required to register with the FDA and meet requirements designed to reduce the risk of SE contamination. To ensure Wisconsin egg producers are meeting critical safety requirements in the federal egg safety act, the rule also requires Wisconsin egg handlers, receiving eggs from producers who own 3,000 or more laying birds, to maintain records showing that the producers are registered with the FDA. The rule also requires egg handlers who grade and pack eggs for the ultimate consumer to register with the USDA, if required to do so under 7 CFR 57.690 of the federal egg products inspection act. Egg producers and egg handlers are not required to register if they are exempted under the federal egg safety rule or federal egg products inspection act. Egg Facilities
ATCP 88.06-Egg handling and storage facilities. The rule lists requirements, consistent with those for all food processing plants, related to construction and maintenance of egg handling and storage facilities, doors and windows, lighting, toilet facilities, cleaning facilities, garbage and refuse disposal, and control of pests.
ATCP 88.08-Egg handling rooms. The rule retains the requirement that egg storage areas maintain eggs at appropriate temperatures and be equipped with temperature measuring devices. The rule also retains the requirement that candling areas be dark enough to permit accurate determinations of egg quality. The rule adds cleanliness requirements for egg washing and egg grading rooms.
ATCP 88.10-Operations water. The rule specifies requirements to ensure water, used in egg handling facilities, is tested and meets drinking water standards. Egg handling facilities are required to keep the results of all health-related tests conducted on operations water.
Equipment and Utensils
ATCP 88.12-Equipment and utensil requirements. The rule presents requirements to ensure equipment and utensils used in egg handling establishments are of sanitary design and construction.
ATCP 88.14-Cleaning and sanitizing equipment and utensils. The rule requires that all egg contact surfaces of equipment and utensils be cleaned and sanitized after each day’s use, or more frequently if necessary. It outlines the procedure for obtaining department approval for alternative cleaning and sanitizing procedures and methods for storing equipment and utensils.
Egg Handling Operations
ATCP 88.16-Personnel standards. The rule lists requirements for personnel, including cleanliness, clothing and jewelry, employee health, and prohibitions against consumption of food or beverages, or use of tobacco in egg handling rooms.
ATCP 88.18-Temperature standards. The rule identifies temperature standards for eggs before and after packing and prohibits the sale of shell eggs that have been frozen. The rule maintains those standards and contains added temperature standards for eggs during transport and at retail sale, with retail sale temperature standards consistent with the Wisconsin Food Code. The rule contains added temperature standards for baluts, which are edible fertile eggs.
ATCP 88.20-Egg cleaning and storage operations. The rule modifies requirements for egg cleaning and storage. It no longer cites the “List of Proprietary Substances and Nonfood Compounds,” which is no longer published by USDA, as a reference for identifying acceptable egg- cleaning or -sanitizing compounds. Instead the rule requires that compounds used to clean or sanitize eggs shall be either 1) generally recognized as safe under 21 CFR parts 182 and 184, and used in accordance with good manufacturing practices under 21 CFR 182.1, 2) approved by the U.S. food and drug administration as a food additive under 21 CFR parts 172 – 174, and 180, and used in accordance with the conditions of this approval, or 3) approved by the U.S. food and drug administration as a sanitizer under 21 CFR 178.1010, used at concentrations specified therein, and registered for this use with the U.S. environmental protection agency. The rule contains an added provision related to the use of ultraviolet light for sanitizing the surface of shell eggs. The rule requires that dirty eggs, which cannot be cleaned, shall be discarded and that eggs shall be handled and stored in a safe, sanitary and orderly manner to protect the safety of the eggs and allow for ready inspection and movement of eggs. ATCP 88.22-Candling. The rule requires use of a candling light or automated grading equipment for determining the interior and exterior quality of eggs, and use of a candling light to verify the performance of automated grading equipment.
ATCP 88.24-Grading standards for chicken eggs. The rule clarifies that grading standards apply to chicken eggs only. The rule maintains the current requirement that graded eggs sold or distributed in Wisconsin shall be labeled for grade and meet grade B or better standards under the United States grade standards, unless they are clearly labeled as “ungraded.” The rule maintains the current size or weight class requirement for chicken egg sizes. The rule adds a table illustrating weights for each size or weight class.
ATCP 88.26-Minimum tolerance standards. The rule maintains the minimum tolerance standards for selling eggs of grade B quality, whether labeled as “graded” or “ungraded,” unless the eggs are sold on the egg producer’s premises or as part of a community-supported agriculture business directly to a consumer and the eggs are labeled as “ungraded.”
ATCP 88.28-Restricted eggs. The rule contains an added prohibition against the sale of restricted eggs and provisions describing the disposition of restricted eggs.
ATCP 88.30-Shell egg protection. The rule maintains the current provision that oiling eggs, to protect shells, shall be performed in a manner that prevents egg contamination and preserves egg quality. The rule removes the requirement that oil used to protect eggs must be listed in the “List of Proprietary Substances and Nonfood Compounds,” which USDA no longer publishes, and substitutes a requirement that oil must comply with 21 CFR 172.878 and 178.3620(a) relating to mineral oil. Packing and Labeling
ATCP 88.32-Egg packing. The rule maintains current requirements related to egg packing, but revises the title of s. ATCP 82.32(1) to clarify that certain mandatory packing practices are intended to maintain egg quality. The rule contains added provisions that eggs may be packed in used, clean cartons as long as the seller obliterates all carton markings that do not pertain to the eggs being sold. ATCP 88.34-Egg labeling. The rule maintains the current requirements related to egg labeling, except that it contains an added requirement that egg cartons include a label with the statement “SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” The rule specifies the font size and location of the safe handling label. The rule maintains requirements related to the packing date, expiration (“sell by”) date, and “use by” date and requirements related to egg shipping containers.
ATCP 88.36-Labeling of baluts. The rule contains an added provision establishing labeling requirements for baluts, including a label clearly indicating that baluts should be stored at a temperature of 41°F or colder.
ATCP 88.38-Deceptive practices. The rule retains the current provisions against deceptive practices, with an added prohibition against any nutrient content or health claims that do not comply with the requirements of 21 CFR part 101. ATCP 88.40-Dealers buying eggs from producers; receipts. The rule maintains the provision related to dealers buying eggs from producers except that, for clarity, it reorganizes the provisions into three, rather than two provisions, and specifies that the producer keeps records of eggs sold to dealers.
ATCP 88.42-Recall plan. The rule requires egg handlers to develop a written plan for recalling eggs in the event of a foodborne illness linked to the eggs handled at the establishment. The rule identifies the recall plan contents, and requires the egg handler to update the plan as necessary and make it available to the department for inspection and copying upon request.
ATCP 88.44-Enforcement. The rule includes the regulatory basis for enforcing ATCP 88.
Summary of, and Comparison with Existing or Proposed Federal Statutes and Regulations
In general, rules designed to ensure egg safety and consistent quality and marketing of eggs cover activities related to: 1) flock health and farm sanitation, 2) egg grading, sanitation, temperature control, packaging, and labeling at egg processing facilities, and 3) transportation, handling and storage of eggs for retail sale. Federal egg regulations consist of several rules involving two agencies, each responsible for different activities designed to promote the production and sale of safe eggs and consistent egg quality and marketing. The rule clearly differentiates Wisconsin’s requirements and those of federal agencies in regulating egg packaging and sales.
Federal Egg Regulations
The Egg Products Inspection Act (Title 21 USC, Chapter 15) authorized the USDA to create regulations (7 CFR Part 57) for egg processing operations. Egg processing operations, now defined in ATCP 88 as “official egg products plants,” generally make products other than shell eggs, such as pasteurized whole eggs and dried egg whites. Additional USDA regulations, created under this act, authorize at least yearly inspection of hatcheries and at least quarterly inspection of businesses that pack shell eggs for the ultimate consumer. As part of these inspections, USDA assures that egg packages are labeled “Keep Refrigerated” and packaged eggs are stored at 45°F or colder. For eggs moving in interstate or foreign commerce, federal law and regulations pre-empt state statutes and regulations relating to temperature control, quality or grade, condition, weight or quantity. A voluntary egg grading service is administered by USDA under the authority of the Agricultural Marketing Act of 1946 as amended (Title 7 USC, Chapter 1621 et seq.; referred to in revised ATCP 88 as the “federal egg grading act”) and requirements, formerly found in 7 CFR part 56, but now available as guidance from USDA’s Agricultural Marketing Service (AMS 56), essentially use the same egg grading standards which are contained in revised ATCP 88. Under the Federal Food, Drug and Cosmetic Act (Title 21 USC, Chapter 9), and the Public Health Service Act (Title 42 USC, Chapter 264), the US Food and Drug Administration (FDA) has enacted egg safety regulations (21 CFR 16.5 (a) (5) and 21 CFR part 118, now referred to in ATCP 88 as the “federal egg safety rule”) applying to shell egg producers with 3,000 or more laying hens at a particular farm, who are not selling all of the eggs directly to consumers or are transporting eggs for processing. The regulations require these egg producers to register with FDA and to develop a written SE prevention plan for each farm. The plan must address procurement of chicks, environmental testing, cleaning and disinfection, biosecurity, pest control, and egg refrigeration. The regulations also require testing of eggs for SE.
