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. Federal and State Regulatory Roles
Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for activities related to disease control in flocks of laying hens. In addition, the Agricultural Marketing Service (AMS) is responsible for quality grading for shell eggs and the Shell Egg Surveillance program, which ensures eggs for sale meet Grade B or better standards. Finally, the Food Safety and Inspection Service (FSIS) is responsible for inspecting egg products sold in interstate commerce and re-inspecting imported egg products. The FDA, on the other hand, is responsible for ensuring sanitation and safety control measures at the farm, monitoring safe handling and good manufacturing practices in shell egg packaging plants that do not use the USDA’s shell egg grading service, and for managing recalls involving shell eggs or egg products inspected by either the FDA or the USDA.
State and local agencies typically are responsible for working in cooperation with the FDA to inspect shell egg packaging plants that do not use the USDA’s shell egg grading service and for inspecting retail food establishments. Wisconsin currently regulates voluntary egg grading in plants that do not use the USDA’s shell egg grading service, egg packaging and warehouse activities, and retail sales of eggs.
Comparison with Rules in Adjacent States
Illinois requires egg producers to hold a limited or full license, for $15 and $50, respectively. Illinois also assesses a per-case inspection fee on eggs sold in-state. Egg producers are not required to hold an Illinois egg license to sell nest-run eggs from the producer’s flock to household consumers for the consumers’ own personal use. The eggs must be sold on the premises where the flock is located. Producers who sell eggs to licensed grading stations also do not require an Illinois egg license. A limited Producer-Dealer egg license is required for producers selling graded eggs from their own flock of fewer than 3,000 laying birds when the eggs are sold off the premises where the flock is located. Egg producers who sell eggs from their own flock of 3,000 or more birds or eggs from another person’s flock, off the premises where their flock is located, are required to obtain a full Producer-Dealer license. Wholesale and retail sales of eggs must meet all requirements found in the Illinois Egg and Egg Products Act.
Iowa requires handlers of candled and graded eggs to hold a license, the cost of which is based on the number of eggs sold in a "snapshot" month. The fee ranges from $15 for egg handlers who purchase or handle fewer than 125 cases in the month of April of a calendar year to $250 for those who purchase or handle 10,000 cases or more during that month. Producers, who sell eggs exclusively from their own flocks directly to handlers, or to consumers, are exempt from licensing.
Michigan does not require a license for selling eggs obtained from flocks of fewer than 3,000 laying hens if the sales are made directly to consumers. Any other sales, including those transacted with consumers by internet, mail, or consignment, are only allowed if the seller holds a $175 license.
Minnesota assesses an annual inspection fee, based on number of eggs sold, which costs from $12.50 to $312. A food handler license is also required for certain sales. The cost of a food handler license is based on the gross annual food sales and ranges from a fee of $77 for establishments with gross annual food sales of less than $50,000 to a fee of $2,001 for establishments with gross food sales of over $25 million. Producers may sell eggs directly from their farm, to individual customers, without meeting any licensing, registration, or inspection requirements. Producers may also sell eggs at farmers’ markets without licensing or registration, but the eggs must be candled, labeled with the producer’s name and address and kept at a temperature of 45° F or colder. Producers with fewer than 3,000 hens may sell eggs to grocery stores, restaurants or other food businesses without a license if they register with the Minnesota Department of Agriculture (MDA). There is no fee for registration and no routine inspection of the producer, although MDA may inspect the premises if they receive a complaint about the producer.
Currently, Wisconsin egg handlers must hold a food processing plant license (potentially hazardous foods category) with the license fee based on annual sales and ranging from a fee of $95 for establishments with annual sales of less than $25,000 to a fee of $835 for food processors with annual sales of at least $250,000. Wisconsin currently also requires egg producers who sell eggs directly to consumers at venues other than their farms or through a community-supported agriculture business, such as at a farmers’ market, to hold a retail food establishment license. The fee for a retail food establishment license issued by DATCP ranges from $45 to $685, depending on the scope of the establishment and its total annual sales, with small egg producers typically paying $45. If the retail sales occur in jurisdictions where local health agents are under contract with the department to conduct retail food establishment inspections, the fees may differ. This ATCP 88 rule now features exemptions from the food processing plant license requirement for producers who sell eggs from small flocks directly to consumers at specified venues, and producers who sell only nest-run eggs to egg handlers. This approach is consistent with that taken in neighboring states to minimize regulatory costs for small-scale direct-sale egg producers.
USDA grading standards are adopted in each of our neighboring states and those standards generally require that eggs sold to retailers must be Grade B or better. Illinois, Iowa, and Minnesota require candled eggs to be stored at 45° F or colder. Michigan requires eggs to be held and transported at no more than 45° F ambient temperature beginning 36 hours after the time of laying. Illinois requires nest-run eggs to be held at 60° F or less at all times. Since temperature control is an essential means of protecting the public from egg-borne illnesses, the Wisconsin rule requires eggs handled by licensed operators to be kept at 45° F or colder before and after packing and during transport, and 41° F or colder for retail sale. Wisconsin egg producers who are exempted under 2013 Wisconsin Act 245 from the requirement to hold a food processing plant license must hold at eggs at 41° F or colder for retail sale. Illinois, Iowa and Minnesota require record-keeping associated with graded-egg sales and retention of these records for varying lengths of time. Wisconsin's rule is consistent with neighboring states in this regard.
Summary of Factual Data and Analytical Methodologies
In developing this rule, DATCP reviewed rules which governed eggs in other states, reviewed the federal rules related to eggs, and sought input from federal egg regulators and egg industry personnel.
Effect on Small Business
This rule is expected to have a positive impact on small-scale egg producers, as it removes the requirement to obtain a food processing plant license to gather and pack eggs from their flock that are later sold to consumers at farmers’ markets and on egg sales routes, and removes the requirement to hold a retail food establishment license for sales of eggs to consumers at the egg producer’s farm or through a community-supported agriculture business. Egg producers selling nest-run eggs to an egg handler will be required to register with DATCP, which will require a very small expenditure of time and, for some producers, postage, but these producers will not be required to hold a food processing plant license. The rule will not increase licensing fees. Some licensed egg handling operations may need to upgrade facilities, e.g. sinks, walls, temperature monitoring devices, in order to meet requirements in the rule. The rule will have no economic impact on local governmental units or public utility rate-payers.
