Notice of Hearings
Agriculture, Trade and Consumer Protection
(DATCP DOCKET #: 13-R-05)
The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) announces that it will hold public hearings on a proposed rule to revise Chapters
ATCP 70,
71,
75, and
88, relating to eggs. DATCP will hold four public hearings at the times and places shown below.
Hearing Information
Date: Tuesday, July 15, 2014
Time: 10:00 a.m. to 1:00 p.m.
Location: Room CBI 110
North Central Technical College
1000 W. Campus Drive
Wausau, Wisconsin 54401
Date: Friday, July 18, 2014
Time: 10:00 a.m. to 1:00 p.m.
Location: Hatch Public Library
111 West State Street
Mauston, Wisconsin 53984
Date: Monday, August 4, 2014
Time: 10:00 a.m. to 1:00 p.m.
Location: Room 106 (Board Room)
Department of Agriculture, Trade and
Consumer Protection
2811 Agriculture Drive
Madison, Wisconsin 53718
Date: Wednesday, August 6, 2014
Time: 10:00 a.m. to 1:00 p.m.
Location: Room D and E
Fond du Lac City Hall
160 South Macy Street
Fond du Lac, Wisconsin 54935
Hearing impaired persons may request an interpreter for this hearing. Please make reservations for a hearing interpreter by July 3, 2014, by writing to Sandra Cleveland, Division of Food Safety, P.O. Box 8911, Madison, Wisconsin 53708-8911; by emailing
sandy.cleveland@wisconsin.gov; or telephoning (608) 224-4712. Alternatively, you may contact the DATCP TDD at (608) 224-5058. The hearing facility is handicap accessible.
Appearances at the Hearing and Deadline for Submission of Comments
DATCP invites the public to attend the hearings and comment on the proposed rule. Following the public hearings, the hearing record will remain open until
August 20, 2014, for additional written public comments. Comments may be sent to the Division of Food Safety at the address below, or to
Peter.Haase@wisconsin.gov, or to
http://adminrules.wisconsin.gov.
Copies of the Rule and Comments Relating to Small Business
You can obtain a free copy of this hearing draft rule and related documents including the economic impact analysis by contacting the Wisconsin Department of Agriculture, Trade and Consumer Protection, Division of Food Safety, 2811 Agriculture Drive, P.O. Box 8911, Madison, Wisconsin 53708. You can also obtain a copy by calling Sandra Cleveland at (608) 224-4670 or by emailing
sandy.cleveland@wisconsin.gov. Copies will also be available at the hearing. To view the hearing draft rule online, go to:
http://adminrules.wisconsin.gov.
Comments or concerns relating to small business may also be addressed to DATCP's small business regulatory coordinator Keeley Moll at the address above, or by email to
keeley.moll@wisconsin.gov, or by telephone at (608) 224-5039.
Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
This proposed rule modifies: Ch.
ATCP 88, Wis. Adm. Code, related to egg grading, handling, and labeling; Ch.
ATCP 70, Wis. Adm. Code, related to food processing plants; and Ch.
ATCP 75, Wis. Adm. Code, related to retail food establishments. The proposed rule comprehensively revises Ch.
ATCP 88 to clarify the regulatory requirements applicable to egg producers and egg handlers. The proposed rule makes minor revisions to chs.
ATCP 70 and
75, moving primary egg regulation to ch.
ATCP 88. By placing requirements for licensing, facilities, equipment and utensils, egg handling operations, packing and labeling, recordkeeping, and recall planning in ch.
ATCP 88, the proposed rule limits the need for small egg-business operators to consult multiple chapters of rules. The proposed rule will implement
2013 Wisconsin Act 245 by eliminating the requirement for small-scale egg producers to hold a food processing plant license when selling eggs to consumers at a farmers' market, on an egg sales route, or at the egg producer's farm. The proposed rule removes obsolete provisions in the existing rule. The proposed rule also provides explanations to improve rule clarity and spells out federal egg safety registration requirements that must also be met by some egg producers and egg handlers.
Statutes interpreted
Section
97.29 (1) (g) and 2
(a), Stats., (Food processing plants) and 97.28, Stats., (Direct sale of eggs).
Statutory authority
Explanation of statutory authority
DATCP has broad general authority, under s.
93.07 (1), Stats., to interpret laws under its jurisdiction. DATCP has authority under s.
97.09 (4), Stats., to establish and enforce rules that are needed to protect the public from the sale of adulterated or misbranded foods and govern the production, processing, packaging, labeling, transportation, storage, handling, display, sale, and distribution of foods. DATCP has general authority under s.
97.29 (1) (g), Stats., to exempt by rule certain activities from the definition of “food processing." It also has specific authority, pursuant to s.
97.28, Stats., to not require a food processing plant license for collection, packing, and storage of eggs by an egg producer, with a flock of not larger than 150 birds, who sells those eggs only to consumers at farmers' markets, on egg sales routes, or at the egg producer's premises.
Related statutes and rules
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 farmer's 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 proposed rule repeals the existing Ch.
ATCP 88, Egg Grading, Handling and Labeling, and creates a new rule, ch.
ATCP 88, Eggs, to consolidate licensing, egg handling, grading, packing, and retail sale requirements into one rule. Specifically, the proposed rule addresses the following:
Food Processing Plant and Retail Establishment Rules
•
The rule revises ch.
ATCP 70, Food Processing Plants, to clarify that egg producers, with flocks of not more than 150 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 ch.
ATCP 70, Food Processing Plants, to clarify that egg producers, with flocks of more than 150 birds, 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 refers egg handlers who hold a food processing plant license to specific sections of ch.
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 ch.
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 ss.
ATCP 88.06 to
ATCP 88.26.
Title and Organization
•
The rule retitles ch.
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
•
Section
ATCP 88.01 — Definitions. The rule adds definitions to Ch.
ATCP 88 for “ambient temperature," “balut," “check," “egg handler," “egg producer," “egg sales route," “farmers' markets," “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 regulatory requirements in the rule.
•
Section
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 handling. 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 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 from a flock of more than 150 birds, 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 and on egg sales routes. A retail food establishment license is not required for eggs sold directly to consumers at the egg producer's premises.
•
Section
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 contamination and ensure the sale of wholesome eggs in commerce. This revision to ATCP 88 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 birds or more are required to register with the FDA and meet requirements designed to reduce the risk of
Salmonella enteritidis contamination. To ensure Wisconsin egg producers are meeting critical safety requirements in the federal egg safety act, the revised 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
• Section
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.
•
Section
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.
•
Section
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
•
Section
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.
•
Section
ATCP 88.18 — Temperature standards. The current rule identifies temperature standards for eggs before and after packing. It prohibits the sale of shell eggs that have been frozen. The revised rule maintains those standards and adds temperature standards for eggs during transport and at retail sale, with retail sale temperature standards consistent with the Wisconsin Food Code. The revised rule adds temperature standards for baluts, which are edible fertile eggs.
•
Section
ATCP 88.20 — Egg cleaning and storage operations. The revised rule modifies requirements for egg cleaning and storage. It no longer cites the reference to 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 meet requirements found in
21 CFR part 178.1010 and be registered with the U.S. Environmental Protection Agency (EPA). The revised rule adds provisions requiring 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.
•
Section
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.
•
Section
ATCP 88.24 — Grading standards for chicken eggs. The revised 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.
•
Section
ATCP 88.26 — Minimum tolerance standards. The revised rule maintains the prohibition against selling eggs graded as less than grade B, whether labeled as “graded" or “ungraded," unless the eggs are sold on the premises directly to a consumer and the eggs are labeled as “ungraded."
•
Section
ATCP 88.28 — Restricted eggs. The revised rule adds a prohibition against the sale of restricted eggs and provisions describing the disposition of restricted eggs.
•
Section
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 revised 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 parts 172.878 and
178.3620(a) relating to mineral oil.
Packing and Labeling
•
Section
ATCP 88.32 — Egg packing. The rule maintains current requirements related to egg packing, but revises the title of ATCP 82.32 (1) to clarify that mandatory packing practices maintain egg quality. The revised rule adds 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.
•
Section
ATCP 88.34 — Egg labeling. The rule maintains the current requirements related to egg labeling, except that it adds the 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 date, and use by date and requirements related to egg shipping containers.
•
Section
ATCP 88.36 — Labeling of baluts. The rule adds a provision establishing labeling requirements for baluts, including a label clearly indicating that baluts should be stored at a temperature of 41
°F or colder.
•
Section
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.
•
Section
ATCP 88.40 — Dealers buying eggs from producers; receipts. The revised rule maintains the provision related to receipts provided by dealers buying eggs from producers except that, for clarity, it reorganizes the provisions into three, rather than two provisions.
Section
ATCP 88.42 — Recall plan. The revised 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.
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 flock health and farm sanitation; egg grading, sanitation, temperature control, packaging, and labeling at egg processing facilities; and transportation, handling, and storage of eggs for retail sale. Federal egg regulations involve two agencies, each responsible for different activities designed to promote egg safety and consistent egg quality and marketing. One objective of this rulemaking process is to clearly differentiate 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, defined in the revised ch.
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 stored at 45
°F or less. 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 Ch.
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), using essentially 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 parts 16.5 (a) (5) and 118, referred to in revised ATCP 88 as the “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
Salmonella enteritidis 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
Salmonella enteritidis.
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 birds when the eggs are sold off the premises from where the flock is located.
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 ranges in cost 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 $77 for establishments with gross annual food sales of less than $50,000 to $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 with flocks of more than 150 birds or who sell washed and graded eggs to other businesses must hold a food processing plant license (potentially hazardous foods category) with the license fee based on annual sales and ranging from $95 for establishments with annual sales of less than $25,000 to $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, 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 revision to ATCP 88 incorporates 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. These exemptions were recently enacted in
2013 Wisconsin Act 245. 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 govern eggs in other states, reviewed the federal rules related to eggs, and sought input from 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 for selling eggs at farmers' markets and on egg sales routes. 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. 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.
Standards Incorporated by Reference
DATCP Contact
Questions and comments related to this this rule may be directed to:
Peter Haase, Director
Bureau of Food Safety and Inspection
