Source: http://www.directfarmbusiness.org/eggs/
Timestamp: 2018-05-20 11:25:23
Document Index: 671279802

Matched Legal Cases: ['§ 341', '§ 57', '§ 57', '§ 57', '§ 57', '§ 1034', '§ 1033', 'art 56', '§ 57', '§ 57', '§ 1034', '§ 1052', '§ 1036', '§ 590', 'art 590', '§ 590', '§ 590', 'art 160', '§ 343', 'art 118', '§ 118', '§ 118', '§ 118', '§ 118', '§ 101', '§ 57', '§ 1034', '§ 1033', 'art 56', 'art 118', '§ 118', '§ 118', '§ 118', '§ 118', '§ 118', '§ 101']

Directfarmbusiness - Eggs
Several laws and agencies regulate egg sales. At the federal level, the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) share regulatory authority. In Illinois, the Illinois Egg and Egg Products Act (410 ILCS 615) and accompanying regulations (8 IAC 65) govern the sale of eggs. The Illinois Department of Agriculture (IDOA) administers the state-level program.
Federal Oversight of Eggs
As mentioned above, there are two primary agencies that regulate eggs at the federal level, the FDA and the USDA. The Egg Products Inspection Act (EPIA) (21 U.S.C. Chapter 15) authorizes the USDA to inspect eggs and egg products and establish standards for uniformity of eggs. The EPIA applies to eggs shipped in interstate and intrastate commerce, but has exemptions for small producers. The Food and Drug Administration (FDA), under the authority of the Federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 341), issues and enforces standards of identity for egg products and requires shell egg producers to implement measures to prevent Salmonella Enteritidis. The FDCA applies only to eggs shipped in interstate commerce. Many direct farm businesses selling their eggs will not be subject to the federal rules, but determining application of the federal law to a specific operation can be difficult. A brief discussion follows.
USDA’s Oversight of Eggs
Within USDA, the Agricultural Marketing Service (AMS) and Food Safety and Inspection Service (FSIS) administer programs that are relevant to egg producers. AMS prohibits buying, selling, or transporting or offering to buy, sell, or transport restricted eggs, unless exemptions apply (7 C.F.R. § 57.700). Exemptions are discussed in the next section. Restricted eggs are eggs that are checks, dirties, incubator rejects, inedible, leakers or loss (unfit for human food) (7 C.F.R. § 57.1).[1] Restricted eggs must be sent to a processing facility (overseen by FSIS, discussed below), destroyed, or processed into animal food (7 C.F.R. § 57.720).
AMS enforces the prohibition through periodic inspections of facilities, transport vehicles, and records of all persons engaged in the business of transporting, shipping, or receiving eggs (7 C.F.R. § 57.28). The EPIA requires AMS to inspect handlers packing shell eggs for sale to the end-consumer at least once per calendar quarter, unless exempt (21 U.S.C. § 1034). The term "handler" means any person who engages in buying or selling any eggs or processing any egg product for human food; the term includes poultry producers (21 U.S.C. § 1033(e)).
AMS also provides voluntary grading services for class, quality, quantity, or condition and any combination thereof (7 C.F.R. Part 56). Inspection by federal or authorized state graders must be requested, and will cost a fee. More information on requesting egg grading services, as well as the form to do so, is available through AMS’s grading website. AMS’s official standards, grades and weight classes are available here.
AMS Exemptions
AMS exempts egg producers from the restrictions and inspections if they sell eggs from their own flocks directly to consumers via a door-to-door retail route or at a place of business away from the site of production so long as they sell fewer than 30 dozen eggs per sale (7 C.F.R. § 57.100(c)). The producer must own and operate the business and personally transport the eggs. The eggs must meet the standards for U.S. Consumer Grade B shell eggs (Id.). Producers with fewer than 3,000 hens, producers selling directly to household consumers, and egg packers selling on site directly to consumers are also exempt from AMS’s regulations (7 C.F.R. § 57.100(d)-(f)).
Processing Subject to FSIS
The EPIA requires USDA to continuously inspect plants processing eggs into egg products (21 U.S.C. § 1034). The Act defines egg products as “any dried, frozen or liquid eggs, with or without added ingredients” (21 U.S.C. § 1052(f)). All egg products must undergo pasteurization (21 U.S.C. § 1036). FSIS oversees the inspection of egg processing plants (9 C.F.R. § 590.24). The procedures and standards for inspections are in 9 C.F.R. Part 590. Producers who process their own eggs and sell directly to consumers are exempt from continuous inspection under the FSIS regulations (9 C.F.R. § 590.100(e)). However, they must apply for an exemption and their facility and operating procedures must meet all otherwise applicable standards. Although not subject to continuous inspection, exempted facilities must undergo periodic FSIS inspections (9 C.F.R. § 590.600-650).
FDA’s Oversight of Eggs
In addition to USDA’s regulation under the EIPA, the FDA regulates eggs under the FDCA. FDA specifies standards of identity for egg products, including dried and frozen eggs (21 C.F.R. Part 160). If a food does not meet the standard of identity, it is misbranded according to the FDCA (21 U.S.C. § 343(g)).
Furthermore, some shell egg producers must adhere to FDA’s Salmonella testing, handling and treatment standards. Producers with 3,000 or more laying hens at a particular farm that produce shell eggs for the table market, and that do not sell all of their eggs directly to consumers, are subject to the additional Salmonella prevention standards (21 C.F.R. Part 118).[2] The regulations require these producers to: (1) develop a written Salmonella Enteritidis prevention plan that involves procuring pullets that are SE monitored, (2) use a bio-security program limiting visitors and controlling cross contamination between houses, (3) control rodents, files and pests, and (4) clean poultry houses between flocks if there was a positive SE test (21 C.F.R. § 118.4). Producers must perform environmental testing for SE when laying hens are 40 to 45 weeks old and 4 to 6 weeks after molt. If an environmental test is positive for SE the producer must conduct shell egg testing (21 C.F.R. §§ 118.5 and 118.6). Producers must maintain a written SE prevention plan as well as records to verify compliance, which they must make available within 24 hours of receipt of an official agency request (21 C.F.R. § 118.10). Shell eggs being held or transported must be refrigerated at or below 45 degrees Fahrenheit ambient temperature beginning 36 hours after laying (21 C.F.R. 118.4). This refrigeration requirement applies to shell egg producers as well as individuals transporting or holding shell eggs (21 C.F.R. § 118.1).
Regardless of whether eggs are sold interstate or intrastate, the FDA requires all shell eggs for distribution to the consumer to have a safe handling label or be treated to kill Salmonella (21 C.F.R. § 101.17(h)). The label must read: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly." The statement must appear on the label prominently, conspicuously, and in a type size no smaller than 1/16 of one inch. The statement must appear in a hairline box and the words "safe handling instructions" must appear in bold capital letters.
Illinois Regulation of Eggs
The following summarizes the most important features of the Illinois statute and regulations that most likely apply to a direct farm business. This summary is not intended to comprehensively discuss all aspects of egg production regulations in Illinois, and is not a substitute for obtaining legal advice prior to starting an egg operation.
The Illinois Egg and Egg Products Act (410 ILCS 615) begins by setting forth definitions of terms. A producer is someone who raises hens for eggs, but does not grade or candle the eggs. A producer-dealer is someone who grades, candles and sells eggs from their own flock either on or off premises to household consumers, institutional consumers, distributors, and manufacturers. The distinction between a producer and a producer-dealer is important because in some instances producers qualify for exceptions not available to producer-dealers. A direct farm business also qualifies as a distributor if it sells eggs to retailers, institutional customers, or to her own retail outlets or stores. A handler includes a producer-dealer who is in the business of distributing or processing eggs or egg products and may include the receiving, assembling, cleaning, grading, sorting, candling, packing or otherwise preparing for market and selling eggs or egg products, or using eggs in the preparation of food. A packer means any person who grades, sizes, candles, and packs eggs for purpose of resale.
The Act also provides definitions of standards for eggs. A "check" is an egg that has a broken shell or crack in the shell but has its membranes intact and whose contents are not leaking. A "dirty" egg is an egg that has a shell that is unbroken, but has adhering dirt or foreign material, or prominent stains on the shell surface, or moderate stains covering more than 1/4 of the shell surface. "Inedible" eggs are any eggs of the following description: black rot, yellow rot, white rot, mixed rot (addled egg), sour egg, egg with a green white, egg with a stuck yolk, moldy egg, musty egg, egg showing a blood ring, egg containing any embryo chick (at or beyond the blood ring stage), and any egg that is adulterated as that term is defined pursuant to the Federal Food, Drug and Cosmetic Act. "Leaker" eggs are eggs that have a crack or break in the shell and shell membranes to the extent that the egg contents are exposed or are exuding or free to exude through the shell. "Loss egg" is an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains bloody white, large meat spots, a large quantity of blood, or other foreign material.
With limited exception, ALL producer-dealers, distributors, handlers and packers must have a license from the State of Illinois to sell eggs.
Licenses are full or limited. A producer-dealer who sells only graded eggs from his or her own flock of 3,000 birds or less may obtain a limited license for $15. A producer-dealer selling eggs produced from 3,000 or more birds must obtain a $50 full license. Producer-dealers should obtain their licenses prior to beginning business, and must renew annually. Each separate business location requires a license, which must hang in a conspicuous location. It is important to note that local health departments may require additional licenses to sell within their respective jurisdictions.
A producer-dealer who sells nest-run eggs (not candled or graded) directly to household consumers from the flock on the premises, or sells to a holder of an Illinois Egg License, does not need an Illinois Egg License. In addition, an Illinois Egg License is unnecessary if all eggs go to the manufacture of a food product (e.g., a farm that uses its eggs in baked goods). Although these limited activities may not need an Illinois Egg License, other requirements (such as storage or packaging rules) may still apply.
Each case of eggs (Grade AA, A or B) sold in Illinois is subject to an inspection fee to cover the cost of enforcing the Act. The fee cannot exceed 6 cents per 30 dozen eggs. The first handler of the eggs is responsible for payment of the fee to the Agricultural Master Fund/Auxiliary Egg Inspection Fund. The invoice (see below) must contain both the price and the amount of the inspection fee. The person responsible for the inspection fee must submit a report on the number of "master containers" (containers of 30 dozen eggs per case) subject to the inspection fee every three months on a form supplied by IDOA. Persons selling fewer than 600 master containers must only report annually. Remittance of the fee must accompany the report.
IDOA inspectors may enter the premises on any business day during regular hours of business, with or without the owner or manager present. The inspector may sample, without reimbursement, any eggs for analysis or testing. The inspector may also review invoices, cases or containers, and equipment. The inspector may seize any product, document, or equipment found in violation of the Act.
No person may sell eggs or egg products for human consumption that are unfit for human food. Eggs or egg products are unfit for human consumption if they are classified as an inedible or loss egg. Egg products are also unfit for human consumption if adulterated, unwholesome, non‑inspected, or otherwise unfit for human consumption. Eggs that are checks, dirties, incubator rejects, inedibles, leakers, or loss eggs are “restricted” and also cannot be sold directly to consumers. As an exception to the rule, producers may sell checks and dirties directly to consumers on the premises where they are produced. A processing plant that undergoes continuous inspection by IDOA may use checks and dirties for human food provided that the facility pasteurizes the eggs.
Sellers, including producer-dealers, must candle and grade all eggs for sale off the premises, such as at the retail level or purchased by institutional customers, or at farmers' markets. Further, they must hold them at 45 degrees Fahrenheit or below after processing until they reach the retailer. Eggs must be Grade B or better. Eggs sold at retail must be in new, consumer-size containers —no bulk eggs may be sold to retailers. Federal grading standards apply in Illinois.
A producer can sell nest run eggs produced from his or her own premises directly to household consumers without candling or grading the eggs. These sales must occur on the premises. The producer must hold the nest run eggs at 60 degrees Fahrenheit or less at all times. For packaging these eggs, producers may use unmarked, new packages or unmarked good condition, used consumer-size containers.
Illinois regulations also establish minimum sanitation and operating requirements for both retailers and grading plants that are not federally inspected. The facility's construction must keep out rodents. Operators must keep rooms and equipment where the eggs are candled, graded, and packaged reasonably clean during the day and must thoroughly clean the rooms at the end of each day. Coolers must be in a clean, sanitary condition. Operators may not hand wash eggs and wash water must be potable and at least 20 degrees above the temperature of the eggs, or 90 degrees Fahrenheit, whichever is higher. Similarly, retailers must keep storage areas clean and sanitary. More importantly, retailers must rotate the eggs so that the first-in are the first-sold. Eggs past their sell by date (see labeling, below) may not be sold.
The package label for eggs for sale at the wholesale or retail level must identify the egg grade and size, the name of the packer, address of the packer, distributor or retailer, the packing or candling date, and the expiration or “sell by” code. For Grade AA eggs, the code must indicate a date (month and day) up to 15 days after the packing date. For all other grades, the code should represent a date up to 30 days after the date of pack. Labeling must be in bold type with letters at least 3/8 inch high, and may not contain any abbreviations. Only producers who sell eggs from their own flock can make the packing claim that the eggs are "fresh eggs," "newly-laid eggs," or similar language. Producers labeling their eggs as “organic” must have USDA certification, as discussed in the "Organic Marketing" section. USDA does not maintain standards for other terms sometimes applied to eggs, such as “free range,” “vegetarian fed,” “natural,” or “omega-3.” Nonetheless, the misbranding provision of the FDCA still applies, so producers should not use these terms unless they can support the claims. USDA regulates the use of some terms on poultry meat, which may inform what practices justify use of a particular label on eggs. Additional guidance is available here.
Invoice Documentation. Each producer-dealer, packer, handler or distributor who sells candled and graded eggs to a retailer, institutional consumer, bakery, or concern that purchases eggs for serving to guests must furnish the purchaser with an invoice or other accounting document covering each sale. The invoice must show the name and address of the seller and purchaser, as well as the exact grade and size of the eggs purchased. Copies of the invoices must be kept for at least 30 days.
If you’re going to sell eggs, make sure you have answered the following question:
Who are your customers (end user, institutions, processor)?
Where will your sales take place (on or off the premises)?
On farm sales have fewer regulations, but limit available customers
Flock size can determine which regulations apply
If you plan to sell off the farm:
Do you have the capacity to grade, candle, and inspect your eggs?
Have you figured out how to package and transport the eggs?
Are you responsible for keeping track of and remitting any fees? If so, what is your record keeping system?
Have you obtained the appropriate licenses? You may want to check with local health departments in addition to IDOA to see if they require other licenses, such as retailers’ license.
USDA's Agricultural Marketing Service, Poultry Programs, Shell Eggs (egg grading and certification):
Ph: 202-720-3271
Illinois Department of Agriculture, Division of Food Safety and Animal Protection (state licensing requirements)
Ph: 217-524-1550
[1] This same section of the code provides definitions of checks, dirties, incubator rejects, inedible, leakers or loss eggs. Many of the definitions are nearly identical to Illinois’s law, discussed below. For this reason, and because Illinois law and inspectors are more likely to regulate the direct farm business selling eggs, the definitions are spelled out in the Illinois section only.
[2] The inverse of this is that producers who have fewer than 3,000 hens and sell all of their eggs directly to consumers are exempt. Producers who process their eggs into egg product are also exempt, but may be subject to FSIS’s egg processing oversight.
Continue to Fruits & Vegetables
I. Federal Oversight of Eggs
AMS enforces the prohibition through periodic inspections of facilities, transport vehicles, and records of all persons engaged in the business of transporting, shipping, or receiving eggs” (7 C.F.R. § 57.28). The EPIA requires AMS to inspect handlers packing shell eggs for sale to the end-consumer at least once per calendar quarter, unless exempt (21 U.S.C. § 1034). The term “handler” means any person who engages in buying or selling any eggs or processing any egg product for human food; the term includes poultry producers (21 U.S.C. § 1033(e)).
AMS also provides voluntary grading services for class, quality, quantity, or condition and any combination thereof (7 C.F.R. Part 56). Inspection by federal or authorized state graders must be requested, and will cost a fee. More information on requesting egg grading services, as well as the form to do so, is available through AMS’s grading website.[2] AMS’s official standards, grades and weight classes are available here.[3]
Furthermore, some shell egg producers must adhere to FDA’s Salmonella testing, handling and treatment standards. Producers with 3,000 or more laying hens at a particular farm that produce shell eggs for the table market, and that do not sell all of their eggs directly to consumers, are subject to the additional Salmonella prevention standards (21 C.F.R Part 118).[4] The regulations require these producers to (1) develop a written Salmonella Enteritidis prevention plan that involves procuring pullets that are SE monitored, (2) use a bio-security program limiting visitors and controlling cross contamination between houses, (3) control rodents, files and pests, and (4) clean poultry houses between flocks if there was a positive SE test (21 C.F.R. § 118.4). Producers must perform environmental testing for SE when laying hens are 40 to 45 weeks old and 4 to 6 weeks after molt; if an environmental test is positive for SE the producer must conduct shell egg testing (21 C.F.R. §§ 118.5 and 118.6). Producers must maintain a written SE prevention plan as well as records to verify compliance, which they must make available within 24 hours of receipt of an official agency request (21 C.F.R. § 118.10). Shell eggs being held or transported must be refrigerated at or below 45 degrees Fahrenheit ambient temperature beginning 36 hours after laying (21 C.F.R. § 118.4). This refrigeration requirement applies to shell egg producers as well as individuals transporting or holding shell eggs (21 C.F.R. § 118.1).
Regardless of whether eggs are sold interstate or intrastate, the FDA requires all shell eggs for distribution to the consumer to have a safe handling label or be treated to kill Salmonella (21 C.F.R. § 101.17(h)). The label must read: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly." The statement must appear on the label prominently, conspicuously, and in a type size no smaller than one-sixteenth of one inch. The statement must appear in a hairline box and the words "safe handling instructions" must appear in bold capital letters.
II. Illinois Regulation of Eggs
The following summarizes the most important aspects of the Illinois statute and regulations that most likely apply to a direct farm business. This summary is not intended to comprehensively discuss all aspects of egg production regulations in Illinois, and is not a substitute for obtaining legal advice prior to starting an egg operation.
The Illinois Egg and Egg Products Act (410 ILCS 615) begins by setting forth definitions of terms. A producer is someone who raises hens for eggs, but does not grade or candle the eggs. A producer-dealer is someone who grades, candles and sells eggs from their own flock either on or off premises to household consumers, institutional consumers, distributors, and manufacturers. The distinction between a producer and a producer-dealer is important because in some instances producers qualify for exceptions not available to producer-dealers. A direct farm business also qualifies as a distributor if it sells eggs to retailers or institutional customers, or to her own retail outlets or stores. A handler includes a producer-dealer who is in the business of distributing or processing eggs or egg products and may include the receiving, assembling, cleaning, grading, sorting, candling, packing or otherwise preparing for market and selling eggs or egg products, or using eggs in the preparation of food. A packer means any person who grades, sizes, candles, and packs eggs for purpose of resale.
The Act also provides definitions of standards for eggs. A “check” means an egg that has a broken shell or crack in the shell but has its membranes intact and whose contents are not leaking. Dirty egg means an egg that has a shell that is unbroken, but has adhering dirt or foreign material, or prominent stains on the shell surface, or moderate stains covering more than 1/4 of the shell surface. Inedible eggs are any eggs of the following description: black rot, yellow rot, white rot, mixed rot (addled egg), sour egg, egg with a green white, egg with a stuck yolk, moldy egg, musty egg, egg showing a blood ring, egg containing any embryo chick (at or beyond the blood ring stage), and any egg that is adulterated as that term is defined pursuant to the Federal Food, Drug and Cosmetic Act. Leaker means an egg that has a crack or break in the shell and shell membranes to the extent that the egg contents are exposed or are exuding or free to exude through the shell. Loss means an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains bloody white, large meat spots, a large quantity of blood, or other foreign material.
With limited exception, ALL producer-dealers, distributors, handlers and packers must have a license[5] from the State of Illinois to sell eggs.
IDOA inspectors may enter the premises on any business day during regular hours of business, with or without the owner or manager present. The inspector may sample, without reimbursement, any eggs for analysis or testing. The inspector may also review invoices, cases or containers, and equipment. The inspector may seize any product, document or equipment found in violation of the Act.
Food Safety. No person may sell eggs or egg products for human consumption that are unfit for human food. Eggs or egg products are unfit for human consumption if they are classified as an inedible or loss egg. Egg products are also unfit for human consumption if adulterated, unwholesome, non‑inspected, or otherwise unfit for human consumption. Eggs that are checks, dirties, incubator rejects, inedibles, leakers or loss eggs are “restricted” and cannot be sold directly to consumers. As an exception to the rule, producers may sell checks and dirties directly to consumers on the premises where they are produced. A processing plant that undergoes continuous inspection by IDOA may use checks and dirties for human food provided that the facility pasteurizes the eggs.
Sellers, including producer-dealers, must candle and grade all eggs for sale off the premises, such as at the retail level or purchased by institutional customers, or at farmers’ markets. Further, they must hold them at 45 degrees Fahrenheit or below after processing until they reach the retailer. Eggs must be Grade B or better. Eggs sold at retail must be in new, consumer-size containers - no bulk eggs may be sold to retailers. Federal grading standards apply in Illinois.
Illinois regulations also establish minimum sanitation and operating requirements for both retailers and grading plants that are not federally inspected. The facility’s construction must be sufficient to keep out rodents. Operators must keep rooms and equipment where the eggs are candled, graded and packaged reasonably clean during the day and must thoroughly clean the rooms at the end of each day. Coolers must be in a clean, sanitary condition. Operators may not hand wash eggs and wash water must be potable and at least 20 degrees above the temperature of the eggs, or 90 degrees Fahrenheit, whichever is higher. Similarly, retailers must keep storage areas clean and sanitary. More importantly, retailers must rotate the eggs so that the first in are the first sold. Eggs past their sell-by date (see labeling, below) may not be sold.
Labeling. The package label for eggs for sale at the wholesale or retail level must identify the egg grade and size, the name of the packer, address of the packer, distributor or retailer, the packing or candling date and the expiration or “sell by” code. For Grade AA eggs, the code must indicate a date (month and day) up to 15 days after the packing date. For all other grades, the code should represent a date up to 30 days after the date of pack. Labeling must be in bold type with letters at least 3/8 inch high, and may not contain any abbreviations. Only producers who sell eggs from their own flock can make the packing claim that the eggs are "fresh eggs," "newly-laid eggs," or similar language. Producers labeling their eggs as “organic” must have USDA certification, as discussed in the “Organic Marketing” chapter of this Guide. USDA does not maintain standards for other terms sometimes applied to eggs, such as “free range,” “vegetarian fed,” “natural,” or “omega-3.” Nonetheless, the misbranding provision of the FDCA still applies, so producers should not use these terms unless they can support the claims. USDA regulates the use of some terms on poultry meat, which may inform what practices justify use of a particular label on eggs. Further guidance is available on the FSIS website.[6]
Invoice Documentation. Each producer-dealer, packer, handler or distributor who sells candled and graded eggs to a retailer, institutional consumer, bakery, or concern that purchases eggs for serving to guests must furnish the purchaser with an invoice or other accounting document covering each sale. The invoice must show the name and address of the seller and purchaser, as well as the exact grade and size of the eggs purchased. Copies of the invoices must be kept for a period of 30 days.
[2] http://www.ams.usda.gov/AMSv1.0/Grading
[3] http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004376
[4] Conversely, producers who have fewer than 3,000 hens and sell all of their eggs directly to consumers are exempt. Producers who process their eggs into egg product are also exempt, but may be subject to FSIS’s egg processing oversight.
[5] Applications are available at http://www.agr.state.il.us/pdf/egglicense.pdf
[6] http://www.fsis.usda.gov/Fact_Sheets/Meat_&_Poultry_Labeling_Terms/index.asp