The United States has a unique and at times, confusing system of federal regulation over its food supply. Generally, jurisdiction over the food supply rests with two federal agencies, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA). USDA has authority over meat, poultry, catfish, and unshelled egg products, while FDA regulates the other 80% of food. One of the most confusing aspects of this joint-jurisdiction is the regulation of eggs, which leads to this article in NALC’s Food Foundations series.
Background
USDA and FDA share authority over eggs. Specifically, the FDA “regulates the production, transportation, and storage of shell eggs.” With USDA, however, regulation is even more complex because the authority and responsibilities are divided between two sub-agencies. The USDA regulates egg products through its Food Safety and Inspection Service (FSIS), and both administers the voluntary egg grading program and inspects shell egg facilities through the Agricultural Marketing Service (AMS). Further, both USDA and FDA play a role in regulating the on-farm activities of laying hens, such as requiring written plans that outline a farm’s Salmonella prevention practices.
The FDA derives its authority over eggs from the Federal Food, Drug, & Cosmetics Act (FDCA). Specifically, the FDCA authorizes FDA to protect “consumers against impure, unsafe, and fraudulently labeled food, including shell eggs.” Modern authority for USDA stems from the Egg Products Inspection Act (EPIA) of 1970, which gave the USDA the authority to continuously inspect the processing of liquid, frozen, and dried egg products. However, the authority to regulate egg products was moved to FSIS in the 1990s after an outbreak of Salmonella Enteriditis (SE) was linked to the consumption of raw, undercooked, or inadequately refrigerated eggs. Additionally, the EPIA was amended to direct USDA to establish refrigeration and labeling rules for the storage and transport of shell eggs. The amended EPIA also required that the FDA enforce the refrigeration requirement of shell eggs at food manufacturing establishments, institutions, and restaurants.
However, there are still more laws and regulations that govern the production and sale of eggs in the United States. For instance, the voluntary grading of shell eggs is detailed in 7 CFR § 56, the regulations governing the inspection of eggs can be found in 7 CFR § 57, and the inspection of egg products is outlined in 9 CFR § 590. Further, components of the voluntary grading of shell eggs are outlined pursuant to the authorities contained in the Agricultural Market Act. 7 USC § 1621.
Defining an Egg
First, to understand the regulatory maze of eggs, it is crucial to understand how eggs are defined. In the EPIA, an egg is the “shell egg of the domesticated chicken, turkey, duck, goose, or guinea.” 21 USC § 1033(g). Egg products, on the other hand, are “dried, frozen, or liquid eggs.” 21 USC § 1033(f). USDA regulations further clarify that egg products do not include cooked egg products; imitation egg products; dietary foods; dried no-bake custard mixes; egg nogg mixes; acidic dressings; noodles; milk and egg dip; cake mixes; French toast; and sandwiches containing eggs or egg products. 9 CFR § 590.5.
Egg substitutes and freeze-dried eggs are considered egg products under the authority of FSIS. However, though FSIS has authority over egg substitutes, the FDA has the authority over imitation eggs. Egg substitutes are defined by FSIS as “consist[ing] of egg whites, artificial color, and other non-egg additives that have the equivalent nutrition of an egg product.” Imitation eggs are specifically excluded from the definition of egg products and could include products like plant-based egg alternatives. In fact, earlier this year, FDA published a draft guidance for industry to advise the labeling of plant-based alternatives, including egg-type products. To read the guidance in its full, click here.
The distinction between egg and egg products is important because it determines which agency has jurisdiction over the food.
Shell Eggs
On Farm
On the farm, animal welfare concerns and animal living conditions are governed by state law. However, USDA’s Animal and Plant Health Inspection Service (APHIS) administers the voluntary National Poultry Improvement Plan, which works to “apply new technology to the improvement of poultry and poultry products by establishing standards for the evaluation (testing) of poultry breeding stock, baby chicks, poults, and hatching eggs with respect to freedom from certain diseases.” While this program is voluntary, producers that ship to certain states or international trading partners must participate. Additionally, in 2019 the FDA finalized the Egg Safety Rule which requires the implementation of SE prevention measures to protect eggs on the farm from contamination. This rule requires registration with the FDA and the maintenance of written plans outlining SE prevention practices.
Inspection of processor
The EPIA mandates that plants where shell eggs are packed for the ultimate consumer are inspected at least once a calendar quarter. Further, the inspection should confirm that shell eggs are being held under refrigeration “at an ambient temperature of no greater than 45°F” after packing and contains labeling that indicates refrigeration is required. 21 USC § 1043(e)(1). AMS conducts these inspections through the Shell Egg Surveillance Program, but does not inspect “egg handler[s] with a flock of not more than 3,000 layers.” 21 USC § 1043(e)(4).
During those inspections, AMS will also conduct quality checks to ensure that “shell eggs sold to consumers contain no more restricted eggs than permitted in U.S. Consumer Grade B.” “U.S. Consumer Grade B” is the grade given to shell eggs of the lowest quality, and its standard allows for a small percentage of restricted eggs to be present. Restricted eggs are those that are dirty, have imperfections such as cracks in the shell, or are inedible for other reasons. Cracked and dirty eggs may be shipped to an official egg products plant for further processing, but eggs restricted for other reasons must be destroyed or used in products not for human food
Additionally, via the EPIA, the FDA is required to inspect egg packing facilities other than plants, such as food manufacturing establishments, institutes, and restaurants. 21 USC § 1043(e)(3). One of the most well-known distinctions between the regulation of the FDA and USDA-FSIS is that FSIS mandates every product under its jurisdiction be inspected for safety before it can enter commerce. On the other hand, FDA engages in periodic and much less frequent inspections for products under its jurisdiction. The same theme is seen with egg inspections, where FDA’s inspection requirements are much less frequent. As a result, shell egg packing facilities under AMS regulation will be inspected approximately four times a year, while the facilities under FDA authority will only be inspected every three to five years.
Grading
As noted above, AMS operates a voluntary shell egg grading program that provides “interested parties a national grading service based on official U.S. standards, grades, and weight classes for shell eggs.” This program, run through AMS’s Livestock and Poultry Program’s Quality Assessment Division, uses official USDA graders to evaluate the quality of shell eggs and assign them a “grade.” The grade is based on the quality standard promulgated in the document, “U.S. Standards, Grades, and Weight Classes for Shell Eggs.” This is a voluntary service that shell egg producers pay for. Eggs that undergo the voluntary grading are permitted to bear the USDA grademark, or shield, that identifies the eggs’ grade. The U.S. Grade categorizes are AA, A, or B – with AA being the highest quality and B being the lowest. The quality is determined on both the external appearance and condition of the shell and the interior quality of the yolk and albumen (white). Along with grading the quality of the shell egg, USDA graders will inspect plants for compliance with established equipment, facility, sanitation, and operating requirements. 7 CFR § 56.76.
Shell Egg Labeling
Since shell eggs are under the jurisdiction of the FDA, their packaging is subject to FDA’s general food labeling regulations. Thus, shell egg cartons must adhere to FDA requirements such as bearing the nutrient facts panel, net weight, and name and address of the manufacturer, packer, or distributor.
In addition to the general labeling requirements, all shell eggs packed in containers for the ultimate consumer must bear safe handling instructions. Specifically, the safe handling instructions must say, “To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cool foods containing eggs thoroughly.” 21 CFR § 101.7(h). This statement must be on the principle display panel, the information panel, or on the inside of the lid of the egg’s cartons. However, if the safe handling instructions are on the inside of the lid, the carton must bear the words “keep refrigerated” on the outside.
Additionally, egg cartons that bear the USDA grademark must include a legible lot number and facility or plant number on the consumer package. A lot number is the consecutive day of the year when the eggs were packed and will be composed of three numbers. 7 CFR § 56.37. For example, an egg carton that was packed on January 1st, would bear the lot number 001. The facility or plant number must be preceded by a “P” with three or four digits following, i.e., “P-1234” or “P-765.” 7 CFR § 56.36(b)(5). Lot numbers and facility or plant numbers are not required on all eggs that enter commerce – these requirements are only applicable to eggs that have undergone USDA’s voluntary shell egg grading program.
As another example of the tricky regulation of eggs, because FDA does not require pre-market approval of labels under its jurisdiction, shell egg carton labels are not required to undergo that process. As a result, the labels may be released for public sale without FDA approval. However, if the eggs were part of the USDA voluntary shell egg grading program and bear the USDA grademark, its label must receive pre-market AMS approval before entering the marketplace.
As another example of the discrepancy between agency practices, consider “raising claims” such as “cage free” or “free range.” These two claims are similarly defined by AMS as requiring “hens that are able to roam vertically and horizontally in indoor houses, and have access to fresh food and water.” Free range, however, also requires “continuous access to the outdoor during their laying cycle.” Since eggs bearing a USDA grademark must get pre-market approval from the USDA and cannot bear labels that are misleading or untruthful, an egg carton with a USDA grademark and a labeling claim like “cage free” must be source verified by USDA. This means that USDA will conduct bi-annual onsite farm visits to confirm that the laying hens are housed in an appropriate production system. To learn more about AMS’s verification of cage free USDA graded shell eggs, click here to view AMS factsheet “Cage-Free Verification of USDA Graded Shell Eggs.” On the other hand, FDA does not currently have finalized regulations on animal raising claims. In theory, that means an egg carton without a USDA grademark (which has no undergone USDA grading), could bear a “cage free” or “free range” claim without additional verification.
Egg Products
Inspection of processor
Despite the complicated nature of the US shell eggs regulatory scheme, the regulation of egg products, or eggs that have been removed from their shells, is less confusing. Typically, the process of creating an egg product will begin at a processing facility called a “breaker plant.” This is where the egg is removed from its shell. However, breaking is only the beginning for many egg products as most of them could undergo processes such as filtering, mixing, stabilizing, blending, pasteurizing, cooling, freezing, or drying before the final product is complete. No matter the level of processing an egg product undergoes, it is all completed at an FSIS-inspected plant. Specifically, the EPIA requires that all facilities that process egg products must be under “continuous inspection” from FSIS official inspectors.
Further, the EPIA requires the pasteurization of all egg products distributed for consumption. Thus, egg products must be “rapidly heated and held at a minimum required temperature for a specified time to destroy harmful bacteria.” However, there are other FSIS accepted lethality treatments for types of egg products that might not be able to undergo pasteurization. These processes include heat treatment and high-pressure cooking.
Labeling
Because egg products are regulated by FSIS, they are subject to USDA’s labeling rules. Thus, egg product labels must receive pre-market approval. However, just like for the regulation of meat and poultry products, FSIS does create an exception for labeling claims that are defined in either FSIS regulations or in the Food Standards and Labeling Policy Book (the Policy Book). This process is called generic approval, and it will exclude a product’s label from having to be submitted FSIS for approval. On the other hand, if the label contains a term not defined in FSIS regulations, the Policy Book, or is a “natural” or negative claim, the egg products label must be submitted to FSIS for “sketch approval.” To learn more about general vs. sketch approval, click here to read NALC article “The Legality of Food Labeling Claims: FSIS’s Regulations for Meat and Poultry Labeling.”
Further, egg products that bear raising claims such as “cage free” must show evidence of their validity. Some such claims, like “vegetarian fed,” are defined by FSIS policies and may be used if the company can demonstrate that it meets the definition. Others, such as “cage free,” are not defined in either FSIS regulations or in the Policy Book. Thus, a label claiming that the eggs are from “cage free” hens must also include information explaining the meaning of the claim for consumers. Further, because “cage free” is considered a “living or raising condition” it will only be approved by FSIS if additional documentation is submitted to substantiate the claim. FSIS typically encourages the use of a third-party certification to substantiate the claim – to read an earlier Food Foundations article on that topic, click here.
Beyond the standard requirements, there are also egg-product-specific requirements. For example, eggs products that are transported frozen, but thawed prior to display for sale at retail must contain the statement “Keep Frozen” on its shipping container and must bear the statement “Previously Handled Frozen for Your Protection, Refreeze or Keep Refrigerated” on consumer-sized containers. 9 CFR § 590.410(a)(2). Additionally, specific nutrition labeling is required for egg products with nutrients like proteins, vitamins, and minerals added or when certain nutritional claims are presented on the labeling. 9 CFR § 411(e). Other required information specific to egg products is outlined in 9 CFR § 590.411.
Finally, all egg products that have been inspected by FSIS will bear an official identification symbol. 9 CFR § 590.413. This symbol is a shield that contains the statement “USDA Inspected Egg Products.” The shield may also bear the official plant number of the plant where the product is inspected with the letter “G” preceding it. However, the plant number is also permitted to be displayed on the egg product’s principal display panel or another prominent location. The shield may not be applied to a detachable cover of the egg product. 9 CFR § 590.414.
Conclusion
The U.S. food system’s regulatory scheme can be confusing, and no food is a better representation of that than eggs. The two agencies primarily responsible for the regulation of food are USDA and FDA. While typically the division of authority is a clear line, with eggs, both agencies share the responsibility.