6314 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

1As defined in the Egg Products Inspection Act 

(21 U.S.C. 1031 et seq.). Exempted plants, as 

defined in 9 CFR 590.5, are also official plants, per 

the statute. 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 416, 417, 500, 590 and 591 

[Docket No. FSIS–2005–0015] 

RIN 0583–AC58 

Egg Products Inspection Regulations 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is proposing 

to amend the egg products inspection 

regulations by requiring official plants 

that process egg products (herein also 

referred to as ‘‘egg products plants’’ or 

‘‘plants’’) to develop and implement 

Hazard Analysis and Critical Control 

Point (HACCP) Systems and Sanitation 

Standard Operating Procedures 

(Sanitation SOPs) and to meet other 

sanitation requirements consistent with 

the meat and poultry regulations. FSIS 

is proposing to eliminate those current 

regulatory provisions that are 

inconsistent with HACCP, Sanitation 

SOPs, and the proposed sanitation 

requirements. FSIS is also proposing to 

specify in the regulations that official 

plants are required to process egg 

products to be edible without additional 

preparation to achieve food safety. 

In addition, FSIS is proposing to: 

Provide for generic approval as part of 

the prior label approval system for egg 

products; make changes to labeling 

requirements for shell eggs consistent 

with those in the Food and Drug 

Administration’s (FDA’s) regulations; 

require special handling instructions on 

egg products; eliminate the 

requirements for prior approval by FSIS 

of egg products plant drawings, 

specifications, and equipment; 

incorporate egg products plants into the 

coverage of the ‘‘Rules of Practice’’ that 

the Agency follows when initiating 

administrative enforcement actions; and 

change the Agency’s interpretation of 

the requirement for continuous 

inspection in agency law. 

FSIS is also announcing that it is 

seeking public comment on draft 

guidance designed to help small and 

very small plants producing egg 

products to meet the new regulatory 

requirements being proposed in this 

rulemaking. Should the rule become 

final, FSIS intends to finalize this 

guidance. 

DATES: Comments must be received on 

or before June 13, 2018. FSIS is 

providing a longer comment period than 

typical for this proposed rule because of 

the magnitude of the proposed action 

and the need to provide for possible 

public meetings on the proposed action. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

proposed rule and the draft guidance. 

Comments may be submitted by any of 

the following methods: 

• Federal eRulemaking Portal: This 

website provides the ability to type 

short comments directly into the 

comment field on this web page or 

attach a file for lengthier comments. Go 

to http://www.regulations.gov. Follow 

the on-line instructions at that site for 

submitting comments. 

• Mail, including CD–ROMs, etc.: 

Send to Docket Clerk, U.S. Department 

of Agriculture, Food Safety and 

Inspection Service, Patriots Plaza 3, 

1400 Independence Avenue SW, 

Mailstop 3782, Room 8–163B, 

Washington, DC 20250–3700. 

• Hand- or Courier-Delivered 

Submittals: Deliver to Patriots Plaza 3, 

355 E Street SW, Room 8–163B, 

Washington, DC 20250–3700. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2005–0015. Comments received in 

response to this docket will be made 

available for public inspection and 

posted without change, including any 

personal information, to http://

www.regulations.gov. 

Docket: For access to background 

documents or comments received, go to 

the FSIS Docket Room at Patriots Plaza 

3, 355 E Street SW, Room 8–164, 

Washington, DC 20250–3700 between 

8:00 a.m. and 4:30 p.m., Monday 

through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Victoria A. Levine, Program Analyst, 

Issuances Staff, Office of Policy and 

Program Development, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, 1400 Independence Avenue 

SW, Room 6079, South Agriculture 

Building, Washington, DC 20250–3700; 

telephone (202) 720–5627; fax (202) 

690–0486. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

FSIS is proposing to amend the egg 

products inspection regulations (9 CFR 

part 590) to require that official plants 1

that process egg products develop and 

implement Hazard Analysis and Critical 

Control Points (HACCP) systems and 

Sanitation Standard Operating 

Procedures (Sanitation SOPs), in 

accordance with the regulations in 9 

CFR parts 416 and 417, and to meet 

proposed sanitation requirements 

(proposed 9 CFR part 591). The Agency 

is proposing to eliminate those 

regulations that are incompatible with 

the regulations for HACCP and 

Sanitation SOPs and to convert 

prescriptive, command-and-control 

requirements to general sanitation 

standards. 

Existing regulations that FSIS is 

proposing to revise or eliminate include 

those relating to egg products plant 

grounds and pest management; plant 

sanitation; plant construction, including 

rooms, doors, and windows; lighting; 

ventilation and odors; plumbing; sewage 

disposal; water supply and solution reuse; and dressing rooms, lavatories, and 

toilets. The Agency is proposing to 

replace all of these with general 

sanitation requirements, as it has 

previously done with the requirements 

on the same subjects in the meat and 

poultry products regulations. 

The Agency is also proposing to 

specify in the regulations that official 

plants are required to process egg 

products to be edible without additional 

preparation to achieve food safety 

(proposed 9 CFR 590.570). This will 

ensure that the products are free of 

detectable pathogens. The proposed 

regulations will require egg product 

plants to maintain control of egg 

products that have been sampled and 

tested for public health hazards, e.g., 

Salmonella, until the test results 

become available (proposed 

amendments to 9 CFR 590.504). The 

proposed amended regulations will 

provide for the use of irradiated shell 

eggs in the processing of egg products 

and food products containing them 

(proposed 9 CFR 590.590). 

The Agency is proposing to make the 

egg products labeling and ‘‘other 

consumer protection’’ requirements, 

including requirements for generically 

approved labeling, more like the 

labeling requirements for meat and 

poultry products (proposed 9 CFR 

590.412). 

FSIS is proposing to align the import 

requirements for eggs and egg products 

more closely with the import 

requirements for meat and poultry 

products (proposed 9 CFR 590, Subpart 

B). 

FSIS is proposing to change 

organizational terms and job titles that 

appear in the regulations but that are no 

longer used in FSIS (proposed 

amendment of 9 CFR 590.5). 

FSIS is also proposing to change the 

Agency’s interpretation of the 

requirement for continuous inspection 

in 21 U.S.C. 1034(a). Inspection will no 


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Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6315 

longer be conducted during all 

processing operations, but may instead 

be provided at least once per shift. 

Finally, FSIS is proposing to replace 

the rules of practice governing 

enforcement procedures for egg product 

plants with those that apply to meat and 

poultry product establishments 

(proposed amendments to 9 CFR part 

500). 

Costs attributable to the proposed rule 

are those associated with the 

development and implementation of 

HACCP plans and Sanitation SOPs and 

the need for new product labels with 

safe-handling instructions. The impact 

of the costs is somewhat mitigated by 

the fact that 93 percent of egg products 

plants already use a written HACCP 

plan to address at least one production 

step in their process. 

FSIS will continue to test for 

Salmonella and Listeria monocytogenes 

(Lm) in egg products. If FSIS detects the 

pathogens in the product, under 

HACCP, plants will be required to take 

corrective actions to prevent recurrence 

of the problem, if the plant has 

determined the pathogen is reasonably 

likely to occur in its production process 

(9 CFR 417.3(a)). If FSIS detects the 

pathogen and the plant has not 

determined that the hazard is 

reasonably likely to occur, the plant will 

be required to take corrective actions 

and also will be required to reassess its 

HACCP plan (9 CFR 417.3(b)). FSIS also 

will continue to require that egg product 

plants test pasteurized egg products for 

pathogens. Plants must ensure that egg 

products that test positive for pathogens 

are condemned or reprocessed (9 CFR 

590.422). 

The proposed rule will provide 

greater flexibility and incentives for 

innovation through reductions in 

paperwork and unnecessary approvals. 

In addition, plants voluntarily meeting 

HACCP requirements and also 

complying with current prescriptive 

regulations would reduce costs because 

they would be operating entirely under 

HACCP requirements. 

TABLE 1—SUMMARY OF ESTIMATED COSTS AND BENEFITS

Discussion of benefits and costs 

Low Mid High 

Benefits ($1,000) a ....................................................................... 5,585 5,585 5,585 

Costs ($1,000) ............................................................................. 2,195.0 4,235.2 6,287.8 

Net Benefits ($1,000) ................................................................... 3,389.7 1,349.5 ¥703.1 

Industry Benefits .......................................................................... • Long-term efficiency gains, as shown in academic literature derived from 

producing egg products in a HACCP system. 

• Less burdensome or elimination of waiver, blueprints, no objection letter, 

changes to production equipment, and label approval submissions to FSIS. 

• Cost savings from the elimination of overtime and holiday pay paid to FSIS 

inspectors for inspection. 

Agency Benefits ........................................................................... • Long-term benefits from improved inspection personnel coverage. Egg 

products inspection personnel will now be trained under a HACCP system and 

can be positioned for inspection in traditional meat and poultry establishments. 

• Salary savings for the reduction in inspection at egg products plants. 

• Savings from the reduction or elimination of waiver, blueprints, no objection 

letter, changes to production equipment, and label approval submissions to 

FSIS from industry. 

Industry Costs .............................................................................. • Cost to the plant to create HACCP plans and Sanitation SOPs. 

• Costs to the plant for additional recordkeeping and monitoring. 

• Cost to the plant for training personnel in the HACCP system. 

Agency Costs ............................................................................... • Costs for training inspection program personnel in HACCP and egg products 

inspection. 

• Costs to the Agency to provide relief inspectors while egg products plants 

inspectors are being trained. 

• Additional travel costs for inspection personnel on patrol assignments in egg 

products plants. 

• Loss of overhead paid to the Agency by industry. 

a Costs were annualized over 10 years at the 7 percent discount rate. 

A copy of each document referenced 

in this notice of proposed rulemaking is 

available for viewing in the FSIS Docket 

Room, on the FSIS website as a related 

document associated with this docket, 

and on www.regulations.gov, unless 

otherwise noted. 

Table of Contents 

I. Background 

FSIS’s Regulatory Jurisdiction Over Egg 

Products 

1. What Products Are Covered Under the 

EPIA 

2. Product Amenability Determinations 

Under the EPIA 

II. Proposed Changes to Specific Regulations 

A. Part 591 

B. HACCP 

C. Sanitation SOPs 

D. Sanitation Requirements 

E. Egg Products Are ‘‘Ready-To-Eat’’ 

F. Not Applying the Mark of Inspection 

Pending Test Results 

G. Irradiated Shell Eggs 

H. Preparing for Implementation of 

Regulatory Requirements 

I. Labeling and Other Consumer Protection 

Regulatory Requirements 

J. Rules of Practice 

K. Other Regulatory Changes 

1. Elimination of Egg Products Plant 

Equipment and Facility Prior Approval 

Requirements 

2. Import Requirements 

3. Changes to Defined Terms 

4. Conditions for Receiving Inspection 

5. Miscellaneous Changes 

6. Reinterpreting the Requirement for 

Continuous Inspection in 21 U.S.C. 

1034(a) 

III. Executive Orders 12866 and 13563 and 

the Regulatory Flexibility Act 

IV. Paperwork Reduction Act 

V. Executive Order 12988 

VI. E-Government Compliance 


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6316 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

2See the United States Standards, Grades, and 

Weight Classes for Shell Eggs, AMS 56.216(c). 

http://www.ams.usda.gov/sites/default/files/media/ 

Shell_Egg_Standard%5B1%5D.pdf. 

VII. Executive Order 13175 

VIII. USDA Nondiscrimination Statement 

IX. Additional Public Notification 

I. Background 

FSIS’s Regulatory Jurisdiction Over Egg 

Products 

FSIS carries out its food safety 

responsibilities with respect to eggs and 

egg products under the provisions of the 

Egg Products Inspection Act (EPIA) (21 

U.S.C. 1031–1056). 

To prevent the entry into commerce of 

any egg product that is capable of use 

as human food and is misbranded or 

adulterated, the Secretary of Agriculture 

regulates the processing of egg products 

under 21 U.S.C. 1034. Section 1034(a) 

states that the Secretary ‘‘shall, 

whenever processing operations are 

being conducted, cause continuous 

inspection to be made, in accordance 

with the regulations promulgated under 

this Act, of the processing of egg 

products, in each plant processing for 

commerce, . . . .’’ Therefore, under 

FSIS’s current interpretation of the 

EPIA, an inspector needs to be on the 

premises during all such operations. 

The Secretary has also been authorized 

to make inspections, as appropriate, of 

the facilities of egg handlers (including 

transport vehicles) to determine 

whether shell eggs destined for the 

ultimate consumer are being held under 

refrigeration at an ambient temperature 

of no greater than 45 degrees Fahrenheit 

after packing and contain labeling that 

indicates that refrigeration is required 

(21 U.S.C. 1034(e)). 

Under 21 U.S.C. 1043, the Secretary of 

Agriculture has the authority to 

promulgate such rules and regulations 

as he deems necessary to carry out the 

purposes or provisions of the Act. The 

Secretary is also responsible for the 

administration and enforcement of the 

EPIA, except as otherwise provided in 

21 U.S.C. 1034(d). 

1. What Products Are Covered Under 

the EPIA 

Under the EPIA, FSIS regulates egg 

products. FSIS also has been delegated 

the authority to establish temperature 

and labeling requirements applicable to 

shell eggs destined for the ultimate 

consumer (see 21 U.S.C. 1034(e)(1)). 

Under 21 U.S.C. 1033(f), the term ‘‘egg 

product’’ means any ‘‘dried, frozen, or 

liquid eggs, with or without added 

ingredients, excepting products which 

contain eggs only in a relatively small 

proportion or historically have not been, 

in the judgment of the Secretary, 

considered by consumers as products of 

the egg food industry, and which may 

be exempted by the Secretary under 

such conditions as he may prescribe to 

assure that the egg ingredients are not 

adulterated and such products are not 

represented as egg products.’’ The EPIA 

does not define ‘‘relatively small 

proportion,’’ nor does it provide 

additional guidance as to what criteria 

the Secretary should take into 

consideration when determining what 

egg products consumers consider to be 

products of the egg food industry. 

Under 21 U.S.C. 1034(a), the Secretary 

requires continuous inspection to be 

made of the processing of egg products 

in each plant processing for commerce. 

There are currently 77 such official 

plants that are under FSIS jurisdiction. 

Under the EPIA, ‘‘processing’’ means 

‘‘manufacturing egg products, including 

breaking eggs or filtering, mixing, 

blending, pasteurizing, stabilizing, 

cooling, freezing, drying, or packaging 

egg products’’ (21 U.S.C. 1033(w)). 

Thus, egg products processing 

operations, such as mixing, 

pasteurizing, freezing, packaging, or 

relabeling, must be conducted under 

continuous Agency inspection. 

The definition of ‘‘egg product’’ in the 

egg products inspection regulations (9 

CFR 590.5) includes a list of specific 

products that have been exempted as 

not being ‘‘egg products.’’ These 

exempted products include freeze-dried 

products; imitation egg products; egg 

substitutes; dietary foods; dried no-bake 

custard mixes; egg nog mixes; acidic 

dressings; noodles; milk and egg dip; 

cake mixes; French toast; and 

sandwiches containing eggs or egg 

products. Such products must, however, 

be prepared from inspected egg 

products or from eggs containing no 

more restricted eggs than are allowed in 

the official standards for U.S. Consumer 

Grade B shell eggs.2 Exempted products 

are subject to the jurisdiction of the 

Food and Drug Administration (FDA). 

As stated above, products that contain 

eggs only in a relatively small 

proportion are exempted from the 

definition of ‘‘egg product’’ and thus not 

amenable under the EPIA. Several of the 

products listed in the preceding 

paragraph have been exempted from the 

coverage of ‘‘egg products’’ for this 

reason, including dried no-bake custard 

mixes; egg nog mixes; acidic dressings; 

noodles; milk and egg dip; cake mixes; 

and French toast. The egg product 

ingredients in these foods are not easily 

distinguished in the food and are used 

simply to add flavor. Other products 

that include eggs but are not subject to 

FSIS jurisdiction are closed-face 

sandwiches containing eggs or egg 

products and balut, a Philippine 

delicacy. These products are subject to 

the jurisdiction of FDA. 

Cooked egg products, such as cooked 

egg patties, cooked omelets, and freezedried cooked eggs, also fall under FDA’s 

jurisdiction because they are produced 

from USDA-inspected and passed egg 

products. To eliminate confusion as to 

who has statutory authority over these 

types of products, FSIS is proposing to 

amend the definition of ‘‘egg product’’ 

in 9 CFR 590.5 to include cooked egg 

products as not being egg products 

under FSIS jurisdiction. 

2. Product Amenability Determinations 

Under the EPIA 

FSIS considers a product to be 

amenable under the EPIA if it consists 

of dried, frozen, or liquid eggs, with or 

without added ingredients. Examples 

include Pasteurized Frozen Whole Egg 

with citric acid; plain Pasteurized 

Frozen Whole Egg without added 

ingredients; Pasteurized Liquid Yolk 

with 10% salt; Pasteurized Frozen 

Scrambled Egg Mix with Whole Egg and 

pepper, starch, and dried milk; Frozen 

Yolks with 10% sugar added; Frozen 

Egg Whites with whipping aids (such as 

sodium sulfate or triethyl citrate); 

Pasteurized Enzyme Modified Dried Egg 

Product with Egg Yolks and xanthan 

gum and citric acid to preserve color, 

and less than 1% silicon dioxide as an 

anticaking agent and phospholipase; 

Spray Dried Albumin; and Spray Dried 

Egg Whites with calcium citrate and salt 

(or other added ingredients). 

FSIS has determined that some of the 

products on the list of specific products 

that have been exempted as not being 

‘‘egg products’’ are incorrectly 

categorized as such. FSIS believes that 

these products, egg substitutes and 

freeze-dried egg products, are, in fact, 

egg products, and should therefore no 

longer be exempt from inspection by 

FSIS under the EPIA. FSIS is seeking 

comment on the number of facilities 

that might become dual jurisdiction 

facilities, that is, regulated by FSIS and 

FDA, if egg substitutes and freeze-dried 

egg products are no longer exempt from 

FSIS inspection. 

Egg Substitutes 

Egg substitutes are low-cholesterol 

products that are characterized by yolk 

replacement by other non-egg 

ingredients such as vegetable oil, nonfat 

dry milk, soy protein, gums, food 

coloring, artificial flavors, and vitamins 

and minerals (for nutritional 

fortification). The fundamental 

ingredient in these products is egg 

white, but they may also include added 


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Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6317 

egg-white solids or a small amount of 

yolk. When the EPIA and the egg 

products inspection regulations were 

written, the production of egg 

substitutes was exempted from United 

States Department of Agriculture 

(USDA) inspection in the egg products 

inspection regulations. 

As a result, egg substitutes are under 

the jurisdiction of FDA. FDA has 

overseen the formulation, packaging, 

labeling, storage, and transportation of 

egg substitutes under the Federal Food, 

Drug, and Cosmetic Act (FFDCA) (21 

U.S.C. 301–399). Egg substitutes do not 

undergo continuous inspection during 

processing (unless the starting 

ingredient is unpasteurized egg white), 

and most egg substitutes do not bear a 

USDA inspection legend. 

However, FSIS tentatively finds that 

egg substitutes should no longer be 

exempt from inspection by FSIS under 

the EPIA. Egg substitutes are similar, if 

not identical, in some cases, in 

formulation to egg products. Indeed, the 

egg product ingredient is distinctive and 

significantly contributes to the basic 

nature of egg substitutes by 

characterizing the food. The only 

substantive difference among these 

categories of products is color and 

nutrients. When a color additive is 

mixed with pasteurized egg whites, the 

resulting product is called an ‘‘egg 

substitute.’’ The application of color to 

pasteurized egg whites has generally not 

been conducted under FSIS inspection. 

The processing of egg substitutes is 

also similar to that of other egg 

products, and the contamination risks 

associated with these types of products 

are the same. Egg products and egg 

substitutes are manufactured using the 

same process, though egg substitutes 

processed in an FDA facility do not 

have to re-pasteurized; where CCPs exist 

in the manufacture of egg products, they 

exist in the production of egg 

substitutes, e.g., during mixing, 

blending, pasteurization, if applicable, 

cooling, and packaging. The fact that egg 

substitutes are formulated with 

pasteurized egg whites does not mean 

that all food safety risks associated with 

the products are eliminated. Some egg 

substitutes are not re-pasteurized after 

production, even though they have been 

further processed in the FDA facility. To 

produce egg substitutes, manufacturers 

need to reprocess pasteurized egg 

whites because of the risk of product 

contamination post-pasteurization. 

Because the risks associated with egg 

substitutes are the same as those 

associated with egg products, and 

because the reprocessing step presents a 

point in the process where 

contamination of egg substitutes might 

occur, under the EPIA, the processing of 

egg substitutes needs to take place 

within the framework of HACCP and 

Sanitation SOP preventive control 

measures. Furthermore, the addition of 

color and other ingredients does not 

materially change the products such 

that the jurisdiction over the inspection 

of the products should be different than 

for other egg products. In an effort to be 

more transparent about the roles and 

responsibilities of FSIS and FDA 

regarding eggs, and after consulting with 

FDA, FSIS is proposing to assert 

jurisdiction over egg substitutes. 

In addition, FSIS is proposing to 

assert jurisdiction over freeze-dried egg 

products. Under 9 CFR 590.5, these are 

exempted from being egg products. 

However, FSIS tentatively finds this 

categorization to be incorrect. Freezedried egg products are amenable under 

the EPIA because they consist of a 

pasteurized egg product that is flash 

frozen and placed in a vacuum chamber 

where ice particles are removed. The 

food safety risks associated with 

freezing the product and contemplated 

by the EPIA are the same whether the 

process takes place in an FSIS-inspected 

egg products plant or an FDA-inspected 

facility. As a result, if this proposal is 

adopted, freeze-dried egg products will 

no longer be exempt and will be subject 

to FSIS’s jurisdiction. Therefore, FSIS is 

proposing to amend the list of products 

exempted as not being egg products in 

9 CFR 590.5 to eliminate freeze-dried 

products and egg substitutes. 

II. Proposed Changes to Specific 

Regulations 

A. 9 CFR Part 591 

Under proposed 9 CFR 591.1(a), all 

official plants will have to comply with 

the requirements contained in 9 CFR 

parts 416, Sanitation, and 417, HACCP 

Systems. For the purposes of these 

parts, as well as 9 CFR part 500, Rules 

of Practice, an ‘‘official establishment’’ 

or ‘‘establishment’’ will include a plant 

that processes egg products (proposed 9 

CFR 591.1(b)). 

B. HACCP 

FSIS is proposing to adopt HACCP as 

the organizing structure for its egg 

products food safety program because 

HACCP has been proven to be an 

optimal framework for building sciencebased process control into food 

production systems to prevent food 

safety hazards. Under proposed 9 CFR 

590.149(b) and 591.1(a), official plants 

will be required to comply with 9 CFR 

part 417, the Agency’s regulation on 

HACCP, as a condition of receiving 

inspection. 

HACCP is a flexible system that will 

enable official plants to tailor their 

control systems to the needs of their 

particular plants and processes. Under 

proposed 9 CFR 590.149(b)and 591.1 

and 9 CFR part 417, each egg products 

plant will be required to develop and 

implement a HACCP system for food 

safety that is designed to prevent, 

eliminate, or reduce to an acceptable 

level the occurrence of biological, 

chemical, and physical hazards that are 

reasonably likely to occur in the plant’s 

process. Plants will be responsible for 

developing and implementing HACCP 

plans that incorporate the controls that 

are necessary to produce safe egg 

products. Given the requirements in 9 

CFR part 417, FSIS is proposing to 

amend or eliminate many of the 

processing and facility requirements 

contained in 9 CFR 590.500–575. 

Under 9 CFR part 417, when 

developing a HACCP plan (9 CFR 

417.2(b)), a plant conducts a hazard 

analysis to identify and list the 

biological, chemical, or physical food 

safety hazards that are reasonably likely 

to occur in its production process for a 

particular product and the measures 

necessary to prevent, eliminate, or 

reduce the occurrence of those hazards 

to an acceptable level. The plant then 

identifies the points in each of its 

processes at which control is necessary 

to achieve this goal (9 CFR 417.2(c)(2)). 

These points are called ‘‘critical control 

points’’ (CCPs). The plant would have to 

establish critical limits for the 

preventive measures associated with 

each identified CCP. A critical limit is 

the maximum or minimum value to 

which a hazard must be controlled at a 

CCP to prevent, eliminate, or reduce to 

an acceptable level the occurrence of the 

identified food safety hazard. Critical 

limits are most often based on process 

parameters such as temperature, time, 

water activity, pH, or humidity. 

FSIS is proposing to treat egg 

products similarly to the way it treats 

ready-to-eat (RTE) meat and poultry 

products. FSIS will require that official 

plants produce egg products to be edible 

without additional preparation to 

achieve food safety. Pathogens detected 

in or on RTE egg products would 

adulterate those egg products under 21 

U.S.C. 1033(a)(1)) because they would 

contain a poisonous or deleterious 

substance which may render them 

injurious to health. 

For example, FSIS regards any 

amount of Lm in an RTE product as a 

product adulterant (9 CFR 430.4). 

Because the product is RTE, it is likely 

to be consumed without any effort to 

kill the pathogen, and the presence of 

the pathogen may render the product 


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6318 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

3Control of Listeria monocytogenes in Ready-toEat Meat and Poultry Products; Final Rule (68 FR 

34208, Jun. 6, 2003). 

4E. coli O157:H7 Contamination of Beef Products 

(67 FR 62325, October 7, 2002) (available at: http:// 

www.fsis.usda.gov/wps/wcm/connect/ad259bcd5b85-4696-9888-89872bee39ee/00-022N.pdf?

MOD=AJPERES). 

5Control of Listeria monocytogenes in Ready-toEat Meat and Poultry Products; Final Rule (68 FR 

34214, Jun. 6, 2003). 

6FSIS. 2013. Establishment Guidance for the 

Selection of a Commercial or Private 

Microbiological Testing Laboratory (available at: 

http://www.fsis.usda.gov/wps/wcm/connect/ 

464a4827-0c9a-4268-8651-b417bb6bba51/ 

Guidance-Selection-Commercial-PrivateMicrobiological-Testing-lab-062013.pdf?MOD=

AJPERES). 

7HACCP Systems Validation (80 FR 27557, May 

14, 2015). 

8 Isolation and Identification of Salmonella from 

Meat, Poultry, Pasteurized Egg, and Siluriformes 

(Fish) Products and Carcass and Environmental 

Sponges. January 2, 2017 (available at: https://

www.fsis.usda.gov/wps/wcm/connect/700c05fe06a2-492a-a6e1-3357f7701f52/MLG-4.pdf?MOD

=AJPERES). 

9 Isolation and Identification of Listeria 

Monocytogenes from Red Meat, Poultry, Ready-ToEat Siluriformes Fish and Egg Products, and 

Environmental Samples January 2, 2017 (available 

at: https://www.fsis.usda.gov/wps/wcm/connect/ 

1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG-8.pdf?

MOD=AJPERES). 

injurious to health (21 U.S.C. 601(m)(1), 

453(g)(1)) and would cause the product 

to be unhealthful.3 The same would be 

true of an RTE egg product containing 

Salmonella or Lm. While egg products 

may receive additional preparation for 

palatability or aesthetic, epicurean, 

gastronomic, or culinary purposes, they 

are produced to be edible without 

additional preparation to achieve food 

safety. The presence of Salmonella or 

Lm, therefore, would render the product 

injurious to health (21 U.S.C. 1033(a)(1)) 

and would cause it to be unhealthful. 

FSIS has also addressed shiga-toxin 

producing E. coli (STEC) in certain raw 

beef products (non-intact or intended 

for non-intact use) in this manner. FSIS 

considers an acceptable reduction for 

STEC to be a reduction to an 

undetectable level (i.e., a level that 

would not be detectable using the FSIS 

testing method or a method with a 

sensitivity at least equivalent to FSIS’s 

method).4 This means that an 

establishment producing RTE meat or 

poultry products or certain raw beef 

products needs to address the pathogens 

so that they will not be detected by FSIS 

or other equivalent testing. FSIS has 

recommended that establishments do 

their own testing to verify that their 

HACCP systems address the pathogens 

of concerns.5 While establishments can 

use their own testing methods, those 

methods should be at least as sensitive 

as FSIS’s.6 FSIS has also said that 

establishments can address the 

pathogen in their HACCP plan or 

Sanitation SOPs or other prerequisite 

program.7 This same guidance would 

apply to egg products plants. 

Under the Agency’s verification 

testing program, egg products are broken 

into seven product categories—four 

liquid and three dried. Each month, 

inspectors collect one egg product 

sample per process from each plant that 

produces egg products. Thus, inspectors 

could sample an egg products plant as 

many as seven times per month 

depending on the number of plant 

production processes occurring during 

the month. After inspectors collect the 

samples, FSIS Field Service 

Laboratories analyze the samples for the 

presence of Salmonella and Lm using 

the protocols listed in the Microbiology 

Laboratory Handbook.8 9

Once a plant has established critical 

limits for the measures associated with 

each identified CCP, it will need to 

monitor the identified CCPs to assess 

whether the CCP is within the 

established critical limit (9 CFR 

417.2(c)(4)). Monitoring is an integral 

part of HACCP, and monitoring 

frequencies must be sufficient to ensure 

that each CCP is under control. The 

plant’s HACCP plan would also have to 

include corrective action to be taken 

when monitoring indicates that there is 

a deviation from a critical limit at a 

CCP, because the existence of a HACCP 

plan does not guarantee that problems 

will not arise (9 CFR 417.2(c)(5)). For 

example, corrective action plans must 

be in place to identify and correct the 

cause of a deviation and to determine 

the disposition of potentially 

adulterated product. 

Plants will also have to develop and 

maintain effective recordkeeping 

procedures that document the entire 

HACCP system (9 CFR 417.2(c)(6)). 

Finally, plants will need to list the 

verification procedures, and the 

frequency with which those procedures 

will be performed, that the plant will 

use to ensure that the HACCP system is 

in compliance with the HACCP plan (9 

CFR 417.2(c)(7)). Periodic verification 

will help the plant to ensure that it is 

operating in accordance with its HACCP 

plan. The occurrence of unforeseen 

hazards evidences that the HACCP plan 

needs to be reassessed. If this proposal 

is adopted, individuals developing, 

reassessing, and modifying HACCP 

plans in accordance with 9 CFR 417.2(b) 

and 417.3 will have to have successfully 

completed a course of instruction in the 

application of the seven HACCP 

principles to meat, poultry, or egg 

products processing, including a 

segment on the development of a 

HACCP plan for a specific product and 

on record review (9 CFR 417.7(b)). 

Under this proposal, if an egg 

products plant fails to develop and 

implement a HACCP plan that complies 

with proposed 9 CFR 590.149(b) and 

591.1 and 9 CFR 417.2, or to operate in 

accordance with other 9 CFR part 417 

requirements, FSIS is likely to file a 

complaint to withdraw or refuse 

inspection services, pursuant to 9 CFR 

500.6 or 500.7. As with official meat and 

poultry products establishments, FSIS 

will verify that the plant’s HACCP plans 

comply with the requirements of 

proposed 9 CFR 590.149(b) and 591.1 

and 9 CFR part 417; that these plans 

have been validated by the facility; and 

that plants are producing egg products 

to be edible without additional 

preparation to achieve food safety. In 

other words, these products must be free 

of detectable pathogens. 

Hazard Analysis 

If this proposal is adopted, each egg 

products plant will be required to 

conduct a hazard analysis to determine 

the food safety hazards reasonably likely 

to occur in its production processes and 

to identify the preventive measures that 

it needs to take to control those hazards 

(proposed 9 CFR 590.149(b) and 591.2 

and 9 CFR 417.2(a)(1)). The analysis 

must include a flow chart that describes 

the steps of the process and that 

identifies the intended use or 

consumers of the finished product (9 

CFR 417.2(a)(2)). 

Contamination with Salmonella spp. 

can be a food safety hazard that is 

reasonably likely to occur in the 

production of egg products. Therefore, 

as part of its hazard analysis, each egg 

products plant should consider 

addressing this food safety hazard in its 

HACCP system. Consistent with the 

application of HACCP in meat and 

poultry operations, plants may 

determine that the Sanitation SOP or a 

prerequisite program is an appropriate 

and suitable means to effectively 

prevent the occurrence of certain food 

safety hazards and thus make them not 

reasonably likely to occur. 

HACCP Plan 

Under this proposed rule, each egg 

products plant will be required to 

develop and implement a HACCP plan 

covering each product produced 

whenever the hazard analysis reveals 

one or more food safety hazards that are 

reasonably likely to occur. Note that a 

single HACCP plan may encompass 

multiple products within a single 

processing category (see proposed 9 CFR 

590.149(b) and 591.2 and 9 CFR 

417.2(b)(1)) if the food safety hazards, 


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10On May 14, 2015, FSIS announced the 

availability of the final revision of its Compliance 

Guideline for Hazard Analysis Critical Control 

Point (HACCP) systems validation (80 FR 27557). 

CCPs, critical limits, and procedures 

identified within are essentially the 

same. 

Once completed, the HACCP plan 

must be signed and dated by a 

responsible official, that is, the 

individual with overall authority on-site 

or a higher level official of the plant. 

This signature signifies that the plant 

accepts and will implement the HACCP 

plan. The HACCP plan must be signed 

and dated not only upon initial 

acceptance by the processor but also 

upon any modification to the plan and 

at least annually, as required by 9 CFR 

417.4(a)(3) (9 CFR 417.2(d)). 

Corrective Actions 

Under this proposed rule, the HACCP 

plan must identify the corrective actions 

that the plant will take when 

responding to a deviation from a critical 

limit and assign responsibility for taking 

corrective action. Corrective actions 

must ensure that no product that is 

injurious to health or that is otherwise 

adulterated as a result of the deviation 

enters commerce; that the cause of the 

deviation is identified and eliminated; 

that the CCP will be under control after 

the corrective action is taken; and that 

measures to prevent recurrence are 

established (proposed 9 CFR 590.149(b) 

and 591.2 and 9 CFR 417.3). 

Because pre-established corrective 

actions may not cover every 

contingency, and unforeseen hazards or 

deviations may occur, 9 CFR 417.3(b) 

provides a series of steps that must be 

taken in such situations. These steps 

include segregating and holding affected 

product and conducting a review to 

determine the acceptability of the 

product for distribution, ensuring that 

any adulterated product or product 

otherwise injurious to health does not 

enter commerce, and reassessing 

HACCP plans to determine whether any 

modification is needed. 

Validation, Verification, and 

Reassessment 

Under this proposed rule, every egg 

products plant will be required to 

validate its HACCP plan’s adequacy in 

controlling the food safety hazards 

identified during the hazard analysis. 

Once the plant has determined that the 

HACCP plan is functioning as intended, 

it will have to validate that the plan is 

being effectively implemented 

(proposed 9 CFR 590.149(b) and 591.1 

and 9 CFR 417.4(a)).10 FSIS will provide 

additional guidance to plants on how to 

validate their HACCP systems. 

Upon completion of the hazard 

analysis and the development of the 

HACCP plan, the plant will conduct its 

initial validation, which consists of the 

activities the plant must perform to 

determine whether the plan is 

functioning as intended. During this 

initial validation, the facility repeatedly 

tests the adequacy of the CCPs, critical 

limits, monitoring and recordkeeping 

procedures, and corrective actions set 

forth in the HACCP plan. Validation 

also encompasses reviews of the 

records, routinely generated by the 

HACCP system, in the context of other 

validation activities. Plants may use 

independent consultants, process 

authorities, or employees trained in 

accordance with 9 CFR 417.7 for plan 

development and validation. 

The data used to validate a HACCP 

plan may be derived from various 

sources, including the scientific 

literature, product testing results, 

experimental research results, 

scientifically-based regulatory 

requirements, FSIS compliance 

guidelines, computer-modeling 

programs, and data developed by 

process authorities (a process authority 

is a person or organization with expert 

knowledge in the relevant products, 

process controls, and regulations). 

However, validation data must include 

at least 90 days of in-plant data or 

information reflecting the plant’s 

experience in implementing the HACCP 

plan during plant operations. These data 

are needed because validation must 

demonstrate not only that the HACCP 

plan is scientifically sound, but also that 

this particular egg products plant can 

implement the HACCP plan and make it 

work. 

To ensure that the HACCP plan is 

functioning as intended on a continual 

basis, the plant would conduct ongoing 

verification activities (proposed 9 CFR 

590.149 and 591.1 and 9 CFR 

417.4(a)(2)). Verification is intended to 

show that the HACCP system is working 

effectively on a day-to-day basis, 

resulting in the production of safe food. 

Verification is distinct from ongoing 

plant monitoring, which is designed to 

provide a record showing that the 

written HACCP plan is being followed. 

Verification includes repeatedly 

reviewing and evaluating the various 

components of the HACCP system. 

Verification activities should provide 

practical results specific to the 

operation of the given HACCP plan and 

could include, but would not be limited 

to, checking the adequacy of critical 

limits; reviewing CCP-monitoring 

records; reviewing monitoring and 

recordkeeping procedures; calibrating 

process-monitoring instruments; 

collecting in-line or finished product 

samples for biological (e.g. Salmonella 

spp.), chemical, or physical analysis; 

and directly observing and evaluating 

the adequacy of corrective actions. 

Under this proposed rule, plants will 

also be required to reassess the 

adequacy of their HACCP plans at least 

annually and whenever any changes 

occur that could affect the hazard 

analysis or alter the HACCP plan. 

Examples of such changes include 

changes in raw materials or the source 

of raw materials; product formulation; 

production volume; packaging; or the 

intended use or consumers of the 

finished product (proposed 9 CFR 

590.149, 591.1, and 591.2, and 9 CFR 

417.4(a)(3)). This reassessment must be 

conducted by an individual who has 

successfully completed a course of 

instruction in the application of the 

seven HACCP principles, including a 

segment on the development of a 

HACCP plan for a specific product, for 

example, liquid egg product, and on 

record review (9 CFR 417.7(b)). 

By periodically monitoring its HACCP 

plan, a plant can ensure that the plan is 

continuously effective in controlling 

and preventing food safety hazards. It 

also provides a plant the opportunity to 

apply relevant experiences to improving 

process controls. 

Records 

Under this proposed rule, plants will 

have to maintain records regarding their 

operations under HACCP. These records 

include the written hazard analysis and 

all supporting documentation, the 

written HACCP plan and all decisionmaking documents associated with the 

development of CCPs and critical limits, 

and documents supporting the 

monitoring and verification procedures 

selected and the frequency of those 

procedures. Records documenting the 

monitoring of CCPs and critical limits, 

corrective actions, verification 

procedures and results, product codes, 

and product name or identity will also 

have to be maintained. Each entry on a 

record maintained under the HACCP 

plan will have to be made at the time 

the specific event occurred and include 

the date and time recorded, and be 

signed or initialed by the employee 

making the entry. 

Prior to shipping product, the plant 

will have to review the processing and 

production records associated with the 

HACCP plan to ensure that they are 

complete, all critical limits were met, 

and, if applicable, that corrective 

actions were taken (proposed 9 CFR 

590.149 and 591.1 and 9 CFR 417.5(c)). 


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6320 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

11Under 21 U.S.C. 1035, official plants must be 

operated in accordance with such sanitary practices 

and have such premises, facilities, and equipment 

as are required by regulations promulgated by the 

Secretary to effectuate the purposes of the EPIA. 

This pre-shipment review will have to 

be conducted by someone other than the 

person who produced the records, 

where practicable, and preferably by an 

individual trained in accordance with 9 

CFR 417.7 or the responsible plant 

official. 

C. Sanitation Standard Operating 

Procedures (Sanitation SOPs) 

General 

Proper sanitation is an important and 

integral part of every food process and 

a fundamental requirement under the 

law. Insanitary facilities and equipment, 

and poor food handling and personal 

hygiene practices among employees, 

create an environment in which 

pathogens can flourish. Furthermore, 

the law is quite clear: Eggs or egg 

products that have been prepared, 

packed, or held under insanitary 

conditions whereby they may have been 

contaminated with filth, or whereby 

they may have been rendered injurious 

to health are deemed adulterated (21 

U.S.C. 1033(a)(4)). FSIS inspection 

program personnel are expressly 

charged with ensuring that product is 

produced and held under sanitary 

conditions.11 For these reasons, FSIS is 

proposing to require that all plants that 

process egg products develop, 

implement, and maintain written 

Sanitation SOPs to prevent direct 

contamination or adulteration of 

product before and during operations (9 

CFR 416.11). Under this proposed rule, 

plants will be required to maintain daily 

records to document adherence to the 

SOPs (§ 416.16). FSIS is proposing to 

cross-reference 9 CFR part 416 in 9 CFR 

591.1 rather than duplicate the 

regulatory text. 

Sanitation SOPs are necessary 

because they clearly define each plant’s 

responsibility to consistently follow 

effective sanitation procedures to 

minimize the risk of direct product 

contamination and adulteration. This 

proposal is based on FSIS’s 

determination for meat and poultry 

plants that effective sanitation is 

essential for food safety and for the 

successful implementation of HACCP. 

FSIS is not aware of any reason why the 

same determination should not be made 

for egg products plants. 

Well-run plants have effective quality 

control and sanitation programs, 

including written Sanitation SOPs. Such 

programs are based, in large part, on the 

plants’ recognition of the link between 

the existence of insanitary conditions 

during the processing and production of 

egg products and the likelihood that 

bacteria, including pathogenic bacteria, 

will contaminate the finished product. 

Some plants, however, do not have 

adequate programs and do not 

consistently maintain good sanitation. 

In fact, poor sanitation is the most 

frequently cited problem identified by 

FSIS inspection program personnel in 

egg products plants. 

If FSIS finalizes this proposal, all 

official plants will be required to 

develop, implement, and maintain 

written Sanitation SOPs, as well as 

comply with the Sanitation 

requirements (9 CFR 416.1–6), in 

accordance with 9 CFR part 416. As a 

result, FSIS is proposing to amend or 

replace many of the current sanitary 

requirements contained in 9 CFR 

590.500–575. The plant’s Sanitation 

SOPs will need to describe all 

procedures the plant conducts daily to 

prevent direct contamination or 

adulteration of products (proposed 9 

CFR 591.1(a) and 9 CFR 416.12(a)). The 

Sanitation SOPs will also need to 

specify the frequency with which each 

procedure in the Sanitation SOPs is to 

be performed and identify the plant 

employees responsible for 

implementing and maintaining the 

procedures (9 CFR 416.12(d)). The 

Sanitation SOPs will have to be signed 

and dated, upon initiation and any 

modification, by ‘‘the individual with 

overall authority on-site or a higher 

level official of the plant.’’ The signature 

will signify that the plant will 

implement and maintain the Sanitation 

SOPs in accordance with 9 CFR part 416 

(proposed 9 CFR 591.1 and 9 CFR 

416.12(b)). Official plants will also have 

to identify their pre-operational 

sanitation procedures in their written 

Sanitation SOPs, distinguishing them 

from sanitation activities to be carried 

out during operations (proposed 9 CFR 

591.1 and 9 CFR 416.12(c)). 

Under this proposal, each plant will 

be required to conduct the preoperational and operational procedures 

as specified in the Sanitation SOPs, 

monitor the conduct of the procedures, 

and routinely evaluate the effectiveness 

of the SOPs and modify the Sanitation 

SOPs as necessary, in light of changes 

to the facility, personnel, or operations, 

to ensure that they remain effective in 

preventing direct product 

contamination and adulteration 

(proposed 9 CFR 591.1 and 9 CFR 

416.13 and 416.14). 

Plants will have to take corrective 

action when either the plant or FSIS 

determines that the Sanitation SOPs, or 

their implementation, may have failed 

to prevent direct product contamination 

or adulteration (9 CFR 416.15(a)). 

Corrective actions include ‘‘procedures 

to ensure appropriate disposition of 

product(s) that may be contaminated, 

restore sanitary conditions, and prevent 

the recurrence of direct contamination 

or adulteration of product(s), including 

appropriate reevaluation and 

modification of the Sanitation SOPs and 

the procedures specified therein . . .’’ 

(proposed 9 CFR 591.1 and 9 CFR 

416.15(b)). 

If this proposed rule is adopted, 

plants will have to keep daily records 

documenting that the sanitation and 

monitoring procedures listed in the 

Sanitation SOPs are performed and 

maintain records documenting any 

corrective actions taken to prevent 

direct contamination or adulteration of 

products, or when the plant determines 

or FSIS notifies it that its Sanitation 

SOPs are inadequate (proposed 9 CFR 

591.1 and 9 CFR 416.16(a)). Under this 

proposal, records may be maintained on 

a computer, provided that plants 

implement controls to ensure the 

integrity of the electronic data (9 CFR 

416.16(b)). Records could be retained 

off-site, provided that they are not 

removed from the plant for at least 48 

hours following their completion, and 

that they can be provided to FSIS 

personnel within 24 hours of being 

requested (9 CFR 416.16(c)). 

Under the proposed Sanitation SOPs, 

FSIS inspection program personnel will 

verify that plant management is 

conducting its operations in a sanitary 

environment and manner. Failure to 

comply with the Sanitation SOPs 

provides presumptive evidence of 

insanitation. As is now the case, 

inspection program personnel will act to 

prevent a facility from operating under 

insanitary conditions. 

D. Sanitation Requirements 

In addition to Sanitation SOP 

requirements, FSIS is proposing to 

remove the current sanitation 

requirements discussed below for egg 

products plants from its regulations. 

Some of the existing plant sanitation 

requirements will no longer be needed 

in light of the proposed HACCP and 

Sanitation SOP requirements. Further, 

some of the existing plant sanitation 

requirements impede innovation and 

blur the distinction between plant and 

inspector responsibilities for 

maintaining sanitary conditions. Should 

these regulations become final, they will 

provide official plants with more 

flexibility to innovate with regard to 

facility design, construction, and 

operations. 


sradovich on DSK3GMQ082PROD with PROPOSALS2
Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6321 

The sanitation requirements proposed 

in this rule will not only provide plants 

with the flexibility to innovate in 

facility design, construction, and 

operations but will also articulate the 

standards for good sanitation and for 

food product safety that must be met by 

egg products processors. All sanitation 

requirements have the same intent: A 

plant that processes egg products must 

operate under sanitary conditions, in a 

manner that ensures that the product is 

not adulterated and that does not 

interfere with FSIS inspection and its 

enforcement of such standards. 

However, because the proposed 

sanitation requirements define the 

results to be achieved by sanitation, but 

not the specific means to achieve those 

results, plants can meet the sanitation 

requirements in different ways. 

Regardless of the means by which plants 

comply with the standards under this 

proposed rule, the required results will 

be the same for all egg products plants. 

FSIS is proposing to replace most of 

the current sanitation regulations in 9 

CFR 590.500 through 590.560 with the 

general sanitation requirements set out 

in 9 CFR 416.1 through 416.6, which the 

Agency is proposing to incorporate by 

reference (proposed 9 CFR 591.1(a)). 

This proposed change will significantly 

reduce the number of egg and egg 

products sanitation regulations and 

consolidate most sanitation 

requirements for eggs and egg products 

with those for meat and poultry 

products. 

General Sanitation—9 CFR 416.1 and 

Proposed 9 CFR 591.1 

The current sanitation regulations for 

eggs and egg products require that 

plants, including rooms, windows, and 

floors, be kept clean and reasonably dry, 

and free from objectionable odors, flies, 

insects, and rodents. Section 416.1 of 9 

CFR, which applies to meat and poultry 

establishments, provides greater 

flexibility: ‘‘Each official establishment 

must be operated and maintained in a 

sanitary manner sufficient to ensure that 

product is not contaminated, 

adulterated, or misbranded.’’ Unlike 

command-and-control regulations, 

examples of which are cited below, 9 

CFR 416.1 will provide facilities with 

the maximum possible flexibility to 

innovate in facility design, construction, 

and operation. 

Examples of current requirements to 

be replaced by the general standards are: 

§ 590.500(d), which states that materials 

and equipment not currently needed 

shall be handled or stored in a manner 

so as not to constitute a sanitary hazard; 

§ 590.500(e), concerning doors and 

windows leading to rooms where 

exposed edible product is handled; 

§ 590.522(a) concerning breaking room 

operations; and § 590.539(a), concerning 

the defrosting of frozen egg product in 

a sanitary manner. 

The proposed rule would also provide 

flexibility to industry in facility design, 

construction, and operation by the 

replacement of the following regulations 

with the general standards in 9 CFR 

416.1: § 590.506(c), which requires the 

installation of an approved exhaust 

system for the continuous removal 

directly to the outside of any steam, 

vapors, odors, or dust in the candling 

and transfer room; § 590.508(a), which 

states that candling and transfer rooms 

and equipment shall be kept clean, free 

from cobwebs, dust, objectionable 

odors, and excess packing materials; 

and § 590.546(b), which requires that 

the air intake source in albumen flake 

process drying facilities be free from 

foul odors, dust, and dirt. 

Establishment Grounds and Pest 

Management—9 CFR 416.2(a) 

The current egg products plant 

requirements for facility grounds are 

unnecessarily prescriptive. For example, 

9 CFR 590.500(b) requires that the 

premises be free from refuse, waste, and 

other materials and conditions that 

constitute a source of odors or a harbor 

for insects, rodents, and other vermin, 

while § 590.500(g) states that drains and 

gutters shall be properly installed with 

approved traps and vents. Several other 

sections (§§ 590.542(a), 547(a), and 

548(a)) require that rooms be kept free 

of flies, insects, and rodents. 

The other prescriptive establishment 

grounds regulations are 9 CFR 

590.500(a) and (c), which require that 

the plant be free from objectionable 

odors, dust, and smoke-laden air and 

state that the buildings shall be of sound 

construction and kept in good repair to 

prevent the entrance or harboring of 

vermin, and § 590.522(a), which states 

that the breaking room shall be kept in 

dust-free clean condition and free from 

flies, insects, and rodents. In addition, 

9 CFR 590.522(a) requires that the plant 

keep the floor clean and reasonably dry 

during breaking operations and free of 

egg meat and shells. 

The general sanitation requirements 

in 9 CFR 416.2(a) preserve the intent of 

these requirements that grounds be 

maintained to prevent conditions that 

could lead to the contamination or 

adulteration of product, and that 

establishments implement and maintain 

an integrated pest control program to 

eliminate the harborage of pests on the 

grounds and within the plant facilities. 

This regulation, however, provides the 

flexibility and leave to innovate that the 

Agency is proposing to incorporate into 

the egg product regulations. 

Establishment Construction—9 CFR 

416.2(b) 

The egg products inspection 

regulations concerning construction of 

egg products plants are very prescriptive 

and inflexible. For example, 9 CFR 

590.500 prescribes numerous, specific 

requirements for different areas within 

an official plant, e.g., dressing rooms, 

toilet facilities, and refuse rooms. Other 

regulations containing prescriptive 

construction requirements include 

§ 590.506, candling and transfer-room 

facilities and equipment; § 590.520, 

breaking room facilities; § 590.546, 

albumen flake process drying 

operations, § 590.560, concerning 

personnel facilities; and § 590.570(a), 

concerning pasteurization facilities. 

Section 416.2(b) of 9 CFR sets out 

construction sanitation requirements 

that will allow for increased flexibility 

in regard to facility operation 

construction and maintenance if 

adopted by reference through proposed 

9 CFR 591.1. Plants will be able to 

design facilities and equipment in the 

manner that they deem best to maintain 

the required sanitary environment for 

food production. 

In addition to the six prescriptive egg 

products construction regulations listed 

above, there are seven more 

construction requirements that will be 

replaced by 9 CFR 416.2(b) if this 

proposal is finalized. They are 9 CFR 

590.146(b)(5) and (d), concerning the 

requirements for floor plans and revised 

blueprints submitted prior to receiving 

inspection service or making changes or 

revisions to an official plant; 

§ 590.500(i), (j), (l), and (o), concerning 

structure construction materials, 

maintenance requirements for rooms in 

which shell eggs or egg products are 

handled, and toilet and refuse room 

requirements; § 590.532(a), concerning 

liquid egg holding tank requirements; 

§ 590.534(a), concerning freezing room 

requirements; § 590.548(c), which 

addresses heat treatment room 

construction requirements; § 590.550, 

dealing with washing and sanitizing 

room or area facility requirements; and 

§ 590.560(a) and (b), concerning the 

health and hygiene of plant personnel 

and the construction of personnel 

facilities. 

Light—9 CFR 416.2(c) 

The lighting requirements for 

breaking rooms in official plants in 

§ 590.520(a) prescribe specific light 

intensities for all working surfaces in 

the room and at breaking and inspection 

stations. For example, all working 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6322 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

surfaces must have at least 30 footcandles of light intensity, while 

breaking and inspection stations must 

have at least 50 foot-candles of light 

intensity. Other egg products 

regulations do not contain specific 

lighting requirements, stating only that 

rooms shall be adequately or welllighted (see §§ 590.500(l)(i), 548(a), and 

550(a)). 

The intent of the lighting 

requirements is to ensure that there is 

enough light of adequate quality to 

monitor sanitary conditions and 

processing operations and to examine 

product for evidence of adulteration or 

misbranding. Section 416.2(c) of 9 CFR 

has codified this intent as a general 

sanitation requirement, and it will be 

applicable to plants that process egg 

products if this proposed rule is 

finalized. Under 9 CFR 416.2, which 

requires that lighting be of good quality 

and of sufficient intensity to ensure that 

sanitary conditions are maintained, and 

that product is not adulterated, plants 

will have the flexibility to determine 

what light intensities are appropriate to 

ensure sanitation in different 

operational contexts. Therefore, FSIS is 

proposing to remove §§ 590.500(l)(1), 

520(a), 548(a), and 550(a) from the egg 

products inspection regulations. 

Ventilation—9 CFR 416.2(d) 

The egg products inspection 

regulations addressing ventilation 

generally require that ventilation 

provide for a positive flow of outside 

filtered air through rooms and air of 

suitable working temperature during 

operations, and that rooms be kept free 

from objectionable odors and 

condensation (see §§ 590.500, 

590.504(p), 590.506(c), 590.520(d), 

590.550(a)). Objectionable odors or 

condensation are to be reduced to the 

extent possible or eliminated because 

they can adulterate product. FSIS has 

codified a single sanitation requirement, 

9 CFR 416.2(d), which preserves the 

intent of the current egg products 

regulations. This codification will 

simplify FSIS’s egg products ventilation 

regulations by consolidating them into 9 

CFR 416.2(d). 

In addition to the regulations 

discussed above, FSIS is proposing to 

remove the following regulations from 9 

CFR part 590 because they will be 

replaced by proposed 9 CFR 416.2(d) if 

this rule is finalized: 9 CFR 590.435(d), 

which states that containers and 

packing or packaging materials in which 

shell eggs are received into the official 

plant shall be free from odors and 

materials which could contaminate or 

adulterate the eggs or egg products; 

§ 590.508(b), requiring the removal of 

containers for trash and inedible eggs at 

least once daily and their cleaning and 

treatment in such a manner as to 

prevent odors or objectionable 

conditions in the plant; § 590.530(a), 

which states that liquid egg storage 

rooms, including surface coolers and 

holding tank rooms, shall be kept clean 

and free from odors and objectionable 

odors and condensation; and 

§ 590.536(a), concerning the conditions 

in which freezing rooms are to be kept. 

Other regulations to be replaced by 9 

CFR 416.2(d) will be: 9 CFR 590.540(d), 

which states that air drawn into the 

drier in spray process drying facilities 

be free from foul odors, dust, and dirt; 

§ 590.546(b), requiring that intake air 

sources in albumen flake process drying 

facilities be free from foul odors, dust, 

and dirt; § 590.549, requiring that dried 

egg storage be sufficient to adequately 

handle the production of the plant and 

be kept clean, dry, and free from 

objectionable odors; and § 590.560(b), 

requiring that toilets and dressings be 

kept clean and that toilet rooms be 

ventilated to the outside of the building. 

Plumbing—9 CFR 416.2(e) 

The design, installation, and 

maintenance of an adequate plumbing 

system are key responsibilities of an egg 

products plant. Because plumbing 

systems carry water into plants and 

convey water, sewage, and other waste 

from plants, problems with plumbing 

systems can easily cause product 

contamination or adulteration. The 

plumbing sanitation requirements in 9 

CFR 416.2(e) set out the essential 

condition plants must achieve with 

their plumbing systems: plumbing 

systems cannot cause adulteration of 

product and must ensure sanitary 

operating conditions. Plants otherwise 

will be allowed to build plumbing 

systems suitable to the nature and 

volume of their production. Therefore, 

FSIS is proposing to eliminate the 

requirement in § 590.500(g) that drains 

and gutters with approved traps and 

vents be installed. The Agency is also 

proposing to eliminate the prescriptive 

requirements regarding lavatory 

accommodations in § 590.500(l) and 

(m). 

Sewage Disposal—9 CFR 416.2(f) 

The current regulations require any 

person desiring to process egg products 

under continuous inspection to submit 

drawings and specifications before 

receiving approval of a plant and 

facilities as an official plant. 

Information that must be submitted 

includes how the plant intends to 

dispose of sewage (§ 590.146(b)(7)). 

Section 590.504(q) states that all liquid 

and solid material in the official plant 

shall be disposed of in a manner 

approved by the Administrator to 

prevent product contamination and in 

accordance with acceptable 

environmental protection practices. 

Section 416.2(f) of 9 CFR, sewage 

disposal, will replace both of these 

regulations by requiring that sewage be 

disposed into a sewage system separate 

from all other drainage lines or disposed 

of through other means sufficient to 

prevent backup of sewage into areas 

where product is processed, handled, or 

stored. 

Water Supply and Reuse—9 CFR 

416.2(g) 

The current regulations regarding 

water supply and reuse in plants require 

that the water supply be ample, clean, 

and potable, with adequate pressure and 

facilities for its distribution throughout 

the plant or portion thereof utilized for 

egg processing and handling operations 

and protected against contamination 

and pollution (§ 590.500(h)). Section 

590.500(h) also requires that the 

applicant for inspection obtain and 

furnish to the Administrator, at the 

Administrator’s request, a water report, 

issued under the authority of a State or 

municipal health authority, certifying to 

the potability of the water supply. When 

ice is used as an emergency refrigerant 

by being placed directly into the egg 

meat, § 590.530(f) requires that the 

source of the ice be certified by the local 

or State board of health and that the ice 

be handled in a sanitary manner. 

Section 416.2(g)(1) of 9 CFR sets out 

a transparent water supply performance 

standard concerning potable water. The 

water must comply with Environmental 

Protection Agency (EPA) National 

Primary Drinking Water regulations. 

These EPA regulations are applicable to 

public water systems. Because these 

regulations already apply to potable 

water used by egg products plants, the 

reference in the sanitation requirements 

would not constitute a new requirement 

for these plants. The sanitation 

requirement also restates the current 

requirement that plants must make 

available to FSIS, upon request, State or 

local certificates attesting to water 

quality. 

The egg products industry uses large 

quantities of water for processing 

products and for cleaning. Water and 

water based (aqueous) solutions are 

widely used for prewetting, washing, 

and rinsing eggs, product formulation, 

and cleaning and sanitizing equipment. 

Reuse of water solutions, therefore, can 

offer significant economic advantages. 

Section 590.515(a), for example, sets 

forth the requirements for washing shell 


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eggs to be presented for breaking. They 

include changing the wash water every 

four hours or more often if needed to 

maintain sanitary conditions and at the 

end of each shift (paragraph (a)(4)); 

adding replacement water to the wash 

water of washers continuously to 

maintain a continuous overflow 

(paragraph (a)(5)); piping waste water 

from the egg washing operation directly 

to drains (paragraph (a)(6)); and 

completing continuous washing 

operation as rapidly as possible 

(paragraph (a)(7)). Section 590.516(a) 

requires that all shell eggs be spray 

rinsed with potable water containing an 

approved sanitizer of not less than 100 

ppm but no more than 200 ppm of 

available chlorine or its equivalent 

immediately prior to breaking. 

Section 590.552 establishes cleaning 

and sanitizing requirements for 

equipment used in egg processing 

operations that comes in contact with 

liquid eggs or exposed edible products. 

While such equipment may be cleaned 

by any sanitary means, it is preferable 

to use water to do so. Paragraph (b)(2) 

requires that shell eggs that have been 

sanitized and equipment that comes in 

contact with edible products be rinsed 

with clean water after sanitizing if other 

than hypochlorites are used as 

sanitizing agents. 

Section 416.2(g)(2) through (6) of 9 

CFR sets forth sanitation requirements 

for the reuse of water in meat and 

poultry establishments. If this proposal 

is adopted, plants will also be able to 

use reuse water in their operations, as 

appropriate. 

Prior to the implementation of 9 CFR 

416.2(g), reuse water was permitted in 

meat and poultry establishments only 

under certain circumstances, and any 

other reuse situation had to be approved 

by the Agency in advance. However, 

once technologies were developed that 

can recondition water for safe and 

effective reuse in various applications, 

the Agency recognized that reuse water 

may be used safely and effectively in 

certain food processing situations. 

Under 9 CFR 416.2(g), reuse water can 

be treated to render it free of biological, 

chemical, and physical hazards. Some 

of the general treatment options used 

include filtration, chlorination, 

ozonation, ultraviolet (UV) radiation, 

and heating. Use of these procedures 

can usually return water to a level of 

quality appropriate to its intended use. 

After treatment, however, such water 

should be tested regularly to ensure 

continual freedom from biological, 

chemical, or physical hazards. 

Depending upon the original use, the 

intended use, and the duration of reuse, 

a wide range of acceptable biological, 

chemical, or physical contaminant 

levels are possible in reuse water. The 

previous degree of exposure or potential 

exposure to contaminants dictates the 

appropriate reconditioning treatment 

and the allowable reuse. 

FSIS requires official egg products 

plants to produce pasteurized, RTE 

products that are free of pathogens. 

Therefore, reuse water that is used to 

chill or cook pasteurized, RTE egg 

products must be free of fecal coliforms 

because their presence would indicate 

that the water was contaminated, 

possibly with pathogenic organisms (9 

CFR 416.2(g)(2)). Other types of 

contamination will also have to be 

reduced sufficiently to prevent 

adulteration of product. 

Section 416.2(g)(3) of 9 CFR deals 

with the use and reuse of water, ice, and 

solutions used to chill or wash raw 

product. In response to questions raised 

at public meetings in Columbus, OH, 

and Sacramento, CA, on March 30 and 

April 6, 2000, and Washington, DC, on 

July 31, 2001, held to obtain comments 

on FSIS’s and FDA’s thinking at the 

time on approaches to ensure egg safety 

from farm to table, FSIS has tentatively 

concluded that unprocessed shell eggs, 

i.e., eggs that have not yet been washed, 

sized, or candled, are more like raw 

product than RTE product. As a result, 

FSIS has determined that the provisions 

of 9 CFR 416.2(g)(3), which regulate the 

use of reuse water to wash raw product, 

will apply to official plants. 

Consequently, water used to wash 

unprocessed shell eggs may be reused 

for the same purpose, provided that 

measures are taken to reduce biological, 

chemical, and physical contamination 

so as to prevent contamination or 

adulteration of the eggs. Such reused 

water from use on raw eggs may not 

come into contact with processed shell 

eggs. 

Paragraph (g)(4) of 9 CFR 416.2 will 

allow plants that recondition their water 

through an advanced wastewater 

treatment facility to use such 

reconditioned water on raw product, 

except in product formulation and 

throughout the plant in edible and 

inedible production areas. This water is 

not, however, potable, and it may not 

have ever contained human waste. 

Product, facilities, and equipment 

coming in contact with this water must 

undergo a separate final rinse with nonreconditioned water that meets the 

criteria prescribed in 9 CFR 416.2(g)(1). 

The reuse water described above would 

most likely be used to wash solid waste 

from equipment and floors. 

Paragraph (g)(5) of 9 CFR 416.2 will 

permit plants to use any water for any 

purpose in edible or inedible product 

areas, provided that it has never 

contained human waste, has been 

conditioned to be free of pathogenic 

organisms, and does not contact edible 

product. Finally, paragraph (g)(6) states 

that any water not meeting the 

conditions of 9 CFR 416.2(g)(1) through 

(5) may not be used, except in areas 

where no edible product is handled or 

prepared, and may not be used in any 

manner which would allow it to 

contaminate or adulterate edible 

product. 

Moving the egg products water supply 

and reuse regulations into 9 CFR 

416.2(g) will consolidate them with 

those for meat and poultry. The 

proposed sanitation requirements in 9 

CFR 416.2(g) are intended to and should 

account for every allowable water reuse 

situation in official plants, including 

those covered by the following egg 

products inspection regulations, which 

will be replaced by 9 CFR 416.2(g) if 

this proposal is finalized: § 590.520(e), 

which requires adequate and easily 

accessible hand washing facilities in an 

official plant; § 590.539(d)(1), which 

permits frozen eggs packed in metal or 

plastic containers to be placed in 

running tap water (70 degrees F or 

lower) without submersion to speed 

defrosting; and § 590.552(a) and (b)(2), 

concerning equipment cleaning and 

sanitizing requirements. 

Dressing Rooms, Lavatories, and 

Toilets—9 CFR 416.2(h) 

The current regulations concerning 

dressing rooms, lavatories, and toilets in 

egg products plants are highly 

prescriptive. For example, 

§ 590.500(l)(2) provides a formula that 

serves as the basis for determining the 

toilet facilities required in an official 

plant, the intent being to ensure that 

plants provide an adequate number of 

toilet bowls, thus maintaining related 

sanitary conditions. The sanitation 

requirement in 9 CFR 416.2(h) gives 

plants the responsibility and flexibility 

to determine how many dressing rooms, 

lavatories, and toilets it needs. Of 

course, plants will have to meet any 

applicable State and local codes 

concerning the number of lavatories and 

toilets in the workplace. 

There are also other requirements for 

dressing rooms, lavatories, and toilets 

currently in the egg products regulations 

(see § 590.520(e), concerning hand 

washing facilities in breaking rooms, 

§ 590.560(a) and (b), concerning health 

and hygiene of personnel, and 

§ 590.146(b)(5), requiring floor plans to 

show the locations of hand-washing 

facilities and toilets). The proposed 

sanitation requirement in 9 CFR 

416.2(h) eliminates the need for these 


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6324 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

requirements because it renders them 

redundant. 

Equipment and Utensils—9 CFR 416.3 

The egg products inspection 

regulations concerning equipment and 

utensils are unduly prescriptive and can 

deprive official plants of the flexibility 

to innovate in regard to equipment and 

utensil sanitation. The equipment and 

utensil sanitation requirement that FSIS 

is proposing to adopt for plants not only 

provides flexibility but also clarifies 

plant responsibility for selecting and 

maintaining equipment and utensils in 

a manner that effectively prevents 

product contamination or adulteration. 

If this proposal is adopted, plants will 

no longer have to install and use 

equipment that complies with the 

applicable 3–A or E–3–A Sanitary 

Standards and accepted practices 

currently in effect for such equipment 

(§ 590.502(b)). Instead, equipment and 

utensils used for processing or 

otherwise handling edible product or 

ingredients will only have to be of such 

material and construction as to facilitate 

thorough cleaning and be durable and 

suitable for its intended use. Plants will 

need to ensure that product is not 

contaminated, adulterated, or 

misbranded during processing, 

handling, or storage. Equipment and 

utensils will still need to be maintained 

in sanitary condition so as not to 

contaminate or adulterate product. In 

addition to 9 CFR 590.502(b), FSIS is 

also proposing to remove the following 

sections from 9 CFR part 590 because 9 

CFR 416.3 will make them redundant: 

• § 590.500(n), requiring suitable 

facilities for cleaning and sanitizing 

utensils and equipment at convenient 

locations throughout the plant 

• § 590.504(f) and (n), requiring 

personnel handling utensils or 

containers which may come into 

contact with egg products to wash 

their hands and maintain them in a 

clean condition and requiring most 

utensils and equipment to be clean 

and sanitized at the beginning of 

processing operations and kept clean 

and sanitary during all processing 

operations 

• § 590.506(a), which states that the 

equipment shall be arranged to 

facilitate cleaning and the removal of 

refuse and excess packing material 

from the candling and transfer room 

• § 590.508(c) and (d), requiring the 

handling of shell eggs in a manner to 

minimize sweating prior to breaking 

and placing shell eggs with 

extensively damaged shells, unless 

otherwise prohibited, into leaker trays 

• § 590.515(a)(1) and (b), requiring that 

shell egg cleaning equipment be kept 

in good repair and be cleaned after 

each day’s use or more frequently, if 

necessary, and requiring that the 

temperature of wash water be 

maintained at 90 degrees F or higher, 

and shall be at least 20 degrees F 

warmer than the temperature of the 

eggs to be washed, throughout the 

cleaning cycle 

• § 590.520(g), states that a suitable 

container conspicuously identified 

shall be provided for the disposal of 

rejected liquid 

• § 590.522(d), (h), (s), (t), (u), (v), (y), 

(aa)(1)–(3), containing prescriptive 

requirements for the cleaning of 

breaking machines and equipment, 

including mechanical breaking 

machines, as well as other equipment 

used in the processing of egg 

products, such as cups, knives, racks, 

etc., dump tanks, drawoff tanks, and 

churns, strainers, filtering devices, 

etc., and containers used for 

transporting liquid eggs products 

• § 590.538, concerning the 

construction and cleaning of 

defrosting facilities 

• § 590.539(f), concerning the cleaning 

of crushers and other equipment used 

in defrosting operations 

• § 590.540(h), requiring the 

construction of powder conveying 

equipment as will facilitate thorough 

cleaning 

• § 590.542(b)(2) and (c)(1), requiring 

the sanitizing of spray process drying 

equipment within 2 hours prior to 

resuming spray drying operations and 

the clearing of sifters and conveyers 

used for other than dried albumen 

powder when such equipment is not 

to be used for 24 hours or longer 

• § 590.548(b)(3)–(5), which requires 

that equipment and utensils used in 

dried eggs be kept off the floor and be 

kept clean at all times and whenever 

contaminated be cleaned and 

sanitized. It also requires that all 

equipment used to mechanically 

package dried egg products be 

vacuum cleaned daily 

• § 590.560(c) and (d), prohibiting 

personnel affected with any 

communicable disease in a 

transmissible stage or a carrier of such 

disease, or affected by a list of other 

health conditions, from coming into 

contact with equipment used to 

process eggs. Paragraph (d) requires 

workers coming in contact with 

equipment to wear clean outer 

uniforms 

Food-Contact Surface Cleaning and 

Sanitation—9 CFR 416.4(a) 

The egg products inspection 

regulations require that egg products 

plants clean food contact surfaces at the 

start of processing operations, and that 

they keep equipment and utensils clean 

and sanitary during all processing 

operations (9 CFR 590.504(n)). Section 

590.522(aa)(3) of 9 CFR states that 

mechanical egg breaking equipment 

shall be clean and sanitized prior to use, 

and during operations the machines 

shall be cleaned and sanitized 

approximately every 4 hours or more 

often if needed to maintain them in a 

sanitary condition. It also requires that 

the equipment be cleaned at the end of 

each shift. See also 9 CFR 590.552(a). 

The objective of the food-contact 

surface cleaning requirements has 

always been to mitigate biological, 

chemical, and physical contamination 

that could adulterate product. The 

proposed food-contact surface cleaning 

sanitary operations requirement in 9 

CFR 416.4(a) embodies this objective 

and clarifies plant responsibility for 

determining how best to achieve it. The 

advantage of this proposed standard is 

that it would provide plants with the 

flexibility to innovate when determining 

how to mitigate biological, chemical, 

and physical contamination that could 

adulterate product. For this reason, 

therefore, FSIS is proposing to remove 

the egg products inspection regulations 

discussed above, as well as following 

sections, and replace them with the 

sanitary operations requirement in 9 

CFR 416.4(a): 

• § 590.504(i) and (k), requiring the 

removal, cleaning, and sanitizing of 

utensils and equipment that are 

contaminated during the course of 

processing egg products and 

containing the admonition that all 

reasonable precautions be taken to 

avoid soiling or contaminating the 

surface of any package or container 

liner which is or will be in direct 

contact with egg products 

• § 590.515(a)(4), which states that 

wash water will be changed every 

four hours or more often, if needed, to 

maintain sanitary conditions and at 

the end of each shift 

• § 590.522(x), (z), and (aa)(2), requiring 

that containers for holding egg 

products variously be washed, rinsed, 

sanitized, and drained immediately 

prior to use and cleaned after each 

use. The pipelines of systems for 

pumping egg liquid directly from egg 

breaking machines must be cleaner or 

flushed as often as necessary to 

maintain them in a sanitary condition, 

and they must be cleaned and 

sanitized at the end of each shift. 

Other pumping system equipment 

must be cleaned and sanitized at least 

every four hours or sooner to maintain 

it in sanitary condition 


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• § 590.539(e), which states that 

sanitary methods will be used in 

handling containers and removing egg 

product 

• § 590.542, which includes 

prescriptive requirements for 

maintaining sanitary conditions in 

spray process drying operations 

• § 590.544(c) and (d), which states that 

dry blending must be done in 

accordance with § 590.548 or in a 

closed blending system and in 

accordance with clean, sanitary 

practices. Edible dried egg powder 

may be reconstituted, repasteurized, 

and redried when accomplished in a 

clean, sanitary manner 

• § 590.548(b)(4), which includes 

prescriptive requirements for 

maintaining sanitary conditions in 

drying, blending, packaging, and heat 

treatment rooms and facilities. 

Non-Food-Contact Surface Cleaning and 

Sanitation—9 CFR 416.4(b) 

If this proposed rule (proposed 9 CFR 

591.1) is adopted, official plants that 

process egg products will have to keep, 

in accordance with 9 CFR 416.4(b), nonfood-contact surfaces, such as floors and 

walls, free of any biological 

contaminants, chemical contaminants, 

or physical contaminants that could 

adulterate egg products. FSIS is 

proposing to remove the following 

sections and replace them with the 

sanitary operations requirement in 9 

CFR 416.4(b) because this requirement 

will give plants greater flexibility and 

responsibility for developing sanitary 

procedures specific to the nature of their 

operations: 

• § 590.500(j) and (l)(1), requiring rooms 

and compartments in which shell eggs 

or egg products are handled or 

processed to be maintained in a clean 

and sanitary condition 

• § 590.504(g) and (h), prohibiting the 

storage of products or materials that 

create objectionable conditions in any 

room, compartment, or place where 

shell eggs or egg products are 

processed, stored, or handled and 

permitting only compounds approved 

by the Administrator that will not 

deleteriously affect shell eggs or egg 

products when used in an approved 

manner to be used in an official plant 

• § 590.515(b), prohibiting shell eggs 

from being washed in the breaking 

room or any room where edible 

products are processes 

• § 590.522(m), stating that ingredients 

used in, or for, processing egg 

products, must be handled in a clean 

and sanitary manner 

• § 590.546(b), requiring that intake air 

sources be free from foul odors, dust, 

and dirt 

• § 590.548(b)(3), requiring that dry 

blending equipment and supplies be 

kept off of the floor 

Cleaning Compounds and Sanitizers—9 

CFR 416.4(c) 

Section 590.504(h) of 9 CFR requires 

that FSIS approve detergents, wetting 

agents, or other similar compounds, 

among other things, before they can be 

used within an official plant. Section 

590.552(b) of 9 CFR states that 

sanitizing shall be accomplished by 

such methods as approved by the 

Administrator and requires the approval 

of chemicals and compounds used for 

sanitizing by the Administrator before 

use. These requirements are intended to 

ensure that egg products are not 

adulterated with chemicals or any 

injurious substance. 

FSIS is proposing to replace 9 CFR 

590.504(h) and 552(b) with proposed 9 

CFR 591.1 and the single sanitary 

operations requirement in 9 CFR 

416.4(c), which states that cleaning 

compounds and sanitizing agents must 

be safe and effective under the 

conditions of use, and that plants would 

not be required to obtain prior approval 

from FSIS. If this proposed rule 

becomes final, plants that process egg 

products would be able to use cleaning 

compounds and sanitizing agents that 

are safe and effective under the 

conditions of use. They would have to 

use, handle, and store them in a manner 

that would not adulterate product or 

create insanitary conditions and 

maintain documentation to support that 

these compounds and agents are safe 

and effective. Plants would, however, 

have to meet the use requirements for 

the substances promulgated by other 

regulatory agencies, such as FDA and 

EPA, who are responsible for ensuring 

that these substances are safe for their 

intended uses. 

Operational Sanitation—9 CFR 416.4(d) 

The egg products requirements for 

operational sanitation (sanitation 

measures carried out during operations) 

are spread through a number of 

regulations. (See 9 CFR 590.515 

concerning egg cleaning operations; 

§ 590.516 concerning sanitizing and 

drying of egg shells prior to breaking; 

and § 590.522 concerning breaking room 

operations.) 

These requirements are unnecessarily 

prescriptive. For example, 

§ 590.515(a)(4) requires an official plant 

to change wash water approximately 

every 4 hours or more often if needed 

to maintain sanitary conditions and at 

the end of each shift. Section 590.522(s) 

requires the cleaning and sanitizing of 

cups, knives, racks, separators, trays, 

spoons, liquid egg pails, and other 

breaking equipment every 21⁄2 hours. 

If adopted, the sanitary operations 

requirement in 9 CFR 416.4(d) will 

consolidate the concepts in all of these 

operational sanitation requirements 

(which are discussed in this preamble 

and are currently spread throughout 

§§ 590.500–575) in a single place and 

remove them from the egg products 

inspection regulations. Plants will be 

required to protect egg products from 

adulteration during processing, 

handling, storage, loading, and 

unloading at and during transportation 

from their premises. 

Employee Hygiene—9 CFR 416.5(a) 

The current egg products inspection 

regulations mandate specific employee 

hygiene practices which egg products 

plants must adopt. For example, plant 

personnel handling exposed edible 

product must wash their hands before 

beginning work and upon returning to 

work after leaving the work room 

(§ 590.560(e)). Section 590.560(f) states 

that expectorating or other unsanitary 

practices are not permitted in official 

plants. 

The proposed sanitation requirement 

in 9 CFR 416.5(a) requires that all 

persons working in contact with 

product, food-contact surfaces, and 

product-packaging materials adhere to 

hygienic practices while on duty to 

prevent adulteration of product and the 

creation of insanitary conditions. It 

would, if adopted, allow plants to 

develop alternative or innovative means 

to ensure that employee hygiene 

practices do not result in product 

adulteration, without being as 

prescriptive and restrictive as the 

current egg products inspection 

regulations. Therefore, FSIS is 

proposing to remove § 590.560 and 

replace it with the proposed sanitation 

requirement in § 416.5(a). 

Employee Clothing—9 CFR 416.5(b) 

The requirements regarding employee 

clothing are prescriptive. For example, 

§ 590.560(d) states that workers coming 

into contact with liquid or dried eggs, 

containers, or equipment shall wear 

clean outer uniforms, while paragraph 

(h) of that section requires all persons in 

breaking and packaging rooms to 

properly wear hair nets or caps. Section 

590.560(g) prohibits the use of tobacco 

in any form or the wearing of jewelry, 

nail polish, or perfumes in any area 

where edible products are exposed. 

As stated in the previous section, 

FSIS is proposing to remove § 590.560 

and replace it with the sanitation 

requirement in 9 CFR 416.5(b) and 

proposed 9 CFR 591.1(a). If the 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6326 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

12FSIS. 2005. Risk Assessments of Salmonella 

Enteritidis in Shell Eggs and Salmonella spp. in Egg 

Products. (http://www.fsis.usda.gov/wps/portal/fsis/ 

topics/science/risk-assessments). 

proposed rule is finalized, cleanliness in 

employee hygiene would be required 

without the prescriptiveness of 

§ 590.560. Under 9 CFR 416.5(b), 

aprons, frocks, and other outer clothing 

worn by persons in plants processing 

egg products who handle product must 

be made of material that is disposable or 

readily cleaned. Clean garments will 

also have to be worn at the start of each 

working day, and garments will have to 

be changed during the day as often as 

necessary to prevent adulteration of 

product and creation of insanitary 

conditions. 

Employee Disease—9 CFR 416.5(c) 

The sanitation requirement in 9 CFR 

416.5(c) is similar to the requirements 

for employee health in § 590.560(c) to 

prevent transmission of communicable 

diseases. FSIS is proposing to remove 

§ 590.560(c) and adopt proposed 9 CFR 

591.1 and 416.5(c) for egg products 

plants. 

Tagging Insanitary Equipment, Rooms, 

or Compartments—9 CFR 416.6 

Retention tags or other devices and 

methods as may be approved by the 

Administrator are used for the control 

and identification of equipment, 

utensils, rooms, or compartments in 

official plants that are found to be 

unclean or otherwise in violation of the 

egg products inspection regulations 

(§ 590.426). This requirement is similar 

to the sanitation requirement articulated 

in 9 CFR 416.6, which requires the 

attachment of a ‘‘U.S. Rejected’’ tag to 

any equipment, utensil, room, or 

compartment at an official 

establishment that is insanitary, or the 

use of which could cause the 

adulteration of product. Both 

regulations prohibit the use of tagged 

equipment, utensils, rooms, or 

compartments until they have been 

made acceptable and require the 

removal of tags by program employees. 

Therefore, FSIS is proposing to replace 

§ 590.426 with 9 CFR 416.5(c) and 

proposed 9 CFR 591.1. This proposed 

sanitation requirement for plants that 

process egg products would serve to 

provide consistency between the egg 

products requirements and the meat and 

poultry requirements. 

Sanitation Performance Standards 

Compliance Guide 

To meet the sanitation requirements 

proposed in this document, egg 

products plants may develop and 

employ sanitation or processing 

procedures customized to the nature 

and volume of their production. 

However, FSIS has developed a 

Sanitation Performance Standards 

Compliance Guide (Compliance Guide) 

that presents or references methods 

already proven to be effective in 

maintaining sanitary conditions in meat 

and poultry products establishments, 

which is posted on the Agency’s web 

page: http://www.fsis.usda.gov/wps/ 

portal/fsis/topics/regulatorycompliance/compliance-guides-index/ 

sanitation-performance-standards. If 

this proposed rule is adopted, and 

before it takes effect, FSIS will update 

the Compliance Guide to include 

methods that are effective in 

maintaining sanitary conditions in egg 

products plants. Past FSIS regulations 

and guidance, as well as 

recommendations from the current 

Model Food Code issued by FDA and 

other technical sources, will be 

included or cited. 

Plants that follow the 

recommendations in the Compliance 

Guide could be reasonably certain that 

they will be meeting the sanitation 

requirements. They would need to be 

mindful, however, that each processing 

environment is unique, and that in some 

cases, the methods presented in the 

Compliance Guide might require 

validating the adequacy to ensure 

sanitary conditions or to prevent the 

adulteration of egg products. 

E. Egg Products Are ‘‘Ready-To-Eat’’ 

21 U.S.C. 1036(a) requires that egg 

products inspected at an official plant 

and found to be not adulterated be 

pasteurized before they leave the official 

plant, except as otherwise permitted by 

the regulations of the Secretary. Any 

detectable pathogen would adulterate 

egg products under 21 U.S.C. 1033(a)(1) 

because it would contain a poisonous or 

deleterious substance which may render 

them injurious to health. Pasteurized 

egg products are ready-to-eat; that is, 

they have been prepared so that they 

can be consumed as is, without any 

additional cooking. 

In 2005, FSIS undertook a 

quantitative microbial risk assessment 

to assist Agency risk managers in 

evaluating possible pasteurization 

performance standards for reducing the 

likelihood of Salmonella spp. 

contamination in liquid and dried egg 

products, and, subsequently, for 

reducing the risk of human illness, 

hospitalization, and death associated 

with egg products.12 However, while the 

risk assessment showed that 

pasteurization resulting in a 6-log10

reduction of Salmonella was predicted 

to be effective for reducing illnesses 

from Salmonella spp. in egg products, 

FSIS has chosen to propose a standard 

for egg products that requires them to be 

produced to be edible without 

additional preparation to achieve food 

safety. FSIS has chosen this approach 

because in-plant inspectors cannot 

effectively verify whether a plant has 

met a specific lethality standard. The 

Agency can, however, effectively verify 

whether Salmonella is present in an egg 

product through testing. Overall, this 

approach is simpler than that of log10

pasteurization performance standards 

and is consistent with the approach 

used by FSIS in establishing 

requirements for most RTE meat and 

poultry products. 

Meat and poultry establishments 

produce the vast majority of their RTE 

products without needing to meet FSISspecified time and temperature 

combinations or lethality performance 

standards codified in the regulations. 

The only FSIS regulations that include 

specific times and temperatures for 

ready-to-eat products are for cooked 

uncured meat patties, which must meet 

or exceed the times and temperatures 

listed in 9 CFR 318.23, and for pork, and 

products containing pork, which must 

meet or exceed the times and 

temperatures listed in 9 CFR 318.10. 

Cooked beef and poultry products must 

meet the lethality performance 

standards listed in 9 CFR 318.17 and 

381.150. FSIS previously removed 

prescriptive time and temperature 

requirements for other ready-to-eat meat 

and poultry products from the meat and 

poultry regulations. Such prescriptive 

time and temperature requirements are 

not necessary because under the 

statutes, establishments need to produce 

ready-to-eat products (including egg 

products) so that no detectable 

pathogens exist in the final products. 

Therefore, FSIS is proposing to amend 

the egg products inspection regulations 

by removing the prescriptive regulations 

on the pasteurization of egg products (9 

CFR 590.570 and .575). If this proposed 

rule is finalized, 9 CFR 590.570 would 

be replaced by a new regulation 

specifying that egg products are readyto-eat and do not require additional 

steps to ensure food safety, consistent 

with the definition of ‘‘ready-to-eat’’ 

product in 9 CFR 430. Egg products 

must be produced such that the finished 

product is free of detectable pathogens. 

In addition, egg products would not be 

required to bear a safe-handling 

instruction or other labeling that directs 

that the product must be cooked or 

otherwise treated for safety. 

The current requirements for egg 

products mandate step-by-step 


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13 9 CFR 411(c)(5) requires that containers of 

product bearing official identification display that 

identification and the plant number. Official 

identification means the official inspection mark or 

any other symbol prescribed by the regulations in 

part 590 to identify the status of any article. See 9 

CFR 590.5. 

14The current Salmonella sampling levels that 

egg products plants must meet are provided in FSIS 

Directive 10,230.4, Salmonella Surveillance 

Program for Liquid and Frozen Egg Products. 

15The USDA, FSIS Pasteurized Egg Products Lab 

(PEPRLab) Program is a program for laboratories 

performing Salmonella analysis on official 

surveillance samples of pasteurized egg products. 

processing measures and specifically 

prescribe minimal time and temperature 

combinations for the pasteurization 

treatment of various egg products. 

Under HACCP, these prescriptive 

requirements are not necessary. Under 

HACCP, egg products plants are 

required to produce product by 

controlling, eliminating, or reducing 

microbial hazards so that the finished 

product has no detectable pathogens. 

Plants that choose not to develop new 

or modified procedures will be able to 

continue to follow a set of 

pasteurization time and temperature 

combinations for products that have 

been validated as achieving the 

intended pathogen reduction, such as 

those in the current regulations. FSIS 

has developed a draft compliance 

guideline document that includes these 

procedures. The draft guideline 

document can be found at: http://

www.fsis.usda.gov/wps/portal/fsis/ 

topics/regulatory-compliance/ 

compliance-guides-index. An official 

plant would then need to validate that 

it is properly applying the FSIS time 

and temperature combinations provided 

in the guidance material and conduct 

monitoring and verification activities to 

demonstrate proper execution of the 

selected combinations. 

The pasteurization time and 

temperature compliance guidelines 

specifically will assist small and very 

small businesses in identifying 

validated procedures. The materials will 

be posted on the Agency’s website. 

F. Not Applying the Mark of Inspection 

Pending Test Results 

As discussed previously, egg products 

inspected at an official plant and found 

to be not adulterated must be 

pasteurized before they leave the official 

plant, except as otherwise permitted by 

the regulations of the Secretary. They 

must also bear the official inspection 

legend and official plant number of the 

plant where the products were 

processed.13

9 CFR 590.504(o) requires that egg 

products be pasteurized in accordance 

with the egg products inspection 

regulations before being released into 

consuming channels, while paragraph 

(o)(1) requires that they be sampled and 

tested for the presence of Salmonella to 

ensure that they were adequately 

pasteurized. 9 CFR 590.580 sets forth 

the specific testing requirements, and in 

this proposal, FSIS has rewritten this 

section for clarity. 

While FSIS does not require final 

product testing for Salmonella in RTE 

meat and poultry products, the Agency 

is continuing to require testing for 

Salmonella for RTE egg products by 

official plants. An egg products plant’s 

Salmonella testing data continues to be 

important in monitoring process 

control.14 15 As part of its control 

verification effort, FSIS also will 

continue to collect and analyze samples 

from egg product processes for 

Salmonella and Lm. 

While 9 CFR 590.504(o) states that egg 

products must be pasteurized before 

being released into consuming channels, 

9 CFR 590.504(d) does permit 

inspection program personnel to allow 

egg products to be moved from an 

official plant before the plant receives 

laboratory results for Salmonella, or any 

other test results, if the plant retains 

control of the product. The plant must 

ensure that the product will be returned 

to the plant for reprocessing if the test 

results show that the product is positive 

for Salmonella. 

FSIS allows meat and poultry 

establishments to move product to 

locations other than the production 

facility prior to the receipt of FSIS test 

results so long as the establishment 

maintains control of the product. It also 

permits them to package and label 

products sampled and tested for 

adulterants with the mark of inspection 

pending negative test results, provided 

those products do not enter commerce, 

i.e., the products remain under the 

establishment’s control until negative 

test results become available. The 

product does not, however, actually 

receive the mark of inspection until 

negative test results have been returned. 

The egg products regulations are the 

same. Egg products plants may move 

product pending test results only under 

circumstances that will ensure the 

return of the product to the plant for 

reprocessing, or under such other 

conditions as the Administrator may 

determine to ensure compliance with 

part 590. FSIS’s practice of allowing egg 

products to be moved pending receipt of 

results of tests done by FSIS or the plant 

is codified in 9 CFR 590.504(d). 

Failure of an egg products plant to 

hold or maintain control of product 

pending Agency or plant test results 

endangers public health. Therefore, 

FSIS is proposing to revise paragraph (e) 

to 9 CFR 590.504 to make clear that egg 

products plants that move product that 

has been sampled by the Agency or the 

plant before receiving test results must 

maintain control of the products 

represented by the sample pending the 

test results. 

The Agency is not requiring the use 

of any particular control measures to 

ensure that product is not used or 

distributed for sale before test results are 

known. Instead, egg products plants 

may continue to use, or develop, their 

own new, effective methods of control. 

G. Irradiated Shell Eggs 

Shell eggs that are subjected to 

ionizing radiation may be used in the 

production of egg products because 

when applied at sufficient doses, 

irradiation can be a means of destroying 

disease-producing bacteria in food and 

result in a pasteurized product. 

Specifically, food irradiation is the 

process of exposing food to high levels 

of radiant energy. Forms of radiant 

energy include: Microwave and infrared 

radiation that heat food during cooking; 

visible light or ultraviolet light used to 

dry food or kill surface microorganisms; 

and ionizing radiation, resulting from 

cobalt-60, cesium-137, x-ray machines, 

or electron accelerators, that penetrates 

deeply into food, killing insect pests 

and microorganisms without 

significantly raising the temperature of 

the food. Food is most often irradiated 

commercially to extend shelf life, 

eliminate insect pests, or reduce 

pathogenic microorganisms. Food 

irradiation for these purposes is 

practiced in many countries, including 

the United States. 

Irradiation is subject to the food 

additive provisions of the FFDCA. FDA 

has the primary responsibility for 

determining whether food additives are 

safe for particular uses. FDA lists uses 

of food additives it has concluded are 

safe in 21 CFR parts 172 through 179. 

Under section 201(s) of the FFDCA (21 

U.S.C. 321(s)), a source of radiation used 

to treat food is defined as a food 

additive. A source of radiation is used 

to process or treat food such that, 

analogous to other food processes, its 

use can affect the characteristics of the 

food. 

In a notice published in the Federal 

Register on March 20, 1998 (63 FR 

13675), FDA announced that a food 

additive petition (FAP 8M4584) had 

been filed by Edward S. Josephson, 

University of Rhode Island, Food 

Science and Nutrition Research Center, 

530 Liberty Lane, West Kingston, RI 

02892–1802, to amend the food additive 


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6328 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

regulations to provide for the safe use of 

ionizing radiation for the reduction of 

Salmonella in fresh shell eggs. 

The petitioner submitted published 

articles and other study reports 

containing data and information related 

to eggs and other kinds of food in the 

areas of radiation chemistry, nutrition, 

toxicology, and microbiology. FDA 

considered the data and studies 

submitted in the petition, as well as 

other information in its files relevant to 

the safety and nutritional adequacy of 

eggs treated with ionizing radiation. 

Based on the totality of evidence from 

all evaluated data and studies, FDA 

determined that: (1) The proposed use 

of irradiation on fresh shell eggs at 

levels not to exceed 3.0 kGy is safe, (2) 

the irradiation can achieve its intended 

technical effect of reducing the numbers 

of Salmonella in fresh shell eggs, and, 

therefore, (3) it should amend 21 CFR 

179.26 to provide for the use of 

irradiation on fresh shell eggs. 

Consequently, on July 21, 2000 (65 FR 

45280), FDA approved the use of 

ionizing radiation on eggs in the shell to 

reduce the internal level of Salmonella. 

It also amended its regulations by 

expanding the list of products (21 CFR 

179.26(b)) for which ionizing irradiation 

may be safely used to include fresh shell 

eggs. (While FDA does not define the 

word ‘‘egg,’’ FSIS has included the 

definition contained in the EPIA in 9 

CFR 590.5.) 

While the irradiation of fresh shell 

eggs at the doses approved by FDA will 

reduce the level of microorganisms in 

shell eggs (65 FR 45281, July 21, 2000), 

the irradiation treatment of shell eggs to 

be processed as liquid egg product will 

not sufficiently eliminate pathogens of 

public health concern from this form of 

egg. As a result, treating shell eggs used 

to process egg products only with 

ionizing radiation will not result in a 

final egg product that is completely 

pasteurized, i.e., RTE. Because the 

irradiation treatment approved by FDA 

is insufficient to produce a ready-to-eat 

product based on the maximum 

approved irradiation dose specified in 

21 CFR 179.26, it must be used in 

combination with other lethality 

treatments to complete the total lethality 

required to result in a pasteurized, RTE 

egg product. 

Under proposed 9 CFR 590.590, the 

irradiation treatment must precede the 

heat or other lethality treatment because 

FDA has not approved the use of 

irradiation on egg products. Irradiated 

shell eggs or the use of the irradiated 

contents of fresh shell eggs for inclusion 

in pasteurized egg products must be 

reflected in the ingredient statement on 

the finished product labeling (proposed 

9 CFR 590.410(a)(3)). 

H. Implementation of Regulatory 

Requirements Domestic Plants 

All official plants will be subject to 

the requirements put forth in this 

proposal if it is adopted. FSIS intends 

to phase in the HACCP requirements in 

this proposal over a 2-year period after 

publication of a final rule, both as a 

means to reduce the impact for small 

and very small businesses and to ensure 

that FSIS inspection program personnel 

are properly trained and equipped with 

the tools to carry out the new 

requirements for inspection. FSIS 

intends to enforce the Sanitation SOP 

measures and the sanitation 

requirements one year after publication 

of a final rule because these regulations 

should involve less significant changes 

for the plants, and these regulations 

provide the plant increased flexibility. 

FSIS intends to enforce the 

requirement that egg products be 

processed to be edible without 

additional preparation to achieve food 

safety on the effective date of the rule. 

This requirement is consistent with 

current regulatory and statutory 

requirements; FSIS tests samples from 

all egg products for Salmonella and Lm. 

FSIS will continue to do so should this 

rule become final. 

Under this proposal, FSIS would no 

longer control design specifications for 

buildings and equipment. Instead, FSIS 

would focus its regulatory attention on 

determining whether an official plant is 

successfully meeting sanitation 

requirements. Should this rule become 

final, plants would be required to 

ensure that the design of buildings and 

equipment is appropriate for sanitary 

food production and for maintaining 

good sanitary conditions in accordance 

with broad sanitation principles. In 

addition, official plants adopting 

Sanitation SOPs of their own design 

would identify the elements of good 

sanitation required to prevent direct 

product contamination, carry out their 

Sanitation SOPs on a daily basis, and 

achieve acceptable sanitation results. 

Foreign Plants 

Under 9 CFR 590.910, to export egg 

products to the United States, foreign 

countries will have to have a system of 

inspection that is equivalent to the 

system in the United States. Should this 

rule become final, as HACCP and other 

regulatory provisions are implemented 

in the American domestic market, 

foreign countries that export egg 

products to the United States would be 

evaluated to ascertain whether their 

inspection systems provide equivalent 

food safety protection, including 

adequate levels of enforcement. 

I. Labeling and Other Consumer 

Protection Regulatory Requirements 

Official plants are responsible for 

ensuring that labeling used on egg 

products is truthful and not false or 

misleading (21 U.S.C. 1036). They are 

also responsible for ensuring that all 

labeling complies with the EPIA and the 

egg products inspection regulations. To 

ensure that official plants comply with 

applicable statutory and regulatory 

labeling requirements, FSIS conducts a 

prior approval program for labels used 

on federally-inspected egg products (9 

CFR 590.411). Examples of label 

features that FSIS evaluates include the 

standardized, common or usual, or 

descriptive name of the product; an 

ingredients statement containing the 

common or usual name of each 

ingredient listed in descending order of 

predominance; and handling statements 

if the product is perishable. 

To obtain label approval, egg products 

plants must submit sketch labels to FSIS 

before they print the labels, containers, 

or packaging materials that bear official 

identification (9 CFR 590.411(a)). The 

information submitted is evaluated by 

the FSIS Labeling and Program Delivery 

Staff (LPDS) for conformance with the 

EPIA and the regulations adopted under 

it. 

Before July 1996, FSIS conducted a 

prior approval program for meat and 

poultry labels used on federallyinspected meat and poultry products. 

As with egg products, the meat and 

poultry prior approval program was 

intended to ensure that the labels 

applied to those products complied 

with the labeling and standards 

requirements of the Federal Meat 

Inspection Act, the Poultry Products 

Inspection Act, and their implementing 

regulations. 

Effective July 1, 1996, FSIS modified 

its prior label approval program for meat 

and poultry products by eliminating the 

need for submitting final labels to the 

Agency. The Agency changed the 

previous program by requiring the 

submission of only sketch labels (i.e., 

printer’s proofs) and by expanding the 

types of labels that are generically 

approved and that could be applied to 

products in final form without first 

submitting such labels to the Agency for 

evaluation and approval (60 FR 67443, 

Dec. 29, 1995). FSIS took this action to 

improve the label approval system by 

eliminating the need for industry to resubmit sketches in final label form, 

thereby reducing the number of labels 

being submitted to the Agency for 

approval. 


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16For the purposes of Part 500, Rules of Practice, 

an official establishment or establishment includes 

an official plant. See proposed § 591.1(b). 

On November 7, 2013, FSIS published 

a final rule that amended the meat and 

poultry products inspection regulations 

to expand the circumstances under 

which the labels of meat and poultry 

products would be deemed to be 

generically approved by the Agency. 

Effective January 6, 2014, FSIS 

regulations only require four categories 

of meat and poultry product labels to be 

submitted to LPDS for approval, as 

described in 9 CFR 412.1. FSIS requires 

the submission of labels: (1) Intended 

for temporary approval; (2) for products 

produced under religious exemption; (3) 

for products for export with labeling 

deviations; and (4) with special 

statements and claims as described in 

§ 412.1(c). All labels that do not fit into 

one of the four categories are eligible for 

generic approval. 

As part of its effort to make the egg 

products inspection regulations as 

consistent as possible with the Agency’s 

meat and poultry products regulations, 

FSIS is proposing to modify the prior 

label approval program for egg products 

labeling. If finalized, the program will 

be consistent with the prior label 

approval system that is in place for meat 

and poultry products, including the 

regulations that permit generically 

approved labeling. Under this system, 

only labeling that meets the criteria 

described in 9 CFR 412.1 will have to 

be submitted to FSIS for evaluation and 

approval. 

Therefore, FSIS is proposing to revise 

9 CFR 590.411 to require all official 

plants, including those certified under a 

foreign inspection system in accordance 

with 9 CFR 590.910, to comply with the 

requirements contained in 9 CFR 412.1. 

As a result, egg products plants will 

have to submit only four categories of 

product labels to FSIS for approval, 

including labels: (1) Intended for 

temporary approval; (2) for products 

produced under religious exemption; (3) 

for products for export with labeling 

deviations; and (4) with special 

statements and claims as described in 9 

CFR 412.1(c). 

In addition, FSIS is proposing to 

revise 9 CFR 590.412 to require that all 

official plants, including those certified 

under a foreign inspection system in 

accordance with § 590.910, comply with 

the requirements in 9 CFR 412.2. Under 

this section, egg products plants would 

be authorized to use generically 

approved labels and thus would be free 

to use such labels without submitting 

them to the Agency for approval, 

provided the label displays all of the 

required mandatory features in a 

prominent manner and is not otherwise 

false or misleading in any particular. 

As with meat and poultry products, 

FSIS would select samples of 

generically approved labels from the 

records maintained by official plants 

and plants certified under foreign 

inspection systems to determine 

compliance with label requirements (9 

CFR 412.2(a)(2)). If the Agency finds 

that an official plant is using a false or 

misleading label, it would institute the 

proceedings prescribed in 9 CFR 500.8 

to revoke the approval for the label. 

Current 9 CFR 590.50 requires shell 

eggs that are packed into containers 

destined for the ultimate consumer to be 

labeled to state that refrigeration is 

required. However, on December 5, 

2000, FDA amended 21 CFR part 101 to 

require that all shell eggs bear a safe 

handling statement. This statement, 

which is intended to inform consumers 

that there may be a risk associated with 

the consumption of eggs, and of the 

ways that they can properly handle and 

prepare eggs in order to reduce such 

risks, specifically instructs consumers to 

keep eggs refrigerated (21 CFR 101.17). 

As a result, FSIS’s labeling requirement 

essentially duplicates FDA’s, which 

became effective on September 4, 2001. 

Since it is FSIS’s intention not to 

unnecessarily burden any parties with 

its regulatory requirements, FSIS is 

proposing to state in its regulations that 

shell eggs packed into containers 

destined for the ultimate consumer must 

be labeled in accordance with 21 CFR 

101.17(h). 

Meat and poultry products that 

require special handling to maintain 

their wholesome condition are required 

to bear handling statements. To ensure 

that the egg products inspection 

regulations will be as consistent as 

possible with the Agency’s meat and 

poultry products regulations, FSIS is 

proposing a similar requirement for 

certain egg products, 9 CFR 590.410(a). 

Under this proposal, packaged egg 

products that require special handling 

to maintain their wholesome condition 

would have to bear the statement ‘‘Keep 

Refrigerated,’’ ‘‘Keep Frozen,’’ 

‘‘Perishable Keep Under Refrigeration,’’ 

or a similar statement. This statement 

would have to be prominently displayed 

on the principal display panel. 

Similarly, egg products that are 

distributed frozen and thawed before or 

during display for sale at retail would 

have to bear the statement ‘‘Keep 

Frozen’’ on the shipping container. 

Consumer-sized containers for such egg 

products would have to bear the 

statement ‘‘Previously Handled Frozen 

for Your Protection, Refreeze or Keep 

Refrigerated.’’ 

J. Rules of Practice 

Under the EPIA, FSIS ensures that egg 

products are wholesome, not 

adulterated, and properly marked, 

labeled, and packaged. FSIS has broad 

authority to issue regulations to carry 

out the provisions of the EPIA, 

including the authority to prescribe 

terms and conditions under which 

inspection will be provided and 

maintained (21 U.S.C. 1035(b) and 

1043). 

Currently, when FSIS refuses to 

inaugurate inspection in a plant, seeks 

to withdraw inspection, or refuses to 

approve egg products markings, labels, 

or containers, the Agency initiates an 

administrative action under 9 CFR 

590.160. FSIS is proposing to replace 9 

CFR 590.160(a)–(c) and (f)(1) with the 

supplemental rules of practice 

contained in 9 CFR part 500. These 

supplemental rules already apply to 

meat and poultry products 

establishments. Should this proposed 

rule become final, 9 CFR part 500, Rules 

of Practice, would apply to egg products 

plants, as an official establishment or 

establishment would include an official 

plant under proposed 9 CFR 591.1(b). 

FSIS is proposing to amend 9 CFR 

500.2(c) to add 9 CFR 590.310 to the list 

of regulatory citations under which an 

establishment 16 may appeal a 

regulatory control action. FSIS is also 

proposing to amend 9 CFR 500.3(a)(7) to 

allow FSIS to take a withholding action 

or to impose a suspension without 

providing an establishment prior 

notification because the establishment 

did not destroy a condemned egg 

product that has been found to be 

adulterated and has not been 

reprocessed, in accordance with 9 CFR 

part 590, within three days of 

notification. 

FSIS is proposing to amend 9 CFR 

500.5(a)(5) and (c) to add 9 CFR 590.310 

to the list of regulatory citations under 

which it must advise an establishment 

that it may appeal a withholding action 

or suspension, and under which an 

establishment may appeal a withholding 

action or suspension. FSIS is also 

proposing to amend 9 CFR 500.6 by 

adding section 18 of the EPIA (21 U.S.C. 

1047) to the statutory citations under 

which the FSIS Administrator may file 

a complaint to withdraw a grant of 

Federal inspection because a recipient 

of inspection, or anyone responsibly 

connected to the recipient, is unfit to 

engage in any business requiring 

inspection. 


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6330 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

FSIS is proposing to amend 

paragraphs (a)(3) and (5) of 9 CFR 500.7 

to permit the FSIS Administrator to 

refuse to grant Federal inspection 

because an applicant has not 

demonstrated that adequate sanitary 

conditions exist in the establishment as 

required by the egg products inspection 

regulations, or because the applicant is 

unfit to engage in any business requiring 

inspection as specified in 21 U.S.C. 

1047. FSIS is also proposing to amend 

9 CFR 500.8(a) to allow FSIS to rescind 

or refuse approval of false or misleading 

marks, labels, or sizes or forms of any 

container for use with any egg product 

under sections 7 or 14 of the EPIA (21 

U.S.C. 1036 and 1043). If this proposal 

is adopted, 9 CFR 500.8(c) will provide 

for an opportunity for a hearing, in 

accordance with the Uniform Rules of 

Practice, 7 CFR subtitle A, part 1, 

subpart H, if FSIS rescinds or refuses 

approval of false or misleading marks, 

labels, or sizes or forms of any container 

for use with any egg product. 

Should this rule become final, FSIS 

would take a withholding action or 

impose a suspension without providing 

the plant prior notification because: (1) 

The official plant does not have a 

HACCP plan as specified in 9 CFR 

417.2; (2) the official plant does not 

have Sanitation Standard Operating 

Procedures as specified in accordance 

with 9 CFR 416.11 and 416.12; or (3) the 

official plant does not maintain sanitary 

conditions (9 CFR 500.3(a)). FSIS would 

also take these actions when facilities 

apply for a grant of inspection and the 

applicant or recipient, or anyone 

responsibly connected with the 

applicant or recipient, is unfit to engage 

in business because of prior criminal 

convictions, or when plant personnel 

assault, intimidate, or interfere with 

Federal inspection service (21 U.S.C. 

1047). 

The proposed rules of practice will 

ensure that enforcement procedures are 

fair; identify situations that may lead 

FSIS to take enforcement action that 

may include refusing to apply or 

withholding the marks of inspection 

from product or suspending or 

withdrawing inspection from facilities; 

provide an opportunity for official 

plants to address and correct problems 

before the Agency files a formal 

administrative complaint to suspend or 

withdraw inspection; establish the 

procedures FSIS will follow in taking 

such actions; and consolidate the rules 

of practice applicable to official plants 

with those applicable to meat and 

poultry products establishments. 

K. Other Regulatory Changes 

1. Elimination of Official Egg Products 

Plant Equipment and Facility 

Prior Approval Requirements 

The egg products inspection 

regulations require that official egg 

products plants applying for inspection 

submit to FSIS multiple sets of drawings 

of and specifications for the facilities for 

approval before inspection can be 

granted (§ 590.146). The regulations 

require plans to be submitted to the 

Agency for approval before any 

remodeling of facilities, and they 

require that prior approval by FSIS be 

obtained for equipment and utensils 

proposed for use in preparing edible 

product or product ingredients in 

official plants (§§ 590.146(d), 590.502, 

590.504). 

The prior-approval process is a 

feature of the traditional ‘‘commandand-control’’ regulatory approach. 

While prior approval provides 

assurance that equipment, facilities, and 

processes, as designed, meet certain 

requirements that are intended to ensure 

food safety or quality, it also reflects the 

emphasis of the current egg products 

inspection system on dictating the way 

in which official plants maintain 

sanitation and produce safe food. This 

feature of the current system is 

inconsistent with FSIS’s view of the 

appropriate allocation of responsibility 

between the Agency and official plants. 

It is an obstacle and too often a deterrent 

to innovation by official plants seeking 

to improve operations, and it 

contributes to unproductive use of FSIS 

resources both in managing the approval 

system and policing official plants’ 

compliance with approved facility and 

equipment specifications. 

Experience has shown that FSIS prior 

approvals are of limited value in 

ensuring good sanitation. They are 

limited in both scope, in that they deal 

only with official plant facilities as 

presented in drawings, and time, in that 

they are given once, on the condition 

that official plants will maintain a 

sanitary operating environment after 

their facilities are approved. Ultimately, 

an official plant’s implementation of 

good Sanitation SOPs on a continuing 

basis is more critical than the actual 

design of a facility. Plant-operated 

sanitation procedures will achieve, 

without prior approval, the same 

objectives as the FSIS prior approvals, 

thereby rendering the prior approval 

procedures unnecessary. Thus, under 

HACCP-based inspection, the FSIS prior 

approvals could no longer be considered 

an efficient and cost-effective means to 

achieve sanitation objectives. 

Under this proposal, although there 

will no longer be a requirement for an 

official plant to submit facility drawings 

and specifications when applying for a 

grant of inspection, FSIS will continue 

to use a specific process to determine 

whether to grant inspection. This 

process will still include an on-site 

review, or ‘‘walk-through,’’ of the 

plant’s facilities by FSIS inspection 

program personnel as part of the predecisional review of the facility’s 

capability to produce complying 

product. However, the decision-making 

process will no longer include the 

review and prior approval of facility 

blueprints and specifications by the 

Agency. The on-site review will not 

involve matching items on the 

blueprints with the actual facilities 

represented. Instead, the focus of the 

review will be on the extent to which 

the facility is able to maintain a sanitary 

environment for food production and 

not impede government inspection. 

Prior approval by FSIS of equipment 

and utensils proposed for use in 

preparing edible egg products or 

product ingredients will also be 

eliminated under this proposal. FSIS’s 

one-time approval does not address 

daily operational issues such as proper 

maintenance and adjustment of 

equipment to prevent product 

contamination. Such issues are covered 

by the requirement in 9 CFR 416.3 that 

equipment and utensils be of such 

material and construction that they can 

be thoroughly cleaned and sanitized, as 

well as by other general sanitation 

requirements. 

While facilities will be required to 

meet the general sanitation 

requirements prescribed in the 

regulations, they will have the 

flexibility to determine the specific 

steps to be taken to comply with those 

requirements. Facilities will be able to 

use equipment based on their own 

evaluation of their ability to utilize the 

equipment in a sanitary way. 

In its inspection activities, FSIS will 

verify that plant equipment meets those 

general standards. FSIS inspection 

program personnel will act if they find 

that the equipment that a facility is 

using creates an insanitary condition 

that may render product injurious to 

health. 

2. Eggs and Egg Products Import 

Requirements 

FSIS is proposing to amend the 

regulations governing the importation 

and inspection of foreign eggs and egg 

products to align them more closely 

with the regulations governing the 

importation of foreign meat and poultry 

products. Historically, significant 


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differences have existed in how FSIS 

makes determinations of eligibility for 

the import of meat and poultry products 

to the United States as opposed to 

determinations for imported egg 

products. Similarly, requirements and 

procedures for the reinspection of 

imported products presented for entry 

into domestic commerce have been 

applied differently to meat and poultry 

products than to egg products. In this 

proposal, therefore, to improve import 

program efficiency and food safety 

controls, FSIS is seeking to harmonize 

the requirements and procedures 

applicable to imported eggs and egg 

products with those applicable to 

imported meat and poultry products. 

FSIS is proposing to amend 9 CFR 

part 590 by adding a new subpart B, 

Imports (9 CFR 590.900 et seq.), that 

will contain the imported egg products 

regulations. FSIS is proposing to amend 

these regulations by adding 9 CFR 

590.900, which includes paragraphs that 

define certain basic terms, Import 

(Imported) and Offered for entry, and for 

product from eligible countries: Entry 

(Entered). FSIS is also proposing to add 

the term Official Import Inspection 

Establishment consistent with the 

definition in the meat inspection 

regulations. 

FSIS is proposing to add a new 9 CFR 

590.901 to 9 CFR part 590 to establish 

the identity of inspected and passed 

imported egg products as domestic 

products. In so doing, the Agency seeks 

to ensure that imported egg products 

that bear the mark of inspection may be 

combined with inspected and passed 

domestic products for purposes of 

further processing or sale in domestic 

commerce. 

FSIS is proposing to amend 9 CFR 

590.910 to establish the process and 

criteria that the Agency will follow to 

evaluate the equivalence of the 

inspection programs of foreign countries 

interested in gaining eligibility to export 

egg products to the United States. This 

section also delineates the manner in 

which foreign governments will be 

required to maintain the equivalence of 

their egg products inspection programs, 

including their certification of eligible 

establishments, separation of certified 

from uncertified establishments, and 

audits to verify the on-going 

equivalence of food safety and HACCP 

controls in certified establishments. 

FSIS is also proposing to prescribe the 

manner in which foreign governments 

are to certify eligible establishments to 

FSIS. Finally, proposed 9 CFR 590.910 

includes provisions for the public 

notification of determinations of 

equivalence made by FSIS of foreign egg 

products inspection programs. 

FSIS is addressing those 

circumstances in which a shipment of 

imported egg products may be rejected 

for container defects, but are otherwise 

found to be acceptable, by proposing to 

add a new paragraph (d) to 9 CFR 

590.945 to identify the conditions under 

which imported egg products 

consignments with damaged containers 

may be reoffered for inspection. 

For the handling of imported egg 

products, FSIS is proposing to amend 9 

CFR 590.930 to require official import 

inspection establishments that reinspect egg products to meet the 

sanitation requirements in 9 CFR part 

416. The sanitation requirements in 9 

CFR part 416 address conditions within 

establishments, such as facility and 

equipment sanitation, employee 

hygiene, and the development and 

implementation of sanitation standard 

operating procedures and associated 

recordkeeping requirements. 

FSIS is proposing to amend 9 CFR 

590.940 to establish official inspection 

marks for imported egg products. 

Current regulations require only that egg 

products found to be acceptable for 

importation be properly labeled and 

bear the inspection mark of the country 

of origin. FSIS is proposing that 

imported egg products bear the same 

mark of inspection that is applied to 

imported meat and poultry products. 

Additionally, this section outlines a 

procedure for the pre-stamping of 

official marks of inspection on product 

containers prior to the completion of an 

inspection assignment. These changes 

are intended to help to facilitate the 

clearance of inspected product during 

the examination process when the 

product is not being held pending the 

receipt of laboratory test results. 

FSIS is proposing to amend 9 CFR 

590.945 to clarify the procedures for the 

treatment and handling of imported egg 

products identified as ‘‘U.S. Refused 

Entry.’’ Paragraph (a)(5) of that section 

states that if the owner or importer fails 

to take the required action within the 

time specified under paragraph (a)(4) of 

this section, the Department will take 

such actions as may be necessary to 

effectuate its order to have the product 

destroyed for human food purposes. The 

Department shall seek court costs and 

fees, storage, and proper expenses in the 

appropriate forum. 

FSIS is proposing to amend 9 CFR 

590.955 to include shipping or 

identification marks among the list of 

required items for the labeling of 

imported egg products shipping 

containers. Shipping and identification 

marks are identifiers included on 

product container labels to distinguish 

product contained in a particular 

shipment from other product shipped 

elsewhere from the same production lot. 

Including shipping and identification 

marks on the shipping container labels 

facilitates identification of the product 

in the event of a recall or compliance 

investigation. 

9 CFR 590.956 permits the relabeling 

of all egg products eligible for 

importation with an approved label 

under the supervision of an FSIS 

inspector at an official egg products 

plant or other location. Under proposed 

9 CFR 590.411(f)(1), if the Administrator 

has reason to believe that any labeling, 

including the size or form of any 

container in use or proposed for use, 

with respect to egg products is false or 

misleading in any way, the 

Administrator may direct that such use 

be withheld unless the labeling or 

container is modified so that it will not 

be false or misleading, or the 

formulation of the product is altered so 

that it is not adulterated or would not 

cause misbranding. 

While 9 CFR 590.956 permits the 

relabeling of all egg products eligible for 

importation with an approved label, 

proposed 9 CFR 590.411(f)(1) would 

permit only those products whose 

containers, labels, or packaging 

materials are false or misleading to be 

modified so that the containers or labels 

are not adulterated or would not be 

misbranded. Therefore, FSIS is 

proposing to amend 9 CFR 590.956 to 

permit only those egg products that 

have been refused entry into the United 

States solely because of misbranding to 

be brought in compliance with the 

labeling requirements of 9 CFR chapter 

III. An authorized representative of the 

Secretary will have authority to 

supervise any such compliance 

activities. 

Under 9 CFR 590.965, egg products 

that have been inspected and marked by 

USDA may be returned from foreign 

countries. They are not considered 

importations within the meaning of 9 

CFR part 590. Because such products 

are inspected and passed U.S. product, 

they are handled in the same manner as 

domestic products. FSIS is proposing to 

amend 9 CFR 590.965 to permit the reentry of inspected and passed egg 

products from foreign countries if they 

are not adulterated or misbranded at the 

time of such return. The product may be 

subject to reinspection in an official 

plant before it can be released into 

commerce. Such products would be 

exempted from further requirements 

under 9 CFR part 590, and returned 

shipments must be reported to the 

Administrator by letter prior to their 

arrival at the United States port of entry. 

The proposed language will be 


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17On April 19, 2006, AMS amended its definition 

of ‘‘eggs of current production’’ to mean shell eggs 

that are no more than 21 days old (71 FR 20288). 

consistent with that for returned United 

States inspected and marked poultry 

products (9 CFR 381.209). 

9 CFR 590.960 provides an exemption 

from foreign export certification and 

import inspection requirements for 

imported egg products that are intended 

for an importer’s personal use, display, 

or laboratory analysis or that are not 

intended for sale or distribution in 

domestic commerce. FSIS is proposing 

to extend the 50 pound exemption for 

dried egg products to liquid or frozen 

egg products, which may currently not 

exceed 30 pounds in weight. This 

proposed change is consistent with the 

personal exemption provisions for 

imported meat and poultry products, 

which permit any product in a quantity 

of 50 pounds or less which was 

purchased by the importer outside of 

the United States for his/her own 

consumption to be imported into the 

United States from any country without 

compliance with the provisions of 

chapter III of title 9. 

On September 19, 2014, FSIS 

published a final rule amending 9 CFR 

590.915 and 590.920 to provide an 

electronic alternative to the paper-based 

import inspection application and the 

foreign inspection and foreign plant 

certificate processes (79 FR 56220). It 

also removed from the regulations the 

discontinued ‘‘streamlined’’ import 

inspection procedures for Canadian 

product. The Agency is reproducing the 

amended regulatory text in the codified 

text of this rule for context and clarity. 

It is not, however, amending that text. 

3. Changes to Defined Terms 

FSIS is proposing to amend the egg 

and egg products inspection regulations 

by updating the terminology used to 

refer to Agency personnel and the 

definitions of various terms. FSIS is 

proposing to remove the undesignated 

paragraphs of 9 CFR 590.5 that define 

Chief of the Grading Branch, Inspector/ 

Grader, National Supervisor, Regional 

Director, and Service because such 

positions/entities do not exist within 

FSIS. As mentioned previously, FSIS 

assumed responsibility for conducting 

the egg products inspection program 

from AMS on May 28, 1995. Therefore, 

9 CFR part 590 references should refer 

to FSIS and its officials. FSIS is also 

proposing to remove the term Sanitize 

from 9 CFR 590.5. As discussed earlier 

in this document, the Agency is 

proposing to consolidate the current 

sanitation regulations applicable to 

official plants into 9 CFR 590.1 and part 

416. While not explicitly defined, the 

concept underlying the term ‘‘sanitize’’ 

is explained in 9 CFR part 416. 

Therefore, to eliminate this difference 

between the meat and poultry 

inspection regulations and the egg and 

egg products inspection regulations, 

FSIS is proposing to remove the term 

Sanitize from 9 CFR 590.5. 

FSIS is also proposing to remove the 

definition for the term Eggs of current 

production. ‘‘Eggs of current 

production’’ are those eggs that have 

moved through the usual marketing 

channels since the time they were laid 

and are not in excess of 60 days old.17

AMS uses the concept of ‘‘eggs of 

current production’’ to maintain the 

integrity of its quality standards and the 

AMS grade shield. It is a quality, not a 

food safety, indicator. Therefore, FSIS is 

proposing to remove the term because 

continued application of the regulatory 

requirement may unduly restrict the 

availability of edible eggs. However, 

FSIS is requesting comments on 

whether it should keep the term ‘‘eggs 

of current production,’’ and any support 

that the term is still necessary. 

Finally, FSIS is proposing to remove 

the definition for the term ‘‘plant.’’ 

Under this definition, the term ‘‘plant’’ 

can refer to an exempted plant, i.e., a 

plant where the Administrator has 

determined that the facilities and 

operating procedures meet the standards 

prescribed in part 590, and where the 

eggs received or used in the 

manufacture of egg products contain no 

more than restricted eggs than are 

allowed by the official standards of U.S. 

Consumer Grade B for shell eggs, and 

where an exemption has been granted, 

or an official plant, which means any 

plant in which the plant facilities, 

methods of operations, and sanitary 

procedures have been found suitable 

and adequate for the continuous 

inspection of egg products in 

accordance with part 590 and in which 

inspection service is carried on. FSIS is 

proposing to remove this definition 

because it is proposing to eliminate the 

exempted plant regulations, which is 

discussed later in this document. FSIS 

is proposing to add, in alphabetical 

order, an undesignated paragraph to 9 

CFR 590.5 defining ‘‘official plant.’’ An 

‘‘official plant’’ will be any plant in 

which the plant facilities, methods of 

operation, and sanitary procedures have 

been found suitable and adequate by the 

Administrator for the inspection of egg 

products pursuant to the regulations in 

this part and in which inspection 

service is carried on. 

FSIS is proposing to revise the 

undesignated paragraphs of 9 CFR 590.5 

that define the terms Administrator, 

Egg, Egg product, Pasteurize, Processing, 

and Shell egg packer. FSIS is proposing 

to revise the definition for the term 

Administrator to make reference to the 

FSIS Administrator instead of the AMS 

Administrator. This change reflects the 

fact that the authority for inspecting egg 

products under the EPIA’s food safety 

provisions was delegated by the 

Secretary of Agriculture to FSIS from 

AMS in November 1994. 

Because the term Dirty egg or Dirties 

is defined twice in 9 CFR 590.5, once as 

an undesignated stand alone term and 

once as a definition under the term Egg 

(paragraph c)), FSIS is proposing to 

eliminate this redundancy by removing 

the undesignated stand-alone term and 

its definition of Dirty egg or Dirties. 

While the definition of Dirty egg or 

Dirties in paragraph (c) of the term Egg 

is properly located, FSIS is proposing to 

revise it. The definition includes 

prominent stains as a criterion for 

classifying an egg as ‘‘dirty,’’ but the 

EPIA’s definition of the term does not 

include this criterion (21 U.S.C. 

1033(g)(3)). In addition, rather than 

being called ‘‘dirties,’’ dirty eggs are 

referred to as ‘‘dirts’’ in 7 CFR 59.720, 

which the Agency is proposing to add 

to the egg products inspection 

regulations. Consequently, FSIS is 

proposing to delete the words 

‘‘prominent stains’’ from the definition 

of Dirty egg or Dirties in the regulations. 

Also in 9 CFR 590.5, FSIS is 

proposing to replace the term Official 

standard with the term Official 

standards, correcting a typographical 

error made when the term was 

transferred from 7 CFR chapter 1, part 

59 to 9 CFR chapter III, part 590 on 

December 31, 1998 (63 FR 72352). 

FSIS is also proposing to amend the 

definition of Processing, to make clear 

that official plants may not repackage 

pasteurized dried egg products unless 

inspection program personnel are 

available to provide inspection 

oversight during the process. FSIS is 

proposing to amend the definition of 

Pasteurize to eliminate the requirement 

that only lethality treatments prescribed 

in the egg products inspection 

regulations may be used to destroy 

harmful viable microorganisms. 

FSIS is also proposing to amend the 

term Shell egg packer (grading station) 

by removing the phrase (grading 

station). Grading station is a term used 

by AMS to differentiate between the two 

primary types of egg handlers: (1) 

Producer-packers, who pack only their 

own production, and (2) grading 

stations, which are all other facilities 

that segregate and pack eggs. While FSIS 

also distinguishes between producerpackers and all other packing facilities 


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in its regulations, the phrase (grading 

station), when included as part of the 

defined term itself, causes confusion 

because FSIS does not perform any 

grading functions. 

FSIS is proposing to add to 9 CFR 

590.5 an undesignated paragraph that 

defines Program employee because it is 

specific to FSIS and refers to Agency 

personnel. FSIS is also proposing to 

define the phrase Shipped for retail sale. 

Shipped for retail sale means eggs that 

are forwarded from the processing 

facility for distribution to the ultimate 

consumer. 

4. Conditions for Receiving Inspection 

FSIS is proposing a 9 CFR 591.1(a) 

which, by cross-reference, will require 

that official plants, before receiving 

Federal inspection, develop written 

sanitation Standard Operating 

Procedures, in accordance with 9 CFR 

part 416, conduct a hazard analysis, and 

develop and implement a HACCP plan, 

in accord with 9 CFR part 417. 

Conditional inspection may be provided 

for a period not to exceed 90 days, 

during which period the plant will have 

to validate its HACCP plan. 

5. Miscellaneous Changes 

FSIS is proposing to amend the 

following egg products inspection 

regulations to match the text in the meat 

and poultry products inspection 

regulations: 

9 CFR 590.118 Identification. 

9 CFR 590.120 Financial interest of 

inspectors. 

9 CFR 590.136 Accommodations and 

equipment to be furnished by facilities for 

use of program employees in performing 

service. 

9 CFR 590.146 Survey and grant of 

inspection. 

9 CFR 590.310 Appeal inspections. 

FSIS is also proposing to eliminate 

the issuance of appeal certificates (9 

CFR 590.360) and the cost of an appeal 

to a plant (9 CFR 590.370). Under 

current 9 CFR 590.300 and proposed 9 

CFR 590.310, official plants have the 

right to appeal inspection decisions. 

6. Reinterpreting the Requirement for 

Continuous Inspection in 21 U.S.C. 

1034(a) 

The EPIA requires the continuous 

inspection of the processing of egg 

products whenever processing 

operations are being conducted in each 

plant processing egg products for 

commerce (21 U.S.C. 1034(a)). FSIS has 

interpreted this to require the presence 

of inspection program personnel at each 

egg products plant whenever the 

manufacturing of egg products is being 

conducted, including breaking eggs or 

filtering, mixing, blending, pasteurizing, 

stabilizing, cooling, freezing, drying, or 

packaging egg products. This level of 

inspection coverage is similar to that 

required at meat and poultry slaughter 

establishments, where FSIS conducts 

inspection during all slaughter 

operations. In contrast, at meat and 

poultry processing establishments, FSIS 

conducts inspection at least once per 

shift. 

Based on the Agency’s experience 

inspecting egg products plants since 

1995, the Agency believes that egg 

products operations are more similar to 

meat and poultry processing operations, 

and especially those that produce readyto eat products, than they are to meat 

and poultry slaughter operations, where 

inspection is required for each meat or 

poultry carcass. Like ready-to-eat meat 

and poultry processing operations, the 

typical egg products processing 

operation is a streamlined, automated 

process, with one or more lethality steps 

to destroy pathogens of concern in the 

finished product. As a result, FSIS is 

proposing to change the Agency’s 

interpretation of ‘‘continuous 

inspection’’ in 21 U.S.C. 1034(a). 

Therefore, FSIS now intends to require 

inspection in egg products plants at 

least once per shift, instead of during all 

processing operations. FSIS welcomes 

comment on possible criteria the 

Agency might use in determining how 

inspection will be specifically adjusted 

in egg products plants. 

Section 590.100 provides exemptions 

from continuous inspection under 

certain circumstances, provided that the 

conditions for exemption and the 

provisions of the regulations are met. 

Paragraph (b) of 9 CFR 590.100 provides 

an exemption from continuous 

inspection at any plant where the 

facilities, sanitation, and operating 

procedures are the same as required in 

part 590 for official plants and where 

the eggs received or used in the 

manufacture of egg products contain no 

more restricted eggs than are allowed by 

the official standards for U.S. Consumer 

Grade B shell eggs, and the egg products 

processed at such plant. Plants granted 

an exemption under 9 CFR 590.100(b) 

are called ‘‘exempted plants.’’ 

Instead of continuous inspection, 

exempted plants are subject to periodic 

inspections, provided they have met the 

facility, operating procedures and 

practices, and sanitation standards 

required for official egg products plants 

as contained in 9 CFR 590.500–590.580. 

They are also subject to other provisions 

applicable to official plants, which 

includes maintaining records which 

must be made available to duly 

authorized representatives of the 

Administrator for review. Product from 

exempted plants may not bear official 

identification (9 CFR 590.680(a)). 

Exempted product labels must bear the 

statement, ‘‘Exempted-E.P.I.A. 

Registration No. __.’’ The registration 

number is that assigned to the exempted 

plant as provided in 9 CFR 590.650. 

The Agency’s proposal to no longer 

require inspection coverage during all 

processing operations removes the need 

for this exemption. The circumstances 

provided by this exemption can be 

accommodated under FSIS’s changed 

interpretation of ‘‘continuous 

inspection’’ in 21 U.S.C. 1034(a) and 

would allow such exempted plants to 

bear official identification. Therefore, 

FSIS is proposing to remove the specific 

exemption from continuous inspection 

found in 9 CFR 590.100(b), as well as 

the regulations in 9 CFR 590.600– 

590.680 authorizing these types of 

exempted egg products plants. The 

other exemptions from inspection for 

certain types of egg products processing, 

provided at 9 CFR 590.100(e) and (g), 

would remain, but would be 

redesignated as paragraphs (b)(1) and 

(2). Paragraph (f), now reserved, would 

be removed. 

III. Executive Orders 12866, 13563, and 

13771 and the Regulatory Flexibility 

Act 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts and equity). 

Executive Order 13563 emphasizes the 

importance of quantifying both costs 

and benefits, or reducing costs, of 

harmonizing rules, and of promoting 

flexibility. This proposed rule has been 

designated a ‘‘significant’’ regulatory 

action under section 3(f) of Executive 

Order 12866. Accordingly, the rule has 

been reviewed by the Office of 

Management and Budget under 

Executive Order (E.O.) 12866. 

A. Need for Regulatory Action 

The proposed rule will enable official 

plants to increase efficiency from 

complying with less burdensome 

regulations. FSIS is proposing that the 

current ‘‘command and control’’ egg 

products inspection regulations be 

changed to more flexible regulatory 

requirements. Under this proposed rule, 

egg products plants would be required 

to develop and maintain HACCP 

systems. A HACCP system allows 

greater flexibility for producers to 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6334 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

18RTI International. 2014. ‘‘Survey of Egg Packing 

and Egg Products Processing Plants.’’ Revised Final 

Report. RTI Project no. 0211740.015.001. 3040 

Cornwallis Rd., P.O. Box 12194 Research Triangle 

Park, NC 27709–2194. OMB No. 0583–0162. 

19 In the Fiscal Year 2014, the monthly average 

production volume was used to calculate the 

annual estimate for 77 egg products plants in the 

PHIS database. 

20 In the Fiscal Year 2014, the monthly average 

production volume was used to calculate the 

percentage for 77 egg products plants in the PHIS 

database. 

21RTI International. 2014. ‘‘Survey of Egg Packing 

and Egg Products Processing Plants.’’ Revised Final 

Report. RTI Project no. 0211740.015.001. 3040 

Cornwallis Rd., P.O. Box 12194 Research Triangle 

Park, NC 27709–2194. 22RTI International. 2014. ‘‘Survey of Egg Packing 

and Egg Products Processing Plants.’’ Revised Final 

Report. RTI Project no. 0211740.015.001. 3040 

Cornwallis Rd., P.O. Box 12194 Research Triangle 

Park, NC 27709–2194. 

23 Ibid. 

24Under the HACCP size definitions, large 

establishments have 500 or more employees and 

small establishments have fewer than 500 but more 

than 10 employees. Very small establishments have 

fewer than 10 employees or annual sales of less 

than $2.5 million. These definitions are outlined in 

Pathogen Reduction: Hazard Analysis and Critical 

Control Point (HACCP) Systems (61 FR 38806 (July 

25, 1996) available at: http://www.fsis.usda.gov/ 

OPPDE/rdad/FRPubs/93-016F.pdf. 

25U.S. Department of Agriculture, Egg Products 

Inspectors Handbook. AMS PY-Instruction No. 910. 

January, 1975. 

realize increased production efficiency. 

In addition, the proposed rule will 

allow plants to use different 

pasteurization methods. With 93 

percent of egg products plants already 

under a HACCP system,18 many have 

incurred additional unnecessary costs 

from complying with FSIS requirements 

in terms of ‘‘command and control’’ 

regulations and by processing under 

their own HACCP systems. By operating 

under the HACCP system alone, egg 

products plants can use plant resources 

in a more efficient manner while 

controlling for hazards in innovative 

ways in their HACCP plans. 

Furthermore, regulatory action is 

warranted by the non-negligible public 

health risks associated with pasteurized 

egg products. The FSIS 2005 risk 

assessment estimated 5,500 cases of 

Salmonella per year due to pasteurized 

liquid egg products. This represents 

0.5% of the approximately 1.03 million 

annual domestically acquired foodborne 

illnesses caused by Salmonella 

estimated by Scallan et al. (2011, 

Emerging Infectious Diseases 17(1):7– 

15). Gurtler et al. (2013, Foodborne 

Pathogens and Disease, 10(6):492–499) 

identifies four Salmonella outbreaks 

during 2007–2012 that were possibly 

caused by contaminated pasteurized egg 

products. Also, process control failures 

in the production of pasteurized egg 

products have the potential for 

especially serious health outcomes 

because the Food Code recommends 

pasteurized egg products for highly 

susceptible populations (FDA 2013 

Food Code, Sec. 3–8). 

Baseline of the Egg Products Industry 

Currently, egg products are produced 

under FSIS jurisdiction by 77 egg 

products plants. Egg products include 

liquid, frozen, and dried whole eggs, 

whites, yolks, and various blends with 

or without non-egg ingredients. 

According to the FSIS Public Health 

Information System (PHIS) Database, we 

estimate that the egg products industry 

produced 1.8 billion pounds of dried, 

frozen, and liquid egg products for 

distribution in commerce and produced 

4 billion pounds of liquid unpasteurized 

product for further processing in 2014.19

Liquid egg products are produced in 73 

percent of plants and accounted for 19 

percent of all egg products marketed as 

finished product in 2014.20 Liquid egg 

products represent the largest product 

type produced by egg products plants. 

A survey by RTI International in 2014, 

Egg Products Industry Survey,21 showed 

that 93 percent of egg products plants 

use a written HACCP plan to address at 

least one production step in their 

process.22 The remaining 7 percent 

would need to create HACCP plans 

under this proposed rule, as well as any 

of the 93 percent of egg products plants 

that have HACCP plans for some egg 

products, but not for others. 

This proposed rule would require that 

egg products plants maintain sanitation 

SOPs equivalent to the specifications of 

FSIS. Ninety-one percent of egg 

products plants already conduct 

sanitation procedures for food contact 

surfaces either daily or more frequently 

and document those procedures for 

sanitation standard operating 

procedures (Sanitation SOPs).23

Egg products production is easily the 

least labor-intensive process of the 

industries and products that FSIS 

regulates. Egg products plants tend to be 

highly mechanized and staffed with 

relatively low numbers of employees. 

Based on the results of a 2014 industry 

survey,24 no egg products plants employ 

enough employees to be categorized as 

HACCP size Large. Because of the high 

product volume output to low employee 

count that egg products plants enjoy, 

nearly all plants that have less than 10 

employees have over $2.5 million in 

annual sales, making them ineligible for 

the HACCP size Very Small category. 

Therefore, the large majority (98 

percent) of egg products plants fall into 

the HACCP size Small category. In this 

section, FSIS discusses the size of 

individual plants. For a discussion of 

the size of egg products businesses 

under the Small Business 

Administration’s (SBA) definition, see 

the initial Regulatory Flexibility 

Analysis section of this document. 

Table 2 displays plants and processes. 

TABLE 2—EGG PRODUCTS PLANTS AND TOTAL PROCESSES

Plants Breaking Liquid Dried Total 

processes 

77 ............................................................................. 56 52 17 125 

FSIS inspection of egg products plants 

includes 95 inspection program 

personnel (IPP), who conduct daily preoperational sanitation inspections and 

monitor sanitary conditions of the plant 

premises, facilities, and equipment 

continually during operations at every 

egg products plant in multiple shifts. 

FSIS IPP are responsible for observing 

the cleanliness, type, and 

wholesomeness of raw materials and 

finished products, the handling of 

ingredients, pasteurization, packaging, 

labeling, freezing, storing, and all other 

operations related to the processing and 

production of egg products. In the past, 

FSIS has determined through regulation 

that, under the EPIA, IPP are required to 

conduct continuous inspection at egg 

products plants. This requirement 

means IPP must be on duty whenever 

eggs are broken; liquid eggs arrive at the 

receiving plant; egg products are 

blended, reconstituted, or reformulated; 

egg products are pasteurized or 

packaged; and non-denatured inedible 

egg products arrive at, or are shipped 

from, the plant.25

Expected Cost of the Proposed Rule 

Presented here are economic analyses 

for the breaking of shell eggs, the 

production of pasteurized liquid egg 


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26Estimates obtained from the Bureau of Labor 

Statistics May 2016 National Industry-Specific 

Occupational Employment and Wage Estimates, for 

Management Occupations (Occupational Code 11– 

0000), https://www.bls.gov/oes/current/ 

oes113051.htm#ind, Food Scientists and 

Technologists (19–1012), https://www.bls.gov/oes/ 

current/oes191012.htm, and Production 

Occupations (51–0000) https://www.bls.gov/oes/ 

current/oes513023.htm. 

27This analysis accounts for fringe benefits and 

overhead by multiplying wages by a factor of two. 28 9 CFR 417.4. 

29See Appendix A, Section 4. 

30For the purposes of the table, the number of 

processes was rounded to the nearest whole 

number. For the purposes of cost calculations and 

to be more exact, the Agency kept the actual figures, 

including digits past the decimal point, for 

instance, the number of total processes is actually 

24.2507 rather than 24. These figures are not exact 

whole numbers because the Agency used the survey 

participant responses for which processes they use, 

as percentages of the total survey responses. These 

percentages were used to derive the total number 

of establishments that use each process applying 

that to the total population of egg products plants 

in Agency data (please see appendix A). 

31RTI International. Cost of Food Safety 

Investments Final Report. Available at: https://

www.fsis.usda.gov/wps/wcm/connect/0cdc568ef6b1-45dc-88f1-45f343ed0bcd/Food-SafetyCosts.pdf?MOD=AJPERES. These cost figures were 

adjusted for inflation using the average CPI–U from 

2014 to 2016. 

32For plan development costs, in order to 

mitigate outliers, the Agency selected the greater of 

the two lowest costs between developing the plan 

internally and the cost for developing with a 

consultant for the low estimate, and the lesser of the 

two highest costs between developing the plan 

internally or with a consultant for the high estimate. 

products (including frozen egg 

products), and the production of 

pasteurized dried egg products. Also 

provided are estimated government 

costs associated with this proposed 

regulation. All recurring and one-time 

cost estimates are in 2016 dollars, and 

discount rates of 3 percent and 7 

percent are used to calculate annualized 

costs over a 10-year period. For the 

purposes of the cost estimate, FSIS did 

not consider plant HACCP size because 

of the regularity in size explained 

previously (98 percent small). FSIS does 

not anticipate costs experienced by Very 

Small plants to differ greatly from those 

experienced by Small plants, because 

this proposed rule does not require any 

major capital, structural, or machinery 

investment or the hiring of additional 

employees, which can impose a large 

burden on Very Small plants. 

Egg products plant personnel 

compensation (wages and benefits) that 

plants would need to provide to their 

employees because of the proposed 

regulation is derived using Bureau of 

Labor Statistics Occupational 

Employment Statistics wage rates and 

National Compensation Survey benefits 

percentages. The wage rate for a Quality 

Control (QC) manager is estimated to be 

$51.47 per hour; for Supervisors or QC 

technicians, $34.26 per hour; and for 

Production workers, $13.00 per hour.26

Plants may pay employees for benefits 

such as paid leave, health insurance, 

and retirement and savings, and FSIS 

applied a benefits factor 27 of two to the 

hourly wage rate to estimate a total 

compensation rate for a Quality Control 

(QC) manager at $102.94 per hour; and 

for Supervisors or QC technicians at 

$68.52 per hour; and for Production 

workers at $26.00 per hour. 

Hazard Analysis & Critical Control 

Points (HACCP) Systems: The cost 

estimates for HACCP implementation 

include costs associated with plan 

development and reassessment, 

training, and monitoring and 

recordkeeping costs. If egg products 

plants follow current time/temperature 

regulations, FSIS would accept their 

approach, and FSIS would not require 

that plants do a significant amount of 

analysis in their HACCP plan. Upon 

completion of the hazard analysis and 

development of the HACCP plans, 

plants are required to determine 

whether their HACCP plans are 

functioning as intended. During the 

initial validation period, plants are to 

test, repeatedly, the adequacy of the 

CCPs, critical limits, monitoring and 

recordkeeping procedures, and 

corrective actions identified in the 

HACCP plan.28 Plants are also required 

to perform an annual reassessment of 

their HACCP plans. 

HACCP Plan Development and 

Reassessment: Egg products plants 

operate to produce a variety of products 

using a number of different processing 

techniques. Under this proposed rule, 

each plant would be required to 

evaluate its processes to determine the 

adequacy of existing written HACCP 

plans and the number of plans that 

would need to be created or modified to 

meet the requirements of the proposed 

rule. A large number of egg products 

plants already have HACCP plans for 

their processes. These plants will be 

required to validate and reassess their 

HACCP plans annually, to ensure that 

their HACCP plans are consistent with 

the regulations that FSIS is proposing in 

this document. For plants that currently 

lack HACCP plans, FSIS estimated the 

cost of initial plan development and 

validation and annual reassessment and 

validation. Under this proposed rule, 

every egg products plant would be 

required to reassess the adequacy of the 

HACCP plan at least annually and 

whenever any changes occur that could 

affect the hazard analysis or alter the 

HACCP plan. Such changes may 

include, but are not limited to, changes 

in raw materials, source of raw 

materials, or product formulation. For 

the purposes of estimating costs, FSIS 

simplified the production of egg 

products into three processes: the 

breaking of shell eggs, the production of 

pasteurized liquid egg products 

(including frozen egg products), and the 

production of pasteurized dried egg 

products. 

Using these three process definitions 

and data from PHIS, FSIS categorized 

plants by process. For reference, Table 

2 above displays plants and processes. 

Using results from the 2014 Egg 

Products Industry Survey, FSIS applied 

a distribution, by process, of plants 

responding affirmatively to having a 

written HACCP plan to the population 

of egg products plants.29 Using this data, 

FSIS estimated the number of processes 

in those plants that require a HACCP 

plan to be developed. This information 

is displayed in Table 3.30

TABLE 3—PROCESSES WITHOUT

WRITTEN HACCP PLANS

Breaking Liquid Dried Total 

processes 

9 ........... 12 3 24 

For plan development and 

reassessment, FSIS used the Cost of 

Food Safety Investments 31 final report, 

updated for inflation from 2014 to 2016 

dollars using the Consumer Price Index 

(CPI) for Urban Consumers, and, with 

the assumed benefits factor of two. FSIS 

estimates the costs for plan 

development and reassessment using 

the low estimate, (plan developed 

internally—low estimate—$17, 130), the 

high estimate (plan developed with 

consultant—high estimate—$42,423), 

and the average of the mid-estimates of 

the plan developed with a consultant 

and internally ($31,271).32 FSIS also 

incorporated an initial validation cost of 

$27,408 ($13,704–$41,112) and an 

ongoing (yearly) reassessment cost of 

$28,188 ($14,094–$42,282) for all 

HACCP plans. FSIS applied these 

estimates to the number of processes 

needing HACCP plans to determine the 

cost of HACCP plan development, 

validation, and reassessment, displayed 

in Table 4. 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6336 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

33See Appendix A, Section 5. 

34RTI International. Cost of Food Safety 

Investments Final Report. Available at: https://

www.fsis.usda.gov/wps/wcm/connect/0cdc568ef6b1-45dc-88f1-45f343ed0bcd/Food-SafetyCosts.pdf?MOD=AJPERES. These cost figures were 

adjusted for inflation using the average CPI–U from 

2014 to 2016. 

35 Ibid. 

36See Appendix A, Section 6. 

TABLE 4—ESTIMATED HACCP PLAN DEVELOPMENT, VALIDATION, AND REASSESSMENT COSTS

[$1,000s] 

Cost component Initial cost 

(low estimate–high estimate) 

Recurring cost 

(low estimate–high estimate) 

Annualized cost—3% 

(low estimate–high estimate) 

over 10 

Annualized cost—7% 

(low estimate–high estimate) 

over 10 years 

Development ............................. 758.3 (415.4–1028.8) 0 86.3 (47.3–117.1) 100.9 (55.3–136.9) 

Initial Validation * for 25 New 

Plans ...................................... 667.4 (332.3–997.0) 0 75.6 (37.8–113.5) 88.4 (44.2–132.7) 

Annual Reassessment ** ........... 2,839.9 (1420.2–4,259.9) 3,523.5 (1,761.8–5,285.3) 3,445.7 (1,722.8–5,168.5) 3,432.5 (1,716.3–5,148.8) 

* These estimates are calculated using the actual number of unrounded processes or 24.2507 processes. 

** ‘‘Initially, plants with existing HACCP plans will begin reassessing in year 1. Plants without existing plans, after developing their plans in year 1, will begin reassessing their plans in the following years. 

The above analysis does not include 

costs associated with taking a corrective 

action when routine monitoring of a 

CCP detects a deviation from an 

established critical limit. It is not 

possible to determine the costs of these 

corrective actions, but we expect that, 

for well-designed processes with 

HACCP, these costs would occur 

infrequently. 

HACCP Training and Personnel: We 

assume that each egg products plant 

will employ a QC manager and a QC 

technician to ensure compliance with 

the proposed measures. Based on the 

2014 Egg Products Industry Survey final 

report, approximately 7 percent of 

plants do not employ any HACCP 

plans.33 Thus, we assume 7 percent of 

plants (approximately five) will need to 

obtain training for a QC manager, 

assuming one per plant, and a QC 

technician and three production 

workers for each processing operation 

shift (an average of 1.7 shifts per plant 

based on the results of the Industry 

Survey). 

Although the HACCP system is 

different than the current system, FSIS 

believes that in egg products plants, 

only a portion of production employees, 

or a minimum number per shift, would 

actually receive training, given that the 

duties for most of the production 

employees will remain very similar or 

even the same when the plant operates 

under HACCP. FSIS is seeking comment 

on its assumed staffing and training cost 

estimates. 

FSIS used initial and recurring annual 

refresher training cost estimates 

(updated using the CPI for Urban 

Consumers from 2014 to 2016 dollars 

and the assumed benefit factor of two) 

and the number of hours of training 

from the Cost of Food Safety 

Interventions 34 final report updated 

with the assumed benefit factor of two. 

QC Managers would be trained initially 

at a cost of $3,991.29 (ranging from 

$1,995.65 to $5,986.94), with an annual 

refresher at a cost of $205.88 ($102.94 to 

$308.82). QC Technicians would be 

trained initially at a cost of $3,165 

($1,583 to $4,748), with an annual 

refresher at a cost of $137 ($69 to $206). 

An additional opportunity cost for 

training was added to account for the 

time lost when employees were in 

training at the per hour compensation 

rate (including wage and benefit factor) 

of the employees being trained for the 

length of the training and for 

replacement personnel to work covering 

the time of the training. Production 

employees would also need to be 

trained; however, FSIS assumed that 

this training would take place on the 

job, and therefore would only impose 

opportunity costs. We use an annual 

turnover rate of 27.9 percent 35 to 

estimate recurring costs due to 

employee separation and the need to 

train new employees. These estimates 

are displayed in Table 5. 

TABLE 5—HACCP-RELATED TRAINING COSTS

[$1000s] 

Plants Shifts Initial training costs 

(low estimate–high estimate) 

Recurring training costs 

(low estimate–high estimate) 

Annualized cost—3% 

(low estimate–high estimate) 

over 10 years 

Annualized cost—7% 

(low estimate–high estimate) 

over 10 years 

5 ........................ 9 78.9 (39.5–118.4) 27.9 (13.9–41.8) 33.7 (16.8–50.5) 34.7 (17.3–52) 

HACCP Recordkeeping: The proposal 

requires facilities to record observations 

when monitoring CCPs and to document 

any deviations and corrective actions. 

The rule requires that an employee not 

involved in recording observations 

certify such records. Recordkeeping 

costs include the time it takes to make 

observations and to record the results of 

those observations, plus the cost of 

certifying and maintaining records. The 

level and extent of recordkeeping for the 

proposed rule should not change greatly 

for egg products plants already using 

HACCP plans. Plants with existing 

HACCP plans are already documenting 

CCPs, as well as documenting 

information for the current regulations. 

For these plants, there will be a cost 

savings and reduction in recordkeeping 

costs, because they are keeping records 

for both a HACCP system and the 

current regulations. 

FSIS used data from the 2014 Egg 

Products Industry Survey to estimate 

how many plants do not have HACCP 

plans, and the number of plans needed 

at these plants. FSIS also estimated the 

number of shifts at those plants.36 The 

cost of recordkeeping is dependent on 

several factors, each of which has to be 

documented in some manner, such as 

the number of HACCP plans developed 

by each plant, the number of shifts 

operated by each plant, the number of 

CCPs per HACCP plan, the number of 

pre-shipment reviews conducted, and 

any decision-making for hazard analysis 

that may require documentation. 


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Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6337 

37Curtis, P., North Carolina State University, 

Raleigh, NC. October 5, 2001. Personal 

communication with Catherine Viator, RTI. 

Reported in RTI International. 2002. ‘‘Pathogen 

Reduction and Other Technological Changes in the 

Meat, Poultry, and Egg Industries.’’ RTI Project no. 

07182.017. 3040 Cornwallis Rd., P.O. Box 12194 

Research Triangle Park, NC 27709–2194 

38FSIS estimated these approximate time 

estimates by first hand observation at egg products 

plants. 39See Appendix A, Section 1. 40RTI International. Cost of Food Safety 

Investments Final Report. Available at: http://

www.fsis.usda.gov/wps/wcm/connect/0cdc568ef6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.

pdf?MOD=AJPERES. 

41For plan development costs, in order to 

mitigate outliers, the Agency selected the greater of 

the two lowest costs between developing the plan 

internally and the cost for developing with a 

consultant, and the lesser of the two highest costs 

between developing the plan internally or with a 

consultant. 

The numbers of CCPs in egg products 

plants likely vary considerably across 

the industry. An FSIS technical expert 37

suggested four to six CCPs per HACCP 

plan, as an average. Therefore, we 

assumed that the average number of 

CCPs is five per egg products plant, per 

plan. We assumed 3 minutes (+/¥ 1 

minute) for monitoring recordkeeping 

and 1 minute (+/¥ 30 seconds) for 

certifying per CCP.38 FSIS is seeking 

comment on these time assumptions. 

From the above assumptions, we 

estimate (Table 6) the annual cost of 

HACCP recordkeeping and monitoring. 

The Agency seeks comment on the 

number of CCPs anticipated, taking into 

account the variables listed above. 

TABLE 6—ANNUAL HACCP RECORDKEEPING AND MONITORING COSTS

[$1000s] 

Plans 

Effective 

annual 

shifts 

Annualized—3% 

recordkeeping costs 

(low estimate–high estimate) 

over 10 years 

Annualized—7% 

recordkeeping costs 

(low estimate–high estimate) 

over 10 years 

Annualized—3% 

monitoring costs 

(low estimate–high estimate) 

over 10 years 

Annualized—7% 

monitoring costs 

(low estimate–high estimate) 

over 10 years 

24 .......................... 10,509 68.3 (45.5–91.9) 68.3 (45.5–91.1) 60.0 (30.0–90.0) 60.0 (30.0–90.0) 

Table 7 presents a summary of the 

total HACCP-related costs as a result of 

the rule. These figures are annualized 

over 10 years at 3 percent and 7 percent 

discount rates. 

TABLE 7—TOTAL HACCP-RELATED INDUSTRY COSTS

[$1000s] * 

Cost component 

Annualized costs—3% 

(low estimate–high estimate) 

over 10 years 

Annualized costs—7% 

(low estimate–high estimate) 

over 10 years 

Plan Development and Reassessment ............................................................... 3,607.7 (1808.0–5399.1) 3,621.9 (1,815.8–5,418.4) 

Training ................................................................................................................ 33.7 (16.8–50.5) 34.7 (17.3–52.0) 

Recordkeeping & Monitoring ............................................................................... 128.3 (75.5–181.1) 128.3 (75.5–181.1) 

Total .............................................................................................................. 3,769.7 (1,900.3–5,630.7) 3,784.9 (1,908.6–5,651.5) 

* Numbers in table may not sum to totals due to rounding. 

Sanitation Standard Operating 

Procedures (Sanitation SOPs) 

Plan Development: For the most part, 

plants already have plans for sanitation 

insofar as FSIS already requires certain 

sanitation procedures. FSIS used 

responses from the 2014 Egg Products 

Industry Survey 39, which describes the 

number of plants where they train their 

employees on sanitation SOPs, to 

estimate the percentage of plants that 

have sanitation SOPs. This accounts for 

approximately 91 percent of all egg 

products plants. FSIS assumed that if a 

plant is training production employees, 

then it has a written plan in place that 

the training is based on and would 

likely meet the requirements of the 

proposed rule. FSIS then applied this 

percentage to determine the number of 

plants that would need to develop 

written sanitation SOPs (approximately 

7). The current Sanitation SOP 

requirements for egg products plants 

will not change greatly, because the 

basis and standards for the sanitation of 

the plants will remain consistent with 

the current guidelines. For the proposed 

rule, the Sanitation SOPs will be created 

by the plant to meet FSIS standards 

under the HACCP system. 

FSIS used cost estimates from the 

Cost of Food Safety Interventions 40

final report, with labor costs updated for 

inflation from 2014 to 2016 dollars and 

for the benefit factor described 

previously. For plan development, FSIS 

estimated costs using the low estimate 

(plan developed internally—low 

estimate—$17,130), the high estimate 

(plan developed with a consultant— 

high estimate, $31,018), and the average 

of the mid-estimates of the plan 

developed internally and with a 

consultant ($27,469).41 The costs of 

Sanitation SOP plan development are 

displayed in Table 8. 

TABLE 8—COSTS ASSOCIATED WITH THE DEVELOPMENT OF SANITATION SOPS

[$1,000s] 

Cost component Initial cost 

(low estimate–high estimate) 

Recurring cost 

(low estimate–high estimate) 

Annualized cost—3% 

(low estimate–high estimate) 

over 10 years 

Annualized cost—7% 

(low estimate–high estimate) 

over 10 years 

Development ............................. 185.5 (115.7–209.5) 0 21.1 (13.2–23.8) 24.7 (15.4–27.9) 


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42See Appendix A, Section 2. 

43At least 1 pre-operational sanitation inspection 

of product contact zones per 9 CFR 416.13 and 

416.12(c). 

44Please see Appendix A. 

45See Appendix A, Section 3. 

46An FSIS expert has also agreed with the 

Industry Survey and provided the likely staff 

needing training at a typical egg products plant. 

47See Footnote 33. 

Recordkeeping: Under the proposed 

rule, plants would be required to 

maintain daily records sufficient to 

document the implementation and 

monitoring of sanitation SOPs. FSIS 

used data from the 2014 Egg Products 

Industry Survey to estimate the 

proportion of plants keeping sanitation 

records that would meet the 

requirements of the proposed rule 

consisting of employee task 

performance and a log for deviations 

and corrective actions.42 FSIS then 

determined how many of those plants 

are completing recordkeeping tasks 

daily.43 Those plants that are not 

conducting recordkeeping or are 

conducting inadequate recordkeeping 

based on the proposed sanitation SOPs 

requirements will incur costs to do so. 

For plants that are not keeping 

adequate sanitation records, FSIS 

estimated costs of recordkeeping based 

on the frequency of reported 

recordkeeping tasks. FSIS assumed that 

each sanitation recordkeeping task 

would be performed by a production 

employee and would take 

approximately 15 minutes (+/¥5 

minutes) to complete. A sanitation 

recordkeeping task would be performed 

daily, unless the plant reported 

performing a task more than daily, in 

which case FSIS assumed there would 

be one task per shift (an average of 1.7 

shifts per plant based on the results of 

the Industry Survey). The average 

number of shifts was calculated using 

question 5.2 of the survey, which asks 

respondents their total number of 

production shifts per day.44 The 

responses by small and large plants to 

question 5.2 were combined along with 

the total responses to get percentages for 

average number of shifts. The 

calculation is 25% × 3 shifts + 18% × 

2 shifts + 57% × 1 shift = 1.7 shifts. 

FSIS further assumed that a QC 

technician would review records for 

approximately 10 minutes (+/¥5 

minutes) once per day. FSIS used the 

recordkeeping estimates and time 

assumptions to estimate the cost to 

industry for Sanitation SOP 

recordkeeping, displayed in Table 9. 

TABLE 9—SANITATION SOP RECORDKEEPING COSTS

[$1,000s] 

Current recordkeeping practices Recordkeeping 

frequency Number of plants 

Annualized—3% 

recordkeeping cost 

(low estimate–high estimate) 

over 10 years 

Annualized—7% 

recordkeeping cost 

(low estimate–high estimate) 

over 10 years 

In compliance with proposed rule ............ <Daily 7 11.4 (7.6–15.2) 11.4 (7.6–15.2) 

Daily 26 0 0 

>Daily * 17 0 0 

Not in compliance with proposed rule ..... <Daily 3 4.6 (3.0–6.1) 4.6 (3.0–6.1) 

Daily 12 20.5 (13.7–27.4) 20.5 (13.7–27.4) 

>Daily 12 34.2 (22.8–45.7) 34.2 (22.8–45.7) 

* For number of plants, FSIS multiplies the percentages from the survey for each category by total number of plants (77). For the category 

>Daily, in compliance, the calculation of 77 × 22.8% yields 17.56. This count was rounded down to 17 plants to be consistent with the total number of plants in the analysis of 77. 

TABLE 10—SANITATION SOP MONITORING COSTS

[$1,000s] 

Current recordkeeping practices Recordkeeping 

frequency Number of plants 

Annualized—3% 

monitoring cost 

(low estimate–high estimate) 

over 10 years 

Annualized—7% 

monitoring cost 

(low estimate–high estimate) 

over 10 years 

In compliance with proposed rule ............ <Daily 7 20.1 (10.0–30.1) 20.1 (10.0–30.1) 

Daily 26 .................................................. ..................................................

>Daily * 17 .................................................. ..................................................

Not in compliance with proposed rule ..... <Daily 3 8.0 (4.0–12.0) 8.0 (4.0–12.0) 

Daily 12 36.1 (18.0–54.1) 36.1 (18.0–54.1) 

>Daily 12 36.1 (18.0–54.1) 36.1 (18.0–54.1) 

* For number of plants, FSIS multiplies the percentages from the survey for each category by total number of plants (77). For the category 

>Daily, in compliance, the calculation of 77 × 22.8% yields 17.56. This count was rounded down to 17 plants to be consistent with the total number of plants in the analysis of 77. 

Training Costs: Egg products plants 

that are implementing new sanitation 

SOPs and those not in compliance will 

also need to conduct initial training for 

employees. Using data from the 2014 

Egg Products Industry Survey, FSIS 

estimated the number of plants that will 

need to develop new sanitation SOPs 

(see Table 11) and the average number 

of shifts at those plants.45 FSIS assumed 

that one QC Manager per plant, and one 

QC Technician and three production 

employees per shift would be trained.46

FSIS is seeking comment on these 

assumptions. FSIS assumed the 

recurring training would occur for all 77 

plants. FSIS used initial and recurring 

annual refresher training cost estimates 

from the Cost of Food Safety 

Interventions 47 final report updated for 

inflation from 2014 to 2016 dollars and 

with the assumed benefit factor of two. 

QC Managers would be trained initially 

at a cost of $2,756 ($1,378 to $4,134) 

with an annual refresher at a cost of 

$205.98 ($102.94 to $308.82). QC 

Technicians would be trained initially 


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48Annual total separations rate for nondurable 

goods, Bureau of Labor Statistics Job Openings and 

Labor Turnover Survey, available at: http://

www.bls.gov/news.release/jolts.t16.htm. 

at a cost of $2,342.97 (1,171.50 to 

3,514.46) with an annual refresher at a 

cost of $137 ($68.52 to $205.56). FSIS 

added an additional opportunity cost to 

account for the lost hours when 

employees are in training. Production 

employees would also need to be 

trained, however, FSIS assumed that 

this training would take place on the job 

and therefore would impose only 

opportunity costs. 

FSIS included recurring training costs 

to account for labor separation and the 

need to train new employees. To 

estimate these ongoing costs, FSIS used 

an annual labor turnover rate of 27.9 

percent 48 and applied that percentage to 

the initial training costs. The Sanitation 

SOP-related training costs due to the 

rule are displayed in Table 11. 

TABLE 11—ONE-TIME AND RECURRING SANITATION SOP TRAINING COSTS

[$1000s] 

Plants Shifts Initial training costs 

(low estimate–high estimate) 

Recurring training costs 

(low estimate–high estimate) 

Annualized cost—3% 

(low estimate–high estimate) 

over 10 years 

Annualized cost—7% 

(low estimate–high estimate) 

over 10 years 

34 ...................... 59 363.7 (214.7–545.6) 140.3 (79.3–225.2) 181.7 (103.8–287.3) 188.7 (107.9–297.8) 

Table 12 presents a summary of the 

total sanitation SOPs-related costs due 

to the rule annualized over 10 years at 

3 percent and 7 percent discount rates. 

TABLE 12—TOTAL SANITATION SOPS-RELATED INDUSTRY COSTS

[$1000s] * 

Cost component 

Annualized costs—3% 

(low estimate–high estimate) 

over 10 years 

Annualized costs—7% 

(low estimate–high estimate) 

over 10 years 

Plan Development ................................................................................................................................. 21.1 (13.2–23.8) 24.7 (15.4–27.9) 

Recordkeeping & Monitoring ................................................................................................................. 171.0 (97.3–244.8) 171.0 (97.3–244.8) 

Training ................................................................................................................................................. 181.7 (103.8–287.3) 188.7 (107.9–297.8) 

Total ............................................................................................................................................... 373.9 (214.2–555.9) 384.5 (220.6–570.5) 

* Numbers in table may not sum to totals due to rounding. 

Special Handling Statements on 

Labels: The proposed egg products rule 

requires ‘‘Keep Refrigerated’’ or ‘‘Keep 

Frozen’’ statements for all egg products 

that require special handling to 

maintain their wholesome condition. 

Plants currently include this 

information on egg products labels; 

therefore, this new requirement for the 

industry should not create additional 

costs. 

Costs from Requiring Egg Products 

Plants to Produce Egg Products That are 

Edible without Additional Preparation 

to Achieve Food Safety: The proposed 

rule requires that egg products plants 

process egg products that are edible 

without additional preparation to 

achieve food safety. FSIS does not 

anticipate that these plants will need to 

change their pasteurization practices to 

meet this requirement and therefore will 

not incur additional costs, except as a 

part of their normal operations in 

regards to complying with HACCP plan 

verification and monitoring activities. 

These verification and monitoring 

activities are discussed above as part of 

the HACCP costs of this proposed rule 

for recordkeeping and monitoring. FSIS 

has developed a Compliance Guideline 

for Small and Very Small Plants that 

produce ready-to-eat egg products. This 

guidance document is designed to help 

small and very small plants meet the 

proposed regulatory requirements by 

providing the best practice 

recommendations by FSIS, based on the 

best scientific and practical 

considerations. FSIS is seeking 

comment on this guidance document, 

which is posted on the Agency’s web 

page: http://www.fsis.usda.gov/wps/ 

portal/fsis/topics/regulatorycompliance/compliance-guides-index. 

Below, the total industry costs are 

presented: 

TABLE 13—TOTAL INDUSTRY COSTS

[$1,000] * 

Cost component Annualized costs—3% 

(low estimate–high estimate) 

Annualized costs—7% 

(low estimate–high estimate) 

HACCP .................................................................................................................................................. 3,769.7 (1,900.3–5,630.7) 3,784.9 (1908.6–5651.5) 

Sanitation SOPs .................................................................................................................................... 373.9 (214.2–555.9) 384.5 (220.6–570.5) 

Total ............................................................................................................................................... 4,143.6 (2,114.5–6,186.6) 4,169.4 (2,129.2–6,220.0) 

* Numbers in table may not sum to totals due to rounding. 

Agency Costs 

Training and Personnel: FSIS employs 

95 egg products inspectors that 

exclusively inspect egg products plants. 

Some egg products plant inspectors 

already have HACCP training from past 

inspection experience in meat and 

poultry plants. For inspectors without 

prior experience, FSIS will need to train 

them in the HACCP system. The longterm objective of the Agency is to 

establish an inspection system where 

inspection program personnel would be 

equally qualified to conduct inspection 


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6340 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

49FSIS Policy Development Staff (PDS) provided 

the number of personnel that will need training. 

PDS estimated this number by contacting each 

district manager in the field where egg products 

plants are located. 

50This figure is a mean estimate of training costs 

from FSIS/OOEET Center for Learning. 51This is the average GSA per diem for meals and 

hotel multiplied by the number of days replacement 

inspectors would be needed to fill positions. http:// 

www.gsa.gov/portal/content/104877. 

52Coglianese, Cary & David Lazer. 2003. 

‘‘Management-Based Regulation: Prescribing Private 

Management to Achieve Public Goals’’. Law & 

Society Review 37. 

activities at meat or poultry 

establishments, and egg product plants. 

The Agency anticipates that it will 

need to train 51 egg products inspection 

personnel 49 and 24 meat or poultry 

inspectors (non-egg products 

inspectors). Fifty-one of these inspectors 

will require a 4-week training course on 

HACCP methods called Inspection 

Methods training, and 24 inspectors 

already trained in HACCP inspection 

will be trained in egg product 

inspection. The inspection methods 

training for egg products inspection 

personnel would be longer than for 

other plant personnel because it 

includes additional topics (e.g., 

processing and slaughter inspection in a 

HACCP environment, rules of practice, 

and fundamental food microbiology) 

that not all egg products plant personnel 

need to perform their job. The total costs 

(including travel, lodging, per diem, and 

training program) for the 4-week 

training program is approximately 

$6,000 50 per inspector, and the oneweek egg product inspection training is 

approximately $1,200 per inspector. 

Therefore, the one-time Agency training 

costs total $334,800 (51 × $6,000) + (24 

× $1,200). 

Replacement inspectors will be 

required during periods when egg 

products plant inspectors are being 

trained. The Agency’s district offices 

estimate the cost of replacement 

inspectors to be $2,800 per person 51 for 

inspection methods training and $700 

per person for egg products inspection 

training. Consequently, the one-time 

cost of replacement inspectors is 

$159,600 derived from (51 × $2,800) and 

(24 × $700). Thus, the total one-time 

cost of training inspectors at egg 

products plants is $494,400. Table 14 

provides the summary of the costs 

associated with inspector training. 

TABLE 14—INSPECTION PROGRAM TRAINING COSTS AT 3% AND 7% DISCOUNT RATES ANNUALIZED OVER 10 YEARS* 

[$1,000] 

Cost component Number of IPP Cost per IPP One-time cost 

Annualized 

cost—3% over 

10 years 

Annualized 

cost—7% over 

10 years 

Inspection Methods Training ................................................ 51 6 306 34.8 40.7 

Egg Products Inspection Training ........................................ 24 1.2 28.8 3.3 3.8 

Replacement IPP ................................................................. 75 ........................ 159.6 18.2 21.2 

Total .............................................................................. ........................ ........................ 494.4 56.3 65.8 

* Numbers in table may not sum to totals due to rounding. 

Total Costs: Table 15 provides a 

summary of the estimated total costs for 

the industry and Agency. The table 

includes annualized costs over 10 years 

at discount rates of 3 percent and 7 

percent. 

TABLE 15—TOTAL COSTS

[$1,000] * 

Total costs 

Annualized costs—3% 

(low estimate–high estimate) 

over 10 years 

Annualized costs—7% 

(low estimate–high estimate) 

over 10 years 

Industry: 

HACCP ......................................................................................................... 3,769.7 (1,900.3–5,630.7) 3,784.9 (1,908.6–5,651.5) 

Sanitation SOPs ........................................................................................... 373.9 (214.2–555.9) 384.5 (220.6–570.5) 

Agency .......................................................................................................... .................................................. ..................................................

IPP Training: 38.1 44.5 

Replacement IPP .......................................................................................... 18.2 21.2 

Total ....................................................................................................... 4,199.9 (2,170.8–6,242.9) 4,235.2 (2,195.0–6,287.8) 

* Numbers in table may not sum to totals due to rounding. 

The total annualized cost to the egg 

products industry of the proposal is 

$0.002 per pound of aggregate egg 

products ($4,143,600/1.8 billion 

pounds) at the 3 percent discount rate. 

The cost of the proposed rule to the egg 

products industry is minimal, and we 

do not expect the costs from this rule to 

have impact on consumer prices. 

Expected Benefits of the Proposed Rule 

The proposed rule will provide firms 

in the egg products industry greater 

flexibility and incentives for innovation. 

Firms derive benefits from opportunities 

to innovate and employ more flexible 

production methods over time.52 Many 

egg products plants have already 

adopted the HACCP system for egg 

product processing. One reason for this 

adoption is buyers of egg products 

(further egg processors or retailers) 

require the production of egg products 

to be done under the HACCP system. In 

addition, under a HACCP system, egg 

products plants can attain quality 

accreditations such as one by the Safe 

Quality Food Institute, which allows egg 

products plants to access different 

markets inaccessible to non-HACCP 


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Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6341 

53 Kay Cao, Oswin Maurer, Frank Scrimgeour and 

Chris Drake. 2004. ‘‘The Economics of HACCP 

(Hazard Analysis & Critical Control Point): A 

Literature Review, Agribusiness Perspectives 

Papers’’, Paper 64, ISSN 1442–6951. 

54Nganje W.E. and Mazzocco M.A. 2003. ‘‘The 

Impact of HACCP on Factor Demand and Output 

Supply Elasticities of Red Meat’’. Journal of 

Agricultural and Resource Economics. 

55Henson, S., Holt, G., and Northen, J. (2000). 

‘‘Costs and benefits of implementing HACCP in the 

UK dairy processing sector’’. In L.J. Unnevehr (Ed.), 

The economics of HACCP: Costs and benefits 

(pp.347–363). 

56 Kay Cao, Oswin Maurer, Frank Scrimgeour, and 

Chris Drake, The Economics of HACCP (Hazard 

Analysis & Critical Control Point): A Literature 

Review, Agribusiness Perspectives Papers 2004, 

Paper 64, ISSN 1442–6951 

57 Kay Cao, Oswin Maurer, Frank Scrimgeour and 

Chris Drake, The Economics of HACCP (Hazard 

Analysis & Critical Control Point): A Literature 

Review, Agribusiness Perspectives Papers 2004, 

Paper 64, ISSN 1442–6951 

58Estimates obtained from the Bureau of Labor 

Statistics May 2016 National Industry-Specific 

Occupational Employment and Wage Estimates, for 

Management Occupations (Occupational Code 11– 

0000), https://www.bls.gov/oes/current/oes113051.

htm#ind, Food Scientists and Technologists (19– 

1012), https://www.bls.gov/oes/current/ 

oes191012.htm, and Production Occupations (51– 

0000) https://www.bls.gov/oes/current/ 

oes513023.htm. 

59Hourly rate, Washington, DC, Office of Personel 

Management https://www.opm.gov/policy-dataoversight/pay-leave/salaries-wages/salary-tables/ 

pdf/2016/DCB_h.pdf. 

60RTI International. 2014. ‘‘Survey of Egg Packing 

and Egg Products Processing Plants.’’ Revised Final 

Report. RTI Project no. 0211740.015.001. 3040 

Cornwallis Rd., P.O. Box 12194 Research Triangle 

Park, NC 27709–2194. 

processors. Academic literature (please 

see next section) has also shown that an 

egg products plant’s choice to process 

under a HACCP system as a 

management tool can also be internally 

driven by efficiency gains.53

A number of studies in the last few 

decades have shown important 

efficiency gains for food production 

industries after moving into a HACCP 

system. In a study by Nganje and 

Mazzocco in 2003,54 individual plants 

in the red meat industry benefited from 

implementing HACCP by gaining 

efficiency in production. In a study by 

Henson et al. (2000) 55 on HACCP 

adoption in the UK dairy industry, the 

authors also report similar benefits such 

as ‘‘the reduction in wastage, increases 

in product shelf life, and decreases in 

production costs.’’ 56

HACCP systems also enable firms that 

purchase egg products plant products to 

reduce costs of raw materials 

inspection, specification, and 

inventory.57 Given the efficiency gains 

in different food production facilities 

under FSIS jurisdiction by 

implementing HACCP, FSIS reasonably 

expects that the egg products industry 

will gain some efficiency from HACCP 

implementation. 

Benefits from removing current 

regulations: A large benefit from moving 

away from the current regulatory 

framework is the lessening of 

administrative burdens on plants and 

plant personnel. With the movement to 

a HACCP-based system, IPP will change 

how they inspect egg products plants by 

ensuring that plants’ HACCP systems 

are functioning as intended rather than 

inspecting for compliance with current 

specifications. This change in how 

inspection is done will allow for 

improved allocation of resources to 

more food- safety tasks and sanitary 

verifications both for the Agency and for 

egg products plants. It also allows egg 

product plants to employ resources in a 

manner that more efficiently produces 

safe product instead of allocating 

resources just to comply with FSIS 

regulations. For instance, instead of 

sampling product for time and 

temperature, a plant can design a system 

in which its HACCP plan specifies 

sampling products at a more convenient 

time in the process, allowing for better 

personnel resource management to 

improve production efficiency. 

Another aspect of the reduced 

administrative burden is a reduced need 

for FSIS approval for changes to plant 

operations that deviate from current 

regulations. For example, official plants 

will no longer need to submit facility 

blueprints and specifications (plant 

changes) to the Agency when applying 

for a grant of inspection, nor will they 

need to obtain prior approval from FSIS 

for equipment and utensils proposed for 

use in preparing edible product or 

product ingredients. The approval 

process for a waiver to a regulation or 

for no objection to production changes 

will also be eliminated if this proposed 

rule is adopted. These changes provide 

cost savings to industry and the Agency 

and are quantified below. It takes 

industry on average 100 hours to make 

an industry submission as described 

above (waiver, plant blueprint, no 

objection, or equipment use), including 

additional correspondence with FSIS. 

The Agency spends an average of 69 

hours to review and approve each 

submission. FSIS is seeking comment 

on its estimates of the time it takes 

industry to develop a submission and to 

respond to FSIS requests in connection 

with the submission. 

FSIS receives on average nine 

submissions per year from egg products 

plants. The submission process involves 

an egg products plant’s QC technician 

providing the initial submission data 

and follow-up correspondence with 

Agency personnel. This follow-up 

correspondence includes responding to 

FSIS questions with supporting data. 

The QC technician is paid an hourly 

wage of $68.52 per hour, which 

includes a benefit rate of two.58 An 

Agency reviewer would have a General 

Schedule 13 salary, step 3, at $94.20 per 

hour, which includes a benefit factor of 

two.59 Eliminating these two 

submission processes will save industry 

approximately $61,600 annually 

discounted over 10 years at the 7 

percent rate. The Agency would save 

approximately $58,498 annually 

discounted over 10 years at the 7 

percent rate. 

TABLE 16—INDUSTRY AND AGENCY

SAVINGS FROM THE ELIMINATION OF

AGENCY APPROVAL FOR PLANT AND

PRODUCT PROCESSING CHANGES

[$1,000s] * 

Total 

savings 

Annualized 

savings—3% 

over 10 years 

Annualized 

savings—7% 

over 10 years 

Industry ..... 61.6 61.6 

Agency ...... 58.5 58.5 

Total ...... 120.1 120.1 

* Numbers in table may not sum to totals 

due to rounding. 

The HACCP plan provision of the 

proposed rule will also give plants 

flexibility to design their pasteurization 

and sampling procedures. Ninety three 

percent of egg products plants have 

indicated that their plants conduct 

microbiological testing in addition to 

those required by regulation.60 By 

giving plants the option to sample as 

determined in their HACCP plan, there 

may be a cost savings from sampling 

less. The proposed rule specifies that 

the final product must be produced to 

be edible without additional preparation 

to achieve food safety. This standard 

provides flexibility to an egg products 

plant by giving it the necessary end 

result of pathogen-free products without 

specifying direct instructions on the 

processing method. This allows plants 

to find the most efficient processing or 

sampling methods to best fit their own 

production process and resources to 

produce a pathogen-free product. 

Additional Benefits from Generic 

Labeling: Additional benefits include 

cost reductions for the Agency and for 

the egg products plants that submit 

labels for changes to an existing label or 

for new label approvals. Currently, an 

egg products plant must submit a formal 

application along with a sketch of a 

product label to FSIS personnel for 

approval, regardless of the change 

(including a color or size change to a 

label). If the proposed rule is finalized, 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6342 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

61As required by 9 CFR 412, the Labeling and 

Program Delivery Staff (LPDS) evaluates certain 

sketch applications and all temporary applications 

for meat and poultry products. All other meat and 

poultry product label applications may be 

generically approved without evaluation by LPDS. 

62This was an approximation made by a label 

reviewer in the FSIS labeling group. 

63 78 FR 66826. 

64Estimates obtained from the Bureau of Labor 

Statistics May 2016 National Industry-Specific 

Occupational Employment and Wage Estimates, for 

Management Occupations (Occupational Code 11– 

0000), https://www.bls.gov/oes/current/ 

oes113051.htm#ind, Food Scientists and 

Technologists (19–1012), https://www.bls.gov/oes/ 

current/oes191012.htm, and Production 

Occupations (51–0000) https://www.bls.gov/oes/ 

current/oes513023.htm. 

the approval process for certain labels 

will be streamlined, allowing egg 

products plants to use certain labels 

without submitting an application to 

FSIS because the labels will be 

generically approvable.61 Labels that 

will not qualify for generic approval 

include temporary approvals, labels for 

export only that bear labeling 

deviations, or labels bearing special 

statements and claims. All other label 

types can be generically approved. 

Presently, many egg products plants use 

special claims on their labels (e.g., 

organic or free range) and so those labels 

would not qualify for generic approval. 

The Agency estimates that 

approximately 80 percent of labels have 

prior approval for these claims.62 If 

these prior approved producers make 

other changes to the labels not involving 

their pre-approved claims, they could 

qualify for generic labeling. 

The number of egg products labels 

submitted in 2015 was approximately 

520, and in 2016, the number rose to 

708 labels. FSIS estimates that 

approximately 50 percent of these new 

labels would qualify for generic label 

approval each year. Generic approval 

would reduce the recordkeeping burden 

at the plant and Agency by about half 

the current levels. In order to estimate 

cost savings through the generic labeling 

process, the number of future label 

submissions was estimated based on the 

annual historic increase in submissions. 

Using the industry cost savings of 

$25.00 per label from the prior label 

approval system: Generic Label 

Approval final rule,63 the proposed 

generic label approval process for egg 

products could save industry 

approximately $16,000 annually, 

discounted over 10 years at the 7 

percent rate, from not submitting labels. 

The Agency would save approximately 

$61,000 annually, given that on average 

the review process takes approximately 

one hour, and a reviewer would have a 

General Schedule 13 salary, step 3 with 

a benefit factor of two,64 having a total 

compensation of $94.20. 

TABLE 17—SAVINGS FROM GENERIC

LABELING

[$1,000s] * 

Total 

savings 

Annualized 

savings—3% 

over 10 years 

Annualized 

savings—7% 

over 10 years 

Industry ..... 16 16 

Agency ...... 60.6 60.4 

Total ...... 76.7 76.4 

* Numbers in table may not sum to totals 

due to rounding. 

Better Agency Resource Coverage: 

Because all egg products plant 

inspectors will now be trained in 

HACCP and can staff FSIS-regulated 

establishments other than egg products 

plants, the Agency will experience an 

improvement in inspection coverage. In 

the egg products plants themselves, the 

Agency can also utilize HACCP trained 

inspectors as relief inspectors. 

Currently, egg products inspectors can 

only work in egg products plants. 

Change in Inspector Coverage: Under 

the proposed rule, FSIS inspectors 

would no longer provide inspection 

during all processing operations at each 

egg products plant, but instead may be 

provided once per shift. Therefore, 

under the proposal, inspectors may 

inspect several plants within a 

reasonable commuting distance (i.e., 

patrol assignments similar to meat and 

poultry processing inspection). The 

Agency expects there to be salary 

savings associated with patrol 

assignments through a 3-year change in 

staffing. The Agency expects to reduce 

the number of egg products inspectors 

by 10 inspectors in year 1, 10 inspectors 

in year 2, and 10 inspectors in year 3, 

for a total reduction of 30 egg products 

inspectors through attrition and 

movement of inspectors to other 

positions in the Agency. 

In addition to Agency savings, there 

would be cost savings to industry 

because there would be a reduction in 

egg products inspector overtime and 

holiday hours, which industry pays for, 

due to patrol assignments. 

The Agency will incur costs for the 

additional travel inspectors will incur 

on patrol assignments, and the loss of 

overhead industry paid to the Agency 

for overtime and holiday hours worked. 

Agency travel costs include mileage 

increases for existing patrol assignments 

and GSA cars for new patrol 

assignments. Please see table 18 for a 

summary of total savings from the 

proposed changes in inspection 

coverage. 

TABLE 18—TOTAL NET SAVINGS FROM CHANGES IN EGG PRODUCTS INSPECTION

[$1,000] * 

Agency Annualized estimate—3% 

over 10 years 

Annualized estimate—7% 

over 10 years 

Costs: 

Changes in inspection coverage .......................................................... 1,421 1,421 

Savings: 

Reduction in salaries due to changes in inspection coverage ............ (2,046) (2,005) 

Agency Net Budget Impact ........................................................... (625) (548) 

Industry 

Savings: 

Elimination of inspection payments for overtime and holidays ............ (4,803) (4,803) 

Grand Total Net Savings ............................................................... (5,428) (5,388) 

* Numbers in table may not sum to total due to rounding. 


sradovich on DSK3GMQ082PROD with PROPOSALS2
Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6343 

65 Gurtler, J.B., Marks, H.M., Bailey, R.B, Juneja, 

V. and Jones, D.R. 2013. Kinetics Model 

Comparison for the inactivation of Salmonella 

Enteritidis and Oranienburg in 10% salted liquid 

whole egg. Foodborne Pathogens and Disease. 

10:492–499. 

Gurtler, J.B., Marks, H.M., Jones, D.R, Bailey, R.B, 

and Bauer, N.E. 2011. Modeling the thermal 

inactivation kinetics of heat-resistant Salmonella 

Enteritidis and Oranienburg in 10 percent salted 

liquid egg yolk. J. Food Prot. 74:882–892. 

Jordan, S.S., Gurtler, J.B., Marks, H.M., Jones, D.R. 

and Shaw, W.K. 2011. A mathematical model of 

inactivation kinetics for a four-strain composite of 

Salmonella Enteritidis and Oranienburg in 

commercial liquid egg yolk. Food Micro. 28:67–75. 

In summary, the benefits from this 

proposed rule include improvements in 

product quality, lower transaction costs, 

plant innovation, and generally lower 

operational costs. Additionally, the egg 

products plants will not have to comply 

with the current ‘‘command and 

control’’ regulations. By eliminating 

regulations, administrative burdens will 

be lessened, including those associated 

with submitting documentation to FSIS 

for changes to the plant and plant 

processes, waivers, and most egg 

products labels, resulting in cost 

savings. Industry will also benefit from 

the reduction in overtime and holiday 

pay paid for the inspection of egg 

products plants. Table 19 summarizes 

the quantified costs and cost savings to 

industry and the Agency if the proposed 

rule is implemented. The rule provides 

a net cost savings of between $1.3 

million and $1.4 million annualized 

over 10 years at the 7 percent and 3 

percent rates. 

TABLE 19—TOTAL COSTS AND NET BENEFITS

[$1,000s] * 

Costs 

Annualized 3% mid estimate 

(low estimate–high estimate) 

over 10 years 

Annualized 7% mid estimate 

(low estimate–high estimate) 

over 10 years 

Industry: 

HACCP ................................................................................................. 3,769.7 (1,900.3–5,630.7) 3,784.9 (1,908.6–5,651.5) 

Sanitation SOPs ................................................................................... 373.9 (214.2–555.9) 384.5 (220.6–570.5) 

Agency: 

IPP Training .......................................................................................... 38.1 44.5 

Replacement IPP .................................................................................. 18.2 21.2 

Total Costs .................................................................................... 4,199.9 (2,170.8 to 6,242.9) 4,235.2 (2,195.0 to 6,287.8) 

Savings 

Industry: 

Reduced Plant Approval Processes ..................................................... ¥61.6 ¥61.6 

Generic Labeling .................................................................................. ¥16 ¥16 

Changes in inspection coverage .......................................................... ¥4,803 ¥4,803 

Agency: 

Reduced Plant Approval Processes ..................................................... ¥58.5 ¥58.5 

Generic Labeling .................................................................................. ¥60.6 ¥60.4 

Changes in inspection coverage ................................................................. ¥625 ¥585 

Total Savings ........................................................................................ ¥5,625 ¥5,585 

Grand Total Net Benefits Mid (low to high) savings minus costs 1,424.8 (¥618.2 to 3,453.9) 1,349.5 (¥703.1 to 3,389.7) 

* Numbers in table may not sum to totals due to rounding. 

Uncertainty Surrounding Public 

Health Impacts: Currently, the 

regulations require specific times and 

temperatures for egg products 

pasteurization. If a plant wishes to 

employ an alternative time and 

temperature combination, the Agency 

reviews scientific research or data 

validating other methods of 

pasteurization (9 CFR 590.570(b)) and 

issues a ‘‘No Objection’’ letters (NOL) 

approving its use. The proposed rule 

will eliminate the codified time and 

temperature regulations and will require 

egg products plants to process egg 

products in a way that will ensure that 

the products are free of detectable 

pathogens. Due to a lack of data, FSIS 

is currently unable to compare food 

safety performance in egg products 

plants operating under the current 

regulations to those plants operating in 

a HACCP system under NOLs with 

differing pasteurization times and 

temperatures from those prescribed in 

the current regulations. 

Under HACCP, an egg products plant 

would be required to conduct a hazard 

analysis to identify and list the 

biological, chemical, or physical food 

safety hazards that are reasonably likely 

to occur in its production process for a 

particular product and the measures to 

prevent, eliminate, or reduce the 

occurrence of those hazards to an 

acceptable level. The plant would also 

be required to identify the points in 

each of its processes at which control is 

necessary to achieve this goal (9 CFR 

417.2(c)(2)). These points are called 

‘‘critical control points’’ (CCPs). The 

plant would have to establish critical 

limits for the preventive measures 

associated with each identified CCP. 

Plants would also be required to 

validate that their process works as 

intended (9 CFR 417.4). The HACCP 

and Sanitation SOP framework will 

make FSIS inspection more efficient and 

effective, because the egg products plant 

would be required to prevent food safety 

problems rather than react to problems 

without preventing recurrence. 

FSIS has developed a Compliance 

Guideline for Small and Very Small 

Plants that produce ready-to-eat egg 

products. This document updates the 

current time and temperature 

regulations based on the best available 

scientific information.65 It provides 

‘‘safe harbors’’ for egg products plants 

that FSIS considers as recognized 

procedures that can be employed 

without any further validation studies. 

However, the plant would need to 

validate that it is properly applying the 

FSIS time and temperature 

combinations provided in the guidance 

material and conduct monitoring and 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6344 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

66This cost is annualized at the 7 percent 

discount rate over 10 years. 

67These figures differ from the number of plants 

in HACCP size categories for small and large as 

mentioned earlier in the document, because the 

sizes are derived from the HACCP size rather than 

a business size. In this section, FSIS does not need 

HACCP sizes for egg products plants for the 

Regulatory Flexibility Analysis. Instead, FSIS must 

analyze egg products company or firm sizes instead 

of an egg products establishment sizes. The HACCP 

size of an establishment alone is not enough to 

verify whether it’s part of a larger business. To 

determine whether a business is small, FSIS 

analyzed whether egg products establishments were 

part of larger companies. 

68 Derived from the RTI Industry Survey, Q.5.11, 

the weighted average of the midpoints of the 

respondents’ answers to the level of annual revenue 

earned in the year prior to the survey. Q.5.11 What 

was the approximate value of egg product sales 

during the past year? 

verification activities in the plant’s 

operating environment. 

FSIS will continue to test egg 

products for Salmonella and Lm. If FSIS 

detects pathogens in the product, plants 

that have identified the pathogen as 

reasonably likely to occur in the HACCP 

hazard analysis will be required to take 

corrective actions to ensure that they 

identify problems that led to production 

of contaminated product, ensure no 

adulterated product is in commerce, and 

take measures to prevent recurrence. 

Plants that have not identified the 

pathogen as reasonably likely to occur 

would need to take corrective actions 

and reassess their HACCP plans in 

accordance with 9 CFR 417.3(b). 

Currently, when FSIS detects positives 

in egg products plants, the Agency 

response is limited to preventing the 

product from which the sample was 

collected from entering commerce or 

requesting that the producer recall its 

products. FSIS inspectors currently 

repeatedly issue noncompliance reports 

at egg products plants with limited 

improvements in operations. Therefore, 

it is possible that the HACCP 

regulations will improve the operations 

of egg products plants. 

Alternative Regulatory Approaches 

The Agency considered two 

alternatives designed to achieve the 

regulatory objective outlined in the 

Need for the Rule section. However, this 

proposed rule was chosen as the least 

burdensome, technically acceptable 

regulatory approach. 

Voluntary HACCP regulatory 

program: A voluntary HACCP system 

would be very close to the current 

system. In the current system, 93 

percent of egg products plants already 

have implemented HACCP systems 

integrated into their processing. Because 

many plants have already changed to a 

HACCP system, the Agency does not 

foresee any non-HACCP operations 

voluntarily implementing HACCP that 

have not already done so. These plants 

would stay at status quo. Therefore, this 

regulatory option would not lead to a 

significant change in current egg 

products plants processing practices. 

However, there would be additional 

costs, such as inspector HACCP training 

and the costs of inspecting a dual 

system. Also, under the current 

regulations, continuous inspection 

prevents inspectors from working patrol 

assignments, which would save 

industry overtime costs and Agency 

resources. These savings would not be 

fully realized in a dual system. For the 

plants not operating under HACCP, 

there are possible consumer benefit 

losses as some plants may fail to 

innovate and might continue to comply 

with current regulation, passing 

production costs on to consumers. 

Therefore, FSIS rejected this alternative. 

HACCP for large volume egg products 

plants: In this alternative, only plants 

with a large production volume would 

be required to implement HACCP. This 

alternative would save Agency HACCP 

training costs for inspection personnel, 

who inspect small production plants. 

Small volume plants would be allowed 

to stay in a non-HACCP system, 

lowering industry costs. This alternative 

would need to have certain volume 

definitions to distinguish the type of 

plant considered in the alternative. A 

difficulty associated with the size 

definition process is that an egg 

products plant’s volume may change 

depending on the season or from 

changes in its source eggs. These 

changes could affect the classification 

system, which is based on volume, and 

could create difficulties in identifying 

the plants most likely to be designated 

as large volume. Another drawback to 

this alternative is the possible costs to 

the small producer in the long run. 

Although the low-production egg 

products plants may save initially on 

costs by not implementing HACCP, this 

alternative may hurt the plants’ long-run 

efficiencies and competiveness because 

they would not be gaining the flexibility 

to innovate that they would by 

producing under the HACCP system. 

TABLE 20—REGULATORY ALTERNATIVES CONSIDERED

Alternative Costs Benefits 

(1) Existing Voluntary Recordkeeping.Additional costs for the Agency ..... No additional benefits. 

(2) HACCP only for large volume 

egg products plants.

In the long run, small plants would 

incur more costs from the lack 

of efficiency gains associated 

with HACCP.

Small volume producers would save on costs from not having to 

change their production process and develop the requisite Sanitation SOP and HACCP plans. Large volume producers would acquire benefits from implementing HACCP. 

(3) The Proposed Rule ................... ($1.34 million 66) annual cost savings to industry and to the 

Agency.

Achievement of regulatory objective of regulations consistent with 

other FSIS regulations, clear responsibility of Agency vs. industry, 

and additional flexibility for industry. 

Initial Regulatory Flexibility Analysis: 

The FSIS Administrator has made a 

preliminary determination that this 

proposed rule would not have a 

significant economic impact on a 

substantial number of small entities in 

the United States, as defined by the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.). 

There are 77 federally-inspected 

plants. We estimate that at least 12 are 

large businesses or companies with 

multiple egg products plants.67 We 

estimate that approximately 46 plants 

are part of these larger companies, 

leaving 31 plants that could be 

considered small businesses. In the cost 

analysis above, FSIS estimated that the 

cost savings for the industry is 

approximately 733 thousand (7 percent, 

10 years). 

This results in an average cost savings 

to a plant of ($9,200/plant) annualized 

(7 percent, 10 years). The average 

revenue for egg products plants is 

approximately $104.4 million.68

Therefore, FSIS believes that the total 

cost savings to revenue ratio per plant 

is .01 percent. FSIS is seeking public 

comment on its conclusion of no 

significant impact on small entities. 


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69This Appendix describes how the Agency used 

the 2014 Egg Products Industry Survey conducted 

and published by RTI International to gather 

information on egg products plants relating to the 

cost section of this proposed rule. Specifically, this 

Appendix outlines how the survey questions were 

used to estimate the number of egg products plants 

that have Sanitation SOPs, HACCP plans, training, 

number of shifts, and record keeping. 

Section (1) describes egg products plants’ use of 

Sanitation SOPs. Section (2) outlines the estimates 

for egg product plants’ recordkeeping for Sanitation 

SOPs. Section (3) describes egg products plants’ 

training for Sanitation SOPs. Section (4) describes 

the type of product produced by egg products 

plants and their use of HACCP plans. Section (5) 

describes the number of egg products plants with 

HACCP plans. Section (6) estimates the average 

number of shifts for egg products plants without 

HACCP plans. 

FSIS has developed a Compliance 

Guideline for Small and Very Small 

Plants that produce ready-to-eat egg 

products. This guidance document is 

designed to help small and very small 

plants meet the proposed regulatory 

requirements by providing the best 

practice recommendations by FSIS, 

based on the best scientific and practical 

considerations. FSIS is seeking 

comment on this guidance document, 

which is posted on the Agency’s web 

page: http://www.fsis.usda.gov/wps/ 

portal/fsis/topics/regulatorycompliance/compliance-guides-index. 

Appendix A to Executive Orders 12866 

and 13563 and the Regulatory 

Flexibility Act Analysis 69

The 2014 Egg Products Industry 

Survey, conducted and published by 

RTI International, surveyed 

approximately 57 egg products plants 

with questions in regard to plants’ use 

of HACCP plans, Sanitation SOPs, the 

number of plant personnel, hours of 

operation and the number of shifts, and 

current sampling practices. The survey 

design involved collaboration between 

FSIS personnel and RTI International. 

The full-scale data collection took place 

over a 16-week period from February 17, 

2014, to June 9, 2014. The survey 

included 18 questions. The survey also 

provided information on production 

volume, types of product, and 

production processes. The survey was 

considered to be a census of the 

industry because all 77 egg products 

plants currently regulated by FSIS were 

contacted and asked to respond. The 

response rate to the survey was 72 

percent. Fifty seven egg products plants 

completed the survey. Of these, 26 (46 

percent) completed the survey via mail 

and 31 (54 percent) completed the Web 

survey. FSIS used the survey results to 

supplement the information that FSIS 

maintains in the Public Health 

Information System. The responses to 

the survey were masked so that 

individual plants could not be 

identified, so FSIS applied response 

distributions to the larger population of 

egg products plants to approximate 

baseline industry characteristics. In 

order to describe the egg products 

plants, which are under FSIS’s 

jurisdiction, brief discussions of the 

major findings of the survey have been 

placed throughout this Executive Order 

12866 and 13563 discussion and the 

regulatory flexibility analysis and 

footnoted accordingly. Please find the 

link to the survey here: http://

www.fsis.usda.gov/wps/wcm/connect/ 

df3e0400-aaa7-423f-bb11-ff080fc8ce2b/ 

Survey-Egg-Products-09302014.

pdf?MOD=AJPERES. 

Section 1 Sanitation SOPs 

FSIS estimated the percentage of 

plants that train production employees 

for Sanitation SOPs using question 4.5: 

During the past year, what types of food 

safety training did permanent 

employees of this plant receive? A plant 

was considered to train production 

employees if it responded affirmatively 

to choice b. Sanitation SOPs. 91.2 

percent of respondents answered that 

employees receive Sanitation SOPs 

training. 

Section 2 Recordkeeping for Sanitation 

SOPs 

FSIS estimated the percentage of 

plants that currently meet the proposed 

recordkeeping requirements using 

survey question 2.2: ‘‘Which of the 

following records that are not required 

by FSIS does this plant maintain?’’ A 

plant was considered to meet both if it 

answered affirmatively to choices 1— 

‘‘Employee task performance log 

verification’’ and 2—‘‘Deviation and 

corrective action log.’’ 

FSIS then determined the frequency 

at which sanitation tasks are performed 

using question 2.6: ‘‘How frequently 

does this plant conduct sanitation 

inspections of product contact zones?’’ 

If a plant responded affirmatively to 

choice 1—‘‘More than once per shift,’’ it 

was considered to be conducting 

sanitation tasks at a frequency greater 

than daily. If it responded affirmatively 

to choice 2—‘‘Once per shift before shift 

operations begin,’’ and operates more 

than one shift daily (determined with 

question 5.2), then it was also 

considered to be conducting sanitation 

tasks at a frequency greater than daily. 

If it responded affirmatively to choice 2 

and operates a single shift per day, or 

if it responded affirmatively to choice 

3—‘‘Once per day before daily 

operations begin,’’ it was considered to 

be conducting sanitation tasks at a daily 

frequency. If it answered affirmatively 

to any other option, it was considered 

to conduct sanitation tasks less than 

daily. 

Records in compliance Records not in compliance 

<Daily Daily >Daily <Daily Daily >Daily 

8.8% 33.3% 22.8% 3.5% 15.8% 15.8% 

Section 3 Training for Sanitation SOPs 

FSIS used the training estimates from 

Section 1 and assumed that any plant 

which did not provide training for 

Sanitation SOPs did not have a written 

plan. Then, FSIS estimated the number 

of shifts of employees needing training 

for Sanitation SOPs by averaging the 

reported number of shifts from question 

5.2—‘‘How many production shifts are 

operated each day at this plant?’’ Only 

those plants that do not provide HACCP 

training were included in the average. 

Plants 

No 

sanitation 

SOPs 

training 

Needed 

sanitation 

SOPs 

Average 

sifts 

Total 

shifts 

77 ..................................................................................................................... 8.8% 7 1.7 8 


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6346 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

Section 4 Use of HACCP Plans 

To determine the percentage of plants 

which have written HACCP plans in 

place for their respective processes, 

FSIS used the survey to first determine 

which respondents produced products 

corresponding to the three main 

processes. 

For breaking, FSIS considered all 

plants that responded to question 1.1: 

‘‘Which statement below describes how 

this plant receives egg inputs?’’ and 

answered affirmatively to choice 1— 

This plant receives shell eggs only’’—or 

to choice 2—This plant receives both 

shell eggs and liquid or dried eggs.’’ 

For dried eggs, FSIS considered all 

plants that responded to question 1.11: 

‘‘Does this plant produce this egg 

product form?’’ and answered 

affirmatively to choice e—‘‘Dried’’—or 

to choice f—‘‘Blended and dried.’’ 

For liquid eggs, FSIS considered all 

plants that which responded to question 

1.11: ‘‘Does this plant produce this egg 

product form?’’ and answered 

affirmatively to choice a—‘‘Liquid’’; to 

choice b—‘‘Blended and liquid’’; to 

choice c—‘‘frozen’’; to choice d— 

‘‘Blended and frozen’’; or g—‘‘Extended 

shelf life liquid’’. 

Next, for each process, FSIS 

determined if the respondent had a 

written HACCP plan using question 2.1: 

‘‘What production steps are used by this 

plant, and if used, is the step addressed 

in a written plan?’’ Specifically, FSIS 

considered the plan acceptable if the 

plant responded affirmatively to option 

3—‘‘Used and Addressed in a Written 

HACCP Plan’’ for option j—‘‘Breaking 

shell eggs’’; option m—‘‘Drying egg 

products’’; or option n—‘‘Pasteurizing 

dried egg whites’’; and option l— 

‘‘Pasteurizing liquid eggs for breaking, 

dried, and liquid processes, 

respectively.’’ 

Breaking w/ 

HACCP 

Dried w/ 

HACCP 

Liquid w/ 

HACCP 

84.6% ........ 80.0% 76.5% 

Finally, FSIS applied these 

percentages to PHIS egg products plants 

production data (see Table below) to 

estimate the number of processes 

currently operating without HACCP 

plans. 

Plants Breaking Dried Liquid Total 

processes 

77 ..................................................................................................................... 56 17 52 125 

Breaking w/o HACCP Dried 

w/o HACCP 

Liquid w/o 

HACCP 

Total 

processes 

operating 

w/o HACCP 

9 ................................................................................................................................................... 3 12 24 

Section 5 Plants With HACCP Plans 

FSIS used the results to question 2.1: 

‘‘What production steps are used by this 

plant, and if used, is the step addressed 

in a written plan?’’ to determine the 

percentage of plants with no HACCP 

plans. Specifically, a plant was 

considered to have no HACCP plans if 

it did not respond with option 3—‘‘Used 

and Addressed in a Written HACCP 

Plan for any of the following: j. Breaking 

shell eggs, l. Pasteurizing liquid eggs, m. 

Drying egg products, or n. Pasteurizing 

dried egg whites.’’ 

Percent with no 

HACCP 

Number 

of plants 

(approximate) 

with no HACCP 

7.% ...................................... 5 * 

* The number of plants was rounded down. 

Section 6 Shifts for Plants Without 

HACCP Plans 

To estimate the number of shifts at 

plants without any HACCP systems in 

place, FSIS averaged the responses to 

question 5.2: ‘‘How many production 

shifts are operated each day at this 

plant?’’ for those respondents 

determined to not have HACCP plans as 

described in Section 5. This average (1.7 

shifts) was then applied to the total 

number of plants estimated to be 

without HACCP systems. 

Executive Order 13771 

This proposed rule, if finalized as 

proposed, is expected to be an E.O. 

13771 deregulatory action. We have 

estimated that this proposed rule would 

yield cost savings. Assuming a 7 percent 

discount rate and a perpetual time 

horizon and a starting year of 2018, the 

proposed rule would yield 

approximately $1.29 million (2016$) in 

annualized cost savings. Assessment of 

the specific costs and cost savings may 

be found in the preceding economic 

analysis. 

IV. Paperwork Reduction Act 

FSIS has reviewed the paperwork and 

recordkeeping requirements in this 

proposed rule in accordance with the 

Paperwork Reduction Act (44 U.S.C. 

3501, et seq.) and has determined that 

the paperwork requirements constitute 

new information collections. 

Title: Egg Products Hazard Analysis 

and Critical Control Point (HACCP) 

Systems and Sanitation Standard 

Operating Procedures (SOPs). 

Type of Collection: New. 

Abstract: Under this proposed rule, 

FSIS is requiring official plants to 

develop and maintain HACCP and 

Sanitation SOP records and plans, as 

well as various transaction records. The 

egg products industry’s documentation 

of its processes, first in a plan and 

thereafter in a continuous record of 

process performance, will be a more 

effective food safety approach than the 

sporadic generating of information by 

inspection program personnel. This 

documentation gives inspection 

program personnel a much broader 

picture of production than they can 

generate and provides them additional 

time to perform higher priority tasks. At 

the same time, it gives plant managers 

a better view of their own process and 

more opportunity to adjust it to prevent 

safety defects. 

Sanitation SOPs 

To meet the proposed regulation’s 

sanitation requirements, each processor 

will develop and maintain a Sanitation 

SOP. The Sanitation SOP would specify 

the cleaning and sanitizing procedures 

for all equipment and facilities involved 

in the production of every product. As 

part of the Sanitation SOP, a plant 

employee will record results of daily 

sanitation checks at the frequencies 

stated in the Sanitation SOP. 

The burden of documenting the 

adherence to Sanitation SOPs is based 

on three factors: Recording, reviewing, 

and storage. Recording encompasses 

conducting and inscribing the finding 


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Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6347 

from an observation and filing of the 

document produced. 

HACCP 

Under this proposal, the requirements 

for the implementation of HACCP in 

official plants will be the same as those 

being met by meat and poultry products 

establishments operating under HACCP. 

The plant will maintain on file the name 

and a brief resume of the HACCPtrained individuals who participate in 

the hazard analysis and subsequent 

development of the HACCP plans. 

Plants will develop written HACCP 

plans that include: Identification of 

hazards reasonably likely to occur in the 

production process; identification and 

description of the CCP for each 

identified hazard; specification of the 

critical limit which may not be 

exceeded at the CCP, and, if 

appropriate, a target limit; description of 

the monitoring procedure or device to 

be used; description of the corrective 

action to be taken if the limit is 

exceeded; description of the records 

which would be generated and 

maintained regarding this CCP; and 

description of the facility verification 

activities and the frequency at which 

they are to be conducted. Critical limits 

that are currently a part of FSIS 

regulations must be included. The 

adequacy of a plant’s HACCP plan must 

be reassessed at least annually and 

whenever changes occur that could 

affect the hazard analysis or alter the 

HACCP plan. 

The HACCP records should be 

reviewed by a plant employee other 

than the one whom produced the 

record, before the product is distributed 

in commerce. If a HACCP-trained 

individual is on-site, that person should 

be the reviewer. The reviewer would 

sign the records. Lastly, HACCP records 

generated by the processor would be 

retained on site for at least 1 year. 

Labeling 

Under this proposal, official plants 

will be authorized to use generically 

approved labels without specific 

evaluation by LPDS. In addition, frozen 

and refrigerated egg products will be 

required to bear labels that say, ‘‘Keep 

Frozen’’ or ‘‘Keep Refrigerated.’’ Plants 

already use special handling statements, 

when appropriate, under general 

Agency policy governing special 

handling statements. Therefore, the 

Agency has already accounted for the 

labeling paperwork burden. 

Estimate of Burden: FSIS estimates 

that each respondent will spend 927.58 

hours per year on this information 

collection. 

Respondents: Official egg products 

plants. 

Estimated Number of Respondents: 

77. 

Estimated Number of Responses per 

Respondent: 927.58. 

Estimated Total Annual Burden on 

Respondents: 71,424 hours. 

Copies of this information collection 

assessment can be obtained from Gina 

Kouba, Paperwork Reduction Act 

Coordinator, Food Safety and Inspection 

Service, USDA, Room 6065–S, South 

Agriculture Building, 1400 

Independence Avenue SW, Washington, 

DC 20250; (202) 720–5627. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FSIS’s functions, including whether 

the information will have practical 

utility; (b) the accuracy of FSIS’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (c) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; ways to 

minimize the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques, or other forms of 

information technology. Comments may 

be sent to both Gina Kouba, Paperwork 

Reduction Act Coordinator, at the 

address provided above, and the Desk 

Officer for Agriculture, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Washington, DC 20253. 

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

also become a matter of public record. 

V. Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. Under this rule: (1) All 

State and local laws and regulations that 

are inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) no 

administrative proceedings will be 

required before parties may file suit in 

court challenging this rule. 

VI. E-Government Act Compliance 

FSIS and USDA are committed to 

achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et 

seq.) by, among other things, promoting 

the use of the internet and other 

information technologies and providing 

increased opportunities for citizen 

access to government information and 

services, and for other purposes. 

VII. Executive Order 13175 

This rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, ‘‘Consultation 

and Coordination with Indian Tribal 

Governments.’’ E.O. 13175 requires 

Federal agencies to consult and 

coordinate with tribes on a governmentto-government basis on policies that 

have tribal implications, including 

regulations, legislative comments or 

proposed legislation, and other policy 

statements or actions that have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

FSIS has assessed the impact of this 

rule on Indian tribes and determined 

that this rule does not, to our 

knowledge, have tribal implications that 

require tribal consultation under E.O. 

13175. If a Tribe requests consultation, 

the Food Safety and Inspection Service 

will work with the Office of Tribal 

Relations to ensure meaningful 

consultation is provided where changes, 

additions and modifications identified 

herein are not expressly mandated by 

Congress. 

VIII. USDA Nondiscrimination 

Statement 

No agency, officer, or employee of the 

USDA shall, on the grounds of race, 

color, national origin, religion, sex, 

gender identity, sexual orientation, 

disability, age, marital status, family/ 

parental status, income derived from a 

public assistance program, or political 

beliefs, exclude from participation in, 

deny the benefits of, or subject to 

discrimination any person in the United 

States under any program or activity 

conducted by the USDA. 

How To File a Complaint of 

Discrimination 

To file a complaint of discrimination, 

complete the USDA Program 

Discrimination Complaint Form, which 

may be accessed online at http://

www.ocio.usda.gov/sites/default/files/ 

docs/2012/Complain_combined_6_8_

12.pdf, or write a letter signed by you 

or your authorized representative. 

Send your completed complaint form 

or letter to USDA by mail, fax, or email: 

Mail: U.S. Department of Agriculture, 

Director, Office of Adjudication, 1400 

Independence Avenue SW, Washington, 

DC 20250–9410. Fax: (202) 690–7442. 

IX. Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, FSIS will 


sradovich on DSK3GMQ082PROD with PROPOSALS2
6348 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

announce this Federal Register 

publication on-line through the FSIS 

web page located at: http://

www.fsis.usda.gov/federal-register. 

FSIS also will make copies of this 

publication available through the FSIS 

Constituent Update, which is used to 

provide information regarding FSIS 

policies, procedures, regulations, 

Federal Register notices, FSIS public 

meetings, and other types of information 

that could affect or would be of interest 

to our constituents and stakeholders. 

The Update is available on the FSIS web 

page. Through the web page, FSIS is 

able to provide information to a much 

broader, more diverse audience. In 

addition, FSIS offers an email 

subscription service which provides 

automatic and customized access to 

selected food safety news and 

information. This service is available at: 

http://www.fsis.usda.gov/subscribe. 

Options range from recalls to export 

information, regulations, directives, and 

notices. Customers can add or delete 

subscriptions themselves, and have the 

option to password protect their 

accounts. 

List of Subjects 

9 CFR Part 416 

Meat inspection, Poultry and poultry 

products, Sanitation. 

9 CFR Part 417 

Meat inspection, Poultry and poultry 

products, Record and recordkeeping 

requirements, Hazard Analysis and 

Critical Control Point (HACCP) Systems. 

9 CFR Part 500 

Administrative practice and 

procedure, Meat inspection, Poultry and 

poultry products, Rules of practice. 

9 CFR Part 590 

Eggs and egg products, Exports, Food 

grades and standards, Food labeling, 

Imports, Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, FSIS proposes to amend 9 

CFR chapter III as follows: 

■ 1. Revise the heading of subchapter E 

to read as follows: 

SUBCHAPTER E—REGULATORY 

REQUIREMENTS UNDER THE FEDERAL 

MEAT INSPECTION ACT, THE POULTRY 

PRODUCTS INSPECTION ACT, AND THE 

EGG PRODUCTS INSPECTION ACT 

PART 416—SANITATION 

■ 2. Revise the authority citation for part 

416 to read as follows: 

Authority: 21 U.S.C. 451–470, 601–695, 

1031–1056; 7 U.S.C. 450, 1901–1906; 7 CFR 

2.18, 2.53. 

PART 417—HAZARD ANALYSIS AND 

CRITICAL CONTROL POINT (HACCP) 

SYSTEMS 

■ 3. Revise the authority citation for part 

417 to read as follows: 

Authority: 21 U.S.C. 451–470, 601–695, 

1031–1056; 7 U.S.C. 450, 1901–1906; 7 CFR 

2.18, 2.53. 

■ 4. In § 417.7, revise paragraph (b) to 

read as follows: 

§ 417.7 Training. 

* * * * * 

(b) The individual performing the 

functions listed in paragraph (a) of this 

section shall have successfully 

completed a course of instruction in the 

application of the seven HACCP 

principles to meat, poultry, or egg 

products, including a segment on the 

development of a HACCP plan for a 

specific product and on record review. 

PART 500—RULES OF PRACTICE 

■ 5. Revise the authority citation for part 

500 to read as follows: 

Authority: 21 U.S.C. 451–470, 601–695, 

1031–1056; 7 U.S.C. 450, 1901–1906; (33 

U.S.C. 1251 et seq.); 7 CFR 2.18, 2.53. 

■ 6. Amend § 500.2 by revising 

paragraph (c) to read as follows: 

§ 500.2 Regulatory control action. 

* * * * * 

(c) An establishment may appeal a 

regulatory control action, as provided in 

§§ 306.5, 381.35, and 590.310 of this 

chapter. 

■ 7. Amend § 500.3 by revising 

paragraphs (a)(1) and (a)(7) to read as 

follows: 

§ 500.3 Withholding action or suspension 

without prior notification. 

(a) * * * 

(1) The establishment produced and 

shipped adulterated or misbranded 

product as defined in 21 U.S.C. 453, 21 

U.S.C. 602, or 21 U.S.C. 1033; 

* * * * * 

(7) The establishment did not destroy 

a condemned meat or poultry carcass, or 

part or product thereof, or egg product, 

that has been found to be adulterated 

and that has not been reprocessed, in 

accordance with part 314 or part 381, 

subpart L, or part 590 of this chapter 

within three days of notification. 

* * * * * 

■ 8. Amend § 500.5 by revising 

paragraphs (a)(5) and (c) to read as 

follows: 

§ 500.5 Notification, appeals, and actions 

held in abeyance. 

(a) * * * 

(5) Advise the establishment that it 

may appeal the action as provided in 

§§ 306.5, 381.35, and 590.310 of this 

chapter. 

* * * * * 

(c) An establishment may appeal the 

withholding action or suspension, as 

provided in §§ 306.5, 381.35, and 

590.310 of this chapter. 

* * * * * 

■ 9. In § 500.6: 

■ a. Redesignate paragraphs (a) through 

(i) as paragraphs (a)(1) through (9). 

■ b. Designate the introductory text as 

paragraph (a). 

■ c. Revise newly redesignated 

paragraph (a)(9). 

■ d. Add reserved paragraph (b). 

The revision and addition read as 

follows: 

§ 500.6 Withdrawal of inspection. 

(a) * * * 

(9) A recipient of inspection or 

anyone responsibly connected to the 

recipient is unfit to engage in any 

business requiring inspection as 

specified in section 401 of the FMIA, 

section 18(a) of the PPIA, or section 18 

of the EPIA. 

(b) [Reserved] 

■ 10. In § 500.7, revise paragraphs (a)(3) 

and (5) to read as follows: 

§ 500.7 Refusal to grant inspection. 

(a) * * * 

(3) Has not demonstrated that 

adequate sanitary conditions exist in the 

establishment as required by part 308, 

subpart H of part 381, part 416, or part 

590 of this chapter; 

* * * * * 

(5) Is unfit to engage in any business 

requiring inspection as specified in 

section 401 of the FMIA, section 18(a) 

of the PPIA, or section 18 of the EPIA. 

* * * * * 

■ 11. In § 500.8, revise paragraphs (a) 

and (c) to read as follows: 

§ 500.8 Procedures for rescinding or 

refusing approval of marks, labels, and 

containers. 

(a) FSIS may rescind or refuse 

approval of false or misleading marks, 

labels, or sizes or forms of any container 

for use with any meat, poultry, or egg 

product, under section 7 of the FMIA, 

under section 8 of the PPIA, or under 

sections 7 or 14 of the EPIA. 

* * * * * 

(c) If FSIS rescinds or refuses 

approval of false or misleading marks, 

labels, or sizes or forms of any container 

for use with any meat, poultry, or egg 

product, an opportunity for a hearing 

will be provided in accordance with the 

Uniform Rules of Practice, 7 CFR 

subtitle A, part 1, subpart H. 


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Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6349 

PART 590—INSPECTION OF EGGS 

AND EGG PRODUCTS (EGG 

PRODUCTS INSPECTION ACT) 

■ 12. The authority citation for part 590 

is revised to read as follows: 

Authority: 21 U.S.C. 1031–1056; 7 CFR 

2.18, 2.53. 

§ § 590.1 through 590.860 [Designated as 

Subpart A] 

■ 13. Designate §§ 590.1 through 

590.860 as subpart A and add a heading 

for subpart A to read as follows: 

Subpart A—GENERAL 

■ 14. Amend § 590.5 by: 

■ a. Revising the definition of 

Administrator. 

■ b. Removing the definition of Chief of 

the Grading Branch and Dirty egg or 

Dirties. 

■ c. Revising paragraph (c) of the 

definition of Egg and the definition of 

Egg product. 

■ d. Removing the definition of Eggs of 

current production, Inspector/Grader, 

and National Supervisor. 

■ e. Adding, in alphabetical order, the 

definition of Official plant. 

■ f. Removing the definition of Official 

Standard. 

■ g. Adding, in alphabetical order, the 

definition of Official standards. 

■ h. Revising the definition of 

Pasteurize. 

■ i. Removing the definition of Plant. 

■ j. Revising the definition of 

Processing. 

■ k. Adding, in alphabetical order, the 

definition of Program employee. 

■ l. Removing the definitions of 

Regional Director, Sanitize, and Service. 

■ m. Revising the definition of Shell egg 

packer. 

■ n. Adding, in alphabetical order, the 

definition of Shipped for retail sale. 

The revisions and additions read as 

follows: 

§ 590.5 Terms defined. 

* * * * * 

Administrator means the 

Administrator of the Food Safety and 

Inspection Service or any officer or 

employee of the Department of 

Agriculture to whom authority has been 

delegated or may be delegated to act in 

his or her stead. 

* * * * * 

Egg * * * 

(c) Dirty egg or Dirt means an egg that 

has a shell that is unbroken and has 

adhering dirt or foreign material. 

* * * * * 

Egg product means any dried, frozen, 

or liquid eggs, with or without added 

ingredients, excepting products which 

contain eggs only in a relatively small 

proportion or historically have not been, 

in the judgment of the Secretary, 

considered by consumers as products of 

the egg food industry, and which may 

be exempted by the Secretary under 

such conditions as the Secretary may 

prescribe to assure that the egg 

ingredients are not adulterated and such 

products are not represented as egg 

products. For the purposes of this part, 

the following products, among others, 

are exempted as not being egg products: 

Cooked egg products, imitation egg 

products, dietary foods, dried no-bake 

custard mixes, egg nog mixes, acidic 

dressings, noodles, milk and egg dip, 

cake mixes, French toast, and 

sandwiches containing no more 

restricted eggs than are allowed in the 

official standards for U.S. Consumer 

Grade B shell eggs. Balut and other 

similar ethnic delicacies are also 

exempted from inspection under this 

part. 

* * * * * 

Official plant means any plant in 

which the plant facilities, methods of 

operation, and sanitary procedures have 

been found suitable and adequate by the 

Administrator for the inspection of egg 

products pursuant to the regulations in 

this part and in which inspection 

service is carried on. 

Official standards means the 

standards of quality, grades, and weight 

classes for eggs. 

* * * * * 

Pasteurize means the subjecting of 

each particle of egg products to heat or 

other treatments to destroy harmful 

viable microorganisms. 

* * * * * 

Processing means manufacturing of 

egg products, including breaking eggs or 

filtering, mixing, blending, pasteurizing, 

stabilizing, cooling, freezing or drying, 

or packaging or repackaging egg 

products at official plants. 

* * * * * 

Program employee means any 

inspector or other individual employed 

by the Department or any cooperating 

agency who is authorized by the 

Secretary to do any work or perform any 

duty in connection with the Program. 

* * * * * 

Shell egg packer means any person 

engaged in the sorting of shell eggs from 

sources other than or in addition to the 

person’s own production into their 

various qualities, either mechanically or 

by other means. 

Shipped for retail sale means eggs that 

are forwarded from the processing 

facility for distribution to the ultimate 

consumer. 

* * * * * 

■ 15. Amend § 590.10 by revising the 

third sentence to read as follows: 

§ 590.10 Authority. 

* * * The Food Safety and Inspection 

Service and its officers and employees 

will not be liable in damages through 

acts of commission or omission in the 

administration of this part. 

§ § 590.17 and 590.22 [Removed] 

■ 16. Remove §§ 590.17 and 590.22. 

■ 17. Revise § 590.28 to read as follows: 

§ 590.28 Other inspections. 

Inspection program personnel will 

make periodic inspections of business 

premises, facilities, inventories, 

operations, transport vehicles, and 

records of egg handlers, and the records 

of all persons engaged in the business of 

transporting, shipping, or receiving any 

eggs or egg products. 

* * * * * 

■ 18. Revise § 590.40 to read as follows: 

§ 590.40 Egg products not intended for 

human food. 

Periodic inspections will be made at 

any plant processing egg products 

which are not intended for use as 

human food of its operations and 

records to ensure compliance with the 

Act and the regulations in this part. Egg 

products not intended for use as human 

food shall be denatured or 

decharacterized prior to being offered 

for sale or transportation unless shipped 

under seal as authorized in § 590.504(c) 

and identified as prescribed by the 

regulations in this part to prevent their 

use as human food. 

■ 19. Revise § 590.50 to read as follows: 

§ 590.50 Egg temperature and labeling 

requirements. 

(a) All shell eggs packed into 

containers destined for the ultimate 

consumer must be stored and 

transported under refrigeration at an 

ambient temperature of no greater than 

45° F (7.2° C) and must bear a safe 

handling label in accordance with 21 

CFR 101.17(h). 

(b) Any producer-packer with an 

annual egg production from a flock of 

3,000 or fewer hens is exempt from the 

temperature and labeling requirements 

of this section. 

■ 20. Revise § 590.100 to read as 

follows: 

§ 590.100 Specific exemptions. 

(a) [Reserved] 

(b) The following are exempt, to the 

extent prescribed, from the continuous 

inspection of egg products processing 

operations in section 5(a) of the Act (21 

U.S.C. 1034(a)), provided the conditions 


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6350 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

for exemption and the provisions of 

these regulations are met: 

(1) The processing and sale of egg 

products by any poultry producer from 

eggs of his own flock’s production when 

sold directly to a household consumer 

exclusively for use by the consumer and 

members of the household and its 

nonpaying guests and employees. 

(2) The processing in non-official 

plants, including but not limited to 

bakeries, restaurants, and other food 

processors, of certain categories of food 

products which contain eggs or egg 

products as an ingredient, as well as the 

sale and possession of such products. 

Such products must be manufactured 

from inspected egg products processed 

in accordance with the regulations in 

this part and 9 CFR part 591 or from 

eggs containing no more restricted eggs 

than are allowed in the official 

standards for U.S. Consumer Grade B 

shell eggs. 

§ 590.105 [Removed] 

■ 21. Remove § 590.105 and 

undesignated center heading 

‘‘Performance of Service’’. 

§ § 590.112, 590.114 and 590.116 

[Removed] 

■ 22. Remove §§ 590.112, 590.114 and 

590.116. 

■ 23. Add an undesignated center 

heading above § 590.118 and revise 

§ 590.118 to read as follows: 

Performance of Service 

§ 590.118 Identification. 

Each program employee will be 

furnished with a numbered official 

badge that will be carried in a proper 

manner at all times while on duty. This 

badge will be sufficient identification to 

entitle the program employee entry at 

all regular entrances and to all parts of 

the official plant and premises to which 

the program employee is assigned. 

§ 590.119 [Removed] 

■ 24. Remove § 590.119. 

■ 25. Revise § 590.120 to read as 

follows: 

§ 590.120 Financial interest of inspectors. 

(a) No program employee will inspect 

any product in which the employee, the 

employee’s spouse, minor child, 

partner, organization in which the 

employee is serving as officer, director, 

trustee, partner, or employee, or any 

other person with whom the program 

employee is negotiating or has any 

arrangements concerning prospective 

employment, has a financial interest in 

the product. 

(b) All program employees are subject 

to statutory restrictions with respect to 

political activities; e.g., 5 U.S.C. 7324 

and 1502. 

(c) Violation of the provisions of 

paragraph (a) of this section or the 

provisions of applicable statutes 

referenced in paragraph (b) of this 

section will constitute grounds for 

dismissal. 

(d) Program employees are subject to 

all applicable provisions of law and 

regulations and instructions of the 

Department and the Food Safety and 

Inspection Service concerning employee 

responsibilities and conduct. The 

setting forth of certain prohibitions in 

this part in no way limits the 

applicability of such general or other 

regulations or instructions. 

■ 26. Revise § 590.134(b) to read as 

follows: 

§ 590.134 Accessibility of product and 

cooler rooms. 

* * * * * 

(b) The perimeter of each cooler room 

used to store eggs must be made 

accessible in order for the Secretary’s 

representatives to determine the 

ambient temperature under which shell 

eggs packed into containers destined for 

the ultimate consumer are stored. 

■ 27. Revise § 590.136 to read as 

follows: 

§ 590.136 Accommodations and 

equipment to be furnished by facilities for 

use of program employees in performing 

service. 

(a) Program employee’s office. Office 

space, including, but not limited to, 

furnishings, light, heat, and janitor 

service, will be provided without cost in 

the official plant for the use of program 

employees for official purposes. The 

room or space set apart for this purpose 

must meet the approval of the Food 

Safety and Inspection Service and be 

conveniently located, properly 

ventilated, and provided with lockers or 

file cabinets suitable for the protection 

and storage of supplies and with 

accommodations suitable for program 

employees to change clothing. At the 

discretion of the Administrator, small 

official plants requiring the services of 

less than one full-time program 

employee need not furnish 

accommodations for program employees 

as prescribed in this section where 

adequate accommodations exist in a 

nearby convenient location. 

(b) Accommodations and equipment. 

Such accommodations and equipment 

must include, but not be limited to, a 

room or area suitable for sampling 

product and a stationary or adequately 

secured storage box or cage (capable of 

being locked only by the program 

employee) for holding official samples. 

■ 28. Revise § 590.140 to read as 

follows: 

§ 590.140 Application for grant of 

inspection. 

The proprietor or operator of each 

official plant and official import 

inspection establishment must make 

application to the Administrator for 

inspection service unless exempted by 

§ 590.100. The application must be 

made in writing on forms furnished by 

the inspection service. In cases of 

change of name or ownership or change 

of location, a new application must be 

made. 

■ 29. Revise § 590.142 to read as 

follows: 

§ 590.142 Filing of application. 

An application for inspection service 

will be regarded as filed only when it 

has been: 

(a) Filled in completely; 

(b) Signed by the applicant; and 

(c) Received in the appropriate 

District Office. 

■ 30. Revise § 590.146 to read as 

follows: 

§ 590.146 Survey and grant of inspection. 

(a) Before inspection is granted, FSIS 

will survey the official plant to 

determine if the construction and 

facilities of the plant are in accordance 

with the regulations in this part. FSIS 

will grant inspection, subject to 9 CFR 

500.7, when these requirements are met 

and the requirements contained in 

§ 590.149 are met. 

(b) FSIS will give notice in writing to 

each applicant granted inspection and 

will specify in the notice the official 

plant, including the limits of the plant’s 

premises, to which the grant pertains. 

§ 590.148 [Removed] 

■ 31. Remove § 590.148. 

■ 32. Add § 590.149 to read as follows: 

§ 590.149 Conditions for receiving 

inspection. 

(a) Before receiving Federal 

inspection, a plant must have developed 

written sanitation Standard Operating 

Procedures, in accordance with part 416 

and § 591.1(a)(1) of this chapter. 

(b) Before receiving Federal 

inspection, a plant must conduct a 

hazard analysis, and develop and 

implement a HACCP plan, in accord 

with part 417 and § 591.1(a)(1) of this 

chapter. Conditional inspection may be 

provided for a period not to exceed 90 

days, during which period the facility 

must validate its HACCP plan. 

(c) Before producing new product for 

distribution in commerce, a plant must 

conduct a hazard analysis and develop 

a HACCP plan applicable to that 


sradovich on DSK3GMQ082PROD with PROPOSALS2
Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 6351 

product, in accordance with § 417.2 of 

this chapter. During a period not to 

exceed 90 days after the date the new 

product is produced for distribution in 

commerce, the plant must validate its 

HACCP plan, in accordance with § 417.4 

of this chapter. 

■ 33. Revise § 590.160 to read as 

follows: 

§ 590.160 Clean Water Act; refusal, 

suspension, or withdrawal of service. 

(a) Any applicant for inspection at a 

plant where the operations thereof may 

result in any discharge into the 

navigable waters in the United States is 

required by subsection 401(a)(1) (33 

U.S.C. 1341) of the Clean Water Act as 

amended (86 Stat. 816, 91 Stat. 1566, 33 

U.S.C. 1251 et seq.), to provide the 

Administrator with a certification, as 

prescribed in said subsection, that any 

such discharge will comply with the 

applicable provisions of sections 301, 

302, 303, 306, and 307 of the Act (33 

U.S.C. 1311, 1312, 1313, 1316, and 

1317). No grant of inspection can be 

issued unless such certification has 

been obtained, or is waived, because 

failure of refusal of the State, interstate 

agency, or the Administrator of the 

Environmental Protection Agency to act 

on a request for certification within a 

reasonable period (which should not 

exceed 1 year after receipt of such a 

request). Further, upon receipt of an 

application for inspection and a 

certification as required by subsection 

401(a)(1) of the Clean Water Act, the 

Administrator (as defined in § 590.5) is 

required by subparagraph (2) of said 

subsection to notify the Administrator 

of the Environmental Protection Agency 

for proceedings in accordance with that 

subsection. No grant of inspection can 

be made until the requirements of 

401(a)(1) and (2) have been met. 

(b) Inspection may be suspended or 

revoked and plant approval terminated 

as provided in subsection 401(a)(4) and 

(5) of the Clean Water Act, as amended 

(33 U.S.C. 1341(a)(4) and (5)). 

■ 34. Revise § 590.200 to read as 

follows: 

§ 590.200 Records and related 

requirements. 

(a) Persons engaged in the 

transporting, shipping, or receiving of 

any eggs or egg products in commerce, 

or holding such articles so received, and 

all egg handlers, except producerpackers with an annual egg production 

from a flock of 3,000 hens or fewer, 

must maintain records documenting, for 

a period of 2 years, the following, to the 

extent applicable: 

(1) The date of lay, date and time of 

refrigeration, date of receipt, quantity 

and quality of eggs purchased or 

received, and from whom (including a 

complete address, unless a master list is 

maintained). Process records 

documenting that the temperature and 

labeling requirements in § 590.50(a) 

have been met must also be kept; 

(2) The date of packaging, ambient air 

temperature surrounding product stored 

after processing, quantity and quality of 

eggs delivered or sold, and to whom 

(including a complete address, unless a 

master list is maintained); 

(3) If a consecutive lot numbering 

system is not employed to identify 

individual eggs, containers of eggs, or 

egg products, record the alternative code 

system used, in accordance with 

§ 590.411(c)(3); 

(4) The date of disposal and quantity 

of restricted eggs, including inedible egg 

product or incubator reject product, sold 

or given away for animal food or other 

uses or otherwise disposed of, and to 

whom (including a complete address, 

unless a master list is maintained); 

(5) The individual or composite 

(running tally) record of restricted egg 

sales to household consumers. Records 

should show number of dozens sold on 

a daily basis. The name and address of 

the consumer is not required; 

(6) The date of production and 

quantity of egg products delivered or 

sold, and to whom (including a 

complete address, unless a master list is 

maintained); 

(7) The date of receipt and quantity of 

egg products purchased or received, and 

from whom (including a complete 

address, unless a master list is 

maintained); 

(8) The production records by 

categories of eggs such as graded eggs, 

nest-run eggs, dirties, checks, etc.; bills 

of sale, inventories, receipts, shipments, 

shippers, receivers, dates of shipment 

and receipt, carrier names, etc. 

(b) All records required to be 

maintained by this section must be 

made available to an authorized 

representative of the Secretary for 

official review and copying. 

(c) Records of all labeling, along with 

the product formulation and processing 

procedures as prescribed in §§ 590.410 

through 590.412 of this chapter, must be 

kept by every person processing, except 

processors exempted under § 590.100 of 

this chapter. 

■ 35. Revise § 590.300 to read as 

follows: 

§ 590.300 Appeal inspections. 

Any person receiving inspection 

service may, if dissatisfied with any 

decision of an inspector related to any 

inspection, file an appeal from such 

decision. 

■ 36. Revise § 590.310 to read as 

follows: 

§ 590.310 Appeal inspections; how made. 

Any appeal from the inspection 

decision of any program employee must 

be made to his or her immediate 

supervisor having jurisdiction over the 

subject matter of the appeal. 

■ 37. Revise § 590.320 to read as 

follows: 

§ 590.320 How to file an appeal inspection 

or decision review. 

The request for an appeal inspection 

or review of a program employee’s 

decision may be made orally or in 

writing. If made orally, written 

confirmation may be required. The 

applicant must clearly identify the 

product involved, the decision being 

appealed, and the reasons for requesting 

the appeal. 

■ 38. Revise § 590.340 to read as 

follows: 

§ 590.340 Who must perform the appeal 

inspection or decision review. 

An appeal inspection or review of a 

program employee’s decision, as 

requested in § 590.310, must be 

performed by a program employee of 

FSIS other than the one who made the 

initial decision. 

■ 39. Revise § 590.350 to read as 

follows: 

§ 590.350 Appeal samples. 

An appeal sample will consist of 

product taken from the original sample 

containers plus an equal number of 

containers selected at random. A 

condition appeal cannot be made unless 

all originally sampled containers are 

available. 

§ § 590.360 and 590.370 [Removed] 

■ 40. Remove §§ 590.360 and 590.370. 

■ 41. Revise § 590.410 to read as 

follows: 

§ 590.410 Egg products required to be 

labeled. 

(a)(1) Packaged egg products that 

require special handling to maintain 

their wholesome condition must have 

the statement ‘‘Keep Refrigerated,’’ 

‘‘Keep Frozen,’’ ‘‘Perishable Keep Under 

Refrigeration,’’ or such similar statement 

prominently displayed on the principal 

display panel. 

(2) Egg products that are distributed 

frozen and thawed prior to or during 

display for sale at retail must bear the 

statement ‘‘Keep Frozen’’ on the 

shipping container. Consumer-sized 

containers for such egg products must 

bear the statement ‘‘Previously Handled 

Frozen for Your Protection, Refreeze or 

Keep Refrigerated.’’ 


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(3) The labels of packages of egg 

products produced from shell eggs that 

have been treated with ionizing 

radiation must reflect that treatment in 

the ingredient statement on the finished 

product labeling. 

(b) Containers, portable tanks, and 

bulk shipments of edible egg products 

produced in official plants must be 

labeled in accordance with §§ 590.411 

through 590.415 and must bear the 

official identification shown in Figure 1 

of § 590.413. 

(c) Bulk shipments of unpasteurized 

egg products produced in official plants 

must bear a label containing the words 

‘‘date of loading,’’ followed by a suitable 

space in which the date the container, 

tanker truck, or portable tank is loaded 

must be inserted. The label must be 

conspicuously located, and printed and 

affixed on material that cannot be 

detached or effaced due to exposure to 

weather. Before the truck or tank is 

removed from the place where it is 

unloaded, the carrier must remove or 

obliterate the label. Such shipments 

must also bear the official identification 

shown in Figure 2 of § 590.415. 

■ 42. Revise § 590.411 to read as 

follows: 

§ 590.411 Label approval. 

(a) All official plants, including 

official plants certified under a foreign 

inspection system in accordance with 

§ 590.910, must comply with the 

requirements contained in 9 CFR 412.1, 

except as otherwise provided in this 

part. 

(b) For the purposes of 9 CFR 412.2, 

an official establishment or 

establishment certified under a foreign 

inspection system includes an official 

plant. 

(c) Labels, containers, or packaging 

materials of egg products must show the 

following information, as applicable, on 

the principal display panel (except as 

otherwise permitted in this part), in 

accordance with the requirements of 

this part, or if applicable, 21 CFR 

101.17(h): 

(1) A statement showing by the 

common or usual names, if any, of the 

kinds of ingredients comprising the 

product. Formulas are to be expressed 

in terms of a liquid product except for 

product that is dry-blended. Also, for 

product to be dried, the label may show 

the ingredients in order of descending 

proportions by weight in the dried form. 

However, the formula submitted must 

include the percentage of ingredients in 

both liquid and dried form. If the 

product is comprised of two or more 

ingredients, such ingredients must be 

listed in the order of descending 

proportions by weight in the form in 

which the product is to be marketed 

(sold), except that ingredients in dried 

product (other than dry blended) may be 

listed in either liquid or dried form. 

When water (excluding that used to 

reconstitute dehydrated ingredients 

back to their normal composition) is 

added to a liquid or frozen egg product 

or to an ingredient of such products (in 

excess of the normal water content of 

that ingredient), the total amount of 

water added, including the water 

content of any cellulose or vegetable 

gums used, must be expressed as a 

percentage of the total product weight in 

the ingredient statement on the label; 

(2) The name, address and zip code of 

the distributor; qualified by such terms 

as ‘‘distributed by,’’ or ‘‘distributors’’; 

(3) The lot number or an alternative 

code indicating the date of production, 

in accordance with § 590.200(a); 

(4) The net content; 

(5) An official inspection symbol and 

the number of the official plant in 

which the product was processed under 

inspection as set forth in § 590.413; 

(6) Egg products processed from 

edible eggs of the turkey, duck, goose, 

or guinea must be clearly and distinctly 

labeled as to the common or usual name 

of the product indicating the type of 

eggs or egg products used in the 

product, e.g., ‘‘Frozen whole turkey 

eggs,’’ ‘‘Frozen whole chicken and 

turkey eggs.’’ Egg products labeled 

without qualifying words as to the type 

of egg used in the product must be 

produced only from the edible egg of the 

domesticated chicken or the egg 

products produced from such eggs. 

(d) Liquid or frozen egg products 

identified as whole eggs and processed 

in other than natural proportions as 

broken from the shell must have a total 

egg solids content of 24.20 percent or 

greater. 

(e) Nutrition information may be 

included on labels used to identify egg 

products, providing such labeling 

complies with the provisions of 21 CFR 

part 101, promulgated under the Federal 

Food, Drug, and Cosmetic Act and the 

Fair Packaging and Labeling Act. Since 

these regulations have different 

requirements for consumer packaged 

products than for bulk packaged egg 

products not for sale or distribution to 

household consumers, label submission 

must be accompanied with information 

indicating whether the label covers 

consumer packaged or bulk packaged 

products. Nutrition labeling is required 

when nutrients, such as proteins, 

vitamins, and minerals are added to the 

product, or when a nutritional claim or 

information is presented on the labeling, 

except for the following, which are 

exempt from nutrition labeling 

requirements: 

(1) Egg products shipped in bulk form 

for use solely in the manufacture of 

other food and not for distribution to 

household consumers in such bulk form 

or containers. 

(2) Products containing an added 

vitamin, mineral, or protein, or for 

which a nutritional claim is made on 

the label, or in advertising, which is 

supplied for institutional food use only, 

provided that the manufacturer or 

distributor provides the required 

nutrition information directly to those 

institutions. 

(3) Any nutrients included in the 

product solely for technological 

purposes may be declared solely in the 

ingredients statement, without 

complying with nutrition labeling, if the 

nutrient(s) is otherwise not referred to 

in labeling or in advertising. All labels 

showing nutrition information or claims 

are subject to review by the Food and 

Drug Administration prior to approval 

by the Department. 

(f)(1) No label, container, or packaging 

material may contain any statement that 

is false or misleading. If the 

Administrator has reason to believe that 

a statement or formulation shows that 

an egg product is adulterated or 

misbranded, or that any labeling, 

including the size or form of any 

container in use or proposed for use, 

with respect to eggs or egg products, is 

false or misleading in any way, the 

Administrator may direct that such use 

be withdrawn unless the labeling or 

container is modified in such a manner 

as the Administrator may prescribe so 

that it will not be false or misleading, or 

the formulation of the product is altered 

in such a manner as the Administrator 

may prescribe so that it is not 

adulterated or would not cause 

misbranding. 

(2) If the Administrator directs that 

the use of any label, container, or 

packaging material be withdrawn 

because it contains any statement that is 

false or misleading, an opportunity for 

a hearing will be provided in 

accordance with § 500.8(c) of this 

chapter. 

§ 590.412 [Redesignated as § 590.413] 

■ 43. Redesignate § 590.412 as 

§ 590.413. 

■ 44. Add a new § 590.412 to read as 

follows: 

§ 590.412 Approval of generic labels. 

(a) All official plants, including 

official plants certified under a foreign 

inspection system in accordance with 

§ 590.910, must comply with the 


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requirements in 9 CFR 412.2, except as 

otherwise provided in this part. 

(b) For the purposes of 9 CFR 412.2, 

an official establishment or 

establishment certified under a foreign 

inspection system includes an official 

plant. 

■ 45. Revise newly redesignated 

§ 590.413 to read as follows: 

§ 590.413 Form of official identification 

symbol and inspection mark. 

(a) The shield set forth in Figure 1 of 

this section containing the letters 

‘‘USDA’’ must be the official 

identification symbol used in 

connection with egg products to denote 

that the official plant receives official 

inspection service. The inspection mark 

used on containers of edible egg 

products is set forth in Figure 1 of this 

section, except that the plant number 

may be preceded by the letter ‘‘G’’ in 

lieu of the word plant. The plant 

number may also be omitted from the 

official mark if applied on the 

container’s principal display panel or 

other prominent location and preceded 

by the letter ‘‘G.’’ 

(b) [Reserved] 

■ 46. Revise § 590.415 to read as 

follows: 

§ 590.415 Use of other official 

identification. 

All unpasteurized egg products 

shipped from an official plant must be 

marked with the identification set forth 

in Figure 2 of this section. Such product 

must meet all requirements for egg 

products that are permitted to bear the 

official inspection mark shown in 

§ 590.413, except for pasteurization, 

heat treatment, or other method of 

treatment sufficient to reduce 

Salmonella. Such product must not be 

released into consumer channels until it 

has been subjected to pasteurization, 

heat treatment, or other method of 

treatment sufficient to reduce 

Salmonella. After pasteurization or 

treatment, the product may bear the 

official inspection mark as shown in 

§ 590.413. 


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6354 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Proposed Rules 

§ 590.418 [Amended] 

■ 47. Amend § 590.418 by removing 

paragraphs (a) and (c) and redesignate 

paragraph (b) as an undesignated 

paragraph. 

■ 48. Revise § 590.420(a) and (b) to read 

as follows: 

§ 590.420 Inspection. 

(a) Inspection shall be made, pursuant 

to the regulations in this part, of the 

processing of egg products in each 

official plant processing egg products 

for commerce, unless exempted under 

§ 590.100. Inspections, certifications, or 

specification-type gradings, and other 

inspections which may be requested by 

the official plant and are in addition to 

the normal inspection requirements and 

functions for the processing, 

production, or certification for a 

wholesome egg product under this part, 

shall be made pursuant to the voluntary 

egg products inspection regulations 

(part 592 of this chapter). 

(b) Any food manufacturing 

establishment or institution which uses 

any eggs that do not meet the 

requirements of 21 U.S.C. 1044(a)(1) in 

the preparation of any articles for 

human food shall be deemed to be a 

plant processing egg products requiring 

inspection under the regulations in this 

part. 

* * * * * 

§ 590.422 [Amended] 

■ 49. Amend § 590.422 by removing the 

last sentence of the section. 

■ 50. Amend § 590.430 by revising 

paragraph (b) to read as follows: 

§ 590.430 Limitation on entry of material. 

* * * * * 

(b) Inedible egg products may be 

brought into an official plant for storage, 

processing, and reshipment provided it 

is handled in such a manner that 

adequate segregation and inventory 

controls are maintained at all times. The 

processing of inedible egg products 

must be done under conditions that will 

not affect the processing of edible 

products, such as processing in separate 

areas or at times when no edible 

products are being processed. If the 

same equipment or areas are used to 

process both inedible and edible eggs, 

then the equipment and processing 

areas used to process inedible eggs must 

be thoroughly cleaned and sanitized 

prior to processing any edible egg 

products. 

■ 51. Revise § 590.435 to read as 

follows: 

§ 590.435 Use of food ingredients and 

approval of materials. 

(a)(1) No substance may be used in 

the processing of egg products, for any 

purpose, unless its use is authorized 

under 21 CFR as a direct food additive 

(part 172), a secondary direct food 

additive (part 173), an indirect food 

additive (parts 174–178), a source of 

radiation (part 179), an interim-listed 

direct food additive (part 180), a priorsanctioned substance (part 181), a 

Generally Recognized As Safe (GRAS) 

substance (parts 182 or 184), or by 21 

CFR 160.185, or by regulation in this 

chapter. Substances and ingredients 

used in the processing of egg products 

capable of use as human food must be 

clean, wholesome, and unadulterated. 

(2) No substance which is intended to 

impart color in any egg product may be 

used unless such use is authorized 

under 21 CFR as a color additive (parts 

73, 74, or 81) or by regulation in this 

chapter. 

(b) Substances permitted for use in 

egg products under 21 CFR will be 

permitted for such use under this 

chapter, subject to declaration 

requirements in 9 CFR 424.22(c) and 9 

CFR 590.411, unless precluded from 

such use or further restricted in this 

chapter. Such substances must be safe 

and effective under conditions of use 

and not result in the adulteration of 

product. The Administrator may 

require, in addition to listing the 

ingredients, a declaration of the additive 

and the purpose of its use. 

(c) Chemical additives to be used in 

the processing of egg products must be 

safe under the conditions of their 

intended use and in amounts sufficient 

to accomplish their intended purpose. 

Chemical additives may not promote 

deception or cause the product to be 

otherwise adulterated or unwholesome. 

Scientific data showing the additive 

meets the above specified criteria must 

be maintained and made available to 

FSIS program employees. 

■ 52. Revise § 590.440(c) to read as 

follows: 

§ 590.440 Processing ova. 

* * * * * 

(c) All products containing ova must 

be labeled in accordance with § 590.411. 

§ § 590.500 and 590.502 [Removed] 

■ 53. Remove §§ 590.500 and 590.502. 

■ 54. Revise § 590.504 to read as 

follows: 

§ 590.504 General operating procedures. 

(a) Operations involving the 

processing, storing, and handling of 

eggs, ingredients, and egg products must 

be strictly in accordance with clean and 

sanitary methods and must be 

conducted as rapidly as practicable. 

(b)(1) Egg products are subject to 

inspection in each official plant 

processing egg products for commerce. 

(2) Any egg products not processed in 

accordance with the regulations in this 

part or part 591 or that are not otherwise 

fit for human food will be removed and 

segregated. 

(c)(1) All loss and inedible eggs or 

inedible egg products must be placed in 

a container clearly labeled ‘‘inedible’’ 

and containing a sufficient amount of 

denaturant or decharacterant, such as an 

acceptable FD&C color additive, 

suspended in the product. Eggs must be 

crushed and the substance dispersed 

through the product in amounts 

sufficient to give the product a 

distinctive appearance or odor. Inedible 

product may be held in containers 

clearly labeled ‘‘inedible’’ which do not 

contain a denaturant as long as such 

inedible product is properly packaged, 

labeled and segregated, and inventory 

controls are maintained. Such inedible 

product must be denatured or 

decharacterized before being shipped 

from a facility. 

(2) Denatured or decharacterized 

inedible egg products may be shipped 

from an official plant for industrial use 

or animal food, provided that it is 

properly packaged, labeled, and 

segregated, and inventory controls are 

maintained. 

(d)(1) Egg products must be processed 

to meet the standard set out in 

§ 590.570. 

(2) Unpasteurized egg products may 

be shipped from an official plant to 

another official plant only when they 

are to be pasteurized, heat treated, or 

treated using other methods of treatment 

sufficient to reduce Salmonella in the 

second official plant. Shipments of 

unpasteurized egg products shipped 

from one official plant to another for 

pasteurization or treatment must be 

sealed in cars or trucks and labeled in 

accordance with § 590.410(c). 

Containers of unpasteurized egg product 

must be marked with the identification 

mark shown in Figure 2 of § 590.415. 

(e) When inspection program 

personnel do not suspect 

noncompliance by an official plant with 

any provisions of this part, they may 

permit that plant to move egg products 

that have been sampled and analyzed 

for Salmonella, or any other reason, 

before receiving the test results so long 

as the plant maintains control of the 

products represented by the sample 

pending test results. 

§ 590.506 [Removed] 

■ 55. Remove § 590.506. 

■ 56. Revise § 590.508 to read as 

follows: 


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§ 590.508 Candling and transfer-room 

operations. 

Eggs must be handled in a manner 

that minimizes sweating prior to 

breaking or processing. 

■ 57. Amend § 590.510 by revising 

paragraphs (a) introductory text, (c)(1) 

and (3), and (d) introductory text to read 

as follows: 

§ 590.510 Classifications of eggs used in 

the processing of egg products. 

(a) The eggs must be sorted and 

classified into the following categories: 

* * * * * 

(c)(1) When presented for breaking, 

eggs must have an edible interior quality 

and the shell must be sound and free of 

adhering dirt and foreign material. 

However, checks and eggs with a 

portion of the shell missing may be used 

when the shell is free of adhering dirt 

and foreign material and the shell 

membranes are not ruptured. 

* * * * * 

(3) Eggs with meat or blood spots may 

be used if the spots are removed. 

(d) All loss or inedible eggs must be 

placed in a designated container and 

handled as required in § 590.504(c). 

Eggs extensively damaged during 

breaking, whether not completely 

cracked open mechanically or in the 

movement of trays of eligible eggs for 

hand breaking, must be broken 

promptly. For the purpose of this 

section and § 590.522, inedible and loss 

eggs include crusted yolks, filthy and 

decomposed eggs, and the following: 

* * * * * 

■ 58. Amend § 590.516 by revising the 

section heading and paragraph (a) to 

read as follows: 

§ 590.516 Cleaning of eggs prior to 

packaging, breaking, or pasteurizing. 

(a) All eggs, except as provided in 

§ 590.801, must be clean prior to 

packaging, breaking, or pasteurizing. If a 

sanitizer is used, it must be used in 

accordance with FDA requirements for 

the intended use. 

* * * * * 

§ 590.520 [Removed] 

■ 59. Remove § 590.520. 

■ 60. Revise § 590.522 to read as 

follows: 

§ 590.522 Egg products processing room 

operations. 

Eggs used in processed egg products 

must be broken in a sanitary manner 

and examined to ensure that the 

contents are acceptable for human 

consumption. 

§ § 590.530 and 590.532 [Removed] 

■ 61. Remove §§ 590.530 and 590.532. 

■ 62. Revise § 590.534 to read as 

follows: 

§ 590.534 Freezing facilities. 

Freezing rooms, either on or off the 

premises, must be capable of solidly 

freezing, or reducing to a temperature of 

10 °F or lower, all liquid egg products. 

§ § 590.536, 590.538 through 590.540, 

590.542, 590.544, 590.546 through 590.550, 

590.552 and 590.560 [Removed] 

■ 63. Remove §§ 590.536, 590.538 

through 590.540, 590.542, 590.544, 

590.546 through 590.550, 590.552 and 

590.560. 

■ 64. Revise § 590.570 to read as 

follows: 

§ 590.570 Control of pathogens in egg 

products. 

Egg products must be produced to be 

edible without additional preparation to 

achieve food safety and may receive 

additional preparation for palatability or 

aesthetic, epicurean, gastronomic, or 

culinary purposes. Egg products are not 

required to bear a safe-handling 

instruction or other labeling that directs 

that the product must be cooked or 

otherwise treated for safety. 

§ 590.575 [Removed] 

■ 65. Remove § 590.575. 

■ 66. Revise § 590.580 to read as 

follows: 

§ 590.580 Pathogen reduction standards 

testing. 

(a) Official plants must test to 

determine that the production of egg 

products is in compliance with the Act 

and the egg products inspection 

regulations. 

(b) To ensure adequate pasteurization: 

(1) Pasteurized liquid, frozen, and 

dried egg products, and heat treated 

dried egg whites must be sampled and 

analyzed for the presence of Salmonella 

spp. Such testing must be performed in 

a manner sufficient such that it is 

possible for the official plant to verify 

that the system is capable of eliminating 

Salmonella spp. at the time that the 

annual reassessment occurs, and as 

regularly as necessary between annual 

reassessments, to show that the system, 

when tested, is working. 

(2) Samples must be analyzed for the 

presence of Salmonella spp. with such 

sequence, with such frequency, and 

using such laboratory methods as is 

sufficient to ensure that product is not 

adulterated. 

(3) Samples must be drawn from the 

final packaged form. 

(c) Results of all partial and 

completed analyses performed under 

paragraph (b) of this section must be 

provided to inspection program 

personnel promptly upon receipt by the 

official plant. Positive test results must 

be provided to inspection program 

personnel immediately upon receipt by 

the official plant. 

■ 67. Add § 590.590 to read as follows: 

§ 590.590 Use of irradiated shell eggs to 

produce egg products. 

Irradiated shell eggs used to produce 

pasteurized egg products must be used 

in conjunction with heat or another 

lethality treatment to produce a readyto-eat product. Unless otherwise 

approved by FDA, the irradiation 

treatment of the shell eggs must precede 

the heat or other lethality treatment 

applied to the egg products. 

§ § 590.600 through 590.680 [Removed] 

■ 68. Remove the undesignated center 

heading ‘‘Exempted Egg Products 

Plants’’ and §§ 590.600 through 590.680. 

■ 69. Add an undesignated center 

heading and § 590.700 to read as 

follows: 

Inspection and Disposition of Restricted 

Eggs 

§ 590.700 Prohibition on disposition of 

restricted eggs. 

(a) No person may buy, sell, or 

transport, or offer to buy or sell, or offer 

or receive for transportation in any 

business in commerce any restricted 

eggs capable of use as human food, 

except as authorized in §§ 590.100 and 

590.720. 

(b) No egg handler may possess with 

the intent to use, or use, any restricted 

eggs in the preparation of human food, 

except as provided in §§ 590.100 and 

590.720. 

■ 70. Add § 590.720 to read as follows: 

§ 590.720 Disposition of restricted eggs. 

(a) Except as exempted in § 590.100, 

eggs classified as checks, dirts, 

incubator rejects, inedibles, leakers, or 

loss must be disposed of by one of the 

following methods at the point and time 

of segregation: 

(1) Checks and dirts must be labeled 

in accordance with § 590.800 and 

shipped to an official plant for 

segregation and processing. Inedible and 

loss eggs must not be intermingled in 

the same container with checks and 

dirts. 

(2) By destruction in a manner that 

clearly identifies the products as being 

inedible and not for human 

consumption, such as crushing and 

denaturing or decharacterizing in 

accordance with § 590.504(c). The 

products must also be identified as 

‘‘Inedible Egg Product—Not To Be Used 

As Human Food.’’ 

(3) Processing for industrial use or for 

animal food. Such products must be 


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denatured or decharacterized in 

accordance with § 590.504(c) and 

identified as provided in §§ 590.840 and 

590.860, or properly handled in a 

manner that clearly identifies the 

products as being inedible and not for 

human consumption and does not 

adulterate egg product intended for 

human consumption. Notwithstanding 

the foregoing, product which was 

produced under official supervision and 

transported for industrial use or animal 

food need not be denatured or 

decharacterized if it is shipped under 

Government seal and received by a 

program employee as defined in this 

part. 

(4) By coloring the shells of loss and 

inedible eggs with a sufficient amount 

of FD&C color to give a distinct 

appearance, or applying a substance that 

will penetrate the shell and 

decharacterize the contents of the egg. 

However, lots of eggs containing 

significant percentages of eggs having 

small to medium blood spots or meat 

spots, but no other types of loss or 

inedible eggs, may be shipped directly 

to official plants, provided they are 

conspicuously labeled with the name 

and address of the shipper and the 

wording ‘‘Spots—For Processing Only 

In Official Egg Products Plants.’’ 

(5) Incubator rejects must be broken or 

crushed and denatured or 

decharacterized in accordance with 

§ 590.504(c) and labeled as required in 

§§ 590.840 and 590.860. 

(b) Eggs that are packed for the 

ultimate consumer and have been found 

to exceed the tolerance for restricted 

eggs permitted in the official standards 

for U.S. Consumer Grade B but have not 

been shipped for retail sale must be 

identified as required in §§ 590.800 and 

590.860 and must be shipped directly or 

indirectly: 

(1) To an official plant for proper 

segregation and processing; or 

(2) Be re-graded so that they comply 

with the official standards; or 

(3) Used as other than human food. 

(c) Records must be maintained as 

provided in § 590.200 to ensure proper 

disposition. 

■ 71. Add § 590.801 to read as follows: 

§ 590.801 Nest-run or washed ungraded 

eggs. 

Nest-run or washed ungraded eggs are 

exempt from the labeling provisions in 

§ 590.800. However, when such eggs are 

sold to consumers, they may not exceed 

the tolerance for restricted eggs for U.S. 

Consumer Grade B shell eggs. 

§ § 590.900 through 590.970 [Removed] 

■ 72. Remove undesignated center 

heading ‘‘Imports’’ and §§ 590.900 

through 590.970. 

■ 73. Add subpart B, consisting of 

§§ 590.900 through 590.965, to read as 

follows: 

Subpart B—Imports 

Sec. 

590.900 Definitions; requirements for 

importation into the United States. 

590.901 Egg products offered for entry and 

entered to be handled and transported as 

domestic; entry into official plants; 

transportation. 

590.905 Importation of restricted eggs. 

590.910 Eligibility of foreign countries for 

importation of eggs and egg products 

into the United States. 

590.915 Imported products; foreign 

inspection certificates required. 

590.920 Import inspection application. 

590.925 Inspection of eggs and egg products 

offered for entry. 

590.930 Eggs and egg products offered for 

entry, retention in customs custody; 

delivery under bond; movement prior to 

inspection; handling; equipment and 

assistance. 

590.935 Means of conveyance and 

equipment used in handling egg 

products offered for entry to be 

maintained in sanitary condition. 

590.940 Identification of egg products 

offered for entry; official import 

inspection marks and devices. 

590.945 Eggs and egg products offered for 

entry; reporting of findings to customs; 

handling of articles refused entry; 

appeals, how made; denaturing 

procedures. 

590.950 Labeling of immediate containers 

of egg products offered for entry. 

590.955 Labeling of shipping containers of 

egg products offered for entry. 

590.956 Relabeling of imported egg 

products. 

590.960 Small importations for importer’s 

personal use, display, or laboratory 

analysis. 

590.965 Returned to the United States 

inspected and identified covered 

products; exemption. 

Subpart B—Imports 

§ 590.900 Definitions; requirements for 

importation into the United States. 

(a) When used in this subpart, the 

following terms will be construed to 

mean: 

(1) Import (Imported). To bring within 

the territorial limits of the United States, 

whether that arrival is accomplished by 

land, air, or water. 

(2) Offer(ed) for entry. The point at 

which the importer presents the 

imported product for reinspection. 

(3) Entry (entered) means the point at 

which imported product offered for 

entry receives reinspection and is 

marked with the official mark of 

inspection, as required by § 590.940. 

(4) Official Import Inspection 

Establishment. This term means any 

establishment, other than an official 

establishment as defined in 9 CFR 

301.2, where inspections are authorized 

to be conducted as prescribed in 

§ 590.925 of this subchapter. 

(b) No egg products may be imported 

into the United States unless they are 

healthful, wholesome, fit for human 

food, not adulterated, and contain no 

dye, chemical, preservative, or 

ingredient which renders them 

unhealthful, unwholesome, 

unadulterated, or unfit for human food. 

Such products must also comply with 

the regulations prescribed in this 

subpart to ensure that they adhere to the 

standards provided for in the Act. The 

provisions of this subpart will apply to 

these products only if they are capable 

for use as human food. 

(c) Approval for Federal import 

inspection must be in accordance with 

§§ 590.140 through 590.149. 

(d) Egg products may be imported 

only if they are processed solely in the 

countries listed in § 590.910(b). 

§ 590.901 Egg products offered for entry 

and entered to be handled and transported 

as domestic; entry into official plants; 

transportation. 

(a) All egg products, after entry into 

the United States in compliance with 

this subpart, will be deemed and treated 

and, except as provided in §§ 590.935 

and 590.960, will be handled and 

transported as domestic product, and 

will be subject to the applicable 

provisions of this part and to the 

provisions of the Egg Products 

Inspection Act and the Federal Food, 

Drug, and Cosmetic Act. 

(b) Imported egg products entered in 

accordance with this subpart may, 

subject to the provisions of the 

regulations, be taken into official plants 

and be mixed with or added to egg 

products that are inspected and passed 

or exempted from inspection in such 

plants. 

(c) Imported egg products that have 

been inspected and passed under this 

subpart may be transported in 

commerce only upon compliance with 

the applicable regulations. 

§ 590.905 Importation of restricted eggs. 

(a) No containers of restricted eggs 

other than checks or dirties will be 

imported into the United States. The 

shipping containers of such eggs shall 

be identified with the name, address, 

and country of origin of the exporter, 

and the date of pack and the quality of 

the eggs (e.g., checks of dirties) 

preceded by the word ‘‘Imported’’ or the 

statement ‘‘Imported Restricted Eggs-For 

Processing Only In An Official USDA 

Plant,’’ or ‘‘Restricted Eggs—Not To Be 

Used As Human Food.’’ Such 

identification shall be legible and 

conspicuous. 


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(b) For properly sealed and certified 

shipments of shell eggs for breaking at 

an official egg products plant, the 

containers need not be labeled, 

provided that the shipment is segregated 

and controlled upon arrival at the 

destination breaking plant. 

§ 590.910 Eligibility of foreign countries 

for importation of eggs and egg products 

into the United States. 

(a)(1) Whenever it is determined by 

the Administrator that the system of egg 

products inspection maintained by any 

foreign country, with respect to plants 

preparing products in such country for 

export to the United States, insures 

compliance of such plants and their 

products with requirements equivalent 

to all the inspection, building 

construction standards, and all other 

provisions of the Act and the 

regulations in this part which are 

applied to official plants in the United 

States, and their products, and that 

reliance can be placed upon certificates 

required under this part from authorities 

of such foreign country, notice of that 

fact will be given by including the name 

of such foreign country in paragraph (b) 

of this section. Thereafter, products 

prepared in such plants which are 

certified and approved in accordance 

with paragraph (a)(3) of this section, 

will be eligible so far as this part is 

concerned for importation into the 

United States from such foreign country 

after applicable requirements of this 

part have been met. 

(2) The determination of acceptability 

of a foreign egg products inspection 

system for purposes of this section must 

be based on an evaluation of the foreign 

program in accordance with the 

following requirements and procedures: 

(i) The system must have a program 

organized and administered by the 

national government of the foreign 

country. The system as implemented 

must provide standards equivalent to 

those of the Federal system of egg 

products inspection in the United States 

with respect to: 

(A) Organizational structure and 

staffing, so as to insure uniform 

enforcement of the requisite laws and 

regulations in all plants throughout the 

system at which products are prepared 

for export to the United States; 

(B) Ultimate control and supervision 

by the national government over the 

official activities of all employees or 

licensees of the system; 

(C) The assignment of competent, 

qualified inspectors; 

(D) Authority and responsibility of 

national inspection officials to enforce 

the requisite laws and regulations 

governing egg products inspection and 

to certify or refuse to certify products 

intended for export; 

(E) Adequate administrative and 

technical support; 

(F) The inspection and residue 

standards applied to egg products 

produced in the United States. 

(G) Other requirements of adequate 

inspection service as required by the 

regulations in this part. 

(ii) The legal authority for the system 

and the regulations thereunder must 

impose requirements equivalent to those 

governing the system of egg products 

inspection organized and maintained in 

the United States with respect to: 

(A) Official controls by the national 

government over plant construction, 

building and facilities, and equipment; 

(B) Official supervision of the 

processing of egg products in plants by 

the assignment of inspectors to plants 

certified under paragraph (a)(2)(iv) of 

this section to ensure that adulterated or 

misbranded product is not prepared for 

export to the United States; 

(C) Any product that is prepared 

under inspection in a plant must be 

inspected in such a plant as often as the 

inspector deems necessary in order to 

ascertain if the product is 

unadulterated, wholesome, properly 

labeled, and fit for human food at the 

time it leaves the plant. Upon any such 

inspection, if any product or portion 

thereof is found to be adulterated, 

unwholesome, or otherwise unfit for 

human food, such product or portion 

thereof must be condemned and must 

receive such treatment as provided in 

§ 590.504(c); 

(D) Complete separation of plants 

certified under paragraph (a)(2)(iv) of 

this section from plants not certified, 

and the maintenance of a single 

standard of inspection and sanitation 

throughout all certified plants; 

(E) Requirements for sanitation at 

certified plants and for sanitary 

handling of egg products; 

(F) Official controls over condemned 

material until destroyed or removed and 

thereafter excluded from the plant; 

(G) A Hazard Analysis and Critical 

Control Point (HACCP) system, as set 

forth in part 417 of this chapter; and 

(H) Other matters for which 

requirements are contained in the Act or 

regulations in this part. 

(iii) Countries desiring to establish 

eligibility for the importation of egg 

products into the United States may 

request a determination of eligibility by 

presenting copies of the laws and 

regulations on which the foreign egg 

products inspection system is based and 

such other information as the 

Administrator may require with respect 

to matters enumerated in paragraphs 

(a)(2)(i) and (ii) of this section. 

Determination of eligibility is based on 

a study of the documents and other 

information presented and an initial 

review of the system in operation by a 

representative of the Department using 

the criteria listed in paragraphs (a)(2)(i) 

and (ii) of this section. Maintenance of 

eligibility of a country for importation of 

egg products into the United States 

depends on the results of periodic 

reviews of the foreign egg products 

inspection system in operation by a 

representative of the Department, and 

the timely submission of such 

documents and other information 

related to the conduct of the foreign 

inspection system, including 

information required by paragraph (e) of 

section 20 of the Act, as the 

Administrator may find pertinent to and 

necessary for the determinations 

required by this section of the 

regulations. 

(iv) The foreign inspection system 

must maintain a program to assure that 

the requirements referred to in this 

section, equivalent to those of the 

Federal system of egg products 

inspection in the United States, are 

being met. The program as implemented 

must provide for the following: 

(A) Periodic supervisory visits by a 

representative of the foreign inspection 

system to each plant certified in 

accordance with paragraph (a)(3) of this 

section to ensure that requirements 

referred to in paragraphs (a)(2)(ii)(A) 

through (H) of this section are being 

met: Provided, that such visits are not 

required with respect to any plant 

during a period when the plant is not 

operating or is not engaged in producing 

products for exportation to the United 

States; 

(B) Written reports prepared by the 

representative of the foreign inspection 

system who has conducted a 

supervisory visit, documenting his or 

her findings with respect to the 

requirements referred to in paragraphs 

(a)(2)(ii)(A) through (H) of this section, 

copies of which must be made available 

to the representative of the Department 

at the time of that representative’s 

review upon request by that 

representative to a responsible foreign 

meat inspection official: Provided, that 

such reports are not required with 

respect to any plant during a period 

when the plant is not operating or is not 

engaged in producing products for 

exportation to the United States; and 

(C) Random sampling and testing at 

the point of production, for residues 

identified by the exporting country’s 

inspection authorities or by this Agency 

as potential contaminants, in 

accordance with sampling and 


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analytical techniques approved by the 

Administrator, provided that such 

testing is required only on samples 

taken of egg products intended for 

importation into the United States. 

(3) Only those plants that are 

determined and certified to the Agency 

by a responsible official of the foreign 

egg products inspection system as fully 

meeting the requirements of paragraphs 

(a)(2)(i) and (ii) of this section are 

eligible to have their products imported 

into the United States. Plant eligibility 

is subject to review by the Agency 

(including observations of the plants by 

official program personnel 

representatives at times prearranged 

with the foreign egg products inspection 

system officials). Foreign plants 

certifications must be renewed 

annually. Notwithstanding certification 

by a foreign official, the Administrator 

may terminate the eligibility of any 

foreign plant for the importation of its 

products into the United States if it does 

not comply with the requirements listed 

in paragraphs (a)(2)(i) and (ii) of this 

section, or if current plant information 

cannot be obtained. The Administrator 

will provide reasonable notice to the 

foreign government of the proposed 

termination of any foreign plant, unless 

a delay in terminating its eligibility 

could result in the importation of 

adulterated or misbranded product. 

(i) For a new plant, or any plant for 

which information from last year’s 

electronic certification or paper 

certificate has changed, the certification 

or certificate must contain: The date; the 

foreign country; the foreign plant’s 

name, address, and foreign plant 

number; the foreign official’s title and 

signature (for paper certificates only); 

the type of operations conducted at the 

plant (e.g., processing, storage, 

exporting warehouse); and the plant’s 

eligibility status (e.g., new or relisted (if 

previously delisted)). Processing plant 

certifications must address the type of 

products produced at the plant (e.g., the 

process category). 

(ii) If the plant information provided 

on the preceding year’s electronic 

foreign plant certification or paper 

certificate, as required in paragraph 

(a)(3)(i) of this section, has not changed, 

the certification or certificate must 

contain: The date, the foreign country, 

the foreign plant’s name, and the foreign 

official’s title and signature (for paper 

certificates only). 

(4) Egg products from foreign 

countries not listed in paragraph (b) of 

this section are not eligible for 

importation into the United States, 

except as provided by §§ 590.960 and 

590.965. The listing of any foreign 

country under this section may be 

withdrawn whenever it is determined 

by the Administrator that the system of 

egg products inspection maintained by 

such foreign country does not assure 

compliance with requirements 

equivalent to all the inspection, 

building construction standards, and 

other requirements of the Act and the 

regulations in this part as applied to 

official plants in the United States; or 

that reliance cannot be placed upon 

certificates required under this part 

from authorities of such foreign country; 

or that, for lack of current information 

concerning the system of egg products 

inspection being maintained by such 

foreign country, such foreign country 

should be required to reestablish its 

eligibility for listing. 

(b) It has been determined that egg 

products from the following countries 

covered by foreign egg products 

inspection certificates of the country of 

origin as required by § 590.915 are 

eligible under the regulations in this 

part for entry into the United States after 

inspection and marking as required by 

the applicable provisions of this part: 

Canada, The Netherlands. 

§ 590.915 Imported products; foreign 

inspection certificates required. 

(a) Except as provided in § 590.960, 

each consignment imported into the 

United States must have an electronic 

foreign inspection certification or a 

paper foreign inspection certificate 

issued by an official of the foreign 

government agency responsible for the 

inspection and certification of the 

product. 

(b) An official of the foreign 

government agency must certify that any 

product described on any official 

certificate was produced in accordance 

with the regulatory requirements of 

§ 590.910. 

(c) The electronic foreign inspection 

certification must be in English, be 

transmitted directly to FSIS before the 

product’s arrival at the official import 

inspection establishment, and be 

available to import inspection 

personnel. 

(d) The paper foreign inspection 

certificate must accompany each 

consignment; be submitted to import 

inspection personnel at the official 

import inspection establishment; be in 

English; and bear the official seal of the 

foreign government responsible for the 

inspection of the product, and the name, 

title, and signature of the official 

authorized to issue the inspection 

certificates for products imported into 

the United States. 

(e) The electronic foreign inspection 

certification and paper foreign 

inspection certificate must contain: 

(1) The date; 

(2) The foreign country of export and 

the producing foreign establishment 

number; 

(3) The species used to produce the 

product and the source country and 

foreign establishment number, if the 

source materials originate from a 

country other than the exporting 

country; 

(4) The product’s description 

including the process category, the 

product category, and the product 

group; 

(5) The name and address of the 

importer or consignee; 

(6) The name and address of the 

exporter or consignor; 

(7) The number of units (pieces or 

containers) and the shipping or 

identification mark on the units; 

(8) The net weight of each lot; and 

(9) Any additional information the 

Administrator requests to determine 

whether the product is eligible to be 

imported into the United States. 

§ 590.920 Import inspection application. 

(a) Applicants must submit an import 

inspection application to apply for the 

inspection of any product offered for 

entry. Applicants may apply for 

inspection using a paper or electronic 

application form. 

(b) Import inspection applications for 

each consignment must be submitted 

(electronically or on paper) to FSIS in 

advance of the shipment’s arrival at the 

official import establishment where the 

product will be reinspected, but no later 

than when the entry is filed with U.S. 

Customs and Border Protection. 

(c) The provisions of this section do 

not apply to products that are exempted 

from inspection by §§ 590.960 and 

590.965. 

§ 590.925 Inspection of eggs and egg 

products offered for entry. 

(a)(1) Except as provided in 

§§ 590.960 and 590.965 and paragraph 

(b) of this section, egg products offered 

for entry from any foreign country must 

be reinspected at an official import 

inspection establishment or official 

plant by a program inspector before they 

may be allowed entry into the United 

States. 

(2) Every lot of product must 

routinely be given visual reinspection 

by a program inspector for appearance 

and condition and be checked for 

certification and label compliance as 

provided in §§ 590.915, 590.950, and 

590.955. 

(3) Program inspectors must consult 

the electronic inspection system for 

reinspection instructions. The electronic 

inspection system will assign 


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1The number ‘‘I–38’’ is given as an example only. 

The plant number of the official plant, facility, or 

official import inspection establishment where the 

product was inspected must be shown on each 

stamp impression. 

reinspection levels and procedures 

based on established sampling plans 

and established product and plant 

history. 

(b) Official program personnel may 

take, without cost to the United States, 

from each consignment of egg product 

offered for entry, such samples of the 

products as are deemed necessary to 

determine the eligibility of the products 

for entry into the commerce of the 

United States. 

§ 590.930 Eggs and egg products offered 

for entry, retention in customs custody; 

delivery under bond; movement prior to 

inspection; handling; equipment and 

assistance. 

(a) No egg products required by this 

subpart to be inspected will be released 

from customs custody prior to required 

inspections, but such product may be 

delivered to the importer, or his agent, 

prior to inspection, if the importer 

furnishes a bond, in a form prescribed 

by the Secretary of the Treasury, on the 

condition that the product must be 

returned, if demanded, to the collector 

of the port where the product was 

offered for clearance through customs. 

(b) Notwithstanding paragraph (a) of 

this section, no product required by this 

subpart to be inspected will be moved 

prior to inspection from the port of 

arrival where first unloaded, and if 

arriving by water from the wharf where 

first unloaded at such port, to any place 

other than the place designated in 

accordance with this part as the place 

where the product must be inspected; 

and no product will be conveyed in any 

manner other than in compliance with 

this subpart. 

(c) The importer, or his agent, must 

furnish such equipment and must 

provide such assistance for handling 

and inspecting, where applicable, egg 

products offered for entry as the 

program inspector may require. 

(d) Official import inspection 

establishments must provide buildings 

and equipment that meet the sanitation 

requirements contained in 9 CFR part 

416. 

§ 590.935 Means of conveyance and 

equipment used in handling egg products 

offered for entry to be maintained in 

sanitary condition. 

(a) Compartments of steamships, 

railroad cars, and other means of 

conveyance transporting any egg 

products to the United States, and all 

chutes, platforms, racks, tables, tools, 

utensils, and all other devices used in 

moving and handling any egg products 

offered for entry into the United States, 

must be maintained in accordance with 

9 CFR 416.4. 

(b) All conveyances containing 

imported liquid egg products must be 

sealed by inspection authorities in the 

exporting country. Seals may be broken 

at U.S. port-of-entry for purposes of 

inspection by official program personnel 

or customs officers. 

§ 590.940 Identification of egg products 

offered for entry; official import inspection 

marks and devices. 

(a) Except for products offered for 

entry from Canada, egg products that 

upon reinspection are found to be 

acceptable for entry into the United 

States must be identified as ‘‘U.S. 

Inspected and Passed’’ product. The 

official inspection legend shown in 

paragraph (b) of this section will 

identify product only after completion 

of official import inspection and 

product acceptance. 

(b) The official mark for identifying 

egg products offered for entry as ‘‘U.S. 

Inspected and Passed’’ must be in the 

following form, and any device 

approved by the Administrator for 

applying such mark must be an official 

device.1

(c) Owners or operators of plants, 

other than official plants, who want to 

have import inspections made at their 

plants, must apply to the Administrator 

for approval of their establishments for 

such purpose. Application must be 

made on a form furnished by the 

Program, Food Safety and Inspection 

Service, U.S. Department of Agriculture, 

Washington, DC, and must include all 

information called for by that form. 

(d) No brand manufacturer or other 

person will cast or otherwise make, 

without an official certificate issued by 

official program personnel, a brand or 

other marking device containing an 

official inspection legend, or simulation 

thereof, as shown in § 590.940(b). 

(e) The inspection legend may be 

placed on containers of product before 

completion of the official import 

inspection if the containers are being 

inspected by an import inspector who 

reports directly to a program supervisor, 

the product is not required to be held 

at the official import inspection 

establishment pending receipt of 

laboratory test results, and a written 

procedure for the controlled stamping, 

submitted by the official import 

inspection establishment and approved 

by the Food Safety and Inspection 

Service, is on file at the import 

inspection location where the 

inspection is to be performed. 

(f)(1) The written procedure for the 

controlled release and identification of 

product should be in the form of a letter 

and must include the following: 

(i) That stamping under this subpart 

is limited to those lots of product that 

can be inspected on the day that 

certificates for the product are 

examined; 

(ii) That all products that have been 

pre-stamped will be stored in the 

facility where the import inspection will 

occur; 

(iii) That inspection marks applied 

under this part will be removed from 

any lot of product subsequently refused 

entry on the day the product is rejected; 

and 

(iv) That the establishment will 

maintain a daily stamping log 

containing the following information for 

each lot of product: The date of 

inspection, the country of origin, the 

foreign establishment number, the 

product name, the number of units, the 

shipping container marks and foreign 

inspection certificate number covering 

the product to be inspected. The daily 

log must be retained by the 

establishment in accordance with 

§ 590.200. 

(2) An establishment’s controlled 

program privilege may be cancelled 

orally or in writing by the inspector who 

is supervising its enforcement whenever 

the inspector finds that the 

establishment has failed to comply with 

the provisions of this subpart or any 

conditions imposed pursuant thereto. If 

the cancellation is oral, the decision and 

the reasons for it must be confirmed in 

writing, as promptly as circumstances 

allow. Any person whose controlled 

pre-stamping program privilege has 

been cancelled may appeal the decision 

to the Administrator, in writing, within 

ten (10) days after receiving written 

notification of the cancellation. The 

appeal must state all of the facts and 

reasons upon which the person relies to 

show that the controlled program was 

wrongfully cancelled. The 

Administrator will grant or deny the 

appeal, in writing, stating the reasons 


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for such decision, as promptly as 

circumstances allow. If there is a 

conflict as to any material fact, a hearing 

must be held to resolve such conflict. 

Rules of practice concerning such a 

hearing will be adopted by the 

Administrator. The cancellation of the 

controlled pre-stamping privilege will 

be in effect until there is a final 

determination of the preceding. 

§ 590.945 Eggs and egg products offered 

for entry; reporting of findings to customs; 

handling of articles refused entry; appeals, 

how made; denaturing procedures. 

(a)(1) Official program personnel must 

report their findings as to any product 

that has been inspected in accordance 

with this subpart to the Director of 

Customs at the original port of entry 

where the same is offered for clearance 

through Customs inspection. 

(2) When product is refused entry into 

the United States, the official mark to be 

applied to the product refused entry 

must be in the following form: 

(3) When product has been identified 

as ‘‘U.S. Refused Entry,’’ official 

program personnel must request the 

Director of Customs to refuse admission 

of such product and to direct that it be 

exported by the owner or importer 

within the time specified in this section, 

unless the owner or importer, within the 

specified time, causes it to be destroyed 

by disposing of it under the supervision 

of official program personnel so that the 

product can no longer be used as human 

food, or by converting it to animal food 

uses, if permitted by the Food and Drug 

Administration. The owner or importer 

of the refused entry product must not 

transfer legal title to such product, 

except to a foreign importer for direct 

and immediate exportation, or to an end 

user, e.g., an animal food manufacturer 

or a renderer, for destruction for human 

food purposes. ‘‘Refused entry’’ product 

must be delivered to and used by the 

manufacturer or renderer within the 45- 

day time limit provided in paragraph 

(a)(4) of this section. Even if such title 

is illegally transferred, the subsequent 

purchaser will still be required to export 

the product or have it destroyed under 

paragraph (a)(4) of this section. 

(4) The owner or importer will have 

45 days after notice is given by FSIS to 

the Director of Customs at the original 

port of entry to take the action required 

in paragraph (a)(3) of this section for 

‘‘refused entry’’ product. An extension 

beyond the 45-day period may be 

granted by the Administrator when 

extreme circumstances warrant it, e.g., a 

dock workers’ strike or an unforeseeable 

vessel delay. 

(5) If the owner or importer fails to 

take the required action within the time 

specified under paragraph (a)(4) of this 

section, the Department will take such 

actions as may be necessary to effectuate 

its order to have the product destroyed 

for human food purposes. The 

Department will seek court costs and 

fees, storage, and proper expenses in the 

appropriate forum. 

(6) No egg product that has been 

refused entry and exported to another 

country pursuant to paragraph (a)(3) of 

this section may be returned to the 

United States under any circumstances. 

Any such product so returned to the 

United States will be subject to 

administrative detention in accordance 

with section 1048 of the Act and seizure 

and condemnation in accordance with 

section 1049 of the Act. 

(7) Egg products that have been 

refused entry solely because of 

misbranding may be brought into 

compliance with the requirements of 

this chapter under the supervision of an 

authorized representative of the 

Administrator. 

(b) Upon the request of the Director of 

Customs at the port where an egg 

product is offered for clearance through 

the customs, the importer of the product 

must, at the importer’s own expense, 

immediately return to the Director any 

product that has been delivered to the 

importer under this subpart and 

subsequently designated ‘‘U.S. Refused 

Entry’’ or found in any request not to 

comply with the requirements in this 

part. 

(c) Except as provided in § 590.930(a) 

or (b), no person will remove or cause 

to be removed from any place 

designated as the place of inspection of 

egg products that the regulations in this 

part require to be identified in any way, 

unless the same has been clearly and 

legibly identified in compliance with 

this part. 

(d) Any person receiving inspection 

services may, if dissatisfied with any 

decision of an inspector relating to any 

inspection, file an appeal from such 

decision. Any such appeal from a 

decision of an inspector must be made 

to the inspector’s immediate supervisor 

having jurisdiction over the subject 

matter of the appeal, and such 

supervisor must determine whether the 

inspector’s decision was correct. Review 

of such an appeal determination, when 

requested, must be made by the 

immediate supervisor of the Department 

employee making the appeal 

determination. The egg products 

involved in any appeal must be 

identified by U.S. retained tags and 

segregated in a manner approved by the 

inspector pending completion of an 

appeal inspection. 

(e) All loss or inedible eggs, or 

inedible egg products must be disposed 

of in accordance with § 590.504(c)(1). 

§ 590.950 Labeling of immediate 

containers of egg products offered for 

entry. 

(a) Immediate containers of product 

offered for entry into the United States 

must bear a label, printed in English, 

showing: 

(1) The name of the product; 

(2) The name of the country of origin 

of the product, and for consumer 

packaged products, preceded by the 

words ‘‘Product of,’’ which statement 

must appear immediately under the 

name of the product; 

(3) [Reserved]; 


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(4) The word ‘‘Ingredients’’ followed 

by a list of the ingredients in order of 

descending proportions by weight; 

(5) The name and place of business of 

the manufacturer, packer, or distributor, 

qualified by a phrase which reveals the 

connection that such person has with 

the product; 

(6) An accurate statement of the 

quantity; 

(7) The inspection mark of the 

country of origin; 

(8) Plant number of the plant at which 

the egg products were processed; and 

(9) The date of production and plant 

number of the plant at which the egg 

products were processed or packed. 

(b) For properly sealed and certified 

shipments of shell eggs for breaking at 

an official plant, the immediate 

containers need not be labeled, 

provided that the shipment is segregated 

and controlled upon arrival at the 

destination breaking plant. 

(c) The labels must not be false or 

misleading in any respect. 

§ 590.955 Labeling of shipping containers 

of egg products offered for entry. 

Shipping containers of imported egg 

products are required to bear in a 

prominent and legible manner the name 

of the product, the name of the country 

of origin, the foreign inspection system 

plant number of the plant in which the 

product was processed, shipping or 

identification marks, production codes, 

and the inspection mark of the country 

or origin. Labeling on shipping 

containers must be examined at the time 

of inspection in the United States and 

if found to be false or misleading, the 

product must be refused entry. 

§ 590.956 Relabeling of imported egg 

products. 

(a) Egg products eligible for 

importation may be relabeled with an 

approved label under the supervision of 

an inspector at an official plant or 

official import inspection establishment. 

The new label for such product must 

indicate the country of origin, except for 

egg products that are processed 

(repasteurized or, in the case of dried 

product, dry blended with product 

produced in the United States) in an 

official plant. 

(b) Egg products that have been 

refused entry into the United States 

solely because of misbranding may be 

brought into compliance with the 

labeling requirements of this chapter. 

(c) The label for relabeled products 

must state the name, address, and zip 

code of the distributor, qualified by an 

appropriate term such as ‘‘packed for’’, 

‘‘distributed by’’, or ‘‘distributors’’. 

§ 590.960 Small importations for 

importer’s personal use, display, or 

laboratory analysis. 

Egg products (other than those that 

are forbidden entry by other Federal law 

or regulation) from any country, that are 

exclusively for the importer’s personal 

use, display, or laboratory analysis, and 

not for sale or distribution; that are 

sound, healthful, wholesome, and fit for 

human food; and that are not 

adulterated and do not contain any 

substance not permitted by the Act or 

regulations, may be admitted into the 

United States without a foreign 

inspection certificate. Such products are 

not required to be inspected upon 

arrival in the United States and may be 

shipped to the importer without further 

restriction under this part, except as 

provided in 9 CFR 590.925(b), provided 

that the Department may, with respect 

to any specific importation, require that 

the importer certify that such product is 

exclusively for said importer’s personal 

use, display, or laboratory analysis and 

not for sale or distribution. The amount 

of liquid, frozen, or dried egg products 

imported must not exceed 50 pounds. 

§ 590.965 Returned to the United States 

inspected and identified covered products; 

exemption. 

U.S. inspected and passed and so 

marked egg products exported to and 

returned from foreign countries will be 

admitted into the United States without 

compliance with this part upon 

notification to and approval of the Food 

Safety and Inspection Service, in 

specific cases. 

SUBCHAPTER I—EGG PRODUCTS 

INSPECTION ACT 

■ 74. Add part 591 to read as follows: 

PART 591—SANITATION 

REQUIREMENTS AND HAZARD 

ANALYSIS AND CRITICIAL CONTROL 

POINT SYSTEMS 

Sec. 

591.1 Basic requirements. 

591.2 Hazard analysis and HACCP plan. 

Authority: 21 U.S.C. 1031–1056; 7 CFR 

2.18, 2.53. 

§ 591.1 Basic requirements. 

(a) All official plants must comply 

with the requirements contained in 9 

CFR parts 416, Sanitation, and 417, 

Hazard Analysis and Critical Control 

Point (HACCP) Systems, except as 

otherwise provided in this chapter. 

(b) For the purposes of 9 CFR parts 

416, Sanitation, 417, Hazard Analysis 

and Critical Control Point (HACCP) 

Systems, and 500, Rules of Practice, an 

official establishment or establishment 

includes an official plant. 

§ 591.2 Hazard analysis and HACCP plan. 

Pursuant to 21 U.S.C. 1035 and 1043, 

the failure of an official plant to develop 

and implement a HACCP plan that 

complies with 9 CFR part 417, or to 

operate in accordance with the 

requirements in this part, may render 

the products produced under those 

conditions adulterated. 

Done at Washington, DC, on: January 9, 

2018. 

Paul Kiecker, 

Acting Administrator. 

[FR Doc. 2018–00425 Filed 2–12–18; 8:45 am] 

BILLING CODE 3410–DM–P 


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