Egg Products Inspection Regulations

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FSIS is also announcing that it is seeking public comment on draft guidance designed to help small and very small plants producing egg products to meet the new regulatory requirements being proposed in this rulemaking.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FSIS invites interested persons to submit comments on this proposed rule and the draft guidance.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.

1

As 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.

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 re-use; 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

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

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).

2

See

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.

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 freeze-dried 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

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. Freeze-dried 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 science-based 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

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.

3

Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products; Final Rule (68 FR 34208, Jun. 6, 2003).

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.

4

E. coli O157:H7 Contamination of Beef Products (67 FR 62325, October 7, 2002) (available at:

http://www.fsis.usda.gov/wps/wcm/connect/ad259bcd-5b85-4696-9888-89872bee39ee/00-022N.pdf?MOD=AJPERES

).

5

Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products; Final Rule (68 FR 34214, Jun. 6, 2003).

6

FSIS. 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-Private-Microbiological-Testing-lab-062013.pdf?MOD=AJPERES

).

7

HACCP Systems Validation (80 FR 27557, May 14, 2015).

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

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/700c05fe-06a2-492a-a6e1-3357f7701f52/MLG-4.pdf?MOD=AJPERES

).

9

Isolation and Identification of Listeria Monocytogenes from Red Meat, Poultry, Ready-To-Eat 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

).

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,

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)).

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FSIS will provide additional guidance to plants on how to validate their HACCP systems.

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On 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).

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 decision-making 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)).

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.

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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.

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Under 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.

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 pre-operational 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.

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

surfaces must have at least 30 foot-candles 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 well-lighted (

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

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 non-reconditioned 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

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

• § 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), non-food-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 2

1/2

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

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/regulatory-compliance/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-log

10

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 log

10

pasteurization performance standards and is consistent with the approach used by FSIS in establishing requirements for most RTE meat and poultry products.

12

FSIS. 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

).

Meat and poultry establishments produce the vast majority of their RTE products without needing to meet FSIS-specified 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 ready-to-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

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

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.

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.

14

The 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.

15

The USDA, FSIS Pasteurized Egg Products Lab (PEPRLab) Program is a program for laboratories performing

Salmonella

analysis on official surveillance samples of pasteurized egg products.

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

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 federally-inspected 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 re-submit sketches in final label form, thereby reducing the number of labels being submitted to the Agency for approval.

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.

16

For the purposes of Part 500, Rules of Practice, an official establishment or establishment includes an official plant.

See

proposed § 591.1(b).

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.

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 “command-and-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 pre-decisional 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

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 re-inspect 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 re-entry 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

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.

17

On 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).

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 producer-packers and all other packing facilities

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 ready-to 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

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.

18

RTI 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.

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.

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.

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.

21

RTI 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.

22

RTI 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.

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

23

Ibid.

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.

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Under 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.

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 pre-operational 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.

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U.S. Department of Agriculture, Egg Products Inspectors Handbook. AMS PY-Instruction No. 910. January, 1975.

Expected Cost of the Proposed Rule

Presented here are economic analyses for the breaking of shell eggs, the production of pasteurized liquid egg

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.

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Plants may pay employees for benefits such as paid leave, health insurance, and retirement and savings, and FSIS applied a benefits factor

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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.

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Estimates 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.

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This analysis accounts for fringe benefits and overhead by multiplying wages by a factor of two.

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.

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Plants are also required to perform an annual reassessment of their HACCP plans.

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9 CFR 417.4.

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.

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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.

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29

See

Appendix A, Section 4.

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For 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).

Table 3—Processes Without Written HACCP Plans

Breaking

Liquid

Dried

Total

processes

9

12

3

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For plan development and reassessment, FSIS used the Cost of Food Safety Investments

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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).

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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.

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RTI International. Cost of Food Safety Investments Final Report. Available at:

https://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES.

Th

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