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

DEPARTMENT OF AGRICULTURE the magnitude of the proposed action accordance with the regulations in 9 and the need to provide for possible CFR parts 416 and 417, and to meet Food Safety and Inspection Service public meetings on the proposed action. proposed sanitation requirements ADDRESSES: FSIS invites interested (proposed 9 CFR part 591). The Agency 9 CFR Parts 416, 417, 500, 590 and 591 persons to submit comments on this is proposing to eliminate those [Docket No. FSIS–2005–0015] proposed rule and the draft guidance. regulations that are incompatible with Comments may be submitted by any of the regulations for HACCP and RIN 0583–AC58 the following methods: Sanitation SOPs and to convert • Federal eRulemaking Portal: This prescriptive, command-and-control Egg Products Inspection Regulations website provides the ability to type requirements to general sanitation AGENCY: Food Safety and Inspection short comments directly into the standards. Service, USDA. comment field on this web page or Existing regulations that FSIS is proposing to revise or eliminate include ACTION: Proposed rule. attach a file for lengthier comments. Go to http://www.regulations.gov. Follow those relating to egg products plant SUMMARY: The Food Safety and the on-line instructions at that site for grounds and pest management; plant Inspection Service (FSIS) is proposing submitting comments. sanitation; plant construction, including to amend the egg products inspection • Mail, including CD–ROMs, etc.: rooms, doors, and windows; lighting; regulations by requiring official plants Send to Docket Clerk, U.S. Department ventilation and odors; plumbing; sewage that process egg products (herein also of Agriculture, Food Safety and disposal; water supply and solution re- referred to as ‘‘egg products plants’’ or Inspection Service, Patriots Plaza 3, use; and dressing rooms, lavatories, and ‘‘plants’’) to develop and implement 1400 Independence Avenue SW, toilets. The Agency is proposing to Hazard Analysis and Critical Control Mailstop 3782, Room 8–163B, replace all of these with general Point (HACCP) Systems and Sanitation Washington, DC 20250–3700. sanitation requirements, as it has Standard Operating Procedures • Hand- or Courier-Delivered previously done with the requirements (Sanitation SOPs) and to meet other Submittals: Deliver to Patriots Plaza 3, on the same subjects in the meat and sanitation requirements consistent with 355 E Street SW, Room 8–163B, poultry products regulations. the meat and poultry regulations. FSIS Washington, DC 20250–3700. The Agency is also proposing to is proposing to eliminate those current Instructions: All items submitted by specify in the regulations that official regulatory provisions that are mail or electronic mail must include the plants are required to process egg inconsistent with HACCP, Sanitation Agency name and docket number FSIS– products to be edible without additional SOPs, and the proposed sanitation 2005–0015. Comments received in preparation to achieve food safety requirements. FSIS is also proposing to response to this docket will be made (proposed 9 CFR 590.570). This will specify in the regulations that official available for public inspection and ensure that the products are free of plants are required to process egg posted without change, including any detectable pathogens. The proposed products to be edible without additional personal information, to http:// regulations will require egg product preparation to achieve food safety. www.regulations.gov. plants to maintain control of egg In addition, FSIS is proposing to: Docket: For access to background products that have been sampled and Provide for generic approval as part of documents or comments received, go to tested for public health hazards, e.g., the prior label approval system for egg the FSIS Docket Room at Patriots Plaza Salmonella, until the test results products; make changes to labeling 3, 355 E Street SW, Room 8–164, become available (proposed requirements for shell eggs consistent Washington, DC 20250–3700 between amendments to 9 CFR 590.504). The with those in the Food and Drug 8:00 a.m. and 4:30 p.m., Monday proposed amended regulations will Administration’s (FDA’s) regulations; through Friday. provide for the use of irradiated shell require special handling instructions on FOR FURTHER INFORMATION CONTACT: eggs in the processing of egg products egg products; eliminate the Victoria A. Levine, Program Analyst, and food products containing them requirements for prior approval by FSIS Issuances Staff, Office of Policy and (proposed 9 CFR 590.590). The Agency is proposing to make the of egg products plant drawings, Program Development, Food Safety and egg products labeling and ‘‘other specifications, and equipment; Inspection Service, U.S. Department of consumer protection’’ requirements, incorporate egg products plants into the Agriculture, 1400 Independence Avenue including requirements for generically coverage of the ‘‘Rules of Practice’’ that SW, Room 6079, South Agriculture approved labeling, more like the the Agency follows when initiating Building, Washington, DC 20250–3700; labeling requirements for meat and administrative enforcement actions; and telephone (202) 720–5627; fax (202) poultry products (proposed 9 CFR change the Agency’s interpretation of 690–0486. 590.412). the requirement for continuous SUPPLEMENTARY INFORMATION: FSIS is proposing to align the import inspection in agency law. requirements for eggs and egg products FSIS is also announcing that it is Executive Summary more closely with the import seeking public comment on draft FSIS is proposing to amend the egg requirements for meat and poultry guidance designed to help small and products inspection regulations (9 CFR products (proposed 9 CFR 590, Subpart very small plants producing egg part 590) to require that official plants 1 B). products to meet the new regulatory that process egg products develop and FSIS is proposing to change requirements being proposed in this implement Hazard Analysis and Critical organizational terms and job titles that rulemaking. Should the rule become Control Points (HACCP) systems and appear in the regulations but that are no final, FSIS intends to finalize this Sanitation Standard Operating longer used in FSIS (proposed guidance. Procedures (Sanitation SOPs), in amendment of 9 CFR 590.5). DATES: Comments must be received on FSIS is also proposing to change the 1 As defined in the Egg Products Inspection Act or before June 13, 2018. FSIS is (21 U.S.C. 1031 et seq.). Exempted plants, as Agency’s interpretation of the providing a longer comment period than defined in 9 CFR 590.5, are also official plants, per requirement for continuous inspection typical for this proposed rule because of the statute. in 21 U.S.C. 1034(a). Inspection will no

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longer be conducted during all plants already use a written HACCP HACCP plan (9 CFR 417.3(b)). FSIS also processing operations, but may instead plan to address at least one production will continue to require that egg product be provided at least once per shift. step in their process. plants test pasteurized egg products for Finally, FSIS is proposing to replace FSIS will continue to test for pathogens. Plants must ensure that egg the rules of practice governing Salmonella and Listeria monocytogenes products that test positive for pathogens enforcement procedures for egg product (Lm) in egg products. If FSIS detects the are condemned or reprocessed (9 CFR plants with those that apply to meat and pathogens in the product, under 590.422). poultry product establishments HACCP, plants will be required to take (proposed amendments to 9 CFR part corrective actions to prevent recurrence The proposed rule will provide 500). of the problem, if the plant has greater flexibility and incentives for Costs attributable to the proposed rule determined the pathogen is reasonably innovation through reductions in are those associated with the likely to occur in its production process paperwork and unnecessary approvals. development and implementation of (9 CFR 417.3(a)). If FSIS detects the In addition, plants voluntarily meeting HACCP plans and Sanitation SOPs and pathogen and the plant has not HACCP requirements and also the need for new product labels with determined that the hazard is complying with current prescriptive safe-handling instructions. The impact reasonably likely to occur, the plant will regulations would reduce costs because of the costs is somewhat mitigated by be required to take corrective actions they would be operating entirely under the fact that 93 percent of egg products and also will be required to reassess its 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 2. Product Amenability Determinations K. Other Regulatory Changes in this notice of proposed rulemaking is Under the EPIA 1. Elimination of Egg Products Plant available for viewing in the FSIS Docket II. Proposed Changes to Specific Regulations Equipment and Facility Prior Approval A. Part 591 Requirements Room, on the FSIS website as a related B. HACCP 2. Import Requirements document associated with this docket, C. Sanitation SOPs 3. Changes to Defined Terms and on www.regulations.gov, unless D. Sanitation Requirements 4. Conditions for Receiving Inspection otherwise noted. E. Egg Products Are ‘‘Ready-To-Eat’’ 5. Miscellaneous Changes F. Not Applying the Mark of Inspection 6. Reinterpreting the Requirement for Table of Contents Pending Test Results Continuous Inspection in 21 U.S.C. G. Irradiated Shell Eggs 1034(a) I. Background H. Preparing for Implementation of III. Executive Orders 12866 and 13563 and FSIS’s Regulatory Jurisdiction Over Egg Regulatory Requirements the Regulatory Flexibility Act Products I. Labeling and Other Consumer Protection IV. Paperwork Reduction Act 1. What Products Are Covered Under the Regulatory Requirements V. Executive Order 12988 EPIA J. Rules of Practice VI. E-Government Compliance

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VII. Executive Order 13175 assure that the egg ingredients are not sandwiches containing eggs or egg VIII. USDA Nondiscrimination Statement adulterated and such products are not products and balut, a Philippine IX. Additional Public Notification represented as egg products.’’ The EPIA delicacy. These products are subject to I. Background does not define ‘‘relatively small the jurisdiction of FDA. proportion,’’ nor does it provide Cooked egg products, such as cooked FSIS’s Regulatory Jurisdiction Over Egg additional guidance as to what criteria egg patties, cooked omelets, and freeze- Products the Secretary should take into dried cooked eggs, also fall under FDA’s FSIS carries out its food safety consideration when determining what jurisdiction because they are produced responsibilities with respect to eggs and egg products consumers consider to be from USDA-inspected and passed egg egg products under the provisions of the products of the egg food industry. products. To eliminate confusion as to Egg Products Inspection Act (EPIA) (21 Under 21 U.S.C. 1034(a), the Secretary who has statutory authority over these U.S.C. 1031–1056). requires continuous inspection to be types of products, FSIS is proposing to To prevent the entry into commerce of made of the processing of egg products amend the definition of ‘‘egg product’’ any egg product that is capable of use in each plant processing for commerce. in 9 CFR 590.5 to include cooked egg as human food and is misbranded or There are currently 77 such official products as not being egg products adulterated, the Secretary of Agriculture plants that are under FSIS jurisdiction. under FSIS jurisdiction. regulates the processing of egg products Under the EPIA, ‘‘processing’’ means 2. Product Amenability Determinations under 21 U.S.C. 1034. Section 1034(a) ‘‘manufacturing egg products, including Under the EPIA states that the Secretary ‘‘shall, breaking eggs or filtering, mixing, whenever processing operations are blending, pasteurizing, stabilizing, FSIS considers a product to be being conducted, cause continuous cooling, freezing, drying, or packaging amenable under the EPIA if it consists inspection to be made, in accordance egg products’’ (21 U.S.C. 1033(w)). of dried, frozen, or liquid eggs, with or with the regulations promulgated under Thus, egg products processing without added ingredients. Examples this Act, of the processing of egg operations, such as mixing, include Pasteurized Frozen Whole Egg products, in each plant processing for pasteurizing, freezing, packaging, or with citric acid; plain Pasteurized commerce, . . . .’’ Therefore, under relabeling, must be conducted under Frozen Whole Egg without added FSIS’s current interpretation of the continuous Agency inspection. ingredients; Pasteurized Liquid Yolk EPIA, an inspector needs to be on the The definition of ‘‘egg product’’ in the with 10% salt; Pasteurized Frozen premises during all such operations. egg products inspection regulations (9 Scrambled Egg Mix with Whole Egg and The Secretary has also been authorized CFR 590.5) includes a list of specific pepper, starch, and dried milk; Frozen to make inspections, as appropriate, of products that have been exempted as Yolks with 10% sugar added; Frozen the facilities of egg handlers (including not being ‘‘egg products.’’ These Egg Whites with whipping aids (such as transport vehicles) to determine exempted products include freeze-dried sodium sulfate or triethyl citrate); whether shell eggs destined for the products; imitation egg products; egg Pasteurized Enzyme Modified Dried Egg ultimate consumer are being held under substitutes; dietary foods; dried no-bake Product with Egg Yolks and xanthan refrigeration at an ambient temperature custard mixes; egg nog mixes; acidic gum and citric acid to preserve color, of no greater than 45 degrees Fahrenheit dressings; noodles; milk and egg dip; and less than 1% silicon dioxide as an after packing and contain labeling that cake mixes; French toast; and anticaking agent and phospholipase; indicates that refrigeration is required sandwiches containing eggs or egg Spray Dried Albumin; and Spray Dried (21 U.S.C. 1034(e)). products. Such products must, however, Egg Whites with calcium citrate and salt Under 21 U.S.C. 1043, the Secretary of be prepared from inspected egg (or other added ingredients). FSIS has determined that some of the Agriculture has the authority to products or from eggs containing no products on the list of specific products promulgate such rules and regulations more restricted eggs than are allowed in that have been exempted as not being as he deems necessary to carry out the the official standards for U.S. Consumer ‘‘egg products’’ are incorrectly purposes or provisions of the Act. The Grade B shell eggs.2 Exempted products categorized as such. FSIS believes that Secretary is also responsible for the are subject to the jurisdiction of the these products, egg substitutes and administration and enforcement of the Food and Drug Administration (FDA). freeze-dried egg products, are, in fact, EPIA, except as otherwise provided in As stated above, products that contain egg products, and should therefore no 21 U.S.C. 1034(d). eggs only in a relatively small longer be exempt from inspection by proportion are exempted from the 1. What Products Are Covered Under FSIS under the EPIA. FSIS is seeking definition of ‘‘egg product’’ and thus not the EPIA comment on the number of facilities amenable under the EPIA. Several of the Under the EPIA, FSIS regulates egg that might become dual jurisdiction products listed in the preceding products. FSIS also has been delegated facilities, that is, regulated by FSIS and paragraph have been exempted from the the authority to establish temperature FDA, if egg substitutes and freeze-dried coverage of ‘‘egg products’’ for this and labeling requirements applicable to egg products are no longer exempt from reason, including dried no-bake custard shell eggs destined for the ultimate FSIS inspection. consumer (see 21 U.S.C. 1034(e)(1)). mixes; egg nog mixes; acidic dressings; Under 21 U.S.C. 1033(f), the term ‘‘egg noodles; milk and egg dip; cake mixes; Egg Substitutes product’’ means any ‘‘dried, frozen, or and French toast. The egg product Egg substitutes are low-cholesterol liquid eggs, with or without added ingredients in these foods are not easily products that are characterized by yolk ingredients, excepting products which distinguished in the food and are used replacement by other non-egg contain eggs only in a relatively small simply to add flavor. Other products ingredients such as vegetable oil, nonfat proportion or historically have not been, that include eggs but are not subject to dry milk, soy protein, gums, food in the judgment of the Secretary, FSIS jurisdiction are closed-face coloring, artificial flavors, and vitamins considered by consumers as products of and minerals (for nutritional 2 See the United States Standards, Grades, and the egg food industry, and which may Weight Classes for Shell Eggs, AMS 56.216(c). fortification). The fundamental be exempted by the Secretary under http://www.ams.usda.gov/sites/default/files/media/ ingredient in these products is egg such conditions as he may prescribe to Shell_Egg_Standard%5B1%5D.pdf. white, but they may also include added

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egg-white solids or a small amount of occur, under the EPIA, the processing of HACCP is a flexible system that will yolk. When the EPIA and the egg egg substitutes needs to take place enable official plants to tailor their products inspection regulations were within the framework of HACCP and control systems to the needs of their written, the production of egg Sanitation SOP preventive control particular plants and processes. Under substitutes was exempted from United measures. Furthermore, the addition of proposed 9 CFR 590.149(b)and 591.1 States Department of Agriculture color and other ingredients does not and 9 CFR part 417, each egg products (USDA) inspection in the egg products materially change the products such plant will be required to develop and inspection regulations. that the jurisdiction over the inspection implement a HACCP system for food As a result, egg substitutes are under of the products should be different than safety that is designed to prevent, the jurisdiction of FDA. FDA has for other egg products. In an effort to be eliminate, or reduce to an acceptable overseen the formulation, packaging, more transparent about the roles and level the occurrence of biological, labeling, storage, and transportation of responsibilities of FSIS and FDA chemical, and physical hazards that are egg substitutes under the Federal Food, regarding eggs, and after consulting with reasonably likely to occur in the plant’s Drug, and Cosmetic Act (FFDCA) (21 FDA, FSIS is proposing to assert process. Plants will be responsible for U.S.C. 301–399). Egg substitutes do not jurisdiction over egg substitutes. developing and implementing HACCP undergo continuous inspection during In addition, FSIS is proposing to plans that incorporate the controls that processing (unless the starting assert jurisdiction over freeze-dried egg are necessary to produce safe egg ingredient is unpasteurized egg white), products. Under 9 CFR 590.5, these are products. Given the requirements in 9 and most egg substitutes do not bear a exempted from being egg products. CFR part 417, FSIS is proposing to USDA inspection legend. However, FSIS tentatively finds this amend or eliminate many of the However, FSIS tentatively finds that categorization to be incorrect. Freeze- processing and facility requirements egg substitutes should no longer be dried egg products are amenable under contained in 9 CFR 590.500–575. exempt from inspection by FSIS under the EPIA because they consist of a Under 9 CFR part 417, when the EPIA. Egg substitutes are similar, if pasteurized egg product that is flash developing a HACCP plan (9 CFR not identical, in some cases, in frozen and placed in a vacuum chamber 417.2(b)), a plant conducts a hazard formulation to egg products. Indeed, the where ice particles are removed. The analysis to identify and list the egg product ingredient is distinctive and food safety risks associated with biological, chemical, or physical food significantly contributes to the basic freezing the product and contemplated safety hazards that are reasonably likely nature of egg substitutes by by the EPIA are the same whether the to occur in its production process for a characterizing the food. The only process takes place in an FSIS-inspected particular product and the measures substantive difference among these egg products plant or an FDA-inspected necessary to prevent, eliminate, or categories of products is color and facility. As a result, if this proposal is reduce the occurrence of those hazards nutrients. When a color additive is adopted, freeze-dried egg products will to an acceptable level. The plant then mixed with pasteurized egg whites, the no longer be exempt and will be subject identifies the points in each of its resulting product is called an ‘‘egg to FSIS’s jurisdiction. Therefore, FSIS is processes at which control is necessary substitute.’’ The application of color to proposing to amend the list of products to achieve this goal (9 CFR 417.2(c)(2)). pasteurized egg whites has generally not exempted as not being egg products in These points are called ‘‘critical control been conducted under FSIS inspection. 9 CFR 590.5 to eliminate freeze-dried points’’ (CCPs). The plant would have to The processing of egg substitutes is products and egg substitutes. establish critical limits for the also similar to that of other egg preventive measures associated with products, and the contamination risks II. Proposed Changes to Specific each identified CCP. A critical limit is associated with these types of products Regulations the maximum or minimum value to are the same. Egg products and egg which a hazard must be controlled at a A. 9 CFR Part 591 substitutes are manufactured using the CCP to prevent, eliminate, or reduce to same process, though egg substitutes Under proposed 9 CFR 591.1(a), all an acceptable level the occurrence of the processed in an FDA facility do not official plants will have to comply with identified food safety hazard. Critical have to re-pasteurized; where CCPs exist the requirements contained in 9 CFR limits are most often based on process in the manufacture of egg products, they parts 416, Sanitation, and 417, HACCP parameters such as temperature, time, exist in the production of egg Systems. For the purposes of these water activity, pH, or humidity. substitutes, e.g., during mixing, parts, as well as 9 CFR part 500, Rules FSIS is proposing to treat egg blending, pasteurization, if applicable, of Practice, an ‘‘official establishment’’ products similarly to the way it treats cooling, and packaging. The fact that egg or ‘‘establishment’’ will include a plant ready-to-eat (RTE) meat and poultry substitutes are formulated with that processes egg products (proposed 9 products. FSIS will require that official pasteurized egg whites does not mean CFR 591.1(b)). plants produce egg products to be edible that all food safety risks associated with without additional preparation to B. HACCP the products are eliminated. Some egg achieve food safety. Pathogens detected substitutes are not re-pasteurized after FSIS is proposing to adopt HACCP as in or on RTE egg products would production, even though they have been the organizing structure for its egg adulterate those egg products under 21 further processed in the FDA facility. To products food safety program because U.S.C. 1033(a)(1)) because they would produce egg substitutes, manufacturers HACCP has been proven to be an contain a poisonous or deleterious need to reprocess pasteurized egg optimal framework for building science- substance which may render them whites because of the risk of product based process control into food injurious to health. contamination post-pasteurization. production systems to prevent food For example, FSIS regards any Because the risks associated with egg safety hazards. Under proposed 9 CFR amount of Lm in an RTE product as a substitutes are the same as those 590.149(b) and 591.1(a), official plants product adulterant (9 CFR 430.4). associated with egg products, and will be required to comply with 9 CFR Because the product is RTE, it is likely because the reprocessing step presents a part 417, the Agency’s regulation on to be consumed without any effort to point in the process where HACCP, as a condition of receiving kill the pathogen, and the presence of contamination of egg substitutes might inspection. the pathogen may render the product

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injurious to health (21 U.S.C. 601(m)(1), many as seven times per month HACCP plan for a specific product and 453(g)(1)) and would cause the product depending on the number of plant on record review (9 CFR 417.7(b)). to be unhealthful.3 The same would be production processes occurring during Under this proposal, if an egg true of an RTE egg product containing the month. After inspectors collect the products plant fails to develop and Salmonella or Lm. While egg products samples, FSIS Field Service implement a HACCP plan that complies may receive additional preparation for Laboratories analyze the samples for the with proposed 9 CFR 590.149(b) and palatability or aesthetic, epicurean, presence of Salmonella and Lm using 591.1 and 9 CFR 417.2, or to operate in gastronomic, or culinary purposes, they the protocols listed in the Microbiology accordance with other 9 CFR part 417 are produced to be edible without Laboratory Handbook.89 requirements, FSIS is likely to file a additional preparation to achieve food Once a plant has established critical complaint to withdraw or refuse safety. The presence of Salmonella or limits for the measures associated with inspection services, pursuant to 9 CFR Lm, therefore, would render the product each identified CCP, it will need to 500.6 or 500.7. As with official meat and injurious to health (21 U.S.C. 1033(a)(1)) monitor the identified CCPs to assess poultry products establishments, FSIS and would cause it to be unhealthful. whether the CCP is within the will verify that the plant’s HACCP plans FSIS has also addressed shiga-toxin established critical limit (9 CFR comply with the requirements of producing E. coli (STEC) in certain raw 417.2(c)(4)). Monitoring is an integral proposed 9 CFR 590.149(b) and 591.1 beef products (non-intact or intended part of HACCP, and monitoring and 9 CFR part 417; that these plans for non-intact use) in this manner. FSIS frequencies must be sufficient to ensure have been validated by the facility; and considers an acceptable reduction for that each CCP is under control. The that plants are producing egg products STEC to be a reduction to an plant’s HACCP plan would also have to to be edible without additional undetectable level (i.e., a level that include corrective action to be taken preparation to achieve food safety. In would not be detectable using the FSIS when monitoring indicates that there is other words, these products must be free testing method or a method with a a deviation from a critical limit at a of detectable pathogens. sensitivity at least equivalent to FSIS’s CCP, because the existence of a HACCP Hazard Analysis method).4 This means that an plan does not guarantee that problems establishment producing RTE meat or will not arise (9 CFR 417.2(c)(5)). For If this proposal is adopted, each egg poultry products or certain raw beef example, corrective action plans must products plant will be required to products needs to address the pathogens be in place to identify and correct the conduct a hazard analysis to determine so that they will not be detected by FSIS cause of a deviation and to determine the food safety hazards reasonably likely or other equivalent testing. FSIS has the disposition of potentially to occur in its production processes and recommended that establishments do adulterated product. to identify the preventive measures that their own testing to verify that their Plants will also have to develop and it needs to take to control those hazards HACCP systems address the pathogens maintain effective recordkeeping (proposed 9 CFR 590.149(b) and 591.2 of concerns.5 While establishments can procedures that document the entire and 9 CFR 417.2(a)(1)). The analysis use their own testing methods, those HACCP system (9 CFR 417.2(c)(6)). must include a flow chart that describes methods should be at least as sensitive Finally, plants will need to list the the steps of the process and that as FSIS’s.6 FSIS has also said that verification procedures, and the identifies the intended use or establishments can address the frequency with which those procedures consumers of the finished product (9 pathogen in their HACCP plan or will be performed, that the plant will CFR 417.2(a)(2)). Contamination with Salmonella spp. Sanitation SOPs or other prerequisite use to ensure that the HACCP system is can be a food safety hazard that is program.7 This same guidance would in compliance with the HACCP plan (9 reasonably likely to occur in the apply to egg products plants. CFR 417.2(c)(7)). Periodic verification production of egg products. Therefore, Under the Agency’s verification will help the plant to ensure that it is as part of its hazard analysis, each egg testing program, egg products are broken operating in accordance with its HACCP products plant should consider into seven product categories—four plan. The occurrence of unforeseen addressing this food safety hazard in its liquid and three dried. Each month, hazards evidences that the HACCP plan HACCP system. Consistent with the inspectors collect one egg product needs to be reassessed. If this proposal application of HACCP in meat and sample per process from each plant that is adopted, individuals developing, poultry operations, plants may produces egg products. Thus, inspectors reassessing, and modifying HACCP determine that the Sanitation SOP or a could sample an egg products plant as plans in accordance with 9 CFR 417.2(b) and 417.3 will have to have successfully prerequisite program is an appropriate and suitable means to effectively 3 Control of Listeria monocytogenes in Ready-to- completed a course of instruction in the Eat Meat and Poultry Products; Final Rule (68 FR application of the seven HACCP prevent the occurrence of certain food 34208, Jun. 6, 2003). principles to meat, poultry, or egg safety hazards and thus make them not 4 E. coli O157:H7 Contamination of Beef Products reasonably likely to occur. (67 FR 62325, October 7, 2002) (available at: http:// products processing, including a www.fsis.usda.gov/wps/wcm/connect/ad259bcd- segment on the development of a HACCP Plan 5b85-4696-9888-89872bee39ee/00-022N.pdf? Under this proposed rule, each egg MOD=AJPERES). 8 Isolation and Identification of Salmonella from 5 Control of Listeria monocytogenes in Ready-to- Meat, Poultry, Pasteurized Egg, and Siluriformes products plant will be required to Eat Meat and Poultry Products; Final Rule (68 FR (Fish) Products and Carcass and Environmental develop and implement a HACCP plan 34214, Jun. 6, 2003). Sponges. January 2, 2017 (available at: https:// covering each product produced 6 FSIS. 2013. Establishment Guidance for the www.fsis.usda.gov/wps/wcm/connect/700c05fe- whenever the hazard analysis reveals Selection of a Commercial or Private 06a2-492a-a6e1-3357f7701f52/MLG-4.pdf?MOD Microbiological Testing Laboratory (available at: =AJPERES). one or more food safety hazards that are http://www.fsis.usda.gov/wps/wcm/connect/ 9 Isolation and Identification of Listeria reasonably likely to occur. Note that a 464a4827-0c9a-4268-8651-b417bb6bba51/ Monocytogenes from Red Meat, Poultry, Ready-To- single HACCP plan may encompass Guidance-Selection-Commercial-Private- Eat Siluriformes Fish and Egg Products, and multiple products within a single Microbiological-Testing-lab-062013.pdf?MOD= Environmental Samples January 2, 2017 (available AJPERES). at: https://www.fsis.usda.gov/wps/wcm/connect/ processing category (see proposed 9 CFR 7 HACCP Systems Validation (80 FR 27557, May 1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG-8.pdf? 590.149(b) and 591.2 and 9 CFR 14, 2015). MOD=AJPERES). 417.2(b)(1)) if the food safety hazards,

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CCPs, critical limits, and procedures additional guidance to plants on how to recordkeeping procedures; calibrating identified within are essentially the validate their HACCP systems. process-monitoring instruments; same. Upon completion of the hazard collecting in-line or finished product Once completed, the HACCP plan analysis and the development of the samples for biological (e.g. Salmonella must be signed and dated by a HACCP plan, the plant will conduct its spp.), chemical, or physical analysis; responsible official, that is, the initial validation, which consists of the and directly observing and evaluating individual with overall authority on-site activities the plant must perform to the adequacy of corrective actions. or a higher level official of the plant. determine whether the plan is Under this proposed rule, plants will This signature signifies that the plant functioning as intended. During this also be required to reassess the accepts and will implement the HACCP initial validation, the facility repeatedly adequacy of their HACCP plans at least plan. The HACCP plan must be signed tests the adequacy of the CCPs, critical annually and whenever any changes and dated not only upon initial limits, monitoring and recordkeeping occur that could affect the hazard acceptance by the processor but also procedures, and corrective actions set analysis or alter the HACCP plan. upon any modification to the plan and forth in the HACCP plan. Validation Examples of such changes include at least annually, as required by 9 CFR also encompasses reviews of the changes in raw materials or the source of raw materials; product formulation; 417.4(a)(3) (9 CFR 417.2(d)). records, routinely generated by the HACCP system, in the context of other production volume; packaging; or the Corrective Actions validation activities. Plants may use intended use or consumers of the independent consultants, process finished product (proposed 9 CFR Under this proposed rule, the HACCP authorities, or employees trained in 590.149, 591.1, and 591.2, and 9 CFR plan must identify the corrective actions accordance with 9 CFR 417.7 for plan 417.4(a)(3)). This reassessment must be that the plant will take when development and validation. conducted by an individual who has responding to a deviation from a critical The data used to validate a HACCP successfully completed a course of limit and assign responsibility for taking plan may be derived from various instruction in the application of the corrective action. Corrective actions sources, including the scientific seven HACCP principles, including a must ensure that no product that is literature, product testing results, segment on the development of a injurious to health or that is otherwise experimental research results, HACCP plan for a specific product, for adulterated as a result of the deviation scientifically-based regulatory example, liquid egg product, and on enters commerce; that the cause of the requirements, FSIS compliance record review (9 CFR 417.7(b)). deviation is identified and eliminated; guidelines, computer-modeling By periodically monitoring its HACCP that the CCP will be under control after programs, and data developed by plan, a plant can ensure that the plan is the corrective action is taken; and that process authorities (a process authority continuously effective in controlling measures to prevent recurrence are is a person or organization with expert and preventing food safety hazards. It established (proposed 9 CFR 590.149(b) knowledge in the relevant products, also provides a plant the opportunity to and 591.2 and 9 CFR 417.3). process controls, and regulations). apply relevant experiences to improving Because pre-established corrective However, validation data must include process controls. at least 90 days of in-plant data or actions may not cover every Records contingency, and unforeseen hazards or information reflecting the plant’s deviations may occur, 9 CFR 417.3(b) experience in implementing the HACCP Under this proposed rule, plants will provides a series of steps that must be plan during plant operations. These data have to maintain records regarding their taken in such situations. These steps are needed because validation must operations under HACCP. These records include segregating and holding affected demonstrate not only that the HACCP include the written hazard analysis and product and conducting a review to plan is scientifically sound, but also that all supporting documentation, the determine the acceptability of the this particular egg products plant can written HACCP plan and all decision- product for distribution, ensuring that implement the HACCP plan and make it making documents associated with the any adulterated product or product work. development of CCPs and critical limits, otherwise injurious to health does not To ensure that the HACCP plan is and documents supporting the enter commerce, and reassessing functioning as intended on a continual monitoring and verification procedures HACCP plans to determine whether any basis, the plant would conduct ongoing selected and the frequency of those modification is needed. verification activities (proposed 9 CFR procedures. Records documenting the 590.149 and 591.1 and 9 CFR monitoring of CCPs and critical limits, Validation, Verification, and 417.4(a)(2)). Verification is intended to corrective actions, verification Reassessment show that the HACCP system is working procedures and results, product codes, Under this proposed rule, every egg effectively on a day-to-day basis, and product name or identity will also products plant will be required to resulting in the production of safe food. have to be maintained. Each entry on a validate its HACCP plan’s adequacy in Verification is distinct from ongoing record maintained under the HACCP controlling the food safety hazards plant monitoring, which is designed to plan will have to be made at the time identified during the hazard analysis. provide a record showing that the the specific event occurred and include Once the plant has determined that the written HACCP plan is being followed. the date and time recorded, and be Verification includes repeatedly HACCP plan is functioning as intended, signed or initialed by the employee reviewing and evaluating the various it will have to validate that the plan is making the entry. components of the HACCP system. Prior to shipping product, the plant being effectively implemented Verification activities should provide will have to review the processing and (proposed 9 CFR 590.149(b) and 591.1 practical results specific to the production records associated with the and 9 CFR 417.4(a)).10 FSIS will provide operation of the given HACCP plan and HACCP plan to ensure that they are could include, but would not be limited complete, all critical limits were met, 10 On May 14, 2015, FSIS announced the availability of the final revision of its Compliance to, checking the adequacy of critical and, if applicable, that corrective Guideline for Hazard Analysis Critical Control limits; reviewing CCP-monitoring actions were taken (proposed 9 CFR Point (HACCP) systems validation (80 FR 27557). records; reviewing monitoring and 590.149 and 591.1 and 9 CFR 417.5(c)).

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This pre-shipment review will have to the existence of insanitary conditions to prevent direct product contamination be conducted by someone other than the during the processing and production of or adulteration (9 CFR 416.15(a)). person who produced the records, egg products and the likelihood that Corrective actions include ‘‘procedures where practicable, and preferably by an bacteria, including pathogenic bacteria, to ensure appropriate disposition of individual trained in accordance with 9 will contaminate the finished product. product(s) that may be contaminated, CFR 417.7 or the responsible plant Some plants, however, do not have restore sanitary conditions, and prevent official. adequate programs and do not the recurrence of direct contamination consistently maintain good sanitation. C. Sanitation Standard Operating or adulteration of product(s), including In fact, poor sanitation is the most Procedures (Sanitation SOPs) appropriate reevaluation and frequently cited problem identified by modification of the Sanitation SOPs and General FSIS inspection program personnel in the procedures specified therein . . .’’ Proper sanitation is an important and egg products plants. (proposed 9 CFR 591.1 and 9 CFR integral part of every food process and If FSIS finalizes this proposal, all 416.15(b)). a fundamental requirement under the official plants will be required to If this proposed rule is adopted, law. Insanitary facilities and equipment, develop, implement, and maintain plants will have to keep daily records and poor food handling and personal written Sanitation SOPs, as well as documenting that the sanitation and hygiene practices among employees, comply with the Sanitation monitoring procedures listed in the requirements (9 CFR 416.1–6), in create an environment in which Sanitation SOPs are performed and accordance with 9 CFR part 416. As a pathogens can flourish. Furthermore, maintain records documenting any result, FSIS is proposing to amend or the law is quite clear: Eggs or egg corrective actions taken to prevent replace many of the current sanitary products that have been prepared, direct contamination or adulteration of requirements contained in 9 CFR packed, or held under insanitary products, or when the plant determines 590.500–575. The plant’s Sanitation conditions whereby they may have been or FSIS notifies it that its Sanitation SOPs will need to describe all contaminated with filth, or whereby SOPs are inadequate (proposed 9 CFR procedures the plant conducts daily to they may have been rendered injurious 591.1 and 9 CFR 416.16(a)). Under this prevent direct contamination or to health are deemed adulterated (21 proposal, records may be maintained on adulteration of products (proposed 9 a computer, provided that plants U.S.C. 1033(a)(4)). FSIS inspection CFR 591.1(a) and 9 CFR 416.12(a)). The program personnel are expressly implement controls to ensure the Sanitation SOPs will also need to integrity of the electronic data (9 CFR charged with ensuring that product is specify the frequency with which each 416.16(b)). Records could be retained produced and held under sanitary procedure in the Sanitation SOPs is to 11 off-site, provided that they are not conditions. For these reasons, FSIS is be performed and identify the plant removed from the plant for at least 48 proposing to require that all plants that employees responsible for hours following their completion, and process egg products develop, implementing and maintaining the that they can be provided to FSIS implement, and maintain written procedures (9 CFR 416.12(d)). The personnel within 24 hours of being Sanitation SOPs to prevent direct Sanitation SOPs will have to be signed requested (9 CFR 416.16(c)). contamination or adulteration of and dated, upon initiation and any product before and during operations (9 modification, by ‘‘the individual with Under the proposed Sanitation SOPs, CFR 416.11). Under this proposed rule, overall authority on-site or a higher FSIS inspection program personnel will plants will be required to maintain daily level official of the plant.’’ The signature verify that plant management is records to document adherence to the will signify that the plant will conducting its operations in a sanitary SOPs (§ 416.16). FSIS is proposing to implement and maintain the Sanitation environment and manner. Failure to cross-reference 9 CFR part 416 in 9 CFR SOPs in accordance with 9 CFR part 416 comply with the Sanitation SOPs 591.1 rather than duplicate the (proposed 9 CFR 591.1 and 9 CFR provides presumptive evidence of regulatory text. 416.12(b)). Official plants will also have insanitation. As is now the case, Sanitation SOPs are necessary to identify their pre-operational inspection program personnel will act to because they clearly define each plant’s sanitation procedures in their written prevent a facility from operating under responsibility to consistently follow Sanitation SOPs, distinguishing them insanitary conditions. effective sanitation procedures to from sanitation activities to be carried D. Sanitation Requirements minimize the risk of direct product out during operations (proposed 9 CFR contamination and adulteration. This 591.1 and 9 CFR 416.12(c)). In addition to Sanitation SOP proposal is based on FSIS’s Under this proposal, each plant will requirements, FSIS is proposing to determination for meat and poultry be required to conduct the pre- remove the current sanitation plants that effective sanitation is operational and operational procedures requirements discussed below for egg essential for food safety and for the as specified in the Sanitation SOPs, products plants from its regulations. successful implementation of HACCP. monitor the conduct of the procedures, Some of the existing plant sanitation FSIS is not aware of any reason why the and routinely evaluate the effectiveness requirements will no longer be needed same determination should not be made of the SOPs and modify the Sanitation in light of the proposed HACCP and for egg products plants. SOPs as necessary, in light of changes Sanitation SOP requirements. Further, Well-run plants have effective quality to the facility, personnel, or operations, some of the existing plant sanitation control and sanitation programs, to ensure that they remain effective in requirements impede innovation and including written Sanitation SOPs. Such preventing direct product blur the distinction between plant and programs are based, in large part, on the contamination and adulteration inspector responsibilities for plants’ recognition of the link between (proposed 9 CFR 591.1 and 9 CFR maintaining sanitary conditions. Should 416.13 and 416.14). these regulations become final, they will 11 Under 21 U.S.C. 1035, official plants must be Plants will have to take corrective provide official plants with more operated in accordance with such sanitary practices flexibility to innovate with regard to and have such premises, facilities, and equipment action when either the plant or FSIS as are required by regulations promulgated by the determines that the Sanitation SOPs, or facility design, construction, and Secretary to effectuate the purposes of the EPIA. their implementation, may have failed operations.

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The sanitation requirements proposed exposed edible product is handled; Agency is proposing to incorporate into in this rule will not only provide plants § 590.522(a) concerning breaking room the egg product regulations. with the flexibility to innovate in operations; and § 590.539(a), concerning Establishment Construction—9 CFR facility design, construction, and the defrosting of frozen egg product in 416.2(b) operations but will also articulate the a sanitary manner. standards for good sanitation and for The proposed rule would also provide The egg products inspection food product safety that must be met by flexibility to industry in facility design, regulations concerning construction of egg products processors. All sanitation construction, and operation by the egg products plants are very prescriptive requirements have the same intent: A replacement of the following regulations and inflexible. For example, 9 CFR plant that processes egg products must with the general standards in 9 CFR 590.500 prescribes numerous, specific operate under sanitary conditions, in a 416.1: § 590.506(c), which requires the requirements for different areas within manner that ensures that the product is installation of an approved exhaust an official plant, e.g., dressing rooms, not adulterated and that does not system for the continuous removal toilet facilities, and refuse rooms. Other interfere with FSIS inspection and its directly to the outside of any steam, regulations containing prescriptive enforcement of such standards. vapors, odors, or dust in the candling construction requirements include However, because the proposed and transfer room; § 590.508(a), which § 590.506, candling and transfer-room sanitation requirements define the states that candling and transfer rooms facilities and equipment; § 590.520, results to be achieved by sanitation, but and equipment shall be kept clean, free breaking room facilities; § 590.546, not the specific means to achieve those from cobwebs, dust, objectionable albumen flake process drying results, plants can meet the sanitation odors, and excess packing materials; operations, § 590.560, concerning requirements in different ways. and § 590.546(b), which requires that personnel facilities; and § 590.570(a), Regardless of the means by which plants the air intake source in albumen flake concerning pasteurization facilities. comply with the standards under this process drying facilities be free from Section 416.2(b) of 9 CFR sets out proposed rule, the required results will foul odors, dust, and dirt. construction sanitation requirements that will allow for increased flexibility be the same for all egg products plants. Establishment Grounds and Pest FSIS is proposing to replace most of in regard to facility operation Management—9 CFR 416.2(a) the current sanitation regulations in 9 construction and maintenance if CFR 590.500 through 590.560 with the The current egg products plant adopted by reference through proposed general sanitation requirements set out requirements for facility grounds are 9 CFR 591.1. Plants will be able to in 9 CFR 416.1 through 416.6, which the unnecessarily prescriptive. For example, design facilities and equipment in the Agency is proposing to incorporate by 9 CFR 590.500(b) requires that the manner that they deem best to maintain reference (proposed 9 CFR 591.1(a)). premises be free from refuse, waste, and the required sanitary environment for This proposed change will significantly other materials and conditions that food production. reduce the number of egg and egg constitute a source of odors or a harbor In addition to the six prescriptive egg products sanitation regulations and for insects, rodents, and other vermin, products construction regulations listed consolidate most sanitation while § 590.500(g) states that drains and above, there are seven more requirements for eggs and egg products gutters shall be properly installed with construction requirements that will be with those for meat and poultry approved traps and vents. Several other replaced by 9 CFR 416.2(b) if this products. sections (§§ 590.542(a), 547(a), and proposal is finalized. They are 9 CFR 548(a)) require that rooms be kept free 590.146(b)(5) and (d), concerning the General Sanitation—9 CFR 416.1 and of flies, insects, and rodents. requirements for floor plans and revised Proposed 9 CFR 591.1 The other prescriptive establishment blueprints submitted prior to receiving The current sanitation regulations for grounds regulations are 9 CFR inspection service or making changes or eggs and egg products require that 590.500(a) and (c), which require that revisions to an official plant; plants, including rooms, windows, and the plant be free from objectionable § 590.500(i), (j), (l), and (o), concerning floors, be kept clean and reasonably dry, odors, dust, and smoke-laden air and structure construction materials, and free from objectionable odors, flies, state that the buildings shall be of sound maintenance requirements for rooms in insects, and rodents. Section 416.1 of 9 construction and kept in good repair to which shell eggs or egg products are CFR, which applies to meat and poultry prevent the entrance or harboring of handled, and toilet and refuse room establishments, provides greater vermin, and § 590.522(a), which states requirements; § 590.532(a), concerning flexibility: ‘‘Each official establishment that the breaking room shall be kept in liquid egg holding tank requirements; must be operated and maintained in a dust-free clean condition and free from § 590.534(a), concerning freezing room sanitary manner sufficient to ensure that flies, insects, and rodents. In addition, requirements; § 590.548(c), which product is not contaminated, 9 CFR 590.522(a) requires that the plant addresses heat treatment room adulterated, or misbranded.’’ Unlike keep the floor clean and reasonably dry construction requirements; § 590.550, command-and-control regulations, during breaking operations and free of dealing with washing and sanitizing examples of which are cited below, 9 egg meat and shells. room or area facility requirements; and CFR 416.1 will provide facilities with The general sanitation requirements § 590.560(a) and (b), concerning the the maximum possible flexibility to in 9 CFR 416.2(a) preserve the intent of health and hygiene of plant personnel innovate in facility design, construction, these requirements that grounds be and the construction of personnel and operation. maintained to prevent conditions that facilities. Examples of current requirements to could lead to the contamination or be replaced by the general standards are: adulteration of product, and that Light—9 CFR 416.2(c) § 590.500(d), which states that materials establishments implement and maintain The lighting requirements for and equipment not currently needed an integrated pest control program to breaking rooms in official plants in shall be handled or stored in a manner eliminate the harborage of pests on the § 590.520(a) prescribe specific light so as not to constitute a sanitary hazard; grounds and within the plant facilities. intensities for all working surfaces in § 590.500(e), concerning doors and This regulation, however, provides the the room and at breaking and inspection windows leading to rooms where flexibility and leave to innovate that the stations. For example, all working

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surfaces must have at least 30 foot- containers for trash and inedible eggs at and solid material in the official plant candles of light intensity, while least once daily and their cleaning and shall be disposed of in a manner breaking and inspection stations must treatment in such a manner as to approved by the Administrator to have at least 50 foot-candles of light prevent odors or objectionable prevent product contamination and in intensity. Other egg products conditions in the plant; § 590.530(a), accordance with acceptable regulations do not contain specific which states that liquid egg storage environmental protection practices. lighting requirements, stating only that rooms, including surface coolers and Section 416.2(f) of 9 CFR, sewage rooms shall be adequately or well- holding tank rooms, shall be kept clean disposal, will replace both of these lighted (see §§ 590.500(l)(i), 548(a), and and free from odors and objectionable regulations by requiring that sewage be 550(a)). odors and condensation; and disposed into a sewage system separate The intent of the lighting § 590.536(a), concerning the conditions from all other drainage lines or disposed requirements is to ensure that there is in which freezing rooms are to be kept. of through other means sufficient to enough light of adequate quality to Other regulations to be replaced by 9 prevent backup of sewage into areas monitor sanitary conditions and CFR 416.2(d) will be: 9 CFR 590.540(d), where product is processed, handled, or processing operations and to examine which states that air drawn into the stored. product for evidence of adulteration or drier in spray process drying facilities Water Supply and Reuse—9 CFR misbranding. Section 416.2(c) of 9 CFR be free from foul odors, dust, and dirt; 416.2(g) has codified this intent as a general § 590.546(b), requiring that intake air sanitation requirement, and it will be sources in albumen flake process drying The current regulations regarding applicable to plants that process egg facilities be free from foul odors, dust, water supply and reuse in plants require products if this proposed rule is and dirt; § 590.549, requiring that dried that the water supply be ample, clean, finalized. Under 9 CFR 416.2, which egg storage be sufficient to adequately and potable, with adequate pressure and requires that lighting be of good quality handle the production of the plant and facilities for its distribution throughout and of sufficient intensity to ensure that be kept clean, dry, and free from the plant or portion thereof utilized for sanitary conditions are maintained, and objectionable odors; and § 590.560(b), egg processing and handling operations that product is not adulterated, plants requiring that toilets and dressings be and protected against contamination will have the flexibility to determine kept clean and that toilet rooms be and pollution (§ 590.500(h)). Section what light intensities are appropriate to ventilated to the outside of the building. 590.500(h) also requires that the ensure sanitation in different applicant for inspection obtain and Plumbing—9 CFR 416.2(e) operational contexts. Therefore, FSIS is furnish to the Administrator, at the proposing to remove §§ 590.500(l)(1), The design, installation, and Administrator’s request, a water report, 520(a), 548(a), and 550(a) from the egg maintenance of an adequate plumbing issued under the authority of a State or products inspection regulations. system are key responsibilities of an egg municipal health authority, certifying to products plant. Because plumbing the potability of the water supply. When Ventilation—9 CFR 416.2(d) systems carry water into plants and ice is used as an emergency refrigerant The egg products inspection convey water, sewage, and other waste by being placed directly into the egg regulations addressing ventilation from plants, problems with plumbing meat, § 590.530(f) requires that the generally require that ventilation systems can easily cause product source of the ice be certified by the local provide for a positive flow of outside contamination or adulteration. The or State board of health and that the ice filtered air through rooms and air of plumbing sanitation requirements in 9 be handled in a sanitary manner. suitable working temperature during CFR 416.2(e) set out the essential Section 416.2(g)(1) of 9 CFR sets out operations, and that rooms be kept free condition plants must achieve with a transparent water supply performance from objectionable odors and their plumbing systems: plumbing standard concerning potable water. The condensation (see §§ 590.500, systems cannot cause adulteration of water must comply with Environmental 590.504(p), 590.506(c), 590.520(d), product and must ensure sanitary Protection Agency (EPA) National 590.550(a)). Objectionable odors or operating conditions. Plants otherwise Primary Drinking Water regulations. condensation are to be reduced to the will be allowed to build plumbing These EPA regulations are applicable to extent possible or eliminated because systems suitable to the nature and public water systems. Because these they can adulterate product. FSIS has volume of their production. Therefore, regulations already apply to potable codified a single sanitation requirement, FSIS is proposing to eliminate the water used by egg products plants, the 9 CFR 416.2(d), which preserves the requirement in § 590.500(g) that drains reference in the sanitation requirements intent of the current egg products and gutters with approved traps and would not constitute a new requirement regulations. This codification will vents be installed. The Agency is also for these plants. The sanitation simplify FSIS’s egg products ventilation proposing to eliminate the prescriptive requirement also restates the current regulations by consolidating them into 9 requirements regarding lavatory requirement that plants must make CFR 416.2(d). accommodations in § 590.500(l) and available to FSIS, upon request, State or In addition to the regulations (m). local certificates attesting to water discussed above, FSIS is proposing to quality. remove the following regulations from 9 Sewage Disposal—9 CFR 416.2(f) The egg products industry uses large CFR part 590 because they will be The current regulations require any quantities of water for processing replaced by proposed 9 CFR 416.2(d) if person desiring to process egg products products and for cleaning. Water and this rule is finalized: 9 CFR 590.435(d), under continuous inspection to submit water based (aqueous) solutions are which states that containers and drawings and specifications before widely used for prewetting, washing, packing or packaging materials in which receiving approval of a plant and and rinsing eggs, product formulation, shell eggs are received into the official facilities as an official plant. and cleaning and sanitizing equipment. plant shall be free from odors and Information that must be submitted Reuse of water solutions, therefore, can materials which could contaminate or includes how the plant intends to offer significant economic advantages. adulterate the eggs or egg products; dispose of sewage (§ 590.146(b)(7)). Section 590.515(a), for example, sets § 590.508(b), requiring the removal of Section 590.504(q) states that all liquid forth the requirements for washing shell

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eggs to be presented for breaking. They chemical, or physical contaminant areas, provided that it has never include changing the wash water every levels are possible in reuse water. The contained human waste, has been four hours or more often if needed to previous degree of exposure or potential conditioned to be free of pathogenic maintain sanitary conditions and at the exposure to contaminants dictates the organisms, and does not contact edible end of each shift (paragraph (a)(4)); appropriate reconditioning treatment product. Finally, paragraph (g)(6) states adding replacement water to the wash and the allowable reuse. that any water not meeting the water of washers continuously to FSIS requires official egg products conditions of 9 CFR 416.2(g)(1) through maintain a continuous overflow plants to produce pasteurized, RTE (5) may not be used, except in areas (paragraph (a)(5)); piping waste water products that are free of pathogens. where no edible product is handled or from the egg washing operation directly Therefore, reuse water that is used to prepared, and may not be used in any to drains (paragraph (a)(6)); and chill or cook pasteurized, RTE egg manner which would allow it to completing continuous washing products must be free of fecal coliforms contaminate or adulterate edible operation as rapidly as possible because their presence would indicate product. (paragraph (a)(7)). Section 590.516(a) that the water was contaminated, Moving the egg products water supply requires that all shell eggs be spray possibly with pathogenic organisms (9 and reuse regulations into 9 CFR rinsed with potable water containing an CFR 416.2(g)(2)). Other types of 416.2(g) will consolidate them with approved sanitizer of not less than 100 contamination will also have to be those for meat and poultry. The ppm but no more than 200 ppm of reduced sufficiently to prevent proposed sanitation requirements in 9 available chlorine or its equivalent adulteration of product. CFR 416.2(g) are intended to and should immediately prior to breaking. Section 416.2(g)(3) of 9 CFR deals account for every allowable water reuse Section 590.552 establishes cleaning with the use and reuse of water, ice, and situation in official plants, including and sanitizing requirements for solutions used to chill or wash raw those covered by the following egg equipment used in egg processing product. In response to questions raised products inspection regulations, which operations that comes in contact with at public meetings in Columbus, OH, will be replaced by 9 CFR 416.2(g) if liquid eggs or exposed edible products. and Sacramento, CA, on March 30 and this proposal is finalized: § 590.520(e), While such equipment may be cleaned April 6, 2000, and Washington, DC, on which requires adequate and easily by any sanitary means, it is preferable July 31, 2001, held to obtain comments accessible hand washing facilities in an to use water to do so. Paragraph (b)(2) on FSIS’s and FDA’s thinking at the official plant; § 590.539(d)(1), which requires that shell eggs that have been time on approaches to ensure egg safety permits frozen eggs packed in metal or sanitized and equipment that comes in from farm to table, FSIS has tentatively plastic containers to be placed in contact with edible products be rinsed concluded that unprocessed shell eggs, running tap water (70 degrees F or with clean water after sanitizing if other i.e., eggs that have not yet been washed, lower) without submersion to speed than hypochlorites are used as sized, or candled, are more like raw defrosting; and § 590.552(a) and (b)(2), sanitizing agents. product than RTE product. As a result, concerning equipment cleaning and Section 416.2(g)(2) through (6) of 9 FSIS has determined that the provisions sanitizing requirements. CFR sets forth sanitation requirements of 9 CFR 416.2(g)(3), which regulate the for the reuse of water in meat and use of reuse water to wash raw product, Dressing Rooms, Lavatories, and poultry establishments. If this proposal will apply to official plants. Toilets—9 CFR 416.2(h) is adopted, plants will also be able to Consequently, water used to wash The current regulations concerning use reuse water in their operations, as unprocessed shell eggs may be reused dressing rooms, lavatories, and toilets in appropriate. for the same purpose, provided that egg products plants are highly Prior to the implementation of 9 CFR measures are taken to reduce biological, prescriptive. For example, 416.2(g), reuse water was permitted in chemical, and physical contamination § 590.500(l)(2) provides a formula that meat and poultry establishments only so as to prevent contamination or serves as the basis for determining the under certain circumstances, and any adulteration of the eggs. Such reused toilet facilities required in an official other reuse situation had to be approved water from use on raw eggs may not plant, the intent being to ensure that by the Agency in advance. However, come into contact with processed shell plants provide an adequate number of once technologies were developed that eggs. toilet bowls, thus maintaining related can recondition water for safe and Paragraph (g)(4) of 9 CFR 416.2 will sanitary conditions. The sanitation effective reuse in various applications, allow plants that recondition their water requirement in 9 CFR 416.2(h) gives the Agency recognized that reuse water through an advanced wastewater plants the responsibility and flexibility may be used safely and effectively in treatment facility to use such to determine how many dressing rooms, certain food processing situations. reconditioned water on raw product, lavatories, and toilets it needs. Of Under 9 CFR 416.2(g), reuse water can except in product formulation and course, plants will have to meet any be treated to render it free of biological, throughout the plant in edible and applicable State and local codes chemical, and physical hazards. Some inedible production areas. This water is concerning the number of lavatories and of the general treatment options used not, however, potable, and it may not toilets in the workplace. include filtration, chlorination, have ever contained human waste. There are also other requirements for ozonation, ultraviolet (UV) radiation, Product, facilities, and equipment dressing rooms, lavatories, and toilets and heating. Use of these procedures coming in contact with this water must currently in the egg products regulations can usually return water to a level of undergo a separate final rinse with non- (see § 590.520(e), concerning hand quality appropriate to its intended use. reconditioned water that meets the washing facilities in breaking rooms, After treatment, however, such water criteria prescribed in 9 CFR 416.2(g)(1). § 590.560(a) and (b), concerning health should be tested regularly to ensure The reuse water described above would and hygiene of personnel, and continual freedom from biological, most likely be used to wash solid waste § 590.146(b)(5), requiring floor plans to chemical, or physical hazards. from equipment and floors. show the locations of hand-washing Depending upon the original use, the Paragraph (g)(5) of 9 CFR 416.2 will facilities and toilets). The proposed intended use, and the duration of reuse, permit plants to use any water for any sanitation requirement in 9 CFR a wide range of acceptable biological, purpose in edible or inedible product 416.2(h) eliminates the need for these

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requirements because it renders them in good repair and be cleaned after start of processing operations, and that redundant. each day’s use or more frequently, if they keep equipment and utensils clean necessary, and requiring that the and sanitary during all processing Equipment and Utensils—9 CFR 416.3 temperature of wash water be operations (9 CFR 590.504(n)). Section The egg products inspection maintained at 90 degrees F or higher, 590.522(aa)(3) of 9 CFR states that regulations concerning equipment and and shall be at least 20 degrees F mechanical egg breaking equipment utensils are unduly prescriptive and can warmer than the temperature of the shall be clean and sanitized prior to use, deprive official plants of the flexibility eggs to be washed, throughout the and during operations the machines to innovate in regard to equipment and cleaning cycle shall be cleaned and sanitized utensil sanitation. The equipment and • § 590.520(g), states that a suitable approximately every 4 hours or more utensil sanitation requirement that FSIS container conspicuously identified often if needed to maintain them in a is proposing to adopt for plants not only shall be provided for the disposal of sanitary condition. It also requires that provides flexibility but also clarifies rejected liquid the equipment be cleaned at the end of plant responsibility for selecting and • § 590.522(d), (h), (s), (t), (u), (v), (y), each shift. See also 9 CFR 590.552(a). maintaining equipment and utensils in (aa)(1)–(3), containing prescriptive The objective of the food-contact a manner that effectively prevents requirements for the cleaning of surface cleaning requirements has product contamination or adulteration. breaking machines and equipment, always been to mitigate biological, If this proposal is adopted, plants will including mechanical breaking chemical, and physical contamination no longer have to install and use machines, as well as other equipment that could adulterate product. The equipment that complies with the used in the processing of egg proposed food-contact surface cleaning applicable 3–A or E–3–A Sanitary products, such as cups, knives, racks, sanitary operations requirement in 9 Standards and accepted practices etc., dump tanks, drawoff tanks, and CFR 416.4(a) embodies this objective currently in effect for such equipment churns, strainers, filtering devices, and clarifies plant responsibility for (§ 590.502(b)). Instead, equipment and etc., and containers used for determining how best to achieve it. The utensils used for processing or transporting liquid eggs products advantage of this proposed standard is otherwise handling edible product or • § 590.538, concerning the that it would provide plants with the ingredients will only have to be of such construction and cleaning of flexibility to innovate when determining material and construction as to facilitate defrosting facilities how to mitigate biological, chemical, thorough cleaning and be durable and • § 590.539(f), concerning the cleaning and physical contamination that could suitable for its intended use. Plants will of crushers and other equipment used adulterate product. For this reason, need to ensure that product is not in defrosting operations therefore, FSIS is proposing to remove contaminated, adulterated, or • § 590.540(h), requiring the the egg products inspection regulations misbranded during processing, construction of powder conveying discussed above, as well as following handling, or storage. Equipment and equipment as will facilitate thorough utensils will still need to be maintained sections, and replace them with the cleaning sanitary operations requirement in 9 in sanitary condition so as not to • § 590.542(b)(2) and (c)(1), requiring contaminate or adulterate product. In CFR 416.4(a): the sanitizing of spray process drying • addition to 9 CFR 590.502(b), FSIS is equipment within 2 hours prior to § 590.504(i) and (k), requiring the also proposing to remove the following resuming spray drying operations and removal, cleaning, and sanitizing of sections from 9 CFR part 590 because 9 the clearing of sifters and conveyers utensils and equipment that are CFR 416.3 will make them redundant: used for other than dried albumen contaminated during the course of • § 590.500(n), requiring suitable powder when such equipment is not processing egg products and facilities for cleaning and sanitizing to be used for 24 hours or longer containing the admonition that all utensils and equipment at convenient • § 590.548(b)(3)–(5), which requires reasonable precautions be taken to locations throughout the plant that equipment and utensils used in avoid soiling or contaminating the • § 590.504(f) and (n), requiring dried eggs be kept off the floor and be surface of any package or container personnel handling utensils or kept clean at all times and whenever liner which is or will be in direct containers which may come into contaminated be cleaned and contact with egg products • contact with egg products to wash sanitized. It also requires that all § 590.515(a)(4), which states that their hands and maintain them in a equipment used to mechanically wash water will be changed every clean condition and requiring most package dried egg products be four hours or more often, if needed, to utensils and equipment to be clean vacuum cleaned daily maintain sanitary conditions and at and sanitized at the beginning of • § 590.560(c) and (d), prohibiting the end of each shift • processing operations and kept clean personnel affected with any § 590.522(x), (z), and (aa)(2), requiring and sanitary during all processing communicable disease in a that containers for holding egg operations transmissible stage or a carrier of such products variously be washed, rinsed, • § 590.506(a), which states that the disease, or affected by a list of other sanitized, and drained immediately equipment shall be arranged to health conditions, from coming into prior to use and cleaned after each facilitate cleaning and the removal of contact with equipment used to use. The pipelines of systems for refuse and excess packing material process eggs. Paragraph (d) requires pumping egg liquid directly from egg from the candling and transfer room workers coming in contact with breaking machines must be cleaner or • § 590.508(c) and (d), requiring the equipment to wear clean outer flushed as often as necessary to handling of shell eggs in a manner to uniforms maintain them in a sanitary condition, minimize sweating prior to breaking and they must be cleaned and and placing shell eggs with Food-Contact Surface Cleaning and sanitized at the end of each shift. extensively damaged shells, unless Sanitation—9 CFR 416.4(a) Other pumping system equipment otherwise prohibited, into leaker trays The egg products inspection must be cleaned and sanitized at least • § 590.515(a)(1) and (b), requiring that regulations require that egg products every four hours or sooner to maintain shell egg cleaning equipment be kept plants clean food contact surfaces at the it in sanitary condition

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• § 590.539(e), which states that • § 590.548(b)(3), requiring that dry spoons, liquid egg pails, and other sanitary methods will be used in blending equipment and supplies be breaking equipment every 21⁄2 hours. handling containers and removing egg kept off of the floor If adopted, the sanitary operations product requirement in 9 CFR 416.4(d) will • § 590.542, which includes Cleaning Compounds and Sanitizers—9 consolidate the concepts in all of these prescriptive requirements for CFR 416.4(c) operational sanitation requirements maintaining sanitary conditions in Section 590.504(h) of 9 CFR requires (which are discussed in this preamble spray process drying operations that FSIS approve detergents, wetting and are currently spread throughout • § 590.544(c) and (d), which states that agents, or other similar compounds, §§ 590.500–575) in a single place and dry blending must be done in among other things, before they can be remove them from the egg products accordance with § 590.548 or in a used within an official plant. Section inspection regulations. Plants will be closed blending system and in 590.552(b) of 9 CFR states that required to protect egg products from accordance with clean, sanitary sanitizing shall be accomplished by adulteration during processing, practices. Edible dried egg powder such methods as approved by the handling, storage, loading, and may be reconstituted, repasteurized, Administrator and requires the approval unloading at and during transportation and redried when accomplished in a of chemicals and compounds used for from their premises. clean, sanitary manner sanitizing by the Administrator before • § 590.548(b)(4), which includes use. These requirements are intended to Employee Hygiene—9 CFR 416.5(a) prescriptive requirements for ensure that egg products are not The current egg products inspection maintaining sanitary conditions in adulterated with chemicals or any regulations mandate specific employee drying, blending, packaging, and heat injurious substance. hygiene practices which egg products treatment rooms and facilities. FSIS is proposing to replace 9 CFR plants must adopt. For example, plant 590.504(h) and 552(b) with proposed 9 personnel handling exposed edible Non-Food-Contact Surface Cleaning and CFR 591.1 and the single sanitary product must wash their hands before Sanitation—9 CFR 416.4(b) operations requirement in 9 CFR beginning work and upon returning to If this proposed rule (proposed 9 CFR 416.4(c), which states that cleaning work after leaving the work room 591.1) is adopted, official plants that compounds and sanitizing agents must (§ 590.560(e)). Section 590.560(f) states process egg products will have to keep, be safe and effective under the that expectorating or other unsanitary in accordance with 9 CFR 416.4(b), non- conditions of use, and that plants would practices are not permitted in official food-contact surfaces, such as floors and not be required to obtain prior approval plants. walls, free of any biological from FSIS. If this proposed rule The proposed sanitation requirement contaminants, chemical contaminants, becomes final, plants that process egg in 9 CFR 416.5(a) requires that all or physical contaminants that could products would be able to use cleaning persons working in contact with adulterate egg products. FSIS is compounds and sanitizing agents that product, food-contact surfaces, and proposing to remove the following are safe and effective under the product-packaging materials adhere to sections and replace them with the conditions of use. They would have to hygienic practices while on duty to sanitary operations requirement in 9 use, handle, and store them in a manner prevent adulteration of product and the CFR 416.4(b) because this requirement that would not adulterate product or creation of insanitary conditions. It will give plants greater flexibility and create insanitary conditions and would, if adopted, allow plants to responsibility for developing sanitary maintain documentation to support that develop alternative or innovative means procedures specific to the nature of their these compounds and agents are safe to ensure that employee hygiene operations: and effective. Plants would, however, practices do not result in product • § 590.500(j) and (l)(1), requiring rooms have to meet the use requirements for adulteration, without being as and compartments in which shell eggs the substances promulgated by other prescriptive and restrictive as the or egg products are handled or regulatory agencies, such as FDA and current egg products inspection processed to be maintained in a clean EPA, who are responsible for ensuring regulations. Therefore, FSIS is and sanitary condition that these substances are safe for their proposing to remove § 590.560 and • § 590.504(g) and (h), prohibiting the intended uses. replace it with the proposed sanitation storage of products or materials that requirement in § 416.5(a). Operational Sanitation—9 CFR 416.4(d) create objectionable conditions in any Employee Clothing—9 CFR 416.5(b) room, compartment, or place where The egg products requirements for shell eggs or egg products are operational sanitation (sanitation The requirements regarding employee processed, stored, or handled and measures carried out during operations) clothing are prescriptive. For example, permitting only compounds approved are spread through a number of § 590.560(d) states that workers coming by the Administrator that will not regulations. (See 9 CFR 590.515 into contact with liquid or dried eggs, deleteriously affect shell eggs or egg concerning egg cleaning operations; containers, or equipment shall wear products when used in an approved § 590.516 concerning sanitizing and clean outer uniforms, while paragraph manner to be used in an official plant drying of egg shells prior to breaking; (h) of that section requires all persons in • § 590.515(b), prohibiting shell eggs and § 590.522 concerning breaking room breaking and packaging rooms to from being washed in the breaking operations.) properly wear hair nets or caps. Section room or any room where edible These requirements are unnecessarily 590.560(g) prohibits the use of tobacco products are processes prescriptive. For example, in any form or the wearing of jewelry, • § 590.522(m), stating that ingredients § 590.515(a)(4) requires an official plant nail polish, or perfumes in any area used in, or for, processing egg to change wash water approximately where edible products are exposed. products, must be handled in a clean every 4 hours or more often if needed As stated in the previous section, and sanitary manner to maintain sanitary conditions and at FSIS is proposing to remove § 590.560 • § 590.546(b), requiring that intake air the end of each shift. Section 590.522(s) and replace it with the sanitation sources be free from foul odors, dust, requires the cleaning and sanitizing of requirement in 9 CFR 416.5(b) and and dirt cups, knives, racks, separators, trays, proposed 9 CFR 591.1(a). If the

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proposed rule is finalized, cleanliness in Compliance Guide (Compliance Guide) to be effective for reducing illnesses employee hygiene would be required that presents or references methods from Salmonella spp. in egg products, without the prescriptiveness of already proven to be effective in FSIS has chosen to propose a standard § 590.560. Under 9 CFR 416.5(b), maintaining sanitary conditions in meat for egg products that requires them to be aprons, frocks, and other outer clothing and poultry products establishments, produced to be edible without worn by persons in plants processing which is posted on the Agency’s web additional preparation to achieve food egg products who handle product must page: http://www.fsis.usda.gov/wps/ safety. FSIS has chosen this approach be made of material that is disposable or portal/fsis/topics/regulatory- because in-plant inspectors cannot readily cleaned. Clean garments will compliance/compliance-guides-index/ effectively verify whether a plant has also have to be worn at the start of each sanitation-performance-standards. If met a specific lethality standard. The working day, and garments will have to this proposed rule is adopted, and Agency can, however, effectively verify be changed during the day as often as before it takes effect, FSIS will update whether Salmonella is present in an egg necessary to prevent adulteration of the Compliance Guide to include product through testing. Overall, this product and creation of insanitary methods that are effective in approach is simpler than that of log10 conditions. maintaining sanitary conditions in egg pasteurization performance standards and is consistent with the approach Employee Disease—9 CFR 416.5(c) products plants. Past FSIS regulations and guidance, as well as used by FSIS in establishing The sanitation requirement in 9 CFR recommendations from the current requirements for most RTE meat and 416.5(c) is similar to the requirements Model Food Code issued by FDA and poultry products. for employee health in § 590.560(c) to other technical sources, will be Meat and poultry establishments prevent transmission of communicable included or cited. produce the vast majority of their RTE diseases. FSIS is proposing to remove Plants that follow the products without needing to meet FSIS- § 590.560(c) and adopt proposed 9 CFR recommendations in the Compliance specified time and temperature 591.1 and 416.5(c) for egg products Guide could be reasonably certain that combinations or lethality performance plants. they will be meeting the sanitation standards codified in the regulations. Tagging Insanitary Equipment, Rooms, requirements. They would need to be The only FSIS regulations that include or Compartments—9 CFR 416.6 mindful, however, that each processing specific times and temperatures for ready-to-eat products are for cooked Retention tags or other devices and environment is unique, and that in some cases, the methods presented in the uncured meat patties, which must meet methods as may be approved by the or exceed the times and temperatures Administrator are used for the control Compliance Guide might require validating the adequacy to ensure listed in 9 CFR 318.23, and for pork, and and identification of equipment, products containing pork, which must utensils, rooms, or compartments in sanitary conditions or to prevent the adulteration of egg products. meet or exceed the times and official plants that are found to be temperatures listed in 9 CFR 318.10. unclean or otherwise in violation of the E. Egg Products Are ‘‘Ready-To-Eat’’ Cooked beef and poultry products must egg products inspection regulations 21 U.S.C. 1036(a) requires that egg meet the lethality performance (§ 590.426). This requirement is similar products inspected at an official plant standards listed in 9 CFR 318.17 and to the sanitation requirement articulated and found to be not adulterated be 381.150. FSIS previously removed in 9 CFR 416.6, which requires the pasteurized before they leave the official prescriptive time and temperature attachment of a ‘‘U.S. Rejected’’ tag to plant, except as otherwise permitted by requirements for other ready-to-eat meat any equipment, utensil, room, or the regulations of the Secretary. Any and poultry products from the meat and compartment at an official detectable pathogen would adulterate poultry regulations. Such prescriptive establishment that is insanitary, or the egg products under 21 U.S.C. 1033(a)(1) time and temperature requirements are use of which could cause the because it would contain a poisonous or not necessary because under the adulteration of product. Both deleterious substance which may render statutes, establishments need to produce regulations prohibit the use of tagged them injurious to health. Pasteurized ready-to-eat products (including egg equipment, utensils, rooms, or egg products are ready-to-eat; that is, products) so that no detectable compartments until they have been they have been prepared so that they pathogens exist in the final products. made acceptable and require the Therefore, FSIS is proposing to amend can be consumed as is, without any removal of tags by program employees. the egg products inspection regulations additional cooking. Therefore, FSIS is proposing to replace by removing the prescriptive regulations In 2005, FSIS undertook a § 590.426 with 9 CFR 416.5(c) and on the pasteurization of egg products (9 quantitative microbial risk assessment proposed 9 CFR 591.1. This proposed CFR 590.570 and .575). If this proposed to assist Agency risk managers in sanitation requirement for plants that rule is finalized, 9 CFR 590.570 would evaluating possible pasteurization process egg products would serve to be replaced by a new regulation performance standards for reducing the provide consistency between the egg specifying that egg products are ready- likelihood of Salmonella spp. products requirements and the meat and to-eat and do not require additional contamination in liquid and dried egg poultry requirements. steps to ensure food safety, consistent products, and, subsequently, for with the definition of ‘‘ready-to-eat’’ Sanitation Performance Standards reducing the risk of human illness, product in 9 CFR 430. Egg products Compliance Guide hospitalization, and death associated must be produced such that the finished 12 To meet the sanitation requirements with egg products. However, while the product is free of detectable pathogens. proposed in this document, egg risk assessment showed that In addition, egg products would not be products plants may develop and pasteurization resulting in a 6-log10 required to bear a safe-handling employ sanitation or processing reduction of Salmonella was predicted instruction or other labeling that directs procedures customized to the nature that the product must be cooked or 12 FSIS. 2005. Risk Assessments of Salmonella and volume of their production. Enteritidis in Shell Eggs and Salmonella spp. in Egg otherwise treated for safety. However, FSIS has developed a Products. (http://www.fsis.usda.gov/wps/portal/fsis/ The current requirements for egg Sanitation Performance Standards topics/science/risk-assessments). products mandate step-by-step

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processing measures and specifically this proposal, FSIS has rewritten this endangers public health. Therefore, prescribe minimal time and temperature section for clarity. FSIS is proposing to revise paragraph (e) combinations for the pasteurization While FSIS does not require final to 9 CFR 590.504 to make clear that egg treatment of various egg products. product testing for Salmonella in RTE products plants that move product that Under HACCP, these prescriptive meat and poultry products, the Agency has been sampled by the Agency or the requirements are not necessary. Under is continuing to require testing for plant before receiving test results must HACCP, egg products plants are Salmonella for RTE egg products by maintain control of the products required to produce product by official plants. An egg products plant’s represented by the sample pending the controlling, eliminating, or reducing Salmonella testing data continues to be test results. microbial hazards so that the finished important in monitoring process The Agency is not requiring the use product has no detectable pathogens. control.14 15 As part of its control of any particular control measures to Plants that choose not to develop new verification effort, FSIS also will ensure that product is not used or or modified procedures will be able to continue to collect and analyze samples distributed for sale before test results are continue to follow a set of from egg product processes for known. Instead, egg products plants pasteurization time and temperature Salmonella and Lm. may continue to use, or develop, their combinations for products that have While 9 CFR 590.504(o) states that egg own new, effective methods of control. products must be pasteurized before been validated as achieving the G. Irradiated Shell Eggs intended pathogen reduction, such as being released into consuming channels, those in the current regulations. FSIS 9 CFR 590.504(d) does permit Shell eggs that are subjected to has developed a draft compliance inspection program personnel to allow ionizing radiation may be used in the guideline document that includes these egg products to be moved from an production of egg products because procedures. The draft guideline official plant before the plant receives when applied at sufficient doses, document can be found at: http:// laboratory results for Salmonella, or any irradiation can be a means of destroying www.fsis.usda.gov/wps/portal/fsis/ other test results, if the plant retains disease-producing bacteria in food and topics/regulatory-compliance/ control of the product. The plant must result in a pasteurized product. compliance-guides-index. An official ensure that the product will be returned Specifically, food irradiation is the plant would then need to validate that to the plant for reprocessing if the test process of exposing food to high levels it is properly applying the FSIS time results show that the product is positive of radiant energy. Forms of radiant and temperature combinations provided for Salmonella. energy include: Microwave and infrared in the guidance material and conduct FSIS allows meat and poultry radiation that heat food during cooking; monitoring and verification activities to establishments to move product to visible light or ultraviolet light used to demonstrate proper execution of the locations other than the production dry food or kill surface microorganisms; selected combinations. facility prior to the receipt of FSIS test and ionizing radiation, resulting from The pasteurization time and results so long as the establishment cobalt-60, cesium-137, x-ray machines, temperature compliance guidelines maintains control of the product. It also or electron accelerators, that penetrates specifically will assist small and very permits them to package and label deeply into food, killing insect pests small businesses in identifying products sampled and tested for and microorganisms without validated procedures. The materials will adulterants with the mark of inspection significantly raising the temperature of be posted on the Agency’s website. pending negative test results, provided the food. Food is most often irradiated those products do not enter commerce, commercially to extend shelf life, F. Not Applying the Mark of Inspection i.e., the products remain under the eliminate insect pests, or reduce Pending Test Results establishment’s control until negative pathogenic microorganisms. Food As discussed previously, egg products test results become available. The irradiation for these purposes is inspected at an official plant and found product does not, however, actually practiced in many countries, including to be not adulterated must be receive the mark of inspection until the United States. pasteurized before they leave the official negative test results have been returned. Irradiation is subject to the food plant, except as otherwise permitted by The egg products regulations are the additive provisions of the FFDCA. FDA the regulations of the Secretary. They same. Egg products plants may move has the primary responsibility for must also bear the official inspection product pending test results only under determining whether food additives are legend and official plant number of the circumstances that will ensure the safe for particular uses. FDA lists uses plant where the products were return of the product to the plant for of food additives it has concluded are processed.13 reprocessing, or under such other safe in 21 CFR parts 172 through 179. 9 CFR 590.504(o) requires that egg conditions as the Administrator may Under section 201(s) of the FFDCA (21 products be pasteurized in accordance determine to ensure compliance with U.S.C. 321(s)), a source of radiation used with the egg products inspection part 590. FSIS’s practice of allowing egg to treat food is defined as a food regulations before being released into products to be moved pending receipt of additive. A source of radiation is used consuming channels, while paragraph results of tests done by FSIS or the plant to process or treat food such that, (o)(1) requires that they be sampled and is codified in 9 CFR 590.504(d). analogous to other food processes, its tested for the presence of Salmonella to Failure of an egg products plant to use can affect the characteristics of the ensure that they were adequately hold or maintain control of product food. pasteurized. 9 CFR 590.580 sets forth pending Agency or plant test results In a notice published in the Federal the specific testing requirements, and in Register on March 20, 1998 (63 FR 14 The current Salmonella sampling levels that 13675), FDA announced that a food 13 9 CFR 411(c)(5) requires that containers of egg products plants must meet are provided in FSIS additive petition (FAP 8M4584) had product bearing official identification display that Directive 10,230.4, Salmonella Surveillance been filed by Edward S. Josephson, identification and the plant number. Official Program for Liquid and Frozen Egg Products. University of Rhode Island, Food identification means the official inspection mark or 15 The USDA, FSIS Pasteurized Egg Products Lab any other symbol prescribed by the regulations in (PEPRLab) Program is a program for laboratories Science and Nutrition Research Center, part 590 to identify the status of any article. See 9 performing Salmonella analysis on official 530 Liberty Lane, West Kingston, RI CFR 590.5. surveillance samples of pasteurized egg products. 02892–1802, to amend the food additive

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regulations to provide for the safe use of the finished product labeling (proposed food safety protection, including ionizing radiation for the reduction of 9 CFR 590.410(a)(3)). adequate levels of enforcement. Salmonella in fresh shell eggs. H. Implementation of Regulatory I. Labeling and Other Consumer The petitioner submitted published Requirements Domestic Plants Protection Regulatory Requirements articles and other study reports containing data and information related All official plants will be subject to Official plants are responsible for to eggs and other kinds of food in the the requirements put forth in this ensuring that labeling used on egg areas of radiation chemistry, nutrition, proposal if it is adopted. FSIS intends products is truthful and not false or toxicology, and microbiology. FDA to phase in the HACCP requirements in misleading (21 U.S.C. 1036). They are considered the data and studies this proposal over a 2-year period after also responsible for ensuring that all submitted in the petition, as well as publication of a final rule, both as a labeling complies with the EPIA and the other information in its files relevant to means to reduce the impact for small egg products inspection regulations. To the safety and nutritional adequacy of and very small businesses and to ensure ensure that official plants comply with eggs treated with ionizing radiation. that FSIS inspection program personnel applicable statutory and regulatory Based on the totality of evidence from are properly trained and equipped with labeling requirements, FSIS conducts a all evaluated data and studies, FDA the tools to carry out the new prior approval program for labels used determined that: (1) The proposed use requirements for inspection. FSIS on federally-inspected egg products (9 of irradiation on fresh shell eggs at intends to enforce the Sanitation SOP CFR 590.411). Examples of label measures and the sanitation features that FSIS evaluates include the levels not to exceed 3.0 kGy is safe, (2) requirements one year after publication standardized, common or usual, or the irradiation can achieve its intended of a final rule because these regulations descriptive name of the product; an technical effect of reducing the numbers should involve less significant changes ingredients statement containing the of Salmonella in fresh shell eggs, and, for the plants, and these regulations common or usual name of each therefore, (3) it should amend 21 CFR provide the plant increased flexibility. ingredient listed in descending order of 179.26 to provide for the use of FSIS intends to enforce the predominance; and handling statements irradiation on fresh shell eggs. requirement that egg products be if the product is perishable. Consequently, on July 21, 2000 (65 FR processed to be edible without To obtain label approval, egg products 45280), FDA approved the use of additional preparation to achieve food plants must submit sketch labels to FSIS ionizing radiation on eggs in the shell to safety on the effective date of the rule. before they print the labels, containers, reduce the internal level of Salmonella. This requirement is consistent with or packaging materials that bear official It also amended its regulations by current regulatory and statutory identification (9 CFR 590.411(a)). The expanding the list of products (21 CFR requirements; FSIS tests samples from information submitted is evaluated by 179.26(b)) for which ionizing irradiation all egg products for Salmonella and Lm. the FSIS Labeling and Program Delivery may be safely used to include fresh shell FSIS will continue to do so should this Staff (LPDS) for conformance with the eggs. (While FDA does not define the rule become final. EPIA and the regulations adopted under word ‘‘egg,’’ FSIS has included the Under this proposal, FSIS would no it. definition contained in the EPIA in 9 longer control design specifications for Before July 1996, FSIS conducted a CFR 590.5.) buildings and equipment. Instead, FSIS prior approval program for meat and While the irradiation of fresh shell would focus its regulatory attention on poultry labels used on federally- eggs at the doses approved by FDA will determining whether an official plant is inspected meat and poultry products. reduce the level of microorganisms in successfully meeting sanitation As with egg products, the meat and shell eggs (65 FR 45281, July 21, 2000), requirements. Should this rule become poultry prior approval program was the irradiation treatment of shell eggs to final, plants would be required to intended to ensure that the labels be processed as liquid egg product will ensure that the design of buildings and applied to those products complied not sufficiently eliminate pathogens of equipment is appropriate for sanitary with the labeling and standards public health concern from this form of food production and for maintaining requirements of the Federal Meat egg. As a result, treating shell eggs used good sanitary conditions in accordance Inspection Act, the Poultry Products to process egg products only with with broad sanitation principles. In Inspection Act, and their implementing ionizing radiation will not result in a addition, official plants adopting regulations. final egg product that is completely Sanitation SOPs of their own design Effective July 1, 1996, FSIS modified pasteurized, i.e., RTE. Because the would identify the elements of good its prior label approval program for meat irradiation treatment approved by FDA sanitation required to prevent direct and poultry products by eliminating the is insufficient to produce a ready-to-eat product contamination, carry out their need for submitting final labels to the product based on the maximum Sanitation SOPs on a daily basis, and Agency. The Agency changed the approved irradiation dose specified in achieve acceptable sanitation results. previous program by requiring the 21 CFR 179.26, it must be used in submission of only sketch labels (i.e., combination with other lethality Foreign Plants printer’s proofs) and by expanding the treatments to complete the total lethality Under 9 CFR 590.910, to export egg types of labels that are generically required to result in a pasteurized, RTE products to the United States, foreign approved and that could be applied to egg product. countries will have to have a system of products in final form without first Under proposed 9 CFR 590.590, the inspection that is equivalent to the submitting such labels to the Agency for irradiation treatment must precede the system in the United States. Should this evaluation and approval (60 FR 67443, heat or other lethality treatment because rule become final, as HACCP and other Dec. 29, 1995). FSIS took this action to FDA has not approved the use of regulatory provisions are implemented improve the label approval system by irradiation on egg products. Irradiated in the American domestic market, eliminating the need for industry to re- shell eggs or the use of the irradiated foreign countries that export egg submit sketches in final label form, contents of fresh shell eggs for inclusion products to the United States would be thereby reducing the number of labels in pasteurized egg products must be evaluated to ascertain whether their being submitted to the Agency for reflected in the ingredient statement on inspection systems provide equivalent approval.

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On November 7, 2013, FSIS published As with meat and poultry products, J. Rules of Practice a final rule that amended the meat and FSIS would select samples of Under the EPIA, FSIS ensures that egg poultry products inspection regulations generically approved labels from the products are wholesome, not to expand the circumstances under records maintained by official plants adulterated, and properly marked, which the labels of meat and poultry and plants certified under foreign labeled, and packaged. FSIS has broad products would be deemed to be inspection systems to determine authority to issue regulations to carry generically approved by the Agency. compliance with label requirements (9 out the provisions of the EPIA, Effective January 6, 2014, FSIS CFR 412.2(a)(2)). If the Agency finds including the authority to prescribe regulations only require four categories that an official plant is using a false or terms and conditions under which of meat and poultry product labels to be misleading label, it would institute the inspection will be provided and submitted to LPDS for approval, as proceedings prescribed in 9 CFR 500.8 maintained (21 U.S.C. 1035(b) and described in 9 CFR 412.1. FSIS requires to revoke the approval for the label. 1043). the submission of labels: (1) Intended Current 9 CFR 590.50 requires shell Currently, when FSIS refuses to for temporary approval; (2) for products eggs that are packed into containers inaugurate inspection in a plant, seeks produced under religious exemption; (3) destined for the ultimate consumer to be to withdraw inspection, or refuses to for products for export with labeling labeled to state that refrigeration is approve egg products markings, labels, deviations; and (4) with special required. However, on December 5, or containers, the Agency initiates an statements and claims as described in 2000, FDA amended 21 CFR part 101 to administrative action under 9 CFR § 412.1(c). All labels that do not fit into require that all shell eggs bear a safe 590.160. FSIS is proposing to replace 9 one of the four categories are eligible for handling statement. This statement, CFR 590.160(a)–(c) and (f)(1) with the generic approval. which is intended to inform consumers supplemental rules of practice As part of its effort to make the egg that there may be a risk associated with contained in 9 CFR part 500. These products inspection regulations as the consumption of eggs, and of the supplemental rules already apply to consistent as possible with the Agency’s ways that they can properly handle and meat and poultry products meat and poultry products regulations, prepare eggs in order to reduce such establishments. Should this proposed FSIS is proposing to modify the prior risks, specifically instructs consumers to rule become final, 9 CFR part 500, Rules label approval program for egg products keep eggs refrigerated (21 CFR 101.17). of Practice, would apply to egg products labeling. If finalized, the program will As a result, FSIS’s labeling requirement plants, as an official establishment or be consistent with the prior label essentially duplicates FDA’s, which establishment would include an official approval system that is in place for meat became effective on September 4, 2001. plant under proposed 9 CFR 591.1(b). and poultry products, including the Since it is FSIS’s intention not to FSIS is proposing to amend 9 CFR regulations that permit generically unnecessarily burden any parties with 500.2(c) to add 9 CFR 590.310 to the list approved labeling. Under this system, its regulatory requirements, FSIS is of regulatory citations under which an only labeling that meets the criteria establishment 16 may appeal a described in 9 CFR 412.1 will have to proposing to state in its regulations that shell eggs packed into containers regulatory control action. FSIS is also be submitted to FSIS for evaluation and proposing to amend 9 CFR 500.3(a)(7) to approval. destined for the ultimate consumer must be labeled in accordance with 21 CFR allow FSIS to take a withholding action Therefore, FSIS is proposing to revise 101.17(h). or to impose a suspension without 9 CFR 590.411 to require all official providing an establishment prior Meat and poultry products that plants, including those certified under a notification because the establishment require special handling to maintain foreign inspection system in accordance did not destroy a condemned egg their wholesome condition are required with 9 CFR 590.910, to comply with the product that has been found to be to bear handling statements. To ensure requirements contained in 9 CFR 412.1. adulterated and has not been that the egg products inspection As a result, egg products plants will reprocessed, in accordance with 9 CFR have to submit only four categories of regulations will be as consistent as part 590, within three days of product labels to FSIS for approval, possible with the Agency’s meat and notification. including labels: (1) Intended for poultry products regulations, FSIS is FSIS is proposing to amend 9 CFR temporary approval; (2) for products proposing a similar requirement for 500.5(a)(5) and (c) to add 9 CFR 590.310 produced under religious exemption; (3) certain egg products, 9 CFR 590.410(a). to the list of regulatory citations under for products for export with labeling Under this proposal, packaged egg which it must advise an establishment deviations; and (4) with special products that require special handling that it may appeal a withholding action statements and claims as described in 9 to maintain their wholesome condition or suspension, and under which an CFR 412.1(c). would have to bear the statement ‘‘Keep establishment may appeal a withholding In addition, FSIS is proposing to Refrigerated,’’ ‘‘Keep Frozen,’’ action or suspension. FSIS is also revise 9 CFR 590.412 to require that all ‘‘Perishable Keep Under Refrigeration,’’ proposing to amend 9 CFR 500.6 by official plants, including those certified or a similar statement. This statement adding section 18 of the EPIA (21 U.S.C. under a foreign inspection system in would have to be prominently displayed 1047) to the statutory citations under accordance with § 590.910, comply with on the principal display panel. which the FSIS Administrator may file the requirements in 9 CFR 412.2. Under Similarly, egg products that are a complaint to withdraw a grant of this section, egg products plants would distributed frozen and thawed before or Federal inspection because a recipient be authorized to use generically during display for sale at retail would of inspection, or anyone responsibly approved labels and thus would be free have to bear the statement ‘‘Keep connected to the recipient, is unfit to to use such labels without submitting Frozen’’ on the shipping container. engage in any business requiring them to the Agency for approval, Consumer-sized containers for such egg inspection. provided the label displays all of the products would have to bear the statement ‘‘Previously Handled Frozen required mandatory features in a 16 For the purposes of Part 500, Rules of Practice, prominent manner and is not otherwise for Your Protection, Refreeze or Keep an official establishment or establishment includes false or misleading in any particular. Refrigerated.’’ an official plant. See proposed § 591.1(b).

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FSIS is proposing to amend K. Other Regulatory Changes Under this proposal, although there will no longer be a requirement for an paragraphs (a)(3) and (5) of 9 CFR 500.7 1. Elimination of Official Egg Products official plant to submit facility drawings to permit the FSIS Administrator to Plant Equipment and Facility refuse to grant Federal inspection and specifications when applying for a because an applicant has not Prior Approval Requirements grant of inspection, FSIS will continue demonstrated that adequate sanitary The egg products inspection to use a specific process to determine conditions exist in the establishment as regulations require that official egg whether to grant inspection. This required by the egg products inspection products plants applying for inspection process will still include an on-site regulations, or because the applicant is submit to FSIS multiple sets of drawings review, or ‘‘walk-through,’’ of the unfit to engage in any business requiring of and specifications for the facilities for plant’s facilities by FSIS inspection inspection as specified in 21 U.S.C. approval before inspection can be program personnel as part of the pre- decisional review of the facility’s 1047. FSIS is also proposing to amend granted (§ 590.146). The regulations capability to produce complying 9 CFR 500.8(a) to allow FSIS to rescind require plans to be submitted to the product. However, the decision-making or refuse approval of false or misleading Agency for approval before any remodeling of facilities, and they process will no longer include the marks, labels, or sizes or forms of any review and prior approval of facility container for use with any egg product require that prior approval by FSIS be obtained for equipment and utensils blueprints and specifications by the under sections 7 or 14 of the EPIA (21 Agency. The on-site review will not U.S.C. 1036 and 1043). If this proposal proposed for use in preparing edible product or product ingredients in involve matching items on the is adopted, 9 CFR 500.8(c) will provide blueprints with the actual facilities official plants (§§ 590.146(d), 590.502, for an opportunity for a hearing, in represented. Instead, the focus of the accordance with the Uniform Rules of 590.504). The prior-approval process is a review will be on the extent to which Practice, 7 CFR subtitle A, part 1, the facility is able to maintain a sanitary feature of the traditional ‘‘command- subpart H, if FSIS rescinds or refuses environment for food production and and-control’’ regulatory approach. approval of false or misleading marks, not impede government inspection. While prior approval provides labels, or sizes or forms of any container Prior approval by FSIS of equipment assurance that equipment, facilities, and for use with any egg product. and utensils proposed for use in processes, as designed, meet certain Should this rule become final, FSIS preparing edible egg products or requirements that are intended to ensure product ingredients will also be would take a withholding action or food safety or quality, it also reflects the eliminated under this proposal. FSIS’s impose a suspension without providing emphasis of the current egg products one-time approval does not address the plant prior notification because: (1) inspection system on dictating the way daily operational issues such as proper The official plant does not have a in which official plants maintain maintenance and adjustment of HACCP plan as specified in 9 CFR sanitation and produce safe food. This equipment to prevent product 417.2; (2) the official plant does not feature of the current system is contamination. Such issues are covered have Sanitation Standard Operating inconsistent with FSIS’s view of the by the requirement in 9 CFR 416.3 that Procedures as specified in accordance appropriate allocation of responsibility equipment and utensils be of such with 9 CFR 416.11 and 416.12; or (3) the between the Agency and official plants. material and construction that they can official plant does not maintain sanitary It is an obstacle and too often a deterrent be thoroughly cleaned and sanitized, as conditions (9 CFR 500.3(a)). FSIS would to innovation by official plants seeking well as by other general sanitation also take these actions when facilities to improve operations, and it requirements. apply for a grant of inspection and the contributes to unproductive use of FSIS While facilities will be required to applicant or recipient, or anyone resources both in managing the approval meet the general sanitation responsibly connected with the system and policing official plants’ requirements prescribed in the applicant or recipient, is unfit to engage compliance with approved facility and regulations, they will have the in business because of prior criminal equipment specifications. flexibility to determine the specific convictions, or when plant personnel Experience has shown that FSIS prior steps to be taken to comply with those assault, intimidate, or interfere with approvals are of limited value in requirements. Facilities will be able to Federal inspection service (21 U.S.C. ensuring good sanitation. They are use equipment based on their own 1047). limited in both scope, in that they deal evaluation of their ability to utilize the only with official plant facilities as The proposed rules of practice will equipment in a sanitary way. presented in drawings, and time, in that In its inspection activities, FSIS will ensure that enforcement procedures are they are given once, on the condition verify that plant equipment meets those fair; identify situations that may lead that official plants will maintain a general standards. FSIS inspection FSIS to take enforcement action that sanitary operating environment after program personnel will act if they find may include refusing to apply or their facilities are approved. Ultimately, that the equipment that a facility is withholding the marks of inspection an official plant’s implementation of using creates an insanitary condition from product or suspending or good Sanitation SOPs on a continuing that may render product injurious to withdrawing inspection from facilities; basis is more critical than the actual health. provide an opportunity for official design of a facility. Plant-operated plants to address and correct problems sanitation procedures will achieve, 2. Eggs and Egg Products Import before the Agency files a formal without prior approval, the same Requirements administrative complaint to suspend or objectives as the FSIS prior approvals, FSIS is proposing to amend the withdraw inspection; establish the thereby rendering the prior approval regulations governing the importation procedures FSIS will follow in taking procedures unnecessary. Thus, under and inspection of foreign eggs and egg such actions; and consolidate the rules HACCP-based inspection, the FSIS prior products to align them more closely of practice applicable to official plants approvals could no longer be considered with the regulations governing the with those applicable to meat and an efficient and cost-effective means to importation of foreign meat and poultry poultry products establishments. achieve sanitation objectives. products. Historically, significant

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differences have existed in how FSIS FSIS is addressing those shipment from other product shipped makes determinations of eligibility for circumstances in which a shipment of elsewhere from the same production lot. the import of meat and poultry products imported egg products may be rejected Including shipping and identification to the United States as opposed to for container defects, but are otherwise marks on the shipping container labels determinations for imported egg found to be acceptable, by proposing to facilitates identification of the product products. Similarly, requirements and add a new paragraph (d) to 9 CFR in the event of a recall or compliance procedures for the reinspection of 590.945 to identify the conditions under investigation. imported products presented for entry which imported egg products 9 CFR 590.956 permits the relabeling into domestic commerce have been consignments with damaged containers of all egg products eligible for applied differently to meat and poultry may be reoffered for inspection. importation with an approved label products than to egg products. In this For the handling of imported egg under the supervision of an FSIS proposal, therefore, to improve import products, FSIS is proposing to amend 9 inspector at an official egg products program efficiency and food safety CFR 590.930 to require official import plant or other location. Under proposed controls, FSIS is seeking to harmonize inspection establishments that re- 9 CFR 590.411(f)(1), if the Administrator the requirements and procedures inspect egg products to meet the has reason to believe that any labeling, applicable to imported eggs and egg sanitation requirements in 9 CFR part including the size or form of any products with those applicable to 416. The sanitation requirements in 9 container in use or proposed for use, imported meat and poultry products. CFR part 416 address conditions within with respect to egg products is false or FSIS is proposing to amend 9 CFR establishments, such as facility and misleading in any way, the part 590 by adding a new subpart B, equipment sanitation, employee Administrator may direct that such use Imports (9 CFR 590.900 et seq.), that hygiene, and the development and be withheld unless the labeling or will contain the imported egg products implementation of sanitation standard container is modified so that it will not regulations. FSIS is proposing to amend operating procedures and associated be false or misleading, or the these regulations by adding 9 CFR recordkeeping requirements. formulation of the product is altered so 590.900, which includes paragraphs that FSIS is proposing to amend 9 CFR that it is not adulterated or would not define certain basic terms, Import 590.940 to establish official inspection cause misbranding. (Imported) and Offered for entry, and for marks for imported egg products. While 9 CFR 590.956 permits the product from eligible countries: Entry Current regulations require only that egg relabeling of all egg products eligible for (Entered). FSIS is also proposing to add products found to be acceptable for importation with an approved label, the term Official Import Inspection importation be properly labeled and proposed 9 CFR 590.411(f)(1) would Establishment consistent with the bear the inspection mark of the country permit only those products whose definition in the meat inspection of origin. FSIS is proposing that containers, labels, or packaging regulations. imported egg products bear the same materials are false or misleading to be FSIS is proposing to add a new 9 CFR mark of inspection that is applied to modified so that the containers or labels 590.901 to 9 CFR part 590 to establish imported meat and poultry products. are not adulterated or would not be the identity of inspected and passed Additionally, this section outlines a misbranded. Therefore, FSIS is imported egg products as domestic procedure for the pre-stamping of proposing to amend 9 CFR 590.956 to products. In so doing, the Agency seeks official marks of inspection on product permit only those egg products that to ensure that imported egg products containers prior to the completion of an have been refused entry into the United that bear the mark of inspection may be inspection assignment. These changes States solely because of misbranding to combined with inspected and passed are intended to help to facilitate the be brought in compliance with the domestic products for purposes of clearance of inspected product during labeling requirements of 9 CFR chapter further processing or sale in domestic the examination process when the III. An authorized representative of the commerce. product is not being held pending the Secretary will have authority to FSIS is proposing to amend 9 CFR receipt of laboratory test results. supervise any such compliance 590.910 to establish the process and FSIS is proposing to amend 9 CFR activities. criteria that the Agency will follow to 590.945 to clarify the procedures for the Under 9 CFR 590.965, egg products evaluate the equivalence of the treatment and handling of imported egg that have been inspected and marked by inspection programs of foreign countries products identified as ‘‘U.S. Refused USDA may be returned from foreign interested in gaining eligibility to export Entry.’’ Paragraph (a)(5) of that section countries. They are not considered egg products to the United States. This states that if the owner or importer fails importations within the meaning of 9 section also delineates the manner in to take the required action within the CFR part 590. Because such products which foreign governments will be time specified under paragraph (a)(4) of are inspected and passed U.S. product, required to maintain the equivalence of this section, the Department will take they are handled in the same manner as their egg products inspection programs, such actions as may be necessary to domestic products. FSIS is proposing to including their certification of eligible effectuate its order to have the product amend 9 CFR 590.965 to permit the re- establishments, separation of certified destroyed for human food purposes. The entry of inspected and passed egg from uncertified establishments, and Department shall seek court costs and products from foreign countries if they audits to verify the on-going fees, storage, and proper expenses in the are not adulterated or misbranded at the equivalence of food safety and HACCP appropriate forum. time of such return. The product may be controls in certified establishments. FSIS is proposing to amend 9 CFR subject to reinspection in an official FSIS is also proposing to prescribe the 590.955 to include shipping or plant before it can be released into manner in which foreign governments identification marks among the list of commerce. Such products would be are to certify eligible establishments to required items for the labeling of exempted from further requirements FSIS. Finally, proposed 9 CFR 590.910 imported egg products shipping under 9 CFR part 590, and returned includes provisions for the public containers. Shipping and identification shipments must be reported to the notification of determinations of marks are identifiers included on Administrator by letter prior to their equivalence made by FSIS of foreign egg product container labels to distinguish arrival at the United States port of entry. products inspection programs. product contained in a particular The proposed language will be

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consistent with that for returned United between the meat and poultry Egg, Egg product, Pasteurize, Processing, States inspected and marked poultry inspection regulations and the egg and and Shell egg packer. FSIS is proposing products (9 CFR 381.209). egg products inspection regulations, to revise the definition for the term 9 CFR 590.960 provides an exemption FSIS is proposing to remove the term Administrator to make reference to the from foreign export certification and Sanitize from 9 CFR 590.5. FSIS Administrator instead of the AMS import inspection requirements for FSIS is also proposing to remove the Administrator. This change reflects the imported egg products that are intended definition for the term Eggs of current fact that the authority for inspecting egg for an importer’s personal use, display, production. ‘‘Eggs of current products under the EPIA’s food safety or laboratory analysis or that are not production’’ are those eggs that have provisions was delegated by the intended for sale or distribution in moved through the usual marketing Secretary of Agriculture to FSIS from domestic commerce. FSIS is proposing channels since the time they were laid AMS in November 1994. to extend the 50 pound exemption for and are not in excess of 60 days old.17 Because the term Dirty egg or Dirties dried egg products to liquid or frozen AMS uses the concept of ‘‘eggs of is defined twice in 9 CFR 590.5, once as egg products, which may currently not current production’’ to maintain the an undesignated stand alone term and exceed 30 pounds in weight. This integrity of its quality standards and the once as a definition under the term Egg proposed change is consistent with the AMS grade shield. It is a quality, not a (paragraph c)), FSIS is proposing to personal exemption provisions for food safety, indicator. Therefore, FSIS is eliminate this redundancy by removing imported meat and poultry products, proposing to remove the term because the undesignated stand-alone term and which permit any product in a quantity continued application of the regulatory its definition of Dirty egg or Dirties. of 50 pounds or less which was requirement may unduly restrict the While the definition of Dirty egg or purchased by the importer outside of availability of edible eggs. However, Dirties in paragraph (c) of the term Egg the United States for his/her own FSIS is requesting comments on is properly located, FSIS is proposing to consumption to be imported into the whether it should keep the term ‘‘eggs revise it. The definition includes United States from any country without of current production,’’ and any support prominent stains as a criterion for compliance with the provisions of that the term is still necessary. classifying an egg as ‘‘dirty,’’ but the chapter III of title 9. Finally, FSIS is proposing to remove EPIA’s definition of the term does not On September 19, 2014, FSIS the definition for the term ‘‘plant.’’ include this criterion (21 U.S.C. published a final rule amending 9 CFR Under this definition, the term ‘‘plant’’ 1033(g)(3)). In addition, rather than 590.915 and 590.920 to provide an can refer to an exempted plant, i.e., a being called ‘‘dirties,’’ dirty eggs are electronic alternative to the paper-based plant where the Administrator has referred to as ‘‘dirts’’ in 7 CFR 59.720, import inspection application and the determined that the facilities and which the Agency is proposing to add foreign inspection and foreign plant operating procedures meet the standards to the egg products inspection certificate processes (79 FR 56220). It prescribed in part 590, and where the regulations. Consequently, FSIS is also removed from the regulations the eggs received or used in the proposing to delete the words discontinued ‘‘streamlined’’ import manufacture of egg products contain no ‘‘prominent stains’’ from the definition inspection procedures for Canadian more than restricted eggs than are of Dirty egg or Dirties in the regulations. product. The Agency is reproducing the allowed by the official standards of U.S. Also in 9 CFR 590.5, FSIS is amended regulatory text in the codified Consumer Grade B for shell eggs, and proposing to replace the term Official text of this rule for context and clarity. where an exemption has been granted, standard with the term Official It is not, however, amending that text. or an official plant, which means any standards, correcting a typographical error made when the term was 3. Changes to Defined Terms plant in which the plant facilities, methods of operations, and sanitary transferred from 7 CFR chapter 1, part FSIS is proposing to amend the egg procedures have been found suitable 59 to 9 CFR chapter III, part 590 on and egg products inspection regulations and adequate for the continuous December 31, 1998 (63 FR 72352). by updating the terminology used to inspection of egg products in FSIS is also proposing to amend the refer to Agency personnel and the accordance with part 590 and in which definition of Processing, to make clear definitions of various terms. FSIS is inspection service is carried on. FSIS is that official plants may not repackage proposing to remove the undesignated proposing to remove this definition pasteurized dried egg products unless paragraphs of 9 CFR 590.5 that define because it is proposing to eliminate the inspection program personnel are Chief of the Grading Branch, Inspector/ exempted plant regulations, which is available to provide inspection Grader, National Supervisor, Regional discussed later in this document. FSIS oversight during the process. FSIS is Director, and Service because such proposing to amend the definition of is proposing to add, in alphabetical positions/entities do not exist within Pasteurize to eliminate the requirement order, an undesignated paragraph to 9 FSIS. As mentioned previously, FSIS that only lethality treatments prescribed CFR 590.5 defining ‘‘official plant.’’ An assumed responsibility for conducting in the egg products inspection ‘‘official plant’’ will be any plant in the egg products inspection program regulations may be used to destroy which the plant facilities, methods of from AMS on May 28, 1995. Therefore, harmful viable microorganisms. operation, and sanitary procedures have 9 CFR part 590 references should refer FSIS is also proposing to amend the been found suitable and adequate by the to FSIS and its officials. FSIS is also term Shell egg packer (grading station) Administrator for the inspection of egg proposing to remove the term Sanitize by removing the phrase (grading products pursuant to the regulations in from 9 CFR 590.5. As discussed earlier station). Grading station is a term used this part and in which inspection in this document, the Agency is by AMS to differentiate between the two service is carried on. primary types of egg handlers: (1) proposing to consolidate the current FSIS is proposing to revise the Producer-packers, who pack only their sanitation regulations applicable to undesignated paragraphs of 9 CFR 590.5 own production, and (2) grading official plants into 9 CFR 590.1 and part that define the terms Administrator, 416. While not explicitly defined, the stations, which are all other facilities concept underlying the term ‘‘sanitize’’ 17 On April 19, 2006, AMS amended its definition that segregate and pack eggs. While FSIS is explained in 9 CFR part 416. of ‘‘eggs of current production’’ to mean shell eggs also distinguishes between producer- Therefore, to eliminate this difference that are no more than 21 days old (71 FR 20288). packers and all other packing facilities

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in its regulations, the phrase (grading filtering, mixing, blending, pasteurizing, Administrator for review. Product from station), when included as part of the stabilizing, cooling, freezing, drying, or exempted plants may not bear official defined term itself, causes confusion packaging egg products. This level of identification (9 CFR 590.680(a)). because FSIS does not perform any inspection coverage is similar to that Exempted product labels must bear the grading functions. required at meat and poultry slaughter statement, ‘‘Exempted-E.P.I.A. FSIS is proposing to add to 9 CFR establishments, where FSIS conducts Registration No. __.’’ The registration 590.5 an undesignated paragraph that inspection during all slaughter number is that assigned to the exempted defines Program employee because it is operations. In contrast, at meat and plant as provided in 9 CFR 590.650. specific to FSIS and refers to Agency poultry processing establishments, FSIS The Agency’s proposal to no longer personnel. FSIS is also proposing to conducts inspection at least once per require inspection coverage during all define the phrase Shipped for retail sale. shift. processing operations removes the need Shipped for retail sale means eggs that Based on the Agency’s experience for this exemption. The circumstances are forwarded from the processing inspecting egg products plants since provided by this exemption can be facility for distribution to the ultimate 1995, the Agency believes that egg accommodated under FSIS’s changed consumer. products operations are more similar to interpretation of ‘‘continuous meat and poultry processing operations, inspection’’ in 21 U.S.C. 1034(a) and 4. Conditions for Receiving Inspection and especially those that produce ready- would allow such exempted plants to FSIS is proposing a 9 CFR 591.1(a) to eat products, than they are to meat bear official identification. Therefore, which, by cross-reference, will require and poultry slaughter operations, where FSIS is proposing to remove the specific that official plants, before receiving inspection is required for each meat or exemption from continuous inspection Federal inspection, develop written poultry carcass. Like ready-to-eat meat found in 9 CFR 590.100(b), as well as sanitation Standard Operating and poultry processing operations, the the regulations in 9 CFR 590.600– Procedures, in accordance with 9 CFR typical egg products processing 590.680 authorizing these types of part 416, conduct a hazard analysis, and operation is a streamlined, automated exempted egg products plants. The develop and implement a HACCP plan, process, with one or more lethality steps other exemptions from inspection for in accord with 9 CFR part 417. to destroy pathogens of concern in the certain types of egg products processing, Conditional inspection may be provided finished product. As a result, FSIS is provided at 9 CFR 590.100(e) and (g), for a period not to exceed 90 days, proposing to change the Agency’s would remain, but would be during which period the plant will have interpretation of ‘‘continuous redesignated as paragraphs (b)(1) and to validate its HACCP plan. inspection’’ in 21 U.S.C. 1034(a). (2). Paragraph (f), now reserved, would Therefore, FSIS now intends to require be removed. 5. Miscellaneous Changes inspection in egg products plants at III. Executive Orders 12866, 13563, and FSIS is proposing to amend the least once per shift, instead of during all 13771 and the Regulatory Flexibility following egg products inspection processing operations. FSIS welcomes Act regulations to match the text in the meat comment on possible criteria the and poultry products inspection Agency might use in determining how Executive Orders 12866 and 13563 regulations: inspection will be specifically adjusted direct agencies to assess all costs and benefits of available regulatory 9 CFR 590.118 Identification. in egg products plants. 9 CFR 590.120 Financial interest of Section 590.100 provides exemptions alternatives and, if regulation is inspectors. from continuous inspection under necessary, to select regulatory 9 CFR 590.136 Accommodations and certain circumstances, provided that the approaches that maximize net benefits equipment to be furnished by facilities for conditions for exemption and the (including potential economic, use of program employees in performing provisions of the regulations are met. environmental, public health and safety service. Paragraph (b) of 9 CFR 590.100 provides effects, distributive impacts and equity). 9 CFR 590.146 Survey and grant of an exemption from continuous Executive Order 13563 emphasizes the inspection. inspection at any plant where the importance of quantifying both costs 9 CFR 590.310 Appeal inspections. facilities, sanitation, and operating and benefits, or reducing costs, of FSIS is also proposing to eliminate procedures are the same as required in harmonizing rules, and of promoting the issuance of appeal certificates (9 part 590 for official plants and where flexibility. This proposed rule has been CFR 590.360) and the cost of an appeal the eggs received or used in the designated a ‘‘significant’’ regulatory to a plant (9 CFR 590.370). Under manufacture of egg products contain no action under section 3(f) of Executive current 9 CFR 590.300 and proposed 9 more restricted eggs than are allowed by Order 12866. Accordingly, the rule has CFR 590.310, official plants have the the official standards for U.S. Consumer been reviewed by the Office of right to appeal inspection decisions. Grade B shell eggs, and the egg products Management and Budget under processed at such plant. Plants granted Executive Order (E.O.) 12866. 6. Reinterpreting the Requirement for an exemption under 9 CFR 590.100(b) Continuous Inspection in 21 U.S.C. are called ‘‘exempted plants.’’ A. Need for Regulatory Action 1034(a) Instead of continuous inspection, The proposed rule will enable official The EPIA requires the continuous exempted plants are subject to periodic plants to increase efficiency from inspection of the processing of egg inspections, provided they have met the complying with less burdensome products whenever processing facility, operating procedures and regulations. FSIS is proposing that the operations are being conducted in each practices, and sanitation standards current ‘‘command and control’’ egg plant processing egg products for required for official egg products plants products inspection regulations be commerce (21 U.S.C. 1034(a)). FSIS has as contained in 9 CFR 590.500–590.580. changed to more flexible regulatory interpreted this to require the presence They are also subject to other provisions requirements. Under this proposed rule, of inspection program personnel at each applicable to official plants, which egg products plants would be required egg products plant whenever the includes maintaining records which to develop and maintain HACCP manufacturing of egg products is being must be made available to duly systems. A HACCP system allows conducted, including breaking eggs or authorized representatives of the greater flexibility for producers to

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realize increased production efficiency. because the Food Code recommends This proposed rule would require that In addition, the proposed rule will pasteurized egg products for highly egg products plants maintain sanitation allow plants to use different susceptible populations (FDA 2013 SOPs equivalent to the specifications of pasteurization methods. With 93 Food Code, Sec. 3–8). FSIS. Ninety-one percent of egg percent of egg products plants already products plants already conduct Baseline of the Egg Products Industry under a HACCP system,18 many have sanitation procedures for food contact incurred additional unnecessary costs Currently, egg products are produced surfaces either daily or more frequently from complying with FSIS requirements under FSIS jurisdiction by 77 egg and document those procedures for in terms of ‘‘command and control’’ products plants. Egg products include sanitation standard operating regulations and by processing under liquid, frozen, and dried whole eggs, procedures (Sanitation SOPs).23 their own HACCP systems. By operating whites, yolks, and various blends with Egg products production is easily the under the HACCP system alone, egg or without non-egg ingredients. least labor-intensive process of the products plants can use plant resources According to the FSIS Public Health industries and products that FSIS in a more efficient manner while Information System (PHIS) Database, we regulates. Egg products plants tend to be controlling for hazards in innovative estimate that the egg products industry highly mechanized and staffed with ways in their HACCP plans. produced 1.8 billion pounds of dried, relatively low numbers of employees. Furthermore, regulatory action is frozen, and liquid egg products for Based on the results of a 2014 industry warranted by the non-negligible public distribution in commerce and produced survey,24 no egg products plants employ health risks associated with pasteurized 4 billion pounds of liquid unpasteurized enough employees to be categorized as egg products. The FSIS 2005 risk product for further processing in 2014.19 HACCP size Large. Because of the high assessment estimated 5,500 cases of Liquid egg products are produced in 73 product volume output to low employee Salmonella per year due to pasteurized percent of plants and accounted for 19 count that egg products plants enjoy, liquid egg products. This represents percent of all egg products marketed as nearly all plants that have less than 10 0.5% of the approximately 1.03 million finished product in 2014.20 Liquid egg employees have over $2.5 million in annual domestically acquired foodborne products represent the largest product annual sales, making them ineligible for illnesses caused by Salmonella type produced by egg products plants. the HACCP size Very Small category. estimated by Scallan et al. (2011, A survey by RTI International in 2014, Therefore, the large majority (98 Emerging Infectious Diseases 17(1):7– Egg Products Industry Survey,21 showed percent) of egg products plants fall into 15). Gurtler et al. (2013, Foodborne that 93 percent of egg products plants the HACCP size Small category. In this Pathogens and Disease, 10(6):492–499) use a written HACCP plan to address at section, FSIS discusses the size of identifies four Salmonella outbreaks least one production step in their individual plants. For a discussion of during 2007–2012 that were possibly process.22 The remaining 7 percent the size of egg products businesses caused by contaminated pasteurized egg would need to create HACCP plans under the Small Business products. Also, process control failures under this proposed rule, as well as any Administration’s (SBA) definition, see in the production of pasteurized egg of the 93 percent of egg products plants the initial Regulatory Flexibility products have the potential for that have HACCP plans for some egg Analysis section of this document. especially serious health outcomes products, but not for others. Table 2 displays plants and processes.

TABLE 2—EGG PRODUCTS PLANTS AND TOTAL PROCESSES

Total Plants Breaking Liquid Dried processes

77 ...... 56 52 17 125

FSIS inspection of egg products plants finished products, the handling of receiving plant; egg products are includes 95 inspection program ingredients, pasteurization, packaging, blended, reconstituted, or reformulated; personnel (IPP), who conduct daily pre- labeling, freezing, storing, and all other egg products are pasteurized or operational sanitation inspections and operations related to the processing and packaged; and non-denatured inedible monitor sanitary conditions of the plant production of egg products. In the past, egg products arrive at, or are shipped premises, facilities, and equipment FSIS has determined through regulation from, the plant.25 continually during operations at every that, under the EPIA, IPP are required to Expected Cost of the Proposed Rule egg products plant in multiple shifts. conduct continuous inspection at egg FSIS IPP are responsible for observing products plants. This requirement Presented here are economic analyses the cleanliness, type, and means IPP must be on duty whenever for the breaking of shell eggs, the wholesomeness of raw materials and eggs are broken; liquid eggs arrive at the production of pasteurized liquid egg

18 RTI International. 2014. ‘‘Survey of Egg Packing 21 RTI International. 2014. ‘‘Survey of Egg Packing small establishments have fewer than 500 but more and Egg Products Processing Plants.’’ Revised Final and Egg Products Processing Plants.’’ Revised Final than 10 employees. Very small establishments have Report. RTI Project no. 0211740.015.001. 3040 Report. RTI Project no. 0211740.015.001. 3040 fewer than 10 employees or annual sales of less Cornwallis Rd., P.O. Box 12194 Research Triangle Cornwallis Rd., P.O. Box 12194 Research Triangle than $2.5 million. These definitions are outlined in Park, NC 27709–2194. OMB No. 0583–0162. Park, NC 27709–2194. Pathogen Reduction: Hazard Analysis and Critical 19 22 RTI International. 2014. ‘‘Survey of Egg Packing In the Fiscal Year 2014, the monthly average Control Point (HACCP) Systems (61 FR 38806 (July production volume was used to calculate the and Egg Products Processing Plants.’’ Revised Final 25, 1996) available at: http://www.fsis.usda.gov/ annual estimate for 77 egg products plants in the Report. RTI Project no. 0211740.015.001. 3040 PHIS database. Cornwallis Rd., P.O. Box 12194 Research Triangle OPPDE/rdad/FRPubs/93-016F.pdf. 20 In the Fiscal Year 2014, the monthly average Park, NC 27709–2194. 25 U.S. Department of Agriculture, Egg Products production volume was used to calculate the 23 Ibid. Inspectors Handbook. AMS PY-Instruction No. 910. percentage for 77 egg products plants in the PHIS 24 Under the HACCP size definitions, large January, 1975. database. establishments have 500 or more employees and

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products (including frozen egg that plants do a significant amount of of egg products plants.29 Using this data, products), and the production of analysis in their HACCP plan. Upon FSIS estimated the number of processes pasteurized dried egg products. Also completion of the hazard analysis and in those plants that require a HACCP provided are estimated government development of the HACCP plans, plan to be developed. This information costs associated with this proposed plants are required to determine is displayed in Table 3.30 regulation. All recurring and one-time whether their HACCP plans are cost estimates are in 2016 dollars, and functioning as intended. During the TABLE 3—PROCESSES WITHOUT discount rates of 3 percent and 7 initial validation period, plants are to WRITTEN HACCP PLANS percent are used to calculate annualized test, repeatedly, the adequacy of the costs over a 10-year period. For the CCPs, critical limits, monitoring and Total purposes of the cost estimate, FSIS did recordkeeping procedures, and Breaking Liquid Dried processes not consider plant HACCP size because corrective actions identified in the of the regularity in size explained HACCP plan.28 Plants are also required 9 ...... 12 3 24 previously (98 percent small). FSIS does to perform an annual reassessment of not anticipate costs experienced by Very their HACCP plans. For plan development and Small plants to differ greatly from those HACCP Plan Development and reassessment, FSIS used the Cost of experienced by Small plants, because Reassessment: Egg products plants Food Safety Investments 31 final report, this proposed rule does not require any operate to produce a variety of products updated for inflation from 2014 to 2016 major capital, structural, or machinery using a number of different processing dollars using the Consumer Price Index techniques. Under this proposed rule, investment or the hiring of additional (CPI) for Urban Consumers, and, with each plant would be required to employees, which can impose a large the assumed benefits factor of two. FSIS burden on Very Small plants. evaluate its processes to determine the estimates the costs for plan Egg products plant personnel adequacy of existing written HACCP compensation (wages and benefits) that plans and the number of plans that development and reassessment using plants would need to provide to their would need to be created or modified to the low estimate, (plan developed employees because of the proposed meet the requirements of the proposed internally—low estimate—$17, 130), the regulation is derived using Bureau of rule. A large number of egg products high estimate (plan developed with Labor Statistics Occupational plants already have HACCP plans for consultant—high estimate—$42,423), Employment Statistics wage rates and their processes. These plants will be and the average of the mid-estimates of National Compensation Survey benefits required to validate and reassess their the plan developed with a consultant percentages. The wage rate for a Quality HACCP plans annually, to ensure that and internally ($31,271).32 FSIS also Control (QC) manager is estimated to be their HACCP plans are consistent with incorporated an initial validation cost of $51.47 per hour; for Supervisors or QC the regulations that FSIS is proposing in $27,408 ($13,704–$41,112) and an technicians, $34.26 per hour; and for this document. For plants that currently ongoing (yearly) reassessment cost of Production workers, $13.00 per hour.26 lack HACCP plans, FSIS estimated the $28,188 ($14,094–$42,282) for all Plants may pay employees for benefits cost of initial plan development and HACCP plans. FSIS applied these such as paid leave, health insurance, validation and annual reassessment and estimates to the number of processes and retirement and savings, and FSIS validation. Under this proposed rule, needing HACCP plans to determine the applied a benefits factor 27 of two to the every egg products plant would be cost of HACCP plan development, hourly wage rate to estimate a total required to reassess the adequacy of the validation, and reassessment, displayed compensation rate for a Quality Control HACCP plan at least annually and in Table 4. (QC) manager at $102.94 per hour; and whenever any changes occur that could for Supervisors or QC technicians at affect the hazard analysis or alter the 29 See Appendix A, Section 4. $68.52 per hour; and for Production HACCP plan. Such changes may 30 For the purposes of the table, the number of workers at $26.00 per hour. include, but are not limited to, changes processes was rounded to the nearest whole Hazard Analysis & Critical Control in raw materials, source of raw number. For the purposes of cost calculations and Points (HACCP) Systems: The cost to be more exact, the Agency kept the actual figures, materials, or product formulation. For including digits past the decimal point, for estimates for HACCP implementation the purposes of estimating costs, FSIS instance, the number of total processes is actually include costs associated with plan simplified the production of egg 24.2507 rather than 24. These figures are not exact development and reassessment, products into three processes: the whole numbers because the Agency used the survey training, and monitoring and breaking of shell eggs, the production of participant responses for which processes they use, recordkeeping costs. If egg products pasteurized liquid egg products as percentages of the total survey responses. These plants follow current time/temperature (including frozen egg products), and the percentages were used to derive the total number regulations, FSIS would accept their production of pasteurized dried egg of establishments that use each process applying approach, and FSIS would not require that to the total population of egg products plants products. in Agency data (please see appendix A). Using these three process definitions 31 RTI International. Cost of Food Safety 26 Estimates obtained from the Bureau of Labor and data from PHIS, FSIS categorized Investments Final Report. Available at: https:// Statistics May 2016 National Industry-Specific plants by process. For reference, Table Occupational Employment and Wage Estimates, for www.fsis.usda.gov/wps/wcm/connect/0cdc568e- Management Occupations (Occupational Code 11– 2 above displays plants and processes. f6b1-45dc-88f1-45f343ed0bcd/Food-Safety- 0000), https://www.bls.gov/oes/current/ Using results from the 2014 Egg Costs.pdf?MOD=AJPERES. These cost figures were oes113051.htm#ind, Food Scientists and Products Industry Survey, FSIS applied adjusted for inflation using the average CPI–U from Technologists (19–1012), https://www.bls.gov/oes/ a distribution, by process, of plants 2014 to 2016. current/oes191012.htm, and Production responding affirmatively to having a 32 For plan development costs, in order to Occupations (51–0000) https://www.bls.gov/oes/ mitigate outliers, the Agency selected the greater of current/oes513023.htm. written HACCP plan to the population the two lowest costs between developing the plan 27 This analysis accounts for fringe benefits and internally and the cost for developing with a overhead by multiplying wages by a factor of two. 28 9 CFR 417.4. consultant for the low estimate, and the lesser of the two highest costs between developing the plan internally or with a consultant for the high estimate.

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TABLE 4—ESTIMATED HACCP PLAN DEVELOPMENT, VALIDATION, AND REASSESSMENT COSTS [$1,000s]

Annualized cost—3% Annualized cost—7% Cost component Initial cost Recurring cost (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) over 10 over 10 years

Development ...... 758.3 (415.4–1028.8) 0 86.3 (47.3–117.1) 100.9 (55.3–136.9) Initial Validation * for 25 New Plans ...... 667.4 (332.3–997.0) 0 75.6 (37.8–113.5) 88.4 (44.2–132.7) Annual Reassessment ** ...... 2,839.9 (1420.2–4,259.9) 3,523.5 (1,761.8–5,285.3) 3,445.7 (1,722.8–5,168.5) 3,432.5 (1,716.3–5,148.8) * These estimates are calculated using the actual number of unrounded processes or 24.2507 processes. ** ‘‘Initially, plants with existing HACCP plans will begin reassessing in year 1. Plants without existing plans, after developing their plans in year 1, will begin reas- sessing their plans in the following years.

The above analysis does not include based on the results of the Industry $1,995.65 to $5,986.94), with an annual costs associated with taking a corrective Survey). refresher at a cost of $205.88 ($102.94 to action when routine monitoring of a Although the HACCP system is $308.82). QC Technicians would be CCP detects a deviation from an different than the current system, FSIS trained initially at a cost of $3,165 established critical limit. It is not believes that in egg products plants, ($1,583 to $4,748), with an annual possible to determine the costs of these only a portion of production employees, refresher at a cost of $137 ($69 to $206). corrective actions, but we expect that, or a minimum number per shift, would An additional opportunity cost for for well-designed processes with actually receive training, given that the training was added to account for the HACCP, these costs would occur duties for most of the production time lost when employees were in infrequently. employees will remain very similar or training at the per hour compensation HACCP Training and Personnel: We even the same when the plant operates rate (including wage and benefit factor) assume that each egg products plant under HACCP. FSIS is seeking comment of the employees being trained for the will employ a QC manager and a QC on its assumed staffing and training cost length of the training and for technician to ensure compliance with estimates. replacement personnel to work covering the proposed measures. Based on the FSIS used initial and recurring annual the time of the training. Production 2014 Egg Products Industry Survey final refresher training cost estimates employees would also need to be report, approximately 7 percent of (updated using the CPI for Urban trained; however, FSIS assumed that plants do not employ any HACCP Consumers from 2014 to 2016 dollars this training would take place on the plans.33 Thus, we assume 7 percent of and the assumed benefit factor of two) job, and therefore would only impose plants (approximately five) will need to and the number of hours of training opportunity costs. We use an annual obtain training for a QC manager, from the Cost of Food Safety turnover rate of 27.9 percent 35 to assuming one per plant, and a QC Interventions 34 final report updated estimate recurring costs due to technician and three production with the assumed benefit factor of two. employee separation and the need to workers for each processing operation QC Managers would be trained initially train new employees. These estimates shift (an average of 1.7 shifts per plant at a cost of $3,991.29 (ranging from are displayed in Table 5. TABLE 5—HACCP-RELATED TRAINING COSTS [$1000s]

Annualized cost—3% Annualized cost—7% Plants Shifts Initial training costs Recurring training costs (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

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

HACCP Recordkeeping: The proposal HACCP plans. Plants with existing number of shifts at those plants.36 The requires facilities to record observations HACCP plans are already documenting cost of recordkeeping is dependent on when monitoring CCPs and to document CCPs, as well as documenting several factors, each of which has to be any deviations and corrective actions. information for the current regulations. documented in some manner, such as The rule requires that an employee not For these plants, there will be a cost the number of HACCP plans developed involved in recording observations savings and reduction in recordkeeping by each plant, the number of shifts certify such records. Recordkeeping costs, because they are keeping records operated by each plant, the number of costs include the time it takes to make for both a HACCP system and the CCPs per HACCP plan, the number of observations and to record the results of current regulations. pre-shipment reviews conducted, and those observations, plus the cost of FSIS used data from the 2014 Egg any decision-making for hazard analysis certifying and maintaining records. The Products Industry Survey to estimate that may require documentation. level and extent of recordkeeping for the how many plants do not have HACCP proposed rule should not change greatly plans, and the number of plans needed for egg products plants already using at these plants. FSIS also estimated the

33 See Appendix A, Section 5. f6b1-45dc-88f1-45f343ed0bcd/Food-Safety- 35 Ibid. 34 RTI International. Cost of Food Safety Costs.pdf?MOD=AJPERES. These cost figures were 36 See Appendix A, Section 6. Investments Final Report. Available at: https:// adjusted for inflation using the average CPI–U from www.fsis.usda.gov/wps/wcm/connect/0cdc568e- 2014 to 2016.

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The numbers of CCPs in egg products CCPs is five per egg products plant, per From the above assumptions, we plants likely vary considerably across plan. We assumed 3 minutes (+/¥ 1 estimate (Table 6) the annual cost of the industry. An FSIS technical expert 37 minute) for monitoring recordkeeping HACCP recordkeeping and monitoring. suggested four to six CCPs per HACCP and 1 minute (+/¥ 30 seconds) for The Agency seeks comment on the plan, as an average. Therefore, we certifying per CCP.38 FSIS is seeking number of CCPs anticipated, taking into assumed that the average number of comment on these time assumptions. account the variables listed above. TABLE 6—ANNUAL HACCP RECORDKEEPING AND MONITORING COSTS [$1000s]

Annualized—3% Annualized—7% Annualized—3% Annualized—7% Effective recordkeeping costs recordkeeping costs monitoring costs monitoring costs Plans annual (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) shifts over 10 years over 10 years over 10 years over 10 years

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

Table 7 presents a summary of the over 10 years at 3 percent and 7 percent total HACCP-related costs as a result of discount rates. the rule. These figures are annualized

TABLE 7—TOTAL HACCP-RELATED INDUSTRY COSTS [$1000s] *

Annualized costs—3% Annualized costs—7% Cost component (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

Plan Development and Reassessment ...... 3,607.7 (1808.0–5399.1) 3,621.9 (1,815.8–5,418.4) Training ...... 33.7 (16.8–50.5) 34.7 (17.3–52.0) Recordkeeping & Monitoring ...... 128.3 (75.5–181.1) 128.3 (75.5–181.1)

Total ...... 3,769.7 (1,900.3–5,630.7) 3,784.9 (1,908.6–5,651.5) * Numbers in table may not sum to totals due to rounding.

Sanitation Standard Operating then it has a written plan in place that FSIS used cost estimates from the Procedures (Sanitation SOPs) the training is based on and would Cost of Food Safety Interventions 40 likely meet the requirements of the final report, with labor costs updated for Plan Development: For the most part, proposed rule. FSIS then applied this inflation from 2014 to 2016 dollars and plants already have plans for sanitation percentage to determine the number of for the benefit factor described insofar as FSIS already requires certain plants that would need to develop previously. For plan development, FSIS sanitation procedures. FSIS used written sanitation SOPs (approximately estimated costs using the low estimate responses from the 2014 Egg Products 7). The current Sanitation SOP (plan developed internally—low Industry Survey 39, which describes the requirements for egg products plants estimate—$17,130), the high estimate number of plants where they train their will not change greatly, because the (plan developed with a consultant— employees on sanitation SOPs, to basis and standards for the sanitation of high estimate, $31,018), and the average estimate the percentage of plants that the plants will remain consistent with of the mid-estimates of the plan have sanitation SOPs. This accounts for the current guidelines. For the proposed developed internally and with a approximately 91 percent of all egg rule, the Sanitation SOPs will be created consultant ($27,469).41 The costs of products plants. FSIS assumed that if a by the plant to meet FSIS standards Sanitation SOP plan development are plant is training production employees, under the HACCP system. displayed in Table 8. TABLE 8—COSTS ASSOCIATED WITH THE DEVELOPMENT OF SANITATION SOPS [$1,000s]

Annualized cost—3% Annualized cost—7% Cost component Initial cost Recurring cost (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

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

37 Curtis, P., North Carolina State University, 38 FSIS estimated these approximate time 41 For plan development costs, in order to Raleigh, NC. October 5, 2001. Personal estimates by first hand observation at egg products mitigate outliers, the Agency selected the greater of communication with Catherine Viator, RTI. plants. the two lowest costs between developing the plan Reported in RTI International. 2002. ‘‘Pathogen 39 See Appendix A, Section 1. internally and the cost for developing with a Reduction and Other Technological Changes in the 40 RTI International. Cost of Food Safety consultant, and the lesser of the two highest costs Meat, Poultry, and Egg Industries.’’ RTI Project no. Investments Final Report. Available at: http:// between developing the plan internally or with a www.fsis.usda.gov/wps/wcm/connect/0cdc568e- 07182.017. 3040 Cornwallis Rd., P.O. Box 12194 consultant. f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs. Research Triangle Park, NC 27709–2194 pdf?MOD=AJPERES.

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Recordkeeping: Under the proposed based on the proposed sanitation SOPs number of shifts was calculated using rule, plants would be required to requirements will incur costs to do so. question 5.2 of the survey, which asks maintain daily records sufficient to For plants that are not keeping respondents their total number of document the implementation and adequate sanitation records, FSIS production shifts per day.44 The monitoring of sanitation SOPs. FSIS estimated costs of recordkeeping based responses by small and large plants to used data from the 2014 Egg Products on the frequency of reported question 5.2 were combined along with Industry Survey to estimate the recordkeeping tasks. FSIS assumed that the total responses to get percentages for proportion of plants keeping sanitation each sanitation recordkeeping task average number of shifts. The would be performed by a production records that would meet the calculation is 25% × 3 shifts + 18% × employee and would take requirements of the proposed rule 2 shifts + 57% × 1 shift = 1.7 shifts. approximately 15 minutes (+/¥5 consisting of employee task minutes) to complete. A sanitation FSIS further assumed that a QC performance and a log for deviations recordkeeping task would be performed technician would review records for 42 and corrective actions. FSIS then daily, unless the plant reported approximately 10 minutes (+/¥5 determined how many of those plants performing a task more than daily, in minutes) once per day. FSIS used the are completing recordkeeping tasks which case FSIS assumed there would recordkeeping estimates and time daily.43 Those plants that are not be one task per shift (an average of 1.7 assumptions to estimate the cost to conducting recordkeeping or are shifts per plant based on the results of industry for Sanitation SOP conducting inadequate recordkeeping the Industry Survey). The average recordkeeping, displayed in Table 9.

TABLE 9—SANITATION SOP RECORDKEEPING COSTS [$1,000s]

Annualized—3% Annualized—7% Recordkeeping recordkeeping cost recordkeeping cost Current recordkeeping practices frequency Number of plants (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

In compliance with proposed rule ...... Daily * 17 0 0 Not in compliance with proposed rule ..... Daily 12 34.2 (22.8–45.7) 34.2 (22.8–45.7) * For number of plants, FSIS multiplies the percentages from the survey for each category by total number of plants (77). For the category >Daily, in compliance, the calculation of 77 × 22.8% yields 17.56. This count was rounded down to 17 plants to be consistent with the total num- ber of plants in the analysis of 77.

TABLE 10—SANITATION SOP MONITORING COSTS [$1,000s]

Annualized—3% Annualized—7% Recordkeeping monitoring cost monitoring cost Current recordkeeping practices frequency Number of plants (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

In compliance with proposed rule ...... Daily * 17 ...... Not in compliance with proposed rule ..... Daily 12 36.1 (18.0–54.1) 36.1 (18.0–54.1) * For number of plants, FSIS multiplies the percentages from the survey for each category by total number of plants (77). For the category >Daily, in compliance, the calculation of 77 × 22.8% yields 17.56. This count was rounded down to 17 plants to be consistent with the total num- ber of plants in the analysis of 77.

Training Costs: Egg products plants of shifts at those plants.45 FSIS assumed from the Cost of Food Safety that are implementing new sanitation that one QC Manager per plant, and one Interventions 47 final report updated for SOPs and those not in compliance will QC Technician and three production inflation from 2014 to 2016 dollars and also need to conduct initial training for employees per shift would be trained.46 with the assumed benefit factor of two. employees. Using data from the 2014 FSIS is seeking comment on these QC Managers would be trained initially Egg Products Industry Survey, FSIS assumptions. FSIS assumed the at a cost of $2,756 ($1,378 to $4,134) estimated the number of plants that will recurring training would occur for all 77 with an annual refresher at a cost of need to develop new sanitation SOPs plants. FSIS used initial and recurring $205.98 ($102.94 to $308.82). QC (see Table 11) and the average number annual refresher training cost estimates Technicians would be trained initially

42 See Appendix A, Section 2. 44 Please see Appendix A. 46 An FSIS expert has also agreed with the 43 At least 1 pre-operational sanitation inspection 45 See Appendix A, Section 3. Industry Survey and provided the likely staff of product contact zones per 9 CFR 416.13 and needing training at a typical egg products plant. 416.12(c). 47 See Footnote 33.

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at a cost of $2,342.97 (1,171.50 to trained, however, FSIS assumed that estimate these ongoing costs, FSIS used 3,514.46) with an annual refresher at a this training would take place on the job an annual labor turnover rate of 27.9 cost of $137 ($68.52 to $205.56). FSIS and therefore would impose only percent 48 and applied that percentage to added an additional opportunity cost to opportunity costs. the initial training costs. The Sanitation account for the lost hours when FSIS included recurring training costs SOP-related training costs due to the employees are in training. Production to account for labor separation and the rule are displayed in Table 11. employees would also need to be need to train new employees. To TABLE 11—ONE-TIME AND RECURRING SANITATION SOP TRAINING COSTS [$1000s]

Annualized cost—3% Annualized cost—7% Plants Shifts Initial training costs Recurring training costs (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

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

Table 12 presents a summary of the to the rule annualized over 10 years at total sanitation SOPs-related costs due 3 percent and 7 percent discount rates. TABLE 12—TOTAL SANITATION SOPS-RELATED INDUSTRY COSTS [$1000s] *

Annualized costs—3% Annualized costs—7% Cost component (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

Plan Development ...... 21.1 (13.2–23.8) 24.7 (15.4–27.9) Recordkeeping & Monitoring ...... 171.0 (97.3–244.8) 171.0 (97.3–244.8) Training ...... 181.7 (103.8–287.3) 188.7 (107.9–297.8)

Total ...... 373.9 (214.2–555.9) 384.5 (220.6–570.5) * Numbers in table may not sum to totals due to rounding.

Special Handling Statements on process egg products that are edible produce ready-to-eat egg products. This Labels: The proposed egg products rule without additional preparation to guidance document is designed to help requires ‘‘Keep Refrigerated’’ or ‘‘Keep achieve food safety. FSIS does not small and very small plants meet the Frozen’’ statements for all egg products anticipate that these plants will need to proposed regulatory requirements by that require special handling to change their pasteurization practices to providing the best practice maintain their wholesome condition. meet this requirement and therefore will recommendations by FSIS, based on the Plants currently include this not incur additional costs, except as a best scientific and practical information on egg products labels; part of their normal operations in considerations. FSIS is seeking therefore, this new requirement for the regards to complying with HACCP plan comment on this guidance document, verification and monitoring activities. industry should not create additional which is posted on the Agency’s web These verification and monitoring costs. page: http://www.fsis.usda.gov/wps/ Costs from Requiring Egg Products activities are discussed above as part of portal/fsis/topics/regulatory- Plants to Produce Egg Products That are the HACCP costs of this proposed rule Edible without Additional Preparation for recordkeeping and monitoring. FSIS compliance/compliance-guides-index. to Achieve Food Safety: The proposed has developed a Compliance Guideline Below, the total industry costs are rule requires that egg products plants for Small and Very Small Plants that presented: TABLE 13—TOTAL INDUSTRY COSTS [$1,000] *

Annualized costs—3% Annualized costs—7% Cost component (low estimate–high estimate) (low estimate–high estimate)

HACCP ...... 3,769.7 (1,900.3–5,630.7) 3,784.9 (1908.6–5651.5) Sanitation SOPs ...... 373.9 (214.2–555.9) 384.5 (220.6–570.5)

Total ...... 4,143.6 (2,114.5–6,186.6) 4,169.4 (2,129.2–6,220.0) * Numbers in table may not sum to totals due to rounding.

Agency Costs already have HACCP training from past term objective of the Agency is to Training and Personnel: FSIS employs inspection experience in meat and establish an inspection system where 95 egg products inspectors that poultry plants. For inspectors without inspection program personnel would be exclusively inspect egg products plants. prior experience, FSIS will need to train equally qualified to conduct inspection Some egg products plant inspectors them in the HACCP system. The long-

48 Annual total separations rate for nondurable Labor Turnover Survey, available at: http:// goods, Bureau of Labor Statistics Job Openings and www.bls.gov/news.release/jolts.t16.htm.

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activities at meat or poultry includes additional topics (e.g., Replacement inspectors will be establishments, and egg product plants. processing and slaughter inspection in a required during periods when egg The Agency anticipates that it will HACCP environment, rules of practice, products plant inspectors are being need to train 51 egg products inspection and fundamental food microbiology) trained. The Agency’s district offices personnel 49 and 24 meat or poultry that not all egg products plant personnel estimate the cost of replacement inspectors (non-egg products need to perform their job. The total costs inspectors to be $2,800 per person 51 for inspectors). Fifty-one of these inspectors (including travel, lodging, per diem, and inspection methods training and $700 will require a 4-week training course on training program) for the 4-week per person for egg products inspection HACCP methods called Inspection training program is approximately training. Consequently, the one-time Methods training, and 24 inspectors $6,000 50 per inspector, and the one- cost of replacement inspectors is already trained in HACCP inspection $159,600 derived from (51 × $2,800) and week egg product inspection training is × will be trained in egg product approximately $1,200 per inspector. (24 $700). Thus, the total one-time inspection. The inspection methods cost of training inspectors at egg Therefore, the one-time Agency training training for egg products inspection products plants is $494,400. Table 14 costs total $334,800 (51 × $6,000) + (24 personnel would be longer than for × provides the summary of the costs other plant personnel because it $1,200). associated with inspector training.

TABLE 14—INSPECTION PROGRAM TRAINING COSTS AT 3% AND 7% DISCOUNT RATES ANNUALIZED OVER 10 YEARS* [$1,000]

Annualized Annualized Cost component Number of IPP Cost per IPP One-time cost cost—3% over cost—7% over 10 years 10 years

Inspection Methods Training ...... 51 6 306 34.8 40.7 Egg Products Inspection Training ...... 24 1.2 28.8 3.3 3.8 Replacement IPP ...... 75 ...... 159.6 18.2 21.2

Total ...... 494.4 56.3 65.8 * Numbers in table may not sum to totals due to rounding.

Total Costs: Table 15 provides a the industry and Agency. The table at discount rates of 3 percent and 7 summary of the estimated total costs for includes annualized costs over 10 years percent.

TABLE 15—TOTAL COSTS [$1,000] *

Annualized costs—3% Annualized costs—7% Total costs (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

Industry: HACCP ...... 3,769.7 (1,900.3–5,630.7) 3,784.9 (1,908.6–5,651.5) Sanitation SOPs ...... 373.9 (214.2–555.9) 384.5 (220.6–570.5) Agency ...... IPP Training: 38.1 44.5 Replacement IPP ...... 18.2 21.2

Total ...... 4,199.9 (2,170.8–6,242.9) 4,235.2 (2,195.0–6,287.8) * Numbers in table may not sum to totals due to rounding.

The total annualized cost to the egg Expected Benefits of the Proposed Rule (further egg processors or retailers) products industry of the proposal is require the production of egg products The proposed rule will provide firms $0.002 per pound of aggregate egg to be done under the HACCP system. In in the egg products industry greater products ($4,143,600/1.8 billion addition, under a HACCP system, egg flexibility and incentives for innovation. pounds) at the 3 percent discount rate. products plants can attain quality Firms derive benefits from opportunities The cost of the proposed rule to the egg to innovate and employ more flexible accreditations such as one by the Safe products industry is minimal, and we production methods over time.52 Many Quality Food Institute, which allows egg do not expect the costs from this rule to egg products plants have already products plants to access different have impact on consumer prices. adopted the HACCP system for egg markets inaccessible to non-HACCP product processing. One reason for this adoption is buyers of egg products

49 FSIS Policy Development Staff (PDS) provided 50 This figure is a mean estimate of training costs 52 Coglianese, Cary & David Lazer. 2003. the number of personnel that will need training. from FSIS/OOEET Center for Learning. ‘‘Management-Based Regulation: Prescribing Private PDS estimated this number by contacting each 51 This is the average GSA per diem for meals and Management to Achieve Public Goals’’. Law & district manager in the field where egg products hotel multiplied by the number of days replacement Society Review 37. plants are located. inspectors would be needed to fill positions. http:// www.gsa.gov/portal/content/104877.

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processors. Academic literature (please egg products plants. It also allows egg two.59 Eliminating these two see next section) has also shown that an product plants to employ resources in a submission processes will save industry egg products plant’s choice to process manner that more efficiently produces approximately $61,600 annually under a HACCP system as a safe product instead of allocating discounted over 10 years at the 7 management tool can also be internally resources just to comply with FSIS percent rate. The Agency would save driven by efficiency gains.53 regulations. For instance, instead of approximately $58,498 annually A number of studies in the last few sampling product for time and discounted over 10 years at the 7 decades have shown important temperature, a plant can design a system percent rate. efficiency gains for food production in which its HACCP plan specifies industries after moving into a HACCP sampling products at a more convenient TABLE 16—INDUSTRY AND AGENCY system. In a study by Nganje and time in the process, allowing for better SAVINGS FROM THE ELIMINATION OF 54 Mazzocco in 2003, individual plants personnel resource management to AGENCY APPROVAL FOR PLANT AND in the red meat industry benefited from improve production efficiency. PRODUCT PROCESSING CHANGES implementing HACCP by gaining Another aspect of the reduced [$1,000s] * efficiency in production. In a study by administrative burden is a reduced need Henson et al. (2000) 55 on HACCP for FSIS approval for changes to plant Annualized Annualized adoption in the UK dairy industry, the operations that deviate from current Total savings savings—3% savings—7% authors also report similar benefits such regulations. For example, official plants over 10 years over 10 years as ‘‘the reduction in wastage, increases will no longer need to submit facility in product shelf life, and decreases in blueprints and specifications (plant Industry ..... 61.6 61.6 production costs.’’ 56 Agency ...... 58.5 58.5 changes) to the Agency when applying Total ...... 120.1 120.1 HACCP systems also enable firms that for a grant of inspection, nor will they purchase egg products plant products to need to obtain prior approval from FSIS * Numbers in table may not sum to totals reduce costs of raw materials for equipment and utensils proposed for due to rounding. inspection, specification, and use in preparing edible product or The HACCP plan provision of the 57 inventory. Given the efficiency gains product ingredients. The approval proposed rule will also give plants in different food production facilities process for a waiver to a regulation or flexibility to design their pasteurization under FSIS jurisdiction by for no objection to production changes and sampling procedures. Ninety three implementing HACCP, FSIS reasonably will also be eliminated if this proposed percent of egg products plants have expects that the egg products industry rule is adopted. These changes provide indicated that their plants conduct will gain some efficiency from HACCP cost savings to industry and the Agency microbiological testing in addition to implementation. and are quantified below. It takes those required by regulation.60 By Benefits from removing current industry on average 100 hours to make giving plants the option to sample as regulations: A large benefit from moving an industry submission as described determined in their HACCP plan, there away from the current regulatory above (waiver, plant blueprint, no may be a cost savings from sampling framework is the lessening of objection, or equipment use), including less. The proposed rule specifies that administrative burdens on plants and additional correspondence with FSIS. the final product must be produced to plant personnel. With the movement to The Agency spends an average of 69 be edible without additional preparation a HACCP-based system, IPP will change hours to review and approve each to achieve food safety. This standard how they inspect egg products plants by submission. FSIS is seeking comment provides flexibility to an egg products ensuring that plants’ HACCP systems on its estimates of the time it takes plant by giving it the necessary end are functioning as intended rather than industry to develop a submission and to result of pathogen-free products without inspecting for compliance with current respond to FSIS requests in connection specifying direct instructions on the specifications. This change in how with the submission. processing method. This allows plants inspection is done will allow for FSIS receives on average nine to find the most efficient processing or improved allocation of resources to submissions per year from egg products sampling methods to best fit their own more food- safety tasks and sanitary plants. The submission process involves production process and resources to verifications both for the Agency and for an egg products plant’s QC technician produce a pathogen-free product. providing the initial submission data Additional Benefits from Generic 53 Kay Cao, Oswin Maurer, Frank Scrimgeour and Labeling: Additional benefits include Chris Drake. 2004. ‘‘The Economics of HACCP and follow-up correspondence with (Hazard Analysis & Critical Control Point): A Agency personnel. This follow-up cost reductions for the Agency and for Literature Review, Agribusiness Perspectives correspondence includes responding to the egg products plants that submit Papers’’, Paper 64, ISSN 1442–6951. FSIS questions with supporting data. labels for changes to an existing label or 54 Nganje W.E. and Mazzocco M.A. 2003. ‘‘The for new label approvals. Currently, an Impact of HACCP on Factor Demand and Output The QC technician is paid an hourly Supply Elasticities of Red Meat’’. Journal of wage of $68.52 per hour, which egg products plant must submit a formal Agricultural and Resource Economics. includes a benefit rate of two.58 An application along with a sketch of a 55 Henson, S., Holt, G., and Northen, J. (2000). Agency reviewer would have a General product label to FSIS personnel for ‘‘Costs and benefits of implementing HACCP in the Schedule 13 salary, step 3, at $94.20 per approval, regardless of the change UK dairy processing sector’’. In L.J. Unnevehr (Ed.), (including a color or size change to a The economics of HACCP: Costs and benefits hour, which includes a benefit factor of (pp.347–363). label). If the proposed rule is finalized, 56 Kay Cao, Oswin Maurer, Frank Scrimgeour, and 58 Estimates obtained from the Bureau of Labor Chris Drake, The Economics of HACCP (Hazard Statistics May 2016 National Industry-Specific 59 Hourly rate, Washington, DC, Office of Personel Analysis & Critical Control Point): A Literature Occupational Employment and Wage Estimates, for Management https://www.opm.gov/policy-data- Review, Agribusiness Perspectives Papers 2004, Management Occupations (Occupational Code 11– oversight/pay-leave/salaries-wages/salary-tables/ Paper 64, ISSN 1442–6951 0000), https://www.bls.gov/oes/current/oes113051. pdf/2016/DCB_h.pdf. 57 Kay Cao, Oswin Maurer, Frank Scrimgeour and htm#ind, Food Scientists and Technologists (19– 60 RTI International. 2014. ‘‘Survey of Egg Packing Chris Drake, The Economics of HACCP (Hazard 1012), https://www.bls.gov/oes/current/ and Egg Products Processing Plants.’’ Revised Final Analysis & Critical Control Point): A Literature oes191012.htm, and Production Occupations (51– Report. RTI Project no. 0211740.015.001. 3040 Review, Agribusiness Perspectives Papers 2004, 0000) https://www.bls.gov/oes/current/ Cornwallis Rd., P.O. Box 12194 Research Triangle Paper 64, ISSN 1442–6951 oes513023.htm. Park, NC 27709–2194.

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the approval process for certain labels Approval final rule,63 the proposed Change in Inspector Coverage: Under will be streamlined, allowing egg generic label approval process for egg the proposed rule, FSIS inspectors products plants to use certain labels products could save industry would no longer provide inspection without submitting an application to approximately $16,000 annually, during all processing operations at each FSIS because the labels will be discounted over 10 years at the 7 egg products plant, but instead may be generically approvable.61 Labels that percent rate, from not submitting labels. provided once per shift. Therefore, will not qualify for generic approval The Agency would save approximately under the proposal, inspectors may include temporary approvals, labels for $61,000 annually, given that on average inspect several plants within a export only that bear labeling the review process takes approximately reasonable commuting distance (i.e., deviations, or labels bearing special one hour, and a reviewer would have a patrol assignments similar to meat and statements and claims. All other label General Schedule 13 salary, step 3 with poultry processing inspection). The types can be generically approved. a benefit factor of two,64 having a total Agency expects there to be salary Presently, many egg products plants use compensation of $94.20. savings associated with patrol special claims on their labels (e.g., assignments through a 3-year change in organic or free range) and so those labels TABLE 17—SAVINGS FROM GENERIC staffing. The Agency expects to reduce would not qualify for generic approval. LABELING the number of egg products inspectors The Agency estimates that by 10 inspectors in year 1, 10 inspectors [$1,000s] * approximately 80 percent of labels have in year 2, and 10 inspectors in year 3, prior approval for these claims.62 for a total reduction of 30 egg products If Annualized Annualized these prior approved producers make Total savings—3% savings—7% inspectors through attrition and other changes to the labels not involving savings over 10 years over 10 years movement of inspectors to other their pre-approved claims, they could positions in the Agency. qualify for generic labeling. Industry ..... 16 16 In addition to Agency savings, there The number of egg products labels Agency ...... 60.6 60.4 would be cost savings to industry submitted in 2015 was approximately Total ...... 76.7 76.4 because there would be a reduction in 520, and in 2016, the number rose to * Numbers in table may not sum to totals egg products inspector overtime and 708 labels. FSIS estimates that due to rounding. holiday hours, which industry pays for, approximately 50 percent of these new due to patrol assignments. labels would qualify for generic label Better Agency Resource Coverage: The Agency will incur costs for the approval each year. Generic approval Because all egg products plant additional travel inspectors will incur would reduce the recordkeeping burden inspectors will now be trained in on patrol assignments, and the loss of at the plant and Agency by about half HACCP and can staff FSIS-regulated overhead industry paid to the Agency the current levels. In order to estimate establishments other than egg products for overtime and holiday hours worked. cost savings through the generic labeling plants, the Agency will experience an Agency travel costs include mileage process, the number of future label improvement in inspection coverage. In increases for existing patrol assignments submissions was estimated based on the the egg products plants themselves, the and GSA cars for new patrol annual historic increase in submissions. Agency can also utilize HACCP trained assignments. Please see table 18 for a Using the industry cost savings of inspectors as relief inspectors. summary of total savings from the $25.00 per label from the prior label Currently, egg products inspectors can proposed changes in inspection approval system: Generic Label only work in egg products plants. coverage.

TABLE 18—TOTAL NET SAVINGS FROM CHANGES IN EGG PRODUCTS INSPECTION [$1,000] *

Annualized estimate—3% Annualized estimate—7% Agency over 10 years over 10 years

Costs: Changes in inspection coverage ...... 1,421 1,421 Savings: Reduction in salaries due to changes in inspection coverage ...... (2,046) (2,005)

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

Industry

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

Grand Total Net Savings ...... (5,428) (5,388) * Numbers in table may not sum to total due to rounding.

61 As required by 9 CFR 412, the Labeling and 62 This was an approximation made by a label Management Occupations (Occupational Code 11– Program Delivery Staff (LPDS) evaluates certain reviewer in the FSIS labeling group. 0000), https://www.bls.gov/oes/current/ sketch applications and all temporary applications 63 78 FR 66826. oes113051.htm#ind, Food Scientists and Technologists (19–1012), https://www.bls.gov/oes/ for meat and poultry products. All other meat and 64 Estimates obtained from the Bureau of Labor poultry product label applications may be current/oes191012.htm, and Production Statistics May 2016 National Industry-Specific Occupations (51–0000) https://www.bls.gov/oes/ generically approved without evaluation by LPDS. Occupational Employment and Wage Estimates, for current/oes513023.htm.

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In summary, the benefits from this be lessened, including those associated the quantified costs and cost savings to proposed rule include improvements in with submitting documentation to FSIS industry and the Agency if the proposed product quality, lower transaction costs, for changes to the plant and plant rule is implemented. The rule provides plant innovation, and generally lower processes, waivers, and most egg a net cost savings of between $1.3 operational costs. Additionally, the egg products labels, resulting in cost million and $1.4 million annualized products plants will not have to comply savings. Industry will also benefit from over 10 years at the 7 percent and 3 with the current ‘‘command and the reduction in overtime and holiday percent rates. control’’ regulations. By eliminating pay paid for the inspection of egg regulations, administrative burdens will products plants. Table 19 summarizes

TABLE 19—TOTAL COSTS AND NET BENEFITS [$1,000s] *

Annualized 3% mid estimate Annualized 7% mid estimate Costs (low estimate–high estimate) (low estimate–high estimate) over 10 years over 10 years

Industry: HACCP ...... 3,769.7 (1,900.3–5,630.7) 3,784.9 (1,908.6–5,651.5) Sanitation SOPs ...... 373.9 (214.2–555.9) 384.5 (220.6–570.5) Agency: IPP Training ...... 38.1 44.5 Replacement IPP ...... 18.2 21.2

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

Savings

Industry: Reduced Plant Approval Processes ...... ¥61.6 ¥61.6 Generic Labeling ...... ¥16 ¥16 Changes in inspection coverage ...... ¥4,803 ¥4,803 Agency: Reduced Plant Approval Processes ...... ¥58.5 ¥58.5 Generic Labeling ...... ¥60.6 ¥60.4 Changes in inspection coverage ...... ¥625 ¥585

Total Savings ...... ¥5,625 ¥5,585

Grand Total Net Benefits Mid (low to high) savings minus costs 1,424.8 (¥618.2 to 3,453.9) 1,349.5 (¥703.1 to 3,389.7) * Numbers in table may not sum to totals due to rounding.

Uncertainty Surrounding Public analysis to identify and list the products. This document updates the Health Impacts: Currently, the biological, chemical, or physical food current time and temperature regulations require specific times and safety hazards that are reasonably likely regulations based on the best available temperatures for egg products to occur in its production process for a scientific information.65 It provides pasteurization. If a plant wishes to particular product and the measures to ‘‘safe harbors’’ for egg products plants employ an alternative time and prevent, eliminate, or reduce the that FSIS considers as recognized temperature combination, the Agency occurrence of those hazards to an procedures that can be employed reviews scientific research or data acceptable level. The plant would also without any further validation studies. validating other methods of be required to identify the points in However, the plant would need to pasteurization (9 CFR 590.570(b)) and each of its processes at which control is validate that it is properly applying the issues a ‘‘No Objection’’ letters (NOL) necessary to achieve this goal (9 CFR FSIS time and temperature approving its use. The proposed rule 417.2(c)(2)). These points are called combinations provided in the guidance will eliminate the codified time and ‘‘critical control points’’ (CCPs). The material and conduct monitoring and temperature regulations and will require plant would have to establish critical egg products plants to process egg limits for the preventive measures 65 products in a way that will ensure that associated with each identified CCP. Gurtler, J.B., Marks, H.M., Bailey, R.B, Juneja, V. and Jones, D.R. 2013. Kinetics Model the products are free of detectable Plants would also be required to Comparison for the inactivation of Salmonella pathogens. Due to a lack of data, FSIS validate that their process works as Enteritidis and Oranienburg in 10% salted liquid is currently unable to compare food intended (9 CFR 417.4). The HACCP whole egg. Foodborne Pathogens and Disease. safety performance in egg products and Sanitation SOP framework will 10:492–499. plants operating under the current make FSIS inspection more efficient and Gurtler, J.B., Marks, H.M., Jones, D.R, Bailey, R.B, and Bauer, N.E. 2011. Modeling the thermal regulations to those plants operating in effective, because the egg products plant inactivation kinetics of heat-resistant Salmonella a HACCP system under NOLs with would be required to prevent food safety Enteritidis and Oranienburg in 10 percent salted differing pasteurization times and problems rather than react to problems liquid egg yolk. J. Food Prot. 74:882–892. temperatures from those prescribed in without preventing recurrence. Jordan, S.S., Gurtler, J.B., Marks, H.M., Jones, D.R. the current regulations. and Shaw, W.K. 2011. A mathematical model of FSIS has developed a Compliance inactivation kinetics for a four-strain composite of Under HACCP, an egg products plant Guideline for Small and Very Small Salmonella Enteritidis and Oranienburg in would be required to conduct a hazard Plants that produce ready-to-eat egg commercial liquid egg yolk. Food Micro. 28:67–75.

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verification activities in the plant’s Need for the Rule section. However, this production costs on to consumers. operating environment. proposed rule was chosen as the least Therefore, FSIS rejected this alternative. FSIS will continue to test egg burdensome, technically acceptable HACCP for large volume egg products products for Salmonella and Lm. If FSIS regulatory approach. plants: In this alternative, only plants detects pathogens in the product, plants Voluntary HACCP regulatory with a large production volume would that have identified the pathogen as program: A voluntary HACCP system be required to implement HACCP. This reasonably likely to occur in the HACCP would be very close to the current alternative would save Agency HACCP hazard analysis will be required to take system. In the current system, 93 training costs for inspection personnel, corrective actions to ensure that they percent of egg products plants already who inspect small production plants. identify problems that led to production of contaminated product, ensure no have implemented HACCP systems Small volume plants would be allowed adulterated product is in commerce, and integrated into their processing. Because to stay in a non-HACCP system, take measures to prevent recurrence. many plants have already changed to a lowering industry costs. This alternative Plants that have not identified the HACCP system, the Agency does not would need to have certain volume pathogen as reasonably likely to occur foresee any non-HACCP operations definitions to distinguish the type of would need to take corrective actions voluntarily implementing HACCP that plant considered in the alternative. A and reassess their HACCP plans in have not already done so. These plants difficulty associated with the size accordance with 9 CFR 417.3(b). would stay at status quo. Therefore, this definition process is that an egg Currently, when FSIS detects positives regulatory option would not lead to a products plant’s volume may change in egg products plants, the Agency significant change in current egg depending on the season or from response is limited to preventing the products plants processing practices. changes in its source eggs. These product from which the sample was However, there would be additional changes could affect the classification collected from entering commerce or costs, such as inspector HACCP training system, which is based on volume, and requesting that the producer recall its and the costs of inspecting a dual could create difficulties in identifying products. FSIS inspectors currently system. Also, under the current the plants most likely to be designated repeatedly issue noncompliance reports regulations, continuous inspection as large volume. Another drawback to at egg products plants with limited prevents inspectors from working patrol this alternative is the possible costs to improvements in operations. Therefore, assignments, which would save the small producer in the long run. it is possible that the HACCP industry overtime costs and Agency Although the low-production egg regulations will improve the operations resources. These savings would not be products plants may save initially on of egg products plants. fully realized in a dual system. For the costs by not implementing HACCP, this plants not operating under HACCP, alternative may hurt the plants’ long-run Alternative Regulatory Approaches there are possible consumer benefit efficiencies and competiveness because The Agency considered two losses as some plants may fail to they would not be gaining the flexibility alternatives designed to achieve the innovate and might continue to comply to innovate that they would by regulatory objective outlined in the with current regulation, passing producing under the HACCP system.

TABLE 20—REGULATORY ALTERNATIVES CONSIDERED

Alternative Costs Benefits

(1) Existing Voluntary Record- Additional costs for the Agency ..... No additional benefits. keeping. (2) HACCP only for large volume In the long run, small plants would Small volume producers would save on costs from not having to egg products plants. incur more costs from the lack change their production process and develop the requisite Sanita- of efficiency gains associated tion SOP and HACCP plans. Large volume producers would ac- with HACCP. quire benefits from implementing HACCP. (3) The Proposed Rule ...... ($1.34 million 66) annual cost sav- Achievement of regulatory objective of regulations consistent with ings to industry and to the other FSIS regulations, clear responsibility of Agency vs. industry, Agency. and additional flexibility for industry.

Initial Regulatory Flexibility Analysis: estimate that approximately 46 plants approximately 733 thousand (7 percent, The FSIS Administrator has made a are part of these larger companies, 10 years). preliminary determination that this leaving 31 plants that could be This results in an average cost savings proposed rule would not have a considered small businesses. In the cost to a plant of ($9,200/plant) annualized significant economic impact on a analysis above, FSIS estimated that the (7 percent, 10 years). The average substantial number of small entities in cost savings for the industry is revenue for egg products plants is the United States, as defined by the approximately $104.4 million.68 Regulatory Flexibility Act (5 U.S.C. 601 mentioned earlier in the document, because the Therefore, FSIS believes that the total et seq.). sizes are derived from the HACCP size rather than cost savings to revenue ratio per plant is .01 percent. FSIS is seeking public There are 77 federally-inspected a business size. In this section, FSIS does not need HACCP sizes for egg products plants for the comment on its conclusion of no plants. We estimate that at least 12 are Regulatory Flexibility Analysis. Instead, FSIS must significant impact on small entities. large businesses or companies with analyze egg products company or firm sizes instead 67 multiple egg products plants. We of an egg products establishment sizes. The HACCP 68 Derived from the RTI Industry Survey, Q.5.11, size of an establishment alone is not enough to the weighted average of the midpoints of the 66 This cost is annualized at the 7 percent verify whether it’s part of a larger business. To respondents’ answers to the level of annual revenue discount rate over 10 years. determine whether a business is small, FSIS earned in the year prior to the survey. Q.5.11 What 67 These figures differ from the number of plants analyzed whether egg products establishments were was the approximate value of egg product sales in HACCP size categories for small and large as part of larger companies. during the past year?

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FSIS has developed a Compliance percent. Fifty seven egg products plants Section 2 Recordkeeping for Sanitation Guideline for Small and Very Small completed the survey. Of these, 26 (46 SOPs Plants that produce ready-to-eat egg percent) completed the survey via mail products. This guidance document is and 31 (54 percent) completed the Web FSIS estimated the percentage of designed to help small and very small survey. FSIS used the survey results to plants that currently meet the proposed plants meet the proposed regulatory supplement the information that FSIS recordkeeping requirements using requirements by providing the best maintains in the Public Health survey question 2.2: ‘‘Which of the practice recommendations by FSIS, Information System. The responses to following records that are not required based on the best scientific and practical the survey were masked so that by FSIS does this plant maintain?’’ A considerations. FSIS is seeking individual plants could not be plant was considered to meet both if it comment on this guidance document, identified, so FSIS applied response answered affirmatively to choices 1— which is posted on the Agency’s web distributions to the larger population of ‘‘Employee task performance log page: http://www.fsis.usda.gov/wps/ egg products plants to approximate verification’’ and 2—‘‘Deviation and portal/fsis/topics/regulatory- baseline industry characteristics. In corrective action log.’’ compliance/compliance-guides-index. order to describe the egg products FSIS then determined the frequency Appendix A to Executive Orders 12866 plants, which are under FSIS’s at which sanitation tasks are performed and 13563 and the Regulatory jurisdiction, brief discussions of the using question 2.6: ‘‘How frequently 69 major findings of the survey have been Flexibility Act Analysis does this plant conduct sanitation placed throughout this Executive Order The 2014 Egg Products Industry inspections of product contact zones?’’ 12866 and 13563 discussion and the Survey, conducted and published by regulatory flexibility analysis and If a plant responded affirmatively to RTI International, surveyed footnoted accordingly. Please find the choice 1—‘‘More than once per shift,’’ it approximately 57 egg products plants link to the survey here: http:// was considered to be conducting with questions in regard to plants’ use www.fsis.usda.gov/wps/wcm/connect/ sanitation tasks at a frequency greater of HACCP plans, Sanitation SOPs, the df3e0400-aaa7-423f-bb11-ff080fc8ce2b/ than daily. If it responded affirmatively number of plant personnel, hours of to choice 2—‘‘Once per shift before shift operation and the number of shifts, and Survey-Egg-Products-09302014. pdf?MOD=AJPERES. operations begin,’’ and operates more current sampling practices. The survey than one shift daily (determined with design involved collaboration between Section 1 Sanitation SOPs question 5.2), then it was also FSIS personnel and RTI International. considered to be conducting sanitation The full-scale data collection took place FSIS estimated the percentage of over a 16-week period from February 17, plants that train production employees tasks at a frequency greater than daily. 2014, to June 9, 2014. The survey for Sanitation SOPs using question 4.5: If it responded affirmatively to choice 2 included 18 questions. The survey also During the past year, what types of food and operates a single shift per day, or provided information on production safety training did permanent if it responded affirmatively to choice volume, types of product, and employees of this plant receive? A plant 3—‘‘Once per day before daily production processes. The survey was was considered to train production operations begin,’’ it was considered to considered to be a census of the employees if it responded affirmatively be conducting sanitation tasks at a daily industry because all 77 egg products to choice b. Sanitation SOPs. 91.2 frequency. If it answered affirmatively plants currently regulated by FSIS were percent of respondents answered that to any other option, it was considered contacted and asked to respond. The employees receive Sanitation SOPs to conduct sanitation tasks less than response rate to the survey was 72 training. daily.

Records in compliance Records not in compliance Daily Daily

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

Section 3 Training for Sanitation SOPs Sanitation SOPs did not have a written 5.2—‘‘How many production shifts are plan. Then, FSIS estimated the number operated each day at this plant?’’ Only FSIS used the training estimates from of shifts of employees needing training those plants that do not provide HACCP Section 1 and assumed that any plant for Sanitation SOPs by averaging the training were included in the average. which did not provide training for reported number of shifts from question

No sanitation Needed Average Total Plants SOPs sanitation sifts shifts training SOPs

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

69 This Appendix describes how the Agency used that have Sanitation SOPs, HACCP plans, training, the type of product produced by egg products the 2014 Egg Products Industry Survey conducted number of shifts, and record keeping. plants and their use of HACCP plans. Section (5) and published by RTI International to gather Section (1) describes egg products plants’ use of describes the number of egg products plants with information on egg products plants relating to the Sanitation SOPs. Section (2) outlines the estimates HACCP plans. Section (6) estimates the average cost section of this proposed rule. Specifically, this for egg product plants’ recordkeeping for Sanitation number of shifts for egg products plants without Appendix outlines how the survey questions were SOPs. Section (3) describes egg products plants’ HACCP plans. used to estimate the number of egg products plants training for Sanitation SOPs. Section (4) describes

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Section 4 Use of HACCP Plans product form?’’ and answered 3—‘‘Used and Addressed in a Written affirmatively to choice e—‘‘Dried’’—or HACCP Plan’’ for option j—‘‘Breaking To determine the percentage of plants to choice f—‘‘Blended and dried.’’ shell eggs’’; option m—‘‘Drying egg which have written HACCP plans in For liquid eggs, FSIS considered all products’’; or option n—‘‘Pasteurizing place for their respective processes, plants that which responded to question dried egg whites’’; and option l— FSIS used the survey to first determine 1.11: ‘‘Does this plant produce this egg ‘‘Pasteurizing liquid eggs for breaking, which respondents produced products product form?’’ and answered dried, and liquid processes, corresponding to the three main affirmatively to choice a—‘‘Liquid’’; to respectively.’’ processes. choice b—‘‘Blended and liquid’’; to For breaking, FSIS considered all choice c—‘‘frozen’’; to choice d— Breaking w/ Dried w/ Liquid w/ plants that responded to question 1.1: ‘‘Blended and frozen’’; or g—‘‘Extended HACCP HACCP HACCP ‘‘Which statement below describes how shelf life liquid’’. this plant receives egg inputs?’’ and Next, for each process, FSIS 84.6% ...... 80.0% 76.5% answered affirmatively to choice 1— determined if the respondent had a This plant receives shell eggs only’’—or written HACCP plan using question 2.1: Finally, FSIS applied these to choice 2—This plant receives both ‘‘What production steps are used by this percentages to PHIS egg products plants shell eggs and liquid or dried eggs.’’ plant, and if used, is the step addressed production data (see Table below) to For dried eggs, FSIS considered all in a written plan?’’ Specifically, FSIS estimate the number of processes plants that responded to question 1.11: considered the plan acceptable if the currently operating without HACCP ‘‘Does this plant produce this egg plant responded affirmatively to option plans.

Plants Breaking Dried Liquid Total processes

77 ...... 56 17 52 125

Total Dried Liquid w/o processes Breaking w/o HACCP w/o HACCP HACCP operating w/o HACCP

9 ...... 3 12 24

Section 5 Plants With HACCP Plans number of plants estimated to be egg products industry’s documentation without HACCP systems. of its processes, first in a plan and FSIS used the results to question 2.1: Executive Order 13771 thereafter in a continuous record of ‘‘What production steps are used by this process performance, will be a more plant, and if used, is the step addressed This proposed rule, if finalized as effective food safety approach than the in a written plan?’’ to determine the proposed, is expected to be an E.O. sporadic generating of information by percentage of plants with no HACCP 13771 deregulatory action. We have inspection program personnel. This plans. Specifically, a plant was estimated that this proposed rule would documentation gives inspection considered to have no HACCP plans if yield cost savings. Assuming a 7 percent program personnel a much broader it did not respond with option 3—‘‘Used discount rate and a perpetual time picture of production than they can horizon and a starting year of 2018, the and Addressed in a Written HACCP generate and provides them additional proposed rule would yield Plan for any of the following: j. Breaking time to perform higher priority tasks. At approximately $1.29 million (2016$) in shell eggs, l. Pasteurizing liquid eggs, m. the same time, it gives plant managers annualized cost savings. Assessment of Drying egg products, or n. Pasteurizing a better view of their own process and dried egg whites.’’ the specific costs and cost savings may be found in the preceding economic more opportunity to adjust it to prevent safety defects. Number analysis. Percent with no of plants Sanitation SOPs HACCP (approximate) IV. Paperwork Reduction Act with no HACCP FSIS has reviewed the paperwork and To meet the proposed regulation’s recordkeeping requirements in this sanitation requirements, each processor 7.% ...... 5 * proposed rule in accordance with the will develop and maintain a Sanitation * The number of plants was rounded down. Paperwork Reduction Act (44 U.S.C. SOP. The Sanitation SOP would specify 3501, et seq.) and has determined that the cleaning and sanitizing procedures Section 6 Shifts for Plants Without the paperwork requirements constitute for all equipment and facilities involved HACCP Plans new information collections. in the production of every product. As Title: Egg Products Hazard Analysis part of the Sanitation SOP, a plant To estimate the number of shifts at and Critical Control Point (HACCP) plants without any HACCP systems in employee will record results of daily Systems and Sanitation Standard sanitation checks at the frequencies place, FSIS averaged the responses to Operating Procedures (SOPs). stated in the Sanitation SOP. question 5.2: ‘‘How many production Type of Collection: New. shifts are operated each day at this Abstract: Under this proposed rule, The burden of documenting the plant?’’ for those respondents FSIS is requiring official plants to adherence to Sanitation SOPs is based determined to not have HACCP plans as develop and maintain HACCP and on three factors: Recording, reviewing, described in Section 5. This average (1.7 Sanitation SOP records and plans, as and storage. Recording encompasses shifts) was then applied to the total well as various transaction records. The conducting and inscribing the finding

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from an observation and filing of the Respondents: Official egg products VII. Executive Order 13175 document produced. plants. This rule has been reviewed in Estimated Number of Respondents: HACCP accordance with the requirements of 77. Executive Order 13175, ‘‘Consultation Under this proposal, the requirements Estimated Number of Responses per and Coordination with Indian Tribal for the implementation of HACCP in Respondent: 927.58. Governments.’’ E.O. 13175 requires Estimated Total Annual Burden on official plants will be the same as those Federal agencies to consult and being met by meat and poultry products Respondents: 71,424 hours. Copies of this information collection coordinate with tribes on a government- establishments operating under HACCP. to-government basis on policies that The plant will maintain on file the name assessment can be obtained from Gina Kouba, Paperwork Reduction Act have tribal implications, including and a brief resume of the HACCP- regulations, legislative comments or Coordinator, Food Safety and Inspection trained individuals who participate in proposed legislation, and other policy Service, USDA, Room 6065–S, South the hazard analysis and subsequent statements or actions that have Agriculture Building, 1400 development of the HACCP plans. substantial direct effects on one or more Independence Avenue SW, Washington, Plants will develop written HACCP Indian tribes, on the relationship DC 20250; (202) 720–5627. plans that include: Identification of between the Federal Government and hazards reasonably likely to occur in the Comments are invited on: (a) Whether the proposed collection of information Indian tribes or on the distribution of production process; identification and power and responsibilities between the is necessary for the proper performance description of the CCP for each Federal Government and Indian tribes. of FSIS’s functions, including whether identified hazard; specification of the FSIS has assessed the impact of this critical limit which may not be the information will have practical rule on Indian tribes and determined exceeded at the CCP, and, if utility; (b) the accuracy of FSIS’s that this rule does not, to our appropriate, a target limit; description of estimate of the burden of the proposed knowledge, have tribal implications that the monitoring procedure or device to collection of information, including the require tribal consultation under E.O. be used; description of the corrective validity of the methodology and 13175. If a Tribe requests consultation, action to be taken if the limit is assumptions used; (c) ways to enhance the Food Safety and Inspection Service exceeded; description of the records the quality, utility, and clarity of the will work with the Office of Tribal which would be generated and information to be collected; ways to Relations to ensure meaningful maintained regarding this CCP; and minimize the burden of the collection of consultation is provided where changes, description of the facility verification information on those who are to additions and modifications identified activities and the frequency at which respond, including through the use of herein are not expressly mandated by they are to be conducted. Critical limits appropriate automated, electronic, Congress. that are currently a part of FSIS mechanical, or other technological collection techniques, or other forms of VIII. USDA Nondiscrimination regulations must be included. The Statement adequacy of a plant’s HACCP plan must information technology. Comments may be reassessed at least annually and be sent to both Gina Kouba, Paperwork No agency, officer, or employee of the whenever changes occur that could Reduction Act Coordinator, at the USDA shall, on the grounds of race, affect the hazard analysis or alter the address provided above, and the Desk color, national origin, religion, sex, HACCP plan. Officer for Agriculture, Office of gender identity, sexual orientation, Information and Regulatory Affairs, The HACCP records should be disability, age, marital status, family/ Office of Management and Budget, reviewed by a plant employee other parental status, income derived from a Washington, DC 20253. than the one whom produced the public assistance program, or political All responses to this notice will be beliefs, exclude from participation in, record, before the product is distributed summarized and included in the request in commerce. If a HACCP-trained deny the benefits of, or subject to for OMB approval. All comments will discrimination any person in the United individual is on-site, that person should also become a matter of public record. be the reviewer. The reviewer would States under any program or activity sign the records. Lastly, HACCP records V. Executive Order 12988 conducted by the USDA. generated by the processor would be This proposed rule has been reviewed How To File a Complaint of retained on site for at least 1 year. under Executive Order 12988, Civil Discrimination Labeling Justice Reform. Under this rule: (1) All To file a complaint of discrimination, State and local laws and regulations that complete the USDA Program Under this proposal, official plants are inconsistent with this rule will be Discrimination Complaint Form, which will be authorized to use generically preempted; (2) no retroactive effect will may be accessed online at http:// approved labels without specific be given to this rule; and (3) no www.ocio.usda.gov/sites/default/files/ evaluation by LPDS. In addition, frozen administrative proceedings will be docs/2012/Complain_combined_6_8_ and refrigerated egg products will be required before parties may file suit in 12.pdf, or write a letter signed by you required to bear labels that say, ‘‘Keep court challenging this rule. or your authorized representative. Frozen’’ or ‘‘Keep Refrigerated.’’ Plants VI. E-Government Act Compliance Send your completed complaint form already use special handling statements, or letter to USDA by mail, fax, or email: when appropriate, under general FSIS and USDA are committed to Mail: U.S. Department of Agriculture, Agency policy governing special achieving the purposes of the E- Director, Office of Adjudication, 1400 handling statements. Therefore, the Government Act (44 U.S.C. 3601, et Independence Avenue SW, Washington, Agency has already accounted for the seq.) by, among other things, promoting DC 20250–9410. Fax: (202) 690–7442. labeling paperwork burden. the use of the internet and other Estimate of Burden: FSIS estimates information technologies and providing IX. Additional Public Notification that each respondent will spend 927.58 increased opportunities for citizen Public awareness of all segments of hours per year on this information access to government information and rulemaking and policy development is collection. services, and for other purposes. important. Consequently, FSIS will

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announce this Federal Register PART 417—HAZARD ANALYSIS AND §§ 306.5, 381.35, and 590.310 of this publication on-line through the FSIS CRITICAL CONTROL POINT (HACCP) chapter. web page located at: http:// SYSTEMS * * * * * www.fsis.usda.gov/federal-register. (c) An establishment may appeal the FSIS also will make copies of this ■ 3. Revise the authority citation for part 417 to read as follows: withholding action or suspension, as publication available through the FSIS provided in §§ 306.5, 381.35, and Constituent Update, which is used to Authority: 21 U.S.C. 451–470, 601–695, 590.310 of this chapter. provide information regarding FSIS 1031–1056; 7 U.S.C. 450, 1901–1906; 7 CFR * * * * * policies, procedures, regulations, 2.18, 2.53. ■ 9. In § 500.6: Federal Register notices, FSIS public ■ 4. In § 417.7, revise paragraph (b) to ■ meetings, and other types of information read as follows: a. Redesignate paragraphs (a) through that could affect or would be of interest (i) as paragraphs (a)(1) through (9). to our constituents and stakeholders. § 417.7 Training. ■ b. Designate the introductory text as The Update is available on the FSIS web * * * * * paragraph (a). page. Through the web page, FSIS is (b) The individual performing the ■ c. Revise newly redesignated able to provide information to a much functions listed in paragraph (a) of this paragraph (a)(9). broader, more diverse audience. In section shall have successfully ■ d. Add reserved paragraph (b). addition, FSIS offers an email completed a course of instruction in the The revision and addition read as subscription service which provides application of the seven HACCP follows: automatic and customized access to principles to meat, poultry, or egg § 500.6 Withdrawal of inspection. selected food safety news and products, including a segment on the information. This service is available at: development of a HACCP plan for a (a) * * * http://www.fsis.usda.gov/subscribe. specific product and on record review. (9) A recipient of inspection or Options range from recalls to export anyone responsibly connected to the PART 500—RULES OF PRACTICE information, regulations, directives, and recipient is unfit to engage in any notices. Customers can add or delete ■ 5. Revise the authority citation for part business requiring inspection as subscriptions themselves, and have the 500 to read as follows: specified in section 401 of the FMIA, section 18(a) of the PPIA, or section 18 option to password protect their Authority: 21 U.S.C. 451–470, 601–695, accounts. 1031–1056; 7 U.S.C. 450, 1901–1906; (33 of the EPIA. (b) [Reserved] List of Subjects U.S.C. 1251 et seq.); 7 CFR 2.18, 2.53. ■ 10. In § 500.7, revise paragraphs (a)(3) ■ 6. Amend § 500.2 by revising and (5) to read as follows: 9 CFR Part 416 paragraph (c) to read as follows: Meat inspection, Poultry and poultry § 500.7 Refusal to grant inspection. products, Sanitation. § 500.2 Regulatory control action. * * * * * (a) * * * 9 CFR Part 417 (c) An establishment may appeal a (3) Has not demonstrated that Meat inspection, Poultry and poultry regulatory control action, as provided in adequate sanitary conditions exist in the products, Record and recordkeeping §§ 306.5, 381.35, and 590.310 of this establishment as required by part 308, requirements, Hazard Analysis and chapter. subpart H of part 381, part 416, or part Critical Control Point (HACCP) Systems. ■ 7. Amend § 500.3 by revising 590 of this chapter; paragraphs (a)(1) and (a)(7) to read as * * * * * 9 CFR Part 500 follows: (5) Is unfit to engage in any business Administrative practice and requiring inspection as specified in procedure, Meat inspection, Poultry and § 500.3 Withholding action or suspension without prior notification. section 401 of the FMIA, section 18(a) poultry products, Rules of practice. of the PPIA, or section 18 of the EPIA. (a) * * * 9 CFR Part 590 (1) The establishment produced and * * * * * Eggs and egg products, Exports, Food shipped adulterated or misbranded ■ 11. In § 500.8, revise paragraphs (a) grades and standards, Food labeling, product as defined in 21 U.S.C. 453, 21 and (c) to read as follows: Imports, Reporting and recordkeeping U.S.C. 602, or 21 U.S.C. 1033; § 500.8 Procedures for rescinding or requirements. * * * * * refusing approval of marks, labels, and For the reasons set forth in the (7) The establishment did not destroy containers. preamble, FSIS proposes to amend 9 a condemned meat or poultry carcass, or (a) FSIS may rescind or refuse CFR chapter III as follows: part or product thereof, or egg product, approval of false or misleading marks, ■ 1. Revise the heading of subchapter E that has been found to be adulterated labels, or sizes or forms of any container to read as follows: and that has not been reprocessed, in for use with any meat, poultry, or egg accordance with part 314 or part 381, SUBCHAPTER E—REGULATORY product, under section 7 of the FMIA, subpart L, or part 590 of this chapter under section 8 of the PPIA, or under REQUIREMENTS UNDER THE FEDERAL within three days of notification. MEAT INSPECTION ACT, THE POULTRY sections 7 or 14 of the EPIA. PRODUCTS INSPECTION ACT, AND THE * * * * * * * * * * ■ 8. Amend § 500.5 by revising EGG PRODUCTS INSPECTION ACT (c) If FSIS rescinds or refuses paragraphs (a)(5) and (c) to read as approval of false or misleading marks, PART 416—SANITATION follows: labels, or sizes or forms of any container ■ 2. Revise the authority citation for part § 500.5 Notification, appeals, and actions for use with any meat, poultry, or egg 416 to read as follows: held in abeyance. product, an opportunity for a hearing Authority: 21 U.S.C. 451–470, 601–695, (a) * * * will be provided in accordance with the 1031–1056; 7 U.S.C. 450, 1901–1906; 7 CFR (5) Advise the establishment that it Uniform Rules of Practice, 7 CFR 2.18, 2.53. may appeal the action as provided in subtitle A, part 1, subpart H.

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PART 590—INSPECTION OF EGGS contain eggs only in a relatively small ■ 15. Amend § 590.10 by revising the AND EGG PRODUCTS (EGG proportion or historically have not been, third sentence to read as follows: PRODUCTS INSPECTION ACT) in the judgment of the Secretary, considered by consumers as products of § 590.10 Authority. ■ 12. The authority citation for part 590 the egg food industry, and which may * * * The Food Safety and Inspection is revised to read as follows: be exempted by the Secretary under Service and its officers and employees Authority: 21 U.S.C. 1031–1056; 7 CFR such conditions as the Secretary may will not be liable in damages through 2.18, 2.53. prescribe to assure that the egg acts of commission or omission in the ingredients are not adulterated and such administration of this part. § § 590.1 through 590.860 [Designated as products are not represented as egg Subpart A] § § 590.17 and 590.22 [Removed] products. For the purposes of this part, ■ 13. Designate §§ 590.1 through the following products, among others, ■ 16. Remove §§ 590.17 and 590.22. 590.860 as subpart A and add a heading are exempted as not being egg products: ■ 17. Revise § 590.28 to read as follows: for subpart A to read as follows: Cooked egg products, imitation egg § 590.28 Other inspections. products, dietary foods, dried no-bake Subpart A—GENERAL custard mixes, egg nog mixes, acidic Inspection program personnel will ■ 14. Amend § 590.5 by: dressings, noodles, milk and egg dip, make periodic inspections of business ■ a. Revising the definition of cake mixes, French toast, and premises, facilities, inventories, Administrator. sandwiches containing no more operations, transport vehicles, and ■ b. Removing the definition of Chief of restricted eggs than are allowed in the records of egg handlers, and the records the Grading Branch and Dirty egg or official standards for U.S. Consumer of all persons engaged in the business of Dirties. Grade B shell eggs. Balut and other transporting, shipping, or receiving any ■ c. Revising paragraph (c) of the similar ethnic delicacies are also eggs or egg products. definition of Egg and the definition of exempted from inspection under this * * * * * Egg product. part. ■ 18. Revise § 590.40 to read as follows: ■ d. Removing the definition of Eggs of * * * * * § 590.40 Egg products not intended for current production, Inspector/Grader, Official plant means any plant in human food. and National Supervisor. which the plant facilities, methods of Periodic inspections will be made at ■ e. Adding, in alphabetical order, the operation, and sanitary procedures have any plant processing egg products definition of Official plant. been found suitable and adequate by the which are not intended for use as ■ f. Removing the definition of Official Administrator for the inspection of egg human food of its operations and Standard. products pursuant to the regulations in records to ensure compliance with the ■ g. Adding, in alphabetical order, the this part and in which inspection Act and the regulations in this part. Egg definition of Official standards. service is carried on. products not intended for use as human ■ h. Revising the definition of Official standards means the food shall be denatured or Pasteurize. standards of quality, grades, and weight decharacterized prior to being offered ■ i. Removing the definition of Plant. classes for eggs. for sale or transportation unless shipped ■ j. Revising the definition of * * * * * under seal as authorized in § 590.504(c) Processing. Pasteurize means the subjecting of and identified as prescribed by the ■ k. Adding, in alphabetical order, the each particle of egg products to heat or regulations in this part to prevent their definition of Program employee. other treatments to destroy harmful ■ viable microorganisms. use as human food. l. Removing the definitions of ■ Regional Director, Sanitize, and Service. * * * * * 19. Revise § 590.50 to read as follows: ■ m. Revising the definition of Shell egg Processing means manufacturing of § 590.50 Egg temperature and labeling packer. egg products, including breaking eggs or requirements. ■ n. Adding, in alphabetical order, the filtering, mixing, blending, pasteurizing, (a) All shell eggs packed into definition of Shipped for retail sale. stabilizing, cooling, freezing or drying, containers destined for the ultimate The revisions and additions read as or packaging or repackaging egg consumer must be stored and follows: products at official plants. transported under refrigeration at an * * * * * § 590.5 Terms defined. ambient temperature of no greater than Program employee means any 45° F (7.2° C) and must bear a safe * * * * * inspector or other individual employed handling label in accordance with 21 Administrator means the by the Department or any cooperating CFR 101.17(h). Administrator of the Food Safety and agency who is authorized by the (b) Any producer-packer with an Inspection Service or any officer or Secretary to do any work or perform any annual egg production from a flock of employee of the Department of duty in connection with the Program. 3,000 or fewer hens is exempt from the Agriculture to whom authority has been * * * * * temperature and labeling requirements delegated or may be delegated to act in Shell egg packer means any person of this section. his or her stead. engaged in the sorting of shell eggs from ■ 20. Revise § 590.100 to read as * * * * * sources other than or in addition to the follows: Egg *** person’s own production into their (c) Dirty egg or Dirt means an egg that various qualities, either mechanically or § 590.100 Specific exemptions. has a shell that is unbroken and has by other means. (a) [Reserved] adhering dirt or foreign material. Shipped for retail sale means eggs that (b) The following are exempt, to the * * * * * are forwarded from the processing extent prescribed, from the continuous Egg product means any dried, frozen, facility for distribution to the ultimate inspection of egg products processing or liquid eggs, with or without added consumer. operations in section 5(a) of the Act (21 ingredients, excepting products which * * * * * U.S.C. 1034(a)), provided the conditions

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for exemption and the provisions of political activities; e.g., 5 U.S.C. 7324 ■ 28. Revise § 590.140 to read as these regulations are met: and 1502. follows: (1) The processing and sale of egg (c) Violation of the provisions of products by any poultry producer from paragraph (a) of this section or the § 590.140 Application for grant of inspection. eggs of his own flock’s production when provisions of applicable statutes sold directly to a household consumer referenced in paragraph (b) of this The proprietor or operator of each exclusively for use by the consumer and section will constitute grounds for official plant and official import members of the household and its dismissal. inspection establishment must make nonpaying guests and employees. (d) Program employees are subject to application to the Administrator for (2) The processing in non-official all applicable provisions of law and inspection service unless exempted by plants, including but not limited to regulations and instructions of the § 590.100. The application must be bakeries, restaurants, and other food Department and the Food Safety and made in writing on forms furnished by processors, of certain categories of food Inspection Service concerning employee the inspection service. In cases of products which contain eggs or egg responsibilities and conduct. The change of name or ownership or change products as an ingredient, as well as the setting forth of certain prohibitions in of location, a new application must be sale and possession of such products. this part in no way limits the made. ■ Such products must be manufactured applicability of such general or other 29. Revise § 590.142 to read as from inspected egg products processed regulations or instructions. follows: ■ in accordance with the regulations in 26. Revise § 590.134(b) to read as § 590.142 Filing of application. this part and 9 CFR part 591 or from follows: An application for inspection service eggs containing no more restricted eggs § 590.134 Accessibility of product and will be regarded as filed only when it than are allowed in the official cooler rooms. has been: standards for U.S. Consumer Grade B (a) Filled in completely; shell eggs. * * * * * (b) The perimeter of each cooler room (b) Signed by the applicant; and § 590.105 [Removed] used to store eggs must be made (c) Received in the appropriate ■ accessible in order for the Secretary’s District Office. 21. Remove § 590.105 and ■ representatives to determine the 30. Revise § 590.146 to read as undesignated center heading follows: ‘‘Performance of Service’’. ambient temperature under which shell eggs packed into containers destined for § 590.146 Survey and grant of inspection. § § 590.112, 590.114 and 590.116 the ultimate consumer are stored. [Removed] (a) Before inspection is granted, FSIS ■ 27. Revise § 590.136 to read as will survey the official plant to ■ 22. Remove §§ 590.112, 590.114 and follows: determine if the construction and 590.116. facilities of the plant are in accordance ■ 23. Add an undesignated center § 590.136 Accommodations and with the regulations in this part. FSIS heading above § 590.118 and revise equipment to be furnished by facilities for will grant inspection, subject to 9 CFR § 590.118 to read as follows: use of program employees in performing service. 500.7, when these requirements are met Performance of Service (a) Program employee’s office. Office and the requirements contained in § 590.149 are met. § 590.118 Identification. space, including, but not limited to, furnishings, light, heat, and janitor (b) FSIS will give notice in writing to Each program employee will be service, will be provided without cost in each applicant granted inspection and furnished with a numbered official the official plant for the use of program will specify in the notice the official badge that will be carried in a proper employees for official purposes. The plant, including the limits of the plant’s manner at all times while on duty. This room or space set apart for this purpose premises, to which the grant pertains. badge will be sufficient identification to must meet the approval of the Food entitle the program employee entry at § 590.148 [Removed] Safety and Inspection Service and be all regular entrances and to all parts of ■ 31. Remove § 590.148. conveniently located, properly the official plant and premises to which ■ 32. Add § 590.149 to read as follows: ventilated, and provided with lockers or the program employee is assigned. file cabinets suitable for the protection § 590.149 Conditions for receiving § 590.119 [Removed] and storage of supplies and with inspection. ■ 24. Remove § 590.119. accommodations suitable for program (a) Before receiving Federal ■ 25. Revise § 590.120 to read as employees to change clothing. At the inspection, a plant must have developed follows: discretion of the Administrator, small written sanitation Standard Operating official plants requiring the services of Procedures, in accordance with part 416 § 590.120 Financial interest of inspectors. less than one full-time program and § 591.1(a)(1) of this chapter. (a) No program employee will inspect employee need not furnish (b) Before receiving Federal any product in which the employee, the accommodations for program employees inspection, a plant must conduct a employee’s spouse, minor child, as prescribed in this section where hazard analysis, and develop and partner, organization in which the adequate accommodations exist in a implement a HACCP plan, in accord employee is serving as officer, director, nearby convenient location. with part 417 and § 591.1(a)(1) of this trustee, partner, or employee, or any (b) Accommodations and equipment. chapter. Conditional inspection may be other person with whom the program Such accommodations and equipment provided for a period not to exceed 90 employee is negotiating or has any must include, but not be limited to, a days, during which period the facility arrangements concerning prospective room or area suitable for sampling must validate its HACCP plan. employment, has a financial interest in product and a stationary or adequately (c) Before producing new product for the product. secured storage box or cage (capable of distribution in commerce, a plant must (b) All program employees are subject being locked only by the program conduct a hazard analysis and develop to statutory restrictions with respect to employee) for holding official samples. a HACCP plan applicable to that

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product, in accordance with § 417.2 of and quality of eggs purchased or ■ 36. Revise § 590.310 to read as this chapter. During a period not to received, and from whom (including a follows: exceed 90 days after the date the new complete address, unless a master list is product is produced for distribution in maintained). Process records § 590.310 Appeal inspections; how made. commerce, the plant must validate its documenting that the temperature and Any appeal from the inspection HACCP plan, in accordance with § 417.4 labeling requirements in § 590.50(a) decision of any program employee must of this chapter. have been met must also be kept; be made to his or her immediate ■ 33. Revise § 590.160 to read as (2) The date of packaging, ambient air supervisor having jurisdiction over the follows: temperature surrounding product stored subject matter of the appeal. after processing, quantity and quality of ■ 37. Revise § 590.320 to read as § 590.160 Clean Water Act; refusal, eggs delivered or sold, and to whom follows: suspension, or withdrawal of service. (including a complete address, unless a (a) Any applicant for inspection at a § 590.320 How to file an appeal inspection master list is maintained); or decision review. plant where the operations thereof may (3) If a consecutive lot numbering result in any discharge into the system is not employed to identify The request for an appeal inspection navigable waters in the United States is individual eggs, containers of eggs, or or review of a program employee’s required by subsection 401(a)(1) (33 egg products, record the alternative code decision may be made orally or in U.S.C. 1341) of the Clean Water Act as system used, in accordance with writing. If made orally, written amended (86 Stat. 816, 91 Stat. 1566, 33 § 590.411(c)(3); confirmation may be required. The U.S.C. 1251 et seq.), to provide the (4) The date of disposal and quantity applicant must clearly identify the Administrator with a certification, as of restricted eggs, including inedible egg product involved, the decision being prescribed in said subsection, that any product or incubator reject product, sold appealed, and the reasons for requesting such discharge will comply with the or given away for animal food or other the appeal. ■ applicable provisions of sections 301, uses or otherwise disposed of, and to 38. Revise § 590.340 to read as 302, 303, 306, and 307 of the Act (33 whom (including a complete address, follows: U.S.C. 1311, 1312, 1313, 1316, and unless a master list is maintained); § 590.340 Who must perform the appeal 1317). No grant of inspection can be (5) The individual or composite inspection or decision review. issued unless such certification has (running tally) record of restricted egg An appeal inspection or review of a been obtained, or is waived, because sales to household consumers. Records program employee’s decision, as failure of refusal of the State, interstate should show number of dozens sold on requested in § 590.310, must be agency, or the Administrator of the a daily basis. The name and address of performed by a program employee of Environmental Protection Agency to act the consumer is not required; FSIS other than the one who made the on a request for certification within a (6) The date of production and initial decision. reasonable period (which should not quantity of egg products delivered or ■ 39. Revise § 590.350 to read as exceed 1 year after receipt of such a sold, and to whom (including a follows: request). Further, upon receipt of an complete address, unless a master list is application for inspection and a maintained); § 590.350 Appeal samples. certification as required by subsection (7) The date of receipt and quantity of An appeal sample will consist of 401(a)(1) of the Clean Water Act, the egg products purchased or received, and product taken from the original sample Administrator (as defined in § 590.5) is from whom (including a complete containers plus an equal number of required by subparagraph (2) of said address, unless a master list is containers selected at random. A subsection to notify the Administrator maintained); condition appeal cannot be made unless of the Environmental Protection Agency (8) The production records by all originally sampled containers are for proceedings in accordance with that categories of eggs such as graded eggs, available. subsection. No grant of inspection can nest-run eggs, dirties, checks, etc.; bills be made until the requirements of of sale, inventories, receipts, shipments, § § 590.360 and 590.370 [Removed] 401(a)(1) and (2) have been met. shippers, receivers, dates of shipment ■ 40. Remove §§ 590.360 and 590.370. (b) Inspection may be suspended or and receipt, carrier names, etc. ■ 41. Revise § 590.410 to read as revoked and plant approval terminated (b) All records required to be follows: as provided in subsection 401(a)(4) and maintained by this section must be made available to an authorized § 590.410 Egg products required to be (5) of the Clean Water Act, as amended labeled. (33 U.S.C. 1341(a)(4) and (5)). representative of the Secretary for ■ 34. Revise § 590.200 to read as official review and copying. (a)(1) Packaged egg products that follows: (c) Records of all labeling, along with require special handling to maintain the product formulation and processing their wholesome condition must have § 590.200 Records and related procedures as prescribed in §§ 590.410 the statement ‘‘Keep Refrigerated,’’ requirements. through 590.412 of this chapter, must be ‘‘Keep Frozen,’’ ‘‘Perishable Keep Under (a) Persons engaged in the kept by every person processing, except Refrigeration,’’ or such similar statement transporting, shipping, or receiving of processors exempted under § 590.100 of prominently displayed on the principal any eggs or egg products in commerce, this chapter. display panel. or holding such articles so received, and ■ 35. Revise § 590.300 to read as (2) Egg products that are distributed all egg handlers, except producer- follows: frozen and thawed prior to or during packers with an annual egg production display for sale at retail must bear the from a flock of 3,000 hens or fewer, § 590.300 Appeal inspections. statement ‘‘Keep Frozen’’ on the must maintain records documenting, for Any person receiving inspection shipping container. Consumer-sized a period of 2 years, the following, to the service may, if dissatisfied with any containers for such egg products must extent applicable: decision of an inspector related to any bear the statement ‘‘Previously Handled (1) The date of lay, date and time of inspection, file an appeal from such Frozen for Your Protection, Refreeze or refrigeration, date of receipt, quantity decision. Keep Refrigerated.’’

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(3) The labels of packages of egg which the product is to be marketed exempt from nutrition labeling products produced from shell eggs that (sold), except that ingredients in dried requirements: have been treated with ionizing product (other than dry blended) may be (1) Egg products shipped in bulk form radiation must reflect that treatment in listed in either liquid or dried form. for use solely in the manufacture of the ingredient statement on the finished When water (excluding that used to other food and not for distribution to product labeling. reconstitute dehydrated ingredients household consumers in such bulk form (b) Containers, portable tanks, and back to their normal composition) is or containers. bulk shipments of edible egg products added to a liquid or frozen egg product (2) Products containing an added produced in official plants must be or to an ingredient of such products (in vitamin, mineral, or protein, or for labeled in accordance with §§ 590.411 excess of the normal water content of which a nutritional claim is made on through 590.415 and must bear the that ingredient), the total amount of the label, or in advertising, which is official identification shown in Figure 1 water added, including the water supplied for institutional food use only, of § 590.413. content of any cellulose or vegetable provided that the manufacturer or (c) Bulk shipments of unpasteurized gums used, must be expressed as a distributor provides the required egg products produced in official plants percentage of the total product weight in nutrition information directly to those must bear a label containing the words the ingredient statement on the label; institutions. ‘‘date of loading,’’ followed by a suitable (2) The name, address and zip code of (3) Any nutrients included in the space in which the date the container, the distributor; qualified by such terms product solely for technological tanker truck, or portable tank is loaded as ‘‘distributed by,’’ or ‘‘distributors’’; purposes may be declared solely in the must be inserted. The label must be (3) The lot number or an alternative ingredients statement, without conspicuously located, and printed and code indicating the date of production, complying with nutrition labeling, if the affixed on material that cannot be in accordance with § 590.200(a); nutrient(s) is otherwise not referred to detached or effaced due to exposure to (4) The net content; in labeling or in advertising. All labels weather. Before the truck or tank is (5) An official inspection symbol and showing nutrition information or claims removed from the place where it is the number of the official plant in are subject to review by the Food and unloaded, the carrier must remove or which the product was processed under Drug Administration prior to approval obliterate the label. Such shipments inspection as set forth in § 590.413; by the Department. must also bear the official identification (6) Egg products processed from (f)(1) No label, container, or packaging shown in Figure 2 of § 590.415. edible eggs of the turkey, duck, goose, ■ material may contain any statement that 42. Revise § 590.411 to read as or guinea must be clearly and distinctly follows: is false or misleading. If the labeled as to the common or usual name Administrator has reason to believe that § 590.411 Label approval. of the product indicating the type of a statement or formulation shows that (a) All official plants, including eggs or egg products used in the an egg product is adulterated or official plants certified under a foreign product, e.g., ‘‘Frozen whole turkey misbranded, or that any labeling, inspection system in accordance with eggs,’’ ‘‘Frozen whole chicken and including the size or form of any § 590.910, must comply with the turkey eggs.’’ Egg products labeled container in use or proposed for use, requirements contained in 9 CFR 412.1, without qualifying words as to the type with respect to eggs or egg products, is except as otherwise provided in this of egg used in the product must be false or misleading in any way, the part. produced only from the edible egg of the Administrator may direct that such use (b) For the purposes of 9 CFR 412.2, domesticated chicken or the egg be withdrawn unless the labeling or an official establishment or products produced from such eggs. container is modified in such a manner establishment certified under a foreign (d) Liquid or frozen egg products as the Administrator may prescribe so inspection system includes an official identified as whole eggs and processed that it will not be false or misleading, or plant. in other than natural proportions as the formulation of the product is altered (c) Labels, containers, or packaging broken from the shell must have a total in such a manner as the Administrator materials of egg products must show the egg solids content of 24.20 percent or may prescribe so that it is not following information, as applicable, on greater. adulterated or would not cause the principal display panel (except as (e) Nutrition information may be misbranding. otherwise permitted in this part), in included on labels used to identify egg (2) If the Administrator directs that accordance with the requirements of products, providing such labeling the use of any label, container, or this part, or if applicable, 21 CFR complies with the provisions of 21 CFR packaging material be withdrawn 101.17(h): part 101, promulgated under the Federal because it contains any statement that is (1) A statement showing by the Food, Drug, and Cosmetic Act and the false or misleading, an opportunity for common or usual names, if any, of the Fair Packaging and Labeling Act. Since a hearing will be provided in kinds of ingredients comprising the these regulations have different accordance with § 500.8(c) of this product. Formulas are to be expressed requirements for consumer packaged chapter. in terms of a liquid product except for products than for bulk packaged egg product that is dry-blended. Also, for products not for sale or distribution to § 590.412 [Redesignated as § 590.413] product to be dried, the label may show household consumers, label submission ■ 43. Redesignate § 590.412 as the ingredients in order of descending must be accompanied with information § 590.413. proportions by weight in the dried form. indicating whether the label covers ■ 44. Add a new § 590.412 to read as However, the formula submitted must consumer packaged or bulk packaged follows: include the percentage of ingredients in products. Nutrition labeling is required both liquid and dried form. If the when nutrients, such as proteins, § 590.412 Approval of generic labels. product is comprised of two or more vitamins, and minerals are added to the (a) All official plants, including ingredients, such ingredients must be product, or when a nutritional claim or official plants certified under a foreign listed in the order of descending information is presented on the labeling, inspection system in accordance with proportions by weight in the form in except for the following, which are § 590.910, must comply with the

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requirements in 9 CFR 412.2, except as § 590.413 Form of official identification products is set forth in Figure 1 of this otherwise provided in this part. symbol and inspection mark. section, except that the plant number (b) For the purposes of 9 CFR 412.2, (a) The shield set forth in Figure 1 of may be preceded by the letter ‘‘G’’ in this section containing the letters an official establishment or lieu of the word plant. The plant ‘‘USDA’’ must be the official establishment certified under a foreign number may also be omitted from the identification symbol used in inspection system includes an official official mark if applied on the connection with egg products to denote plant. container’s principal display panel or that the official plant receives official other prominent location and preceded ■ 45. Revise newly redesignated inspection service. The inspection mark by the letter ‘‘G.’’ § 590.413 to read as follows: used on containers of edible egg

(b) [Reserved] in Figure 2 of this section. Such product released into consumer channels until it ■ 46. Revise § 590.415 to read as must meet all requirements for egg has been subjected to pasteurization, follows: products that are permitted to bear the heat treatment, or other method of § 590.415 Use of other official official inspection mark shown in treatment sufficient to reduce identification. § 590.413, except for pasteurization, Salmonella. After pasteurization or All unpasteurized egg products heat treatment, or other method of treatment, the product may bear the shipped from an official plant must be treatment sufficient to reduce official inspection mark as shown in marked with the identification set forth Salmonella. Such product must not be § 590.413.

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§ 590.418 [Amended] purpose, unless its use is authorized (2) Any egg products not processed in ■ 47. Amend § 590.418 by removing under 21 CFR as a direct food additive accordance with the regulations in this paragraphs (a) and (c) and redesignate (part 172), a secondary direct food part or part 591 or that are not otherwise paragraph (b) as an undesignated additive (part 173), an indirect food fit for human food will be removed and paragraph. additive (parts 174–178), a source of segregated. ■ 48. Revise § 590.420(a) and (b) to read radiation (part 179), an interim-listed (c)(1) All loss and inedible eggs or as follows: direct food additive (part 180), a prior- inedible egg products must be placed in sanctioned substance (part 181), a § 590.420 Inspection. a container clearly labeled ‘‘inedible’’ Generally Recognized As Safe (GRAS) and containing a sufficient amount of (a) Inspection shall be made, pursuant substance (parts 182 or 184), or by 21 denaturant or decharacterant, such as an to the regulations in this part, of the CFR 160.185, or by regulation in this acceptable FD&C color additive, processing of egg products in each chapter. Substances and ingredients suspended in the product. Eggs must be official plant processing egg products used in the processing of egg products crushed and the substance dispersed for commerce, unless exempted under capable of use as human food must be through the product in amounts § 590.100. Inspections, certifications, or clean, wholesome, and unadulterated. specification-type gradings, and other (2) No substance which is intended to sufficient to give the product a inspections which may be requested by impart color in any egg product may be distinctive appearance or odor. Inedible the official plant and are in addition to used unless such use is authorized product may be held in containers the normal inspection requirements and under 21 CFR as a color additive (parts clearly labeled ‘‘inedible’’ which do not functions for the processing, 73, 74, or 81) or by regulation in this contain a denaturant as long as such production, or certification for a chapter. inedible product is properly packaged, wholesome egg product under this part, (b) Substances permitted for use in labeled and segregated, and inventory shall be made pursuant to the voluntary egg products under 21 CFR will be controls are maintained. Such inedible egg products inspection regulations permitted for such use under this product must be denatured or (part 592 of this chapter). chapter, subject to declaration decharacterized before being shipped (b) Any food manufacturing requirements in 9 CFR 424.22(c) and 9 from a facility. establishment or institution which uses CFR 590.411, unless precluded from (2) Denatured or decharacterized any eggs that do not meet the such use or further restricted in this inedible egg products may be shipped requirements of 21 U.S.C. 1044(a)(1) in chapter. Such substances must be safe from an official plant for industrial use the preparation of any articles for and effective under conditions of use or animal food, provided that it is human food shall be deemed to be a and not result in the adulteration of properly packaged, labeled, and plant processing egg products requiring product. The Administrator may segregated, and inventory controls are inspection under the regulations in this require, in addition to listing the maintained. part. ingredients, a declaration of the additive (d)(1) Egg products must be processed * * * * * and the purpose of its use. (c) Chemical additives to be used in to meet the standard set out in § 590.422 [Amended] the processing of egg products must be § 590.570. ■ 49. Amend § 590.422 by removing the safe under the conditions of their (2) Unpasteurized egg products may last sentence of the section. intended use and in amounts sufficient be shipped from an official plant to ■ 50. Amend § 590.430 by revising to accomplish their intended purpose. another official plant only when they paragraph (b) to read as follows: Chemical additives may not promote are to be pasteurized, heat treated, or § 590.430 Limitation on entry of material. deception or cause the product to be treated using other methods of treatment otherwise adulterated or unwholesome. sufficient to reduce Salmonella in the * * * * * (b) Inedible egg products may be Scientific data showing the additive second official plant. Shipments of brought into an official plant for storage, meets the above specified criteria must unpasteurized egg products shipped processing, and reshipment provided it be maintained and made available to from one official plant to another for FSIS program employees. pasteurization or treatment must be is handled in such a manner that ■ adequate segregation and inventory 52. Revise § 590.440(c) to read as sealed in cars or trucks and labeled in controls are maintained at all times. The follows: accordance with § 590.410(c). Containers of unpasteurized egg product processing of inedible egg products § 590.440 Processing ova. must be done under conditions that will must be marked with the identification * * * * * mark shown in Figure 2 of § 590.415. not affect the processing of edible (c) All products containing ova must products, such as processing in separate be labeled in accordance with § 590.411. (e) When inspection program areas or at times when no edible personnel do not suspect products are being processed. If the § § 590.500 and 590.502 [Removed] noncompliance by an official plant with same equipment or areas are used to ■ 53. Remove §§ 590.500 and 590.502. any provisions of this part, they may process both inedible and edible eggs, ■ 54. Revise § 590.504 to read as permit that plant to move egg products then the equipment and processing follows: that have been sampled and analyzed areas used to process inedible eggs must for Salmonella, or any other reason, § 590.504 General operating procedures. be thoroughly cleaned and sanitized before receiving the test results so long prior to processing any edible egg (a) Operations involving the as the plant maintains control of the products. processing, storing, and handling of products represented by the sample ■ 51. Revise § 590.435 to read as eggs, ingredients, and egg products must pending test results. follows: be strictly in accordance with clean and sanitary methods and must be § 590.506 [Removed] § 590.435 Use of food ingredients and conducted as rapidly as practicable. approval of materials. (b)(1) Egg products are subject to ■ 55. Remove § 590.506. (a)(1) No substance may be used in inspection in each official plant ■ 56. Revise § 590.508 to read as the processing of egg products, for any processing egg products for commerce. follows:

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§ 590.508 Candling and transfer-room ■ 62. Revise § 590.534 to read as personnel promptly upon receipt by the operations. follows: official plant. Positive test results must Eggs must be handled in a manner be provided to inspection program that minimizes sweating prior to § 590.534 Freezing facilities. personnel immediately upon receipt by breaking or processing. Freezing rooms, either on or off the the official plant. ■ 57. Amend § 590.510 by revising premises, must be capable of solidly ■ 67. Add § 590.590 to read as follows: paragraphs (a) introductory text, (c)(1) freezing, or reducing to a temperature of 10 °F or lower, all liquid egg products. § 590.590 Use of irradiated shell eggs to and (3), and (d) introductory text to read produce egg products. as follows: § § 590.536, 590.538 through 590.540, Irradiated shell eggs used to produce § 590.510 Classifications of eggs used in 590.542, 590.544, 590.546 through 590.550, pasteurized egg products must be used the processing of egg products. 590.552 and 590.560 [Removed] in conjunction with heat or another (a) The eggs must be sorted and ■ 63. Remove §§ 590.536, 590.538 lethality treatment to produce a ready- classified into the following categories: through 590.540, 590.542, 590.544, to-eat product. Unless otherwise 590.546 through 590.550, 590.552 and * * * * * approved by FDA, the irradiation 590.560. (c)(1) When presented for breaking, treatment of the shell eggs must precede ■ 64. Revise § 590.570 to read as eggs must have an edible interior quality the heat or other lethality treatment follows: and the shell must be sound and free of applied to the egg products. adhering dirt and foreign material. § 590.570 Control of pathogens in egg § § 590.600 through 590.680 [Removed] However, checks and eggs with a products. ■ 68. Remove the undesignated center portion of the shell missing may be used Egg products must be produced to be heading ‘‘Exempted Egg Products when the shell is free of adhering dirt edible without additional preparation to Plants’’ and §§ 590.600 through 590.680. and foreign material and the shell achieve food safety and may receive ■ 69. Add an undesignated center membranes are not ruptured. additional preparation for palatability or heading and § 590.700 to read as * * * * * aesthetic, epicurean, gastronomic, or follows: (3) Eggs with meat or blood spots may culinary purposes. Egg products are not Inspection and Disposition of Restricted be used if the spots are removed. required to bear a safe-handling Eggs (d) All loss or inedible eggs must be instruction or other labeling that directs placed in a designated container and that the product must be cooked or § 590.700 Prohibition on disposition of handled as required in § 590.504(c). otherwise treated for safety. restricted eggs. Eggs extensively damaged during (a) No person may buy, sell, or § 590.575 [Removed] breaking, whether not completely transport, or offer to buy or sell, or offer cracked open mechanically or in the ■ 65. Remove § 590.575. or receive for transportation in any movement of trays of eligible eggs for ■ 66. Revise § 590.580 to read as business in commerce any restricted hand breaking, must be broken follows: eggs capable of use as human food, promptly. For the purpose of this § 590.580 Pathogen reduction standards except as authorized in §§ 590.100 and section and § 590.522, inedible and loss testing. 590.720. (b) No egg handler may possess with eggs include crusted yolks, filthy and (a) Official plants must test to the intent to use, or use, any restricted decomposed eggs, and the following: determine that the production of egg eggs in the preparation of human food, * * * * * products is in compliance with the Act except as provided in §§ 590.100 and ■ 58. Amend § 590.516 by revising the and the egg products inspection section heading and paragraph (a) to 590.720. regulations. ■ 70. Add § 590.720 to read as follows: read as follows: (b) To ensure adequate pasteurization: § 590.516 Cleaning of eggs prior to (1) Pasteurized liquid, frozen, and § 590.720 Disposition of restricted eggs. packaging, breaking, or pasteurizing. dried egg products, and heat treated (a) Except as exempted in § 590.100, dried egg whites must be sampled and (a) All eggs, except as provided in eggs classified as checks, dirts, analyzed for the presence of Salmonella § 590.801, must be clean prior to incubator rejects, inedibles, leakers, or spp. Such testing must be performed in packaging, breaking, or pasteurizing. If a loss must be disposed of by one of the a manner sufficient such that it is sanitizer is used, it must be used in following methods at the point and time possible for the official plant to verify accordance with FDA requirements for of segregation: that the system is capable of eliminating the intended use. (1) Checks and dirts must be labeled Salmonella spp. at the time that the in accordance with § 590.800 and * * * * * annual reassessment occurs, and as shipped to an official plant for § 590.520 [Removed] regularly as necessary between annual segregation and processing. Inedible and reassessments, to show that the system, ■ 59. Remove § 590.520. loss eggs must not be intermingled in when tested, is working. ■ 60. Revise § 590.522 to read as the same container with checks and (2) Samples must be analyzed for the follows: dirts. presence of Salmonella spp. with such (2) By destruction in a manner that § 590.522 Egg products processing room sequence, with such frequency, and clearly identifies the products as being operations. using such laboratory methods as is inedible and not for human Eggs used in processed egg products sufficient to ensure that product is not consumption, such as crushing and must be broken in a sanitary manner adulterated. denaturing or decharacterizing in and examined to ensure that the (3) Samples must be drawn from the accordance with § 590.504(c). The contents are acceptable for human final packaged form. products must also be identified as consumption. (c) Results of all partial and ‘‘Inedible Egg Product—Not To Be Used completed analyses performed under As Human Food.’’ § § 590.530 and 590.532 [Removed] paragraph (b) of this section must be (3) Processing for industrial use or for ■ 61. Remove §§ 590.530 and 590.532. provided to inspection program animal food. Such products must be

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denatured or decharacterized in ■ 73. Add subpart B, consisting of 301.2, where inspections are authorized accordance with § 590.504(c) and §§ 590.900 through 590.965, to read as to be conducted as prescribed in identified as provided in §§ 590.840 and follows: § 590.925 of this subchapter. (b) No egg products may be imported 590.860, or properly handled in a Subpart B—Imports manner that clearly identifies the into the United States unless they are products as being inedible and not for Sec. healthful, wholesome, fit for human 590.900 Definitions; requirements for food, not adulterated, and contain no human consumption and does not importation into the United States. adulterate egg product intended for 590.901 Egg products offered for entry and dye, chemical, preservative, or human consumption. Notwithstanding entered to be handled and transported as ingredient which renders them the foregoing, product which was domestic; entry into official plants; unhealthful, unwholesome, produced under official supervision and transportation. unadulterated, or unfit for human food. transported for industrial use or animal 590.905 Importation of restricted eggs. Such products must also comply with food need not be denatured or 590.910 Eligibility of foreign countries for the regulations prescribed in this decharacterized if it is shipped under importation of eggs and egg products subpart to ensure that they adhere to the Government seal and received by a into the United States. standards provided for in the Act. The program employee as defined in this 590.915 Imported products; foreign provisions of this subpart will apply to inspection certificates required. these products only if they are capable part. 590.920 Import inspection application. (4) By coloring the shells of loss and 590.925 Inspection of eggs and egg products for use as human food. inedible eggs with a sufficient amount offered for entry. (c) Approval for Federal import of FD&C color to give a distinct 590.930 Eggs and egg products offered for inspection must be in accordance with appearance, or applying a substance that entry, retention in customs custody; §§ 590.140 through 590.149. will penetrate the shell and delivery under bond; movement prior to (d) Egg products may be imported decharacterize the contents of the egg. inspection; handling; equipment and only if they are processed solely in the However, lots of eggs containing assistance. countries listed in § 590.910(b). significant percentages of eggs having 590.935 Means of conveyance and equipment used in handling egg § 590.901 Egg products offered for entry small to medium blood spots or meat and entered to be handled and transported spots, but no other types of loss or products offered for entry to be maintained in sanitary condition. as domestic; entry into official plants; inedible eggs, may be shipped directly 590.940 Identification of egg products transportation. to official plants, provided they are offered for entry; official import (a) All egg products, after entry into conspicuously labeled with the name inspection marks and devices. the United States in compliance with and address of the shipper and the 590.945 Eggs and egg products offered for this subpart, will be deemed and treated wording ‘‘Spots—For Processing Only entry; reporting of findings to customs; and, except as provided in §§ 590.935 In Official Egg Products Plants.’’ handling of articles refused entry; and 590.960, will be handled and appeals, how made; denaturing (5) Incubator rejects must be broken or transported as domestic product, and crushed and denatured or procedures. 590.950 Labeling of immediate containers will be subject to the applicable decharacterized in accordance with provisions of this part and to the § 590.504(c) and labeled as required in of egg products offered for entry. 590.955 Labeling of shipping containers of provisions of the Egg Products §§ 590.840 and 590.860. egg products offered for entry. Inspection Act and the Federal Food, (b) Eggs that are packed for the 590.956 Relabeling of imported egg Drug, and Cosmetic Act. ultimate consumer and have been found products. (b) Imported egg products entered in to exceed the tolerance for restricted 590.960 Small importations for importer’s accordance with this subpart may, eggs permitted in the official standards personal use, display, or laboratory subject to the provisions of the for U.S. Consumer Grade B but have not analysis. regulations, be taken into official plants been shipped for retail sale must be 590.965 Returned to the United States and be mixed with or added to egg identified as required in §§ 590.800 and inspected and identified covered products; exemption. products that are inspected and passed 590.860 and must be shipped directly or or exempted from inspection in such indirectly: Subpart B—Imports plants. (1) To an official plant for proper (c) Imported egg products that have segregation and processing; or § 590.900 Definitions; requirements for been inspected and passed under this (2) Be re-graded so that they comply importation into the United States. subpart may be transported in with the official standards; or (a) When used in this subpart, the commerce only upon compliance with (3) Used as other than human food. following terms will be construed to (c) Records must be maintained as the applicable regulations. mean: provided in § 590.200 to ensure proper (1) Import (Imported). To bring within § 590.905 Importation of restricted eggs. disposition. the territorial limits of the United States, (a) No containers of restricted eggs ■ 71. Add § 590.801 to read as follows: whether that arrival is accomplished by other than checks or dirties will be § 590.801 Nest-run or washed ungraded land, air, or water. imported into the United States. The eggs. (2) Offer(ed) for entry. The point at shipping containers of such eggs shall Nest-run or washed ungraded eggs are which the importer presents the be identified with the name, address, exempt from the labeling provisions in imported product for reinspection. and country of origin of the exporter, § 590.800. However, when such eggs are (3) Entry (entered) means the point at and the date of pack and the quality of sold to consumers, they may not exceed which imported product offered for the eggs (e.g., checks of dirties) the tolerance for restricted eggs for U.S. entry receives reinspection and is preceded by the word ‘‘Imported’’ or the Consumer Grade B shell eggs. marked with the official mark of statement ‘‘Imported Restricted Eggs-For inspection, as required by § 590.940. Processing Only In An Official USDA § § 590.900 through 590.970 [Removed] (4) Official Import Inspection Plant,’’ or ‘‘Restricted Eggs—Not To Be ■ 72. Remove undesignated center Establishment. This term means any Used As Human Food.’’ Such heading ‘‘Imports’’ and §§ 590.900 establishment, other than an official identification shall be legible and through 590.970. establishment as defined in 9 CFR conspicuous.

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(b) For properly sealed and certified to certify or refuse to certify products (a)(2)(i) and (ii) of this section. shipments of shell eggs for breaking at intended for export; Determination of eligibility is based on an official egg products plant, the (E) Adequate administrative and a study of the documents and other containers need not be labeled, technical support; information presented and an initial provided that the shipment is segregated (F) The inspection and residue review of the system in operation by a and controlled upon arrival at the standards applied to egg products representative of the Department using destination breaking plant. produced in the United States. the criteria listed in paragraphs (a)(2)(i) (G) Other requirements of adequate and (ii) of this section. Maintenance of § 590.910 Eligibility of foreign countries inspection service as required by the eligibility of a country for importation of for importation of eggs and egg products regulations in this part. egg products into the United States into the United States. (ii) The legal authority for the system depends on the results of periodic (a)(1) Whenever it is determined by and the regulations thereunder must reviews of the foreign egg products the Administrator that the system of egg impose requirements equivalent to those inspection system in operation by a products inspection maintained by any governing the system of egg products representative of the Department, and foreign country, with respect to plants inspection organized and maintained in the timely submission of such preparing products in such country for the United States with respect to: documents and other information export to the United States, insures (A) Official controls by the national related to the conduct of the foreign compliance of such plants and their government over plant construction, inspection system, including products with requirements equivalent building and facilities, and equipment; information required by paragraph (e) of to all the inspection, building (B) Official supervision of the section 20 of the Act, as the construction standards, and all other processing of egg products in plants by Administrator may find pertinent to and provisions of the Act and the the assignment of inspectors to plants necessary for the determinations regulations in this part which are certified under paragraph (a)(2)(iv) of required by this section of the applied to official plants in the United this section to ensure that adulterated or regulations. States, and their products, and that misbranded product is not prepared for (iv) The foreign inspection system reliance can be placed upon certificates export to the United States; must maintain a program to assure that required under this part from authorities (C) Any product that is prepared the requirements referred to in this of such foreign country, notice of that under inspection in a plant must be section, equivalent to those of the fact will be given by including the name inspected in such a plant as often as the Federal system of egg products of such foreign country in paragraph (b) inspector deems necessary in order to inspection in the United States, are of this section. Thereafter, products ascertain if the product is being met. The program as implemented prepared in such plants which are unadulterated, wholesome, properly must provide for the following: certified and approved in accordance labeled, and fit for human food at the (A) Periodic supervisory visits by a with paragraph (a)(3) of this section, time it leaves the plant. Upon any such representative of the foreign inspection will be eligible so far as this part is inspection, if any product or portion system to each plant certified in concerned for importation into the thereof is found to be adulterated, accordance with paragraph (a)(3) of this United States from such foreign country unwholesome, or otherwise unfit for section to ensure that requirements after applicable requirements of this human food, such product or portion referred to in paragraphs (a)(2)(ii)(A) part have been met. thereof must be condemned and must through (H) of this section are being (2) The determination of acceptability receive such treatment as provided in met: Provided, that such visits are not of a foreign egg products inspection § 590.504(c); required with respect to any plant system for purposes of this section must (D) Complete separation of plants during a period when the plant is not be based on an evaluation of the foreign certified under paragraph (a)(2)(iv) of operating or is not engaged in producing program in accordance with the this section from plants not certified, products for exportation to the United following requirements and procedures: and the maintenance of a single States; (i) The system must have a program standard of inspection and sanitation (B) Written reports prepared by the organized and administered by the throughout all certified plants; representative of the foreign inspection national government of the foreign (E) Requirements for sanitation at system who has conducted a country. The system as implemented certified plants and for sanitary supervisory visit, documenting his or must provide standards equivalent to handling of egg products; her findings with respect to the those of the Federal system of egg (F) Official controls over condemned requirements referred to in paragraphs products inspection in the United States material until destroyed or removed and (a)(2)(ii)(A) through (H) of this section, with respect to: thereafter excluded from the plant; copies of which must be made available (A) Organizational structure and (G) A Hazard Analysis and Critical to the representative of the Department staffing, so as to insure uniform Control Point (HACCP) system, as set at the time of that representative’s enforcement of the requisite laws and forth in part 417 of this chapter; and review upon request by that regulations in all plants throughout the (H) Other matters for which representative to a responsible foreign system at which products are prepared requirements are contained in the Act or meat inspection official: Provided, that for export to the United States; regulations in this part. such reports are not required with (B) Ultimate control and supervision (iii) Countries desiring to establish respect to any plant during a period by the national government over the eligibility for the importation of egg when the plant is not operating or is not official activities of all employees or products into the United States may engaged in producing products for licensees of the system; request a determination of eligibility by exportation to the United States; and (C) The assignment of competent, presenting copies of the laws and (C) Random sampling and testing at qualified inspectors; regulations on which the foreign egg the point of production, for residues (D) Authority and responsibility of products inspection system is based and identified by the exporting country’s national inspection officials to enforce such other information as the inspection authorities or by this Agency the requisite laws and regulations Administrator may require with respect as potential contaminants, in governing egg products inspection and to matters enumerated in paragraphs accordance with sampling and

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analytical techniques approved by the withdrawn whenever it is determined (1) The date; Administrator, provided that such by the Administrator that the system of (2) The foreign country of export and testing is required only on samples egg products inspection maintained by the producing foreign establishment taken of egg products intended for such foreign country does not assure number; importation into the United States. compliance with requirements (3) The species used to produce the (3) Only those plants that are equivalent to all the inspection, product and the source country and determined and certified to the Agency building construction standards, and foreign establishment number, if the by a responsible official of the foreign other requirements of the Act and the source materials originate from a egg products inspection system as fully regulations in this part as applied to country other than the exporting meeting the requirements of paragraphs official plants in the United States; or country; (a)(2)(i) and (ii) of this section are that reliance cannot be placed upon (4) The product’s description eligible to have their products imported certificates required under this part including the process category, the into the United States. Plant eligibility from authorities of such foreign country; product category, and the product is subject to review by the Agency or that, for lack of current information group; (including observations of the plants by concerning the system of egg products (5) The name and address of the official program personnel inspection being maintained by such importer or consignee; representatives at times prearranged foreign country, such foreign country (6) The name and address of the with the foreign egg products inspection should be required to reestablish its exporter or consignor; system officials). Foreign plants eligibility for listing. (7) The number of units (pieces or certifications must be renewed (b) It has been determined that egg containers) and the shipping or annually. Notwithstanding certification products from the following countries identification mark on the units; by a foreign official, the Administrator covered by foreign egg products (8) The net weight of each lot; and may terminate the eligibility of any inspection certificates of the country of (9) Any additional information the foreign plant for the importation of its origin as required by § 590.915 are Administrator requests to determine products into the United States if it does eligible under the regulations in this whether the product is eligible to be not comply with the requirements listed part for entry into the United States after imported into the United States. in paragraphs (a)(2)(i) and (ii) of this inspection and marking as required by § 590.920 Import inspection application. section, or if current plant information the applicable provisions of this part: cannot be obtained. The Administrator Canada, The Netherlands. (a) Applicants must submit an import will provide reasonable notice to the inspection application to apply for the foreign government of the proposed § 590.915 Imported products; foreign inspection of any product offered for termination of any foreign plant, unless inspection certificates required. entry. Applicants may apply for a delay in terminating its eligibility (a) Except as provided in § 590.960, inspection using a paper or electronic could result in the importation of each consignment imported into the application form. adulterated or misbranded product. United States must have an electronic (b) Import inspection applications for (i) For a new plant, or any plant for foreign inspection certification or a each consignment must be submitted which information from last year’s paper foreign inspection certificate (electronically or on paper) to FSIS in electronic certification or paper issued by an official of the foreign advance of the shipment’s arrival at the certificate has changed, the certification government agency responsible for the official import establishment where the or certificate must contain: The date; the inspection and certification of the product will be reinspected, but no later foreign country; the foreign plant’s product. than when the entry is filed with U.S. name, address, and foreign plant (b) An official of the foreign Customs and Border Protection. number; the foreign official’s title and government agency must certify that any (c) The provisions of this section do signature (for paper certificates only); product described on any official not apply to products that are exempted the type of operations conducted at the certificate was produced in accordance from inspection by §§ 590.960 and plant (e.g., processing, storage, with the regulatory requirements of 590.965. exporting warehouse); and the plant’s § 590.910. eligibility status (e.g., new or relisted (if (c) The electronic foreign inspection § 590.925 Inspection of eggs and egg previously delisted)). Processing plant certification must be in English, be products offered for entry. certifications must address the type of transmitted directly to FSIS before the (a)(1) Except as provided in products produced at the plant (e.g., the product’s arrival at the official import §§ 590.960 and 590.965 and paragraph process category). inspection establishment, and be (b) of this section, egg products offered (ii) If the plant information provided available to import inspection for entry from any foreign country must on the preceding year’s electronic personnel. be reinspected at an official import foreign plant certification or paper (d) The paper foreign inspection inspection establishment or official certificate, as required in paragraph certificate must accompany each plant by a program inspector before they (a)(3)(i) of this section, has not changed, consignment; be submitted to import may be allowed entry into the United the certification or certificate must inspection personnel at the official States. contain: The date, the foreign country, import inspection establishment; be in (2) Every lot of product must the foreign plant’s name, and the foreign English; and bear the official seal of the routinely be given visual reinspection official’s title and signature (for paper foreign government responsible for the by a program inspector for appearance certificates only). inspection of the product, and the name, and condition and be checked for (4) Egg products from foreign title, and signature of the official certification and label compliance as countries not listed in paragraph (b) of authorized to issue the inspection provided in §§ 590.915, 590.950, and this section are not eligible for certificates for products imported into 590.955. importation into the United States, the United States. (3) Program inspectors must consult except as provided by §§ 590.960 and (e) The electronic foreign inspection the electronic inspection system for 590.965. The listing of any foreign certification and paper foreign reinspection instructions. The electronic country under this section may be inspection certificate must contain: inspection system will assign

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reinspection levels and procedures (b) All conveyances containing completion of the official import based on established sampling plans imported liquid egg products must be inspection if the containers are being and established product and plant sealed by inspection authorities in the inspected by an import inspector who history. exporting country. Seals may be broken reports directly to a program supervisor, (b) Official program personnel may at U.S. port-of-entry for purposes of the product is not required to be held take, without cost to the United States, inspection by official program personnel at the official import inspection from each consignment of egg product or customs officers. establishment pending receipt of offered for entry, such samples of the laboratory test results, and a written § 590.940 Identification of egg products procedure for the controlled stamping, products as are deemed necessary to offered for entry; official import inspection determine the eligibility of the products marks and devices. submitted by the official import inspection establishment and approved for entry into the commerce of the (a) Except for products offered for by the Food Safety and Inspection United States. entry from Canada, egg products that Service, is on file at the import upon reinspection are found to be § 590.930 Eggs and egg products offered inspection location where the acceptable for entry into the United for entry, retention in customs custody; inspection is to be performed. delivery under bond; movement prior to States must be identified as ‘‘U.S. (f)(1) The written procedure for the inspection; handling; equipment and Inspected and Passed’’ product. The controlled release and identification of assistance. official inspection legend shown in product should be in the form of a letter (a) No egg products required by this paragraph (b) of this section will and must include the following: subpart to be inspected will be released identify product only after completion (i) That stamping under this subpart from customs custody prior to required of official import inspection and is limited to those lots of product that inspections, but such product may be product acceptance. can be inspected on the day that delivered to the importer, or his agent, (b) The official mark for identifying certificates for the product are prior to inspection, if the importer egg products offered for entry as ‘‘U.S. examined; furnishes a bond, in a form prescribed Inspected and Passed’’ must be in the (ii) That all products that have been by the Secretary of the Treasury, on the following form, and any device pre-stamped will be stored in the condition that the product must be approved by the Administrator for facility where the import inspection will returned, if demanded, to the collector applying such mark must be an official occur; 1 of the port where the product was device. (iii) That inspection marks applied offered for clearance through customs. under this part will be removed from (b) Notwithstanding paragraph (a) of any lot of product subsequently refused this section, no product required by this entry on the day the product is rejected; subpart to be inspected will be moved and prior to inspection from the port of (iv) That the establishment will arrival where first unloaded, and if maintain a daily stamping log arriving by water from the wharf where containing the following information for first unloaded at such port, to any place each lot of product: The date of other than the place designated in inspection, the country of origin, the accordance with this part as the place foreign establishment number, the where the product must be inspected; product name, the number of units, the and no product will be conveyed in any shipping container marks and foreign manner other than in compliance with inspection certificate number covering this subpart. the product to be inspected. The daily (c) The importer, or his agent, must log must be retained by the furnish such equipment and must (c) Owners or operators of plants, establishment in accordance with provide such assistance for handling other than official plants, who want to § 590.200. and inspecting, where applicable, egg have import inspections made at their (2) An establishment’s controlled products offered for entry as the plants, must apply to the Administrator program privilege may be cancelled program inspector may require. for approval of their establishments for orally or in writing by the inspector who is supervising its enforcement whenever (d) Official import inspection such purpose. Application must be the inspector finds that the establishments must provide buildings made on a form furnished by the establishment has failed to comply with and equipment that meet the sanitation Program, Food Safety and Inspection the provisions of this subpart or any requirements contained in 9 CFR part Service, U.S. Department of Agriculture, conditions imposed pursuant thereto. If 416. Washington, DC, and must include all information called for by that form. the cancellation is oral, the decision and § 590.935 Means of conveyance and (d) No brand manufacturer or other the reasons for it must be confirmed in equipment used in handling egg products person will cast or otherwise make, writing, as promptly as circumstances offered for entry to be maintained in without an official certificate issued by allow. Any person whose controlled sanitary condition. official program personnel, a brand or pre-stamping program privilege has (a) Compartments of steamships, other marking device containing an been cancelled may appeal the decision railroad cars, and other means of official inspection legend, or simulation to the Administrator, in writing, within conveyance transporting any egg thereof, as shown in § 590.940(b). ten (10) days after receiving written products to the United States, and all (e) The inspection legend may be notification of the cancellation. The chutes, platforms, racks, tables, tools, placed on containers of product before appeal must state all of the facts and utensils, and all other devices used in reasons upon which the person relies to moving and handling any egg products 1 The number ‘‘I–38’’ is given as an example only. show that the controlled program was offered for entry into the United States, The plant number of the official plant, facility, or wrongfully cancelled. The official import inspection establishment where the must be maintained in accordance with product was inspected must be shown on each Administrator will grant or deny the 9 CFR 416.4. stamp impression. appeal, in writing, stating the reasons

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for such decision, as promptly as be in effect until there is a final that has been inspected in accordance circumstances allow. If there is a determination of the preceding. with this subpart to the Director of conflict as to any material fact, a hearing Customs at the original port of entry must be held to resolve such conflict. § 590.945 Eggs and egg products offered where the same is offered for clearance for entry; reporting of findings to customs; through Customs inspection. Rules of practice concerning such a handling of articles refused entry; appeals, hearing will be adopted by the how made; denaturing procedures. (2) When product is refused entry into Administrator. The cancellation of the the United States, the official mark to be controlled pre-stamping privilege will (a)(1) Official program personnel must applied to the product refused entry report their findings as to any product must be in the following form:

(3) When product has been identified specified under paragraph (a)(4) of this part require to be identified in any way, as ‘‘U.S. Refused Entry,’’ official section, the Department will take such unless the same has been clearly and program personnel must request the actions as may be necessary to effectuate legibly identified in compliance with Director of Customs to refuse admission its order to have the product destroyed this part. of such product and to direct that it be for human food purposes. The (d) Any person receiving inspection exported by the owner or importer Department will seek court costs and services may, if dissatisfied with any within the time specified in this section, fees, storage, and proper expenses in the decision of an inspector relating to any unless the owner or importer, within the appropriate forum. inspection, file an appeal from such specified time, causes it to be destroyed (6) No egg product that has been decision. Any such appeal from a by disposing of it under the supervision refused entry and exported to another decision of an inspector must be made of official program personnel so that the country pursuant to paragraph (a)(3) of to the inspector’s immediate supervisor product can no longer be used as human this section may be returned to the having jurisdiction over the subject food, or by converting it to animal food United States under any circumstances. matter of the appeal, and such uses, if permitted by the Food and Drug Any such product so returned to the supervisor must determine whether the Administration. The owner or importer United States will be subject to inspector’s decision was correct. Review of the refused entry product must not administrative detention in accordance of such an appeal determination, when transfer legal title to such product, with section 1048 of the Act and seizure requested, must be made by the except to a foreign importer for direct and condemnation in accordance with immediate supervisor of the Department and immediate exportation, or to an end section 1049 of the Act. employee making the appeal user, e.g., an animal food manufacturer (7) Egg products that have been determination. The egg products or a renderer, for destruction for human refused entry solely because of involved in any appeal must be food purposes. ‘‘Refused entry’’ product misbranding may be brought into identified by U.S. retained tags and must be delivered to and used by the compliance with the requirements of segregated in a manner approved by the manufacturer or renderer within the 45- this chapter under the supervision of an inspector pending completion of an day time limit provided in paragraph authorized representative of the appeal inspection. (a)(4) of this section. Even if such title Administrator. (e) All loss or inedible eggs, or is illegally transferred, the subsequent (b) Upon the request of the Director of inedible egg products must be disposed purchaser will still be required to export Customs at the port where an egg of in accordance with § 590.504(c)(1). the product or have it destroyed under product is offered for clearance through § 590.950 Labeling of immediate paragraph (a)(4) of this section. the customs, the importer of the product containers of egg products offered for (4) The owner or importer will have must, at the importer’s own expense, entry. 45 days after notice is given by FSIS to immediately return to the Director any (a) Immediate containers of product the Director of Customs at the original product that has been delivered to the offered for entry into the United States port of entry to take the action required importer under this subpart and must bear a label, printed in English, in paragraph (a)(3) of this section for subsequently designated ‘‘U.S. Refused showing: ‘‘refused entry’’ product. An extension Entry’’ or found in any request not to (1) The name of the product; beyond the 45-day period may be comply with the requirements in this (2) The name of the country of origin granted by the Administrator when part. of the product, and for consumer extreme circumstances warrant it, e.g., a (c) Except as provided in § 590.930(a) packaged products, preceded by the dock workers’ strike or an unforeseeable or (b), no person will remove or cause words ‘‘Product of,’’ which statement vessel delay. to be removed from any place must appear immediately under the (5) If the owner or importer fails to designated as the place of inspection of name of the product; take the required action within the time egg products that the regulations in this (3) [Reserved];

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(4) The word ‘‘Ingredients’’ followed indicate the country of origin, except for returned from foreign countries will be by a list of the ingredients in order of egg products that are processed admitted into the United States without descending proportions by weight; (repasteurized or, in the case of dried compliance with this part upon (5) The name and place of business of product, dry blended with product notification to and approval of the Food the manufacturer, packer, or distributor, produced in the United States) in an Safety and Inspection Service, in qualified by a phrase which reveals the official plant. specific cases. connection that such person has with (b) Egg products that have been SUBCHAPTER I—EGG PRODUCTS the product; refused entry into the United States INSPECTION ACT (6) An accurate statement of the solely because of misbranding may be quantity; brought into compliance with the ■ 74. Add part 591 to read as follows: (7) The inspection mark of the labeling requirements of this chapter. country of origin; (c) The label for relabeled products PART 591—SANITATION (8) Plant number of the plant at which must state the name, address, and zip REQUIREMENTS AND HAZARD the egg products were processed; and code of the distributor, qualified by an ANALYSIS AND CRITICIAL CONTROL (9) The date of production and plant appropriate term such as ‘‘packed for’’, POINT SYSTEMS number of the plant at which the egg ‘‘distributed by’’, or ‘‘distributors’’. Sec. products were processed or packed. § 590.960 Small importations for 591.1 Basic requirements. (b) For properly sealed and certified 591.2 Hazard analysis and HACCP plan. shipments of shell eggs for breaking at importer’s personal use, display, or an official plant, the immediate laboratory analysis. Authority: 21 U.S.C. 1031–1056; 7 CFR containers need not be labeled, Egg products (other than those that 2.18, 2.53. provided that the shipment is segregated are forbidden entry by other Federal law § 591.1 Basic requirements. and controlled upon arrival at the or regulation) from any country, that are (a) All official plants must comply destination breaking plant. exclusively for the importer’s personal (c) The labels must not be false or use, display, or laboratory analysis, and with the requirements contained in 9 misleading in any respect. not for sale or distribution; that are CFR parts 416, Sanitation, and 417, sound, healthful, wholesome, and fit for Hazard Analysis and Critical Control § 590.955 Labeling of shipping containers human food; and that are not Point (HACCP) Systems, except as of egg products offered for entry. adulterated and do not contain any otherwise provided in this chapter. Shipping containers of imported egg substance not permitted by the Act or (b) For the purposes of 9 CFR parts products are required to bear in a regulations, may be admitted into the 416, Sanitation, 417, Hazard Analysis prominent and legible manner the name United States without a foreign and Critical Control Point (HACCP) of the product, the name of the country inspection certificate. Such products are Systems, and 500, Rules of Practice, an of origin, the foreign inspection system not required to be inspected upon official establishment or establishment plant number of the plant in which the arrival in the United States and may be includes an official plant. product was processed, shipping or shipped to the importer without further § 591.2 Hazard analysis and HACCP plan. identification marks, production codes, restriction under this part, except as and the inspection mark of the country provided in 9 CFR 590.925(b), provided Pursuant to 21 U.S.C. 1035 and 1043, or origin. Labeling on shipping that the Department may, with respect the failure of an official plant to develop containers must be examined at the time to any specific importation, require that and implement a HACCP plan that of inspection in the United States and the importer certify that such product is complies with 9 CFR part 417, or to if found to be false or misleading, the exclusively for said importer’s personal operate in accordance with the product must be refused entry. use, display, or laboratory analysis and requirements in this part, may render not for sale or distribution. The amount the products produced under those § 590.956 Relabeling of imported egg conditions adulterated. products. of liquid, frozen, or dried egg products imported must not exceed 50 pounds. (a) Egg products eligible for Done at Washington, DC, on: January 9, 2018. importation may be relabeled with an § 590.965 Returned to the United States approved label under the supervision of inspected and identified covered products; Paul Kiecker, an inspector at an official plant or exemption. Acting Administrator. official import inspection establishment. U.S. inspected and passed and so [FR Doc. 2018–00425 Filed 2–12–18; 8:45 am] The new label for such product must marked egg products exported to and BILLING CODE 3410–DM–P

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