# Egg Products Inspection Regulations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2020-20151 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** October 29, 2020 - **Citation:** 85 FR 68640 ## Text DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 416, 417, 500, 590, and 591 [Docket No. FSIS-2005-0015] RIN 0583-AC58 Egg Products Inspection Regulations AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the egg products inspection regulations to require official plants that process egg products (herein also referred to as “egg products plants” or “plants”) to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with FSIS's meat and poultry regulations. DATES: This rule is effective December 28, 2020, except for: The amendments to 9 CFR 590.146, 590.149(a), 590.500, 590.502, 590.504(f), (g), (h), (i), (j), (k), (l), (m), (n), (p), and (q), 590.506, 590.508, 590.510(a), (c)(1) and (c)(3), and (d), 590.515, 590.516 section heading and (a), 590.520, 590.522, 590.530, 590.532, 590.534, 590.536, 590.538, 590.539, 590.540, 590.542, 590.544, 590.546 through 590.550, 590.552, 590.560, 590.570(a), 591.1(a) and 591.2(b), which are effective October 29, 2021; and The amendments to 9 CFR 417.7(b), 590.149(b) and (c), 590.504(d)(1) and (2), 590.504(o)(1), (2), and (3), 590.570(b), 590.575, 590.580(b)(1), 591.1(b), and 591.2(a) and (c), which are effective October 31, 2022. Comment date: FSIS is seeking comments on the Egg Products Hazards and Controls Guide. Commenters may use the Egg Products Hazards and Controls Guide during the comment period. Comments must be received by December 28, 2020. ADDRESSES: Comments may be submitted by one of the following methods: • Federal eRulemaking Portal: This website provides the ability to type short comments directly into the comment field on this web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. • Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-3700. • Hand- or courier-delivered submittals: Deliver to 1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700. • Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2005-0015. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http://www.regulations.gov. • Docket: For access to background documents or comments received, call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700. FOR FURTHER INFORMATION CONTACT: Victoria Levine, Program Analyst, Office of Policy and Program Development by telephone at (202) 690-3184. SUPPLEMENTARY INFORMATION: Executive Summary On February 13, 2018, FSIS published a proposed rule to amend the egg products inspection regulations (9 CFR part 590 and other relevant parts) to require egg products plants to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to comply with the Sanitation Performance Standards (SPS), in accordance with the regulations in 9 CFR parts 416 and 417 (83 FR 6314). Additionally, FSIS proposed: • To eliminate prescriptive regulations, including those requiring prior approval by FSIS of egg products plant drawings, specifications, and equipment, and replace outdated pasteurization requirements with a performance standard requiring that official plants process egg products to be edible without additional preparation to achieve food safety. • To change the Agency's interpretation of “continuous inspection” to provide for the presence of inspectors at official plants at the same frequency that meat and poultry processing establishments are provided inspectors, i.e., at least once per shift. • To require egg products plants to maintain control of egg products that have been sampled and tested for microbiological public health hazards until the test results become available. • To apply the egg products regulations to egg substitutes and freeze-dried products and require inspection of these products. • To eliminate the prohibition on the use of irradiated shell eggs in the production of egg products and food products containing them. • To make egg products labeling requirements, including requirements for generically approved labeling and special handling labels, more consistent with the requirements for meat and poultry products, as well as to make changes to labeling requirements for shell eggs consistent with those in the Food and Drug Administration (FDA) regulations. • To align the import requirements for egg products more closely with the import requirements for meat and poultry products. • To change organizational terms and job titles that appear in the regulations but are no longer used by FSIS. • To replace the rules of practice governing enforcement procedures for egg product plants with those that apply to meat and poultry product establishments under 9 CFR part 500. And, • To add the undesignated paragraph defining the term Program employee and eliminate the undesignated paragraph defining the term Eggs of current production. This final rule adopts all the proposed revisions to the egg products inspection regulations, except for the two proposed changes to the regulatory definitions. First, FSIS is not eliminating the definition for the term Eggs of current production from 9 CFR 590.5. Second, the Agency is not adding the undesignated paragraph that defines Program Employee to 9 CFR 590.5. Cost and Benefits Costs attributable to the final rule are those associated with the development and implementation of HACCP plans and Sanitation SOPs. The impact of the costs is mitigated by the fact that 93 percent of egg products plants already use a written HACCP plan to address at least one production step in their process. The benefits of the final rule include providing greater flexibility and incentives for innovation through reductions in paperwork and eliminating unnecessary requirements. In addition, plants voluntarily meeting HACCP requirements and also complying with current prescriptive regulations are expected to reduce costs, because they will be operating solely under HACCP requirements. Plants will also benefit from a reduction in overtime and holiday pay paid to FSIS due to changes in inspection coverage. Table 1—Summary of Estimated Benefits and Costs Industry Benefits • Elimination of requirements for requests of approval for waivers, blueprints, and labels. • A HACCP system allows for long-term efficiency gains resulting from removing barriers to innovation found in the existing command and control system. • Cost savings from the reduction 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, 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 HACCP 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. Summary of Estimated Quantified Benefits and Costs Low Mid High Benefits ($1,000) 5,893 5,893 5,893 Costs ($1,000) 2,506.3 4,826.6 7,163.7 Net Benefits ($1,000) −1,270.6 1,066.5 3,386.8 Figures were annualized over 10 years at the 7 percent discount rate. Numbers may not sum due to rounding. Table of Contents I. Background II. Comments and Responses A. Continuous Inspection B. HACCP, Sanitation SOPs, and Other Sanitation Requirements C. Control of Pathogens in Egg Products D. Labeling E. Blueprints F. Freeze-Dried Egg Products and Egg Substitutes G. Exempted Plant Status H. Eggs of Current Production I. Implementation Timeframe and Training J. Radioactive Content of Irradiated Egg Products K. Temperature and Labeling Requirements L. Dietary Supplements M. Hard-Cooked Eggs N. Cooking as a Lethality Step O. Egg Breaking: Proposed Change to 9 CFR 590.522 P. Immersion-Type Shell Egg Washers Q. Equivalency of Foreign Inspection Systems R. Draft FSIS Compliance Guideline for Small and Very Small Plants That Produce Ready-To-Eat (RTE) Egg Products S. Shipment of Unpasteurized Egg Products: Proposed 9 CFR 590.410(c) T. Proposed 9 CFR 590.504(d)(2) U. Cooked, Salted, and Preserved Eggs V. Health and Hygiene W. Light X. Ventilation Y. Egg Handling: 21 U.S.C. 1034(d) and 1034(e)(1) Z. Non-Compliance Reports AA. Water Supply and Water, Ice, and Solution Reuse BB. Hold and Test (9 CFR 590.504(e)) CC. Plant Testing DD. 9 CFR Part 430 EE. Costs FF. Food Ingredients Used During the Production of Egg Products III. Executive Orders 12866, 13563, and 13771 and the Regulatory Flexibility Act IV. Paperwork Reduction Act V. Executive Order 12988, Civil Justice Reform VI. E-Government Act Compliance VII. Executive Order 13175 VIII. USDA Nondiscrimination Statement IX. Congressional Review Act X. Additional Public Notification I. Background Miscellaneous information The implementation of HACCP will eliminate many of the prescriptive regulations that lead to the issuance of waivers and no objection letters. Therefore, plants implementing HACCP earlier than two years after publication of this rule in the Federal Register will have their new technology waivers and no objection letters in effect at that time revoked on the date they implement HACCP. All other new technology waivers and no objection letters currently in effect will be revoked two years after this final rule is published in the Federal Register . Egg substitutes and freeze-dried egg products will fall under FSIS's jurisdiction three years after this final rule is published in the Federal Register . Plants producing egg substitutes already under FSIS inspection because they also make inspected and passed egg products should have little difficulty meeting the Agency's regulatory requirements. For plants producing egg substitutes that are not currently under FSIS inspection, the Agency will provide additional information about how to meet the regulatory requirements prior to the effective date of this portion of this final rule. Official plants may begin operating under HACCP and Sanitation SOP regulations at earlier dates, provided FSIS has verified that they are in compliance with the regulations. More information on implementation is provided below. FSIS is discontinuing the PEPRLab Program 60 days after this final rule is published in the Federal Register . Proposed Rule On February 13, 2018, FSIS published a proposed rule to amend the egg products inspection regulations (9 CFR part 590 and other relevant parts) to require egg products plants to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to comply with the Sanitation Performance Standards (SPS), in accordance with the regulations in 9 CFR parts 416 and 417 (83 FR 6314). The proposed rule also required egg products to be produced to be edible without additional preparation to achieve food safety. In addition to these requirements, the proposed rule: • Changed the Agency's interpretation of “continuous inspection” to provide for the presence of inspectors at official plants at the same frequency that meat and poultry processing establishments are provided inspectors, i.e., at least once per shift. • Provided for generic approval for certain egg products labels. • Made changes to labeling requirements for shell eggs consistent with those in FDA's regulations. • Required special handling instructions on egg products. • Eliminated the requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment. And • Incorporated egg products plants into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions. The proposed rule's comment period closed on June 13, 2018, 120 days after its publication. After reviewing comments on the proposed rule, FSIS is finalizing, with two exceptions, the provisions in the February 2018 proposed rule. In the proposed rule, FSIS proposed to eliminate the definition for the term Eggs of current production (83 FR 6332). As noted in the proposed rule, “ Eggs of current production” are those eggs that have moved through the usual marketing channels since the time they were laid and are not in excess of 60 days old. The term is an indicator of quality, not food safety, and, FSIS thought, might unduly restrict the availability of edible eggs. In response to comments opposed to removing the term, however, FSIS has decided to retain it in this final rule. Second, FSIS is not adding the proposed undesignated paragraph that defines Program Employee to 9 CFR 590.5 (83 FR 6333). FSIS uses the phrase “inspection program personnel” rather than “program employee” to refer to inspectors and other field personnel. Therefore, instead of adding the undesignated paragraph Program employee to 590.5, FSIS is adding to 9 CFR 590.5 the undesignated paragraph “ Inspection program personnel” because it is specific to FSIS field personnel. FSIS also is amending the following regulations to replace the words “program employee,” “import inspection personnel,” “program inspector,” “official program personnel,” or “import inspector” with “inspection program personnel”: 9 CFR 590.118 9 CFR 590.120 9 CFR 590.136 9 CFR 590.310 9 CFR 590.340 9 CFR 590.435 9 CFR 590.504 9 CFR 590.915 9 CFR 590.925 9 CFR 590.940 9 CFR 590.945 Technical Corrections This final rule makes the following technical changes to the proposed to correct inadvertent errors in the proposed regulatory text: • In paragraph (b) of 9 CFR 417.7, the word “processing” was inadvertently omitted from the existing regulatory text. The paragraph now reads, “The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat, poultry, or egg products processing, including a segment on the development of a HACCP plan for a specific product and on record review.” • A commenter noted that FSIS inadvertently omitted language in the definition of “egg product” in 9 CFR 590.5. The language has been restored and is discussed elsewhere in this document. • The final language for 9 CFR 590.40 concerning egg products not intended for human food no longer contains a provision for shipping such product under seal, as authorized in 9 CFR 590.504(c), because in the final rule, 9 CFR 590.504(c)(1) no longer requires denatured or decharacterized egg products to move under Government seal and certificate. • FSIS is correcting two typographical errors found in 9 CFR 590.149. Paragraph (a) references § 591.1(a)(1) of this chapter. The correct citation is § 591.1(a) of this chapter. Paragraph (b) references § 591.1(a)(1) of this chapter. The correct citation is § 591.1(a) of this chapter. • FSIS is correcting a typographical error found in 9 CFR 590.411. Paragraph (b) references 9 CFR 412.2. The correct citation is 9 CFR 412.1. • FSIS is correcting an error found in 9 CFR 590.412. Paragraph (a) states that official plants must comply with the requirements in 9 CFR 412.2, except as otherwise provided in this part. Section 412.2 permits the approval of generic labels. Official plants do not have to have generically approved labels. Therefore, the Agency is changing the word “must” in paragraph (a) to “may” and removing the phrase “except as otherwise provided in this part.” • FSIS is making the same technical correction to 9 CFR 590.415 and 590.504(d)(2). Both regulations refer to a performance standard that is different than the one that was proposed in 9 CFR 590.570. As proposed, they stated that the relevant standard is “sufficient to reduce Salmonella.” The performance standard that will correctly reflect what was proposed in 9 CFR 590.570 is “sufficient to produce egg products that are edible without additional preparation to achieve food safety.” • FSIS is making a second technical correction to clarify the regulations at 9 CFR 590.504(d)(2). The paragraph states that shipments of unpasteurized egg products shipped from one official plant to another official plant for pasteurization or treatment must be sealed in cars or trucks. FSIS is amending the paragraph to clarify that the official plant is responsible for sealing the car or truck. That the plant is responsible for sealing a shipment of unpasteurized egg products is consistent with the labeling requirements for such shipments, proposed (and made final) in 9 CFR 590.410(c). • FSIS is making a change to 9 CFR 590.424(b) so that the egg products reinspection procedures are consistent with those in the meat regulations, are consistent with the new interpretation of the requirement for continuous inspection found in this final rule, and do not unduly restrict the formation of patrol assignments in egg products plants. Unlike the current egg products regulations, which require reinspection of egg products at the time they are brought into the official plant, the meat regulations permit products to be received in an official establishment during the absence of inspection program personnel. Such products are subject to reinspection by inspection program personnel at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations in Subchapter A of Chapter III, Title 9 of the Code of Federal Regulations. Paragraph (b) of 9 CFR 590.424 will permit the reinspection of egg products brought into an egg products plant under similar circumstances. • FSIS is correcting a typographical error found in proposed 9 CFR 590.514(c)(2). The proposed paragraph stated that “Denatured or decharacterized inedible egg products may be shipped from an official plant for industrial use or animal food, provided that it is properly packaged, labeled, and segregated, and inventory controls are maintained.” It should instead read, “Undenatured egg products or inedible egg products that are not decharacterized may be shipped from an official plant for industrial use or animal food, provided that they are properly packaged, labeled, and segregated, and inventory controls are maintained.” This will allow official plants to ship inedible egg products that look like wholesome egg products to entities desirous of such products, while at the same time ensuring that they are not diverted for human food use. • In the preamble to the proposed rule, FSIS discussed in detail eliminating the regulations at 9 CFR 590.515, regarding egg cleaning operations, as they are inconsistent with the proposed requirements for Sanitation Standard Operating Procedures (Sanitation SOPs). However, the Agency inadvertently failed to include an instruction in the regulatory text to do so. Nonetheless, FSIS received considerable support for its proposal to require official plants to develop and implement Sanitation SOPs and eliminate current regulatory provisions that are inconsistent with them. The Agency is therefore removing 9 CFR 590.515 from the egg products inspection regulations. • FSIS is making a technical correction in the final version of paragraphs (b)(1) and (b)(2) of 9 CFR 590.504 so that they read the same as the current regulations. The proposed rule incorrectly removed the word “Eggs” from these regulations. In this final rule, the Agency is including the words “Eggs and” at the beginning of paragraph (b)(1) to read as follows: “Eggs and egg products are subject to inspection in each official plant processing egg products for commerce.” It is also adding “eggs and” to paragraph (b)(2) so that it reads: “Any eggs and egg products not processed in accordance with the regulations in this part of part 591 or that are not otherwise fit for human food will be removed and segregated.” • FSIS is making a technical correction to 9 CFR 590.570. Section 590.570, Control of pathogens in egg products, applies only to pasteurized egg products, not unpasteurized products. To clarify this, FSIS is changing the title and regulatory text of 9 CFR 590.570 by adding the word “pasteurized” to it to make clear that that regulation requires pasteurized product, not unpasteurized product, to be produced to be edible without additional preparation to achieve food safety. Unpasteurized egg products may continue to be sent to other official plants for further processing to achieve food safety; they may not, however, enter commerce (9 CFR 590.415). The title of 9 CFR 590.570 will read Control of pathogens in pasteurized egg products. FSIS is also adding the word “pasteurized” to the first and second sentences of 9 CFR 590.570 for the same reason. • FSIS is making a technical correction to 9 CFR 590.590. The proposed regulation referred to a performance standard that is different than the one that was proposed in 9 CFR 590.570. As proposed, it stated that the relevant standard is “heat or another lethality treatment to produce a ready-to-eat product.” The language that will correctly reflect what was proposed in 9 CFR 590.570 is “Irradiated shell eggs used to produce pasteurized egg products must be used in conjunction with heat or another lethality treatment sufficient to produce egg products that are edible without additional preparation to achieve food safety.” • FSIS is making a technical correction to 9 CFR 590.910. On November 27, 2019, FSIS published a final rule amending its regulations to remove lists of foreign countries eligible to export meat, poultry, or egg products to the United States, and, instead, maintain such lists on its website (84 FR 65265). That final rule amended 9 CFR 590.910 and its title. FSIS is amending 9 CFR 590.510 and its title in this final rule to match the language newly amended by the Publication Method for Lists of Foreign Countries Eligible To Export Meat, Poultry, or Egg Products to the United States final rule (84 FR 65269). FSIS also made two technical corrections in the regulatory text. First, the Agency removed the word “continuous” before the phrase “Government inspection” in the first sentence of paragraph (a) to be consistent with the language used in this final rule. Second, FSIS removed the second to last sentence of paragraph (a) allowing the survey of the foreign inspection system to occur more expediently by payment by the interested Government agency in the foreign country of the travel expenses incurred in making the survey. • FSIS is making technical corrections to the titles of 9 CFR 590.925, 590.930, and 590.945. Each title refers to “eggs.” The regulatory text, however, refers only to egg products. Removing the word “eggs” from these titles will eliminate any confusion that may exist regarding what product is being regulated. Guidance for Small and Very Small Plants FSIS is also announcing the availability of guidance to help small and very small plants producing egg products meet the pasteurization requirements proposed in this rulemaking. When FSIS published the proposed rule, FSIS posted a draft of the FSIS Compliance Guideline for Small and Very Small Plants that Produce Ready-to-Eat (RTE) Egg Products on its website and requested comments on it. FSIS has revised the draft guidance based on comments on the proposed rule, updated it regarding hazards related to Listeria monocytogenes ( Lm ) and residues, and improved readability. Additionally, FSIS previously did not incorporate the pasteurization time and temperature requirements from 9 CFR 590.570 for liquid egg whites in the draft guidance. It had been intentionally excluded because the current scientific literature indicates that the time and temperature for liquid egg whites in 9 CFR 590.570 does not achieve a 5-log 10 reduction of Salmonella. FSIS reviewed the available data to determine the appropriateness of a 5-log 10 reduction of Salmonella in egg whites as a safe harbor. As such, FSIS is incorporating a separate section with specific conditions under which the pasteurization time and temperature from 9 CFR 590.570 for liquid egg whites may be used as a safe harbor. Comments on the draft guidance are discussed in more detail below. FSIS has posted the final guidance, FSIS Food Safety Guideline for Egg Products, on its web page at (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index). FSIS also is posting an Egg Products Hazards and Controls Guide on its web page at https://www.fsis.usda.gov/wps/wcm/connect/089c71f4-b634-44c8-a69c-389e289f50b2/egg-hazards-controls-guide.pdf?MOD=AJPERES. This guide will help egg products plants design and control safer food production systems, particularly small and very small plants that may need additional assistance as they develop their hazard analyses, support their hazard analyses decisions, and amend existing HACCP systems after reassessment. The guide identifies the process steps relevant to each process category, lists some potential hazards in the process steps, and cites some of the controls frequently used by processors to address these hazards. II. Comments and Responses FSIS received 87 comments from consumers, individuals, a trade association representing the egg products industry, the egg products industry, a consumer group, a trade association representing egg farmers and egg further processing facilities, inspection program personnel (IPP), students and a college professor, an independent consultant, an engineer, an individual working in a field allied with the egg products industry, one foreign government, an FDA-regulated facility, and one U.S. government agency. Most commenters supported the proposed rule overall, with many stating that they thought that the proposed regulations would ensure food safety and protect public health. There was, however, disagreement among commenters about FSIS's suggested change to the Agency's interpretation of the requirement for continuous inspection and questions about the cost of the proposal. FSIS also received some comments from consumers indicating confusion about the scope of the proposed rule. For example, one commenter asked whether the same standards that were proposed for egg products plants would be in place for shell egg producers. The proposed rule did not include requirements for shell egg producers. FSIS regulates official egg products plants and their processing operations and does not generally regulate shell eggs outside of egg products plants, except when checking to ensure that shell eggs packed into containers destined for the ultimate consumer meet the packaging and labeling requirements of the EPIA and 9 CFR 590.50. Therefore, the comments received in response to this proposed rule dealing with shell egg producers and shell eggs located outside of official plants are outside the scope of this rulemaking. A second commenter expressed concern about animal welfare issues, while others requested aid, tax incentives, or rebates to offset the burden of changes required by this rulemaking. These comments were also all outside the scope of this rulemaking. In addition, the Agency received comments about surplus broiler eggs/out-of-specification hatching eggs being thrown away and not used to produce egg products for consumption because they cannot meet the FDA's requirement that eggs sent for breaking be refrigerated at 45 °F within 36 hours of lay (21 CFR 118.4(e)). These comments are outside the scope of this rulemaking. Below is a summary of comments received and FSIS's responses. A. Continuous Inspection Comments: FSIS received three comments from a trade association representing the egg products industry and from the egg products industry, generally in favor of FSIS's proposal to reinterpret “continuous inspection” to require the presence of inspectors in egg products plants at least once per shift, instead of during all processing operations. FSIS received 16 comments from individuals, students, a trade association representing egg farmers and egg further processing facilities, an individual working in a field allied with the egg products industry, and IPP opposing the change. FSIS received one comment asking for more details. Comment: The college professor suggested that the decrease in the amount of onsite inspection would increase the burden on manufacturers to adhere to new standardized food safety and sanitation protocols. Response: FSIS disagrees. Manufacturers must meet certain requirements under this final rule. The amount of onsite inspection provided does not change those requirements, and IPP do not help manufacturers meet these requirements by completing tasks for them. The burden remains the same, regardless of the amount of onsite inspection provided. Comment: The comment from the consumer group stated that “continuous inspection” is defined in the EPIA. As such, according to this commenter, the proposed change would need to be done legislatively and not simply through a rulemaking as proposed by the Agency. Response: FSIS disagrees. The EPIA does not contain a definition of “continuous inspection.” Under 21 U.S.C. 1043, the Secretary of Agriculture has the authority to promulgate rules and regulations deemed necessary to carry out the provisions or purposes of the Act. Under this authority, 1 FSIS proposed a rule that would change its interpretation of “continuous inspection” because such change is necessary to effectively and efficiently administer the egg products inspection program. 1 The Secretary of Agriculture's authority to exercise the functions contained in the EPIA is delegated to the Under Secretary of Food Safety and can be found in 7 CFR 2.18(a)(1)(ii)(C). As FSIS explained in the proposed rule, egg products operations are more like meat and poultry processing operations, and especially those that produce ready-to-eat (RTE) products, than they are meat and poultry slaughter operations, where inspection is required for each meat or poultry carcass. Like RTE meat and poultry processing operations, the typical egg products processing operation is a streamlined, automated process, with a lethality step to destroy pathogens of concern in the finished product (83 FR 6333). As a result, changing the Agency's interpretation of continuous inspection will allow FSIS to better use its inspection resources to conduct more efficient and effective inspections. Comment: The trade association representing the egg products industry said that FSIS should move cautiously in forming a different approach to continuous inspection. This commenter pointed out that there are highly controlled processing steps, often requiring minimal human interaction, that may pose less risk than other processing steps, like breaking, blending, or pasteurizing, which are more like slaughter processes than not. For less risky processes, the commenter suggested that an inspector's unannounced presence for something less than the entire processing shift may be satisfactory. Several commenters opposed to the proposed change in continuous inspection, including IPP and the engineer, argued that breaking eggs is more like meat and poultry slaughter than processing. Because inspection is required in slaughter plants for all slaughter operations, they stated that inspection should also be required during breaking operations. Response: FSIS disagrees that breaking eggs is more like meat and poultry slaughter than processing. As discussed above, the Agency believes that egg products operations are more like meat and poultry processing operations than they are meat and poultry slaughter operations, because the typical egg products processing operation is a streamlined, automated process, with a lethality step to destroy pathogens of concern in the finished product. Further, the shift to processing inspection frequencies will give FSIS the flexibility to focus inspection coverage and tasks in consideration of public health risk, consistent with what the trade association comment recommended. FSIS's shift to processing inspection frequencies will take place in individual plants as they implement HACCP. Comment: Three comments from the trade association representing the egg products industry and the two official plants supported the proposed change to the interpretation of continuous inspection, provided that the number of available inspectors is adequate to prevent interruptions in processing, in the movement of export shipments, or in the performance of certifications of customer specifications or requirements on a fee basis under the Agricultural Marketing Act. Similarly, one comment from an inspector stated that monitoring the requirements for the Agricultural Marketing Service's Commodity Procurement Program would be difficult under patrol assignments, as would collecting samples and applying seals. In addition, this commenter said that patrol assignments would prevent the performance of final inspections. The trade association representing the egg products industry, an egg products plant, and the FDA-regulated facility asked about possible changes to inspection under the proposal. Response: The Agency is required by the EPIA to adequately assign inspection resources to ensure that the requirements of the EPIA are being met. IPP in meat and poultry processing establishments are able to monitor the requirements for the Commodity Procurement Program, perform export certification, and provide fee-based inspection services, while on patrol assignments. They will be able to do so in egg products plants, as well. When the proposed rule is finalized, egg products plants will continue to operate under inspection regulations during all hours of operation, but will most likely have an inspector present only once during each production shift. While at each plant, FSIS inspectors will monitor the plant's sanitary operating practices and the execution of its HACCP plan, such as the critical control point (CCP) related to the heat treatment of egg products, conduct the Agency's food safety related Public Health Information System (PHIS) tasks, and perform other consumer protection tasks, such as conducting product labeling reviews. Under the final rule, however, plants will still be required to have approved operating schedules per 9 CFR 590.124. Comment: One comment from the trade association representing the egg products industry stated that changing the Agency's interpretation of continuous inspection could result in inspection being inconsistently applied, that is, it would be provided as a matter of management efficiency rather than based on need. Under the new interpretation of continuous inspection, this commenter stated that inspection could significantly differ among two or more similar plants based on the location of each. Response: As noted above, the EPIA requires the Secretary of Agriculture to adequately assign inspection resources, as he deems necessary, to ensure that the requirements of the Act are being met. Accordingly, the Agency will provide each plant the amount of inspection coverage that is appropriate for that plant and will provide an inspector at least once each operating shift. Additionally, FSIS inspectors in egg products plants will receive the same routine inspection tasks in PHIS, so inspection activities that inspectors conduct will be consistent across all egg products plants. Moreover, FSIS has many years of experience with using patrol assignments to efficiently and effectively inspect the preparation of food products. Therefore, FSIS is confident that the use of patrol assignments, as necessary, will result in appropriate inspection assignments at all egg products plants. Comment: The trade association representing the egg products industry, while commending the Agency's desire to reduce inspection costs to taxpayers and industry, questioned how much FSIS will save for government or industry. This commenter said that biosecurity concerns will impact the availability of IPP among plants and that egg products plants already have issues with the limited availability of IPP at certain times, usually during overtime periods. The commenter indicated that most overtime now required by the egg products industry is during times when nearby meat and poultry further processors, when they exist, are inactive or otherwise not required to have inspection. Response: Through this final rule, the Agency will reduce the use of inspectors outside their normal work schedules and during overtime hours and holidays in plants by using patrol assignments. The use of patrol assignments likely will reduce the costs for overtime and holiday hours because plants will not be required to operate under the previous interpretation of continuous inspection during overtime and holiday hours. As a result, industry should realize cost savings of approximately $4.8 million annualized at the 7 percent discount rate over ten years. Comment: A comment from the trade association representing the egg products industry in favor of the proposed change pointed out that most firms already have very restrictive biosecurity systems in place and indicated that there are many restrictions on the movement of personnel within a single production or processing site for food safety and animal health reasons. While acknowledging that FSIS IPP already comply with industry biosecurity protocols, this commenter stated that IPP need to continue to honor all reasonable biosecurity requirements at inspected plants, including minimum times between entry to a plant and entry to another plant or farm. Another comment from an egg products plant said that FSIS needs to think about biosecurity when considering an inspector's ability to visit more than one facility a day, as such restrictions may limit IPP travel among inspected plants, such as inline operations that house live chickens and off-line operations. A comment from an inspector said that if continuous inspection is replaced with patrol assignments, only one facility in the assignment could have live birds, as other facilities having live birds would create biosecurity concerns. This commenter also stated that finding available replacements for IPP in cases of emergency would be difficult for FSIS, as a potential replacement could not have been in a facility with live birds within the time limit provided by the biosecurity policies of the other plants in the assignment. Another inspector said that by jeopardizing biosecurity measures, patrol assignments could result in other countries banning the export of egg products if there is an outbreak associated with eggs. Response: Changing the interpretation of continuous inspection under the EPIA will allow for more flexibility to inspect egg products plants using patrol assignments, but FSIS will continue to assign inspectors to ensure both that the requirements of the EPIA are met and the biosecurity of plants is not compromised. IPP have successfully complied with the biosecurity measures put in place by official meat and poultry establishments and egg products plants since 2015, when FSIS issued FSIS Notice 17-15, FSIS Program Personnel Hygiene and Biosecurity Practices. Since that time, FSIS is unaware of any disease transmission caused by the movement of IPP or issues regarding inspection coverage resulting from the implementation of industry biosecurity measures. When this final rule is issued, IPP will continue to follow biosecurity measures put in place by official establishments and plants in accordance with FSIS Directive 5060.1, Hygiene and Biosecurity Practices. Comment: Two comments from IPP opposed to the proposed change in continuous inspection stated that the proposal would not protect public health or would be detrimental to the public. Two other inspectors said that continuous inspection is an integral part of the food safety aspect of egg products. Others said that without continuous inspection, plants will not follow HACCP and Sanitation SOP protocols, and as a result, will produce adulterated product. These commenters argued that plants will take short cuts because IPP will not be there to verify or monitor production, and they will break ineligible eggs. One inspector said that because plants will know when IPP arrive under a patrol assignment, there is no deterrent for them to not break ineligible eggs. A comment by an inspector stated that without continuous inspection, IPP will not know what occurred before and after they are onsite. Another inspector said that with only one site visit a day in an egg products drying plant operating 24 hours a day, seven days a week, equipment that is cleaned in place could potentially rarely be inspected. This commenter also said that IPP would not have the opportunity to observe or conduct many required tasks if the proposed change to continuous inspection is implemented. Response: FSIS's paramount obligation is to protect the public health. This final rule does that by building the principle of prevention into production processes through HACCP and Sanitation SOP requirements. This final rule also protects public health by better delineating and clarifying the respective roles of industry and FSIS to ensure that egg products are produced in accordance with sanitation and safety standards and are not adulterated or misbranded within the meaning of the EPIA. FSIS and establishment data show that HACCP and the related sanitation requirements have been an effective system for reducing or eliminating food safety hazards in meat and poultry processing establishments, inspected under patrol assignments. IPP have had no difficulties verifying regulatory compliance. The application of HACCP to egg products processing should be no different and these changes should significantly enhance the effectiveness of the egg products inspection program. Under HACCP, FSIS will verify that plants have conducted the hazard analysis to identify all hazards reasonably likely to occur and then will verify that plants follow their HACCP plans. 2 If plants do not follow their HACCP plans, FSIS will take regulatory enforcement actions in accordance with 9 CFR part 500. 2 Continuous inspection in egg products plants requires an inspector to be on the premises at least once per shift, not once per day. If a plant has multiple shifts, such inspector presence will be required for each shift. Plants will not know when IPP are to arrive under a patrol assignment. Under patrol assignment inspection, FSIS will observe the breaking of shell eggs and will review plant records concerning incoming eggs to verify that plants are not breaking dirty eggs. Finally, FSIS will test product for pathogens and residues to verify that it is not adulterated. HACCP is a flexible system tailored as a structured food safety program designed for a plant's specific processes and products. Once implemented, egg products plants will be required to develop and implement a HACCP system for food safety that is designed to prevent, eliminate, or reduce to an acceptable level the occurrence of biological, chemical, and physical hazards that are reasonably likely to occur in the plant's process. Plants will be responsible for developing and implementing HACCP plans that incorporate the controls that are necessary to produce safe egg products. Plants will also have to develop and maintain effective recordkeeping procedures that document the entire HACCP system and perform on-going verification procedures to ensure that the plant's HACCP system follows the regulatory requirements. At the same time, proper sanitation is an important and integral part of every food process and a fundamental requirement under the law. Once the sanitation requirements under 9 CFR part 416 are implemented, all plants that process egg products will have to develop, implement, and maintain written Sanitation SOPs to prevent direct contamination or adulteration of product before and during operations (9 CFR 416.11). Plants will also be required to maintain daily records to document adherence to the SOPs (9 CFR 416.16). The implementation of 9 CFR parts 416 and 417 for egg products plants modernizes inspection procedures consistent with inspection procedures in meat and poultry processing establishments, using the Agency's resources more efficiently and removing unnecessary regulatory obstacles to innovation by plants. This will ensure the same level of inspection oversight to achieve FSIS's public health mission and will not diminish the inspector's ability to conduct verification procedures to ensure regulatory compliance by the egg products plants. Comment: A comment from the college professor suggested that FSIS provide for video streaming feeds of several facilities simultaneously to one inspector to remotely monitor safety and sanitation operations, with another in-plant inspector supplementing the video stream with one in-person visit per shift. The commenter said that this would allow for more efficient use of manpower and be consistent with reducing the number of hours inspectors would be present in egg products plans. Response: FSIS does not believe that it is necessary to constantly inspect operations via video to effectively inspect egg products plants. As mentioned above, FSIS has experience using patrol assignments to conduct food safety inspection. FSIS believes that by conducting patrol assignments, reviewing records, and sampling products, it obtains a complete view of establishment operations. B. HACCP, Sanitation SOPs, and Other Sanitation Requirements Comment: Some commenters questioned whether the current regulations for egg products plants are equal to the requirements that the meat and poultry industry must meet and suggested the proposed requirements would “make egg products safer.” Other commenters stated that egg products would (and should) be regulated more strictly than meat and poultry products. Response: The current and proposed egg products regulations are both effective, i.e., they prevent the adulteration and misbranding of egg products, and egg products produced under them are RTE and safe for consumption. However, the current regulations are overly prescriptive and not flexible. They do not, for example, allow official plants to tailor their control systems to the needs of their particular plants and processes. They do not allow official plants to innovate regarding facility design, construction, and operations, and they unnecessarily define the specific means needed to achieve sanitation requirements. The HACCP, Sanitation SOPs, and other sanitation requirements being finalized in this rulemaking are consistent with, and not stricter than, the meat and poultry regulations. They will ensure food safety protection while offering egg products plants flexibility in their operations and the ability to innovate. Comment: FSIS received many comments in favor of requiring official plants to develop and implement HACCP Systems and Sanitation SOPs and to meet other sanitation requirements consistent with the meat and poultry regulations. Commenters, including individuals, academic students, the trade association representing the egg products industry, and the trade association representing egg farmers and egg further processing facilities contended that these requirements would provide a more standardized approach for food safety across all products inspected by FSIS, serve to ensure uniformity among all egg products plants, and make the egg products inspection regulations more effective by eliminating numerous prescriptive command-and-control regulations. One comment from the individual working in a field allied with the egg products industry stated that a benefit of HACCP is its recordkeeping requirements, as records reviews by plant personnel and IPP would ensure the safety of product and that the system is functioning as required. The trade association representing egg farmers and egg further processing facilities supported the application of corrective actions to prevent the recurrence of detectable pathogens. Another comment from an individual supported the proposed HACCP and sanitation requirements because, according to the commenter, egg products present similar food safety risks as meat and poultry. The individual working in a field allied with the egg products industry stated that sanitation regulations for egg products should be consistent with those for meat and poultry, because dirt attached to eggs or equipment can affect product integrity. Comments from the trade association representing the egg products industry and the egg products industry supported the proposed requirements for HACCP and Sanitation SOPs because, according to these commenters, many egg products plants have already voluntarily instituted these programs due to customers' requirements. These same commenters believed that the implementation of these programs will eliminate industry and IPP confusion due to the inconsistency of HACCP requirements in meat and poultry establishments and prescriptive command-and-control requirements in egg products plants. Several commenters specifically expressed support for the proposed sanitation requirements. An individual stated that measures taken to improve the food supply are worthwhile, even if it means higher egg products prices for consumers. Other individuals felt that the provisions of the proposed rule could prevent future unsanitary conditions that may give way to spoiled or contaminated eggs. One comment from a student stated that while shifting liability and responsibility for oversight onto manufacturers via HACCP and Sanitation SOPs would increase efficiency, such efficiency could not be measured until the proposal had been implemented. This commenter thought that FSIS should phase in the requirements of the proposed rule for two to three years to measure the effectiveness of the new rule and make further changes to the regulations, if necessary. Response: FSIS agrees with these comments supporting the proposed HACCP, Sanitation SOP, and other sanitation requirements. FSIS believes that the efficiency of HACCP and Sanitation SOPs, in general, has been shown. The meat and poultry industries have operated under these programs since the late 1990s; their efficiency in eliminating food safety hazards since that time has been clearly demonstrated. For example, by 2000-2001, cleaning and sanitation tasks and tasks required to implement HACCP had accounted for approximately a one-third reduction in the number of meat and poultry samples testing positive for Salmonella spp. 3 In addition, shortly after HACCP was introduced, Salmonella meat contamination levels were generally reduced, a finding consistent with improvement through HACCP implementation. 4 FSIS believes that the HACCP, Sanitation SOPs, and sanitation performance standards will similarly be effective in egg products plants. In any event, FSIS retains the authority to further amend its regulations as needed in the future. 3 Economic Research Service, “The Interplay of Regulation and Marketing Incentives in Providing Food Safety,” July 2009. 4 Rose BE, Hill WE, Umholtz R, Ramnsom GM, James WO. 2002. “Testing for Salmonella in raw meat and poultry products collected at federally inspected establishments in the United States, 1998 through 2000.” J Food Prot 65:937-947. Comment: A comment from an individual said that there needs to be a set, thorough way to fully examine and determine the cleanliness of equipment. This commenter also stated that cleaning and sanitizing solutions used on equipment in egg products plants should be identified and their use indicated on egg products labels. Response: When the proposed rule becomes final, IPP will verify plants' compliance with the sanitation requirements in 9 CFR 416.3(a), which requires that equipment and utensils be maintained in sanitary conditions so as not to adulterate product. Cleaning and sanitizing solutions are not intended to be added to food and are not food ingredients. They do not need to be identified and their use indicated on egg products labels because they do not remain as a constituent of the finished egg product. Comment: The engineer stated that FSIS needs to include a requirement for equipment standards, such as the E-3-A standards, or the 3-A standards used by the Agricultural Marketing Service in the dairy industry. This commenter stated that individual pieces of equipment can be quite complex and that the incorrect design, materials, manufacturing specifications, operation, and maintenance of systems to process liquid and dried eggs can and will lead to product contamination. Response: FSIS disagrees that the egg products inspection regulations need to include a requirement for equipment standards. When finalized, 9 CFR 416.3 will apply to egg products plants and clarify the requirements that plants select and maintain equipment to effectively prevent product contamination or adulteration. Plants will still need to ensure that product is not contaminated, adulterated, or misbranded during processing, handling, or storage. FSIS will verify that plant equipment and systems meet the sanitation performance standards through regular inspection tasks. Comment: A consumer group questioned whether FSIS can determine if HACCP plans adopted by egg products plants are valid within the effective dates of the regulations. Response: As with HACCP for meat and poultry processing, under this final rule, 9 CFR 417.4(a) requires plants to validate that their HACCP system works as intended within their plant. To validate their HACCP systems, plants need scientific support to show that their system can eliminate hazards and also need in-plant data showing that their system works as intended within the plant. FSIS will be able to verify compliance with these requirements. FSIS has ample experience in reviewing and evaluating HACCP plans and their implementation in food processing environments. Given this, and FSIS's experience regulating the egg products industry specifically, FSIS anticipates no difficulties regulating the development and implementation of HACCP plans for egg products processing. Section 9 CFR 590.149(b) will be effective two years after the publication date of this final rule. All existing plants will have 90 days starting on that effective date during which they must validate their HACCP plans. New plants will have 90 days from the date they receive their grant of inspection to validate their HACCP plans and plants producing new products will have 90 days from the date they start producing them during which to validate their HACCP plans. FSIS will verify whether plants have validated their HACCP systems after the effective date of the HACCP regulations and after any new plants have had time to validate their HACCP systems. C. Control of Pathogens in Egg Products Comment: Three consumers supported the requirement that official plants be required to process egg products to be edible without additional preparation to achieve food safety. A comment from an inspector stated, however, that the new regulations would require unpasteurized egg products to be tested and found negative before they could be shipped from the producing plant, without needing further cooking/pasteurization. As a result, the inspector stated that the egg product would no longer meet the definition of Pasteurized in 9 CFR 590.5. Response: When finalized, the proposed rule will not allow unpasteurized egg products to enter commerce. This is consistent with the current regulations, which permit such product to move only to another official plant for further processing (9 CFR 590.415(a)). Proposed Section 590.570, Control of pathogens in egg products, applies only to pasteurized egg products, not unpasteurized products. To clarify any misunderstanding, FSIS changed the title and regulatory text of 9 CFR 590.570 by adding the word “pasteurized” to it to make clear that that regulation is requiring pasteurized product, not unpasteurized product, to be produced as edible without additional preparation to achieve food safety. 5 Unpasteurized egg products may continue to be sent to other official plants for further processing to achieve food safety; they may not, however, enter commerce (9 CFR 590.415). 6 The title of 9 CFR 590.570 will read Control of pathogens in pasteurized egg products. FSIS is also adding the word “pasteurized” to the first and second sentences of 9 CFR 590.570 for the same reason. 5 To verify whether egg products are edible without additional preparation to achieve food safety, FSIS samples and tests pasteurized egg products for Salmonella spp. and Lm. 6 Unpasteurized egg products may also be exported from the U.S. to Canada for further processing to achieve food safety. See https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/requirements-for-processed-egg-products/canada-egg-products. Comment: One comment from an industry member stated that requiring egg products to be edible without additional preparation to achieve food safety would place a significant cost impact on plants that process unpasteurized egg products. In a similar vein, a comment from the engineer asked if egg breaking plants that do not have a kill step to eliminate pathogens and ship raw liquid egg products for further processing would be exempt from the regulations. Response: Plants that process unpasteurized egg products do not have to treat egg products to be edible without additional preparation to achieve food safety. As noted above, unpasteurized egg products may continue to be sent to other official plants for further processing to achieve food safety; they may not, however, enter commerce (9 CFR 590.415). Therefore, there is no associated cost impact on plants that process unpasteurized egg products. Egg products in commerce currently cannot have any detectable pathogens. Therefore, requiring egg products to be edible without additional preparation to achieve food safety does not create any additional costs for producers of pasteurized egg products either. Plants that process unpasteurized egg products, i.e., products that do not receive a kill step to eliminate pathogens, and ship raw liquid egg products for further processing are not generally exempt from the regulations, but they do not have to meet the requirements of 9 CFR 590.570, which applies only to pasteurized egg products. D. Labeling Comment: A comment from the trade association representing egg farmers and egg further processing facilities supported the Agency's proposal to make egg products labeling, including providing for generic labeling, more like labeling requirements for meat and poultry. An inspector noted that FDA-regulated egg substitutes may use food colorings not presently considered suitable by FSIS. This commenter stated that the generic labeling provisions would lead to unapproved ingredients being used in egg substitute products once they are under FSIS jurisdiction. An industry member sought assurances that existing label claims and product names on egg substitutes will continue to be allowed once the products are under FSIS jurisdiction. Response: FSIS will actively review coloring and ingredient approvals for egg substitutes while those products transition from FDA's jurisdiction to FSIS's. FSIS has a Memorandum of Understanding 7 with FDA that establishes the working relationship to be followed by FSIS and FDA when responding to requests ( i.e., petitions or notifications) for the use of food additives, including sources of radiation and food contact substances, generally recognized as safe substances, prior-sanctioned substances, and color additives subject to FDA regulation and intended for use in the production of FSIS-regulated meat, poultry, and egg products. Under this agreement, FDA determines whether substances are safe for use in human food, and FSIS determines whether they are suitable for use in meat, poultry, or egg products. After the effective date of this final rule, the Agency will continue to work with FDA on assessing any food colorings or food ingredients used in egg substitutes. 7 225-00-2000 Amendment 1: Memorandum of Understanding Between the United States Department of Agriculture Food Safety Inspection Service and the United States Department of Health and Human Services Food and Drug Administration, ( http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm441552.htm ), 2000. FSIS is likely to approve label claims, product names on egg substitutes and similar products, and food colorings that have met FDA requirements. FSIS will conduct timely and transparent reviews of specific claims, products names, and food colorings, and will provide guidance on labeling claims and names for egg substitute and similar products. Comment: Another comment from the FDA-regulated facility asked if all liquid/frozen whole egg products must have 24.2 percent solids per 9 CFR 590.411(d) and if so, whether this requirement would eliminate from the marketplace the liquid/frozen product being sold now as whole egg but at 17 percent solids (products currently using gums and starches). Response: As described, this egg product is prepared in other than natural proportions. Therefore, it would not comply with the requirement in 9 CFR 590.411(d) that liquid or frozen egg products identified as whole eggs and prepared in other than natural proportions, as broken from the shell, have a total egg solids content of 24.20 percent or greater. This rulemaking did not make substantive changes to 9 CFR 590.411(d). Under that regulation, as amended, “Liquid and frozen egg products identified as whole eggs and processed in other than natural proportions as broken from the shell must have a total egg solids content of 24.20 percent or greater.” Such egg products may have a total egg solids content of less than 24.20 percent, but they may not be identified as “whole eggs.” Such labeling would cause the products to be misbranded. They may, for example, be labeled as “Liquid Egg Product” with “Ingredients: Egg whites, egg yolks.” E. Blueprints Comments: The individual working in a field allied with the egg products industry said that the submission of drawings to USDA for prior approval before making structural changes should be kept and that plants should know what they can and cannot do prior to making changes. Response: FSIS believes that the development and implementation of effective Sanitation SOPs and HACCP systems and compliance with the other sanitation requirements will meet the same objectives as prior approval of plant drawings and equipment specifications by FSIS. The prior approval process is inconsistent with FSIS's view of the appropriate division of responsibility between the Agency and official plants for the production of safe, unadulterated egg products. Plants develop and implement validated HACCP systems to produce safe egg products; FSIS verifies the efficacy of these processes through inspection activities, including product sampling and testing. Further, as discussed in the proposed rule, the prior approval requirement is an obstacle and too often a deterrent to innovation by official plants seeking to improve operations, and it contributes to the inefficient use of FSIS resources both in managing the approval system and verifying official plants' compliance with approved facility and equipment specifications. In addition, FSIS prior approvals are of limited value in ensuring good sanitation. They are limited in both (1) scope, in that they deal only with official plant facilities as presented in drawings and equipment presented as new, and (2) time, in that they are given once, on the condition that official plants will maintain a sanitary operating environment after their facilities and equipment are approved. The Sanitation SOP regulations and sanitation standards require plants to account for structural changes and maintenance over time. The sanitation regulations set forth general principles for plant construction to ensure the maintenance of sanitary conditions and to prevent product adulteration. Paragraph (b) of 9 CFR 416.2 specifically addresses construction requirements in official establishments. Paragraph (b)(1) requires that establishment buildings meet certain sanitation requirements, while paragraphs (b)(2) and (3) provide requirements for interior construction and materials. Paragraph (b)(4) contains requirements for rooms and compartments in which edible product is processed, handled, or stored. The elimination of prior approval for drawings and equipment specifications will provide official plants the flexibility to determine the specific steps to be taken to comply with these requirements. Comment: The individual working in a field allied with the egg products industry thought that many egg products inspection regulations needed to be updated or removed due to gray areas, irrelevancy, or because inspection determinations are left to the discretion of each inspector. This commenter stated that consistency is not possible under the proposed regulations and that having more regulations that are firmly written with absolute requirements or circumstances would be extremely beneficial to plants. Response: FSIS disagrees that such prescriptive regulations are needed in egg products plants. HACCP has been proven to be the best framework for building science-based process control into food production systems to prevent food safety hazards. 8 9 Furthermore, HACCP is a flexible system that will provide an establishment the ability to tailor its control systems to the needs of its particular processes. 8 Neal D. Fortin, Food Regulation: Law, Science, Policy, and Practice, (Hoboken, NJ: John Wiley and Sons, 2017) 181. 9 Rose BE, Hill WE, Umholtz R, Ramnsom GM, James WO. 2002. “Testing for Salmonella in raw meat and poultry products collected at federally inspected establishments in the United States, 1998 through 2000.” J Food Prot 65:937-947. The Agency is also removing some prescriptive sanitation requirements because they impede innovation and blur the distinction between plant and inspector responsibilities for maintaining sanitary conditions. The intent of the final regulation is to provide establishments with more flexibility to innovate regarding facility design, construction, and operations. Inspection program personnel are trained to evaluate an establishment's control system to ensure that the system as designed and implemented meets regulatory requirements. F. Freeze-Dried Egg Products and Egg Substitutes Comment: The trade association representing the egg products industry and a member of industry were in favor of FSIS no longer exempting freeze-dried egg products from inspection, while these two commenters and a third member of industry were in favor of FSIS no longer exempting egg substitutes from inspection. One industry member asked that FSIS work with industry to implement inspection of egg substitutes in a manner to minimalize the costs to industry and to limit the potential disruption of supply to customers as these products are transitioned from FDA to FSIS jurisdiction. Response: Producers of freeze-dried egg products and egg substitutes do not have to meet the requirements of this final rule until three years from the date of publication. Similarly, FSIS will not inspect production of these products until that date. FSIS will be transparent concerning how it plans to inspect egg substitutes and freeze-dried egg products and will publish additional information concerning the transition as necessary. Comment: The trade association representing the egg products industry noted that in the proposed rule FSIS removed egg products from the definition of an egg source for exempted products in 9 CFR 590.5 and stated that the change would lead to confusion on the part of food manufacturers and others. Response: A portion of existing regulatory text was inadvertently omitted from the proposed term Egg product in 9 CFR 590.5. FSIS has reinserted that language so the definition now reads, “For the purposes of this part, the following products, among others, are exempted as not being egg products: Cooked egg products, imitation egg products, dietary foods, dried no-bake custard mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, and sandwiches containing eggs or egg products, provided such products are prepared from inspected egg products or eggs containing no more restricted eggs than are allowed in the official standards for U.S. Consumer Grade B shell eggs.” G. Exempted Plant Status Comment: The trade association representing the egg products industry and an industry member supported FSIS's decision to eliminate the exemption from continuous inspection available for any plant that meets the standards required for official plants in 9 CFR 590.500 through 590.580 and where the eggs received or used in the manufacture of egg products contain no more restricted eggs than are allowed by the official standards for U.S. Consumer Grade B shell eggs found in 9 CFR 590.100(b). These same commenters also supported FSIS's decision to eliminate the corresponding regulations in 9 CFR 590.600-680 containing the requirements plants have to meet if they wish to be exempt from continuous inspection. Both commenters acknowledged that section 1044(a)(2) of the EPIA gives the Secretary of Agriculture discretion to exempt qualifying plants from specific provisions of the Act; however, both commenters stated that these regulatory provisions are inconsistent with the stated intent of the EPIA to protect the health and welfare of consumers. Response: FSIS agrees with these comments. The exemption from continuous inspection found in 9 CFR 590.100(b) and the corresponding regulations in 9 CFR 590.600-680 would permit periodic inspection in egg products plants. FSIS believes that such plants should be inspected at least once per shift. Therefore, the Agency is moving forward as proposed in the rule to eliminate the exemption from continuous inspection found in 9 CFR 59.100(b) for certain egg products plants and the exempted egg products plant regulations in 9 CFR 590.600-680. H. Eggs of Current Production A comment from a trade association representing the egg products industry agreed with FSIS that eggs over 60 days of age have lessened quality and will not meet most customers' expectations for functional properties. This commenter recommended that FSIS leave the “eggs of current production” definition in the regulations because, according to the commenter, the lessened value of product produced from eggs not of current production should be reflected on the label of that product. Other comments from IPP and the egg products industry opposed FSIS's proposal to remove the definition without explanation. Because FSIS agrees with the points raised by the first commenter, it is not eliminating the definition for the term “eggs of current production.” I. Implementation Timeframe and Training Comment: A member of industry found the one-year implementation schedule for Sanitation SOPs and two-year implementation schedule for HACCP acceptable. This commenter then asked that FSIS provide training for the industry when training is provided to FSIS inspectors at egg products plants to ensure that there is clear communication of FSIS's expectations for the programs between all parties. If the implementation timeframe listed does not provide sufficient time to provide training to both inspectors and industry, the commenter asked that the implementation be extended to complete both training and implementation steps. Response: FSIS agrees that effective training of both FSIS and industry employees is critical to the success of Sanitation SOPs and HACCP. However, FSIS does not plan to allow industry to attend Agency training sessions because of complex logistical and cost considerations. The Agency also believes that responsible plant officials are in the best position to determine the training needs for each plant. As is discussed above, FSIS is providing guidance to the industry that the industry may decide to use to train industry employees. FSIS also believes that the current timeframe provides sufficient time for the industry to train its employees in Sanitation SOPs and HACCP and then implement each of the programs. Comment: A comment from the college professor stated that because the effective implementation of HACCP and Sanitation SOPs relies on well-trained and performing employees, user-centered training and instructional materials should be given added consideration to ensure a robust supportive framework is in place in the planned change. This commenter stated that FSIS should guide industry on how to adopt and implement HACCP and Sanitation SOPs, and training should be user-focused and modernized to maximize both agency and industry resources in the training and change implementation process. A comment from an individual said that promises for guidance about the proposed changes were mentioned in the proposal, but were not directly addressed. Response: In the preamble to the proposed rule, FSIS said that it would provide additional guidance to plants on how to validate their HACCP systems (83 FR 6319). FSIS previously provided a Compliance Guideline for Hazard Analysis Critical Control Point (HACCP) Systems Validation in April 2015. While the examples in the compliance guideline reference meat and poultry products, the concepts contained in the document apply to egg products as well. FSIS also is announcing the availability of a Generic HACCP Models Guide for Egg Products that will be published before the HACCP regulations are implemented. And, as discussed earlier, FSIS is making available its FSIS Food Safety Guideline for Egg Products, which will help small and very small plants producing egg products meet the pasteurization requirements proposed in this rulemaking, and its Egg Products Hazards and Controls Guide, which will help egg products plants design and control safer food production systems. Both can be found on FSIS's web page. J. Radioactive Content of Irradiated Egg Products Comment: The foreign government asked FSIS whether it would test the radioactive content of irradiated egg products and if so, what test method or basis would the Agency use in the detection of radiation in egg products. Response: FSIS is finalizing the proposed regulation 9 CFR 590.590, which will permit the use of irradiated shell eggs in the production of pasteurized egg products. As stated in the proposed rule, FDA amended its regulations in July 2000 to permit the use of ionizing radiation on shell eggs to reduce the level of Salmonella (July 21, 2000, 65 FR 45280). Ionizing radiation does not increase the normal radioactivity level of the food, regardless of how long the food is exposed to the radiation, or how much of an energy dose is absorbed. FSIS, therefore, does not intend to test for the radioactive content of egg products produced from irradiated shell eggs. K. Temperature and Labeling Requirements Comment: A federal agency asked FSIS to change proposed 9 CFR 590.50(b) by deleting the words “and labeling” from the paragraph because 21 CFR 101.17(h) does not exempt producer-packers with an annual egg production from a flock of 3,000 or fewer hens from its labeling requirements. The agency asked that FSIS do this so that it is clear that producer-packers with an annual egg production from a flock of 3,000 or fewer hens are exempt only from the temperature requirements of 9 CFR 590.50(a) and not the labeling requirements in 21 CFR 101.17(h). Response: The EPIA exempts producer-packers with an annual egg production from a flock of 3,000 or fewer hens from the refrigeration and labeling requirements of that Act. Section 1034(e)(1)(A) and (B) of Title 21 of the U.S. Code requires the Secretary of Agriculture to make such inspections as the Secretary considers appropriate of a facility of an egg handler (including a transport vehicle) to determine if shell eggs destined for the ultimate consumer are being held under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit after packing and contain labeling that indicates that refrigeration is required. However, 1034(e)(4) exempts any egg handler with a flock of not more than 3,000 layers from an inspection by the Secretary and, therefore, exempts such egg handler from compliance with the refrigeration and labeling requirements of the EPIA. Nevertheless, producer-packers with an annual egg production from a flock of 3,000 or fewer hens are still required to comply with FDA's labeling requirement in 21 CFR 101.17(h) and 9 CFR 590.50(b) has been changed to reflect that requirement. L. Dietary Supplements Comment: The FDA-regulated facility asked if “dietary supplements” are still exempt from labeling requirements. Response: Dried, frozen, or liquid egg products that are dietary supplements, as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), are exempt from FSIS labeling requirements because they are under FDA, not FSIS, jurisdiction. However, dried, frozen, or liquid egg products that purport to be dietary supplements, but are represented for use as conventional foods or as the sole item of a meal or the diet do not, in fact, meet the definition of “dietary supplement” in 21 U.S.C. 321(ff)(2)(B)). Such products would be amenable to inspection under the EPIA and its conforming regulations and are therefore not exempt from FSIS's labeling requirements. Comment: The FDA-regulated facility asked if dehydrated egg whites labeled as “dietary supplements” that do not bear a USDA shield are still exempt from labeling requirements. Response: These products are not exempt from labeling requirements. Dehydrated egg whites are amenable egg products under the EPIA. They must be processed in an official plant under FSIS inspection, contain labels that are not false or misleading, and bear the official mark of inspection. M. Hard-Cooked Eggs Comment: A comment from an inspector thought that it would make sense to move hard-cooked eggs from FDA's jurisdiction to FSIS's using the same logic as was used to transfer egg substitutes from FDA to FSIS jurisdiction. Response: Egg substitutes are being transferred from FDA to FSIS because FSIS determined, and FDA agreed, that egg substitutes are in fact egg products, as defined in the EPIA. As such, they correctly belong under FSIS's oversight. Hard-cooked eggs, however, do not fit the definition of “egg product” under the EPIA, i.e., they are not dried, frozen, or liquid eggs. Therefore, they cannot be regulated by FSIS under that statute. N. Cooking as a Lethality Step Comment: The trade association representing the egg products industry and a member of industry asked FSIS to clarify whether cooking under FSIS inspection is, and under the proposal will remain, an acceptable lethality step when properly validated. The industry member also asked that only finished (saleable) egg products be required to be RTE. Response: Cooking unpasteurized egg products under FSIS inspection is an acceptable lethality step instead of pasteurization, if validated. Pasteurized or cooked egg products are required to be RTE. O. Egg Breaking: Proposed Change to 9 CFR 590.522 Comment: FSIS proposed to amend 9 CFR 590.522 by eliminating its numerous prescriptive sanitation provisions on breaking room operations and replacing them with a single provision requiring eggs used in processed egg products to be broken in a sanitary manner and examined to ensure that the contents are acceptable for human consumption. Comments from the trade association representing the egg products industry and the engineer stated that the language proposed for 9 CFR 590.522 would eliminate the requirement for individual examination of each egg after breaking and before commingling, and would therefore result in the production of unwholesome egg products because individual examination of eggs is still necessary to remove adulterated eggs from production. Response: FSIS agrees with these comments and will amend proposed 9 CFR 590.522 to clarify that eggs must be broken individually and examined for wholesomeness. The Agency will insert the word “Each” at the beginning of the regulation so that it reads, “Each egg used in processed egg products must be broken in a sanitary manner and examined to ensure that the contents are acceptable for human consumption.” P. Immersion-Type Shell Egg Washers Comment: As part of FSIS's proposal to eliminate 9 CFR 590.515, the explicit prohibition against the use of immersion-type washers is being eliminated (current 9 CFR 590.515(a)(7)). The trade association representing the egg products industry asked if the use of immersion-type washers will therefore be permitted, without the submission of a regulatory waiver, provided the egg products plant, working with an equipment manufacturer, validates the safety of the process. Response: As discussed in the proposed rule, waivers of the type needed to permit the use of immersion-type washers will no longer be necessary (83 FR 6330). Under the final rule, the elimination of the prohibition on immersion-type washers will give plants the option to use such equipment, without applying for a regulatory waiver, provided the equipment does not create insanitary conditions and does not adulterate product. The plant must also have documentation supporting its decision to use an immersion-type washer (417.4(a)(1) and 417.5(a)(1) and (a)(2)). Because the implementation of HACCP will eliminate the need for most regulatory waivers, previous waivers and no objection letters (NOL) in effect will be revoked on the date the HACCP requirements become effective, unless a plant implements HACCP earlier than that date, as they will no longer be applicable. If a plant determines that it still needs a waiver or NOL, it will need to reapply for a new one. Q. Equivalency of Foreign Inspection Systems Comment: A comment from the trade association representing the egg products industry questioned how FSIS verifies that imported egg products are as safe as products produced in the Unites States under FSIS inspection. This commenter also said that not all foreign HACCP programs ensure the same level of food safety as domestic HACCP systems and questioned how FSIS can verify that foreign countries require equivalent HACCP programs when FSIS audits those countries only infrequently. This commenter asked that FSIS increase transparency by identifying what is required of foreign governments, publicly sharing plans for verifying that foreign governments have implemented the final rule changes before they manufacture egg products for the United States, and not permitting plants in foreign countries to self-designate that they are eligible to produce products for the United States. This commenter believes that the implementation date of the final rule should allow time for auditors trained in egg products and the new rules to first complete audits of the governments previously determined to be equivalent and that the approval of new countries should be delayed until those countries demonstrate to a qualified FSIS auditor full compliance with the requirements of the laws and regulations. Response: Upon publication of the final rule, FSIS will notify countries either currently eligible to export egg products to the United States (Canada and the Netherlands), or that have requested eligibility to export egg products to the United States, of the new requirements. Before the effective dates of the HACCP, Sanitation SOP, and other sanitation requirements, these countries will be required to submit an updated Self-Reporting Tool and provide documentation that the country's laws, regulations, requirements, and procedures meet FSIS's new HACCP, Sanitation SOP, and other sanitation requirements. FSIS will determine on a case-by-case basis whether currently eligible countries or countries that have requested eligibility have implemented requirements equivalent to this final rule. If countries currently shipping egg products do not meet these requirements, FSIS will require that they make necessary changes to be able to continue shipping product. For other countries, FSIS will not find their inspection systems equivalent and will not allow them to ship egg products to the United States until they meet necessary requirements. FSIS provides guidance on the equivalence process on its website at: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/Equivalence. FSIS also publishes its on-site verification audit reports at: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports. FSIS communicates initial equivalence decisions through the Federal Register . Once FSIS determines a country's food safety inspection system to be equivalent, the foreign competent authority is responsible for certifying establishments that meet FSIS requirements. The foreign competent authority provides FSIS a list of certified establishments for review that is published on FSIS's website at: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/eligible-foreign-establishments. R. Draft FSIS Compliance Guideline for Small and Very Small Plants That Produce Ready-To-Eat (RTE) Egg Products Comment: FSIS received two comments supporting FSIS's draft FSIS Compliance Guideline for Small and Very Small Plants that Produce Ready-to-Eat (RTE) Egg Products. One commenter suggested that there would be some benefit to translating the guideline into Spanish and Chinese. This commenter also suggested that guidelines dealing with shell egg imports be translated into Dutch or French. Response: FSIS will translate the final guidance, the FSIS Food Safety Guideline for Egg Products, into Spanish and will consider translating it into other languages. FSIS does not have guidance dealing with shell egg imports because it does not have jurisdiction over that product. Comment: A comment from the trade association representing the egg products industry, noting that Table 1 on page 16 of the compliance guideline lists the current regulatory requirements for pasteurization treatments, asked why the times and temperatures for liquid egg whites were not included in the table. This commenter also asked for confirmation that FSIS is not suggesting two standards for RTE egg products, i.e., one by regulation that requires the products to be edible without further preparation as verified by the absence of Salmonella and a second “administrative standard” that imposes a specific log reduction that may not be practical. Response: The time and temperature pasteurization parameter for liquid egg whites was not included in Table 1 on page 16 of the draft guidance because the scientific literature indicates that it may no longer result in a minimum 5-log 10 reduction of Salmonella in the product, which is the reduction consistent with other FSIS RTE safe harbors and the FDA's Shell Egg Rule (74 FR 33030, July 9, 2009). 10 10 In the 1998 Risk Assessment, FSIS stated, “[t]he pH of albumen has a significant effect on the reduction of SE, when liquid egg white is pasteurized. Pasteurization is more effective at higher pH levels. Egg albumen has a bicarbonate buffer system which allows the pH to rise very rapidly. The pH of a freshly laid egg is about pH 7.8 and rises to pH 8.7 or 8.8 over three days of storage. After that, the pH increases much more slowly over time to a maximum pH of 9.3 to 9.4. The time and temperature requirements of the pasteurization regulations were based on a pH of about 9 for egg white which was the case in 1969 when the regulations were written, and eggs did not arrive at the egg processing plant before three to five days. Since that time conditions have changed. Eggs reach the egg processing plant sooner now than in 1969, and the pH of the albumen is lower in eggs. For these reasons pasteurization today may be less effective than in 1969 because of the lower pH of eggs at the time of processing in 1998.” In response to the comments, FSIS reviewed the available data to determine the effectiveness of the previous time and temperature pasteurization parameter for achieving a 5-log 10 reduction of Salmonella in egg whites as a safe harbor. The available research indicates that the natural antimicrobial properties of the albumen, the current vaccination and sanitation practices at the farm, and the refrigeration requirement of eggs within 36 hours of lay all limit the growth of Salmonella. Available studies examined Salmonella in eggs from chickens infected with Salmonella. Humphrey et. al., 11 12 enumerated Salmonella from the egg, but also looked at Salmonella growth when inoculated into different parts of the egg (albumen versus yolk). Garibaldi et. al., 13 enumerated Salmonella from whole egg and from the albumen while Gast and Beard 14 enumerated the Salmonella from the whole egg. Their studies demonstrated that most eggs had less than 1-log 10 of Salmonella per egg while a few eggs had 2.1-log 10 of Salmonella. Humphrey et. al., (1991) determined that Salmonella inoculated into the outer edge of the albumen was less likely to grow than when inoculated next to the yolk membrane, fresh eggs were less likely to support Salmonella growth regardless of its position in the albumen, and that Salmonella positive eggs contained less than 1.3-log 10 of Salmonella when stored at room temperature for less than three weeks. Gast and Beard (1992) studied the effect of storage temperature on frequency of isolation and concentration of Salmonella in eggs from experimentally infected hens and determined that eggs stored at 45 °F for 7 days had 0.75-log 10 of Salmonella. Since that time, the industry has continued to lower Salmonella levels in egg products. FSIS performed a Salmonella baseline survey from 2012 to 2013. 15 Results of that baseline indicate that raw liquid whole egg samples had -0.60-log 10 to -0.31-log 10 (95% confidence interval) Salmonella, meaning that there was 1 Salmonella organism per 2 to 4 mL. Raw liquid egg whites had -0.92-log 10 to -0.24-log 10 Salmonella, meaning that there was 1 Salmonella organism per 2 to 8 mL. In addition, FSIS sampling indicated that pasteurized egg whites had a Salmonella prevalence of 0.61% from 1995 to 1999. That prevalence decreased to 0.19% from 2013 to 2018. 11 Humphrey, T.J., Baskerville, A., Mawer, S., Rowe, B., and Hopper, S. 1989. Salmonella Enteritidis phage type 4 from the contents of intact eggs: A study involving naturally infected hens. Epidemiology and Infection. 103:415-423. 12 Humphrey, T.J., Whitehead, A, Gawler A.H.L, Henley, A., and Rowe, B. 1991. Numbers of Salmonella Enteritidis in the contents of naturally contaminated hens' eggs. Epidemiology and Infection. 106:489-496. 13 Garibaldi, J.A., Lineweaver, H., and Ijichi, K. 1969. Number of Salmonellae in commercially broken eggs before pasteurization. Poultry Science. 48(3):1096-1101. 14 Gast. R.K., and Beard, C.W. 1992. Detection and enumeration of Salmonella Enteritidis in fresh and stored eggs laid by experimentally infected hens. Journal of Food Protection. 55(3):152-156. 15 Food Safety and Inspection Service. 2013. Nationwide Raw Liquid Egg Products Baseline Survey. Retrieved from: https://www.fsis.usda.gov/wps/wcm/connect/f83a51b2-35b1-4451-a1cd-aac33e424ad7/Baseline-Raw-Liquid-Eggs.pdf?MOD=AJPERES. Under ideal conditions ( i.e., not from a farm that has Salmonella enteriditis (SE)-positive eggs), any Salmonella present in the eggs are not expected to reach more than 2.1-log 10. As such, FSIS has incorporated a new, separate section into the FSIS Food Safety Guideline for Egg Products using the pasteurization time and temperature from 9 CFR 590.570. This section provides awareness that while the time and temperature does not always provide a 5-log 10 reduction of Salmonella in egg whites, with the history in footnote 7 above, the compilation of the available scientific literature to support the safe use of the time and temperature, and the use of specific conditions under which the time and temperature may be used, the time and temperature can be used as a safe harbor. Egg product plants sourcing from farms with SE-positive eggs may be unable to support the use of the egg white pasteurization time and temperature from 9 CFR 590.570, as these eggs need to be processed in a manner that achieves a 5-log 10 reduction of Salmonella in accordance with the FDA 2009 Shell Egg Final Rule. For plants that are processing SE-positive eggs, FSIS included the tables in the appendix of the guideline to provide times and temperatures for egg whites to achieve the minimum 5-log 10 reduction of Salmonella. FSIS is not establishing two standards for RTE egg products. The standard that official plants must meet is found in proposed 9 CFR 590.570: Egg products must be produced to be edible without additional preparation to achieve food safety. The tables in the appendix of the compliance guideline for pasteurization times and temperatures are not minimum lethalities, but rather safe harbors for plants to follow and be reasonably certain that they will be meeting the requirement in 9 CFR 590.570, as well as meeting the supporting documentation requirement in 9 CFR 417.4(a) and 417.5(a). Consistent with other FSIS compliance guidelines, plants are not required to follow the safe harbors and may use alternate procedures, if they have adequate scientific support (9 CFR 417.4(a) and 417.5(a)) that the alternate procedure will meet the requirement in 9 CFR 590.570, as finalized. S. Shipment of Unpasteurized Egg Products: Proposed 9 CFR 590.410(c) Comment: Comments from IPP did not support the proposed change to eliminate the requirement that unpasteurized liquid egg products transported from one official plant to another be sealed and accompanied by an official certificate (9 CFR 590.410). One inspector stated that the proposal did not adequately allow for the monitoring of the movement of unpasteurized liquid egg product for further processing. A second inspector stated that he did not support the change to 9 CFR 590.410(c), which requires that bulk shipments must state that egg products are for further processing. This commenter stated that it would be unwise to advertise what a tanker may be loaded with due to the threat of agro-terrorism and bio-terrorism in any liquid food industry. A third inspector sought clarification on what should happen when the load is shipped to a different location than originally intended. Response: FSIS disagrees that the proposed change does not adequately allow for the monitoring of the movement of unpasteurized liquid egg product for further processing. The revised regulations provide adequate controls for the monitoring of shipments of unpasteurized products by plants and for adequate inspection by IPP. Egg products shipped for further processing must be in compliance with the revised regulation at 9 CFR 590.504(d)(2), which requires shipments of unpasteurized egg products shipped from one official plant to another for pasteurization or treatment be sealed by the official plant and labeled with the date of loading, per 9 CFR 590.410(c), and identified as intended for further processing, per 9 CFR 590.415. The documentation and labeling requirements for shipments of unpasteurized egg products should raise no terrorism or tampering risks from terrorism. Significantly, the tanker identification for egg products shipped for further processing is already required at 9 CFR 590.415. Finally, clarification on IPP actions when the load is shipped to a different location than originally intended will be provided to IPP through a directive after this rule is finalized. Comment: The trade association representing the egg products industry asked if the exterior of bulk transport vessels carrying unpasteurized egg products must be labeled with the date of loading or if a bill of lading or other documentation accompanying the load is sufficient. Response: The exterior of bulk shipments of unpasteurized egg products produced in official plants must bear a label containing the words “date of loading,” followed by a suitable space in which the date the container, tanker truck, or portable tank is loaded must be inserted (9 CFR 590.410(c)). Placing the date of loading on a bill of lading or other documentation accompanying the load is not sufficient. Comment: A comment from an inspector stated that the movement of tankers without a PY-200 Egg Products Inspection and Grading Certificate (PY-200) would allow tankers carrying nondenatured inedible egg products to be washed and used for edible product with only plant examination and without FSIS visual inspection. One inspector did not support the revision of 9 CFR 590.504(d) as proposed. This commenter objected to the proposed paragraph because it eliminates the use of the PY-200, which is used to record specific data associated with the shipment of unpasteurized egg products. Response: The PY-200 serves as a label for bulk shipments of unpasteurized egg products. In proposed 9 CFR 590.410(c), FSIS changed how bulk shipments are labeled. When this rule is finalized, bulk shipments will no longer move under government seal and certificate; instead, they will move under company seal and bear a label containing the words “date of loading” followed by a suitable space in which the date the container, tanker truck, or portable tank is loaded must be inserted. With the new labeling requirement for bulk shipments of unpasteurized products in place, there is no longer a need for the PY-200 to be used as a label. IPP will still verify that unpasteurized product is properly identified, moved to an official plant, and pasteurized. It is not necessary for IPP to record the specific data associated with the shipment of unpasteurized egg products on a PY-200 cited by the commenter. When a tanker of unpasteurized egg products arrives at an official plant, IPP conduct an organoleptic reinspection of the product in accordance with 9 CFR 590.424(b). This can be done without marking down the tanker's date and time, temperature of the product (which is a data point that should specifically not be taken), the seal numbers (which will no longer be a data point as this rule is eliminating the use of FSIS seals on tankers of unpasteurized products), and the transport vessel's license plate number. Under this final rule, FSIS inspectors will also conduct sanitation verification activities, which will include tanker inspection, to verify that the plant is meeting its Sanitation SOP requirements. Official plants are responsible for storing inedible material in receptacles of such material and construction that their use will not result in the adulteration of any edible product or the creation of insanitary conditions (9 CFR 416.3(c)). In addition, a plant's Sanitation SOPs will have to address the cleaning of food contact surfaces of facilities, equipment, and utensils prior to the start of operations (9 CFR 416.12(c)). As such, egg products plants must ensure that tankers are cleaned before use and maintained in sanitary condition so as not to adulterate product. They must also verify that their Sanitation SOPs are current and effective. If they are not, the Sanitation SOPs must be revised. The issuance of the PY-200 certificate has no bearing on the sanitation of the tanker if the plant designates it as inedible and then decides to use it for edible purposes. The plant has to comply with the sanitation requirements and FSIS IPP will have the opportunity to conduct sanitation tasks to verify the plant is meeting those requirements. Comment: An inspector asked how plants would be required to maintain the cleanliness of equipment used for transporting liquid eggs under the proposed regulations. Response: Under 9 CFR 416.3(a), equipment and utensils must be maintained in a sanitary manner so as not to adulterate product. Egg products plants are required under this regulation for ensuring that equipment used for transporting liquid eggs is sanitary before and after use. T. Proposed 9 CFR 590.504(d)(2) Comment: A comment from an inspector also proposed alternative language for 9 CFR 590.504(d)(2). This alternative language permits the shipment of nonpasteurized or salmonella positive egg products when they are to be pasteurized, repasteurized, or heat treated in another official plant and requires these shipments to be in cars or trucks with an accompanying certificate stating that the product is not pasteurized or is salmonella positive. It allows these shipments to be stored in other than the official plant facilities if the inspectors at the receiving and origin plants are aware of the disposition of the product until it is further processed. It requires nonpasteurized or salmonella positive product to bear the identification mark shown in Figure 3 of § 590.415. Response: FSIS agrees that the language in 9 CFR 590.504(d)(2) should allow for the shipment of Salmonella -positive egg products for further processing under appropriate controls. Therefore, FSIS is changing that paragraph to permit the movement of microbial pathogen-positive products, provided the products move under establishment controls, which include being sealed in a car or truck and labeled per 9 CFR 590.410(c). As a result of this change, FSIS also modified 9 CFR 590.410(c) to permit the movement of microbial pathogen-positive product. Containers of unpasteurized or microbial pathogen-positive egg product must be marked with the identification mark shown in Figure 2 of § 590.415. The proposed language otherwise does not properly reflect FSIS's new regulations on the labeling of bulk shipments of unpasteurized or microbial pathogen-positive egg products that will become effective when this proposal is finalized (9 CFR 590.410(c)). The commenter's recommendation requires the shipment to move with an accompanying certificate stating that the product is not pasteurized or is microbial pathogen-positive and bears the identification mark shown in Figure 3 of § 590.415. Under this final rule, shipments will not have to move with such an accompanying certificate. Instead, they will have to bear a label containing the words “date of loading,” followed by a suitable space in which the date the container, tanker truck, or portable tank is loaded must be inserted in accordance with 9 CFR 410(c). They must also bear a label setting forth the identification found in Figure 2 in final 9 CFR 415. U. Cooked, Salted, and Preserved Eggs Comment: A foreign government asked FSIS to exempt cooked, salted, and preserved eggs from the egg products inspection regulations related to refrigerated storage, transportation, and relevant labeling requirements. Response: Cooked, salted and preserved eggs are not subject to the egg products inspection regulations because they are not egg products ( i.e., they are not dried, frozen, or liquid eggs). V. Health and Hygiene Comment: Paragraph (g) of 9 CFR 590.560 currently prohibits the use of perfume in any area where edible products are exposed. FSIS proposed to remove this provision in the proposed rule. One inspector noted that removing it could make it possible for employees to wear perfume. As a result, according to the commenter, Agency or plant employees may not be able to smell spoiled eggs over the scent of the perfumes. Response: Under this final rule, official plants must comply with the employee hygiene regulations in 9 CFR 416.5, which require that plant employees adhere to hygienic practices while on duty to prevent adulteration of product and the creation of insanitary conditions. Therefore, to meet the regulations, plants are required to provide for an environment in which its employees can properly identify spoiled egg, which would include prohibiting employees from wearing perfumes that restrict employees' ability to smell spoiled eggs. FSIS will verify that the plant meets employee hygiene regulations and that no spoiled eggs adulterate the egg products. W. Light Comment: Current section 590.520(a) provides prescriptive requirements for lighting in egg products plant breaking rooms. 16 An inspector said that removing this regulation could potentially create inedible product since adequate lighting is necessary to identify loss or inedible eggs. 16 The breaking room shall have at least 30 foot-candles of light on all working surfaces except that light intensity shall be at least 50 foot-candles at breaking and inspection stations. Response: Section 416.2(c) requires establishments to provide lighting of good quality and sufficient intensity in areas where food is processed, handled, stored, or examined to ensure that sanitary conditions are maintained, and that product is not adulterated. Under the final rule, the plant is required to demonstrate that it has met this regulatory requirement. If an egg products plant were unable to identify loss or inedible eggs and prevent them from being broken because of inadequate lighting in the breaking room, IPP will find the plant noncompliant with the regulations and will take actions to prevent the adulteration of egg products. X. Ventilation Comment: A comment from an inspector noted that the current egg products inspection regulations addressing ventilation generally require that ventilation provide for a positive flow of outside filtered air through rooms and driers ( e.g., 9 CFR 590.504(p), 506(c), 520(d), and 550(a)). This commenter stated that removing the positive air flow requirement could potentially produce an unwholesome product caused by unfiltered outside air. Response: Under 9 CFR 416.2(d), establishments are required to provide ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent the adulteration of product and the creation of insanitary conditions. Under this final rule, the egg products plant will be required to meet this regulation and ensure that unfiltered outside air does not adulterate product or create insanitary conditions. IPP will verify that the plant meets these requirements; if the plant does not, IPP will find the plant noncompliant with the regulations and will take actions to prevent the adulteration of egg products. Y. Egg Handling: 21 U.S.C. 1034(d) and 1034(e)(1) Comment: The trade association representing egg farmers and egg further processing facilities and an egg products industry member recommended that two provisions of the EPIA be maintained under current regulation: 21 U.S.C. 1034(d) and 21 U.S.C. 1034(e)(1). Section 1034(d) of Title 21 of the U.S. Code authorizes the Secretary of Health and Human Services to inspect egg handlers (other than plants processing egg products) and their records, as well as the records and inventory of other persons required to keep records under section 1040 of the EPIA, to assure that only eggs fit for human food are used for such purpose and otherwise assure compliance by egg handlers and other persons with the requirements of section 1037 (Prohibited acts). The relevant regulatory provisions are 9 CFR 590.28 and 590.132. Section 1034(e)(1) of Title 21 of the U.S. Code authorizes the Secretary of Agriculture to inspect the facility of an egg handler (including a transport vehicle) to determine if shell eggs destined for the ultimate consumer (A) are being held under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit after packing; and (B) contain labeling that indicates that refrigeration is required. The relevant regulatory provision is current 9 CFR 590.50(b). Response: The EPIA was not amended by FSIS's proposed rule. Therefore, 21 U.S.C. 1034(d) and 1034(e)(1) remain unchanged. In addition, FSIS did not propose to eliminate either 9 CFR 590.28 or 9 CFR 590.132 in the proposed rule and thus will not be doing so in the final rule. FSIS has combined into a new, single provision at 9 CFR 590.50(a), the requirement that shell eggs destined for the ultimate consumer be held under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit after packing and the requirement that such eggs contain labeling that indicates that refrigeration is required. Further, as proposed, FSIS's regulations for shell eggs packed into containers destined for the ultimate consumer will now require those products to bear safe handling instructions in accordance with 21 CFR 101.17(h)(1), 17 instead of being labeled to specifically indicate that refrigeration is required. The safe handling instructions read “. . . keep eggs refrigerated . . .” FSIS's new requirement will take effect on the final rule's effective date. 17 21 CFR 101.17(h)(1) says, “SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” Z. Non-Compliance Reports Comment: The same egg products industry member also said that FSIS's enforcement through issuing noncompliance records (NRs) to plants needs to be further improved upon and that FSIS and plants need to follow up after the issuance of an NR so that future issues can be prevented. Response: The NR serves as official notice to an official plant that some aspect of its operation is noncompliant. Certain regulations require that plants implement corrective actions or preventive measures to ensure future compliance (9 CFR 416.15 and 9 CFR 417.3). Depending on the NR, IPP may conduct additional inspection activities to verify that noncompliance documented on an NR has been corrected and that the plant has taken measures to prevent recurrence of the noncompliance ( see FSIS Directive 5000.1, Verifying an Establishment's Food Safety System ). In addition, FSIS has numerous directives and notices that state that when noncompliance is found, IPP are to issue an NR to the establishment. The directives or notices typically state which regulation to cite on the NR. FSIS has also strengthened its approach to noncompliance and made it more data-driven. FSIS utilizes Early Warning Alerts through its Public Health Information System, 18 an additional tool for IPP, which are based on adverse trends in Public Health NRs 19 and give IPP the data to be able to determine trends and take appropriate actions. The Office of Field Operations typically has work unit meetings concerning new instructions to the field, including instructions on how to document noncompliance. FSIS training for the field includes training on new instructions issued to the field, again including instructions on how to document noncompliance. 18 The Public Health Information System is a dynamic, comprehensive data analytic system that collects, consolidates and analyzes data in order to improve public health. https://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/phis. . 19 https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/fsis-data-analysis-and-reporting/data-reporting/public-health-regulations. AA. Water Supply and Water, Ice, and Solution Reuse Comment: Two comments from students requested clarification regarding the use of reconditioned water in 9 CFR 416.2(g)(4). One of them asked that FSIS define “raw product” and provide further clarification on the approved uses of reconditioned water that is processed through advanced wastewater treatment facilities. The other saw the same conflict within the regulation and indicated that more specificity is needed for this part of the rule. Response: Reconditioned water that is processed through advanced wastewater treatment facilities may be used in official plants. Any product, facilities, equipment, and utensils that come into contact with reconditioned water must undergo a separate final rinse with non-reconditioned water that meets the criteria prescribed in 416.2(g)(1). Therefore, once this rule is finalized, reconditioned water may be used in egg products plants on shell eggs prior to breaking and on facilities, equipment, and utensils within the plant. If reconditioned water is used on shell eggs, facilities, equipment, or utensils, they must be rinsed with non-reconditioned water prior to breaking or use (9 CFR 416.2(g)(4)). BB. Hold and Test (9 CFR 590.504(e)) Comment: FSIS received two comments regarding its hold and test policy for egg products in 9 CFR 590.504(d): One from the trade association representing egg farmers and egg further processing facilities supporting it and one from the individual working in a field allied with the egg products industry stating that it was not necessary. Response: Requiring egg products plants to control product pending the receipt of pathogen test results has been a long-standing feature of the egg products inspection regulations (9 CFR 590.504(d)). In the rule, FSIS did not propose to change this policy, but revised its wording to make clear that egg products plants that move product that has been sampled by the Agency or the plant, before receiving test results, must maintain control of the products represented by the sample pending the test results (83 FR 6327). An official plant's failure to maintain control of product pending FSIS or plant pathogen test results endangers public health. Not allowing product to move into commerce until the results of any testing for adulterants become available eliminates this concern. This is also consistent with the policy for other FSIS-regulated meat and poultry RTE products. CC. Plant Testing Comment: A comment from the individual working in a field allied with the egg products industry stated that there is too much variability in egg product industry testing methods, and recommended that FSIS establish a Salmonella testing method that all egg products producers be required to use. This commenter also said that standardizing test methods across the industry will allow for better analysis of results. Response: To gain efficiencies and best protect public health, FSIS is moving towards a sampling program that is focused on production volume rather than the number of products produced. FSIS believes this approach will allow for a more risk-based allocation of samples. It will also align with our other sampling projects. To ensure adequate pasteurization of egg products, egg products plants are required to sample and analyze pasteurized egg products and heat-treated dried egg whites for the presence of Salmonella (9 CFR 590.580(b)). Currently, laboratories that conduct such analyses for plants must participate in FSIS's Pasteurized Egg Product Recognized Laboratory (PEPRLab) Program. Under the PEPRLab Program, recognized laboratories must use a rapid screening method that is equivalent to conventional culture methods in their testing program. If they do not, they must use one of the following three cultural methods as their primary protocol for egg product analysis: AMS—Laboratory Methods for Egg Products—Section I (1993 revision) and Section VII (1994 revision), FSIS method—Microbiology Laboratory Guidebook (MLG) online, Chapter 4—Isolation and Identification of Salmonella from Meat, Poultry, and Egg Products, or FDA method—Bacteriological Analytical Method (BAM) online, Chapter 5— Salmonella. Sixty days after the publication of this final rule, FSIS will discontinue the PEPRLab Program. As a result, laboratories will no longer need to be accredited under it to perform microbiological testing for egg products plants. Egg products plants will be able to select commercial or private laboratories to analyze plant microbiological samples, such as the Salmonella spp. samples required by 9 CFR 590.580. To assist egg products plants with selecting such laboratories, FSIS has made available on its website its guide, Establishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory, which provides criteria for selecting a commercial or private microbiological testing laboratory to analyze establishment samples. Under this final rule, egg products plants are required to ensure that microbiological testing meets their food safety needs. Egg products plants should clearly communicate their needs to the testing laboratory and direct them to any necessary testing protocols or any other guidance, including the guide discussed above, on the FSIS website. The plant is required to take corrective actions in response to positive results (9 CFR 417.3). The plant should not assume that an unexpected result is incorrect. Re-sampling or retesting a sample is typically not an appropriate action. FSIS is not going to prescribe test methods because that would be inconsistent with HACCP regulations and inconsistent with other meat and poultry regulations. DD. 9 CFR Part 430 Comment: A comment from an inspector said that because egg products are RTE, egg products plants should have to comply with 9 CFR part 430, “Requirements for Specific Classes of Products,” because after pasteurization, the product is exposed to the environment during cooling, adding of non-egg ingredients, and packaging. As such, the commenter said, the product should be sampled for Lm. Response: Although eggs products are not currently subject to the requirements in 9 CFR part 430, Control of Listeria monocytogenes in Post-lethality exposed Ready-to-Eat Products ( Listeria Rule), FSIS currently tests egg products for Lm. FSIS will continue to evaluate the data to determine whether Lm contamination is a post-lethality hazard of concern for egg products. EE. Costs Comment: Several individuals and students expressed concern about the impact of the proposed rule on small businesses. Specifically, some of these commenters were concerned about the costs of transitioning to a HACCP system, including the range of HACCP development and validation costs, and whether establishments would need to hire more personnel and provide training. A few commenters noted that the proposed rule would improve food safe [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2020-20151. Public record. Not legal advice.