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Proposed Updates to Egg Products Inspection Regulations

FSIS is proposing new rules for egg products inspection regulations, including requirements for HACCP systems, sanitation SOPs, and sanitation performance standards. The proposed updates aim to improve food safety, streamline processes, and reduce costs for egg product plants.

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Proposed Updates to Egg Products Inspection Regulations

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  1. Agenda Revisit Egg Products Inspection Regulations Proposed Rule Proposed Rule comments and Final Rule timeline and implementation Equivalency Process Overview/Recent Updates Egg Products Inquiries Policy Issuances – proposed updates

  2. Egg Products Inspection Regulations • Proposed Rule FSIS is proposing to: • Require egg products plants to: • Develop and implement: • Hazard Analysis and Critical Control Point (HACCP) Systems (9 CFR Part 417) • Sanitation Standard Operating Procedures (Sanitation SOPs) (9 CFR §§416.11-17) • Meet sanitation performance standards in 9 CFR §§ 416.1-6 • Eliminate regulatory provisions inconsistent with HACCP, Sanitation SOPs, and the proposed sanitation performance standards • Convert prescriptive, command-and-control requirements to performance standards • Plant sanitation (416.2(a)) • Plant construction – rooms, doors, windows (416.2(b)) • Plumbing and sewage disposal (416.2(e); 416.2(f))

  3. Egg Products Inspection Regulations • Proposed Rule FSIS is proposing to: • Require egg products to be edible without additional preparation to achieve food safety (590.570) • Provide for generic approval as part of the prior label approval system for egg products (412.2) • Make changes to labeling requirements for shell eggs consistent with those in the Food and Drug Administration’s (FDA’s) regulation (590.50(a)) • Require special handling instructions on egg products (590.410(a))

  4. Egg Products Inspection Regulations • Proposed Rule FSIS is proposing to: • Eliminate the requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment (590.146) • Incorporate egg products plants into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions (9 CFR Part 500) • Change the Agency’s interpretation of the requirement for continuous inspection in 21 U.S.C. 1034(a)

  5. Egg Products Inspection Regulations • Proposed Rule The proposed rule will: • Provide greater flexibility and incentives for innovation through reductions in paperwork and unnecessary approvals • Reduce costs for plants currently meeting HACCP requirements and also complying with current prescriptive regulations

  6. Egg Products Inspection Regulations • Proposed Rule HACCP: • Official egg products plants will be required to comply with 9 CFR Part 417 as a condition of receiving inspection • Failure to develop and implement a HACCP plan or operate in accordance with part 417 could result in the withdrawal or refusal of inspection services • FSIS will verify that: • The plant’s HACCP plans comply with proposed 9 CFR 590.149(b) and 591.1 and part 417 • These plans have been validated by the plant • Plants are meeting the standard that requires egg products to be edible without additional preparation to achieve food safety

  7. Egg Products Inspection Regulations • Proposed Rule Sanitation SOPs: • All plants that process egg products must develop, implement, and maintain written Sanitation SOPs to prevent direct contamination or adulteration of product before or during operations (9 CFR 416.11-17) • Failure to comply with the Sanitation SOPs provides presumptive evidence of insanitation

  8. Egg Products Inspection Regulations • Proposed Rule Sanitation Performance Standards: • All plants that process egg products must comply with the Sanitation Performance Standards (9 CFR 416.1-6) • FSIS is proposing to amend or replace many current sanitary requirements in 9 CFR 590.500-575 with sanitation performance standards • Define results to be achieved by sanitation, but not specific means to achieve those results • Will significantly reduce the number of sanitation regulations and consolidate most requirements for eggs and egg products with those for meat and poultry

  9. Egg Products Inspection Regulations • Proposed Rule Pasteurized egg products are “ready-to-eat”: • FSIS is proposing to remove the prescriptive pasteurization regulations and replace them with a new regulation specifying that egg products must be produced to be edible without additional preparation to achieve food safety. • The finished product may have no detectable pathogens.

  10. Egg Products Inspection Regulations • Proposed Rule Elimination of prior approval requirements: • Plants will no longer have to submit facility drawings and specifications when applying for a grant of inspection • Plants will no longer have to receive prior approval of equipment and utensils used in preparing edible egg products or product ingredients • Equipment and utensils will have to be of such material and construction that they can be thoroughly cleaned and sanitized (9 CFR 416.3)

  11. Egg Products Inspection Regulations • Proposed Rule Change in the Agency’s interpretation of the requirement for continuous inspection in 21 U.S.C. 1034(a): • Inspection program personnel will not be required to be present within plants during all processing operations • Plant visits of once per shift are expected • Inspection program personnel will remain on duty during a plant’s schedule of operations.

  12. Egg Products Inspection Regulations • Proposed Rule Egg Substitutes: • Low-cholesterol products that are characterized by yolk replacement by other non-egg ingredients • Exempted from USDA inspection in the egg products inspection regulations; under FDA jurisdiction • Egg substitutes should no longer be exempt from inspection by FSIS under the egg products inspection regulations because egg substitutes are similar, if not identical, in some cases, in formulation to egg products • The processing of egg substitutes is also similar to that of other egg products, and the contamination risks associated with these types of products are the same

  13. Egg Products Inspection Regulations • Proposed Rule Egg Substitutes: • To date, the egg products industry has not expressed concern with this proposal • The size and opinion of the egg substitutes industry that is not part of the egg products industry is not yet known *NOTE: Freeze-dried eggs will also be considered an egg product similar, if not identical, in some cases, in formulation to egg products • The processing of freeze-drying is also similar to that of other egg products, and the contamination risks associated with these types of products are the same

  14. Egg Products Inspection Regulations • Proposed Rule Irradiated shell eggs: • Shell eggs that have been irradiated may be used in the production of egg products • Ionizing radiation approved for use on eggs in the shell to reduce the internal level of Salmonella by FDA on July 21, 2000 • Irradiation treatment of shell eggs to be processed as liquid egg product will not sufficiently eliminate pathogens of public health concern from this form of egg. • Therefore, must be used in combination with other lethality treatments to complete the total lethality required to result in a pasteurized, RTE egg product. • The use of irradiated shell eggs or their contents must be reflected in the egg product ingredients statement on the finished product labeling.

  15. Egg Products Inspection Regulations • Proposed Rule Egg and egg products import requirements: • FSIS is proposing to align the egg and egg products import regulations more closely with the regulations governing the importation of foreign meat and poultry products

  16. Egg Products Inspection Regulations • Proposed Rule Costs and Benefits of the Proposed Rule

  17. Egg Products Inspection Regulations • Proposed Rule Baseline • There are 77 FSIS Federally Inspected egg processing plants, 93% currently operate under a HACCP system. • 56 are breakers, 52 produce pasteurized liquid or frozen, and 17 produce pasteurized dried product. A plant could do more than 1 of these activities. For example, a plant could break eggs and produce pasteurized liquid product. • All of the egg products plants fall into the HACCP size Small category (less than 500 employees). • 12 businesses own more than 1 plant. • Egg processing plants produce approximately 1.8 billion pounds of product (2014).

  18. Egg Products Inspection Regulations • Proposed Rule Qualitative Benefits • Egg products plants will improve harmonization with other FSIS-inspected establishments that already operate in a HACCP system, including most egg products plants. • Increase flexibility for egg products plants in product creation, sampling techniques, and plant design. • Less burdensome or total elimination of waivers, no objection letters, and label approval processes. • Long term benefits from improved inspection personnel coverage. Egg products inspection personnel will now be trained in HACCP and can be positioned for inspection in traditional meat and poultry establishments.

  19. Egg Products Inspection Regulations • Proposed Rule • Timeline of Final Rule Implementation (once finalized and issued): • Labeling requirements – 60 days after issuance • Sanitation requirements (Part 416 – SSOP/SPS) – 1 year after issuance • HACCP requirements (Part 417) – 2 years after issuance

  20. Equivalence Process Overview • What is Equivalence? • Types of Equivalence Determinations • Equivalence Process

  21. What is Equivalence? Equivalence is the process of determining whether a country’s food safety inspection system achieves the Food Safety and Inspection Service's (FSIS) appropriate level of public health protection as applied domestically in the United States (US).  Additionally, the foreign food safety inspection system is to provide standards equivalent to the FSIS to ensure other non-food safety requirements (such as humane handling, accurate labeling, and assurance that meat, poultry, or egg products are not economically adulterated) are met.  This means that the country is not required to develop and implement the same procedures that the US does, but rather the country must objectively demonstrate how its procedures meets the US level of protection. Countries wishing to become eligible to export meat, poultry, or egg products to the US must demonstrate that they have a regulatory food safety inspection system that is equivalent to that of the US.

  22. Types of Equivalence Determinations There are four (4) types of equivalency determinations: Initial Equivalence Ongoing Equivalence Verification Reinstatement of Equivalence Individual Sanitary Measure

  23. Types of Equivalence Determinations • Con’t • Initial Equivalence • For Countries seeking to export, meat, poultry, Siluriformes fish, or egg products to the U.S. for the 1st time. • FSIS evaluates a country’s food safety inspection system to make an initial equivalence determination before the country can export products to the U.S. • Rulemaking is only required for initial equivalence determinations

  24. Types of Equivalence Determinations • Con’t • (2) Ongoing Equivalence Verification • For countries that have an equivalence determination and are exporting products to the U.S. • Countries are to maintain communication with U.S. concerning updates to their food safety inspection system

  25. Types of Equivalence Determinations • Con’t • (3) Reinstatement of Equivalence • For countries that FSIS has determined to have an equivalent food safety inspection system and stopped exporting to the U.S. for an extended period of time • FSIS will reassess the food safety inspection system before the country can export products to the U.S. again

  26. Types of Equivalence Determinations • Con’t • (4) Individual Sanitary Measure • For countries that have an equivalence determination and want to change a procedure in their food safety inspection system • FSIS will assess the new procedure before the country can implement the procedure for products it exports to the U.S.

  27. The Equivalence Process: • Initial Equivalence • Six Process steps on how initial equivalence determinations are made: • Country Submits Written Requests to FSIS • Document Submission Through Self-Reporting Tool (SRT) • Document Review • On-site verification audit • Public Notification Proposed Rule in Federal Register • Final Determination of Equivalence Final Rule in Federal Register

  28. The Equivalence Process: • Initial Equivalence • SRT is arranged into six (6) components: • Government Oversight • Government Statutory Authority and Food Safety and Other Consumer Protection Regulations (i.e., Inspection system operation, product standards, labeling, etc.) • Government Sanitation • Government HACCP System • Government Chemical Residues Testing Programs • Government Microbiological Testing Programs

  29. The Equivalence Process: • Ongoing Equivalence Verification • Part 1 – Document Reviews • Updated SRT responses, communicate to FSIS that Central Competent Authority (CCA) has verified its SRT responses, etc. • Up-to-date list of all certified establishments • Updated government residue control program, test results and reactions to residue findings • Updated government microbiological sampling and testing programs, including test results and reactions to findings

  30. The Equivalence Process: • Ongoing Equivalence Verification • Part 2 – On-Site Audits • FSIS will periodically conduct an on-site audit of every eligible country’s food safety inspection system to verify whether the country continues to maintain an equivalent inspection system. • *Note: Current IES staff will be accompanying Audit staff on these audits

  31. The Equivalence Process: • Ongoing Equivalence Verification • Part 3 – Point of Entry Reinspection • All imported shipments of meat, poultry, and egg products that enter the US are presented to FSIS for reinspection. FSIS checks every imported shipment for eligibility, certification, transportation damage, and labeling. The purpose of point-of-entry reinspection is to monitor the effectiveness of an eligible exporting country’s food safety inspection system, not to assess the performance of an individual certified establishment.

  32. The Equivalence Process: • Reinstatement of Equivalence • 5 Process Steps • Country Submits Written Requests to FSIS • Document Submission through SRT • Document Review • On-Site Verification Audit • FSIS Notifies Country of Equivalence Determination through formal letter (no rulemaking necessary)

  33. The Equivalence Process: • Individual Sanitary Measure • 2 Reasons • The country wants to make a change to a procedure in its food safety inspection system that FSIS previously determined was equivalent. • FSIS has updated its US domestic food safety procedures or requirements and identified that the procedures or requirements affect previous equivalence determinations for specific eligible countries.

  34. Equivalence: • Recent Improvements • Improvements to the Self-Reporting Tool (SRT) • Implementation of improved SRT in PHIS • Resources to assist countries during transition

  35. Equivalence: • Improvements to the SRT • Reduced number of questions from 200+ to 46. • Questions no longer restate all of FSIS’s domestic regulations and policies. • Questions ask the country’s Central Competent Authority (CCA) how they ensure FSIS’s food safety and other non-food safety equivalence objectives are met. • Questions have been restructured to make it easier for countries to understand the equivalence criteria. • Redundancies have been eliminated. • The SRT will be routinely evaluated and updated. • Version control.

  36. Equivalence: • Resources to Assist Countries during Transition • Update to the equivalence process guidance document and equivalence presentation. • Develop a click-by-click presentation for countries on how to navigate PHIS and complete an SRT in PHIS. *The presentation will be turned into a guidance document. • Videotape Equivalence Process and SRT-PHIS presentations during fall international seminar and post to FSIS website. • Complete an SRT with US domestic policies as example responses. • Update the equivalence portion of the FSIS website to improve navigability and plain language. • Ensure key materials are translated and readily available in multiple languages.

  37. Equivalence: • Resources/Website links The main link to the equivalence webpage on the FSIS website (https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/Equivalence) The link to referenced resources in the attached ppt presentation (https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/Equivalence/equivalence-resources) The link to the equivalence status chart that list the status of countries with initial and reinstatement of equivalence requests (https://www.fsis.usda.gov/wps/wcm/connect/2514b05f-82b2-4c1a-a7f2-fdf4610d4d8e/Equivalence-Process-Status.pdf?MOD=AJPERES) Link to the eligibility table that lists equivalent countries and eligible commodities that can be exported to the U.S. (https://www.fsis.usda.gov/wps/wcm/connect/4872809d-90c6-4fa6-a2a8-baa77f48e9af/Countries_Products_Eligible_for_Export.pdf?MOD=AJPERES)

  38. Parking Lot Issues and Questions: Guidance for Shell Egg Cleaners and Sanitizers • Regulated by FDA – general guidance for acceptability of use: • Substances that are GRAS (Generally Recognized as Safe) for use in food(Title 21 CFR Parts 182 and 184). Not specifically limited when used to clean shell eggs. Should be used in accordance with GMP as defined in 21 CFR, Section 182.1 • Substances regulated for any purpose as food additives in 21 CFR Parts 172-186. They may be used up to the maximum allowable concentration permitted by regulations • Dyes and pigments regulated as color additives for use in food may be used provided they are used at levels not to exceed that specified in the color additive regulations *Note: Any chemical that does not meet the criteria set forth above would need to be reviewed by FDA

  39. Parking Lot Issues and Questions: Guidance for Shell Egg Cleaners and Sanitizers con’t: • Sanitizers formulated in compliance with 21 CFR, Section 178.1010 are acceptable for use in sanitizing shell eggs provided they are registered with EPA for this use. New sanitizers (i.e., not formulated in compliance with 21 CFR, Section 178.1010) intended for use on shell eggs that will be used for commercial purposes must be submitted to the FDA Center for Food Safety and Applied Nutrition for clearance. Questions regarding sanitizers applied to shell eggs in the field or at a treatment facility where raw commodities are the only food treated should be addressed to the Antimicrobial Division, Office of Pesticide Programs, EPA.

  40. Parking Lot Issues and Questions: Fipronil in Shell eggs in the Netherlands • product in question may have been exported to the United States • HHBS decision Shell Egg Recall – North Carolina • Salmonella Bradenrup – FDA Shell Egg Rule Egg Products Compliance guideline – egg whites – pH needs to be certain level achieve 5 log reduction in Salmonella Shipment of Egg Products in Tankers • Temperature requirements of 9 CFR 590.530 (Table 1) • FSIS Notice on returned tankers New Technology – submission and approval process FSIS Compliance Guideline Procedures for New Technology Notifications and Protocols

  41. Parking Lot Issues and Questions: Interpretation of small amounts of egg product in food products (4 criteria) - The egg product must be: • Prepared under USDA/FSIS inspection; • Prepared for export to the U.S. in a foreign establishment certified by a foreign inspection system that has been determined equivalent by FSIS; • Derived from shell eggs that were broken, pasteurized, and properly stored prior to being incorporated into the food product; or • Derived directly from shell eggs broken and immediately incorporated into the resulting food product

  42. Policy Issuances/Updates • FSIS will begin residue testing in egg products awaiting issuance of Egg Products Residue Notice. • Domestic and imported egg products • Targeting unpasteurized liquid egg products & Dried egg products • Elimination of EGGDOM sampling program • FSIS considers egg products to be Ready-to-Eat and thus all FSIS verification testing will include testing for Salmonella and Listeria Monocytogenes (Lm) – September 21, 2016 • Salted egg products shown history of Lm positive • Higher D-value threshold requires higher time/temperature application to reduce to non-detectable levels • Proposal to modify EM sampling categories • Risk assessment is being conducted • Currently FSIS has 7 sampling categories – propose to reduce to 2 under the RTE_RAND (Liquid/Frozen) and RTE_RAND (Dried)

  43. Policy Issuances/Updates • Con’t • FSIS analyzing current directives • Revise/develop policy incorporate HACCP/SSOP language for egg products • Looking at over 20 directives to revise or develop • Range from Sanitation, HACCP, RTE, Sampling, Imports, etc.

  44. FSIS – One Team/One Purpose • QUESTIONS??? • Jose Gabiola, Staff Officer • FSIS, OPPD, Policy Development Staff • Edward Zorinsky Federal Building • 1616 Capitol Avenue, Suite 260 • Omaha, Nebraska  68102-5908

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