1. Egg Safety Regulatory Program Standards Development – CAP Update
Michelle Boyd – Iowa Department of Agriculture & Land Stewardship
Emma Middlemiss – California Department of Food & Agriculture
February 25, 2019
Savannah, Georgia
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2. FDA Egg CAP Collaborative Effort
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A three year federal and state cooperative agreement began September and runs through September The CAP allow FDA to leverage existing state resources and efforts to strengthen its infrastructure under the Food Safety Modernization Act (FSMA).
Iowa Department of Agriculture and Land Stewardship and California Department of Food and Agriculture was awarded this 3 year cooperative agreement. We are currently into the last year of the contract.
Part of the contract is the collaboration of the grantees, California and Iowa. Our short time working together have shown considerable progress with the gap analysis, regulatory review, data sharing, and recommendations of the nationwide shell egg safety regulatory program standards.

3. Egg Safety Regulatory Program Standards (ESRPS) Goals
Recommend & establish Egg Safety Regulatory Program Standards (similar to MFRPS or AFRPS) to create a uniform foundation for the design and management of State programs for the regulation of egg safety
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4. ESRPS Goals Facilitate Collaborate Strengthen Create Improve
Facilitate long-term improvements to the National Food Safety System
Facilitate
Improve interagency collaboration & consistency among states
Collaborate
Strengthen information sharing among the states
Strengthen
Create uniform standards that define a quality regulatory system
Create
Improvement of regulatory response, compliance & enforcement tools
Improve
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Strengthen interagency collaboration & create consistency – create uniform approach to egg regulation among jurisdictions including the sharing of info and the coordination of resources such as FoodShield
Create national uniformity among regulatory programs responsible for egg food protection. Improve industry and consumer confidence in egg safety programs by enhancing uniformity within and between regulatory agencies. Share data among strategic partners. Create consistancy among the states regarding egg standards (training, inspectional stds, etc). Stregthen information sharing among the states - foodshield
To implement (an efficient) risk-based, (prevention focused), nationally integrated, food safety system focused on protecting public health – according to FSMA (FDA food safety modernization act) signed into law in 2011, is changing food safety by shifting focus from responding to foodborne illness to preventing it.
Program improvement - to achieve compliance with egg safety laws and regs

5. Project Objectives
Conduct baseline program self-assessments (using MFRPS & AFRPS) & develop an improvement plan – completed in Jan. 2017
Identify gaps and areas of improvement between Federal and States – completed in Aug. 2017
Develop and implement an agreement and protocol for the electronic sharing of egg regulatory information between State and FDA – on going
Conduct joint inspections between FDA and the State – on going
Make recommendations for national egg regulatory program standards – completed recommendations for standards 1 through 5, 8 & 10
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The program self-assessment requires the completion of the appendices and worksheets found in standards 1-8, and 10, or equivalent forms
Identify gaps and areas of improvement between Federal and States – including voluntary egg safety programs, regulatory authorities, and requirements
Develop and implement an agreement and protocol for the electronic sharing of egg regulatory information between State and FDA - this includes sharing of egg program data, such as inspections, sample analyses, firm inventory and individual firm information, collaborative work planning, and joint discussions around compliance actions between State and FDA
Conduct joint inspections between FDA and the State - All State egg inspectors participate in a minimum of one joint inspection with FDA

6. ESRPS Recommendations
1. Regulatory Foundation
2. Training
3. Inspection Program
4. Inspection Audit Program
5. Egg-related Illness, Outbreak & Emergency Response
6. Compliance & Enforcement*
7. Industry & Community Outreach*
8. Program Resources
9. Program Assessment*
10. Comprehensive Sampling & Laboratory Program (OPTIONAL)
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* This standard is yet to be completed
* This standard is currently in development

7. Standard 1 - Regulatory Foundation
The State program evaluates the scope of its legal authority and regulatory provisions that correspond to the sections of the FD&C and CFR to ensure the protection of shell eggs within its jurisdiction The State Program conducts an evaluation to determine if State laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT to Federal statutes and regulations
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Equivalent means that the federal statute or regulation that is incorporated into the state law
Federal Food, Drug, and Cosmetic Act (FD&C) and Code of Federal Regulations (CFR

8. Standard 2 - Training
The State Program maintains training records and establishes a training plan that promotes development and demonstrates that all inspectors who will conduct shell egg inspections complete the following to adequately perform their work:
Course Work – within 24 mo. of the start date, the inspector must complete courses available online or in classroom through Pathlore, Compliance Wire, IFPTI, or FEMA
Field Training – within 24 mo. of the start date, the inspector must complete a checklist of competencies and number of joint inspections specified by the State Program
Continuing education – every 36 mo. a total of 20 contact hrs. are required for each inspector to complete in continuing education
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List of Course work and continuing education on next slide
IFPTI - International Food Protection Training Institute
10 of the 20 contact hrs can be from presenting, training, or publishing

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Course curriculum and field training shall be successfully completed within 24 months of the inspector’s start date with the Shell egg program
Course Curriculum – majority of FDA courses are available through Pathlore (ORAU) or Compliance Wire, or IFPTI and FEMA
Attachment 2.5 has a detailed list of courses that are possible courses available to meet requirements
Field Training - checklist of competencies and number of joint inspections are specified by the State Program Continuing education - a total of 20 contact hrs required every 36 months
Presenting, training, or publishing max. 10 contact hrs.

10. Standard 3 – Inspection Program
This standard describes the foundation for inspecting shell egg producers and handlers to determine compliance with the laws administered by Federal and State jurisdictions.
The State program has:
a risk based inspection program
an inspection protocol
a system to respond to consumer & industry complaints
a recall system
a sampling procedure (optional)
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The State program has documented procedures that will determine a firm’s level of associated risk and the program’s inspectional priorities
The inspectional protocol includes each state have a written procedure that inspectors are required to conduct (including establishing jurisdiction, reviewing records SE plan, and how to issue NOV)
The program has system procedures for handling consumer & industry complaints including receiving, tracking, evaluating, responding, closing, and maintaining records
The program has a shell egg recall system with written voluntary and mandatory recall procedures including keeping contact info and sharing info with industry and partner agencies and ensuring recalled products are removed from the market
States are not required to have written sampling procedure unless they collect samples (those that do there is a link to FDA compliance manual and other guidance docs)

11. Standard 3 – Inspection Program
Example of a Risk-based Assessment for Shell Egg Producers and Handlers
This Risk-based Inspection Matrix is intended solely to assist State programs with establishing their own risk-based assessment system.
Risk Level
Site SE Prevention Measures Deficiencies
Site Environmental/Egg Sampling Deficiencies
Compliance History
High
Temperature requirement violation
No cleaning and disinfection after an environmental or egg positive samples
Inadequate rodent control measures
Missing vaccine(s)
Recent identified SE positive environmental or egg samples
Missing environmental samples
Business with an inconsistent, poor, or no history of compliance with shell egg safety requirements
Moderate
Missing NPIP or equivalent forms
Inadequate biosecurity
Inadequate fly control measures
Flock size greater than 30,000 birds
Firm routinely practices induced molting via feed and water withdrawal
None Identified
Business with an occasional and unintentional non-compliance history with shell egg safety requirements
Low
Missing or incomplete SE plan as documentation of “SE Clean” pullets
Missing or incomplete general record information/retention
Missing testing window with proof of negative results
Business routinely in compliance with shell egg safety requirements
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12. Standard 4 – Inspection Audit Program
The State program has a process that conducts audits to assess the effectiveness and accuracy of its inspections and sample collections (optional) which includes:
a field inspection audit component
a desk audit component
a corrective action plan
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a field inspection audit component, which is an on-site performance evaluation of inspections by a qualified field inspector auditor onece per contract year and sample collections (optional);
a desk audit component, which is a performance review of the written reports of inspections and sample collections (optional); and
a corrective action plan that addresses action to be taken when certain conditions are not met such as if an individual receives an overall rating of “needs improvement” or if an overall rating for the program falls below 80%

13. Standard 4 – Inspection Audit Program
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14. Standard 5 – Egg-Related Illness, Outbreak and Emergency Response
The State program has written procedures for documenting and investigating egg-related illnesses, outbreaks, and emergencies within the program’s authority to:
communicate with appropriate agencies;
determine, initiate, and complete the appropriate response;
manages an event using formalized Incident Command System structure;
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formalized Incident Command System structure or an official action plan that includes:
Outlining containment
Communication
Control
Correction
After action protocol

15. Standard 5 – Egg-Related Illness, Outbreak and Emergency Response
maintain a list of relevant agencies and emergency contacts;
rapidly notify government agencies, law enforcement, departments, and/or appropriate parties;
release information to the public; and
coordinate media information with other jurisdictions
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16. Standard 6 – Compliance & Enforcement
This Standard is currently in draft form. We are working on the following elements to be incorporated for this Standard:
Compliance history
Responsiveness
Scope
Nature of the Violation
Impact of the Violation
Resources
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17. Standard 7 – Industry & Community Outreach
This Standard is currently in draft form. We are working on the following elements to be incorporated for this Standard:
Workshops – commercial & small flock producers
Seminars – educational seminars put on by academia, regulators, & poultry organizations
Training courses – for local government or industry
Online educational opportunities – pamphlets, FAQs, videos
Poultry shows & fairs – provide handouts & education
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The State program coordinates or participates in outreach activities that provide educational information about food safety that includes:

18. Small Producer Workshop Example
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small flock producers workshops put on throughout the state allows for networking with each other, candling exercises, educational outreach, & handouts which focuses on biosecurity & food safety

19. Standard 8 – Program Resources
This standard describes the elements of resource evaluation used to support a shell egg safety regulatory program. The State program conducts an assessment of resource needs for staffing, equipment, and funding and is required to have a documented workplan which includes:
an inspectional plan – includes number & type of inspections, risk category of facility, and frequency;
a sample plan (optional) – includes number & type of samples; and
a timeframe that the workplan is applicable
The State Program has a documented procedure for evaluating the workplan and for identifying and reviewing its resources within the applicable timeframe
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20. Standard 9 – Program Assessment
This standard describes the process a State program uses to assess and demonstrate its conformance with each of the program standards
In the first year the program conducts a baseline self- assessment to:
identify if the program meets the elements of each standard;
determine areas of the State program that need improvement;
develop a strategic improvement plan; and
establish timeframes for making improvements
Subsequent self-assessments are used to track progress toward meeting and maintaining conformance with the program standards
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A Strategic improvement plan includes:
- The individual element or documentation requirement of the standard that was not met;
- Improvements needed to meet the program element or documentation requirement of the standard;
- Projected completion dates for each task;
Personnel responsible
Date completed for each task.

21. Standard 10 – Comprehensive Sampling & Laboratory Program (optional)
This optional standard describes the elements of comprehensive sampling and the laboratory program used to support a shell egg safety regulatory program
The State program must have elements of comprehensive sampling including sampling support, plan, & procedures in place
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Support – training and list of services
Sampling plan that includes program’s sampling prioirties, analysis schedule and availablility coordination
procedures - methods for collecting, storing, and transporting samples & instructions for documenting the sample collection
Manure drag swab sampling – high rise house
2 pads per row/bank of cages
Sterile guaze pads with skim milk sampling chick papers

22. Standard 10 – Comprehensive Sampling & Laboratory Program (optional)
The State program must have access to a laboratory including:
a lab that is capable of analyzing a variety of samples including egg or environmental samples;
a maintained list of routine and non-routine analytical services;
a contract or written agreement with each primary servicing laboratory; and
regulatory testing laboratories that
have a current accreditation to ISO/IEC standards or
have a quality system in place which incorporates the management and technical requirements of ISO/IEC 17025
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23. Potential Benefits for State’s to get Involved
Voluntary egg safety program
Strengthen information sharing among the states
Comprehensive baseline for egg inspection
Cohesive training plan
Support from other State’s as programs are being developed
To create a networking foundation for program assistance
Strengthen inspectional knowledge
Financial assistance to establish egg safety regulatory program
Potential Benefits for State’s to get Involved
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24. Next Steps for Recommended Egg Standards
NERO
Timeframe – approx. 1 year
Subcommittee specific to Standards
Elevate organizational structure nationwide
MOU or
FDA
Timeframe – at least 2 or more years
Public comment period
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NERO Timeframe – approx. 1 year to finalize the standards
At least 2 or more years before it would get to the states.
Have an MOU agreement for who is responsible for what and what will be the funding mechanism

25. Contacts Name Affiliation Phone Number Email Michelle Boyd
Iowa Department of Agriculture & Land Stewardship
Emma Middlemiss
California Department of Food & Agriculture
Mei-Ying Li
Food & Drug Administration
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Questions?