RFPEgg-SOW-2021.pdf

FDA-2021-EGG

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 - Background and Objectives

In performing the work as described in detail in Section C-1 Scope of Work, the Contractor shall consider the following:

a. Background

On July 9, 2009, the Food & Drug Administration (FDA) published a final rule requiring shell egg producers to implement certain measures to prevent Salmonella

Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation. The rule requires producers with 3,000 or more laying hens on a farm to implement SE prevention measures including procurement of chicks from

SE-monitored breeder flocks, having a biosecurity program, a rodent and pest control program, testing the layer house environment at certain time points and testing eggs following a positive environmental test. Producers are also required to comply with cleaning and disinfection requirements if a layer house environment or eggs from that house test positive for SE. Additionally, producers are required to comply with registration and recordkeeping requirements.

FDA took this action because SE is among the leading bacterial causes of foodborne illness in the United States and shell eggs are a primary source of human SE infections.

The correlation between eggs and SE has been confirmed through epidemiological and laboratory data collected by the Center for Disease Control (CDC). This link has been further substantiated through data collected by various surveillance networks overseen by CDC. It is well accepted that shell eggs are the predominant source of SE-related cases of salmonellosis in the United States where a food vehicle is identified.

Many egg farms participate in voluntary state-run egg quality assurance programs

(EQAP). These EQAPs have similar requirements, however, there is significant variation in how these requirements are implemented from state to state. Although similar to FDA’s final rule, state run EQAPs are voluntary, vary in their requirements between states, and not all states have an EQAP.

This final rule is the most recent in a series of farm-to-table egg safety efforts begun by

FDA and Food Safety and Inspection Service (FSIS) in the 1990’s. Although there are currently several Federal regulations related to food safety at the food service level, this is the first and only federal rule that addresses the introduction of SE into the egg during production.

Although the incidence of SE declined from the mid to late 1990’s, it has remained relatively stable the last several years. This makes interventions at the production level of particular importance. Since eggs remain one of the primary sources of SE infections, continued actions to improve egg safety are the most effective way to reduce the overall number of SE infections and outbreaks. FDA believes the additional preventive measures required by this rule shall further reduce the incidence of egg-associated SE illnesses and meet the agency’s published health goals.

The final rule, which is codified in 21 CFR 118, was implemented in a staggered fashion with larger producers required to come into compliance before smaller producers. Producers having between 49,999 - 3,000 layers were required to be in compliance by July 9, 2012 while producers with more than 50,000 layers were required to be in compliance by July 9, 2010.

https://www.ecfr.gov/cgi-bin/text-idx?SID=bbd50b0182c48947ebbcd33fdcccb39c&mc=true&tpl=/ecfrbrowse/Title21/21 cfr118_main_02.tpl

b. Objectives

This contract is designed to acquire state assistance for the inspectional coverage of egg producing facilities covered by FDA’s final SE egg rule, specifically:

1. To conduct inspections of egg layer farms to assess compliance with 21 CFR 118:

Production, Storage and Transportation of Shell Eggs, the “Egg Rule”.

2. To monitor or inspect persons involved in holding or transporting eggs for shell egg processing or egg product facilities to verify compliance with refrigeration requirements during storage and transport.

3. To encourage voluntary corrective action by the facility when appropriate and document deficiencies to take additional action.

4. To furnish the FDA with reports of inspections accomplished under the contract. Reports on any compliance follow-up, sample results and corrections achieved by the Contractor under its own program shall also be submitted.

B-2 – Prices/Cost

a. As consideration for full performance of the work stated in Section C-1 Scope of

Work, the Government shall pay the Contractor a total fixed price of $________ for inspections, $________ for environmental samples $_______, egg regulatory program assessment, $__________ for a total contract amount of $________ .

b. Payment up to the full amount of this contract shall be contingent upon receipt and acceptance by the Government of inspection and acceptance E 1, inspection reports and proper invoices as required by Section F-2 Reports/Deliverables and Section G-

3 Invoice Submission, and in accordance with the following schedule referenced in section E1.

c. Inspection Visits:

https://www.ecfr.gov/cgi-bin/text-idx?SID=bbd50b0182c48947ebbcd33fdcccb39c&mc=true&tpl=/ecfrbrowse/Title21/21cfr118_main_02.tpl https://www.ecfr.gov/cgi-bin/text-idx?SID=bbd50b0182c48947ebbcd33fdcccb39c&mc=true&tpl=/ecfrbrowse/Title21/21cfr118_main_02.tpl https://www.ecfr.gov/cgi-bin/text-idx?SID=bbd50b0182c48947ebbcd33fdcccb39c&mc=true&tpl=/ecfrbrowse/Title21/21cfr118_main_02.tpl

An inspection visit is defined as when an inspection is attempted and the establishment is found to be:

1. Out of Business (OOB) – OOB is defined as a firm that is no longer in business for reasons other than having moved.

2. Not an official establishment (NOE) – NOE is defined as an establishment that is no longer engaged in activities or manipulates products subject to FDA regulation, but still remains in business.

3. Relocated outside of the contractor’s geographical jurisdiction.

4. Not operational or other unforeseen circumstances that prevent a full inspection from being accomplished during the contract period of performance.

Reasonable efforts to verify a firm is OOB/Visit shall include a physical visit and records research. After performing a reasonable effort to locate the possible new site or conduct the inspection, an establishment inspection report (or other form as directed by the District) shall be submitted to the FDA Program Division Director or Designee.

Additional guidance may be found in SOP-130 “OEI Development and Maintenance

Procedure”. Reasonable efforts to conduct a complete inspection shall be approved by the District prior to invoicing for a visit.

Inspections conducted at egg producers sending all shell eggs to an egg breaking facility with a 5-log destruction are required to only comply with registration and refrigeration requirements of the Egg Rule are considered inspections under this contract.

e. Schedule

Base Year: 09/30/2021 to 09/29/2022

Item Quantity Unit Price Per Swab Amount

Inspection $

Environmental

Samples**

Egg Regulatory

Program Assessment

$10,000

Inspection

Visits/OOBs

Option Year 1: 09/30/2022 to 09/29/2023

Item Quantity Unit Price Per Swab Amount

Inspection $

Environmental

Samples**

Egg Regulatory

Program Self-

Assessment

$10,000

Inspection

Visits/OOBs

Select one:

Option 1: Inspection OOB/Visits are included as a separately priced line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor shall be paid for any visits/OOBs that exceed

20% of the total number of all inspections stated above.

Note: The award for number of inspections shall be based on the FDA’s inventory and recommendation of the FDA Program Division Director or Designee.

**Environmental Samples are per swab.

Section C – Description/Specifications/Work Statement

C-1 Scope of Work

a. Scope

Independently or as an agent of the Government the Contractor shall furnish the necessary personnel, materials, services, facilities, except as provided in the schedule, and otherwise do all things necessary for or incident to the performance of the work as described below:

The Contractor shall conduct farm inspections of those egg production farms subject to the

Egg Rule and follow the FDA Compliance Program Guidance Manual (CPGM) 7303.836

(Refer to Section J). At a minimum, the Contractor shall:

▪ Evaluate the firm's written SE prevention plan, and implementation.

▪ Evaluate the firm's biosecurity measures and implementation.

▪ Evaluate the firm's implementation and records of their rodent and pest control programs.

▪ Evaluate the firm’s records documenting compliance with the cleaning and disinfection procedures.

▪ Evaluate the firm’s implementation and records for refrigeration requirements

(transportation and holding records to be included, if applicable).

▪ Verify the firm’s shell egg producer registration status with the FDA, which is separate from Bio-Terrorism Act of 2002 (BT Act). An egg farm may be required to register under the BT Act (Food Facilities Registration rule).

▪ Verify the firm’s personnel that is responsible for ensuring compliance with each farm’s SE prevention plan is qualified to perform the assigned duties.

▪ Verify the firm's procurement of SE-monitored pullets and chicks.

▪ Evaluate the firm's environmental testing procedures, records and results of the test and egg sampling programs.

▪ Determine if environmental testing was conducted at required time period and if positive samples were found, whether or not appropriate actions were taken in accordance with the Egg Rule.

▪ Conduct an environmental assessment (walk-through) of a minimum of four layer houses (chosen by the inspectors).

▪ Issue a form FDA-483 to cover any significant objectionable conditions observed during the inspections and prepare the Establishment Inspection Report (EIR) in accordance with established procedures. State may use equivalent forms if using their own regulatory authorities.

▪ Contact the FDA Program Division Director or Designee within three (3) business days if during an inspection, egregious conditions or significant violations and positive violative samples are observed that presents a strong likelihood of SE contamination in shell eggs.

All information collected during the performance of this contract shall be considered to be confidential commercial information, including the Establishment Inspection Report

(EIR), FDA 483, or equivalent forms, evidence collected, and all other supporting documentation. Evidence and supporting documentation may include supplier, receiving, and distribution records, photographs, complaint records, laboratory results, and other documents collected during the performance of the contract. The Contractor shall notify the District within three (3) business days after receipt of a public records request for information obtained during the performance of the contract is received.

The Contractor is not authorized to release confidential commercial information. Refer to Section H – Special Contract Requirements for additional requirements for maintaining confidential commercial information.

b. Coverage

▪ The establishments to be inspected by the Contractor include those egg producers required to register with FDA under 21 CFR 118.11 of FDA’s Egg Rule.

Specifically, those egg producers with 3,000 or more laying hens at a particular farm that do not sell all of their eggs directly to consumers and that produce shell eggs for the table egg market shall be subject to inspection. Individuals who transport or hold shell eggs for shell egg processing or egg products facilities shall also be subject to inspection to verify compliance with the registration and refrigeration requirements in 21 CFR 118.11 and 118.4(e).

c. Work planning Sessions

An annual work planning session(s) between appropriate FDA District, and state contractor personnel shall take place no later than sixty (60) calendar days after the start of the contract period of performance. The FDA Program Division Director or

Designee shall coordinate with the Contracting Officer Representative (COR) to ensure that a farm inventory list is available prior to the workplanning session. The

District Technical Advisor will draft the work planning session(s) minutes for review by the State within thirty (30) business days. Corrections must be agreed upon by both the State and District. The goals of the session(s) are to:

▪ Coordinate an inspection schedule that shall avoid duplication of inspections to be accomplished by FDA and state personnel and ensure that the work obligated on the contract is aligned with anticipated work assignments.

▪ Develop a consensus of the priority in the selection of firms to inspect.

▪ Discuss and ensure clarity the definition of an inspection visit per the contract, criteria for considering a firm Out of Business (OOB), and reporting requirements.

▪ Confirm that state regulatory authorities are equivalent to Federal requirements, or the state officials are commissioned, and the Contractor has the contractual obligations to accomplish the inspection schedule.

▪ Establish and exchange primary contact information. Along with program management, it is recommended that senior management from the state and district are also part of the process.

▪ Confirm training requirements are met by state officials to perform inspections, audits and other work obligated under the contract.

▪ Confirm understanding of key contract deliverables and schedules specifically for quarterly reporting and invoicing.

▪ Discuss training needs, sharing of resources and other collaborative efforts.

▪ Discuss and develop an audit schedule. The audit rate for the egg contract is one (1) joint inspection per contract year (refer to the most recent version of FMD – 76 for additional details).

▪ Identify point of contact at the FDA Program Division Director or Designee for notification of egregious violations observed during the contract inspection to ensure timely notification of inspectional findings and the need for expedited response from the FDA Program Division Director or Designee.

▪ Identify facilities for environmental sampling during the work planning session with their FDA District, if applicable.

▪ Identify state laboratory facilities for environmental sampling testing, if applicable.

▪ Review the utilization of electronic State Access to FACTS (eSAF) and data entry requirements.

A minimum of one additional meeting shall be held with the FDA Program Division

Director or Designee and state during the second or third quarter of the contract performance period to review the progress and verify the contract deliverables are being satisfactorily met.

C-2 Detailed Tasks

a. General Requirements for Conducting Inspections

1. Registration of Shell Egg Producer

• Shell egg producers covered under 21 CFR 118.11 are required to register their farms with the FDA within thirty (30) days of becoming an egg producer or, applicable effective date of this regulation. Registered egg producers shall submit an update to a registration within sixty (60) calendar days of any changes to information previously submitted. For facilities that are required to register, but have not as of yet done so, the Contractor shall encourage electronic registration at the following website:

https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration

/ShellEggProducerRegistration/default.htm https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/default.htm https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/default.htm

• During the inspection of farms covered by the Egg Rule, the

Contractor shall confirm the firm’s management or person(s) responsible for administering the SE prevention plan are aware of the registration requirements in section 118.11 of the rule.

• The Contractor shall document the shell egg producer registration status of the shell egg farm and document discussions which occurred with firm management or the individual(s) in charge of administering the SE prevention plan in the summary section of the inspection report.

Observations about failure to register are NOT to be placed on the

FDA Form-483 or equivalent form. If a facility is not registered and they do not intend to register, contractors are required to notify the

FDA Program Division Director or Designee.

2. The FDA Unified Registration and Listing System (FURLS)

The FDA Unified Registration and Listing System (FURLS) was built to electronically register all domestic and foreign facilities that export food to the

U.S. Shell Egg Producer Registration Module (SEPRM) is one of the modules/tracking systems within FURLS. The Contractor shall establish user accounts for at least two (2) key personnel in FURLS/SEPRM within the first sixty (60) calendar days of the contract period of performance. Key personnel shall have direct responsibility for meeting the obligations of the contract.

The Contractor may gain access to SEPRM by creating a State specific-

Online Account Administration (OAA) account at the following web address:

https://www.access.fda.gov/oaa/

Information that shall be required from each requestor includes personal information (i.e., name and email address), a FDA District State Liaison email address, the physical address of State Contracting office, and State Contract

Project Director’s information. After successfully completing and submitting the OAA account, the requestor shall be notified by email regarding the status of account.

For questions related to creating OAA account, please contact the Office of

Partnerships at FFRMStateAccess@fda.hhs.gov

Shell Egg Producer Registration Status Verification

The Contractor shall verify shell egg producer registration status via

SEPRM using the link below prior to conducting inspections to avoid unnecessary effort spent in OOBs/Visits. It also assists inspectors to adequately prepare for their inspections by obtaining firm information, such as the number of houses at the egg farm.

mailto:FFRMStateAccess@fda.hhs.gov

3. Targeted and Comprehensive Inspections

The Contractor shall conduct inspections to gain information regarding the firm’s compliance with the Egg Rule focusing on facilities identified by FDA for coverage under this contract.

In the absence of the contracting state agency responsible for egg inspection having adopted 21 CFR Part 118, the Contractor shall conduct inspections of these establishments using state officials who have been commissioned and credentialed as officers of the Department of Health and Human Services, Food and Drug Administration (FDA), under the authority of the Federal FD&C Act.

This includes the use of credentials and FDA forms, including the issuance of

Notice of Inspection, Inspectional Observations and Receipt for Sample forms. If the contracting state has adopted 21 CFR Part 118 or can demonstrate State authority that is equivalent in effect, the agency can conduct the inspections under State credentials and use reporting forms equivalent to FDA or as required by state law.

Egg farms can have multiple physical locations (sites with different addresses), which can contain numerous separate poultry houses. Each site with a different address shall receive a separate FDA-482, Notice of Inspection. An egg farm with multiple physical locations shall be invoiced as one inspection.

The Contractor shall categorize inspections according to risk, with farms providing outdoor access being considered the highest risk. Large farms (those with 50,000 or more layers) shall be inspected first. Inspections at farms with outdoor access shall be inspected last. For example, if the Contractor was assigned fifteen (15) inspections and five (5) of those firms provide outdoor access, the ten (10) farms that do not provide outdoor access shall be inspected first and the five (5) with outdoor access shall be inspected last. There shall also be a one (1) week wait time between each of the final five (5) inspections (i.e.

those firms with outdoor access).

4. Enforcement

Compliance actions are not provided for under this contract. However, the

Contractor may wish to pursue any necessary compliance follow-up to violative conditions under the state's program. Any state actions shall be coordinated with the FDA Program Division Director or Designee. If an inspection conducted under contract results in a final classification of “OAI” by FDA and details violations that are “materially related to food safety”, the state shall be notified by the District and any re-inspection of the firm shall be conducted by the FDA Program Division Director or Designee.

5. Bio-Terrorism Act of 2002

Food Defense Security Preventive Measure Guidance

During the inspection, the Contractor shall determine if the facility is aware of food defense security preventive measures. If the facility is not aware of these measures, the inspector shall facilitate an exchange of information to heighten awareness of the subject of food defense. Inform the establishment management of the appropriate security preventive guidance or provide information on how to obtain the guidance from FDA. Guidance related to

Food Defense and Emergency Response efforts are available on

FDA/CFSAN’s web site:

http://www.fda.gov/Food/FoodDefense/default.htm

The Contractor shall make sure that the firm’s management is aware of the

BioTerrorism Act (BT Act) registration requirements, if applicable, and any updates needed. The firm’s management shall also be informed that information regarding food defense, the BT Act, facility registration, required and optional information, definitions, exemptions, and penalties for failure to register is available at the following website:

http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.ht m

Documentation

The fact that the discussion regarding the firm’s food defense security preventive measures took place and, if applicable, guidance documents were provided shall be recorded in the Summary section of the inspection report. The details of inspectional findings regarding security shall NOT be recorded.

b. Inspections: Targeted and Comprehensive

1. Farm Inspections (Priority 1): Inspections of those farms covered by the

Egg Rule shall include the following:

• Confirm that a written SE prevention plan is in place at the specific farm and located on site either in a hard or electronic copy and identify the individual(s) responsible for administering and revising the plan.

• Review records to ensure chicks were procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan standards for “US Salmonella Enteritidis Clean” status and/or that pullets were raised under SE monitored conditions.

http://www.fda.gov/Food/FoodDefense/default.htm http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm

• Review ALL records required under the Egg Rule to ensure compliance.

• Evaluate the SE plan to ensure it minimally includes the following:

a. Biosecurity Program

b. Rodent and Pest Control Program

c. Cleaning and Disinfection protocols

d. Pullet environmental testing records and applicable cleaning and disinfection records

e. Procurement of pullets that are SE monitored

f. Adequate refrigeration of shell eggs

g. Sampling and testing methodologies for SE

h. SE plan administration

• Conduct a walk-through of the farm’s facilities and assess a minimum of four (4) houses, selected by the Contractor based on on-site observations unless the number of houses is less than four (4). For comprehensive inspections, all assessed houses shall be sampled. The Contractor shall visually inspect for gross non-compliance with the rule (e.g. excessive rodent activity, stray animals in layer house, and lack of biosecurity measures) and implementation of the SE prevention plan.

• Determine if the farm conducted environmental testing at required time periods and if positive samples were found, whether or not appropriate actions were taken in accordance with the Egg Rule.

• Verify rodent and pest control activity through review of records, assuring proper placement of bait stations and visual observation for rodent and pest activity including harborage areas during the walk-through.

• Verify on farm cooler temperatures through visual observation and review of temperature logs or temperature recorder charts to ensure compliance with refrigeration requirements.

• Verify shell egg producer registration of the farm as required by the rule.

• If applicable, review records indicating diversion of eggs to treatment (as defined in the rule) noting dates eggs were diverted and where they were sent for treatment.

• Conduct comprehensive inspections with a minimum of three (3) inspectors; five (5) are preferable, especially for larger facilities. For

Targeted inspections, a minimum of 2 inspectors are needed.

2. Transportation and/or Holding Facility Inspections (Priority 2):

Individuals involved in transportation or holding of eggs for shell egg processing or egg products facilities are required to comply with refrigeration requirements of the rule. These inspections shall verify that transportation vehicles and holding facilities are maintained at temperatures at or below that required by the rule (45° F).

3. Sample Collections:

The Contractor shall collect environmental samples as outlined in this contract, or as otherwise advised by the FDA Program Division Director or

Designee during comprehensive inspections. Water, feed, and egg samples are NOT to be collected under this contract.

Environmental sampling in the poultry houses shall be conducted during all comprehensive inspections to assess conditions and obtain baseline information about the state of the industry.

Sample Shipment:

The environmental samples shall be collected during Comprehensive inspections and analyzed at their State laboratory. Environmental samples shall arrive to the state laboratory within 24 hours and shall be analyzed for

Salmonella Enteritidis (SE).

Sample Reporting Requirements:

The Contractor shall document the sample collection in the narrative

Establishment Inspection Report (EIR).

Environmental samples are to be analyzed using analytical methods that are appropriately validated and fit-for-purpose for the required analysis of the sample.

4. Sampling Techniques:

Drag swabbing manure is the preferred environmental sampling method.

Sampling technique shall vary depending upon the poultry house style. The

State contractor shall follow the Compliance Program Guidance Manual

(Refer to Section J) for sample collections. Detailed instructions are available at the following website:

Compliance Program Guidance Manual:

https://www.fda.gov/media/105120/download

The FDA Program Division Director or Designee and FDA/ORA/Office of

Regulatory Science (ORAHQORSMANAGEMENT@fda.hhs.gov) shall be notified within one (1) business day of potentially significant positive laboratory results, preliminary positive (Can’t Rule Out (CRO)) pending confirmation, or when a sample is determined to be confirmed positive.

https://www.fda.gov/media/105120/download

Sample reports for positive (violative) samples shall be submitted to the FDA

Program Division Director or Designee within three (3) business days of final determination. Sample reports for negative samples (non-violative) shall be received by the District within thirty (30) business days of final determination.

The data laboratory package may also be requested by the District.

b. Elective Work to Add State Egg Regulatory Program Assessment

The Food Safety Modernization Act (FSMA) mandates that the FDA establish an Integrated Food Safety System (IFSS). An IFSS requires partnerships between federal, state, local, and tribal agencies to collaborate and leverage resources to ensure the protection of public health. Adding the egg regulatory program assessment is a critical step to prepare state, local, and tribal agencies to establish a uniform basis for measuring and improving the performance of prevention, intervention, and response activities of egg inspection programs.

Under this elective, the Contractor shall use the Manufactured Food

Regulatory Program Standards (MFRPS) (Refer to the Section J), specifically Standard No. 9 – Program Assessment as general guidance and shall be specific to the egg regulatory program when completing the baseline self-assessment. The Contractor shall complete both the Self-

Assessment Worksheet and Self-Assessment Summary Report (or equivalent forms) (Refer to the Section J).

The FDA may provide the Contractor updated regulatory program standards specific to egg safety inspection programs. The FDA reserves the right to modify the requirement and criteria related to program assessment elements according to the latest standards.

The Manufactured Food Regulatory Program Standards (MFRPS) are intended to ensure that State programs develop and maintain best practices for a high-quality regulatory program. The goal is to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United

States. The development and implementation of these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. These standards do not address the performance appraisal processes that state agency may use to evaluate individual employee performance. FDA will use the program standards as a tool to improve contracts with state agencies.

The Egg Regulatory Program Standards is a critical component in establishing FDA’s Integrated Food Safety System. It establishes a uniform foundation for regulatory agencies responsible for oversight of eggs and egg products. When fully implemented, program standards define a set of best practices of a regulatory system. Conformance with the program standards requires a regulatory agency to continuously assess, evaluate, and take necessary corrective actions to address gaps. It will facilitate a system of mutual reliance between the FDA and other regulatory agencies and support continuous improvements in regulatory oversight of eggs and egg products throughout the nation.

Egg Regulatory Program Assessment Elements

The Contractor shall conduct the following:

1. The state program conducts a baseline self-assessment within the first year to determine if the program meets the elements of the program standards.

2. The state program has a continuous improvement process to meet and maintain conformance with the program standards.

3. The state program has written procedures for determining when

CORRECTIONS and CORRECTIVE ACTIONS are needed to maintain CONFORMANCE with elements and standards.

Procedures include how the program:

• Responds when a NON-CONFORMITY occurs or is suspected;

• Determines cause(s) of the NON-CONFORMITY;

• Evaluates the need for CORRECTION(S) and/or

CORRECTIVE ACTION(S) to address the NON-

CONFORMITY;

• Implements and documents CORRECTIONS and

CORRECTIVE ACTION(S) when needed; and

• Reviews the effectiveness of the CORRECTIVE

ACTION(S) in preventing future occurrences.

4. The state program develops and maintain a strategic improvement plan including the following information if the state program fails to meet any of the program elements and documentation requirement:

• The individual element or documentation requirement of the standard that was not met;

• Improvements needed to meet individual element or documentation requirement of the standard that are under development;

• CORRECTIONS and/or CORRECTIVE ACTIONS needed to address NON-CONFORMITIES described in

#3 (above) including the cause of the NON-

CONFORMITY and effectiveness of the CORRECTIVE

ACTION taken;

• Projected completion dates for each task, personnel responsible and date completed for each task;

5. The state program review and update the self-assessment appendices and its strategic improvement plan at least annually.

6. The state program participates in FDA Assessments to determine implementation and conformance to the standards.

7. Retain records or procedures required under each standard for the three previous years, or per the state program’s record retention policy, whichever is longer. Records or procedures can be maintained either electronically or in hardcopy.

8. The state program has a written document control procedure that ensures all guidance, procedures, documents, and forms required by the standards are current and fit-for-use; All documents subject to this procedure can demonstrate they are current and fit-for-use through maintenance of a master document list or other system that shows:

• Documents are reviewed for accuracy;

• Documents are approved for release by authorized personnel and signed/dated with an approval or revision date;

• Documents are distributed to and used at the location where the prescribed activity is performed.

Deliverables

To receive reimbursement for participation in the program assessment elective, the Contractor must complete and submit a copy of the Self-

Assessment Worksheet and Self-Assessment Summary Report (or equivalent forms). The Worksheet and Summary Report must be emailed to MFRPS@fda.hhs.gov for review and acceptance prior to invoicing.

D. Method of Coverage

1. General

The activities under the contract shall be conducted using the procedures, techniques, and methodologies specified by FDA in the Egg Rule. While conducting inspections, Contractors shall follow biosecurity measures enforced by the specific farm where the inspection is being conducted in addition to following general biosecurity measures listed in the latest version of the FDA’s Investigations Operations Manual (IOM).

FDA’s IOM, the primary source regarding Agency policy and procedures for field investigators and inspectors, discusses biosecurity measures for FDA inspectors in

Chapter 5.2.10.3 “Standard Operating Biosecurity Procedures for Egg Farm

Inspections/ Commercial Poultry Operations” and is available at:

https://www.fda.gov/iceci/inspections/iom/default.htm https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf

2. General Procedures:

• Do not enter a poultry house if the house is determined to be SE positive based on the firm’s environmental testing or information provided by the FDA or State.

• The Contractor is responsible to have their inspectors be respirator fitted and certified or follow their state requirements for respiratory protective gear.

• The inspectors shall NOT be a bird and/or reptile owner in their own home or have been in any other poultry facility up to 72 hours before an inspection.

• The inspectors shall not have contact with birds for 72 hours prior to an inspection, including visits to aviaries, tending backyard feeders, etc.

• Wear Personal Protective Equipment (PPE) inside the poultry houses. PPE includes disposable body coverings, boot covers, hair coverings, non-sterile gloves, respirators, eye and hearing (in areas where loud machinery is in use) protection. The use of disposable PPE and respirators is preferred to eliminate the need for disinfection between poultry houses.

• Wear rubber boots or other suitable footwear, which you disinfect upon arriving at the site and prior to departure. It is preferable to also place disposable foot coverings over your footwear, regardless of the type, after you have disinfected them. If the firm has footbaths, use them. Boots and footwear shall be disinfected using a good brush. Clean and disinfect the brush(es) and bucket you use for these activities.

• Some facilities may provide disposable coveralls and require visitors to shower in and shower out at their facilities. If requested by the firm and facilities are provided, you shall follow those requests.

• Minimize any materials you carry with you such as notebooks, flashlights, etc. to what is required. Consider keeping these things in clean plastic bags or containers between uses. Disinfect any of these types of items as best you can between visits to facilities or between different animal-housing areas. Things such as flashlights and cameras shall be used inside a plastic bag, unless the inspector has a new set for each poultry house they enter. Items shall be cleaned and sanitized prior to using on another egg farm. Do not bring notebooks into the poultry houses as they are not able to be properly disinfected; consider taking a piece of paper in a plastic bag.

https://www.fda.gov/iceci/inspections/iom/default.htm https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf

• If you are visiting production units with animals of multiple ages, always work from the youngest to the oldest.

• Avoid direct contact with livestock or wild animals, bodily fluids or animal byproducts when visiting facilities.

• Vehicles to be used for transport to egg farms shall be cleaned and disinfected prior to arrival. Prior to leaving the farm location, the vehicle shall be cleaned, vacuumed and disinfected, including the car, tires and wheel wells.

• Contractors shall ensure that any waste generated during egg farm inspections is not disposed on the farm.

These practices shall be followed on every egg farm inspection. It is the responsibility of the lead inspector to brief his/her inspectional team on these practices prior to arrival at the farm:

Pre-Inspection Measures:

• Contact the State Veterinarian to check for quarantines. No egg inspections shall be initiated without first contacting the State Veterinary office and checking for quarantines. The Contractor shall ask if there is any type of quarantine and follow that up with a question specifically about Highly Pathogenic Avian Influenza

(HPAI)-related quarantines. If quarantines are in place, the Contractor shall ask how long they are expected to continue. If the State Veterinarian or official designated by the state indicates that inspections shall not continue, those instructions shall be followed and no inspections shall be conducted until state clearance is given. In the interim, if an extended quarantine is expected (longer than 2 weeks) the Contractor shall notify the FDA Program Division Director or

Designee. The FDA Program Division Director or Designee shall organize a follow up meeting to include the FDA district, the Contractor, State Veterinary

Office or designated state official, and FDA Center for Food Safety and Applied

Nutrition. The purpose of these meetings shall be to establish a channel of communication between FDA and the State to ensure state concerns are addressed while ensuring FDA’s inspectional obligations are met.

• Following clearance from the State Veterinarian’s office, the lead inspector shall conduct a cross reference check of the inspection location against the HPAI Current

Avian Influenza findings on the USDA/APHIS web page:

http://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/avian-influenza-disease/ct_avian_influenza_disease;

• During the cross check, the Contractor shall check the state and county from the

USDA/APHIS website against the location of the farm to be inspected. If the farm is in the same county as a confirmed HPAI occurrence, the inspection shall be canceled and the FDA Program Division Director or Designee notified.

http://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/avian-influenza-disease/ct_avian_influenza_disease http://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/avian-influenza-disease/ct_avian_influenza_disease

• The mandatory minimum wait time between different farms is (72) hours.

However, many farms have increased the wait period to longer than (72) hours in response to lessons learned from the 2015 HPAI outbreak. If the wait time established by the producer is longer than (72) hours, that specified wait time shall be adhered to. If the wait time established seems excessive, i.e. longer than two (2) weeks, the Contractor shall notify the FDA Program Division Director or

Designee. The FDA Program Division Director or Designee shall organize a follow-up meeting to include the FDA Program Division Director or Designee, the Contractor and FDA Center for Food Safety and Applied Nutrition to establish an appropriate wait time. In situations where outdoor access is provided to hens, the wait time between farms shall be increased to one (1) week.

• When possible, the Contractor shall send separate inspection teams on egg farm inspections to maximize the time between farm visits for each inspection team.

For example, rather than sending Inspection Team A to conduct inspections at

Farm 1, Farm 2 and Farm 3, every attempt shall be made to instead send a separate inspection team to each farm.

• Inspectors shall adhere to the following requirements:

o Do not come in contact with bird feeders or bird baths for a minimum of one (1) week prior to participating in an egg farm inspection.

o Stay away from family members, friends or acquaintances that are pet bird owners or have backyard poultry flocks of any type.

o Do not visit fairs where poultry or birds are shown or exhibited.

o Do not visit live bird markets of any type, or gatherings where live birds may be present.

o Do not visit flea markets, trade shows, or swap meets where live poultry or birds of any type may be present.

o Do not visit zoos, theme or amusement parks where live birds may be present.

o Do not visit known nesting grounds or resting place for wild birds, such as natural preserves or refuges, known breeding grounds or bird sanctuaries.

o Do not attend birthday parties or functions where a petting zoo that includes poultry is part of the event, e.g., baby chicks, pet ducks or geese are present.

o Do not come in contact with birds, such as ducks or geese, at municipal, state or other types of parks, e.g., where ducks, geese or pigeons and other birds are local inhabitants and people congregate to feed them.

o Do not visit an oceanside town where contact may occur with shorebirds, e.g., gulls.

o Do not visit feed stores or other retail establishments where live poultry may be sold, e.g., baby chicks, turkey poults, ducklings, etc.

o Do not go hunting for wild fowl or handle wild fowl. If you have family members or friends who hunt, do not come in contact with them for a minimum of one (1) week prior to participating in an egg farm inspection.

o Do not meet with other known bird owners either as part of your work (e.g., meeting another producer at a location away from their farm) or meet with other known bird owners in your social circle.

o Where possible, wear clothing that has not been on another egg farm and ensure the clothing is laundered.

• Given that HPAI is highly susceptible to detergents, high temperatures and desiccation, car washes where hand held nozzles are available shall be used.

Initially, a cycle shall be conducted where a high-pressure rinse is used to remove all organic matter (e.g. mud, dirt and debris) with specific care taken to address the wheel wells, in addition to the whole vehicle. This shall be followed with a cycle where a scrub brush with a detergent is used on the whole vehicle including the wheel wells and shall be followed by a high-pressure rinse. Finally, a drive through cycle shall be used that cleans the undercarriage shall be sprayed when the hand-held nozzle is being used. When necessary or during inclement weather, drive-through car washes may be substituted for manual car washes if the cycle includes an undercarriage wash, application of a detergent and a high-pressure rinse. The vehicle shall then be allowed to dry thoroughly in a sunny area (as opposed to a shaded garage). After the vehicle has dried, disinfectant shall be applied with a hand-held sprayer. The interior of the vehicle shall be vacuumed thoroughly to remove organic matter and floor mats sprayed with a disinfectant aerosol spray.

• Selection of disinfectants:

Ethanol shall be used to disinfect the lids of evaporated milk cans, scissors and can openers used during sampling within a poultry house.

Phenolic or quaternary ammonium-based sanitizers shall be used on wheel wells, tires and vehicle under carriage. The vehicle body shall not be disinfected, as the detergent from the car wash is sufficient and some sanitizing compounds can damage the vehicles finish.

Lysol or equivalent based aerosol spray shall be used on floor mats and soles of shoes.

Purell or equivalent hand gel shall be used for hand disinfection.

During Inspection Measures

• Always change all Personal Protective Equipment (PPE) between houses. PPE includes disposable body coverings, boot covers, hair bonnets, sterile gloves, respirators, eye and hearing (in areas where loud machinery is in use) protection.

The use of disposable PPE and respirators is preferred to eliminate the need for disinfection between poultry houses. In situations where permanent eyewear is worn it shall be cleaned and disinfected between each poultry house.

• No item which has been in a layer house may be brought into a different house without a complete cleaning and disinfection or replacement with a new one.

This includes all items, e.g., pens, supply tubs, scissors. Replacement of items is more effective than disinfection and lessens the workload on site; therefore, all efforts shall be made to replace items rather than transfer between houses.

• Use disposable cameras, when possible. Otherwise digital cameras are to be placed within plastic bags prior to entry into the house.

• Double bag all garbage. Specifically, one bag is to be left at the vehicle and the other taken into the house to be inspected. When the garbage is removed, it is placed into the bag left at the vehicle to assure that the bag which went into the layer house never makes contact with the vehicle interior.

• No jewelry is allowed to be worn into poultry houses.

• Inspectors shall clean hands thoroughly before donning gloves for entry into the house. Where available, use soap and water; if not available, use hand sanitizing gels. This shall be done at both the clean and dirty areas established at the farm and prior to entry into any poultry house.

• If possible, inspectors shall park their car at the beginning of the driveway or outside the farm and carry all their equipment onto the farm.

• Eyeglasses shall be cleaned and disinfected.

• If possible, use the hot water cycle to launder clothing that shall be used during an egg inspection.

Post Inspection Measures

• Wash the vehicle used during the inspection as specified in the pre-inspection procedures.

• If applicable, clean and disinfect reusable sampling tools, e.g. tubs, scissors, can openers.

• If applicable, clean and disinfect reusable respirators in accordance with manufacturer’s recommendations.

3. Compliance Documents

The activities under the contract shall be conducted using procedures, techniques, and reporting forms equivalent to FDA or as required by state law. The contract inspections shall be conducted in accordance with the applicable sections of the following current FDA Compliance Program Guidance Manual (Refer to Section J).

State contractors shall use the Egg Safety Inspection Intelligent Questionnaire provided in the Compliance Program Guidance Manual (Refer to Section J) or equivalent state forms. The FDA District shall provide technical guidance to the state.

4. Training

The lead inspector is required to complete and pass the Egg Safety Inspections training course (FD107) provided by the FDA. Non-lead inspectors performing work under this contract are also strongly encouraged to attend FD 107 if seats/funds are available. It is the responsibility of the Contractor to assess the training and expertise of its staff and verify contracted inspections are conducted by staff with the requisite training and experience. Training needs shall be communicated to the

Office of Partnerships (OP) and the FDA Program Division Director or Designee during work planning or when information related to training is requested.

The FDA Office of Training Education & Development (OTED) offers additional training (videos) specific to egg farm inspections that are available in Pathlore

Learning Management System:

Pathlore State/Local/Tribal User Job Aids:

https://orauportal.fda.gov/stc/ORA/PathloreStateUserJobAid.pdf

a. Conventional Cage Production – FD8015W

b. Environmental Sampling in Manure Pits – FD8016W

c. Overview of the Egg Industry – FD8017W

d. Egg Sampling of Cage Housing Systems – FD8018W

5. Quality Control

FDA shall evaluate contractor performance throughout the contract period. This shall be accomplished by a variety of techniques, including: review of reports, joint inspections

(included as contract inspections), and audits. Joint inspections shall be provided to the

Contractor for review and information. For comprehensive information regarding the audit program, refer to Field Management Directive (FMD)-76 (Refer to Section J)

a. Inspector Performance Standard: All contractor inspectors shall be audited at the frequency described in FMD-76.

b. Inspector Performance Measurement: All contractor inspectors shall successfully pass audit requirements with an acceptable rating. For audit requirements, refer to FMD-76.

c. Inspector Performance Deduction: All contractor inspectors who receive an overall score of “needs improvement” shall receive remedial training in deficient areas as agreed upon by the District and State program. The State may be required to absorb the costs of the training. The State inspector shall discontinue conducting contract inspections until remedial training is completed. Refer to FMD-76 for additional details.

https://orauportal.fda.gov/stc/ORA/PathloreStateUserJobAid.pdf

d. Contract Inspection Audit Performance Evaluation

The District shall coordinate with the State to take appropriate action when the audit program identifies deficiencies in the performance of contract inspections as described in FMD-76.

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