revised_egg_rfp.doc

FDA-16-EGG

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 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 and 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 states participate in voluntary state run egg quality assurance programs (EQAP). These EQAP’s all having 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 EQAP’s 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 source 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 will 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.

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 in order 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 will also be submitted.

B-2 – Compensation 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 and not to exceed $_______ for travel/training, 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:

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.

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) will be submitted to the FDA District Office. Additional guidance may be found in Field Management Directive (FMD-130). Reasonable efforts to conduct a complete inspection must be approved by the District prior to invoicing for an inspection. Visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm.

d. Training and Travel

Total expenditures for domestic travel (transportation, lodging, meals, and incidental expenses) and training not to exceed $________ incurred in direct performance of this contract, shall be allowed based on the Federal Travel Regulation. All travel/training must be approved prior to attendance by the contracting officer’s representative (COR) and the contracting officer. All travel needs to be in accordance with Federal Travel Regulations and HHS Travel Regulations needs to be in accordance with Federal Travel Regulations and HHS Travel Regulations.

e. Schedule

Base Year

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 1

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 2

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 3

Egg Inspections

Training and Travel

Inspection Visits/OOBs

Option Year 4

Egg Inspections

Training and Travel

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 will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above.

Option 2: Inspection OOB/Visits are excluded and not reimbursed under this contract. If this is selected, the contractor shall not be reimbursed for any visits/OOBs under this contract.

Note: The award for number of inspections will be based on the FDA’s inventory and the recommendation of District Office.

Section C – Description/Specifications/Work Statement

C-1 Scope of Work

a. Scope

Independently and not 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. 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 registration status with the FDA, which is separate from Bio-Terrorism Act of 2002 (BT). A firm is required to register under the BT Act (Food Facilities Registration rule) if they ever pack eggs from any farm that is not under their ownership

· Verify the firm’s personnel that is responsible for ensuring compliance with each farm’s SE prevention plan qualifies 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 periods 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 investigator)

· 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

· Contact their Food and Drug Administration (FDA) district office immediately if during an inspection egregious conditions are observed (conditions would be considered egregious, and appropriate for more in-depth follow-up by FDA if the firm failed to implement the SE prevention plan and operate in an environment that presents a strong likelihood of SE contamination in shell eggs)

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 will be subject to inspection. Individuals who transport or hold shell eggs for shell egg processing or egg products facilities will 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 Region, District, and State contractor personnel shall take place within sixty (60) days of awarded contract. The goals of the session(s) are to:

· Coordinate an inspection schedule that will avoid duplication of inspections to be accomplished by FDA and state personnel

· Develop a consensus of the priority in the selection of firms to inspect

· Discuss and ensure clarity in regards to 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 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 coordinate audit requirements. The minimum audit rate for the egg contract is one(1)joint inspection per program

· Identify point of contact at the District level for notification in the event that egregious violations of the rule are observed during the contracted inspection to ensure timely notification of the FDA District office to advise the district of the inspection findings and the need for expedited response from the FDA District office

A minimum of one additional meeting shall be held with the District and State during the second or third quarter of the contract performance period to review the progress of the State and verify the contract deliverables are being satisfactorily met.

C-2 Detailed Tasks

a. General Requirements for Conducting Inspections

1. Food Safety Modernization Act of 2011

The Food Safety Modernization Act (FSMA), signed into law January 2011, authorized FDA to collect new user fees for specific domestic and foreign food re-inspections. FSMA authorizes FDA to assess and collect re-inspection fees to capture 100% of the costs related to certain domestic and foreign food facility re-inspections. The user fee for re-inspection is to cover re-inspection-related costs when the initial inspection, initiated on or after October 1, 2011, has a final OAI classification supported by “violations materially related to food safety requirements.” The re-inspection must be conducted specifically to determine whether compliance has been achieved.

Egg processing facilities which receive any egg(s) from a company/farm under different ownership are subject to FSMA re-inspection fees. To assist FDA in communicating the Re-Inspection Fee requirement to industry, the contractor shall print and hand out the attached FSMA User Fee Information Sheet to the most responsible individual at the inspected establishment during the opening meeting. The information sheet provides the statutory authority granted to FDA to collect user fees for re-inspections by FSMA, who will be assessed re-inspection fees and the rates. Please see the links below for FSMA guidance and the rates of fees information (Attachment 5).

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257982.htm#intro

2. Bio-Terrorism Act of 2002

Food Defense Security Preventative Measure Guidance

During the inspection, the inspector shall determine if the facility is aware of food defense security preventative measures. If the facility is not aware of these measures.

Inform the establishment management of the appropriate security preventive Measure Guidance or 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

3. Documentation

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

The contractor shall document that the re-inspection fee information sheet was provided to the firm in the summary section of the inspection report.

4. Abbreviated Inspections

The state agency (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 state contract. No environmental sampling will be conducted by the Contractor. If conditions present that would warrant environmental sampling, a referral/assignment will be made by the FDA District Office.

5. Registration During the inspection of farms covered by the Egg Rule, the contractor shall make sure 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 firm’s management or individual(s) responsible for administering the SE prevention plan also shall be informed that information regarding the Egg Rule, including a link to the rule itself can be found at the following website:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/default.htm Registered egg producers shall submit an update to a registration within 60-calendar days of any change to any of the 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.access.fda.gov/

6. Registration Documentation The contractor shall document the 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 local FDA District office.

7. 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 district. The warning letter for an Official Action Indicated (OAI) classification must be signed by the FDA District Director and must contain the specific language stated in the Compliance Program.

If an inspection conducted under contract results in a final district classification of “OAI” and details violations that are “materially related to food safety”, the State will be notified by the District and any re-inspection of the firm will be conducted by the FDA District office.

b. Inspections

(a.) Farm Inspections (Priority 1): Inspections of those farms covered by the Egg Rule should include the following:

1. 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.

2. 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.

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

4. Ensure that SE prevention measures are in place, including:

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

5. 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. The contractor must 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.

6. 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.

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

8. Verify registration of the farm as required by the rule.

9. 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.

(b.)

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 should verify that transportation vehicles and holding facilities are maintained at temperatures at or below that required by the rule (i.e. 45 F).

C.

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 should follow biosecurity measures enforced by the specific farm where the inspection is being conducted in addition to following general biosecurity measures listed in FDA’s Investigations Operations Manual (IOM). FDA’s Investigations Operations Manual, the primary source regarding Agency policy and procedures for field investigators and inspectors, discusses biosecurity measures for FDA inspectors in Chapter 5.2.10 “Routine Biosecurity Procedures for Visits to Facilities Housing or Transporting Domestic or Wild Animals” and is available at:

http://www.fda.gov/ICECI/Inspections/IOM/ucm122530.htm#5.2.10.2 The general procedures are listed below: (based on 21 CFR 118):

(Please note: State contractor shall follow the modified Biosecurity Practice requirement in the attached HPAI Field Directive)

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

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

· Disposable personal protective clothing (e.g., tyvek suits, booties, and gloves) must be changed between poultry houses on the farm to avoid cross-contamination of not just Salmonella Enteritidis but other infectious bird diseases such as avian influenza (AI) and exotic Newcastle disease (END).

· 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 should be disinfected with any of the agents identified at the end of this subsection using a good brush. Clean and disinfect the brush(es) and bucket you use for these activities.

· Wash your hands with soap and water. Use of hand sanitizers is encouraged. If you are visiting a facility where a known animal disease is present or the firm's biosecurity protocol requires, wear disposable gloves.

· Wear disposable or freshly laundered coveralls, when appropriate. 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 should follow those requests.

· Wear appropriate head coverings, as necessary. If you wear a head covering, clean and disinfect between facilities or use disposable head coverings.

· 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.

· 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 must be cleaned and disinfected prior to arrival. Prior to leaving the farm location the vehicle should be cleaned 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.

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, under the authority of the Federal FD&C Act. This includes the use of credentials, and 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.

Modifications to Current Biosecurity Practices:

Background: Since early March 2015, highly pathogenic H5N2 avian influenza virus has been identified in commercial poultry flocks in multiple Midwestern states; there have been multiple outbreaks in the US. Given the severity of the disease, the increasing incidence across the country, and the debilitating impact it could have on the poultry industry, poultry producers across the country are on high alert and have begun to implement more stringent biosecurity measures.

The following changes have been made to current practices:

· No egg inspections should be initiated without first contacting the state veterinary office and checking for quarantines. Investigators should ask if there is any type of quarantine and follow that up with a question specifically about HPAI-related quarantines. If quarantines are in place investigators should ask how long they are expected to continue. If the state veterinarian or official designated by the state indicates that inspections should notcontinue, those instructions should be followed and no inspections should be conducted until state clearance is given. In the interim, if an extended quarantine is expected (longer than 2 weeks) the district should organize a follow up meeting to include the District, State Veterinary Office or designated state official, and FDA Headquarters. The purpose of these meetings will 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.

· When possible, Districts should send separate inspectional teams on egg farm inspections such that the time between separate farm visits for any one inspectional team is maximized. For example, rather than sending Inspectional Team A to conduct inspections at Farm 1, Farm 2 and Farm 3, every attempt should be made to instead send Inspectional Team A to conduct the inspection at Farm 1, Inspectional Team B to conduct the inspection at Farm 2 and Inspectional Team C to conduct the inspection at Farm 3. The goal being to increase the length of time that any of the three inspectional teams have to visit the next farm up for inspection.

· Districts should categorize inspections according to risk with farms providing out door access being considered the highest risk. Inspections at farms with outdoor access should be inspected last. Additionally, the length of time between inspections should be increased from the standard 72 hrs to one (1) week following any visit to a farm with outdoor access. For example, if a District was assigned 15 inspections as part of the FY 15 Egg Assignment, and 5 of those firms provide outdoor access, the 10 farms that do not provide outdoor access should be inspected first and the 5 with outdoor access should be inspected last, with a 1 week wait time between the final 5 inspections (i.e. those firms with outdoor access).

· Disinfectants recommended by the USDA-APHIS that are effective against both HPAI and SE, and are more appropriate to the poultry house environment and high organic matter load in their “Biosecurity Guide for Poultry and Bird Owners”include:

Roccal: mixed at one-half fluid ounces per gallon of water.

Nolvasan (chlorhexidine diacetate 2%): mixed at three fluid ounces per gallon of water.

Tek-trol: mixed per manufacturer’s instructions.

One Stroke Environ: mixed per manufacturer’s instructions

Household bleach (sodium hypochlorite 6%): mix three-fourth of a cup of bleach per gallon of water.

Lysol spray for footwear

Purell hand pump for hand disinfection

In order for most disinfectants to work properly the object to be disinfected must be thoroughly cleaned and washed prior to being disinfected. Disinfectants should be applied using brushes, sponges, or spray units and appropriate contact times should be allowed (follow the manufacturer’s instructions).

The following disinfectant guidelines are provided by USDA-APHIS in their “Highly Pathogenic

Avian Influenza Standard Operating Procedures: Overview of Etiology and Ecology”:

If organic matter is present: aldehydes, β-propiolactone and binary ethyleneimine

After organic matter has been removed: phenolics, quaternary ammonium compounds, oxidizing agents (such as sodium hypochlorite), hydroxylamine, and lipid solvents

For clean surfaces with no organic matter: use sodium hypochlorite (5.25%), sodium hydroxide

(2%), phenols, acidified ionophors, chlorine dioside, or strong oxidizing agents

· Given that HPAI is highly susceptible to detergents, high temperatures and desiccation, cars washes where hand held nozzles are available should be used. Initially, a cycle should 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 should be followed with a cycle where a scrub brush with a detergent is used on the whole vehicle including the wheel wells and should be followed by a high pressure rinse. Finally a drive through cycle should be used that cleans the undercarriage should be sprayed when the hand held nozzle is being used. The vehicle should then be allowed to dry thoroughly in a sunny area (as opposed to a shaded garage). After the vehicle has dried, disinfectant should be applied with a hand held sprayer. Select the disinfectant to be based on the guidelines above and follow the manufacturer’s instruction for proper dilution and use. The interior of the vehicle should be vacuumed thoroughly to remove organic matter and floor mats sprayed with a disinfectant aerosol spray.

· Investigators should wash hands thoroughly before donning gloves for entry into the house. Where available use soap and water; if not available use hand sanitizing gels. It is the responsibility of the team lead to ensure that all members of the team are adhering to protocol. This should be done at both the clean and dirty areas established at the farm, prior to entry into any poultry house.

· The minimum wait time between farm inspections is 72 hours as established by our internal protocol. However, if a producer has established a longer wait time that requirement should be followed. If the wait time established seems excessive, i.e. longer than two (2) weeks, the district should organize a follow up meeting to include the District and FDA Headquarters (see contacts at the end of attached document) to established an appropriate wait time.

· Although bird feeders are addressed in the egg rule inspectional assignments issued by the FDA, some modifications will be made. Specifically, investigators are not to come in contact with bird feeders or bird baths for a minimum of one (1) week prior to participating in an egg farm inspection.

Additional Biosecurity Measures to be Implemented:

In response to the ongoing HPAI situation, additional biosecurity measures have been developed. These measures should be followed on all egg farm inspections. They include:

Pre-Inspection Measures Prior to an egg inspection being initiated the lead investigator should conduct a cross reference check of the inspection location against the HPAI Current Avian Influenza findings on the USDA/APHIS web page. The Current Avian Influenza findings can be found at the following web address, under the Press Releases and Updates section:

http://www.aphis.usda.gov/wps/portal/aphis/home/!ut/p/a1/hY7NDoIwEISfxiu7IAIeQRIo_pBoIrgXA6Z WFFqDxL6- xXhV5zaZbzIDBCWQrJ6NqIZGyaodPXnHLE8dO0KH5UvmIdvstxilsY27qQEOBsAvCvFfvwB6I4skTF1_ZTpu4C CLTe7P14jM-wA_JjIg0ara3C0ioAnGMmn0- CyU9TQQQD0_85731kU9Bii11pZQSrTcOqkO7l2J19mteAED8Cxn/?1dmy&urile=wcm%3apath%3a%2Fap his_content_library%2Fsa_our_focus%2Fsa_animal_health%2Fsa_animal_disease_information%2Fsa_av ian_health%2Fct_avian_influenza_disease The Current Avian Influenza findings include the state, county, flyway, flock-type, Avian Influenza Subtype and confirmation date for each occurrence. Investigators should check the state and county from the USDA/APHIS webpage against the location of the farm to be inspected. If the farm is in the same county as a confirmed HPAI occurrence the District should cancel the inspection and set up a follow up meeting to include the District and FDA Headquarters. During this meeting the following information will be considered: the confirmation date of the occurrence (how far removed from the time HPAI was detected to when the current inspection is scheduled), the relative locations of the HPAI infected site and the farm to be inspected

(the infected, buffer, and surveillance zone criteria established by APHIS will be considered), and other pertinent information. After all pertinent information is considered, a decision will be made to either cancel the inspection or reschedule it for a more appropriate time.

In addition to the USDA/APHIS Current Avian Influenza Findings Weblink, a publisher of several poultry industry publications, WATTAgNet has established an interactive map that is updated with HPAI findings in the US. The map can be found at the link below and used to supplement the APHIS webpage when cross checking egg farms locations.

http://www.wattagnet.com/Track_avian_influenza_outbreaks_in_North_American_poultry.html A minimum of one (1) week, preferably longer, prior to participating in an FDA egg farm inspection, all investigators involved in the inspections should:

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

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

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

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

· Do not visit zoos, theme or amusement parks where live birds maybe present.

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

· 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.

· 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.

· Do not visit an ocean side town where you may come in contact with shorebirds, e.g., gulls.

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

· 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 least the week prior to the inspection.

· 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.

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

· If possible use the hot water cycle to launder clothing that will be used during an egg inspection.

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

· Eyeglasses should be cleaned and disinfected with disposable decontamination wipes.

2. 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 Programs. The FDA regional/district offices will provide technical guidance to the Contractor.

3. Training The State inspectors shall complete and pass the Egg Safety training course (FD107) available through FDA. It is the responsibility of the Contractor to assess the training and expertise of its staff and determine contracted inspections are conducted by staff with the requisite training and experience. Training needs must be communicated to the Office of Partnerships (OP) and the District during work planning or when information related to training is requested.

All travel requests under this contract to participate in FDA-approved training courses must be negotiated and pre-approved by OP and the Contracting Officer. Reimbursement for training cannot exceed the total cost. (See B2 d Funds Available). If your travel costs increase, a modified cost estimate must be approved prior to attending the course or you will not be reimbursed for the additional costs. All travel arrangements will be accomplished under State travel authorities and reimbursed to the State through the contract voucher/invoice. The Contractor shall submit receipts with their training invoice(s) or they will not be reimbursed.

d.

Samples

Environmental or egg samples will not be collected during farm inspections. In situations where conditions may warrant sample collection, the contractor shall immediately contact their FDA district office.

e. Quality Control

FDA will evaluate contractor performance throughout the contract period. This will be accomplished by a variety of techniques, including: review of reports, joint inspections (included as contract inspections), and audits. Joint inspections will be provided to the Contractor for review and information. For comprehensive information regarding Audit program, refer to Field Management Directive 76(Attachment 7):

http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm

1. Inspector Performance Standard: All contractor inspectors shall be audited at the frequency described in FMD-76(Attachment 7) or the link:

http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm

2. Inspector Performance Measurement: All contractor inspectors must successfully pass audit requirements with an acceptable rating. For audit requirements refer to FMD 76.

3. 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 will discontinue conducting contract inspections until remedial training is completed. Refer to FMD-76 for additional details.

4. Contract Inspection Audit Performance Evaluation The District will 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.

An unacceptable audit will not cause a contract to be altered or unpaid, nor will payment for the contract inspection be withheld. The contractor will be evaluated on its overall work performance during the contract year, not the outcome of one contract audit. A single audit may give an indication of a problem, but may not prove sufficient to determine its scope. If this occurs, it may indicate an area in the Contractor’s inspection program that may be improved.

5. Contract Performance Standard: In accordance with contract requirements, the contractor shall conduct assigned initial inspections, necessary re-inspections, and visits within the state and report all completed inspection results no later than thirty (30) days after completion of the inspection. At least 90% of all submitted inspection reports shall be timely, accurate, completed and acceptable for data entry, analyses, and processing. Payment could be withheld for delayed submission.

6. Contract Performance Measurement: The Government will measure compliance with contract inspection requirements by reviewing inspection records and conducting audits or joint inspections. Results of all FDA quality assurance reviews will be furnished to the contractor. A sample of inspection records will be reviewed by FDA to verify that the required data and information are complete and accurate.

7. Payment Withholding: If FDA finds an inspection record quarterly report or invoice to be unacceptable, the Contractor will be advised and given an opportunity to correct or submit a new inspection record. Each instance whereby the Contractor fails to submit or correct the required report shall result in withholding of invoice payment until the corrected report(s) are received and accepted by the FDA.

f.

Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF)

The FDA has an automated Field Accomplishment and Tracking System (FACTS) in which all firm/facility/farm inspection data is captured and tracked. In an effort to automate some processes and to streamline communications between the States and FDA, the eSAF concept was developed.

The eSAF system allows FDA to automate the issuance of work requests to the State egg facility contractors and will allow the state contractors to enter and update inspection results electronically. Additionally, the states will have access to the firm’s data that FDA has maintained in FACTS for the past several years. This data will enable the States to identify firms considered to be “high risk” and to obtain information about past inspections and violations for firms within their jurisdictional area (Attachment 2), “Electronic State Access to Field Accomplishments and Compliance Tracking System (eSAF),” represents the requirements associated with eSAF. The state contractor shall consult the FDA District Office regarding the eSAF training.

Following completion of FDA eSAF training, and in accordance with eSAF Requirements Document, the contractor shall input complete inspection information into the eSAF system.

1. eSAF Support

After training has been successfully completed, the Contractor shall contact the ORA Applications Helpdesk for technical assistance via e-mail at APPSDESK@fda.hhs.gov or at telephone number, 866-807-3742. The Helpdesk operates 24hrs/daily.

2. Change in eSAF Users The Contractor shall notify APPSDESK@fda.hhs.gov with a courtesy copy to the District Technical Advisor at least twenty-four (24) hours prior to an eSAF user departing from State employment or transferring/reassignment to a position that does not require the use of eSAF.

g. Confidentiality of Information: The contractor shall protect non-public information in accordance with (list FDA/HHS standards).

The contractor shall develop and provide a physical security plan to detail how sensitive and private information will be protected.

The contractor’s inspectors shall complete and submit Form FDA 3398, “Contractor’s Commitment to Protect Non- Public Information (NPI) Agreement,” prior to performing any work under this contract. (See List of Attachments)

SECTION D – PACKING AND MARKING

This section is not applicable to this solicitation/contract.

SECTION E – INSPECTION AND ACCEPTANCE

E-1 – Inspection and Acceptance

Pursuant to the appropriate inspection clause as referenced below, inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer at the Food and Drug Administration, State Contracts and Compliance, HFA-500, 5630 Fishers Lane, Rockville, Maryland 20857.

FAR 52.246-4 Inspection of Services (AUG 1996)

SECTION F – DELIVERIES OR PERFORMANCE

F-1 – Period of Performance

The contract will be from the effective date of award for 12 months. There will be 4, 12 month option periods for a total 5 year period of performance.

F‑2 - Reports/Deliverables

Significant violations and/or

State regulatory action has been conducted or is being considered: District shall be notified within three (3) business days and the report submitted within thirty (30) business days after the completion of the inspection.

Significant violations and/or State regulatory action have been conducted or are being considered: Submitted within three (3) business days after the completion of the inspection.

Quarterly Reports Submit no later than thirty (30) business days after the end of each ninety (90) day reporting period.

a. Establishment Inspection Reports: In accordance with contract requirements, the contractor shall conduct assigned initial inspections, necessary re-inspections and visits within the state.

The contractor shall complete a detailed Establishment Inspection Report for the appropriate industry. The Contractor shall use the FDA Product Code List to complete the appropriate sections of eSAF or the Coversheet, including Part C: Products Covered, where the products inspected will be recorded. Also, corrective action shall be reported and coded on Part E of the coversheet or equivalent form under the newly revised Compliance Achievement Reporting System, which replaces the Voluntary Correction Reporting System. If eSAF is utilized by the States corrective action information, it shall be submitted with a hard copy Establishment Inspection Report, or equivalent form. The Government will furnish the necessary FDA forms.

The Contractor shall submit inspection findings to the District Office as follows:

1. For any inspection that has significant violations, the State shall NOTIFY the District Office via email within three (3) days after completion of the inspection, and submit the complete inspection report, within thirty (30) business days.

2. For inspections without significant violations and not requiring state regulatory actions (generally rated as “No Action Indicated (NAI)” or “Voluntary Action Indicated (VAI)”), the State shall submit the inspection reports within thirty (30) business days.

NOTE: The above time frames will not apply for inspections conducted in September of each year as those inspections must be entered into the FDA data system prior to October 15th to be counted in the FDA’s fiscal year data. As a result, state contract inspections conducted in September must be entered into eSAF no later than October 10th of each year. At least 90% of all notifications and submitted inspection reports shall be timely, accurate, complete and acceptable for date entry, analyses and processing.

b.

Electronic Reporting: Upon completion of the FDA eSAF training, the contractor shall henceforth input complete inspection information into the eSAF system within thirty (30) business days after the completion of the inspection.

c.

Quarterly Summary Report: SUBMIT VIA EMAIL NO LATER THAN THIRTY (30) BUSINESS DAYS AFTER END OF EACH NINETY (90) DAY REPORTING PERIOD.

For each 90-day period of the contract (based upon the performance period), a Quarterly Summary Report (Form FDA‑2684a) on the inspections, samples, and actions shall be prepared.

The contractor must submit a Quarterly Summary Report (Form FDA 2684; Attachment 6) to the District for approval with a courtesy copy to the COR. The report must be submitted via email no later than thirty (30) business days after the end of each ninety (90) day reporting period of the contract. In those periods where no inspections were performed, a report showing no inspection IS REQUIRED.

Included with the Quarterly Summary Report shall be the contract number, a list of the establishments inspected specifying the name and address of the firm inspected, FEI#, inspection date, and type of inspection. Where visits were encountered, they should also be noted.

d. Quarterly Summary Report Approval: A review of the Quarterly Summary Report will be conducted by the District and a notification provided to the contractor on the acceptability of the Quarterly Summary Report with ten (10) business days of receipt. If questions exist regarding the Quarterly Summary Report, the State will have ten (10) business days to respond to the District by providing additional information or submitting a revised Quarterly Summary Report. Following the review and confirmation of acceptance of all work detailed on the Quarterly Summary Report, the District will provide the contractor (via email with copy to the COR) approval of Quarterly Summary Report.

Approval of the Quarterly Summary Report by the District is required prior to submission of the invoices. Invoices cannot be submitted to OAGS nor will invoices be paid without District approval of the Quarterly Summary Report. Documentation of District approval of the Quarterly Summary Report shall be submitted with the invoice and Quarterly Summary Report to OAGS and the COR.

Copies of the District approved Quarterly Summary Report shall be provided as follows:

1. One copy to:

Food and Drug Administration

Office of Partnerships

ATTN: Mei Ying Li

Meiying.li@fda.hhs.gov

12420 Parklawn Drive, Room 3019

Rockville, MD 20857

** Preferred method of delivery is via email**

2. One copy to:

Food and Drug Administration/OAGS/DASG

State Contracts and Compliance

Attn: Julia A. Savage

State Contracts and Compliance, HFA-500

5630 Fishers Lane, Room 2005

Rockville, Maryland 20857

Julia.savage@fda.hhs.