FY21 PT announcement 1030020.docx

FSIS FERN Proficiency Sample Preparation, Distribution and Reporting

Section I - Funding Opportunity Description

The Food Emergency Response Network (FERN) currently comprises 169 federal, state, and local government regulatory laboratories with varying capacities to perform threat agent testing and is jointly overseen by the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) and Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA). The FERN Staff in USDA FSIS is seeking to award one cooperative agreement used in assessing the FERN program members providing capacity and capability for food defense and food safety testing, in both microbiology and chemistry disciplines. This agreement will be used in the assessment of the network’s microbiological and chemical threat agent testing utilizing FERN and other methods by administering proficiency samples under ISO 17043 accreditation. This cooperative agreement is on a 1 year funding cycle and up to $100,000 annually. This announcement may be annually renewable for up to 5 years. All funding is contingent on continued Agency funding of the program and a review of past performance of the participant laboratory. Note: Indirect costs are capped at 10% of the total award amount.

Project Description - Under the agreement the PT provider will perform all preliminary research, modeling, analysis, storage, packing and shipment for each PT event. The PT events will encompass three major project areas for FY 21:

1) FERN wide proficiency samples for microbiological (up to 75 sample sets) and chemical agents (up to 60 sample sets), delivered in FSIS regulated matrices. Each sample set will contain 5-8 individual samples. At least 2 – 3 offerings per year will be administered and each will be agreed upon by the FERN Proficiency Testing Committee.

2) Provide 8 FERN laboratories C. perfringens challenge samples to include at a minimum:

Sample Set 1 Requested 1 samples uninoculated 2 samples high vegetative 1 sample high vegetative/spores 1 sample low spores

Sample Set 2 Requested 1 sample uninoculated 2 samples low vegetative cells 1 sample low vegetative cells/spores 1 sample high spores

3) Thermally processed foods presents an additional possible funding source later in the agreement year. Description of Thermally Processed PT’s: 4 - 6 times annually, a series of 12 samples will be sent to one USDA FSIS Field laboratory. These samples may contain microbiological agents as possible contaminants of ineffective thermal processing and also include samples from retort canning, tetrapak processing to be used for physical examination of cans/packages for defects. Organisms to be used may include, but not limited to, Clostridium sporogenes, Enterococcus faecalis, Geobacillus stearothermophilus. See appendix A for an example of thermally processed foods PT program expectations.

Proficiency Samples provided to the FERN network may include any of the following:

1) Screening assays/FERN methods for the following microbiology food defense analytes in foods:

Bacillus anthracis Yersinia pestis Francisella tularensis Brucella spp.

Burkholderia spp.

Shigella spp.

Clostridium botulinum toxin Ricin toxin staphylococcal enterotoxins Abrin toxin Alpha amanitin toxin

2) Screening assays/FERN chemistry methods in the following areas:

GC/MS assays (FERN CHE0006.01);

LC/MS assays (FERN CHE0008.00);

Screening for metals (FERN CHE0009.00 (based on EAM4.7)/FSIS CLG TM3.06);

PT providers with the following capabilities are preferred:

1) Select Agent Registration (SAR) preferred

2) Current BSL3 capable laboratory preferred

3) Accredited to ISO 17043 for proficiency sample supplies

PT providers should describe how they can provide PT samples and meet the following program criteria.

1. PT Sample matrices will be provided in FSIS regulated products.

2. Each FERN wide PT will contain 5 – 8 samples per event.

3. A special, one time, C. perfringens challenge sample set will contain 8 – 12 samples containing a mixture of spores and vegetative cells for enumeration.

4. Thermally Processed Sample Proficiency Testing provided 4 – 6 times per year, 12 samples per event with either microbiological inoculation of samples or physical examination of can/package defects for one FSIS Laboratory.

5. The awardee will provide upon request an exact cost for each of the individual PT Events supported by this agreement to include the following: estimated total number of laboratories participating, total amount and cost of food matrix prepared, total amount and cost of standard material needed, cost per each sample prepared and cost per each PT shipment package.

6. The awardee will coordinate all pre-work in support of each of these events; including, but not limited to acquiring the necessary standard materials, food matrices, laboratory supplies, etc. Additionally, the awardee will supply any standards or supplies needed for member laboratories to properly evaluate each of the proficiency samples sets sent out.

Section II – Government Responsibilities

A FERN Project Officer will be assigned to work with the awardee of this cooperative agreement and will act as the technical point of contact for the Government, initiate communications, and perform review and acceptance of each proficiency event. The Project Officer’s authority is limited to technical issues and he/she is not authorized to make contractual decisions.

The authority to resolve monetary issues and contractual interpretation is the responsibility of the USDA Administrative Services Division.

Section III: Reporting Requirements and Deliverables:

A. Event Pre-shipment Requirements: The awardee shall provide written verification prior to each Proficiency Test addressing the following:

· Proficiency Sample Set Schematic (# Positive; # Negative)

· Inoculum level of organism or analyte

· Confounding Organism(s) type and inoculum level

· Holding Time & Temperature (prior to beginning PT analysis)

· Shipment Temperature Range

· Results of Awardee Lab assessing PT Sample Set prior to shipment

B. Post Event Requirements: Upon completion of a completed FERN PT event, the awardee shall provide a report detailing member lab performance according to the FERN PT SOP. A final cost for the full execution of each individual FERN PT event will be required.

C. PT Provider responsibilities:

· Logistical aspects of the PT program as well as Quality Control testing of samples and statistical analysis of results are managed by the PT Provider.

· Designate dates, agents and sample matrices of PT Challenges in collaboration with FSIS and FDA FERN National Program Office (NPO).

· Provide timeline for production and delivery of sample panels for QC testing, to be mutually agreed upon by FDA ORA and USDA FSIS.

· Provide biological and chemical agent samples for culture and/or spiking of panel matrices.

· Perform QC testing on sample panels during production to determine if panel is spiked with correct agent and at correct concentration levels

· Provide information and requirements for supplies needed for matrices production.

· Receive and analyze results of PT Challenge from participating/Member Laboratories.

· The PT provider is to produce sufficient sample quantities to meet FSIS PT Challenge requirements. The PT provider shall produce and distribute samples of USDA FSIS Proficiency Testing challenges for biological and chemical agents following the requirements listed below and the standards specified.

· Have proper facility (ies) and equipment(s) for the production and storage of samples and panels. Necessary equipment includes an incubator, biosafety cabinet, water bath, freezers, and refrigerator.

· Provide verification that all personnel working under this contract have proper scientific skills and chemical and biological safety training.

· Abide by all relevant federal regulations.

· Follow safety practices for the manipulation of biological agents as outlined in the Biosafety in Microbiological and Biomedical Laboratories, 5th ed., published by the CDC, HHS, and NIH.

· Provide all raw materials, including biological and chemical agents, as instructed by the USDA FSIS, for PT panel production.

· Participate in biweekly conference calls with the FERN PT Advisory Committee Laboratory.

· Package and ship PT Challenge panels to Member Laboratories, nationally, on date specified by the USDA FSIS Project Officer at specified temperature (e.g. frozen, room temperature) following all shipping regulations IATA Regulations and DOT Regulations).

· Culture and propagate biological agent samples recommended by the USDA FSIS.

· Spike designated matrices with biological and chemical agents at concentrations defined by the USDA FSIS.

· Produce number of panels for PT challenge as directed by USDA FSIS and store as directed until designated ship date.

· Test sample panels at designated points and methods during production for Quality Control (QC) testing. Samples must pass QC testing.

· Reproduce PT Challenge samples or panels that do not pass QC testing as instructed by USDA FSIS.

· Store a certain percentage of panels produced as directed by USDA FSIS for up to 6 months after initial PT Challenge shipment.

· Ship panels as directed by USDA FSIS FERN to national labs for receipt next business day, arriving by Tuesday or Wednesday.

· Maintain a Quality System throughout all production steps.

· Ship additional subset of samples to participating laboratories for remediation testing as needed within 1 month of initial PT challenge.

D. List of Equipment: All equipment, supplies, reagents, required to produce PT panels in compliance with this Agreement will be the responsibility of the PT provider.

Section IV: Security Requirements:

The awardee shall be responsible for compliance to any and all guidelines and regulations (local, state, federal) pertaining to activities pursued in support of this Agreement. The concerns of which include but are not limited to IATA packaging and shipping guidelines, DOT packaging and shipping requirements, APHIS Select Agent rules, CDC Select Agent rules, ISO Proficiency Provider Accreditation Guidelines, etc.

REFERENCES:

DOT

http://hazmat.dot.gov/regs/rules.htm

IATA

http://www.iata.org/ps/publications/9065.htm Select Agent Regulations http://www.cdc.gov/od/sap/faq.htm http://www.access.gpo.gov/nara/cfr/waisidx_04/15cfrv2_04.html#700 http://www.aphis.usda.gov/plant_health/permits/index.shtml http://www.cdc.gov/od/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf

Section V: Application Submission and Application Review Information

Eligible Applicants – Higher Education Institutions (Public/State controlled), State and Local Governments, County Governments and Federally Recognized Indian/Native American Tribal Governments who have demonstrated experience providing regulatory laboratories with accredited proficiency samples.

Cost Sharing or Matching – Not required.

Applicants may download the SF424 and other forms associated with this funding opportunity using or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in this announcement. Compliance with the application requirements is required and strictly enforced. Applications that are out of compliance with these instructions may not be accepted for review.

Instructions for Application Submission The following narrative and documents must be submitted for a complete application. Application received by the December 1st, 2020 deadline missing a section or required document will not be reviewed.

All proposals should be submitted electronically to the FSIS FERN email address, FSIS.FERNHeadquarters@fsis.usda.gov . All proposals received before 11:59pm on the due date will be acknowledged by email as received and will be considered for scoring. Proposal received after December 1st, 2020 or missing required information will not be reviewed.

Funding Restrictions:

· Applicants should not include travel funds in their budgets at this time.

· Construction costs are not allowable.

· No pre-Federal costs allowed.

· Indirect costs are limited to 10% of the total award.

Review Criteria A group of reviewers will be utilized to score all applications received by the deadline. Reviewers will provide an overall score to reflect their assessment of the proposal. Final panel scores will be forwarded to the selection official for ranking and selection. Reviewers will consider each of the areas below:

· Facilities – 20 Points

· Personnel – 20 Points

· Ability to meet section III PT provider responsibilities – 20 Points

· Past Experience providing Proficiency Samples to Food Testing Labs - 20 Points

· Laboratory Procedures, Policies, Support, Management – 20 points

Review and Selection Process Applications will be ranked using panel scores. The FSIS FERN selecting official will also include other factors when making the final selection of applications for Federal award based on program policy and need to support overall FSIS activities.

Additional Areas to be considered in selection of laboratories:

· ISO 17043 Accreditation

· Past Performance in providing PT programs to FERN Note: scores and recommendations by the technical review panel are only advisory. The agency is not bound to award to those with highest scores.

Section VI: Award Administration Information

Simplified Acquisition Threshold

i. That the Federal awarding agency, prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313);

ii. That an applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered and is currently in the designated integrity and performance system accessible through Feder;

iii. That the Federal awarding agency will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in §200.205 Federal awarding agency review of risk posed by applicants.

Anticipated Announcement and Federal Award Dates

Federal Award Notices After review of all submissions, program selectees will be notified by the FSIS FERN staff. The notification of intent to award will include a request to submit your final proposal with updates and changes, completed and signed forms to the FSIS Administrative Services Division. This notification is not binding and awards will still be subject to approval by FSIS management.

Applicants that receive a notification of intent to make a Federal award will be required to make any suggested updates or changes to the proposal and submit additional required Forms (available on the Grants.gov website).

USDA AD-1047 Certification Regarding Debarment, Suspension, and Other Responsibility Matters

An official and binding notice of award signed by a representative of FSIS’ Administrative Services Division will be provided following receipt of the final proposal and supporting documents.

Administrative and National Policy Requirements These cooperative agreements will be administered under the guidance of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (OMB Uniform Guidance 2014, available at Grants.gov). Below are listed some of the pertinent rules that will be followed.

Cooperative Agreement Terms and Conditions of Award Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated quarterly by the project officer. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism (rather than an “acquisition” mechanism), in which substantial FSIS programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FSIS’ purpose is to support and stimulate the recipients’ activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

A Project Officer (PO) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including reviewing progress reports and making site visits.

Recommended support beyond the first year will depend on the availability of funds and approved performance.

Reporting Performance reports are to be submitted electronically 30 days after the end of each quarter (due dates April 30, 2021; July 30, 2021; Oct. 30, 2021). Financial status (SF-425) are to be submitted on a quarterly basis (April 30, 2021, July 30, 2021, and Oct 30, 2021). Financial reports will be reported electronically through the Payment Management System (PMS). Additionally, a final performance and financial report is required within 90 days of the end of the award period (December 30th, 2021). The award period will run from January 1, 2021 to September 29, 2021.

Section VII: Agency Contacts

For further information or assistance concerning this funding opportunity, please contact one of the following:

Email: FSIS.FERNHeadquarters@fsis.usda.gov Phone: 706-546-3578

Dr. Marcus Head Sr. Staff Officer, National Program Office FSIS FERN Staff 950 College Station Road Athens, GA 30605

PH: 706-546-2336

Marcus.head@usda.gov

Dr. Robert Phillips Sr. Staff Officer, National Program Office FSIS, FERN Staff 950 College Station Road Athens, GA 30605

PH: 706-546-2349

Robert.phillips@usda.gov

Dr. Patrick Sisco Sr. Staff Officer, National Program Office FSIS, FERN Staff 950 College Station Road Athens, GA 30605

PH: 706-546-2382

Patrick.sisco@usda.gov

Kevin Vought Sr. Staff Officer, National Program Office FSIS, FERN Staff 601 Robert Street North Saint Paul, MN 55155

PH: 651-201-6085

Kevin.vought@usda.gov

For more information about the Food Safety Inspection Service (FSIS) or the Food Emergency Response Network (FERN) please visit our websites:

http://www.fsis.usda.gov/ http://www.fernlab.org/

Appendix A – Thermal Processing Sample Set Description

Frequency

Sample Matrix

Physical Examination

Proficiency Testing Events Provide 4-6 sets of cans per year Each set will contain 6 abnormal and 6 normal cans.

Sample Preparation Spike cans with microorganisms. Microorganisms spiked to vary between sets.

Annual sets to include a variety of microorganisms – spore-formers, non-spore-formers, gas producing, and non-gas producing.

Can Seam Test Provide can with known double seam measurements for analysis.

Defects Provide sets with a variety with physical defects that could be attributed to microorganisms found.

Pinhole leaks Double seam defect

Cultural Analysis

Reporting Allow the ability to submit results for verification. Provide a final report comparing the submitted results to the expected results.