3a Exhibit 1 - LP-SSD-FPPS-LAB-SOW - 2021 ADL w appx A B C 061321.pdf

APPROVED

STATEMENT OF WORK (SOW)

AND TECHNICAL

REQUIREMENTS FOR

MICROBIOLOGICAL AND FAT

TESTING AND ANALYSIS TO

SUPPORT MEAT PURCHASES

FOR USDA FEDERAL FOOD AND

NUTRITION ASSISTANCE

PROGRAMS

Agricultural Marketing Service (AMS)

Livestock and Poultry (LP) Program Standards and Specification Division (SSD)

Room 2628 S, STOP 0258 Phone: (202) 690-3148

Supersedes: LP-FPPS-LAB-SOW April 2021 –

Changes from previous requirements in blue

Effective: June 2021

Approved by__________DBJ Date Issued: 04/01/10 Date Revised: 06/13/21

100 SCOPE

101 The Agricultural Marketing Service (AMS) procures food for the National

School Lunch Program and other Federal food and nutrition assistance programs. Meat, poultry, and egg products procured by AMS must meet specific microbiological purchase specifications. Timely and accurate sample processing, analysis, and reporting of results are essential.

200 OBJECTIVE

201 This SOW provides the requirements for laboratories seeking to enter into a service contract with AMS to conduct microbiological and fat tests on samples of red meat commodities produced for AMS. Laboratories that are awarded contracts by AMS and pass all applicable audits are referred to as AMS-designated laboratories (ADLs).

202 Each ADL shall be a third-party, independent analytical laboratory, not owned by a company or companies that are or may bid on meat procurement contracts with AMS.

203 ADLs will submit a detailed technical proposal addressing all AMS requirements (described below). The Contracting Officer will award contract(s) to ADLs based on the best value to the government.

Date Revised: 06/13/21

300 APPLICABLE DOCUMENTS

301 AMS Federal Purchase Program Specifications (FPPS) for Boneless Beef, Coarse Ground Beef, and Ground Beef Products (Effective Versions).

https://www.ams.usda.gov/selling-food/product-specs

302 AOAC International, Official Methods of Analysis (Current Edition)

303 Food Safety and Inspection Service (FSIS) Microbiological Laboratory

Guidebook (MLG), Chapter 3, Quantitative Analysis of Bacteria in Foods as Sanitary Indicators (Effective Version;

http://www.fsis.usda.gov/Science/Microbiological Lab Guidebook/index.asp)

304 FSIS MLG, Chapter 4C, FSIS Procedure for the Use of a Polymerase Chain

Reaction (PCR) Assay for Screening Salmonella in Raw Meat, Carcass Sponge Samples, Whole Bird Rinses, Ready-to-Eat Meat and Poultry Products, and Pasteurized Egg Products (Effective Version)

305 FSIS MLG, Chapter 4, Isolation and Identification of Salmonella from Meat, Poultry, and Egg Products (Effective Version)

306 FSIS MLG, Chapter 5A, FSIS Procedure for the Use of Escherichia coli

O157:H7 Screening Tests (Effective Version)

FSIS MLG, Chapter 5B, Detection and Isolation of non-O157 Shiga Toxin- Producing Escherichia coli (STEC) from Meat Products

307 FSIS MLG, Chapter 5, Detection, Isolation, and Identification of Escherichia coli O157:H7 from Meat Products (Effective Version)

308 ISO/IEC 17025, General Requirements for the Competence of Calibration and

Testing ADLs (Current Edition)

309 AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals; an Aid to Interpretation of ISO/IEC 17025:2005 (Current Edition)

310 AMS Instructions for the Reporting of Microbiological and Fat Test Results in

Spreadsheet and Comma Separated Values (CSV) Text File (Database) Format (Current Version)

311 AMS Instructions for the notification of pathogen test results by email to AMS, AMS vendors, and FSIS (Current Version)

Date Revised: 06/13/21

400 ANALYTICAL TESTING REQUIREMENTS

410 MICROBIOLOGICAL TESTING REQUIREMENTS

411 Sample Preparation, Testing, and Test Results

411.1 Sample Preparation – AMS vendors will submit samples for microbiological testing to their assigned ADL in accordance with the requirements outlined in this SOW.

411.2 The ADL will be responsible for supplying to each AMS vendor sampling procedures in accordance with sample preparation requirements within the applicable AMS FPPS. The sampling procedure shall include sampling plans that define specified sample size (weight) in accordance with the applicable FPPS, packaging and handling instructions that also address handling of reserve samples, and procedures for submitting samples to the ADL.

411.3 The procedure for submitting samples shall require an ADL form to be completed by the AMS vendor and submitted as an official record with each sample. The form shall contain sample tracking information including, but not limited to, company name, contact person, contact information, lot number, pounds of product represented by sample, purchase order, material description, and production date.

411.4 The ADL will be responsible for supplying shipping supplies, including sampling bags and shipping materials, to each AMS vendor. Reserve samples shall not be analyzed without written consent of an SSD/Food Safety and Technology Branch (FSTB) representative.

411.5 Testing – Samples will be tested for all microorganisms specified within the applicable AMS FPPS. All applicable and updated specifications will be made available to the ADL by AMS via this link: https://www.ams.usda.gov/selling-food/product-specs.

411.6 Note: Should a change occur in FSIS regulatory requirements that would impact the requirements of the Federal food and nutrition assistance programs, AMS will notify the ADL and AMS vendors concerning changes to the AMS microbiological testing requirements.

411.7 Boneless beef and ground beef will be tested for all microorganisms specified within current FPPS-BB, FPPS-CGB, and FPPS-GB. These specifications can be found here: https://www.ams.usda.gov/selling-food/product-specs

411.8 The ADL will be required to test boneless beef and ground beef (coarse and fine) samples for concentrations of:

Date Revised: 06/13/21

411.8.1 Aerobic (standard) plate counts (APCs);

411.8.2 Total coliforms; and

411.8.3 Generic Escherichia coli.

411.9 The ADL will be required to test boneless beef and ground beef (coarse and fine) samples for the presence of:

411.9.1 Salmonella and

411.9.2 Shiga-toxigenic E. coli (STEC) O157 and the non-O157 STECs declared adulterants by FSIS, i.e. O26, O45, O103, O111, O126, and O145.

411.10 Test Methods – Microbiological tests will be done as described in the FSIS

MLG, Chapter 3, Quantitative Analysis of Bacteria in Foods as Sanitary Indicators or alternative Official Methods of Analysis of AOAC International (AOAC) described below:

411.10.1 For APCs, the acceptable methods are AOAC-OM 966.23 and 990.12 or as approved through the AMS alternative methods program.

411.10.2 For total coliforms and generic E. coli, the methods acceptable are AOAC-OM

966.24 (E. coli in foods MPN) and AOAC-OM 998.08 (3M Petrifilm™ E.

coli/Coliform Count Plate™) or as approved through the AMS alternative methods program.

411.11 Samples may be tested for Salmonella using screening tests as described in the FSIS MLG, Chapter 4C, FSIS Procedure for the Use of a Polymerase Chain Reaction (PCR) Assay for Screening Salmonella in Raw Meat, Carcass Sponge Samples, Whole Bird Rinses, Ready-to-Eat Meat and Poultry Products, and Pasteurized Egg Products. The isolation, purification, and identification steps of Salmonella testing will be completed as per the MLG, Chapter 4, Isolation and Identification of Salmonella from Meat, Poultry, and Egg Products (including Section 4.5.4 d-i and Section 4.6.1) or as approved through the AMS alternative methods program.

Date Revised: 06/13/21

411.12 Samples may be screened for E. coli O157:H7 using screening tests as described in the MLG, Chapter 5A, FSIS Procedure for the Use of Escherichia coli O157:H7 Screening Tests or as approved through the AMS alternative methods program. The ADL shall use the BAX® System PCR Assay for Screening E. coli O157:H7. In the event that the BAX® System equipment fails or BAX® E. coli O157:H7. Test kits are unavailable, the ADL must request permission from the AMS Contracting Officer to use the RapidCheck® for E.

coli O157 (including H7) Lateral Flow Assay with modified enrichment broth.

The RapidCheck® may be used (following the MLG instructions for preparation of sample test portions) until the BAX® System is available. The presence (cultural confirmation) of E. coli O157:H7 will be determined using the test method in the MLG, Chapter 5, Detection, Isolation, and Identification of Escherichia coli O157:H7 from Meat Products. The test method must comply with the MLG method, including the instructions for preparation of sample test portions, the specific procedures and devices specified for immunomagnetic separation, and procedures and systems for confirmatory testing.

411.13 Samples may be screened for non-O157 STECs using screening tests described in the MLG 5B at a frequency of one in every ten samples, selected at random by the ADL.

411.14 Test Results – The ADL shall record all results on spreadsheets and calculate the process capability (CPU) for indicator organism tests performed on production lots as outlined in the applicable FPPS.

411.15 For Salmonella and all STECs, the ADL shall record all results on spreadsheets. Positive and Negative results will be designated with a one (1) and zero (0), respectively. The central line (cl) value will also be documented for process capability.

411.16 The required records of test results for other AMS meat product contracts

(e.g., FPPS for Frozen Ground Bison) will be identified in the appropriate issued specification.

412 Reporting of Test Results – ADLs will simultaneously report results to AMS and the vendor. The ADL will notify FSIS when STEC results are presumptive positive and confirmed positive. The ADL will notify FSIS when Salmonella results are confirmed positive. ADLs will follow FSIS directions for submitting STEC and Salmonella purified confirmed cultures for further characterization by FSIS. FSIS directions for submitting samples will be supplied to the ADL by a representative of SSD/FSTB.

412.1 Reporting requirements for other AMS meat product contracts (e.g., FPPS for

Frozen Ground Bison) will be identified in the appropriate issued specification.

Date Revised: 06/13/21

413 Process Assessment Monitoring – The AMS vendor will notify SSD/FSTB of any change in process assessment status, and SSD/FSTB will direct the ADL regarding computation needs. The ADL must have knowledge of any status change associated with a vendor’s process assessment for AMS microbiological requirements.

420 FAT TESTING REQUIREMENTS – Ground Beef

421 Sample Preparation, Testing, and Test Results

421.1 Sample Preparation – AMS vendors will submit samples for fat testing to an

ADL selected under this solicitation in accordance with the requirements outlined in this SOW.

421.2 The ADL will be responsible for supplying sampling procedures in accordance with sample preparation specifications within the applicable AMS FPPS to each vendor for sample preparation and submission. The sampling procedure shall define sampling plans, sample size (weight), packaging and handling instructions, including handling of reserve samples, and procedures for submitting samples to the ADL.

421.3 The procedure for submitting samples shall require an ADL form to be completed by the AMS vendor and submitted as an official record with each sample. The form shall contain sample tracking information including, but not limited to, company name, contact person, contact information, lot number, pounds of product represented by sample, and production date.

421.4 The ADL will be responsible for supplying shipping supplies, including sampling bags and shipping materials, to each AMS vendor. Reserve samples shall not be analyzed without written consent of an FSCS Division representative.

421.5 Testing – Samples will be tested for fat content as specified within the applicable AMS FPPS. For AMS-contracted ground beef, the quantification requirements for target fat content, the upper and lower specification level limits, and sampling frequency are stated within the effective version of the FPPS-CGB and FPPS-GB. If other AMS meat product contracts (e.g., FPPS for Frozen Ground Bison) require fat testing on the finished product, the requirements will be provided in the applicable specification. All applicable specifications will be made available to the ADL by AMS.

421.6 Test Methods – The ADL will be required to test ground beef samples or other meat samples for fat content using test methods that conform to the Official Methods of Analysis of AOAC International (Chapter 39). Test methods used must be appropriate for the product matrix (meat and meat product) and test portion and fit for the intended purpose of the analysis.

Date Revised: 06/13/21

421.7 Test Results – The ADL shall record results on spreadsheets and will supply the SPC results to AMS and the vendor.

421.8 Fat testing results shall be reported in spreadsheets and complemented with the calculated process capability value (Cpk).

421.9 The required records of test results for other AMS meat product contracts

(e.g., FPPS for Frozen Ground Bison) will be identified in the appropriate specification.

422 Reporting of Test Results – ADLs will simultaneously report fat test results to both AMS and the vendor.

422.1 Reporting requirements for other AMS meat product contracts (e.g., FPPS for

Frozen Ground Bison) will be identified in the appropriate specification.

422.2 The ADL will supply a daily status report for each vendor that submits samples under the applicable purchase program to the Contracting Officer and other AMS personnel identified by the Contracting Officer. The report will identify if the process capability value (CPU/Cpk) is out of specification.

423 Process Assessment Monitoring – The ground beef contractor will notify the

FSCS Division of any change in process assessment status, and the FSCS Division will direct the ADL regarding computation needs. The ADL must have knowledge of any status change associated with a vendor’s process assessment for AMS fat limitation requirements.

430 DATA MANAGEMENT

431 All microbiological and fat testing data completed under contract from this solicitation are proprietary information of AMS and must be securely maintained and only reported as described in this SOW.

500 ADDITIONAL ADL INFORMATION TO BE ADDRESSED IN THE

TECHNICAL PROPOSAL

510 QUALITY ASSURANCE

511 The ADL must submit a time schedule under which it will operate for testing and reporting of submitted samples once received. The time schedule shall state time requirements for (1) negative, presumptive (as defined by FSIS), and confirmatory (positive) test results for microbes requiring presence-only reporting; (2) microbiological testing requiring quantification; and (3) fat limitation testing.

Date Revised: 06/13/21

512 The ADL must define the internal quality control validation process used to assure accurate testing and analysis and reporting of results.

520 PROXIMITY

521 Identify location(s) of the ADL(s) that will be used for the analysis of samples identified in this SOW.

530 ACCREDITATION

531 The ADL’s technical proposal shall include:

531.1 Documentation that the ADL and methods used by the ADL to perform testing for AMS Federal Purchase Program requirements are assessed for compliance with the quality system requirements of ISO/IEC 17025, General Requirements for the Competence of Calibration and Testing ADLs, assessed for technical competency to perform specific tests (including proficiency testing), and accredited by an accreditation body that is a signatory and in good standing with the Mutual Recognition Arrangement of the International ADL Accreditation Cooperation (ILAC). The accreditation body must have technical expertise in the fields of biological/microbiological and chemical testing of meat and meat products. The ADL’s scope of the accreditation must expressly include test methods in accordance with the requirements of this solicitation. ADLs shall stay current with their ISO/IEC 17025 accreditation and shall provide the AMS Contracting Officer with up-to-date documentation (Certificate of Accreditation and Scope of Accreditation) of their ISO/IEC 17025 accreditation.

531.2 The ADL shall also provide the Contracting Officer copies of any additional certifications granted by other internationally recognized accreditation and certification organizations.

540 CONFLICT OF INTEREST STATEMENT

541 The ADL’s technical proposal shall declare that the ADL has no financial or management affiliation with any company that is or may become involved in meat procurement contracts with AMS. In addition, if a conflict of interest develops after contract award, the contracted ADL must immediately notify the Contracting Officer for resolution, which could result in termination of the awarded contract.

550 PROGRAM REMOVAL OR SUSPENSION

551 Voluntary Removal – A laboratory may voluntarily remove itself from the program at any time by submitting a request to SSD/FSTB.

Date Revised: 06/13/21

552 Involuntary Removal or Scope Reduction – A laboratory may be involuntarily removed, or scope reduced from the approval program. SSD/FSTB will inform the laboratory through written communication with one of the following reasons, but may not be limited to:

552.1 Falsification of analytical results/records.

552.2 Failure to use methods and procedures approved by SSD/FSTB.

552.3 Failure to meet technical requirements.

552.4 Failure to maintain an acceptable performance level as indicated by

SSD/FSTB results and/or check samples.

552.5 Persistently failed to preform corrective actions in a timely manner and/or satisfactory response as described in this document.

553 Program Re-Entry

553.1 A laboratory involuntary removed from the program must wait, at least, three

(3) months before it can reapply for approval.

553.2 A laboratory that voluntary removed itself may reapply for approval at any time.

553.3 SSD/FSTB reserves the right to not allow a laboratory program re-entry depending on the circumstance for their removal.

600 COMPLAINT RESOLUTION/HISTORY

610 The ADL shall provide its complaint resolution policy and procedures.

700 ON-SITE CAPABILITY ASSESSMENT AND REPORT

710 PRE-PRODUCTION ON-SITE CAPABILITY ASSESSMENT

711 On-site Audit – After a contract has been awarded by the Contracting Officer and prior to the ADL conducting any work under the contract (i.e., receiving samples for testing), the ADL must complete a pre-production on-site capability assessment.

Date Revised: 06/13/21

712 The capability assessment consists of an on-site audit to determine the ADL’s ability to meet AMS requirements and the declarations made in the ADL’s approved technical proposal. The LP Program’s Quality Assessment (QA) Division will conduct the on-site assessment of the ADL’s facility, process, and internal quality control validation process. All costs associated with the on-site assessment will be paid by the ADL. The QA Division audit fees are available at www.ams.usda.gov/ARCAudits.

713 Any non-conformances that are identified during the audit must be corrected and approved by the Program Office and/or Contracting Officer. If the audit report finds that the contractor cannot perform as stated in the contractor’s technical proposal, the Contracting Officer reserves the right to terminate the contract.

714 Audit/Evaluation Criteria – The audit will include, but is not limited to, a thorough evaluation of the ADL facilities, equipment, and test methods and procedures referenced in the ADL’s technical proposal. The audit will also include a detailed review of training, A2LA reports, purchasing, receiving, production, internal quality control validation process, inventory and shipping records, and interviews with management and ADL personnel.

715 AMS reserves the right to evaluate additional quality control, quality assurance, and good ADL practices to ensure the ADL’s ability to meet and adequately perform AMS microbiological and fat testing requirements. AMS auditors will utilize applicable provisions within the AOAC International Guidelines for ADLs Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals; an Aid to Interpretation of ISO/IEC 17025:2005 to evaluate the additional criteria as needed.

716 Audit Report – The QA Division will provide an audit report to the FSCS

Division for distribution to the ADL.

720 ADL SCHEDULE – POST AWARD

721 If awarded a contract, the ADL is subject to periodic on-site audits. The routine frequency of audits will be on an annual basis. However, when deficiencies are detected, AMS may conduct an on-site audit at any time. The ADL must have its technical proposal and supporting documents readily available for review by AMS agents. The records may be maintained as hard copy or electronic media. However, records maintained as electronic media shall be made available in printed form upon request by AMS agents.

Date Revised: 06/13/21

730 CHANGES TO TECHNICAL PROPOSAL AND CONTRACT DEVIATIONS

731 Changes to an ADL’s technical proposal must be submitted based on the

FSCS Division’s or the Contracting Officer’s amendments or clarification request, on on-site capability assessment, or at the request of the AFDL.

Maintenance of the integrity and clarity of each technical proposal is critical.

Changes to an approved technical proposal must be submitted to the Contracting Officer for approval prior to implementation. All technical proposal revisions must meet the following criteria:

731.1 Any changes to a technical proposal made by the ADL after its initial submittal shall be accomplished by submitting replacement pages or an entire technical proposal package. A cover letter must be submitted with the changes identified and an explanation of the need for the change. The ADL shall include the revision date and the appropriate page number(s).

731.2 Changes must be submitted in the same number of copies as the initial technical proposal and must have the same information provided electronically. The revised electronic PDF format should contain only the pages that are being changed. Additional pages should be numbered using a page number suffix (e.g., 1.1, 1.2, 1.a., 1.b).

731.3 The ADL should submit changes to the technical proposal as a complete page change for each page on which a change occurs. Changes in text shall be highlighted, and deletions shall be identified through strikeout text.

731.4 Revisions to the approved technical proposal may be submitted electronically in PDF format in an e-mail provided to both the applicable FSCS Division personnel and the Contracting Officer.

732 Any deviations to contractual requirements will be immediately reported to the applicable FSCS Division personnel and to the Contracting Officer. The Contracting Officer will notify the ADL regarding continued eligibility to be an AMS-designated ADL.

Date Revised: 06/13/21

740 RESPONDING TO NONCONFORMANCES AND ADL ERRORS

741 The ADL must submit a time schedule under which the ADL will operate for responding to audit nonconformance and identified ADL errors.

742 All nonconformances must be addressed, including those found through pre-production and post-award on-site assessments (audits) and through deviations (ADL errors) from the procedures within the ADL’s technical proposal. The ADL must submit the internal process used to conduct an acceptable root-cause analysis of the nonconformance. The ADL must submit appropriate and sufficient corrective and preventative actions along with documentation demonstrating the implementation of the corrective and preventative actions.

Approved by_____CMS

Date Revised: 06/04/15 13

APPENDIX A

DATA ENTRY AND PROCESS CAPABILITY VALUES

Data Entry The ADL will record microbiological and fat test results on spreadsheets and have those spreadsheets readily available to AMS and its vendors. Quantitative (plate count) results will be expressed as colony forming units (CFU) per gram or per ml reflecting the original sample measurement. Test results will be entered as a whole number (i.e., no decimal places, no preceding “<” (less than) symbol). Qualitative results for E. coli O157:H7, each of the non-O157 STEC serotypes, and Salmonella will be recorded as a 1 for a positive result and as a 0 for a negative result.

The ADL will provide the calculated process capability values (CPU, Cpk, and Cl) in the spreadsheets so that the vendor’s process capability assessment can be determined, as described in APPENDIX B.

Process Capability Values – CPU or Cpk

The process capability value (CPU or Cpk) is calculated by the ADL. CPU will be used for microbiological tests and for Beef Patties – 90/10 fat tests since these requirements only have an upper specification limit. Cpk will be used for fat testing requirements that have an upper and lower specification limit (see section 3.5). The upper specification limits (USL) for microbiological requirements will be found in

APPENDIX B. The calculations for CPU and Cpk are as follows:

Calculation of process capability (CPU) with an upper specification limit only

Step 1. The first calculation will determine the Z-value (upper):

Z-value (upper) = (USL – Process Average) / Standard Deviation

Step 2. The Z-value divided by 3 will calculate the CPU:

CPU = Z-value (upper) / 3

Calculation of process capability (Cpk) with an upper and lower specification limit

Step 1. The first set of calculations will determine the smaller value of the two Z-values (upper or lower):

Z-value (upper) = (USL – Process Average) /

Z-value (lower) = (Process Average – LSL) /

Step 2. The smaller of the two Z-values (upper or lower) divided by 3 will calculate the Cpk.

CPU = Z-value (smaller value of the upper or lower) / 3

Process Capability Value – Cl The central line (Cl; x-bar) is the process average or arithmetic mean that indicates the incidence of positive E. coli O157:H7 and Salmonella results. Results from non-O157 STECs are not used to calculate process capability.

Date Revised: 06/13/21

APPENDIX B

Example Data Spreadsheet

The headings listed within the sample data spreadsheets below reflect the minimum amount of information (variables) needed by AMS to conduct program analysis. For data management purposes, the ADL is encouraged to insert other headings, including but not limited to, Lab ID and testing time. Further guidance for the reporting of microbiological and fat test results in spreadsheets and comma separated values (CSV) is discussed in the ADL Instructions for Reporting Test Results document (current version).

Microbial Results Spreadsheets – Do not enter values with the “<” sign. For presence-only organisms (Salmonella and E. coli O157:H7), enter “1” for positive and “0” for negative results. For data entry purposes, when microbial test results are presented with “<” (less than) symbols preceding the values, the value to be entered will be the number minus one (i.e., “<10” will be entered as “9”; “<2500” will be entered as “2499”).

Microbial Results Spreadsheet - example

Fat Results Spreadsheet - example

Name Production

Date Production Lot

Number

TCC

Generic E-Coli

Salmonella APC E. coli

O157:H7 Company A 7/12/2004 73361204 9 9 0 999 0

Company A 7/13/2004 73361304 9 9 0 999 0

Company B 7/14/2004 6063A4196 9 9 1 2500 0

Company A 7/14/2004 73361404 9 9 0 999 0

Company B 7/15/2004 6063A4197 9 9 0 999 0

Company A 7/15/2004 73361504 9 9 0 999 0

Company B 7/16/2004 6063A4198 9 9 0 27000 0

Company A 7/16/2004 73361604 9 9 0 999 0

Company B 7/19/2004 6063A4201 9 9 0 999 0

Company C 7/19/2004 001 9 9 0 27000 0

Company D 7/19/2004 201 100 9 0 999 0

Company Name Product

Code Production

Date

Percent Fat

Sample 1

Percent Fat

Sample 2

Percent Fat

Sample 3

Percent Fat

Sample 4 Average

Fat Company A A 608 8/4/2004 17.80 15.98 15.94 14.85 16.14 Company A A 608 8/9/2004 15.59 12.62 16.85 13.69 14.69 Company A A 608 8/11/2004 12.46 15.03 13.02 15.71 14.06 Company B A 608 8/16/2004 15.53 16.01 15.04 14.22 15.20 Company A A 608 8/17/2004 14.85 16.28 18.29 14.26 15.92 Company A A 608 8/17/2004 13.00 12.93 14.18 14.98 13.77 Company C A 608 8/18/2004 13.52 15.01 16.50 15.17 15.05 Company A A 608 8/19/2004 14.83 13.64 12.56 14.18 13.80

APPROVED

INSTRUCTIONS FOR THE

NOTIFICATION OF PATHOGEN

TEST RESULTS BY E-MAIL TO

AMS, AMS VENDORS, AND FSIS

Agricultural Marketing Service (AMS) Livestock and Poultry (LP) Program

Standards and Specification Division (SSD) Room 3932 S, STOP 0258

Phone: (202) 690-3148

Supersedes document version dated February 2018 – changes noted in blue

Effective: April 2021

Approved by _ DBJ Date Issued: 02/08/18 Date Revised: 04/01/21

100 Overview

110 The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) procures a variety of meat and fish products that are distributed to participants in the National School Lunch Program (NSLP) and other Federal food and nutrition assistance programs. Products destined for distribution through USDA must meet product-specific microbiological testing requirements in addition to fat content requirements. The need for timely and accurate laboratory sample results and analysis of the results is critical to AMS, AMS’ vendors, and the health and safety of those eating the meat and fish products distributed through USDA. AMS enters into service contracts with laboratories to conduct the required microbiological and fat testing, to analyze data, and to report results and summaries of the data.

120 This instruction is applicable to the AMS Designated Laboratories (ADL) that provide microbiological and fat testing and analysis for Federal food and nutrition assistance programs.

200 Scope

210 The ADL are required by contract (Statement of Work) to simultaneously report results to both AMS and the AMS vendor. The ADL is also required to notify FSIS of presumptive positive E.

coli O157:H7 tests and the subsequent confirmation results and confirmed positive Salmonella tests.

220 This document contains the instructions for ADL to follow to notify AMS, AMS vendors and FSIS of pathogen results. This document contains the list of AMS personnel, FSIS (headquarters) personnel and FSIS District Offices that results are to be sent to and the information that is to be included in the email.

300 Reference Documents

APPENDIX C

Approved by DBJ Date Issued: 02/08/18

Date Revised: 04/01/21 2

310 Technical Requirements Statement of Work for Microbiological and Fat Testing and Analysis to Support USDA Meat Purchase Programs can be found at:

https://www.ams.usda.gov/selling-food/product-specs#Beef

Microbial Test USL Critical Limits

Standard Plate Count 50,000/gram 100,000/gram

Total Coliforms 200/gram 1,000/gram

E.Coli 100/gram 500/gram

Salmonella Positive (+) results/25 grams

E. Coli 0157:H7 Positive (+) results/325 grams

400 Information Flow to Stakeholders https://www.ams.usda.gov/selling-food/product-specs#Beef

Date Revised: 04/01/21 3

410 FSIS District Office Notification Emails for E. coli O157:H7 Presumptive Positive and Confirmed Results ONLY

Company Est. Number City State FSIS District

FSIS District Emails

AFG-Cimpl Meat Co M2460-P2460 Yankton SD 25 FODO25BITES@fsis.usda.gov

AFG-Gibbon Packing M5511 Gibbon NE 15 FODO15BITES@fsis.usda.gov

AFG-Green Bay M410 Green Bay WI 25 FODO25BITES@fsis.usda.gov

AFG-Green Bay M18076 Green Bay WI 25 FODO25BITES@fsis.usda.gov

AFG-Long Prairie Packing M253 Long Prairie MN 25 FODO25BITES@fsis.usda.gov

AFG-Skylark Meats M4215-P4215 Omaha NE 15 FODO15BITES@fsis.usda.gov

American Beef Packers M34741 Chino CA 5 FODO05BITES@fsis.usda.gov

American Custom Meats M44189 Tracy CA 5 FODO05BITES@fsis.usda.gov

Beef Products Inc. M19872-P19872 S. Sioux City IA 25 FODO25BITES@fsis.usda.gov

Best Chicago Meats M1791-P27353 Chicago IL 50 FODO50BITES@fsis.usda.gov

Cargill Meat Solutions M86R Fort Morgan CO 15 FODO15BITES@fsis.usda.gov

Cargill Meat Solutions M354 Fresno CA 5 FODO05BITES@fsis.usda.gov

Cargill Meat Solutions M86C Columbus NE 15 FODO15BITES@fsis.usda.gov

Cargill Meat Solutions M31913 Fresno CA 5 FODO05BITES@fsis.usda.gov

Caviness Beef Packers M675 Hereford TX 40 FODO40BITES@fsis.usda.gov

Central Valley Meat M6063A Hanford CA 5 FODO05BITES@fsis.usda.gov

Cherry Meat Packers M24-P18217 Chicago IL 50 FODO50BITES@fsis.usda.gov

Chicago Meat Authority M1957-1957A Chicago IL 50 FODO50BITES@fsis.usda.gov

CS Beef Packers M630 Kuna ID 15 FODO15BITES@fsis.usda.gov

FM Meat Products M45261 Fort McCoy FL 85 FODO85BITES@fsis.usda.gov

Harris Ranch Beef M783-P783 Selma CA 5 FODO05BITES@fsis.usda.gov

Ida Beef M45948 Burley ID 15 FODO15BITES@fsis.usda.gov

Jancorp (Criss Cross) M27260 Rantol IL 50 FODO50BITES@fsis.usda.gov

JBS Tolleson M267 Tolleson AZ 5 FODO05BITES@fsis.usda.gov

Jenson Meat Co. M1899 San Diego CA 5 FODO05BITES@fsis.usda.gov

Manning Beef M934 Pico Rivera CA 5 FODO05BITES@fsis.usda.gov

National Beef M262 Dodge City KS 35 FODO35BITES@fsis.usda.gov

National Beef M208A Liberal KS 35 FODO35BITES@fsis.usda.gov

Native American Enterprises

M5541A-P5541A Wichita KS 35 FODO35BITES@fsis.usda.gov

Palo Duro M7282 Amarillo TX 40 FODO40BITES@fsis.usda.gov

APPENDIX C

mailto:FODO25BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO25BITES@fsis.usda.gov mailto:FODO25BITES@fsis.usda.gov mailto:FODO25BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO25BITES@fsis.usda.gov mailto:FODO50BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO40BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO50BITES@fsis.usda.gov mailto:FODO50BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO85BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO50BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO05BITES@fsis.usda.gov mailto:FODO35BITES@fsis.usda.gov mailto:FODO35BITES@fsis.usda.gov mailto:FODO35BITES@fsis.usda.gov mailto:FODO40BITES@fsis.usda.gov

Date Revised: 04/01/21 4

Sterling Meat Co M550-P18178 Commerce CA 5 FODO05BITES@fsis.usda.gov

Swift Beef Co M532 Omaha NE 15 FODO15BITES@fsis.usda.gov

T&W Meat Co M34377 Kingman KS 35 FODO35BITES@fsis.usda.gov

Tyson Fresh Meats M245C Dakota City NE 15 FODO15BITES@fsis.usda.gov

VPP Group M1361 Norwalk WI 25 FODO25BITES@fsis.usda.gov

500 Instructions for Submission via E-mail format

510 When reporting pathogen results for boneless beef, the email content should be in the following format:

511 Subject line: Indicate the result (Potential Positive or Presumptive Positive or Confirmed Positive/Confirmed Negative), the pathogen test (E. coli O157:H7 or Salmonella), and the company name, including establishment number

Body of Email: (The information in the right-hand column is only intended as an example.)

AMS Action (list action if needed) No, Notification only

Pathogen Tested E. coli O157:H7

Test Status – Potential Positive, Presumptive Positive or Confirmed Positive/NegativeSample ID FSN13-000736-001

EST # M410

LOT # 5903000200010 ABC

Production Date 01/02/13

Product (Commodity) Type (i.e., material description)

Boneless Beef

Name of Contractor (Grinder) Supplier Name

520 When reporting pathogen results for finished product, the email content should be in the following format:

521 Subject line: Indicate the result (Potential Positive or Presumptive Positive or Confirmed Positive/Confirmed Negative), the pathogen test (E. coli O157:H7 or Salmonella), and the company name, including establishment number

Body of Email: (The information in the right-hand column is only intended as an example.)

AMS Action (list action if needed) No, Notification Only

Pathogen Tested E. coli O157:H7

Test Status – Potential Positive, Presumptive Positive or Confirmed Positive/Negative

APPENDIX C

mailto:FODO05BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO35BITES@fsis.usda.gov mailto:FODO15BITES@fsis.usda.gov mailto:FODO25BITES@fsis.usda.gov

Date Revised: 04/01/21 5

Sample ID SIL13336887631

EST # M27260

LOT # 002

Production Date 01/02/13

Material Code 100154

Product (Commodity) Type (i.e., material description)

Course ground beef

# pounds Produced 9960

Sub Lot # 1

Name of Contactor Name

600 The AMS Designated Laboratory shall submit the email as designated by the informational flow chat to the following individuals:

AMS Microbiological Notification Contacts

FSIS Microbiological Notification Contacts

Office of Investigation and Enforcement OIEA [previously OPPEER]

Carl Mayes Carl.Mayes@usda.gov OIEA

Carl-Martin Ruiz Carl-Martin.Ruiz@usda.gov OIEA

Mark Crowe Mark.Crowe@usda.gov OIEA

Robertson, Randy Randy.Robertson@usda.gov OIEA

AMS Contact AMS contact e-mail address Program Area Darin Doerscher Darin.Doerscher@usda.gov FSTB

Terry Lutz Terry.Lutz@usda.gov FSTB

Mike Lopez mike.lopez@usda.gov ASB

Angelia Gale angelia.gale@usda.gov FSTB

Steve Whisenant Steve.Whisenant@usda.gov FSTB

William Stone William.Stone@usda.gov

FSTB

Martin Friesenhahn Martin.friesenhahn@usda.gov ASB mailto:Carl.Mayes@usda.gov mailto:Carl-Martin.Ruiz@usda.gov mailto:Mark.Crowe@usda.gov mailto:Randy.Robertson@usda.gov mailto:Darin.Doerscher@usda.gov mailto:Terry.Lutz@usda.gov mailto:mike.lopez@usda.gov mailto:angelia.gale@usda.gov mailto:Steve.Whisenant@usda.gov mailto:William.Stone@usda.gov mailto:Martin.friesenhahn@usda.gov

Date Revised: 04/01/21 6

Office of Data Integration and Food Protection

Greenwell, Nathan Nathan.Greenwell@usda.gov ODIFP

Clinch, Nelson Nelson.Clinch@usda.gov ODIFP

Izsak, Yoel Yoel.Izsak@usda.gov ODIFP

Zamora, Dee Dee.Zamora@usda.gov ODIFP

Crockett, Jackson Jackson.Crockett@usda.gov ODIFP

Alvares, Christopher Christopher.Alvares@usda.gov ODIFP

Clinch, Nelson Nelson.Clinch@usda.gov ODIFP

Mah, Kim MingYiKim.Mah@usda.gov ODIFP

Berg-Devney, Sarah Sarah.Berg-Devney@usda.gov ODIFP

Office of Field Operations

Reed, Jeremy “Todd” Jeremy.Reed@usda.gov OA

Michael Watts Michael.Watts@usda.gov OFO

Will Gillingwater Will.Gillingwater@usda.gov OFO

RMTAD FORECALLS@usda.gov OFO

Sidrak, Hany Hany.Sidrak@usda.gov OFO

Smith, William William.Smith@usda.gov OFO

APPENDIX C

mailto:Nathan.Greenwell@usda.gov mailto:Nelson.Clinch@usda.gov mailto:Yoel.Izsak@usda.gov mailto:Dee.Zamora@usda.gov mailto:Jackson.Crockett@usda.gov mailto:Christopher.Alvares@fsis.usda.gov mailto:Alvares@usda.gov mailto:Nelson.Clinch@usda.gov mailto:MingYiKim.Mah@usda.gov mailto:Sarah.Berg-Devney@usda.gov mailto:Jeremy.Reed@fsis.usda.gov mailto:y.Reed@usda.gov mailto:Michael.Watts@usda.gov mailto:Will.Gillingwater@usda.gov mailto:FORECALLS@usda.gov mailto:Hany.Sidrak@usda.gov mailto:William.Smith@usda.gov

Date Revised: 04/01/21 7

FSIS Office of Policy & Program Development

Arrington, Isabel Isabel.Arrington@usda.gov OPPD

Arnold, Ilene Ilene.Arnold@usda.gov OPPD

Roberta Wagner Roberta.Wagner@usda.gov OPPD

Linville, John John.Linville@usda.gov OPPD

Silverman, Meryl Meryl.Silverman@usda.gov OPPD

McGinn, Janet Janet.McGinn@usda.gov OPPD

Rockwell, Catherine Catherine.Rockwell@usda.gov OPPD

Seebohm, Scott Scott.Seebohm@usda.gov OPPD

Webb, Jennifer Jennifer.Webb@usda.gov OPPD

Shaw, William William.Shaw@usda.gov OPPD

Taylor, Teresa Teresa.Taylor@usda.gov OPPD

Tohamy, Soumaya Soumaya.Tohamy@usda.gov OPPD

Robinson, Hazel Hazel.Robinson@usda.gov OPPD

Wilkus, James James.Wilkus@usda.gov OPPD

Office of Public Health Science

Buchanan, Stephanie Stephanie.Buchanan@usda.gov OPHS

Cook, Victor Victor.Cook@usda.gov OPHS

Cray, William William.Cray@usda.gov OPHS

Gardner, Myra Myra.Gardner@usda.gov OPHS

Layton, Randal Randal.Layton@usda.gov OPHS

Narang, Neelam Neelam.Narang@usda.gov OPHS mailto:Isabel.Arrington@usda.gov mailto:Ilene.Arnold@usda.gov mailto:Roberta.Wagner@usda.gov mailto:John.Linville@usda.gov mailto:Meryl.Silverman@fsis.usda.gov mailto:n@usda.gov mailto:Janet.McGinn@usda.gov mailto:Catherine.Rockwell@usda.gov mailto:Scott.Seebohm@usda.gov mailto:Jennifer.Webb@fsis.usda.gov mailto:bb@usda.gov mailto:William.Shaw@fsis.usda.gov mailto:Shaw@usda.gov mailto:Teresa.Taylor@usda.gov mailto:Soumaya.Tohamy@usda.gov mailto:Hazel.Robinson@fsis.usda.gov mailto:on@usda.gov mailto:James.Wilkus@fsis.usda.gov mailto:ilkus@usda.gov mailto:Stephanie.Buchanan@usda.gov mailto:Victor.Cook@usda.gov mailto:William.Cray@usda.gov mailto:Myra.Gardner@usda.gov mailto:Randal.Layton@usda.gov mailto:Neelam.Narang@fsis.usda.gov mailto:ang@usda.gov