ALP_RFI_2019.pdf

United States Department of Agriculture

Food Safety and Inspection Service

Request for Information

Expanding the Accredited Laboratory Program

(ALP)

Accredited Laboratory Program

Request for Information 2

1.0 DESCRIPTION

1.1 Food product testing is commonly performed by manufacturers to support the safety and suitability of their products. Testing often includes microbiological analyses for pathogens and indicator organisms, as well as chemical analyses for antimicrobial residues and food chemistry attributes such as moisture, protein, fat, and salt content. FSIS-regulated establishments perform testing (or contract with an outside laboratory) to fulfill specific regulatory requirements for testing and also as part of their required Hazard Analysis and

Critical Control Point (HACCP) food safety systems. Results of testing can be used as part of on-going verification of the HACCP plan and to support decisions in the establishment’s hazard analysis including prerequisite programs such as sanitation programs. Finally, FSIS-regulated establishments use testing to comply with a customer’s purchase specifications or requirements. Ultimately it is the responsibility of the regulated establishment to ensure that testing meets its needs and that results are accurate and reliable.

The Agency recognizes that it can be challenging for establishments, especially small and very small establishments, to make decisions about which analytical methods and laboratories to use in order to satisfy regulatory and customer needs.

1.2 The purpose of this Request for Information is to obtain feedback from interested parties, particularly FSIS regulated establishments and commercial laboratories, on what should be included in an expanded ALP. FSIS is interested in getting feedback on what food matrices and testing analytes an expanded ALP should include to gain the greatest participation as well as other feedback on the administration of the ALP. FSIS is also requesting feedback on logistics related to receiving and managing data associated with allowing pathogen and process control testing results from establishments to be included in FSIS databases from laboratories that meet the ALP accreditation requirements. Please keep in mind that only sample matrices derived from products that fall under the jurisdiction of FSIS may be considered for comment.

This request for information does not commit the Government to contract for any supply or service whatsoever. Further, the Government is not at this time seeking proposals and will not accept unsolicited proposals. The RFI respondees are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it will be synopsized on the Federal Business

Opportunities (FedBizOpps) website: https://www.fbo.gov and the GSA E-Commerce Central website:

http://www.gsa.gov. It is the responsibility of the potential offerors to monitor these sites for additional information pertaining to this requirement.

2.0 BACKGROUND

Currently FSIS administers an Accredited Laboratory Program (ALP) that accredits commercial analytical laboratories to analyze meat and poultry for moisture, protein, fat, and salt content as well as a small number of chemical residues including chlorinated hydrocarbons, polychlorinated biphenyls, sulfonamides, nitrosamines, and arsenic. The voluntary program is completely supported by user fees. The goal of the program is to ensure accurate and reliable results to enhance food safety. Although the ALP program is presently relatively small with a limited number of analytes, the program has great benefits for the laboratories who gain accreditation. ALP accreditation provides formal recognition to competent laboratories that customers such as FSIS regulated establishments can use to identify reliable laboratories for their testing

Request for Information 3 needs. ALP is recognized by all Federal and State government agencies dealing with meat and poultry inspection as well as some foreign countries. The ALP works by laboratories applying for accreditation, undergoing an initial review process by FSIS, followed by regularly scheduled review audits and proficiency check sample testing based on FSIS method expectations. The ALP is both an ISO 17043 proficiency testing provider and is ISO 17034 reference material producer certified and therefore laboratories can obtain routine proficiency testing by being a member. In addition, the ALP conducts technical support conference calls as a forum for participating laboratories to discuss analytical issues.

3.0 VISION

FSIS believes that adding ALP accreditations for laboratory activities already being performed by regulated establishments, such as foodborne pathogen testing, would fit well with the proposed ALP expansion. The

Agency sees opportunities to modernize the ALP and provide greater assistance (i) to the regulated industry by expanding the ALP to include more analytes and (ii) to commercial laboratories that can perform accurate and reliable testing that regulated industry can depend on to make supportable decisions for the safety and suitability of their products. FSIS intends to perform rulemaking to propose expanding the scope of the ALP and provide greater flexibility in the analyte accreditation offerings since current regulatory language limits the analytes the ALP can offer for accreditation.

The ALP is a logical choice to perform evaluations of laboratories producing establishment results for conformance to FSIS standards. FSIS is proposing to expand the ALP to include accreditation for the first time in microbiology to include pathogens and indicators, as well as expanding the chemistry offerings for additional veterinary drugs and other chemical residues of interest. Additional matrices including pasteurized egg products and Siluriformes fish could be considered. Furthermore, FSIS envisions that expansion to microbiological analytes could provide the opportunity for establishments to submit to FSIS pathogen and process control test results from ALP accredited labs of tests already performed routinely by establishments. This could be a benefit to establishments who are verifying corrective actions or low volume producers who get sampled by FSIS at a lower frequency and want to provide additional data for process control categorization that FSIS publishes. These test results may be included in FSIS databases for agency consideration in compliance decisions as well as for future inspection resource allocations. Data integration and integrity would be key requirements with this type of data sharing system therefore the agency is seeking feedback from interested parties.

A vibrant and expanded ALP would allow FSIS to respond to those interested in FSIS integrating both FSIS and external testing data as discussed in the response to comments section of a February 11, 2016 Federal

Register Notice where FSIS announced new performance standards for Salmonella and Campylobacter in not-ready-to-eat comminuted chicken and turkey products and raw chicken parts while ensuring the testing data submitted is accurate and reliable.

4.0 REQUESTED INFORMATION

4.1 FSIS would greatly appreciate participation in this Request for Information and respondents are not required to answer all questions for the information provided to be considered.

What Is Your Vision For The Alp?

Request for Information 4

1. The ALP is examining additional microbiological and chemical analytes to include for new accreditations such as penicillin G in meat and foodborne pathogens such as Salmonella in egg products.

What other new accreditation offerings (food matrix/analyte pairs) would you like to see?

2. Is there any interest in multi-residue analyte accreditations (including specific tests or fields of tests)?

3. Is there any interest in proficiency testing to support screening (presence or absence) without confirmations, for either chemical or microbiological testing? Please identify specific areas of testing.

4. Is there any interest in proficiency testing to support confirmation testing for microbiological analytes? Please identify specific areas of testing.

5. Do you have any suggestions for improving the existing proficiency testing sample process?

6. In addition to meat and poultry product proficiency testing, do you believe that adding pasteurized egg products as a matrix is beneficial?

7. Do you believe that adding Ready-To-Eat products as a matrix is beneficial?

8. Would proficiency testing in fish of the order Siluriformes (catfish) be helpful to participating laboratories?

9. Do you have any other general feedback or information for the ALP?

How Should We Shape The Data System?

10. Would your facility like to share your in-house testing data for inclusion in FSIS databases? Why or why not?

11. Would your facility like to share your in-house testing data to be used in making inspection verification decisions such as published process control categorization? Why or why not?

12. What technical information technology capabilities does your laboratory have to share data?

13. How would you envision the process of data sharing to occur?

14. What is the overall scope of the sample demographic information and testing data that you gather?

15. How should FSIS use any submitted ALP derived testing data from industry?

16. How do you envision the relationship between industry/laboratory and FSIS data systems?

17. Do you have any other feedback or concerns about sharing testing data?

What’s In It for My Establishment or Laboratory?

18. What benefits to your establishment or laboratory can you anticipate from ALP membership?

19. What would your facility like to see back from FSIS for participating in an updated ALP?

Request for Information 5

20. What type of analytical reports would you like to be available from FSIS data systems?

21. What benefits do you see from a relationship between your industry and the FSIS ALP?

22. Do you have any other feedback concerning the relationship between your establishment and the

FSIS ALP?

5.0 RESPONSES

5.1 RFI Response. The RFI response should be in Microsoft Word for Office 365 compatible format and due NLT May 6, 2019, 1600 EST. The response is limited to 5 single-sided pages and submitted via e-mail only to the Government Point of Contract (POC): Tracy Pope, Contract Officer, tracy.pope@usda.gov.

Proprietary information, if any, should be kept to minimum and MUST BE CLEARLY MARKED. Please be advised that all submissions become Government property and will not be returned. If any respondee does not currently have a Proprietary Data Protection Agreement (PDPA) that would permit the Government’s personnel to review and evaluate the submitted in response to this RFI, the respondee should request to sign

PDPAs with the Government.

5.2 Company Information. The RFI response should provide the following information:

1. Company Information. Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated point of contact.

2. Government Software Development Contractual Vehicle Information. Identify the Government service contract vehicle that services can be provided for OPHS and the recommended contracting strategy.

3. Proprietary Information. Identify and handle of respondee’s company proprietary information should include either: 1) Copies of executed NDAs with the Government or 2) A statement stating the respondee will not allow the Government to release its proprietary data for the RFI response evaluation.

6.0 MEETING AND DISCUSSIONS

The Government representatives may or may not choose to meet with potential RFI service provider. Such meetings and discussions would only be intended to get further clarification of potential capability, especially any development and certification risks.

7.0 QUESTIONS

Questions and the response regarding this RFI should be submitted in writing by e-mail to the FSIS Contracting

Representative, Ms. Tracy Pope, tracy.pope@usda.gov , due NLT April 22, 2019, 1600 EST. responses should be posted to the questions not later than April 29, 2019.

8.0 SUMMARY

This RFI is only intended for the Government to identify sources that can provide feedback, particularly FSIS regulated establishments and commercial laboratories, on what should be included in an expanded ALP. The information provided in this RFI is subject to change and is not binding to the Government. The Government has not made a commitment to procure any of the RFI requirements discussed, and release of this RFI should mailto:tracy.pope@usda.gov

Request for Information 6 not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned.