Micro December 2018

AOAC EXPERT REVIEW PANEL MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES

THURSDAY, DECEMBER 6, 2018 ROCKVILLE, MARYLAND USA

AOAC INTERNATIONAL OFFICIAL METHODS OF ANALYSIS SM (OMA) PROGRAM

The Official Methods of Analysis SM (OMA) program is AOAC INTERNATIONAL's premier methods program. The program evaluates chemistry, microbiology, and molecular biology methods. It also evaluates traditional benchtop methods, instrumental methods, and proprietary, commercial, and/or alternative methods. In 2011, AOAC augmented the Official Methods SM program by including an approach to First Action Official Methods SM status that relies on gathering the experts to develop voluntary consensus standards, followed by collective expert judgment of methods using the adopted standards. All methods in the AOAC Official Methods SM program are now reviewed by Expert Review Panels for First Action AOAC Official Methods of Analysis SM status, continuance, repeal, and/or to recommend for AOAC Final Action Official Methods status. The OMA program has undergone a series of transitions in support of AOAC's collaborations, evolving technology, and evolving technical requirements. Methods approved in this program have undergone rigorous scientific and systematic scrutiny such that analytical results by methods in the Official Methods of Analysis of AOAC INTERNATIONAL are deemed to be highly credible and defensible. The methods are published in the Official Methods of Analysis of AOAC INTERNATIONAL and supporting manuscripts are published in the Journal of AOAC INTERNATIONAL . AOAC Official Methods SM program allows for submissions for all proprietary, single and sole source methods. Methods submitted through the PTM-OMA harmonized process also will be reviewed through the O fficial Methods of Analysis SM (OMA) program. Other complementary products and services include expanded consulting services for validation protocol development and AOAC INTERNATIONAL Organizational Affiliate Membership.

AOAC INTERNATIONAL 2275 Research Blvd, Suite 300 Rockville, Maryland 20850 Phone: (301) 924-7077

AOAC INTERNATIONAL ● 2275 RESEARCH BLVD, SUITE 300 ● ROCKVILLE, MARYLAND 20850 USA

EXPERT REVIEW PANEL (ERP) FOR MICROBIOLOGY FOR FOOD AND ENVIRONMENTAL SURFACES EXPERT REVIEW PANEL CO-CHAIRS: WENDY MCMAHON, SILLIKER, INC. AND MICHAEL BRODSKY, BRODSKY CONSULTANTS

THURSDAY, DECEMBER 6, 2018 8:30 AM EST - 12:00PM EST MEETING ROOM: AOAC INTERNATIONAL BOARDROOM

I.

WELCOME AND INTRODUCTIONS Expert Review Panel Co-Chairs

II. REVIEW OF AOAC VOLUNTEER POLICIES & EXPERT REVIEW PANEL PROCESS OVERVIEW AND GUIDELINES Deborah McKenzie, Senior Director, Standards Development, AOAC INTERNATIONAL

III.

REVIEW OF METHODS FOR AOAC FIRST ACTION OFFICAL METHODS STATUS For each method, the ERP members will present a review of the proposed collaborative study manuscript, after which the ERP will discuss the method and render a decision on the status for each method. 1) OMAMAN-46: EVALUATION OF THE 3M™ PETRIFILM™ RAPID E. COLI /COLIFORM COUNT PLATE FOR THE ENUMERATION OF E. COLI AND COLIFORM: COLLABORATIVE STUDY Study Directors: Hannah Bakken, 3M Food Safety, 3M Center, Building 260-06-B-01, St. Paul, MN 55144 ERP will discuss, review and track First Action methods for 2 years after adoption, review any additional information (i.e., additional collaborative study data, proficiency testing, and other feedback) and make recommendations to the Official Methods Board regarding Final Action status. 1) OMA 2016.01: SALMONELLA SPP. IN SELECT FOODS AND ENVIRONMENTAL SURFACES 3M™ Molecular Detection Assay (MDA) 2–Salmonella Method Study Directors: Lisa Monteroso, 3M Food Safety, 3M Center, Building 260-06-B-01, St. Paul, MN 55144 2) OMA 2016.07: DETECTION OF LISTERIA SPECIES IN SELECT FOODS AND ENVIRONMENTAL SURFACES 3M™ Molecular Detection Assay (MDA) 2-Listeria Method Study Directors: Lisa Monteroso, 3M Food Safety, 3M Center, Building 260-06-B-01, St. Paul, MN 55144 3) OMA 2016.08: LISTERIA MONOCYTOGENES IN A VARIETY OF FOODS AND SELECT ENVIRONMENTAL SURFACES 3M™ Molecular Detection Assay (MDA) 2-Listeria Monocytogenes Method Study Directors: Lisa Monteroso, 3M Food Safety, 3M Center, Building 260-06-B-01, St. Paul, MN 55144

IV. DISCUSS FINAL ACTION REQUIREMENTS FOR FIRST ACTION OFFICIAL METHODS (IF APPLICABLE )

V.

DISCUSS UPCOMING MEETINGS AND VOLUNTEER ROLES

VI.

ADJOURNMENT

Page 1 of 1

Official Methods of Analysis SM (OMA) Expert Review Panel MEETING AND METHOD REVIEW GUIDANCE

The AOAC Research Institute administers AOAC INTERNATIONAL's premier methods program, the AOAC Official Methods of Analysis SM (OMA). The program evaluates chemistry, microbiology, and molecular biology methods. It also evaluates traditional benchtop methods, instrumental methods, and proprietary, commercial, and/or alternative methods and relies on gathering the experts to develop voluntary consensus standards, followed by collective expert judgment of methods using the adopted standards. The Official Methods of Analysis of AOAC INTERNATIONAL is deemed to be highly credible and defensible. All Expert Review Panel (ERP) members are vetted by the AOAC Official Methods Board (OMB) and serve at the pleasure of the President of AOAC INTERNATIONAL. In accordance to the AOAC Expert Review Panel Member and Chair Volunteer Role Description all Expert Review Panel members are expected to 1) serve with the highest integrity, 2) perform duties and method reviews, and 3) adhere to review timelines and deadlines.

To assist the ERP Chair and its members, please note the following in preparation for Expert Review Panel meetings and method reviews.

Pre-Meeting Requirements 1. Confirm availability and plan to be present to ensure a quorum of the ERP.

(Please refer to page 25, Quorum Guidelines, Expert Review Panel Information Packet ) 2. Ensure that your laptop, CPU or mobile device can access online web documentation. 3. Be prepared for the meeting by reviewing all relevant meeting materials and method documentation.

In-Person Meeting and Teleconference Conduct 1. Arrive on time.

2. Advise the Chair and ERP members of any potential Conflicts of Interest at the beginning of the meeting. 3. Participation is required from all members of the ERP. All members have been deemed experts in the specific subject matter areas. 4. The ERP Chair will moderate the meeting to ensure that decisions can be made in a timely manner. 5. Follow Robert’s Rules of Order for Motions. 6. Speak loud, clear, and concise so that all members may hear and understand your point of view. 7. Due to the openness of our meetings, it is imperative that all members communicate in a respectful manner and tone. 8. Refrain from disruptive behavior. Always allow one member to speak at a time. Please do not interrupt. 9. Please note that all methods reviewed and decisions made during the Expert Review Panel process are considered confidential and should not be discussed unless during an Expert Review Panel meeting to ensure transparency. Reviewing Methods Prior to the Expert Review Panel meeting, ERP members are required to conduct method reviews. All methods are reviewed under the following criteria, technical evaluation, general comments, editorial criteria, and recommendation status. These methods are being reviewed against their collaborative study protocols as provided in the supplemental documentation. Note: The method author(s) will be present during the Expert Review Panel session to answer any questions.

Page 1 of 2

Version 1 – OMA ERP Meeting Conduct

Official Methods of Analysis SM (OMA) Expert Review Panel MEETING AND METHOD REVIEW GUIDANCE

Reviewing Methods (Cont’d)

Reviewers shall conduct in-depth review of method and any supporting information. In-depth reviews are completed electronically via the method review form. The method review form must be completed and submitted by the deadline date as provided. All reviews will be discussed during the Expert Review Panel meeting. Any ERP member can make the motion to adopt or not to adopt the method. If the method is adopted for AOAC First Action status, Expert Review Panel members must track and present feedback on assigned First Action Official Methods . Recommend additional feedback or information for Final Action consideratio n. Here are some questions to consider during your review based on your scientific judgment: 1. Does the method sufficiently follow the collaborative study protocol? 2. Is the method scientifically sound and can be followed? 3. What are the strengths and weaknesses of the method? 4. How do the weaknesses weigh in your recommendation for the method? 5. Will the method serve the community that will use the method? 6. What additional information may be needed to further support the method? 7. Can this method be considered for AOAC First Action OMA status? Reaching Consensus during Expert Review Panel Meeting 1. Make your Motion. 2. Allow another member to Second the Motion. 3. The Chair will state the motion and offer the ERP an option to discuss the motion. 4. The Chair will call a vote once deliberations are complete. 5. Methods must be adopted by unanimous decision of ERP on first ballot, if not unanimous, negative votes must delineate scientific reasons. Negative voter(s) can be overridden by 2/3 of voting ERP members after due consideration. 6. All other motions will require 2/3 majority for vote to carry.

Page 2 of 2

Version 1 – OMA ERP Meeting Conduct

9/13/2018

AOAC Expert Review Panels An Orientation

Deborah McKenzie רב Sr. Dir., Standards Development AOAC INTERNATIONAL Staff Liaison ‐ Official Methods Board

1

9/13/2018

As a

,

AOAC INTERNATIONAL advances and ,

members, organizations, and experts dedicated to developing and validating and of

by

Analytical  Excellence

AOAC  Strategic  Goals

Core  Programs

2

9/13/2018

AOAC STRATEGIC PLAN

Accessible at AOAC homepage   www.aoac.org

Analytical Excellence addresses emerging issues and influence standards development as a global leader in analytical excellence

Standards Development

Official Methods of Analysis SM (OMA) & Performance Tested Methods SM (PTM)

Laboratory Proficiency Testing & Quality Management

Analytical Excellence

Journal of AOAC INTERNATIONAL, OMA, ALACC Guide

3

9/13/2018

AOAC Method Approval Programs

Official Methods of Analysis SM (OMA)   • AOAC’s premiere methods  program • Approved methods  – published in the Official Methods  of Analysis of AOAC  INTERNATIONAL  (print and  online) – Manuscripts published in the  Journal of AOAC INTERNATIONAL – First Action and Final Action  status

Performance Tested Methods SM (PTM)  • AOAC’s method certification  program • Certified methods – Commercial/proprietary rapid  methods (test kits) – Certifications published on AOAC  website – Manuscripts published in the Journal  of AOAC INTERNATIONAL – Method developers licensed to use  certification mark – Annual review & recertification

AOAC Official Methods SM Program

Submit Methods Responding to issued Call for Methods • Adoption of methods as Official Methods  is contingent upon  standards development activities • No application fee required to submit methods in response to Call  for Methods Submit Individual & Sole Source Methods • Adoption of methods as Official Methods  is contingent upon data  supporting applicability and community based validation guidance  information • Including proprietary/commercial methods and harmonized PTM – OMA methods • Application fee required

4

9/13/2018

Status of Official Methods of Analysis First Action, Final Action, Repeal

AOAC Policies & Procedures

Policy on Use of  Association Name,  Identifying Insignia,  Letterhead, Business  Cards

Policy on Volunteer  Conflict of Interest

Policy on Antitrust

OMA Appendix G ‐ Use  of AOAC Voluntary  Consensus Standards to  Evaluate Characteristics  of a Method of Analysis

Expert Review Panel  Policies and Procedures

5

9/13/2018

Road to First Action OMA Status

1. PTM – OMA Methods 2. Other Sole Source Methods 3. Response to Call for Methods

Method submitted 

Expert Review Panels  review all methods  submitted methods

Notify  Method  author 

Reject

ERP 

Adopt

Published First  Action OMA

Road to Final Action OMA  Status

Method reproducibility must be  demonstrated before Final Action  consideration. 

ERP determines if sufficient  evidence merits a  recommendation for Final Action  status or repeal. • Only the OMB promotes a  method to “Final Action” status or   repeal the method. • Methods that did not meet the  bar would be repealed. • Same for all method submissions

6

9/13/2018

PTM Overview for PTM‐OMA  Harmonized Process • Administered by the Research  Institute in 2003. • Well established and streamlined • Original approved by consensus  with the OAs, OMB, RI Board of  Directors and AOAC  INTERNATIONAL Board of  Directors. • ERP may be formed during  Consulting Service. • Criterion for OMA:  manufacturer’s method claims.

Recruiting Experts and Methods  • AOAC issues  – Call for Methods  (Stakeholder affiliated methods) – Call for Experts  • Sole Source/Individual Method Submissions  – Individually completed Application not associated  with an open Call for Methods

7

9/13/2018

Qualifications for ERP Membership Candidate must meet one of the following: • Demonstrated knowledge in the appropriate scientific  disciplines. • Demonstrated knowledge regarding data relevant to  adequate method performance.

• Demonstrated knowledge of practical application of  analytical methods to bona fide diagnostic requirements.

Candidate application package includes: • Statement of Expertise • Current Abridged CV or Resume

ERP Member Vetting Process

Approved roster  sent to AOAC  President for  volunteer  appointment

Candidate  submits  application  package

Reviewed by  AOAC staff with  recommendation  to OMB

Reviewed by  OMB and roster  approved

• All members serve at the pleasure of the AOAC President • OMB assigns a representative to serve as a resource for every ERP

8

9/13/2018

Candidate Method Assignments  A minimum of primary and secondary reviewers may be assigned  to every method.  In depth review via review form  Prepare to attend and speak on the method and make a recommendation  for ERP discussion and consideration.  Review forms are completed and returned to AOAC staff in advance  of the  meeting.  An email is sent with information on how to access the  candidate methods and how to submit reviews

 Members of both Committee on Safety and Committee on  Statistics serve as  advisory resources for all ERPs

Candidate Method Reviews

 In your judgment, does the method sufficiently meet the Standard Method   Performance Requirements (SMPR) or community‐based guidance?

 In your judgment, is the method scientifically sound and can be followed?  In your judgment, what are the strengths and weaknesses of the method?  In your judgment, how do the weaknesses weigh in your recommendation for   the method?  In your judgment, will the method serve well the stakeholder community that   will use the method?  In your judgment, what additional information may be needed to further   support the method meeting the SMPR or community‐based guidance?  Members of both Committee on Safety and Committee on Statistics serve  as  advisory resources for all ERPs

9

9/13/2018

ERP Meetings  ERPs can meet in person at a minimum of twice a year and up to four times  per year*:  AOAC Mid‐Year meeting  (DC metro area)  AOAC Annual Meeting.  *2 additional designated times for proprietary method Organziational Affiliates  At the ERP meeting:  Reviews will be presented and the reviewers can make a motion to the ERP  whether to adopt the method as First Action OMA.  ERP discusses the method.  ERP renders a decision on First Action status.  ERP renders decisions on modifications to Official Methods .  If the method is adopted  ERP decides on what additional information is needed to recommend the  method for Final Action status

ERP Teleconferences • Only after the initial in‐person ERP meeting  for First Action consideration of methods • Possible for some method modifications • Possible for First Action to Final Action ERP  recommendations

10

9/13/2018

ERP Meetings

Quorum

Presence of 7  vetted ERP  members 

Presence of  2/3 vetted  ERP members

OR

WHICHEVER IS GREATER IF NO QUORUM, NO OFFICIAL MEETING

Method Review Overview

 Method authors may be invited to make a presentation on their method  REVIEWERS PRESENT THEIR REVIEWS AND MAY  INITIATE A MOTION TO ADOPT THE  METHOD IF THEY CHOOSE  Chair recognizes each reviewer  Reviews are presented.

 If in favor, reviewers may make and second a motion to adopt  adopt the method  Chair can then entertain discussion on themethod  Chair can call for a vote once deliberation is complete

11

9/13/2018

Consensus – First Action Adoption

 First Action Official Methods status is granted:

 Method must be adopted by unanimous decision of ERP on first   ballot, if not unanimous, negative votes must be based on scientific reasons.

 Negative voter(s) can be overridden by 2/3 of voting ERP   members after due consideration.

 Method becomes First Action on the date when ERP decision is   made.

Consensus – First Action to Final Action

 The ERP may then reach consensus on any additional   information that it needs to review to be able to make a   recommendation for Final Action Official Methods   status.

 This is a separate motion.

12

9/13/2018

ERP Meetings – Review for First Action  METHOD AUTHOR:    present any method and any resulting changes to  the method since submission for review, summary of SLV and/or  reproducibility evaluation, any recognitions (from AOAC or external)  and, final draft of method proposed for decision

ERP CHAIR & MEMBERS:    present reviews and discuss any resulting  issues or questions on the method, review and agree upon final draft of  method proposed for decision, and chair calls for ERP decision in  accordance to procedures.

CONSENSUS:   Method must be adopted by unanimous decision of ERP  on first ballot. If not  unanimous, negative votes must delineate   scientific reasons. Negative voter(s) can be overridden by 2/3 of non‐ negative voting ERP members after due consideration.    Abstentions do not count towards vote; in case of multiple abstentions the results  will need to be evaluated.  Staff will monitor  and record consensus voting.

STAFF:   Will organize and coordinate meeting,  record  ERP  actions and decisions, draft ERP report and distribute after  chair approval,  work with chair and OMB liaison to complete  checklist and assemble recommendation package  for OMB.

ERP Methods Review & Approval

Methods should be scientifically sound with demonstrating  that it will meet the needs of those using the method  (evidenced by meeting the standard, or other acceptance  criteria) 

ERPs have approved methods with evidence of high potential  to First Action and request additional work or support be  submitted for review prior to ERP convening to recommend an  action to OMB

OMB requires a justification or rationale for methods that are  deemed acceptable and adopted but may not fully meet the  standard set or acceptance criteria.

13

9/13/2018

OMB Expectations for First Action

Safety review needed  prior to First Action  status

SLV type of supporting  information available  per the SMPR

• Applicability, Method Performance Requirements  Table, System Suitability, Reference Materials, and  Validation Guidance

• Documented method performance versus a SMPR • Document reasons for acceptability if method  does not meet the SMPR

Comparison to SMPR

Any approved  method(s) along with  supporting  manuscript(s) and   documentation sent to  AOAC Publications  after the meeting.

Method incorporating ERP revisions (preferably  in AOAC Format) Method Manuscript incorporating specified ERP  revisions (in AOAC  Format) Signed AOAC Copyright Authorization form

NO OMA NUMBER ASSIGNED   UNTIL ALL DOCUMENTATION  SUBMITTED

Publication  of First  Action Methods

Method and method manuscript prepared for  publication  in the Official Methods of  Analysis of AOAC  INTERNATIONAL and in  Journal of AOAC INTERNATIONAL Updates on methods approved or status  changes are  published in the Inside  Laboratory Management magazine  and on  the AOAC website

14

9/13/2018

ERP Meetings – Method Tracking METHOD AUTHOR:    present any method feedback obtained  and any resulting changes to the method, any reproducibility  information, any implemented ERP recommendations, final  draft of method proposed for decision ERP MEMBERS:    present any method feedback obtained and 

discuss any resulting changes to the method, any  reproducibility information, any implemented ERP  recommendations, review and agree upon final draft of  method proposed for decision, and make a recommendation  to OMB. CONSENSUS:    2/3 vote in favor of a motion.    Abstentions do not count towards vote; in case of  multiple abstentions.  Staff will monitor  and record  consensus voting.

STAFF:   Will organize and coordinate meeting,  record   ERP actions and decisions, draft ERP report and  distribute after chair approval,  work with chair and  OMB liaison to complete checklist and assemble  recommendation package  for OMB.

Documentation Needed

Method Safety Evaluation

Reference Materials

Evidence of Single Laboratory Validation or equivalent 

Evidence of Reproducibility Assessment 

Published First Action OMA

Method Performance versus SMPR or acceptance criteria

Final draft of First Action OMA to be considered for status update

Rationale or Justification for Repeal or Continuance of First Action OMA

15

9/13/2018

OMB Meeting for Review of ERP  Recommendations

OMB Review (renders decision on  recommendation) 

ERP Chair/or  designee  (addresses  questions/comment)

OMB Liaison (presents  recommendation)

Modifications to Official Methods • Types of Modifications – Editorial

– Major – Minor

• Applicable to First Action and Final Action  OMA

• Relevant to all ERPs

16

9/13/2018

Editorial Modifications • The applicant must submit a written explanation of  the change(s) including a statement that the  modification does not alter the validated  performance of the method.

• Examples include: Typos or editorial corrections or  clarifications that strengthen instruction.

• Methods that have undergone an editorial  modification will retain the same number. 

Editorial Changes

• Editorial changes to methods only require AOAC staff review and  the change is made to the OMA with changes noted in next printed  edition of OMA. • A list of the methods with editorial modifications will be published  in  Inside Laboratory Management and on  the Website.

17

9/13/2018

Minor Modifications • Results in no changes to the current validated  performance. There is no significant effect to the  results. The method will retain the original number. • Supporting data to justify the proposed modification  must be submitted. Equivalency data is required unless  adequate Justification to exclude this data is provided. • Examples include: Reagent change, a change in a  column or consumables that do not impact the  validated method performance.

Major Modifications • Results in a change to the current validated  performance of the method.  • This level of modification will result in a new method  as part of AOAC standards development and will  receive a new method number. • Examples include: significant change to the  technology, sample preparation, or chemistry.

18

9/13/2018

Minor & Major Modifications

Based on AOAC staff review, a public comment  period for the proposed modification is required.

Applicant Options

• Following the comment period, any comments are reconciled and  recommends a response to the applicant.  • The applicant can decide to proceed based on the reconciled comments

19

9/13/2018

Pathways for Minor & Major  Modification • If applicant  decides to 

proceed, an ERP is  formed – Level of  modification  determined by ERP

– Applies to 

modifications of  First Action and  Final Action  methods

Documentation and Communication • AOAC carefully documents the actions of Stakeholder Panel, Working  Groups, and Expert Review Panels • AOAC will prepare summaries of the meetings  – Communicate summaries to the stakeholders – Publish summaries in the Referee section of AOAC’s  Inside  Laboratory Management • AOAC publishes its voluntary consensus standards and Official  Methods – Official Methods of Analysis of AOAC INTERNATIONAL – Journal of AOAC INTERNATIONAL • AOAC publishes the status of standards and methods in the Referee  section of AOAC’s  Inside Laboratory Management

20

9/13/2018

Requirements for ERP Service

 Must have demonstrated expertise in the method, technology,   analyte/matrix, etc… Be a subject matter expert.  Must be able to attend ERP meetings  Must be able to complete assigned reviews on time  Must be prepared to speak on the method and share reviews   during the meeting  Must be proactive in tracking assigned First Action Official   Methods  Must be able to assist in peer reviewing paper for publication  Must sign and submit AOAC Volunteer Acceptance Form

General Expectations for ERPs • You can expect to have a minimum of three weeks to review  methods prior to ERP meeting.  – You are requested to submit written reviews by specified deadline.  Please  alert staff if you are not able to complete on time. – You may have individually assigned methods to review or all of the methods  to review.  Please be prepared to discuss these methods during meeting. – You may use the OMA appendices as guidance for types of validation work  that can be expected.  If additional information is needed, please ask staff. • ERP Meeting Quorum – If there is no quorum, there is no official meeting.  Please alert staff as early  as possible if you are not able to attend a meeting. • ERP Consensus – ERP consensus may not reflect your own personal view – There may be times when a method may not meet all of the criteria exactly;  however, the ERP can adopt the method.

21

9/13/2018

Ethical Expectations of AOAC Expert  Review Panel Members • Respect for your peer ERP members and chair – Each member has been vetted for expertise relevant to the  review of the method(s) in the ERP  • Be considerate of each others perspectives and points of view • Be considerate of the ERP’s consensus even if you disagree – Inform staff as early as possible if you cannot attend the  scheduled ERP meeting • Be considerate in that your absence can impact the quorum of the  ERP and its ability to have an official meeting to make decisions – Notify staff and/or disclose in the ERP meeting if you have a  direct or perceived conflict of interest for a specific method • Please review AOAC’s policy on Volunteer Conflict of Interest Ethical Expectations of Expert Review Panel  Members  (con’t) • Respect for Method Authors and Intellectual Property – Each Method Author is encouraged to attend the ERP meeting – Each candidate methods (not yet adopted or published as Official  Methods of Analysis of AOAC INTERNATIONAL ) are still the intellectual  property of the method author.  Therefore, the information is shared only  with the vetted ERP members and is available during the meetings.  Please  do not distribute the information without expressed written permission  from an appropriate AOAC staff liaison.  – Be clear about and justify how additional recommended work is a  requirement for First Action, a requirement for Final Action consideration,  or something recommended, but not necessary. – Keep your focus on the science

22

9/13/2018

ERP Chair Responsibilities

Before Meeting

During Meeting

Moderate discussions based  on agenda

Work with staff on meeting  coordination

Engage staff to encourage  members to reach decision  points

Review submitted and/or  assigned methods

Engage staff on procedural  questions

Review method reviews if  applicable

Engage discussion on feedback  mechanism

Review SMPR(s) and/or  relevant guidance and criteria

ERP Chair Responsibilities

Other Efforts and  Recognitions Can nominate methods for  OMB Award

After Meeting Review Meeting Report  and Approve Final Version

Can nominate ERP members  for OMB Award

Assist with any follow up on  methods

Can assist in identifying  methods for review

Assist in Publication  Reviews

Can serve as a guest editor for  the Journal

23

9/13/2018

Roles and Responsibilities

AOAC Official Methods Board Vet and approve stakeholder panel chair & voting members Vet and approve ERP membership and AOAC Experts Render decisions on status of First Action methods (Final Action,  repeal, etc…) Assign a liaison to each stakeholder panel and ERP Coordinate OMB Awards AOAC Expert Review Panels Review methods and meet in person to render decisions on  methods for First Action Official Methods SM status. Track First Action Official Methods SM and modify, if necessary Recommend First Action methods after 2 years or less to OMB  for Final Action, continuance, or Repeal Participate in Consulting Service and PTM reviews for OMA and  harmonized PTM and harmonized OMA method studies AOAC Experts Review and approve PTM validationtesting protocol documentation Peer review of PTM validation manuscript and supporting  documentation AOAC Research Institute ‐ PTM Expert Reviewers Peer Review of PTM validationmanuscripts and supporting  documentation

AOAC Research Institute Independent Laboratories Conduct independent evaluation of candidate method using AOAC  approved testing protocols AOAC Stakeholder Panels Develop  voluntary consensus standards  Assign working groups to  draft standards method performance  requirements Voting members demonstrate  consensus on behalf of  stakeholders AOAC Staff Coordinate method reviews and method approval activities Coordinate OMB meetings Provide trainings and orientations Maintain website and communication Document and publish actions and decisions Coordinate standards development activities Publish standards and methods AOAC Research Institute Technical Consultants Draft validation protocols in Consulting Service for assigned methods

Facilitate PTM evaluation of assigned candidate methods Facilitate comments/responses for assigned OMA reviews

Questions?

Thank you 

24

1 Evaluation of the 3M™ Petrifilm™ Rapid E. coli /Coliform Count 2 Plate for the Enumeration of E. coli and Coliform: 3 Collaborative Study 4 5 Patrick Bird, Benjamin Bastin, Nicole Klass, Erin Crowley, James Agin, David Goins 6 Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214 9 3M Food Safety Department, 3MCenter – Bldg. 260-6B-01, St. Paul, MN 55144 10 11 Collaborators: A. Calle, K. Suntharesan, V. Gohil, A. Donkers, R. Smith, D. Wood, S. Diederich, S. 12 Kuchenberg, I. Satoshi, M. Brown, N. Alvarez, S. Corti, M. Hochreuter 13 The 3M™ Petrifilm™ Rapid E. coli /Coliform Count (REC) Plate is a selective and 14 differential sample-ready-culture medium designed for the rapid enumeration of 15 Escherichia coli and coliform in the food and beverage industries. The 3M Petrifilm Rapid 16 E. coli /Coliform Count Plate was compared to the U.S. FDA Bacteriological Analytical 17 Manual (BAM) Chapter 4 Enumeration of Escherichia coli and the Coliform Bacteria , the 18 International Organization of Standards (ISO) 4832:2006 Microbiology of food and animal 19 feeding stuffs – Horizontal method for the enumeration of coliforms—Colony-count 20 technique and ISO 16649-2:2017 Microbiology of food and animal feeding stuffs – Horizontal 21 method for the enumeration of beta-glucuronidase-positive Escherichia coli - - Part 2 Colony- 22 count technique at 44 degrees C using bromo-4-chloro-3-indolyl beta-D-glucuronide methods 23 for the enumeration of E. coli and coliform in dry dog kibble. The candidate method was 24 evaluated using two diluents, Butterfield’s phosphate buffered diluent and peptone salt 25 solution, in a paired study design with each reference method in a multi-laboratory 26 collaborative study following the current AOAC Validation Guidelines. Three (3) target 27 contamination levels (low, 10-100 colony forming unit (CFU)/g; medium, 100-1,000 CFU/g; 28 high 1,000-10,000 CFU/g) and an uninoculated control level (0 CFU/g) were evaluated. No 29 statistical difference was observed between the candidate method and either the BAM or 30 ISO methods for each contamination level. 31 Coliform bacteria are a category of rod-shaped, non-spore forming Gram-negative bacteria. 32 These organisms can be motile or non-motile and can ferment lactose with the production of acid 33 and gas. While coliform bacteria are very common and normally harmless, coliform 34 contamination in food or beverage products does pose a health risk. Since coliforms are 35 commonly found in soil and vegetation, when coliform contamination is found, it usually is 36 caused by the environment. Coliform presence in food products raises the question of pathogen 37 contamination occurring through a similar process. Many coliforms, including E. coli , a 38 subgroup of coliform, can be found in the human digestive tract. While some strains of E. coli 39 are harmless, other strains can cause serious illness. Just like coliform, if E. coli contamination is 40 detected, this poses a greater risk for other pathogens to be present [1]. 41 Traditional screening and confirmation of E. coli or coliform bacteria can require 3 to 7 days 42 are can be very labor intensive for laboratories. The 3M Petrifilm Rapid E. coli /Coliform Count 43 Plate allows for the simple, rapid enumeration and differentiation of coliform and E. coli in food 44 and environmental samples. Test portions are diluted in an appropriate diluent and a sample 45 7 8 Hannah Bakken

1

aliquot is plated onto the plate. The plates can be incubated at multiple temperatures (30 ± 1 o C, 1 32 ± 1 o C, 35 ± 1 o C, 37 ± 1 o C or 42 ± 1 o C) with enumeration occurring in as little as 18 hours 2 The 3M Petrifilm Rapid E. coli /Coliform Count Plate was validated according to AOAC 3 Validation Guidelines [2] following the AOAC Official Methods of Analysis (OMA) process. 4 The objective of these studies was to demonstrate that the candidate method accurately 5 enumerated E. coli and coliform in a broad range of foods and select environmental surfaces as 6 claimed by the manufacturer and that no difference in repeatability was observed between the 7 candidate method and the reference methods. For the pre-collaborative studies, thirty-three (33) 8 matrices were evaluated. The following matrices were evaluated with Butterfield’s Phosphate 9 Buffered Diluent (BPBD) only: Pasteurized whole milk, butter, non-fat dry milk, raw ground 10 pork, lamb chop, raw ground chicken, chicken carcass rinsate, shell eggs, liquid egg whites, 11 powdered egg whites, sprouts, cranberries, infant formula with probiotics, infant formula without 12 probiotics, infant rice cereal without probiotics, dry dog kibble, dry cat food, flour and chocolate 13 chip cookie dough. The following matrices were evaluated with BPBD and peptone salt solution 14 (PSS): raw ground beef (73% lean), raw frozen chicken wings, raw milk, whole liquid egg, tuna 15 sushi, smoked salmon, bunched spinach, pasteurized carrot juice, ready-made sandwiches, raw 16 vegetable salad with dressing, chicken feed, soybean meal, stainless steel environmental sponges 17 and sealed concrete environmental sponges. Additional pre-collaborative parameters (inclusivity 18 and exclusivity testing) satisfied the requirements for OMA approval. 19 The purpose of this collaborative study was to compare the 3M Petrifilm Rapid E. 20 coli /Coliform Count Plate to the FDA BAM Chapter 4: Enumeration of Escherichia coli and the 21 Coliform Bacteria [3] , ISO 4382: 2006 Microbiology of food and animal feeding stuffs – 22 Horizontal method for the enumeration of coliforms – Colony-count technique [4] and ISO 23 16649-2:2001 Microbiology of food and animal feeding stuffs – Horizontal method for the 24 enumeration of β-glucuronidase-positive Escherichia coli – Part 2: Colony count technique.at 44 25 °C using 5-bromo-4-chloro-3-indolyl β-D-glucuronide [5] reference methods for the 26 enumeration of coliform and E. coli in dry pet food. 31 32 One matrix, dry dog kibble, was evaluated in this study. The matrix was obtained from a local 33 retailer and screened for the presence of naturally occurring E. coli and coliforms by the FDA 34 BAM and ISO reference methods. No natural contamination was observed so four separate levels 35 of contamination were targeted for the evaluation: uninoculated, 0 colony forming unit (CFU)/g; 36 low, 10-100 CFU/g; medium, 100-1,000 CFU/g; high 1,000-10,000 CFU/g. To obtain the 37 required contamination levels, bulk lots of the matrix were artificially contaminated with a 38 lyophilized culture of Escherichia coli [Q Laboratories (QL) isolate 11007-8 (origin – beef 39 hide)] and Klebsiella pneumonia [Q Laboratories (QL) isolate 11007-7 (origin – raw 40 hamburger)]at each target contamination level. Two replicate samples from each of the four 41 contamination levels were analyzed by both the candidate and reference methods in a paired 42 study design. 43 A detailed collaborative study packet outlining all necessary information related to the study 44 including media preparation, test portion preparation and documentation of results was sent to 45 each collaborating laboratory prior to the initiation of the study. 27 28 29 30 Collaborative Study Study Design

46 47 48

Preparation of the Inocula and Test Portions

2

1 The isolates used in this evaluation were lyophilized prior to inoculation. The cultures were 2 first propagated onto Tryptic Soy Agar with 5% Sheep Blood (SBA) from a Q Laboratories 3 frozen stock culture stored at -70°C. To prepare the culture for lyophilization, a single, well 4 isolated colony from SBA was transferred into brain heart infusion (BHI) broth and incubated at 5 37 ± 2 o C for 18-24 hours. The cultures were diluted in a sterile cryoprotectant, reconstituted 6 10% non-fat dry milk (NFDM), and freeze dried for 48-72 hours. A bulk lot of the test matrix 7 was inoculated with each culture at a high level. An aliquot of the high-level inoculated matrix 8 was further mixed with uninoculated matrix to produce the medium and low level inoculum. 9 After inoculation, the matrix was held for a minimum of 2 weeks at ambient temperature (20 - 10 25 o C). The inoculated test product was packaged into separate 10 g (ISO) and 50 g (BAM) 11 samples in sterile Whirl-Pak ® bags and shipped to the collaborators. 12 Test Portion Distribution 15 sample container. Nine participants from 8 separate locations participated. Test portions were 16 shipped in leak-proof insulated containers via overnight delivery according to the Category B 17 Dangerous Goods shipment regulations set forth by International Air Transport Association 18 (IATA). Test portions were shipped at ambient temperatures (20-25 o C). Upon receipt, samples 19 were held at ambient temperature until analysis was initiated. In addition to each of the test 20 portions, collaborators also received a test portion for the matrix labeled as Aerobic Plate Count 21 (APC), to determine total background count in the matrix using the FDA BAM Chapter 3 22 Aerobic Plate Count reference method [6]. The APC background screen samples were prepared 23 from the bulk lot of test matrix, prior to inoculation. Additionally, a temperature probe was 24 included in the shipment. Participants were instructed to submit the data from the temperature 25 probe upon receipt of the shipment. 28 29 Collaborators followed the appropriate preparation and analysis protocol provided to them in 30 the collaborator instructions (Version 2, August,2018). Each collaborator received 16 test 31 portions (2 high, 2 medium, 2 low and 2 uninoculated for paired analysis with the 3M Petrifilm 32 Rapid E. coli /Coliform Count Plate and ISO methods, and 2 high, 2 medium, 2 low and 2 33 uninoculated for analysis with the 3M Petrifilm and BAM method). 36 37 A 50 g test portion was diluted with 450 mL of BPBD, allowed to sit for 20 minutes to soften 38 the dry dog kibble, and homogenized with a paddle blender for 2 minutes ± 10 sec. Ten-fold 39 serial dilutions of each sample were prepared in BPBD and a 1.0 mL aliquot of each dilution was 40 plated onto a single 3M Petrifilm Rapid E. coli /Coliform Count Plate for each dilution. The plate 41 was incubated at 35 ± 1 o C for 18-24 hours. After incubation, plates were enumerated for total 42 coliform and E. coli . Plates containing greater than 100 CFU were recorded as too numerous to 43 count (TNTC). Final results were determined by multiplying the counts by the dilution factor for 44 that plate. 45 Each test portion analyzed by the candidate method was also analyzed using the FDA BAM 46 Chapter 4 reference method in a paired study design. A 1.0 mL aliquot from each sample dilution 47 was plated onto a Petri dish. To each plate, 10 mL of Violet Red Bile (VRB) agar was added and 48 13 14 All samples were labeled with a randomized, blind-coded 3 digit number affixed to the 26 27 Test Portion Analysis 34 35 3M Petrifilm Rapid E. coli/Coliform Count Plate & BAM

3

allowed to solidify. To avoid spreading colonies and surface growth, an overlay of 5 mL of VRB 1 with 4-methyl-umbelliferyl-β-D-glucuronide (MUG) was added. All plates were inverted, 2 incubated for 18 - 24 hours at 35 ± 1 ºC and enumerated. Purple-red colonies that were 0.5 mm 3 or larger in diameter and surrounded by a zone of precipitated bile acids were enumerated as 4 coliform colonies. E. coli colonies were determined by observing bluish fluorescence when 5 viewed under a longwave UV light. Counts of 25 – 250 CFU/plate were considered countable, 6 while counts outside that range were considered estimates. Coliform colonies were confirmed by 7 picking typical colonies to tubes containing BGLB broth and incubating at 35 ± 1°C. Tubes were 8 examined at 24 and 48 hours for gas production. E. coli colonies were confirmed by transferring 9 presumptive colonies to EC-MUG broth and incubating at 35 ± 1°C for 48 ± 2 hours. Tubes were 10 then examined for fluorescence. In addition, for each positive sample, a single colony was 11 confirmed using API 20E, AOAC OMA 978.24 [7]. 12 3M Petrifilm Rapid E. coli/Coliform Count Plate & ISO 13 14 A 10 g test portion was diluted with 90 mL of PSS, allowed to sit for 20 minutes to soften the 15 dry dog kibble, and homogenized with a paddle blender for 2 minutes ± 10 sec. Ten-fold serial 16 dilutions of each sample were prepared in PSS and a 1.0 mL aliquot of each dilution was plated 17 onto duplicate 3M Petrifilm Rapid E. coli /Coliform Count Plates for each dilution. One plate 18 was incubated at 37 ± 1 o C for 18-24 hours and the other plate was incubated at 42 ± 1 o C for 18- 19 24 hours. After incubation, plates were enumerated for total coliform (37 o C) and E. coli (37 o C & 20 42 o C). Plates containing greater than 100 colonies were recorded as too numerous to count 21 (TNTC). Final results were determined by multiplying the counts by the dilution factor for that 22 plate. 23 Each test portion analyzed by the candidate method was also analyzed with the ISO 4382 and 24 ISO16649-2 reference methods in a paired study design. For ISO 4832, serial dilutions for each 25 sample were plated in sterile Petri dishes followed by the addition of violet red bile agar with 26 lactose (VRBL). To avoid spreading colonies and surface growth, an overlay of 5 mL of VRBL 27 was added. Agar plates were incubated for 24 ± 2 h at 37 ± 1 o C. Typical colonies in the 28 countable range (10-150) were enumerated using a standard colony counter. If atypical colonies 29 were present, further confirmation was conducted by transferring colonies to brilliant green 30 lactose bile broth (BGLB). For ISO 16649-2, serial dilutions for each sample were plated in 31 singular using tryptone bile X-glucuronide medium (TBX). Agar plates were incubated for 18-24 32 h at 44 ± 1 o C. Typical colonies in the countable range (10-150) were enumerated using a 33 standard colony counter. 36 37 Each collaborating laboratory recorded the CFU/g results for the reference methods and the 38 candidate method on the electronic spreadsheet provided. The data sheets were submitted to the 39 study director at the end of the study for analysis. A logarithmic transformation [CFU/g +0.1f, 40 where f is the reported CFU/g corresponding to the smallest reportable result]. A Youden plot 41 was prepared to identify discrepancies between test replicates. Outliers were identified using the 42 Cochran and Grubbs’ tests. The differences of means, including 95% upper and lower 43 confidence limits, were determined for each contamination level [8]. If the difference of means 44 between the two methods was < 0.5 Log10, it was considered that no statistical difference 45 existed between the two methods [9]. The repeatability (s r ) and reproducibility (s R ) of the 46 methods were also determined [10]. 47 34 35 Statistical Analysis

4

AOAC Official Method 2018.XX 1 Enumeration of Escherichia coli and Coliform in a Broad Range of Foods and Select 2 Environmental Surfaces 3 3M Petrifilm Rapid E. coli/ Coliform Count Plate 4 First Action 2018 5 6 (Applicable to the enumeration of E. coli and coliform from pasteurized whole milk, butter, non- 7 fat dry milk, raw ground pork, lamb chop, raw ground chicken, chicken carcass rinsate, shell 8 eggs, liquid egg whites, powdered egg whites, sprouts, cranberries, infant formula with 9 probiotics, infant formula without probiotics, infant rice cereal without probiotics, dry dog 10 kibble, dry cat food, flour, chocolate chip cookie dough, raw ground beef (73% lean), raw frozen 11 chicken wings, raw milk, whole liquid egg, tuna sushi, smoked salmon, bunched spinach, 12 pasteurized carrot juice, ready-made sandwiches, raw vegetable salad with dressing, chicken 13 feed, soybean meal, stainless steel environmental sponges and sealed concrete environmental 14 sponges) 15 16 See Table 2018.1A-B for a summary of results of the collaborative study. 17 See Tables 1-4 for detailed results of the collaborative study 20 21 The 3M Petrifilm Rapid E. coli /Coliform Count Plate is a self-contained, sample-ready-culture- 22 medium system which contains a cold-water-soluble gelling agent and two different indicators; 23 5-bromo-4-chloro-3-indolyl-D-glucuronide that indicates glucuronidase activity and tetrazolium 24 that facilitates colony enumeration. The 3M Petrifilm Rapid E. coli /Coliform Count Plate is 25 intended for the use for the enumeration of both Escherichia coli and coliforms in various food 26 and beverage products and from environmental surfaces. The 3M Petrifilm Rapid E. 27 coli /Coliform Count Plates can be incubated for 18 - 24 hours at 30 o C, 32 o C, 35 o C, 37 o C, and 28 42 o C.The typical colony morphology for E. coli is blue to blue-green colonies with or without 29 gas production, regardless of size or color intensity. Other coliform isolates will appear as red 30 colonies with entrapped gas (within approximately one colony diameter) for enumeration 31 according to FDA BAM, and red colonies with and without gas production according to ISO 32 4832:2006. The accurate quantitative range is less than or equal to 100 CFU per plate for the 33 total coliform count, and less than or equal to 100 blue to blue-green CFU per plate for the E. 34 coli count. 18 19 A. Principle

35 36 37 38 39 40 41 42 43 44 45 46 47 48

B. Apparatus and Reagents

a. 3M Petrifilm Rapid E. coli/Coliform Count Plates –. Available from 3M Food Safety

- CAT# 6436/6437.

b. 3M Petrifilm Spreader – CAT# 1223767436

c. Sterile Diluent- Peptone Salt Solution & Butterfield’s Phosphate Buffered Diluent d. Pipettes- capable of pipetting 1,000 µL or a serological pipette

e. Sterile pipette tips- capable of 1,000 µL f. Laboratory paddle-blender- Seward 400 or equivalent g. Filter Stomacher bags - Seward or equivalent

h. Incubators – Capable of maintaining 30 ± 1 o C, 32 ± 1 o C, 35 ± 1 o C, 37 ± 1 o C or 42 ±

1 o C

i. Refrigerator - capable of maintaining 0-8 o C, for storing plates

5

j. Freezer – capable of maintaining -20-0 o C for storing plates k. Standard Colony Counter or Illuminated Magnifier l. Top-loading balance – capable of weighing 1-2000 g

1 2 3 4 5 6 7 8 9

C. General Instructions

a. Read the instruction manual carefully before use

b. Storage conditions: Store the plates at -20-8°C. Allow the plates to warm to ambient temperature (20-25 o C/<60% RH) prior to use. After opening the pouch, unused plates should be placed back in the pouch, sealed and stored at ambient temperature for no longer than 4 weeks. If the temperature of the site is > 25 o C with a relative humidity greater than 50%, it is recommended to place the plates in a sealed container and store in c. The countable range is f or E. coli less than or equal to 100 blue to blue-green colonies with and without gas, regardless of the number of total colonies, and f or total coliforms is less than or equal to 100 colonies. Note, the countable range for E. coli or total coliforms a freezer for no more than 4 weeks. Do not use this plate for the specific detection of E. coli O:157 because most E. coli O:157 strains are atypical, glucuronidase negative, and will not be detected as E. coli but only as coliform. After use, 3M Petrifilm Rapid E. coli /Coliform Count Plates may contain microorganisms that may be a potential biohazard. Follow current industry standards and local regulations for disposal of biohazardous waste. To reduce the risks associated with release of contaminated product: • Follow all product storage instructions contained in the instructions for use. may occur on separate dilutions. Safety Precautions

10 11 12 13 14 15 16 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 17

• Do not use beyond the use by date

• Do not use 3M Petrifilm Rapid E. coli /Coliform Count Plates that show

discoloration

• Do not use diluents containing citrate, bisulfate or thiosulfate; they can inhibit

growth

To reduce the risks associated with bacterial infection and workplace contamination: • Perform testing in a properly equipped laboratory under the control of a skilled

microbiologist

• The user must train its personnel in current proper testing techniques

To reduce the risk associated with misinterpretation of results:

• 3M has not documented 3M Petrifilm Rapid E. coli /Coliform Count Plates for use in industries other than food and beverage. 3M has not documented 3M Petrifilm Rapid E. coli /Coliform Count Plates for testing water, pharmaceuticals

or cosmetics

• Do not use 3M Petrifilm Rapid E. coli /Coliform Count Plates in the diagnosis of

conditions in humans or animals

• 3M Petrifilm Rapid E. coli /Coliform Count Plates do not differentiate any one E.

coli or coliforms strain from another

6

Made with FlippingBook HTML5