AOAC BOD June 2018 Pre-Meeting Materials

AOAC INTERNATIONAL B OARD OF D IRECTORS M EETING J UNE 12 –13, 2018

AOAC HQ 2275 Research Blvd, Suite 300 Rockville, MD, 20850 USA Contact:AMeiklejohn@aoac.org

MASTER SCHEDULE

BOARD MEMBER

AOAC INTERNATIONAL Board of Directors June 12-13, 2018 AOAC HQ, Rockville, MD USA

Tuesday June 12, 2018 CLOSED Meeting Breakfast (8:00)

1. Finance Committee (Joyce Schumacher) (8:30-10:00) (Guests: Bert Swain and Sarah McGarity/Dembo Jones)

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2. 2018 Business Plan & Recommendations (Schmidt/staff) (10:00- 12:30)

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LUNCH (12:30-1:30)

2.1 Business Plan Supplemental Presentation: CASA Proposal (1:30-2:30) (Guest: Susan Audino)

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3. China Relationships and Follow-up (2:45-3:45)

• Chinese Institute of Food Safety and Technology (CIFST)

• China Society of Inspection and Quarantine (CSIQ)

• Chinese Academy of Inspection and Quarantine (CAIQ)

4. Task Force Updates (4:00-5:00) ( this time is slated for any necessary discussion, updates during Wednesday’s open Board meeting are expected to be very brief)

RI Process Improvements (Tony Lupo)

• Elections and Nominations (Brad Goskowicz)

Food Fraud (Samuel Godefroy)

MOU (Jonathan Goodwin)

Sections (Benesh)

AOAC Board of Directors

DRAFT AGENDA SUBJECT TO CHANGE Highlighted Text indicates potential Board vote * Pre-meeting Materials Included

June 12-13, 2018 Version 5

2018 Business Plan &Recommendations – PresentationOutline I. Introduction II. 2018 Business Plan Progress Q2 A. * Analytical Excellence: Stakeholder Process Improvements Phase I, “A La Carte Pricing” B. People: Communication Initiatives C. Relationships: International Partnerships D. Core Programs: RI Process Improvements E. * Sustainability: Viable Contracts/Business Proposals F. * Sustainability: New Products/Revenue Sources G. Governance: Executive Director & Elections and Nominations III. Timeline: 2018 Business Plan Q3 & Q4 IV. Future Objectives

* Pre-meeting materials included

AOAC Board of Directors June 12-13, 2018

II. 2018 Business Plan Progress Q2 A. Analytical Excellence: Stakeholder Process Improvements, Phase I – A la carte Pricing

Multi-year contracts do not meet all customers’ needs (the traditional 2 Stakeholder Panels per year, 3-5 working groups, SMPR development, Expert Review Panel). The following components have been priced to accommodate modified work schedules, and are applicable when there is an existing, relevant stakeholder panel in place to provide infrastructure for consensus-based decisions. Prices were determined by averaging actual costs from several projects (SPIFAN, SPDS, SPADA) over a number of years. This model was successfully used to develop a proposal to keep the AOAC SPIFAN project moving forward, while consideration of larger improvements to the stakeholder panel process are in development.

Price:* $60,000

Includes:

New Working Group

• web conferences • chair orientation • volunteer management • DRAFT SMPR • web conferences • volunteer management • CSO participation • recruitment • volunteer management • CSO participation • Call for Methods • reviewer orientation

• CSO participation • public comment period and reconciliation • presentation at 2 Stakeholder Panel Meeting (launch and SMPR approval) • DRAFT SMPR • public comment period and reconciliation • SMPR approval at Stakeholder Panel Meeting • method assignments • in-person meeting with potential for web

Re-Open Working Group

$45,000

Expert Review Panel

$50,000

conference follow-up • ERP Meeting Report • manuscript follow-up

Additional Costs

Price: $1,000 $2,000 $2,000

Publication of SMPR

Publication of First Action Method Publication of Final Action Method

Travel (Approved Experts)

Priced as Needed

*These prices are intended for use only as a guideline, and will be adjusted accordingly on a case-by-case basis; taking into account variables such as project scope, time-line, and technical complexity.

AOAC Board of Directors June 12-13, 2018

II. 2018 Business Plan Progress Q2 E. Sustainability: Viable Contracts/Business Proposals

1. SPIFAN

Leads: Meiklejohn

Synopsis: AOAC will continue work on SPIFAN activities during the period April 1, 2018 through September 30, 2018. Activities will include publishing relevant outputs and execute actions from the AOAC 2018 Mid-Year Meeting, participating in activities related to Codex endorsement of SPIFAN methods, engaging as appropriate Working Groups related to original SPIFAN priority nutrients, and planning and executing an Expert Review Panel meeting in August in conjunction with the AOAC Annual Meeting. AOAC will continue to coordinate with ISO/IDF and other SPIFAN stakeholders as necessary for the submission of technically equivalent methods for review by the Codex Committee on Methods of Analysis and Sampling (CCMAS) and Codex Alimentarius Commission (CAC). AOAC will continue to register delegate(s) to represent AOAC at CCMAS and CAC.

2. SPADA Soil Testing Guideline

Leads: McIver/Coates

Synopsis: Evaluation of potential biothreat detection assays for inhibition, interference, and cross-reactivity from components in soil is an essential test to determine the reliability of a candidate biothreat detection assay. Yet, there are no generally agreed-upon standards for the preparation and characterization of soils, nor for the use of soil samples to evaluate candidate biothreat detection assays. Formal published standards would aide both assay developers and evaluators, and provide an increased confidence level for the robustness of assays with regards to soil contamination. Develop two formal standards: 1) preparation of soil samples for the evaluation of biothreat detection assays, and 2) use of soil samples in the evaluation of candidate biothreat detection assays.

3. SPADA Consensus Standards for In Silico Analysis

Leads: McIver/Coates

Synopsis: There is no consensus on the use of in silico PCR analysis, therefore, the standard will address this gap and will provide the biothreat detection community with a consensus regarding the application of in silico PCR analysis. Develop a formal standard describing the application of in silico polymerase chain reaction ( PCR) analysis to biothreat agent assays to predict the overall accuracy and potential cross-reactivities of biothreat agent assays. The standard will prescribe the procedures for the use of in silico PCR

AOAC Board of Directors June 12-13, 2018

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II. 2018 Business Plan Progress Q2 E. Sustainability: Viable Contracts/Business Proposals analysis so that different analysts and laboratories working separately will achieve equivalent results, and thus build confidence in in silico PCR analysis results.

4. SPADA Consensus Standards for Bacteria Verification

Leads: McIver/Coates

Synopsis: It is not an uncommon occurrence for an investigator to discover that a bacterial culture is not what it is purported to be in terms of species or strain. There is no consensus on the process to authenticate bacterial strains. A standard would provide the biothreat detection community with a consensus standard regarding the minimum characterization that should be performed to authenticate the strain/species of a bacterial culture before using in any investigation or evaluation.

5. Cannabis

Leads: Coates/Senior AOAC Management

Synopsis: AOAC has been involved with the cannabis industry for a little over a year developing SMPRs for cannabinoids in plants, extracts and edibles. This experience has given AOAC insight and connections to this emerging community. Approximately 23 US states have legalized possession and use of marijuana. Marijuana is illegal at the federal level and not regulated at the federal level. Therefore, the federal government is unwilling and may not be allowed to lead the states on analytical issues. There is a lot of confusion at state laboratories on many analytical issues. There is no consensus and no apparent mechanism to develop consensus. There is a gap for a venue for the state labs where analytical issues can be identified, prioritized, discussed, and consensus arrived at. The proposal is to create an AOAC subsidiary [Cannabis Analytical Science Association (CASA)] to service the government (state, provincial, and/or federal) laboratories. CASA would limit its scope to analytical science of cannabis only.

6. SPIFAN – Next Phase

Leads: Meiklejohn/Coates

Synopsis: The current SPIFAN project is scheduled to be completed in September 2018. AOAC needs to develop a proposal for projects beyond September 2018 that will incorporate more of the “a la carte” new products, and meet more of the needs of the infant formula industry.

AOAC Board of Directors June 12-13, 2018

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II. 2018 Business Plan Progress Q2 E. Sustainability: Viable Contracts/Business Proposals

7. Food Fraud

Leads: Meiklejohn/Coates

Synopsis: AOAC Board members have expressed an interest in expanding AOAC’s footprint in the area of food fraud. In particular, Board members have expressed interest in non-targeted testing. The basic concept for this proposal would be to create a funded non-targeted testing OMA program. The analytical concept for non-targeted testing is different than traditional AOAC methods that detect or measure specific contaminants. It envisions that AOAC would need to survey existing non- targeted testing guidance and adopt as AOAC guidance, or revise as necessary. An advisory group would be formed to identify top priority commodities/foods. Sponsors with interests in the top priority commodities/foods would then be solicited to sponsor projects to develop standard profiles for specific commodities/foods for specific technique combination. These standard profiles could potentially be adopted as AOAC standards which sponsors would have access to and non-sponsors would pay for access.

8. Dietary Supplements Methods Development

Leads: Frazier/Coates

Synopsis: AOAC is in the final months of completing a 5-year project to create SMPRs for 25 dietary supplement ingredients, and to evaluate and adopt as many methods as possible that meet the SMPRs. AOAC and NIH/ODS staff are in discussion regarding follow-on projects that may be proposed before 4 th quarter 2018.

9. Clinical Dietary Supplements

Leads: McKenzie/Frazier/Coates

Synopsis: AOAC staff was apprised of a potential opportunity by NIH for a program to evaluate clinical test methods for dietary supplements. The National Center for Complementary and Integrative Health (NCCIH) sponsors an array of research to see how dietary supplements might affect the body and tests their use in clinical trials. In fiscal year 2011, NCCIH supported approximately 200 research projects studying dietary supplements. Among these projects was an RFP for “Validation Studies of Analytical Methods for Dietary Supplements and Natural Products”. AOAC is considering preparation of a proposal to satisfy the RFP.

AOAC Board of Directors June 12-13, 2018

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II. 2018 Business Plan Progress Q2 E. Sustainability: Viable Contracts/Business Proposals

10. Codex Referenced Methods

Leads: McKenzie/Coates

Synopsis: AOAC OMB members have taken the lead in updating AOAC methods that are adopted by Codex Alimentarius in their food standards. Codex food standards “incorporate by reference” methods to be used to measure analytes, usually contaminants and nutritional analytes, in their Codex food standards. Many AOAC, as well as other organizations like ISO and IDF, methods are “incorporated by reference.” Many Codex food standards were created in the 1980’s and 1990’s, so many of the “incorporated by reference” methods are older. In fact, much of the impetus for the SPIFAN project was at its core intended to update the “incorporated by reference” infant formula methods. Several Board members have been very active in this process for infant formula methods. As mentioned before, AOAC OMB members have taken the lead in updating AOAC methods that are adopted by Codex Alimentarius in their food standards. There might be an opportunity to collect these updated methods into a new electronic product of collected Codex food standard methods. Additional AOAC products could include Proficiency Testing and AOAC certified reference materials.

11. Dairy

Leads: Meiklejohn/Coates

Synopsis: AOAC convened a Thought Leader Advisory meeting on February 15 th for infant formula manufacturers, dairy producers, contract laboratories, and technology providers with the goal of identifying future AOAC projects for infant formula and/or dairy. The group identified several areas for potential collaboration, further business development will require follow-up with key dairy contacts and engaged AOAC Board members. Further, AOAC ‘s current relationships with ISO and IDF could be both leveraged and strengthened by cooperative efforts in the dairy sector.

AOAC Board of Directors June 12-13, 2018

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

Top 8 New Products Ideas 1. AOAC RI Consulting Services

Background The Performance Tested Methods (PTM) program relies on the same technical guidelines used for the Official Methods SM program. However, the guidelines are general, and need to be applied to each test kit claims. This can be a difficult and time-consuming task for a test kit company, especially for a test kit company that has not been involved with AOAC before attempting an application. The AOAC Research Institute created a consulting program about 15 years ago to assist test kit companies to design their individual validation packages for PTM application. The program was well-received and has been very successful. Potential PTM applicants are offered a consulting service and are matched up with one of four or five AOAC contract consultants. The consulting service is not a requirement, but most (≈ 90%) PTM applicants choose to use the service. PTM- applicants can choose a flat fee of $3000 or choose to pay-by-the-hour for additional work. The applicant gets an approved PTM testing protocol based on their test kit claims. The flat fee and guaranteed approval of the test design are a huge draw. Some companies have spent much more money to design their own testing protocols which were then used to collect data (very expensive) which wasn’t acceptable to AOACRI reviewers (even more expensive since the PTM application fee were paid). Even more important to most test kit companies, delays to the approval timeline impacts their marketing campaign which are often predicated on obtaining the approved PTM certification mark. The consulting service program has many other benefits. It helps to streamline PTM reviews since the data packages are correct to start with. The consulting service program also builds a connection between the test kit company and AOACRI, leading to a more cooperative relationship with the goal of getting the fairest evaluation of a test kit. The AOACRI consulting service serves as a gateway for PTM applications and is priced to create the smallest possible financial barrier (cheap) on the premise that the service allows a company to “dip their toe into the water,” and then know what will be required to follow through. This builds customer confidence and trust. The pricing also recognizes that providing a low starting cost increases the number of complete PTM applications ($15,000) and even more importantly, many years of recertification income (usually 5 – 15 years at $3000 per year to renew). The consulting services program directly generates about $100,000/ year of break-even income. However, for every additional PTM application with ten years of recertification, the consulting service attracts income of $45,000.

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

Proposal The proposal is very simple: 1) expand the consulting services program to the Official Methods program for all potential method submitters; 2) expand the consulting services program to other anticipated certification programs such as the instrument certification program; and 3) create a more general consulting service program to address general analytical issues. The goal is to build on the current consulting service model where prospective customers will be offered consulting services when AOAC becomes aware of intentions to submit methods into the existing OMA program. In addition, the consulting service program could apply to all new certification programs being discussed now (instrument/equipment certification, OMA certification, application notes). Additionally, the consulting services could be employed by AOAC customers/members to resolve analytical questions and problems. These analytical questions and problems can be specific, such as which analytical methods should be used for their specific application. For example, a state lab wanting to know whether to use a plate count method or a PCR method to determine bacterial load in a given matrix. AOAC would recruit a pool of qualified contract consultants, just as it has for the current AOACRI program, but expand to a larger number of topics. It is envisioned that the contract consultants would be used on an as-needed basis just as is done with the AOACRI model. AOAC staff will coordinate the projects and assignment of contract consultants. Services to include: 1. Design and provide technical support for OMA and PTM testing protocols. 2. Design and provide technical support for planned certification programs for OMA, application notes, and instrument/equipment. 3. Technical writing services primarily related to but limited to validation manuscripts. 4. General scientific consulting related to analytical science. Potential Partners Technology providers and contract laboratories who have a variety of expertise but do not have a consulting service program themselves. Other science-based associations (that do not have a consulting service program themselves): IDF USP AOCS Potential Competition None, except independent consultants not working thru AOAC.

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

Financial Considerations Fee-for-service: 1. Flat fees for standard services 2. OMA & PTM protocol design: $3000/protocol or $100/hr

3. Tech services for other certification program: $3000/protocol or $100/hr. 4. Technical writing services: $250/hr. Or case-by-case quoted project prices. 5. General scientific consulting: $250/hr. Or case-by-case quoted project prices. 6. Contract projects: include a line item for consulting services.

It is expected that expanding the consulting services to OMAs will generate about a 50% increase in income ($50,000.)

Consulting service income could double or triple in several years if the three proposed certification programs (OMA, instrument/equipment, and application notes) are implemented.

Assumptions AOAC implements one of more of the proposed certification programs. Administered by the AOAC Research Institute using existing infra-structure. Therefore, AOAC RI to collect consulting service fees. Additional technical support from CSO for general scientific consulting projects. The primary function of the AOAC consulting services would serve as a gateway for expansion of AOAC certification programs.

Roll-Out Plan 1. Initial Exec Director review. 2. Review consulting application and agreements and modify as needed. 3. Legal review. 4. Recruit standing expert pool. 5. Determine required expertise. 6. Draft Contract. 7. Communication, media, marketing strategy. 8. Exec Dir approval for implementation. 9. Announce new services via AOAC communication channels.

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

2. License a service mark for Official Methods of Analysis. Rationale : The Performance Tested Methods (PTM) certification mark is an important marketing tool for both the company and AOAC. Some companies submit to the PTM program in addition to the Official Methods of Analysis (OMA) because the PTM program has a certification mark the companies can use in advertisements. There is no certification mark for OMA-approved methods. We think an OMA-certification mark would be useful to companies to promote their methods. Financial Expectation : Using the AOAC Research Institute model: set application fees at $15K for OAs and $20K for non-OAs; and annual renewal fees at $3k for OAs and $5K for non-OAs. Estimate 10 - 20 application fees per year and 80% renewal fees. Estimate same per unit cost and therefore same 10% net income as PTM model. 1 st year income ≈ $150K. 2 nd year income ≈ $174K. 3 rd year income ≈ $198K. Steps: • Gauge interest • Program and Policies o Pricing and business plan o Flowcharts/SOPs • Legal o Draft license agreement Rationale : The Official Methods of Analysis (OMA) product is a two-volume compendium of ca. 3000 methods for many analytes in many matrixes. This is fine for all-purpose libraries, but most laboratories would use a small fraction of the methods in the OMA. Also, manuscripts describing the validation results are not in the OMA compendia, but must be retrieved from the Journal of the AOAC International . It stands to reason that a more focused, stand-alone collection of Standard Performance Requirements (SMPRs), methods, validation manuscripts, articles, relevant technical manuscripts and presentation would be a very useful addition for laboratory libraries. It is envisioned that the product would be provided in electronic form with a print-on-demand option. Start with infant formula, dietary supplements, and food panel topics. Include a helpline and user feedback Financial Expectations : Cost – Minimum costs are anticipated. AOAC owns copyrights to most of the materials to be included; and materials are already formatted for publication. Estimate $5,000 production cost per stand-alone products. Assuming 3 topics = $15,000 investment. o Develop a certification mark o Mark/service registration • Marketing and communication plan 3. Rebrand and Repackage Official Methods of Analysis

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

Income - Guesstimate about 100 topical method manuals per topic sold at $400 per piece for a total of $40,000. Assuming 3 topical products ≈ $120,000 total income Steps: • Gauge interest • Determine pricing and costs.

• Marketing and communication plan • Assemble materials and resources. 4. License certification mark application notes

Rationale : Technology providers routinely provide “Application Notes” that describe procedures for using instruments/equipment to determine analytes in matrixes. One instrument typically can be used for tens of, or even hundreds of, different applications. Application notes are regularly submitted to AOAC in response to calls for methods. Application notes cannot be used for Official Methods of Analysis because they lack much of the required information. This business proposal envisions a slimmed down review process specifically for Application Notes. Technology providers would be required to provide data to support claims made in an Application Note. AOAC would review the data, claims, and application note and if the application note met certain minimum requirements, then a certification mark could be awarded to the technology provider to use on the application note. Financial Expectation : Using the AOAC Research Institute model: set application fees at $5K for OAs and $7.5K for non-OAs; and annual renewal fees at $2k for OAs and $5K for non-OAs. Estimate 10 - 20 application fees per year and 80% renewal fees. Estimate smaller per unit cost and therefore same 10% net income as PTM model. 1 st year income ≈ $50K. 2 nd year income ≈ $66K. 3 rd year income ≈ $82K. Steps: • Gauge interest • Program and Policies o Pricing and business plan o Flowcharts/SOPs • Legal o Draft license agreement

o Develop a certification mark o Mark/service registration • Marketing and communication plan

5. AOAC TV: Subscription based broadcasting and podcasting using video, social media, and podcasting outlets for Education, Training, and Webinars. Rationale : There is need to provide an effective and efficient educational, tutorial, and training experiences for members, customers, and volunteers. In the past, AOAC offered training on single laboratory validation, multi-laboratory testing. Currently, AOAC has orientations for SMPR

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

development, method approval processes, AOAC microbiology method validation, and expert review panels. Traditional AOAC education is in the standard slide presentation format containing overwhelming amounts of information and the reach to members and others is limited. Use of social media outlets and other technological advances allow for varying educational opportunities for varying segments of the AOAC audience. A recent recommendation by the AOAC INTERNATIONAL Board of Directors Task Force on RI Improvements supports the use of enhanced training materials in the form of narrated videos segmented into chapters. AOAC TV makes use of live and recorded broadcasting using video, enhanced streaming technology and streaming via social media (e.g., YouTube, LinkedIn, Facebook, Twitter) to engage AOAC members, volunteers, customers, and guests by allowing for segmented and multiple educational experiences. It also includes a podcasting component to expand the reach to the international scientific community It is envisioned that on a regular basis, AOAC could broadcast live or recorded videos and host podcasts providing instruction and information. These broadcasts and podcasts can be cataloged for future and ease of access by viewers and listeners. Depending on approved topics, technical staff, volunteers, and others would provide content for dissemination. ILM articles, Journal papers, or technical and method validation issues offer tremendous sources of topics for broadcasting and podcasting. Subscribers would also be able to recommend topics for content. Viewing and listening audience would need to subscribe to access content. Financial Expectation : Costs for production of and broadcasting live or recorded videos for future release can vary from low to high based on the streaming platform(s) used, format of content to be shared, the level of professional production required, and the interaction (if any) expected with the audience. Some social media outlets have low costs associated with video production. Podcasting costs will also range from low to moderate based on staff preparation time and using a professional audio production format. The AOAC Annual Meeting and the AOAC Mid-Year meeting also offer ideal venues for opportunities to produce video and audio for live and future broadcasting. Moreover, broadcasting and podcasting are efficient ways to expand AOAC’s reach globally and engage many more scientists who may not be aware of AOAC, and potentially draw in new members. Steps: • Program and Policies o Pricing and business plan o Flowcharts/SOPs o Topics • Marketing and communication plan

6. License certification mark to instruments/equipment

Rationale : AOAC has had requests to review and certify instruments/equipment. There are three scenarios where a certification mark for instruments could be useful and desirable:

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

1) Some AOAC OMA methods are based on a specific instrument on which multiple different methods can be applied. The instrument certification mark could be used to pull together multiple OMA methods that can be used with the specific instrument. The certificate could list all the OMA methods. 2) Some AOAC OMA methods provide instrument specifications, but leave it to users to decide what instruments can be used. The instrument certificate could be used by technology providers to identify that a particular instrument can be used for a method that only contains specifications. 3) Many AOAC OMAs name a brand and model, and then incorporate the term “or equivalent.” The instrument certificate could be used by technology providers to identify that a particular instrument meets the “or equivalent” requirements. This program would provide technology providers with additional recognition, and provide clarity to AOAC method users. Financial Expectation : Using the AOAC Research Institute model: set application fees at $5K for OAs and $7.5K for non-OAs; and annual renewal fees at $2k for OAs and $5K for non-OAs. Estimate 10 - 20 application fees per year and 80% renewal fees. Estimate smaller per unit cost and therefore same 10% net income as PTM model. 1 st year income ≈ $50K. 2 nd year income ≈ $66K. 3 rd year income ≈ $82K. Steps: • Gauge interest • Program and Policies o Pricing and business plan o Flowcharts/SOPs • Legal o Draft license agreement

o Develop a certification mark o Mark/service registration • Marketing and communication plan

7. License certification mark to reagents/reference materials Rationale : All AOAC OMA methods lists reagents, sometimes identifying a provider, but oftentimes without a reference to a provider. A few methods and most SMPRs identify potential reference materials. Some reagent and reference material providers might desire a certification mark that specifies that a reagent or reference material can apply to an OMA method(s), especially if another provider is identified in an OMA method or SMPR. It is envisioned that AOAC could provide a certificate that list a provider’s reagents and/or reference materials to their relevant application(s) to OMA methods.

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

Financial Expectation : Using the AOAC Research Institute model: set application fees at $1000 for OAs and $2000 for non-OAs; and annual renewal fees at $500 for OAs and $750 for non-OAs. Estimate 10 - 20 application fees per year and 80% renewal fees. Estimate smaller per unit cost and therefore same 10% net income as PTM model. 1 st year income ≈ $22K. 2 nd year income ≈ $25K. 3 rd year income ≈ $30K. Steps: • Gauge interest • Program and Policies o Pricing and business plan o Flowcharts/SOPs • Legal o Draft license agreement

o Develop a certification mark o Mark/service registration • Marketing and communication plan

8. Create Standard Instrument Performance Requirements (SIPR) Program

Rationale : AOAC’s Standard Methods Performance Requirements (SMPRs) program has been very successful. This proposal applies the SMPR concept to instruments and equipment.

There are several scenarios envisioned where SIPRs could be useful and desirable:

1) When consensus performance requirements for class of instruments is desired. 2) Develop SIPRs in conjunction with SMPRs when a specific analytical technique is identified in an SMPR. 3) SIPRs could be used to document minimum specifications when an AOAC OMA method identifies an instrument and then gives the “or equivalent” term. This program would provide technology providers with additional recognition and provide clarity to AOAC method users. Financial Expectation : Using the AOAC Research Institute model: set application fees at $5K for OAs and $7.5K for non-OAs; and annual renewal fees at $2K for OAs and $5K for non-OAs. Estimate 10 - 20 application fees per year and 80% renewal fees. Estimate smaller per unit cost and therefore same 10% net income as PTM model. 1 st year income ≈ $50K. 2 nd year income ≈ $66K. 3 rd year income ≈ $82K. Steps: • Gauge interest • Program and Policies o Pricing and business plan o Flowcharts/SOPs • Legal

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II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

o Draft license agreement o Develop a certification mark o Mark/service registration • Marketing and communication plan

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2018 Business Plan - Supplemental Presentation CASA: Opportunities for AOAC in Cannabis Analysis

AOAC has been involved with the cannabis analytical community for over a year now. AOAC adopted 3 Standard Method Performance Requirements (SMPRs) for cannabis analysis (see attachment 1) last year, and is working on a fourth SMPR for pesticides in cannabis. This project has provided AOAC an opportunity to become involved with and known by the fast-growing cannabis industry. Legalization of cannabis is a significant trend in the US and Canada. Cannabis is either legal in some form, or on the ballot for legalization, in 23 US states (see map), and in Canada this summer. There are many foods such as edible chocolate and brownies that incorporate cannabis. Many US states have started programs to test the safety of cannabis food products. The US federal government would normally provide technical expertise for food safety analysis. However, possession of cannabis is still a federal crime in the US, and therefore the US federal government has declined to become involved with testing of cannabis products. This has led to a chaotic situation for the states and contract testing laboratories. There is no federal oversight, nor a forum for discussion of common problems for the analysis of cannabis products. The lack of federal oversight and lack of a forum is leading to many questions (see article in attachment 3). There is an opportunity for AOAC to become more involved in the cannabis analytical community by providing a forum for discussion of common analytical problems. AOAC’s staff will present some new and exciting solutions for the cannabis community during the next Board of Director’s meeting.

AOAC Board of Directors June 12-13, 2018

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Attachment 1

Synopsis of Cannabis Standard Methods Performance Requirements

• AOAC SMPR® 2017.001 Quantitation of Cannabinoids in Cannabis Concentrates Methods will be able to identify and quantify individual cannabinoids (as listed in Tables 1 and 2) present in cannabis concentrates.

• AOAC SMPR® 2017.002 Quantitation of Cannabinoids in Dried Plant Materials

Methods will be able to identify and quantify individual cannabinoids (as listed in Tables 1 and 2) in dried plant materials.

• AOAC SMPR® 2017.019 Quantitation of Cannabinoids in Edible Chocolate Identification and quantification of individual cannabinoids (as listed in Tables 1 and 2) in finished edible chocolate as listed.

Table 1: Required Cannabinoids Cannabidiol (CBD) Cannabidiolic acid (CBDA) Cannabinol (CBN) Tetrahydro-cannabinol (THC) Tetrahydro-cannabinolic acid (THCA) Table 2: Additional, Desirable Cannabinoids Cannabichromene (CBC)

Cannabichromenicacid (CBDA) Cannabidivarinic acid (CBDVA Cannabigerol (CBG) Cannabigerolic acid (CBGA) Cannabidivarin (CBDV)

Δ8 Tetrahydro-cannabinol ( Δ8 THC) Tetrahydro-cannabivarin (THCV) Tetrahydrocannabivarin acid (THCVA)

AOAC Board of Directors June 12-13, 2018

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Attachment 2

AOAC Board of Directors June 12-13, 2018

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Attachment 3

AOAC Board of Directors June 12-13, 2018

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Attachment 3

AOAC Board of Directors June 12-13, 2018

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Attachment 3

AOAC Board of Directors June 12-13, 2018

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MASTER SCHEDULE

BOARD MEMBER

AOAC INTERNATIONAL Board of Directors June 12-13, 2018 AOAC HQ, Rockville, MD USA

Wednesday, June 13, 2018 Breakfast (8:30) Lunch (12:00)

1 Introductory Items (9:00) 1.1 Call to Order, Introductions, Announcements (DeAnn Benesh) 1.2 Review of Policy Statements, Agenda, and Past Meeting Minutes (Benesh) 2 Board of Directors & Executive Office Affairs (9:10) 2.1 Announcements from Closed Session (Benesh) 2.2 Strategic Plan Implementation (David Schmidt/Jonathan Goodwin/Benesh) 2.3 Finance Committee (Jonathan DeVries) 2.4 Fellows Committee Recommendations (Ron Johnson) 2.5 Wiley Award Winner – 2019 (Benesh) *

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3

International Relationships (10:00) 3.1 CAIQ (Darryl Sullivan) 3.2 Chinese Institute of Food Safety and Technology (CIFST)(Sullivan) 3.3 AOAC/ISO/IDF – CSIQ opportunity (Erik Konings) 3.4 Codex Committee on Methods of Analysis and Sampling (CCMAS) Meeting (Sullivan/Greg Noonan/Melissa Phillips) 3.5 Inter-Agency Meeting (IAM) (Sullivan/Konings)

4

Task Force Updates (1:00) 4.1 RI Process Improvements (Tony Lupo) 4.2 Nominations and Elections Processes (Brad Goskowicz) 4.3 Food Fraud (Samuel Godefroy)

4.4 MOUs (Goodwin) 4.5 Sections (Benesh)

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AOAC Board of Directors

DRAFT AGENDA SUBJECT TO CHANGE Highlighted Text indicates potential Board vote * Pre-meeting Materials Included

June 13, 2018 PAGE 1

MASTER SCHEDULE

BOARD MEMBER

5

AOAC Section Meeting Updates (1:20) 5.1 Sub-Saharan Africa (April) (Benesh) 5.2 Southern US (April) (Johnson) 5.3 China Section (May) (Benesh) 5.4 Midwest US (June) ()

6

Volunteer Board Leadership Updates (1:45) 6.1 Official Methods Board (Erin Crowley) 6.2 Research Institute Board (Deborah McKenzie/Patrice Arbault)

7 AOAC Stakeholder Panel Dashboards (Alicia Meiklejohn/Krystyna McIver/Dawn Frazier) (2:15)

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Annual Meeting (2:45) 8.1 AOAC Annual Meeting Report (Frazier) 8.2 Board Activities at the Annual Meeting (Meiklejohn)

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AOAC Board of Directors

DRAFT AGENDA SUBJECT TO CHANGE Highlighted Text indicates potential Board vote * Pre-meeting Materials Included

June 13, 2018 PAGE 2

AOAC INTERNATIONAL Board of Directors Meeting

December 13, 2017 AOAC Headquarters Rockville, MD, USA

Attendees:

Members

Organizational Affiliate Member Representatives (present for all or part of meeting) Erin Crowley, Q Laboratories John Szpylka, Merieux NutriSciences Linda Zhao, Abbott Nutrition

(present or for all or part of meeting)

DeAnn Benesh , President (3M Food Safety) Ronald Johnson , Immediate Past President (bioMerieux) Brad Goskowicz, President-Elect (Microbiologics) Jonathan DeVries , Treasurer (Consultant) Darryl Sullivan, Secretary (Covance) Jo Marie Cook, Director (FL Department of Agriculture Clay Detlefsen, Director (National Milk Producers Federation) Daniel Fabricant, Director-at-Large (Natural Products Association) Anthony Lupo, Director (Neogen Corporation)

Guests (present or on teleconference for all or part of meeting) Joseph Betz, NIH Office of Dietary Supplements

AOAC Staff (present for all or part of meeting) Scott Coates Arlene Fox Dawn Frazier Jonathan Goodwin Krystyna McIver Deborah McKenzie Alicia Meiklejohn Tien Milor Robert Rathbone Joyce Schumacher

Dan Schmitz, Director-at-Large (Abbott Nutrition)

Stephen Wise, Director (Retired, NIST)

Members Absent (with regrets)

Lei Bao, Director ( Nestle Food Safety Institute) Samuel Godefroy, Director (University Laval)

1.

Introductory Items 1.1 Call to Order, Introductions, Announcements

President DeAnn Benesh called a meeting of the Board of Directors to order at 1:04 pm EST on Wednesday, December 13, 2017. A quorum was declared based on the presence of the above members.

1.2 Review of Policy Statements The Board’s attention was called to the Association’s Bylaws and the Policies of Antitrust, Use of Association Name and Logo, and Conflict of Interest. President Benesh announced that the business of the Board meeting would be conducted in accordance to these policies. 1.3 Approval of December 13, 2017 DRAFT Agenda President Benesh presented the DRAFT Agenda for the December 13, 2017 Board of Directors Meeting. Motion: Sullivan/DeVries moved/seconded approval of the DRAFT Agenda as presented, with the request that AOAC staff members provide updates on future business prospects during agenda item 7: Midyear Meeting Preview/Stakeholder Panel Updates. Vote : PASSED UNANIMOUSLY 1.4 Approval of Past Meeting Minutes President Benesh presented past meeting minutes for review and approval. Motion: DeVries/Sullivan moved/seconded approval of the September 25, 2017 Board of Directors meeting minutes with a spelling correction in item 2.2. Vote: PASSED UNANIMOUSLY 2 Board of Directors & Executive Office Affairs 2.1 Executive Session Report The Board met in Executive Session on December 13, 2017. President Benesh summarized topics discussed during the meeting. Benesh mentioned the Board chose June 12-13, 2018, for the summer meeting. They also discussed AOAC’s international relationships, and the executive director search. Action Item: Benesh requested Jonathan Goodwin lead the staff in designing a dashboard template for slides for departmental/project reports at future Board meetings. 2.2 Finance Committee Report Jon DeVries, Treasurer, presented the Finance Committee Report, Treasurer. The Finance Committee met immediately prior to this meeting. In the nine months ending September 30, 2017, the Association experienced an accrual basis net gain of $182,135 on income of $4,378,970 and expenses of $4,196,835. DeVries explained that AOAC has incurred several unbudgeted expenses in 20017, including legal fees and search firm costs. Motion: DeVries/Cook moved/seconded cashing out $200,000 from the equity side of the Association reserve accounts to pay for the extra costs incurred in 2017. Vote : PASSED UNANIMOUSLY

*Complete reports/presentations referenced herein are included in the “December 2017 Board Meeting Book” and are available upon request*

AOAC Board of Directors December 13, 2017 Meeting Minutes

2.3 Consideration of the 2017 Association Budget The proposed 2018 Association budget was prepared by AOAC staff and discussed in detail during the Finance Committee Meeting. The proposed budget shows an estimated expense total of $5,534,523 with total income estimated at $5,622,703. The proposed budget includes expected income from a continuation contract with the Infant Nutrition Council of America, a contract with the US National Institutes of Health and the US Department of Defense. Motion: DeVries/Lupo moved/seconded approval of the proposed 2018 Association budget as presented. Vote: PASSED UNANIMOUSLY 3 Task Force Updates 3.1 Strategic Planning Co-Chairs Jonathan Goodwin and Ron Johnson provided updates on the progress on the collection of member feedback on AOAC’s DRAFT Strategic Plan, and provided a final draft version for consideration. The Task Force would plan to meet in January 2018 to determine if they need to continue or close the task force. Motion: Johnson/Sullivan moved/seconded approval of the strategic plan components: Mission, Vision, and Strategic Goals, as presented in the Board book. Vote: PASSED UNANIMOUSLY 3.2 Search Committee Chair Jon DeVries provided an overview of the process of recruiting and hiring a new executive director. Three candidates were interviewed by the search committee and the AOAC senior staff at AOAC HQ on December 12, 2017. The committee would be extending an offer before the end of the year, and hopes to onboard a new executive in early 2018. 3.3 Food Fraud Benesh reported that Chair Samuel Godefroy was in the process of recruiting and confirming members for the Food Fraud Task Force. 3.4 RI Process Improvement Chair Tony Lupo reported that the task force interviewed RI participants, contract labs, consultants, and expert reviewers; he will be creating a report with any recommendations for improvements to the RI processes by the Midyear Meeting in March 2018. Action Item: Benesh asked Lupo to also reach out to international organizations that work with the RI, such as MicroVal, NordVal, and AFNOR.

*Complete reports/presentations referenced herein are included in the “December 2017 Board Meeting Book” and are available upon request*

AOAC Board of Directors December 13, 2017 Meeting Minutes

3.5 Nominations and Elections Processes Brad Goskowicz described plans of the task force to conduct bylaws reviews and audits of governance practices, including the composition and make-up of the Board of Directors. The AOAC Nominating Committee should continue with its Call for Nominations and election planning. The Nominations Task Force plans to develop further guidance on candidate qualifications and possible ballot changes. 3.6 New TF: MOU and BOD Connection DeAnn Benesh proposed the creation of a new task force to examine the way AOAC handles formal relationships with other international organizations. This proposal came on the heels of AOAC signing a Memorandum of Understanding (MOU) with the Chinese Institute of Food Science and Technology (CIFST), and a potential agreement in negotiations with the Food Safety and Standards Authority of India (FSSAI). Benesh asked Jonathan Goodwin to lead the group, Dan Schmitz, Darryl Sullivan, DeAnn Benesh, and Brad Goskowicz volunteered to participate. Action Item: DeAnn Benesh and Jonathan Goodwin will finalize a Terms of Reference to define the mission of a new task force on AOAC and agreements with other organizations, and launch the task force. 4 International Cooperation 4.1 CIFST Dan Schmitz and Linda Zhao presented information on the AOAC and CIFST agreement. CIFST has created an advisory board and core team to lead the efforts for reviewing and updating GB testing method development process, planning a workshop for April 2018 with CFDA and CFSA, and introducing AOAC SMPR and method validation processes. 4.2 FSSAI Benesh provided an update on the status of an MOU drafted between FSSAI and AOAC. The president of the India Section Dr. Kaushik Banerjee has facilitated the negotiations. The MOU is expected to be signed in February 2018. 4.3 ISO/IDF Darryl Sullivan and Alicia Meiklejohn provided updates on AOAC’s cooperation agreement with ISO. AOAC and ISO personnel have been exploring ways to expand on the scope of the agreement, beyond just dairy/infant formula projects. Action Item: Determine whether AOAC will have a delegation participate in the April 2018 CIFST meetings.

5 Official Methods Board

*Complete reports/presentations referenced herein are included in the “December 2017 Board Meeting Book” and are available upon request*

AOAC Board of Directors December 13, 2017 Meeting Minutes

Erin Crowley, Chair of the Official Methods Board, provided a summary of OMB activities since the AOAC Annual Meeting. Crowley announced the election of Dr. Joe Boison (CFIA) as OMB Vice-Chair. The OMB established a working group to review AOAC methods in Codex STAN 234, beginning with methods in the Milk and Milk Products section. The OMB winter meeting will take place January 31-February 1, 2018; all board members are invited to attend.

6 Publications/Editorial Board 6.2 Launch of Electronic Inside Laboratory Management (ILM)

Robert Rathbone, Senior Director of Publications, and Joe Betz, Chair of the Editorial Board, presented updates to the Board. Beginning with the November/December issue, the ILM would be going digital. All international subscribers will begin receiving their issues in online format, allowing them to get information must faster and providing a cost savings to AOAC. Betz proposed that a seat on the AOAC Board of Directors be held by a member of the Editorial Board for improved communications, Benesh responded that as the Board and staff review governance and composition they would keep this in mind. 6.3 Journal Author Award Proposal Rathbone described a proposal to create an award for journal authors which could be presented at the Annual Meeting (the initial award would be given in 2019, to allow for a full year of papers to evaluate). Motion: Benesh/Sullivan moved/seconded approval of moving forward with the development of the Best Manuscript Award to Authors as presented to the Board. Vote: PASSED UNANIMOUSLY 7 Midyear Meeting Preview/Stakeholder Panel Updates 7.1 General Meeting Logistics Dawn Frazier and Alicia Meiklejohn provided general information about the 2018 Midyear Meeting. The meeting is scheduled for March 12-16, at the Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Hotel information can be found on the AOAC website and registration would be open soon. 7.2 Infant Nutrition Council of America – SPIFAN Sullivan and Meiklejohn described AOAC efforts to continue and grow the SPIFAN project. The SPIFAN stakeholder panel and expert review panel will meet on March 14, 2018 at the Midyear meeting. AOAC is hosting a Thought Leader Advisory meeting in late January/early February to engage other infant formula manufacturers, labs, tech providers, and the dairy industry.

7.3 Stakeholder Panel on Strategic Food Analytical Methods – SPSFAM

*Complete reports/presentations referenced herein are included in the “December 2017 Board Meeting Book” and are available upon request*

AOAC Board of Directors December 13, 2017 Meeting Minutes

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