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RAC Meeting Minutes (March 30, 2005)

Quarterly Meeting

Agency Updates:

Department of Defense Veterinary Services Agency (VSA) and U.S. Army Center for Health Promotion and Preventive Medicine (CHPPM)
Brandolyn Thran

 

EPA National Center for Environmental Administration (NCEA)
Michael Broder
Deferred update to Stephen Schaub

 

EPA Office of Research and Development (ORD)
Lynn Papa

 

EPA Office of Water (OW)
Steven Schaub

 

FDA Center for Food Safety and Applied Nutrition (CFSAN)
Dick Whiting


Sharon Edelson Mammel

 

David Carlson

 

Marianne Miliotis

 

FDA Center for Veterinary Medicine (CVM)
Mary Bartholomew

 

Joint Institute for Food Safety and Applied Nutrition
Wesley Long

 

NOAA Fisheries
Angela Ruple

USDA Agricultural Research Service (ARS)
Andy Hwang

 

USDA Economic Research Services (ERS)
Tanya Roberts

 

USDA Food and Nutrition Service (FNS)
Margaret Venuto

 

USDA Food Safety and Inspection Services (FSIS)
Uday Desai

 

Carl Schroeder

 

New business

EPA Thoughts on Improving the State-of-the- Art in Microbial Risk Assessment

The questions addressed to the RAC included: can we and how should the RAC member agencies coordinate and work closer together? Is there a mechanism for formalizing relationships to work together more effectively? One answer was to get EPA management to contact management of the different agencies and formally request assistance. This was further discussed during the RAC Policy Council meeting (see below).

 

Presentation

Ronald Roy, FDA/CFSAN presented on “FDA Food Sampling Approaches”

 

RAC POLICY COUNCIL MEETING

Work Group Updates

 

Data and Information Quality Work Group

Dr. Celine Nadon (FSIS Microbiology Branch) has joined the workgroup.

The workgroup has met and reviewed feedback based on (i) our five-page document reviewing the actions different agencies were taking in response to the OMB directive on data quality, (ii) our questionnaire distributed among the RAC members to learn more about what RAC members perceived as the foremost challenges in ensuring data quality and what they were doing, if anything, to address these challenges, and (iii) our talk titled The Risk Assessment Consortium Working Group on Data and Information Quality: Towards a "Best Practices" Approach presented as part of a symposium on data quality at the 2004 Society for Risk Analysis General Meeting.

We propose authoring a brief article for a trade journal such as Food Safety Magazine (i.e., for the Ask the Regulator series) or Meat and Poultry, etc. to summarize the RAC workgroup's activities and what we have learned. Any such document would be cleared through the RAC and its member agencies prior to submission for publication. We would next like to explore developing a public meeting on data quality to be followed by potential development of a technical report.

The RAC Policy Council chair noted that this is an area of high interest and suggested a synopsis of the OMB Data Quality Act and how it affects regulatory agencies be prepared and provided to the stakeholders to give them a better understanding of the data quality requirements. It was also recommended by the RAC policy council that the work group seeks input from pesticide and chemical risk assessors.

 

Dose-Response Work Group

The DRWG is going on hiatus for a while. This would provide members of this work group an opportunity to join some of the other work groups, which require more members.

 

Peer Review Work Group

The Peer Review Working Group discussion document has undergone revision by the EPA WG member, Jackie McQueen, to ensure that the discussion about public comment specifies how the EPA views public comment. Subsequently, FSIS WG member, David Goldblatt, has made several changes and is reviewing the document to make sure it that it indicates future compliance with the final OMB Peer Review guidelines published in December 2004.

Much discussion evolved around the issue of public comments. Although public review may not be actual peer review, public comments are still useful. It was pointed out that with EPA’s IRIS program, the program is posted on the web, and although public comment is not sought, EPA will accept and address public comments.

The RAC Policy Council Chair highly recommended the work group ensure the document is consistent with the OMB guidance issued in December 2004. Specifically, use of the terms “highly influential” vs. “influential” peer review, when considering significance of the issue. It was also noted by the RAC policy council chair that with the new OMB guidelines, there is the option of using government experts for review of documents that are too sensitive for public review. It was suggested a letter be sent from the RAC to the different government agencies asking for a list of people with specific expertise in their areas.

 

Data Gaps Analysis Work Group

The group continues to seek feedback for the data gaps list "Data Gaps List for Selected Microbial Risk Assessments."  In addition to the announcement of the list through FSNET, the group plans to distribute the list in the upcoming annual meetings of International Food Technologists and The International Association of Food Protection.  The group would also like to seek feedback from RAC members and their assistance in distributing the list.  The list is available on the Clearinghouse Data Gaps Analysis Work Group Accomplishments page.

 

Microbiological Criteria Work Group

A six-member team has recently been formed which includes 2 modelers and one statistician with a specific task in mind.  The RAC Microbiological Criteria work group was charged with assisting the CODEX effort by developing principles for relating microbiological criteria to public health goals and the stringency of food and water control programs. 

The Group recently held a conference call and discussed its objectives and products that it would create.  Steve Schaub described EPA’s similar activities on controlling pathogens in drinking water and suggested our objectives are “to provide a criterion methodology for the United States food and water agencies and to assist CODEX develop international methodology.”  It was noted that two international working groups will be starting this fall to further refine the concepts of performance objectives, food safety objectives and microbiological criteria and to demonstrate their application for improving food safety.  Bob Buchanan suggested this RAC group advance ideas and develop examples that represent current US thinking on these concepts to assist the US participants in these meetings. 

The two meetings include:

  1.  A WHO/FAO Joint Expert Committee on Microbial Risk Assessment (JEMRA), which will probably meet near the end of the year in Kiel, Germany.
  2. An ICMSF/ILSI symposium and working group, which will meet in Washington in early November.  The RAC will participate with ILSI and ICMSF in developing the 2 day symposium for this latter meeting (see below).

The work group exchanged reprints and other documents to begin its deliberations.  Regular conference calls will occur leading up to these two international meetings.

 

Data Utility Work Group

The Data Utility Work Group invited Ron Roy to the quarterly RAC meeting to discuss sampling plans.  This talk was designed to help educate the group in regards to sampling plan and data collection issues so we may better design a discussion paper and fall seminar.

 

Risk-Risk Work Group

No update, but possible project to be discussed during the Policy Council meeting.

 

Risk Ranking Symposium

A group has been formed to organize the symposium for August 18th, as described above in new business.

 

ILSI/ICMSF/RAC Symposium

The symposium is being planned for the first week of November, at Gallaudet University, Washington, DC The focus of this symposium will be developing principles for determining microbiological criteria.

FAO/WHO will be conducting two consultations on how to use micro RA’s to establish health based microbiological criteria, performance criteria (as described previously by Richard Whiting).  Many groups are currently working on this; one group is the International Conference on Microbiological Specifications for Food (ICMSF).  The symposium will last 2 days and will focus on how to use RA to set criteria.  The RAC policy council chair requested and obtained the RAC’s blessing to offer the RAC as co-organizer/co-sponsor. This could enable some of the RAC members to participate in the 5-day work shop following the symposium. Focus this year is to generate examples for the consultation.  The RAC will send letters to member agencies for contributions towards the symposium.   Depending on the amount of money collected, there will be a registration fee to defray costs.  This would be an opportunity to raise visibility of the RAC worldwide.  General support from policy council recorded.  This is a joint industry, NGO, international activity.

 

Possible project for Risk-Risk Work Group

There’s a possibility that an international FAO/WHO risk assessment be requested on microbial risk to the public if use of active chlorine products that come into contact with food is banned. Basically, this could be better termed “Risk Optimization Activity”. Discussion followed on real world examples, such as pandemic outbreak of cholera in Peru after chlorination of drinking water was stopped. Another example includes removal of chlorine from chill tanks for poultry.

Role of the Risk-Risk work group would be to gather data for the risk assessment or become involved in the FAO/WHO risk assessment as part of the expert consultation. The RAC needs to play a part in the international arena.

 

EPA Microbial Risk Assessment Guidelines

In response to Stephen Schaub’s request that the RAC play a role in reviewing and/or working more closely with EPA on the various projects listed above, the RAC policy council co-chair reminded the RAC policy council designees and technical representatives that the RAC is a formal MOU of 17 agencies that support each other in their risk assessment activities. It was recommended, however, that before a letter is sent out to either the Policy lead or chief scientist of the different agencies, the RAC member agencies first conduct a self-assessment test; i.e., what resources do they have? How much can they provide? What are the successes and failures?

In attendance (* participated by phone):

Mary Bartholomew, FDA/CVM
*Mike Broder, EPA/NCEA
Robert Buchanan, FDA/CFSAN
David Carlson, FDA/CFSAN
*Uday Dessai, USDA/FSIS
*Sharon Edelson-Mammel, FDA/CFSAN
Andy Hwang, USDA/ARS/ERRS
*Wesley Long, FDA/CFSAN
*Michael McElvaine, USDA/ORACBA
Cristina McLaughlin, FDA/CFSAN
Marianne Miliotis, FDA/CFSAN
*Lynn Papa, EPA/ORD
* Tanya Roberts, USDA/ERS
*Ronald Roy, FDA/CFSAN
*Angela Ruple, NOAA Fisheries
Stephen Schaub, EPA/OW
*Carl Schroeder, USDA/FSIS
*Brandolyn Thran, DOD/CHPPM
Mary Torrence, USDA/CSREES
Iris Valentin-Bon, FDA/CFSAN
Margaret Venuto, USDA/FNS
Richard Whiting, FDA/CFSAN

 

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