RAC Meeting Minutes (December 18, 2003)
Quarterly Meeting
Agency Updates:
Centers for Disease Control and Prevention (CDC)
Welcome to Don Sharp - selected as new RAC technical representative
for CDC.
- International Conference on Emerging Infectious Diseases (ICEID) is Feb 29- March 3 in Atlanta, GA.
- CID articles – 25 of them, to appear in Clinical
Infectious Diseases in April of 2004
- Consumers' Willingness to Pay for Food Safety
The Foodborne Diseases Active Surveillance Network (FoodNet) 2002 population survey data were analyzed. Respondents were asked about their willingness to pay for an imaginary vaccine that would protect them against major food-borne pathogens for a certain duration of time. Each respondent's choice to accept or reject the elicited amount ($25,$50, $75 and $100) is treated as a function of type of pathogen (Salmonella, E. coli and Listeria), duration of prevention (one year, five years, ten years and lifetime), respondent's demographic characteristics, current health status, and awareness of food safety. Some of the preliminary findings are (other variables remaining constant): 1. Sixty eight percent of respondents were willing to pay a minimum of $25. When the amount was increased to $100, the number of respondents accepting the bid went down to 45 percent. 2. Estimated willingness to pay was higher if a vaccine was presented as being effective for a longer period of time.
3. Respondents were willing to pay significantly more for a hypothetical vaccine for E.coli than for vaccines for Salmonella or Listeria.
4. Younger respondents were willing to pay significantly more than elderly respondents. 5. Willingness to pay also varied by ethnicity. For example, Hispanic respondents were willing to pay more than non-Hispanic respondents for the same hypothetical vaccine.
Contact person at CDC: Bishwa Adhikari
DOD Veterinary Services Agency (VSA) and U.S. Army Center for
Health Promotion and Preventive Medicine (CHPPM)
Eric Torring (DOD VSA) – nothing to report
Brandolyn Thran, (CHPPM) – nothing to report
EPA Office of Water
Stephen Schaub
- Moving forward agency wide to develop EPA guidelines
for conducting microbial risk assessment. Working on final game
plan to send to Science Policy Council.
- For drinking water – plan a meeting in near future
to put together a thesaurus of terms within and outside EPA.
- Homeland Security Office is trying to develop a rapid Risk Assessment for microbials in food and water. The EPA Office of Water is supporting these efforts. Just getting started, appears to only involve EPA, not clear how it will go forward.
FDA/CFSAN
Dick Whiting
- October 16 - release of Listeria monocytogenes Risk
Assessment
- December 4 - held Public Meeting
- The FDA Risk Management team issued an outline for
implementation at the public meeting.
- Public acceptance of microbial RA among constituencies
has grown greatly in the past four years.
- Currently in the planning process for follow
up RA’s
on Listeria monocytogenes. For example, may look more closely
at selecting food categories, model through the process from
raw materials to consumption and illness, and look at the impact
of various interventions.
- Still challenging to get FDA program offices to understand
what a risk assessment can actually do and to define exactly
what should be calculated that improves their decision making.
- WHO/FAO L. monocytogenes risk assessment is in final editing stage internationally.
Marianne Miliotis
- Vibrio parahaemolyticus risk assessment modeling piece
is due to be completed December 19, 2003 . New version of risk
assessment includes much more output data to improve transparency.
Hoping to publish mid May.
- Foodborne Virus data feasibility evaluation - literature
review is complete. Five subject matter experts from CFSAN reviewed
literature on five viruses – Hepatitis A, Noroviruses,
Rotavirus, Astrovirus, and Adenovirus serotypes 40 and 41. Document
on recommendations in preparation for review by FDA leadership
team
- Data feasibility and literature review for future Listeria RA completed. Document on recommendations in preparation for review by FDA leadership team.
Wes Long
- The Joint Institute for Food Safety and Applied Nutrition rolled out their first online course, “Overview of Risk Analysis” as a workshop in conjunction with the Society for Risk Analysis Annual Conference last week.
FDA Center for Veterinary Medicine
Barry Hooberman
- The Draft Virginiamycin Risk Assessment is complete
and under senior management review. Discussions of RM strategies
are ongoing.
- Reasonable certainty of no harm legal standard is a
challenge to the risk assessors and risk managers and is currently
being discussed.
- A draft risk assessment on the human food safety
and target animal safety of cloned food-producing animals will soon
be publicly available. A public meeting of CVM's Veterinary Medicine
Advisory Council was held in November to discuss these issues.
- Transgenic animal issues are being raised, and may
require risk assessment in the future; but regulatory responsibility
and authority is unclear between FDA and other agencies. A lawsuit
may be filed to get FDA to regulate genetically modified “glowing” aquarium
fish.
- Greg Claycamp is working with CDER staff on risk-based GMP’s for prioritizing GMP inspections and other activities.
NIH National Institute of Allergy and Infectious Diseases (NIAID)
Robert Hall
- NIH National Institute of Allergy and Infectious Diseases (NIAID) The Food and Waterborne Diseases Integrated Research Network contracts were awarded, and the following research units are now available to the Division of Microbiology and Infectious Diseases (DMID) under contract.
In addition, the Regional Centers for Excellence (RCEs) were awarded:
These two initiatives will provide a valuable mechanism to get needed research accomplished that is not suitable for grant mechanisms.
- If the RAC is interested, we could hold a meeting in
Rockledge and have a presentation from the Project Staff
involved in the RCEs and FWD-IRN.
- Planning continues on an expert workshop to
be sponsored by DMID, FDA, and the Gates Foundation on Pediatric
Enteric Vaccines.
The estimated date is in the last week of April, just prior to
the 3rd International Conference on Enteric Vaccines (Montego
Bay, Jamaica).
- The (NIAID) has awarded a five year contract to The Institute for Genomic Research (TIGR) to establish the Pathogen Functional Genomics Resource Center (PFGRC). The PFGRC is a centralized facility providing the research community with resources necessary to conduct functional genomics research on human pathogens and invertebrate vectors of infectious diseases. TIGR is developing microarrays for many important pathogens including Listeria monocytogenes and Helicobacter pylori, Salmonella Typhimurium, and others. The application form to use in applying for these reagents is on the following websites More info.
USDA Agricultural Research Service (ARS)
Andy Hwang, works in the Predictive Microbiology and Risk Assessment
group at ARS Eastern Regional Research Center
- Pathogen modeling program – V7.0 launched last
week. New features include– embedded publications; also
lag and no-lag time toggle feature available. Also includes FAQ’s.
- Version 2 of COMBASE will be finished early in 2004.
30,000 data points now (6,000 increase).
- Tom Oscar moving into the new building at UMES.
USDA Cooperative State Research Education, and Extension Service
(CSREES)
Margaret Venuto
- CSREES published 2 requests for proposals – National
Integrated FoodSafety Initiative – due December 19, 2003.
- The Epidemiological Approaches to Food Safety (NRI 32.1) deadline is March 16, 2004
USDA Food Safety and Inspection Service (FSIS)
Peg Coleman
- Reorganization/new hires. Michael Kasnia continues
to serve as Acting Director of Risk Assessment Division. Selection
of the permanent Director will be announced at the next quarterly
RAC meeting. On December 28, Janell Kause will serve in a new
position as Senior Public Health Scientist for the Office of
Program Evaluation, Enforcement and Review of FSIS. She will
continue her role as the co-lead for the RAC Peer Review Work
Group.
- Revised FDA/FSIS Risk Ranking
of RTE Foods for Listeria Roll Out. Carol Maczka and Janell Kause coordinated
with FDA in the roll this fall of the revised Quantitative Assessment
of the Relative Risk to Public Health From Foodborne Listeria
monocytogenes Among Selected Categories of Ready-to-Eat Foods.
This collaboration culminated in a public meeting held on December
4, 2003.
- Regulatory Peer Review and OMB Bulletin. Carol Maczka
and Janell Kause are part of an FSIS work group that has developed
comments on the August 29, 2003 Office of Management and Budget
proposed bulletin on regulatory peer review. These comments will
be submitted as part of a USDA response to the OMB on this issue.
In addition, this FSIS work group is also working to develop
guidelines/standard operating procedures for peer review of regulatory
analyses, including risk assessments, within FSIS.
- Comparative L. monocytogenes Risk Assessment
for Deli Meat Sliced and Packaged at Retail versus In-plant. Project Leader
Heather Hicks-Quesenberry will be working with Elke Jensen, Mike
Kasnia, Carol Maczka, and Dan Gallagher (Virginia Polytechnic
Institute and State University) to collect data and modify the
current FSIS Listeria risk assessment to evaluate the risk of
listeriosis from deli meats sliced and packaged in-plant versus
at retail. This project involves the collection of state and
industry retail L. monocytogenes contamination data for deli
meats and will involve additional support from Martin Wiedmann
at Cornell University.
- Listeria Verification Sampling. Project Leader Heather
Hicks-Quesenberry will be working with. Dan Gallagher of Virginia
Polytechnic Institute and State University to modify the FSIS
Listeria risk assessment to evaluate the effectiveness of targeted
Listeria verification sampling protocols.
- E. coli O157:H7 Verification Sampling. Project Leader
Uday Dessai will be working with Wayne Schlosser to develop targeted
verification sampling protocols for E. coli O157:H7 in beef.
- Clostridium perfringens risk assessment.
Neal Golden is serving as Project Leader with Edmund Crouch of Cambridge
Environmental contracted to complete a risk assessment for C.
perfringens in RTE meat and poultry. Uday Dessai is the COTR
for the contract. Once complete, this risk assessment will be
externally peer-reviewed and revised in response to those comments.
It will then be used, along with a cost-benefit analysis, to
inform the FSIS rulemaking on stabilization standards for ready-to-eat
and partially cooked meat and poultry products.
- BSE risk assessment. Terry Disney, Uday Dessai, Carol
Maczka, and Elke Jensen continue to work with other staff in
the FSIS Office of Public Health Science, the Office for Policy
Planning and Development (OPPD), as well as colleagues from Harvard
Center for Risk Analysis, Tuskegee University, APHIS, and the
FDA Center for Veterinary Medicine, to develop scenarios to address
policy questions and identify high-risk materials that require
further management control.
- Salmonella Enteritidis Risk Assessment (SERA)
Revision.
Project Leader Carl Schroeder continues to work with the SERA
team and RTI to prepare a draft of the revised Salmonella Enteritidis
in shell eggs and Salmonella spp. in egg products risk assessments.
This draft will initially be provided to the FSIS OPPD for internal
review in December. Carl is also managing the contract with SAIC
to administer the external peer-review process for the revised
SERA documentation.
- E. coli Risk Assessment (ECRA) Revision. Neal Golden
and Wayne Schlosser serve as co-leaders on a new team to begin
addressing public comments and recommendations of the National
Academies committee for revision of the E. coli O157:H7 risk
assessment in ground beef. The team will also coordinate the
development of an expert elicitation designed to address certain
data gaps identified by the NAS report.
- Campylobacter in poultry risk
profile/feasibility study. Project Leader Peg Coleman expanded her work on a feasibility
study for campylobacteriosis to address the needs of the Codex
Committee on Food Hygiene work group for a campylobacteriosis
risk profile. Additional data analysis is underway relating to
both exposure assessment and dose-response assessment from the
WHO/FAO draft Campylobacter risk assessment in poultry. Analysis
of USDA datasets for Campylobacter enumeration and intervention
are underway, and risk factors identified by epidemiologic studies
are under study. In addition, new human data were presented to
the RAC Dose-Response Work Group by colleagues at the Naval Medical
Research Center on December 17 that address dose-response assessment
issues for campylobacteriosis.
- Lethality for RTE products. Elke Jensen and Carl Schroeder
serve as co-leads on a risk assessment with the objective of
modeling the impact of the Salmonella lethality performance standards
for ready-to-eat (RTE) meat and poultry products with Greg Paoli
of Decisionalysis. This risk assessment will subsequently be
externally peer reviewed, revised, and used to inform, along
with a cost-benefit analysis, to inform the FSIS rulemaking on
lethality performance standards for RTE meat and poultry products.
- SOPs for eliciting information
and data from industry sources. Mike Kasnia is preparing standard operating
procedures (SOPs) for RAD and OPHS for the collection of data
from industry for future risk assessment work. Historically,
industry specific manufacturing and operational data account
for a high percentage of data gaps. Initial meetings with industry
representatives have been positive.
- Use of risk assessment approach
in food biosecurity. Carol Maczka and Abdel Kadry continue to work with
other colleagues from FDA/CFSAN, USDA/FNS and scientists from
academia, and a contractor to examine various scenarios by which
terrorists could tamper with the food supply. Also, they study
the best mitigation strategies and agency preparedness. The information
generated from this project has been used to inform the upper
management of laboratory testing needs for biological and chemical
agents. Also, the information will be used to inform the procedures
we follow under the Homeland Security color-alert system.
- Use of Risk Assessment in FSIS Recall and Trace
Back.
Project Leader Abdel Kadry is providing FSIS/ Recall Management
Division (RMD) with toxicological evaluation and hazard characterization
in the recall cases that involve chemical contamination or mis-labeling.
The Recall Committee recommends class determinations for each
of the examined cases.
- Use of risk assessment in FSIS regulated products Disposition. Abdel Kadry leads this team addressing chemical risk assessment (hazard identification and hazard characterization) with the FSIS Technical Service Center (TSC). The information is used in disposition of products that exposed to chemical or physical adulterants.
Carl Schroeder
- Draft RA's for Salmonella Enteritidis in shell eggs
and Salmonella species in egg products. Will pass on to managers
by
end of the year.
- NAS toxicogenomics group is planning a public meeting in April
2004 - targeting use of "omics" technologies in risk
assessment. Carl will forward info to RAC.
- RA for lethality standards for RTE meat products also coming to an end, ready for policy review.
Welcome to David Goldblatt - a new AAAS Risk Policy Fellow at FSIS - working on peer review, the ECRA revision, and Salmonella spp. risk assessment and performance standard activities.
Welcome to Abdel Kadry. Abdul wants to explore how the RAC can help identify human resources to evaluate RA. Can the RAC help? (Suggestion from Margaret Venuto to use CSREES database of reviewers).
USDA Office of Risk Assessment and Cost Benefit Analysis (ORACBA)
Michael McElvaine
- Working on EPA pesticide issues in Washington state.
- A number of OMB initiatives coming down in the next six months
Workgroup Updates:
Dose-response workgroup
Report from Lead - Peg Coleman (FSIS)
The RAC DRWG expanded its membership and scope for FY 2004. New
participants include: Dave Tribble and Pat Guerry, US Naval Medical
Research Center; Lynda Kelley and Neal Golden, FSIS Office of Public
Health and Science; Steve Anderson and Dennis Kopecko of FDA Center
for Biologics Evaluation and Research; Rich Raybourne, FDA Center
for Food Safety and Applied Nutrition; and Steve Schaub EPA Office
of Water. The scope in 2003 was a more general compilation of data
on animal and human models for dose-response for many enteropathogens.
In 2004, the group selected campylobacteriosis as its first case
study to develop in more detail. The group met on October 28 and
December 17 to discuss human, ferret, and in vitro data for campylobacteriosis.
Future seminars are planned in the next two quarters to develop
additional case studies that will be compiled into manuscript format
by work group members in summer 2004. The goals of the manuscript
are to incorporate additional mechanistic data into dose-response
models to more realistically describe variability in each aspect
of the disease triangle (host, pathogen, and environment, and interactions).
Data quality workgroup
Report from lead - Carl Schroeder (FSIS)
- After discussions at the RAC summer meeting, a workgroup was
formed – brainstormed four questions or tasks
- Summary of OMB guidelines
- Collection of web site links for agencies with data quality
guidelines
- Summary of data needs for Clearinghouse web site
- Development of a RAC document based on member agencies’ data
quality guidelines
-The workgroup produced a 5-6 page document which was made available at the last meeting.
-At the last RAC Policy Council meeting, October 1, 2003, the
Policy council recommended a change in the focus of the workgoup.
Carl recommends that the group meet with Carol Maczka and Bob Buchanan
to better articulate objectives.
- Workgroup will reconvene after clarification from policy council.
Risk-Risk workgroup
Workgroup lead is Elke Jensen
Report by Margaret Venuto
Workgroup members include: Margaret Venuto (CSREES), Abdel Kadry
(FSIS), Mark Walderhaug (CFSAN), Angelo Turturro (NCTR), Stephen
Schaub (EPA OW).
-Workgroup meeting held November 14, 2003. Objectives and goals
were to be drafted and sent to the rest of the group for review
and comments:
-Workgroup discussions included:
-rename group?
-Balancing chemical vs. microbial risk
-Addressing x-agency issues relative to risk - risk comparisons
-Agency experiences
-Common issues germane
-How should results be presented
-Seeking a series of presentations based on agency experiences
-Concept paper – useful to those who want to develop risk-risk comparisons
-Steve named a group who is interested in talking,
-EPA NCEA may be able to provide some insight in comparative risk
Data gap analysis workgroup –
Workgroup lead is Mark Tamplin. Mark wants to step down as the
lead. Andy Hwang may take over as lead.
-Group revised spreadsheets and getting it ready for posting on
the CH website. Hope to present at meetings to get the word out
to researchers.
Peer review workgroup (PRWG)
Workgroup co- leads are Mary Bartholomew (FDA/CVM) and Janell Kause
(USDA/FSIS); update presented today by Marianne
-Summary of September 30, 2003 Peer Review workshop is currently
being reviewed by the Policy Council co-chairs.
-Working on an outline for the discussion paper that will be the
deliverable of the work group. There have been several meetings
to discuss the issue. Next meeting planned for Jan 13.
-Looking at possible joint symposium on peer review and data quality.
Decided to wait until OMB guidelines are final before holding the
meeting and finalizing the peer review discussion paper. (Regulatory
agencies received an extension through January for responding to
the OMB bulletin.)
-Nov 18, NAS had workshop on regulatory peer review was attended
by many members of the PRWG.
Future presentations on Sampling
Marianne and Wes gave an overview. Sampling plan design impacts the utility of data for risk assessments. It was recommended at the October 1, 2003 RAC meeting to have presentations to help us understand the scope and impact of the problem, possibly as an all-day meeting.
Through the discussion, at least four different issues were identified, and several audiences.
Audiences:
- Risk Assessors who try to use data from surveys, surveillance, and studies to make predictions about the status quo and the likelihood of future events.
- Researchers who design and conduct sampling plans or programs
- Risk Managers who must respond to limited data (e.g., when only 1 positive sample is obtained in an e coli outbreak, what does this say about the other 1 million servings?)
Issues:
- Methodologies – e.g. MPN method and individual sample size (quantity)
- Statistical validity
- Sampling Strategies - representativeness and sample size (how many samples need to be taken?)
- Dose reconstruction
Discussion by RAC included mention of a number of existing sampling programs, for example:
- FSIS has 25 years of drug residue data, but have struggled
to find usefulness in terms of RA
- EPA OW has sampling frequency, quantity ,and size issues frequently
recur in rulemaking efforts
- CDC mentioned FDA-funded UNC study to extract viruses from food
matrices
- The Hart Building Anthrax cleanup – how clean is clean
enough?
- EPA OW has a treatise on sampling
- screening at Salt Lake City Olympics
- the Japanese have a restaurant food retention program.
-Because of the many issues and perspectives of potential audiences
if the presentations were to be held as a public meeting, a suggestion
was made to develop a scoping paper for the RAC Policy Council
by the March meeting.
-,The RAC might want to come up with an issues paper ahead of time
to help frame the meeting.
-A discussion also arose about whether this group really ought
to be a part of the data quality workgroup, since the issues are
inter-twined. Both use the same conceptual analysis – what
do you need to get a good answer that you can rely on? It was decided,
however, to keep it as a separate work group at least for the present.
-A possible name for the workgroup is the “Data Utility Workgroup.”
-Possible Workgroup volunteers:
Mary Bartholomew (CVM perhaps)
Peg Coleman (FSIS)
John Newland (CFSAN)
Michael McElvaine (ORACBA)
Steve Schaub (EPA OW)
Andy Hwang (ARS)
Brandolyn Thran, DOD/CHPPM
Presentations:
Carol Maczka, USDA/FSIS, RAC policy council co-chair, gave a presentation on “The USDA Food Safety Risk Assessment Committee.”
John Painter, CDC gave a presentation on “Allocating the burden of Foodborne illness by food commodity- the role of outbreak reports”
In attendance:
Peg Coleman, USDA/FSIS
David Goldblatt, USDA/FSIS
Robert Hall, NIH/NIAID
Barry Hooberman, FDA/CVM
Andy Hwang, USDA/ARS/ERRC
Abdel Kadry, USDA/FSIS
Wes Long, FDA/CFSAN
Michael McElvaine, USDA/ORACBA*
Marianne Miliotis, FDA/CFSAN
Stephen Schaub, EPA/OW
Carl Schroeder, USDA/FSIS
Don Sharp, CDC
Brandolyn Thran, DOD/CHPPM
Erik Torring, DOD/VSA
Margaret Venuto USDA/CSREES
Richard Whiting, FDA/CFSAN
* Attended by conference call
