RAC Meeting Minutes (March 26-27, 2003)
5100 Paint Branch Parkway, College Park
March 26 & 27, 2003
Wednesday, March 26
9:30 -9:40 a.m: Introductions
9:41 - 10:10 a.m: 3 minute updates
Peg Coleman & Michael Kasnia - (USDA/FSIS)
- The FSIS Listeria risk assessment evaluates the effectiveness
of post-lethality interventions in mitigating the risk of illness from
L. monocytogenes in deli meats. In January 2003, OMB was briefed on
this risk assessment. A public meeting for this risk assessment was
held on February 26, 2003. FSIS responses to public comments and peer
review input have been developed and included in the docket for the
FSIS RTE rule. For more information on this risk assessment, see: http://www.fsis.usda.gov/oa/topics/lm.htm.
- FSIS is working with ARS to revise the growth and
cooling curves used in the C. perfringens risk assessment. Data for
this assessment were provided by academia, industry and other governmental
agencies. Completion of this risk assessment is expected in the next
few months.
- Salmonella Enteritidis in shell eggs and egg products
risk assessment will be revised using FSIS baseline data being collected
on the level of Salmonella prior to pasteurization of egg products.
Egg baseline data is expected in April 2003, with the completion of
the risk assessment model and documentation later this summer.
- FSIS is working with Decisionalysis to develop a risk
assessment for Salmonella in ready-to-eat meat and poultry products
to evaluate the effectiveness of various lethality standards. A preliminary
model and report will be completed in mid-April. Risk assessors will
continue to work with risk managers to refine the model to provide outputs
to inform specific risk management questions.
- FSIS provided input to an USDA/ORACBA project on sensitivity
analysis (led by Chris Frey, North Carolina State University). The tools
developed from this project will be posted on the RAC clearinghouse
website.
- FSIS will participate in an upcoming (end of April)
2-day workshop on risk analysis with the Pan American Health Organization.
FSIS plans to present case examples involving Salmonella in eggs and
BSE.
Wendy Fineblum Hall - (USDA/APHIS)
- Hosting a Risk Communication Forum on April 2 from
1:30-4:00 at APHIS Conference Center, rooms C & D, 4700 River Road,
Riverdale, MD. Featuring Prof. Katherine McComas, U. MD, who will give
a primer on risk communication in the regulatory context and Dr Buchanan,
who will discuss communication between CFSAN risk managers and CFSAN
risk assessors.
Tanya Roberts - (USDA/ ERS)
- Official roll out on April 24 at 9:00 am for the foodborne cost calculator, an online model.
- Performance standards conference on Oct. 22
- She participated in the Joint FAO/WHO workshop on
Risk Characterization of Microbiological Hazards in Food, 23-28 February,
Copenhagen on the economics chapter.
- Proceedings from conference on sensitivity analysis will be published.
- Philip Smith, Texas Tech., will discuss risks from food crops grown with perchlorate-contaminated water.
- Catherine Logue, N. Dakota State U., will present food
safety risk assessment (contamination of turkeys in processing and risk
of human foodborne illness).
Rolando Flores (USDA/ARS)
- Submitted a paper describing effect of temperature
on the behaviour of E. coli O157:H7 in raw, irradiated ground beef to
Int. J. Food Microbiol..
- Researching competition models for behaviour of E. coli O157:H7 in raw ground beef containing defined and undefined spoilage flora.
- Currently modeling growth of Listeria monocytogenes
on cured ham slices (aerobic & anaerobic) including effects of
previous temperature history.
- New PMP 7.0 version will be available this spring.
Includes the following: new model for E. coli O157:H7 in sterile raw
ground beef from 5- 47º C; model for thermal inactivation of Salmonella
in beef; lag & no lag predictions in existing growth models; help
section with frequently asked questions; and associated model references
will appear within the output screen.
- Will be available on CD and internet-downloadable
version
- Will be available in 3 languages: English, Chinese & Spanish
- Will be available on CD and internet-downloadable
version
- ComBase Internet browser will be launched this spring.
- Studied distribution of E. coli O157:H7 in beef grinding.
One manuscript published (small scale grinding) and another in preparation
(Mid scale grinding).
- Also researched L. monocytogenes distribution in grinding.
- Will investigate distribution of Salmonella in grinding
process.
- Submitted an article on distribution of E. coli O157:H7
in beef produced by bowl-cutter to J. Food Prot.
- Continuing research in the development of transfer
coefficients for E. coli O157:H7 in fabrication step of beef processing.
- Starting to evaluate pathogen viability in the chilling
process of beef carcasses at -3 to 5º C and water activities above
0.9.
John Cicmanec - (EPA/ORD)
- Looking at homeland security treatment effectiveness
of killing or disinfecting various infectious agents in water.
- Boiling water spreads organisms
- Anthrax spores are more resistant to chlorination
than Giardia, but less than Cryptosporidium
- Chronic wasting disease (CWD) - Lymphnode biopsy procedure
for preclinical diagnosis
Stephen Schaub (EPA/OW)
- Looking at food chain control. Re-evaluating policies.
- Studying BSE & SE in blood supply.
- Counter terrorism using C. botulinum
- Provided Web address for information quality guidelines:
(www.epa.gov/qualityguidelines/index.html#reqcorr)
- 5 year plan: Safe Food, Drinking Water, and Safe Communities
Multi-Year Plans.
- Safe Food Multi-Year Plan supports implementation
of 1996 Food Quality Protection Act; Drinking Water Multi-Year
Plan; and Safe Communities Multi-Year Plan (includes biotechnology
research
for food & computational toxicology).
- Homeland Security Research Center focus is on
developing methods to clean up contaminated buildings, protecting
nation's drinking water and improving risk assessment techniques.
- Safe Food Multi-Year Plan supports implementation
of 1996 Food Quality Protection Act; Drinking Water Multi-Year
Plan; and Safe Communities Multi-Year Plan (includes biotechnology
research
for food & computational toxicology).
- EPA's science forum is May 5-7, 2003. There is no
registration fee, but need to pre-register for this forum.
- Petition on atrazine
Angela Ruple- (NOAA fisheries)
- Looking at total mercury levels in Gulf of Mexico,
fish associated with oilrigs and highly migratory fish. Equipment is
up & running.
- Attended Interstate Shellfish Sanitation Conference
(ISSC) Vibrio parahemolyticus management meeting. Annual ISSC meeting
is in August.
Erik Torring DOD/VSA
- Studying vulnerability of food supply and infrastructure.
- Rapid diagnosis for select agents.
Robert Hall (NIH/ NIAID)
- He has replaced Dennis Lang, who moved to NIEHS in
N. Carolina.
- Located in Enteric and Hepatic Diseases Branch in Division
of Microbiology and Infectious Diseases
- Branch oversees extramural activity in enteric bacterial
and viral diseases.
- Background in Vibrio, Listeria, and Campylobacter.
Mary Bartholomew - (FDA/CVM)
- Looking at BSE antibiotic resistance.
- Court case on fluoroquinolones. See Oct. & April
regulations
- Involved in April 25th FDA Science Forum session on
cancer risks. Dr. Albert Keeney will present genetics of structure function
model.
- John Bowers also participated in the Joint FAO/WHO
workshop on Risk Characterization of Microbiological Hazards in Food,
23-28 February, Copenhagen.
- Previously there was a workshop on Guidelines for
Risk assessment and the Exposure Assessment is now out for review.
- Revised Listeria monocytogenes and Vibrio parahaemolyticus
risk assessments nearing completion - In the L. monocytogenes risk
assessment, most food categories have similar risks as estimated in
the earlier
draft." In the V. parahaemolyticus risk assessment, although there
were some modeling changes, the overall results are similar to the
previous
model's results. Both will be completed this spring.
- Discussed JIFSAN's professional development training
program. Last summer they piloted a 14-day web-based risk analysis overview
course. Funding came form a CSREES grant. Currently working on web-based
risk assessment and risk communication courses.
Cristina McLaughlin (FDA/CFSAN)
- Significant changes in Food Safety Risk Analysis Clearinghouse:
- New section on nutrition labeling
- Working on epidemiology section with emphasis on a thesaurus on risk assessment terms.
- NFPA Listeria risk assessment was published on the Clearinghouse March 27, 2003.
Marianne Miliotis - (FDA/CFSAN)
- An application of V. parahaemolyticus risk assessment
model was proposed to ISSC as a possible alternate plan for reducing
illness due to this organism at the V. parahaemolyticus management meeting
earlier this month.
- First International conference on Microbial Risk Assessment
(ICMRA) - Proceedings: Expecting 2 more documents by the end of the
month, then will proceed with publishing.
- Last May CFSAN initiated implementation of the CFSAN
Risk Analysis Framework. Three risk assessments have been selected and
about to start the data feasibility evaluation.
- Announced 2003 CSL/JIFSAN Joint Symposium on Food
Safety and Nutrition: Risk Analysis, June 11-13 at Inn and Conference
Center, U. MD. Registration for government is $175 due before May 116,
2003.
10:15 - 11:15 a.m: 5 minute work group updates
Dose-Response Work Group - Marianne Miliotis (CFSAN)
1) Mechanistic dose-response data from animals, humans
and tissue culture - Peg Coleman (FSIS) and Marianne Miliotis (CFSAN).
- Objectives are:
-
1) compiling and interpreting mechanistic data for
modeling variability (host, pathogen, environment, and interactions)
for dose - response;
2) interpreting evidence for selected pathogens; and
3) describing potential improvements to current dose-response models for predicting adverse endpoints in humans from foodborne or waterborne hazards.
- Status:
- Angelo Turturro (NCTR) presented "Target
Dose Concept Applied to Microbial Risk Assessment" at the
September quarterly meeting.
- Peg Coleman discussed "Mechanistic Dose-Response
Data From Animals and Humans" at this meeting.
- Marianne Miliotis (CFSAN) will highlight "mechanistic
Dose Response Data From in Vitro Studies at the fall quarterly
meeting.
- Angelo Turturro (NCTR) presented "Target
Dose Concept Applied to Microbial Risk Assessment" at the
September quarterly meeting.
2) 3 clinical and animal DR grants - Marianne Miliotis (CFSAN)
- LM in Rhesus monkeys - UGA: published 1 paper in collaboration
with CFSAN personnel; currently extending studies on a contract with
FDA/CFSAN.
- Cryptosporidium parvum -TUFTS/UTX Med School: delivered
several presentations and papers. Project is completed with following
conclusions: mouse model is unsuitable surrogate to the majority of
C. parvum isolates, but useful for discerning isolate-specific differences
in pathogenicity.
- Vibrio spp. - UMD: Animal study results presented at
101st Am. Society for Micro. May 20-24. Project has been terminated.
Performance Standards Work Group - Janell Kause (FSIS)
- A proposed 2-day public meeting is planned on "Perspectives
Regarding Performance Standards: Risk Assessment and Economics" to
be held October 21-22, 2003.
- The Oct. 21st risk assessment session is awaiting
approval from FSIS later this month. Given FSIS present commitments
for public meetings and the soon to be delivered NAS report on performance
standards, FSIS has elected not to co- host this meeting at this time.
- The Oct. 22nd economic portion will be held at the
Economic Research Service Building, 18th & M Street, Washington,
DC.
Biological Terrorism Treat Assessment Tools/Methodology Work
Microbial Risk Assessment Framework - Wes Long (CFSAN)
- Draft "Interim Observations on the Practice of
Microbiological Risk Assessment" by Charlie Yoe has been reviewed
by the work group and is ready to be presented to RAC Policy Council
for review and clearance.
11:15 - 12:00 a.m.: Begin FY 2004 annual plan discussion (data quality)
The afternoon session featured the following presentation:
- EPA's Council for Regulatory Environmental Modeling
- Pasky Pascual, EPA/ORD, lead for EPA's Council for Regulatory Environmental
Modeling.
- Announced symposium on use of computerized environmental
models: May 14th, 1-3 p.m. at Woodrow Wilson International Center
for Scholars, 5th floor conference room. Located near Federal Triangle,
Washington, D.C. (http://wwics.si.edu/index.cfm?fuseaction=about.directions)
- Announced symposium on use of computerized environmental
models: May 14th, 1-3 p.m. at Woodrow Wilson International Center
for Scholars, 5th floor conference room. Located near Federal Triangle,
Washington, D.C. (http://wwics.si.edu/index.cfm?fuseaction=about.directions)
- RAC Dose-Response Work Group's "Mechanistic Dose-Response Data from Animals & Humans" - Peg Coleman
4:00 p.m: meeting ended
Thursday, March 27
9:30 am -1:00 pm Continue FY04 annual planning
1:00 pm -4:00 pm Policy Council meeting
-
1:00 pm -2:00 pm Presentations on Food Safety Risk Analysis
Clearinghouse by:
- Cristina McLaughlin (CFSAN/FDA)
- Hitesh Patel (UMD)
- Jennifer Hinton (UMD)
2:00 pm-4:00 pm The policy council representatives reviewed
the progress of the RAC towards FY03 annual plan goals, discussed and
approved Charter revisions, and commented on FY04 goals. The Draft "Interim
Observations on the Practice of Microbiological Risk Assessment" by
Charlie was presented to RAC Policy Council for review and clearance.
RAC Policy Council was asked to comment by the end of April. Revisions
are scheduled to be completed by May 16, 2003.
In attendance:
Peg Coleman USDA/FSIS
Janell Kause USDA/FSIS ('phone)
Michael Kasnia USDA/FSIS
Carol Maczka USDA/FSIS
Robert McDowell USDA/APHIS
Wendy Fineblum Hall USDA/APHIS
Michael McElvaine USDA/ORACBA
Rolando Flores USDA/ ARS
Mary Torrence USDA/ CSREES
Tanya Roberts USDA/ ERS ('phone)
John Cicmanec EPA/ORD ('phone)
Jacqueline McQueen EPA/ORD
Stephen Schaub EPA/OW ('phone)
Angela Ruple NOAA Fisheries
Spencer Garrett, NOAA Fisheries
Erik Torring DOD/VSA
Robert Hall NIH/NIAID
Mary Bartholomew FDA/CVM
Barry Hooberman FDA/CVM ('phone)
Angelo Turturro FDA/NCTR
Robert Buchanan FDA/CFSAN
Sherri Dennis FDA/CFSAN
Richard Whiting FDA/CFSAN
Cristina McLaughlin FDA/CFSAN
John Hicks FDA/CFSAN
Mary Bender FDA/CFSAN
Wes Long FDA/CFSAN
Marianne Miliotis CFSAN/FDA
Sharon Edelson-Mammel FDA/CFSAN
Carole Shore FDA/CFSAN
Agencies represented:
Veterinary Service Activity (DOD/VSA)
Environmental Protection Agency, Office of Research and Development (EPA/ORD)
Environmental Protection Agency, Office of Water (EPA/OW)
Center for Food Safety and Applied Nutrition (DHHS/FDA/CFSAN)
Center for Veterinary Medicine (DHHS/FDA/CVM)
National Center for Toxicological Research (DHHS/FDA/NCTR)
National Oceanic and Atmospheric Administration Fisheries (NOAA Fisheries)
Animal Plant Health Inspection Service (USDA/APHIS)
Agricultural Research Service (USDA/ARS)
Economic Research Service (USDA/ERS)
Food Safety Inspection Service (USDA/FSIS)
Office of Risk Assessment and Cost Benefit Analysis (USDA/ORACBA)
Cooperative State Research, Education, and Extension Service (USDA/CSREES)


