Transcript ORA Laboratory Portfolio

FDA/ORA/ORS and FERN Update
Ruiqing Pamboukian, Ph.D.
Office of Regulatory Affairs/Office of Regulatory Science
U.S. Food and Drug Administration
AAFCO Mid-Year Meeting
San Antonio, Texas
January 11 - 15, 2015
2
ORA Organizational Chart
3
Office of Operations
Office of
Operations
Office of
Enforcement and
Import Operations
Office of Food and
Feed Operations
Office of Medical
Products and
Tobacco
Operations
Office of
Regulatory Science
ORA Regions
Food and Feed
Scientific Staff
Northeast Region
Medical Products
and tobacco
Scientific Staff
Southeast Region
Laboratory
Operations and
Support Staff
Central Region
Southwest Region
Pacific Region
Office of Regulatory Science (ORS)
organizational chart
ORS Director Brian
Baker (acting)
Deputy Director of Food and
Feed
Tim McGrath
Food and Feed
Scientific Staff
Director: Michael
McLaughlin
Deputy Director of
Medical Products and
Tobacco
Selen Stromgren
Medical Products and
Tobacco Staff
Director: George Salem
Laboratory Operations
and Support Staff
Director: LCDR Jean
Paul
5
ORS Website
http://inside.fda.gov:9003/ORA/OfficeofRegionalOperations/Division
ofFieldScience/default.htm
6
ORA Laboratory Locations
FCC
Cincinnati, OH
Forensic
Chemistry
WA
NY
MI
OH
CA
CO
KS
AR
GA
ORA Regulatory Lab
ORA Regulatory/Specialty Lab
PR
PA
MA
WEAC
Winchester,
MA
Radionuclides
7
Local Structure of an ORA Laboratory
ORA Science
Executive at Office
of Reg Science
Regional Food and
Drug Director
(RFDD)
Current line of
command
Chemistry Branch
Director
Quality System
Manager
Drug Chemistry
Supervisor
Support Staff:
Admin
Industrial Hygienist
Sample Custodian
Future line of command
Lab Director
• Analysts
• Lab
Technicians
Microbiology
Branch Director
Food Chemistry
Supervisor
Micro
Supervisor
• Analysts
• Lab
Technicians
Sensory/Filth
Supervisor*
*Sensory/Filth groups
may also appear under
Chemistry Branch in
some labs’ organization.
Roles and Responsibilities
Food and Feed Scientific Staff
• The Food and Feed Scientific Staff (FFSS)
responsibilities cover scientific issues (e.g. methodology,
lab selection) involving food and feed testing conducted
under FDA jurisdiction.
• Their testing coordination activities involve the 13 labs in
the FDA/ORA network as well as the cooperative
agreement laboratories within the Food Emergency
Response Network (FERN).
• The staff coordinates various testing assignments and
programs involving numerous FDA food safety issues as
well as FERN activities.
Roles and Responsibilities
Food and Feed Scientific Staff
• Examples include:
• Import and Domestic Acidified and Low-Acid Canned
Foods
• Domestic and Imported Cheese and Cheese Products
• Pesticides and Industrial Chemicals in Domestic and
Imported Foods
• Domestic and Imported Fish and Fishery Products
• Infant Formula Program
• Deep Water Horizon Testing Program (Reopening of
Gulf States fisheries)
• FERN: Proficiency testing Program, training program,
Cooperative Agreement Program
• ISO Laboratory Accreditation Program
Roles and Responsibilities
Medical Products and Tobacco Scientific Staff
 Coordinate all activities related to CDER, CDRH and CTP.
 Coordinate analytical response to pharmacy compounding
events
 Coordinate and provide analytical/compliance strategy for
drug/device/tobacco programs and assignments
 Solicit research interest from ORA laboratories in new
method development/validation to bridge analytical gaps
 Manage and prioritize capital equipment budget
 Manage workplan projections in drug/device/tobacco arena
 Identify new technology platforms to perform program work
 Form collaborations with Centers on analytical projects
Roles and Responsibilities
Laboratory Operations Scientific Staff











Laboratory Information Management System (LIMS)
Electronic Laboratory Exchange (eLEXNET)
Mobile Labs, Chemistry and Microbiology screening labs
FDA web posting Lab Information Bulletins (LIB)
Method Development and Validation Program (MDVP)
Component Automated Research Tracking System
(CARTS)
National Sample Distribution (NSD)
Equipment purchasing: VITEK, VIDAS
Technology transfer/development
ORS Science Seminar.
Whole Genome Sequence
12
ORA Labs Program Work
Work plan – Annual map for allocation of ORA resources (inspectional, collections, analytical
testing) to different areas of concern.
Centers, in dialogue with Field Committees, determine how ORA resources should be distributed.
ORA utilizes analytical capabilities in areas of chemistry, microbiology, radiochemistry, and engineering to
perform the designated program work.
ORA supports the various Centers in the following areas of testing.
Product
Areas of Testing/Analytical Activities Performed by ORA
Foods & Feeds
Pesticides, dioxins, mycotoxins, chemotherapeutics, color additives,
toxic metals, filth, select radioisotopes
Pharmaceutical Products
Active pharmaceutical ingredient testing, dissolution testing
Devices
Risk-identified products such as infusion pumps, catheters, surgical
tools
Tobacco Products
Flavor compounds in cigarettes, contaminants testing, substantial
equivalence
Nanotechnology
Method development and research activities
All products
Private lab package reviews
Analysts-on-inspections
ORA Analytical Capability Snapshot
Test
Main Instrument
Platform
Targeted Analytes
Pesticide
Testing
(fresh produce)
GCMSD, LC-MS/MS,
GCQQQ
Up to 670 pesticides
covered
Melamine Testing
(pet food, dairy products,
protein containing
processed foods)
GCMSD and
LCMSMS
Melamine, cyanuric
acid, ammelide and
ammeline
Oil Markers Testing
(seafood during Deepwater
Horizon Oil Spill)
LC-FLD and
LCMSMS
Polyaromatic
hydrocarbons (12 total,
7 being carcinogenic),
dispersant, toxic metals
Persistent Organic
Pollutants Testing
(feed, seafood)
GC X GC – TOF,
HRMS
40 compounds that
include dioxins, PCBs
and PBDEs
Radionuclide Testing
(milk, fresh produce after
Fuskushima Meltdown)
Gamma counters
Cs-134, Cs-137, I-131
Representative Picture
napthalene
13
14
Test
Main Instrument
Platform
Targeted Analytes
Filth Analysis
(bulk ingredients)
Optical Microscopes
Insects, glass shards,
metal scraps, etc
Toxic Metals
(candy, dinnerware,
seafood, juice, rice)
ICP-MS, portable XRF,
HPLC-ICPMS (speciation),
ICP-OES
Pb, Hg, Cd, Cr, As, etc
Microbiology
(fresh produce, cheese,
seafood, etc)
ELISA tests, selective
media, PCR, PFGE, WGS
Salmonella, E. Coli,
Shigella, Campylobacter,
Cyclospora
Mycotoxins
(grains, nuts, seeds, juice)
LCMSMS, HPLC
Aflatoxin, patulin,
deoxynivalenol,
fumonisins, ochratoxin A
Acidified and Low-Acid
Canned Foods
(canned foods)
pH Meters, headspace
GCMS
Preservation: pH and
water activity
Representative Picture
Aflatoxin
15
Test
Main Instrument
Platform
Targeted Analytes
Color / Food Additives
(processed foods)
TLC, LCMSMS
Banned colors, additives such
as rhodamine B, sulfites in
shrimp, dried fruits/vegs,
coumarin in “vanilla” products,
nitrosamines in baby bottle
nipples, benzoates in
beverages
Cosmetics
(face creams, hair sprays,
lipsticks, henna, hair/skin
dyes)
TLC, XRF, LCMSMS,
ICP-MS,
microbiological kits
Metals, microbiological
contamination
Forensic Chemistry
(drugs, tobacco, tampered
products)
General chemistry,
microbiology,
molecular methods
Packaging features, product
featuers, contaminant profiles,
country-of-origin analysis
Economic Adulteration
(honey, maple syrup,
pomegranate juice, olive
oil, pet jerky treats, juices)
GCMS, LCMSMS,
HPLC, isotope ratio MS
Anthocyanin pigment profile,
sugar profile, fatty acid profile,
protein profile
Veterinary Drug Residues
(seafood, milk)
LCMSMS, LC-QTOF,
ELISA Kits
Vet drug residues such as
chloramphenicols,
fluorquinolones
Representative
Picture
16
Test
Main Instrument
Platform
Targeted Analytes
Pharmaceutical Survey
Testing
(finished dosage forms,
raw APIs, parenterals,
excipients)
HPLC, dissolution
apparati,
spectroscopic
techniques
Drug potency, content uniformity,
split pill testing, impurities testing
Spiked Active
Pharmaceutical
Ingredients in Dietary
Supplements
(dietary supplements
with health claims)
LCMSMS
Erectile dysfunction active drugs,
weight loss drugs, anabolic
steroids, mood-altering drugs
Microbiology testing in
drugs (finished dosage
forms, injectables,
parenteral bags,
compounded human/vet
products)
Sterility testing
equipment,
endotoxin test
strips
Bacteria, fungi, bacterial
endotoxins
Consumer Complaints,
Adverse Events and
Outbreaks (drugs, foods,
pet foods, devices)
All available
chemical,
microbiological,
physical tools
Broad-band investigative testing to
identify causative agent: chemical
contaminant, microbiological
agent, manufacturing defect, etc
Representative
Picture
17
Test
Main Instrument
Platform
Targeted Analytes
Shelf Life Extension
Testing
(finished dosage forms)
HPLC, dissolution
apparati, stability
chambers
Drug potency, dissolution, pH,
water content, physical appearance,
functionality tests
Device Testing
(thermometers, catheters,
intrauterine devices,
forceps, tubing, pumps,
radiological health)
Various
instruments to
conduct
engineering
investigations –
fracture/fatigue
tests, software
tests
Medical devices, radiological health
devices
Tobacco Testing
(cigarettes)
LCMSMS, GCMS,
Smoking Machines
Flavor compounds, hazardous and
potentially hazardous compound
testing, nicotine levels, substantial
equivalence testing
Nanotechnology (dietary
supplements, food
packaging, feeds,
sunscreens)
Various physical
chemistry
instruments – TEM,
SEM, XRD, DLS
Broad-band testing to characterize
nanoparticles and elucidate their
physico-chemical properties
Representative Picture
18
Internal
Collaboration
•
CDER
CDRH
CTP
•
13 field
labs
CVM
OP
CFSAN
ORS
OFVM
NCTR
APHL
External
CollaborationAAFCO
AFDO
EPA
CDC
ACIL
CBP
Networks:
FERN
ICLN
NATRLN
USDA
Committees leading
collaboration
Scientific
Collaboration areas:
food and feed,
medical device and
radiation emitting
product, Tabaco and
pharmaceuticals
19
ORA External Collaborations
Food Emergency Response Network (FERN) – State Labs
Areas of interaction:
Sample analysis (complementary capacity, surge capacity)
Intelligence sharing
Data sharing
Augmentation of enforcement authority
Capability sharing/building
FERN labs augmented ORA analytical response in following incidents:
Melamine Contamination in Foods/Feeds (2008)
Deepwater Horizon Oil Spill (2010)
Peanut Butter from Peanut Butter Corporation of America (2008)
Toxic Metals Surveillance (2013-2014)
High Volume Microbiology Surveillance – Avocados (2014)
20
ORA External Collaborations
Organization
Interaction
Association of Public Health
Laboratories /Association of Food and
Drug Officials/Association of American
Feed Control Officials
(APHL/AFDO/AAAFCO)
Building a mutually reliant food/feed safety network of labs to
promote food/feed safety.
American Council of Independent
Laboratories (ACIL)
Collaborating on standardizing analytical requirements in
submissions from private labs to ORA in preparation for
conforming to FSMA mandates.
Science Board to the FDA
ORA is preparing for its cyclical Science Board Review
(performed on a rotating basis for every Center/ORA). ORA has
requested that the Science Board review ORA’s investment in FERN
and ISO Laboratory Accreditation as a
mechanism to create increased laboratory food safety capacity.
ORA’s last Science Board review occurred in 2008.
Centers for Disease Control (CDC)
Analytical reliance: ORA obtained microbial ID, fungal sequencing
training from CDC.
Customs & Border Protection (CBP)
Analytical reliance: CBP obtained training in melamine testing
methods from ORA.
North American Tobacco Research
Laboratory Network (NATRLN)
Alcohol and Tobacco Tax and Trade Bureau, FDA/CTP, FDA/ORA,
Health Canada, CDC, USDA forum to collaborate on setting
common tobacco standards: methods, terminology, etc
21
FERN Update – FDA large scale
surveillance assignment
BACKGROUND OF THE
ASSIGNMENT
•The Food Safety Modernization Act (FSMA) outlines a new
approach to food safety that is risk-informed and preventive in
focus
•Sampling process - serves as a mechanism to actively identify
risks and – when possible – identify areas where preventive
controls can be put into place to better protect public health
•As FDA increases its understanding of the sources of
contamination in high risk commodities/practices, it can more
effectively allocate resources to address public health risks
through compliance sampling, targeted sampling or other risk
mitigation strategies.
22
WHY AVOCADO?
•A CFSAN working group was established to perform a five year
review of microbiological sampling data.
•Development of a new analytical tool which calculated risk
scores of each commodity collected and analyzed over the past
five years based on the risk criteria
•Based on the ranking results from the analytical tool, the
following commodities were selected for FY 2014: sprouts
(seeds, spent irrigation water, and finished product), raw milk
cheese (aged 60 days), and avocados (whole pit fruit and pulp)
23
WHY AVOCADO?
FDA ranked foods based on a variety of criteria and
identify three foods to serve as surveillance sampling
pilot programs.
Food consistently causing illnesses or
linked to outbreaks
High consumption level; and/or
consumed by a high risk
Ready-to-eat (RTE) food population
Ingredient in ready-to-eat (RTE)
products
Food regularly comes in contact with
contaminated sources (water, or soil or
equipment) during growing, harvesting,
processing, or at retail
Food is intended to be cooked by
consumer
Processed or manufactured in a manner
without a "kill step"
24
MORE INFORMATION
•CDC reported the rise of guacamole and salsa as common
vehicles in foodborne outbreaks Emergence of Salsa and Guacamole as Frequent Vehicles of
Foodborne Disease Outbreaks in the United States, 1973–2008
•FDA’s limited sampling of avocado indicates the potential for a
high incidence of contamination in this commodity.
•Avocado products have been associated with six (6) recalls due
to the presence of foodborne pathogens from 2004-2011:
Salmonella in fresh avocado (n=1) and L. monocytogenes in
frozen/processed products (n=5)
25
OBJECTIVES OF
THE ASSIGMENT
•To explore new processes and parameters for sample
collections and analysis that will enhance the current FDA system
- usage of the FERN labs
•To fill knowledge gaps of microbiological hazards by determining
the prevalence of selected microbiological hazards (Salmonella)
in whole pit fresh avocados and L. monocytogenes in avocado
pulp
•To take appropriate enforcement action when positive samples
and environmental sampling findings are observed
26
REPORTING
(FERN labs and FDA staff)
•eLEXNET project folder housed all documents
related to the assignment
•Data reporting:
–FERN website – activation module
–Emails
–FDA FACTS data entry
–Communication from ORS to CFSAN, district offices
(both import and domestics)
27
RESULTS SUMMARY
•~689 samples received
•~682 sample analysis
completed
•70 L. mono confirmed and
CRO (~18% soak method)
- 1 confirmed L. mono (pulp
method)
•10 confirmed Salmonella
positive (~1.4%)
Labs
# of POS
MN
14
TX
10 (2 SLM)
PA
8
WA
7
IL
5
FL
3
OH
3
NC
2
CO
2
VA
2
MI
2
NMSU
1
NH
1
RI
1
28
FERN LAB SAMPLE DISTRIBUTION
90
Number of Sample Received
80
70
60
50
40
30
20
10
0
NMSU
OH
MI
MN
VA
NC
IL
TX
WA
PA
RI
FL
CO
NH
States Receiving Samples
29
PFGE/SEROTYPING/WGS
•FL serves as the primary Listeria serotyping and PFGE lab
•79 Isolates submitted for PFGE
•232 Isolates submitted for serology
•~106 uploads to the PulseNet Database via CFSAN
•WGS: 19 L. mono and 10 Salmonella isolates have been
sequenced by FDA Labs.
30
31
Questions?