FOOD & DRUG LABORATORY BRANCH

FOOD & DRUG LABORATORY BRANCH

Ensures the safety of Californians by providing: – services and leadership as a public health

reference and research laboratory – necessary analytical support to screen for,

identify and quantify chemical and microbiological contaminants in food and drugs

– regulatory services for substances of abuse laboratories

All activities implement and support legislatively mandated programs

Three Sections

Chemistry Microbiology

Abused Substances Analysis

FOOD & DRUG LABORATORY BRANCH

FDLB CURRENT ORG CHART

Chemistry Section FOOD & DRUG LABORATORY BRANCH

• Lead in Candies In support of AB 121 (2005), analysis of 1000-2000 samples per year

• Domoic Acid in Seafood In support of Food and Drug Branch (FDB) and the Marine Biotoxin Monitoring Program, analysis of 400-500 samples per year

• Other Analytes and Matricies Analysis of toxic metals, chemicals, and natural toxins in

foods, drugs, herbal medicines, supplements, and cosmetics • Food Emergency Response Network (FERN)

Total Arsenic, Arsenic speciation, ricin, biotoxins in seafood, mycotoxins in fruit/nut products, toxin screening of foods, inter-lab validation of methods

FOOD & DRUG LABORATORY BRANCH Chemistry Section

Notable investigations in 2014-2015 - CDPH Health Advisories issued on Feb 6, Jun 1, Jul 3, Aug 26, Oct 10th , 2015 - elevated levels of domoic acid in mussels, clams, scallops or organs of lobster & rock crab. - May 2014 - Mercury poisoning - skin creams brought from Mexico, contained more than 200,000 times the legal limit of mercury. - Sept 10, 2015 - ABC Shaped Cookies Banh Chu – elevated lead - Sept. 11, 2015 - Baby Spinach -tests found unacceptable levels of cadmium.

Cannabis legislation

• FDLB provides technical support to legislature for any bills that have applications in areas of food, drugs, cosmetics for public health

• AB 266, AB 243, and SB 643 • Impact on laboratory for method development, proficiency testing,

and certification of laboratories that perform testing of medical cannabis and medical cannabis products.

• Testing listed in regulations – Medical cannabinoid profile, potency level, pesticide/herbicide/growth promoter residue testing, solvent residue testing, metals analysis, fungal toxins, microbiological impurity testing, etc.

Food Packaging Safety

• Collaboration between DTSC, FDB, and FDLB in response to the European Container Glass Federation study for lead leached from glass bottles

• Concerns raised by DTSC over use of recycled glass that may be high in metals, used with food contact material

• FDLB & FDB Study of potential heavy metals (lead, cadmium, mercury, & chromium) leaching from glass containers to foods

• X-ray fluorescence of glass bottles, ICP-MS analysis of leachate from bottles using ASTM C738-94 (4% acetic acid, 24 hours), ICP-MS analysis of foods inside bottles

Metals analysis – validation of FDA method

• Inter-lab validation of FDA method EAM 4.7 • Chromium, Manganese, Nickel, Copper,

Zinc, Arsenic, Molybdenum, Cadmium, Mercury and Lead in foods

• 18 state and federal labs participating • Complete coverage of AOAC foods triangle

with food samples and reference material from each area, 6 RMs, 9 Foods, 1 dietary supplement, 1 water, 1 spice

• Submit as level 4 (multilab >8 labs) validation once completed

Mycotoxins – validation with FDA

• Validation of a new LC-MS/MS isotope dilution method • Current methods are analyte and matrix specific,

requiring multiple methods • New single method will allow a broad range of

mycotoxins and food matrices • Expand capability for testing, and allow testing for

mycotoxins where commingling of food types and contamination are a concern

Histamine- surveillance project • Scombroid food poisoning is one of the most frequently reported seafood

illnesses. • Unlike many other types of food poisoning, this type of food poisoning is

not caused by direct ingestion of a bacterium or virus. The amino acid histidine, existing naturally in many types of fish, is converted to histamine when temperatures go up to 16°C (60°F) and above.

• Survey of the levels of histamine in seafood from the Northern California Bay Area. Fresh, frozen, canned, fish sauce, dried fish and pouched fish samples were collected through a risk based sampling plan and analyzed

Types of fish Average Max Min N Action Level ppm(US)

EU Action Level (ppm)

Salmon (pouched)

10.5 16.4 6.52 10 50 50

Tuna (pouched)

1.76 7.65 ND 16 50 50

Histamine- surveillance pouched seafoods

0 2 4 6 8 10 12 14 16 18

TunaTunaTunaTuna

Chuck Light TunaTuna Salad

Albacore White TunaSolid White Albacore Tuna

Chunk Light TunaPremium Albacore

Omega-3 Albacore TunaPremium Light Tuna

Chuck White TunaWild Albacore Tuna

Albacore White TunaTuna Salad Albacore

Premium Wild Pink SalmonPremium Wild-Caught Pink SalmonPremium Wild-Caught Pink SalmonPremium Wild-Caught Pink SalmonPremium Wild-Caught Pink SalmonPremium Wild-Caught Pink SalmonPremium Wild-Caught Pink SalmonPremium Wild-Caught Pink Salmon

Pink SalmonSalmon

ppm histamine

Histamine- surveillance fresh seafoods

0 20 40 60 80 100 120 140 160 180 200

SardineSardineSardineSardineSardine

Fresh escolarFresh escolar

Tuna LoinWhole Milk fishRainbow trout

Albacore Tuna filletMahi Mahi fillet

Tuna MaguroTuna Hamachi

TilapiaSnapper

Salmon filletKing mackerel

Tuna (Hamachi)King Mackerel

ppm histamine

FOOD & DRUG LABORATORY BRANCH Chemistry Section Test list

FOOD & DRUG LABORATORY BRANCH Microbiology Section

• State Reference Laboratory for Food Microbiology Analysis for foodborne pathogens: E.coli O157:H7, Salmonella, Listeria, Campylobacter, Vibrio, Staphylococcus, Bacillus

• Outbreak response Microbiological analysis of over 3000 samples per year including food, drug, cosmetic, environmental, water samples and medical devices.

CDC PulseNET Certified Lab • Partners in Emergency Response Food Emergency Response Network (FERN): FDA, USDA CDC registered Select Agent Program : Anthrax, botulinum toxin, ricin CalFERT, State and local partners

FOOD & DRUG LABORATORY BRANCH Microbiology Section

• Notable investigations in 2014 - 2015: - Frozen Raw Tuna — Salmonella paratyphi B, Weltevreden, 65 cases, 11 states, March - July 2015 - Caramel Apples — Listeria monocytogenes, 35 cases, 12 states, 7 deaths, Oct 2014 - Jan 2015 - Nutritional Supplement (Chia seeds) — Salmonella Newport, Salmonella Hartford, Salmonella Oranienburg, 31 cases, 16 states, May - August 2014 - Raw Milk - Campylobacter jejuni Statewide recall and quarantine order following the confirmed detection of campylobacter bacteria in raw milk and cream - Smoked Salmon - Listeria monocytogenes Voluntary recall after contamination found in product surveillance samples and environmental samples collected at the processing facility

FOOD & DRUG LABORATORY BRANCH Microbiology Section

Research and Preparedness Funding • FERN Cooperative Agreement Program

(USDA, FSIS) • FDA ISO 17025:2005 Accreditation

Cooperative Agreement Program • Public Health Emergency Preparedness

Program (CDC) • Block Grant (CDC)

Genome Trakr

• Network of : – 14 federal labs, – 14 state health and

university labs, – 1 U.S. hospital lab, – 5 labs located

outside of the U.S. utilizing whole genome sequencing for pathogen identification

Genome Trakr

• • network has

sequenced : – more than 32,000

isolates – more than 100

genomes – 1,000 isolates

each month.

Illumina Miseq

• Whole Genome Sequencing

• In collaboration with Genome Trackr (FDA)

• In 2015, FDLB will be sequencing 192 isolates from outbreaks and archived stocks (Listeria, E. coli, Campylobacter, and Salmonella)

Bruker Biotyper

• Identifies pathogen using MALDI-TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) Mass Spectrometry

• Identifies unique molecular fingerprint of organism

Abused Substances Analysis Section FOOD & DRUG LABORATORY BRANCH

• Forensic Alcohol Laboratory Program Regulates laboratories that conduct chemical testing to determine the concentration of ethyl alcohol in the blood of persons involved in traffic accidents or in traffic violations.

• Methadone Drug Analysis Laboratory Program Licenses and regulates laboratories that conduct drugs of abuse analysis for patients in California narcotic treatment programs.

• Program Activities Both programs are mandated in statutes and completely described in regulations. Both programs conduct periodic proficiency tests, qualify laboratory personnel, and approve laboratory methods and procedures.

Thank you