Bioterrorism Preparedness

1
Bioterrorism Preparedness Response Act of 2002

• Association Experimental Station Directors
• Spring Meeting

2
Examples of FDA-Regulated Food

• Food and food additives for man or animals
• Dietary supplements and dietary ingredients
• Infant formula
• Pet food
• Beverages (including alcoholic beverages and
  bottled water)
• Fruits and vegetables

Source FDA overview presentation
3
Examples of FDA-Regulated Food

• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food or
  components of food
• Canned foods
• Live food animals
• Bakery goods, snack food, and candy

Source FDA overview presentation
4
Examples of University Locations Needing to
Comply with Recordkeeping Requirements

• Dairy processing plants
• Extrusion labs
• Custom feed labs
• Feed mills (poultry, aquatic, large animal)
• Farms that process feed, e.g., blend feed
  premix with forage
• Farms that feed animals that enter the food
  chain (sold or slaughtered and processed)

5
Who is excluded from the regulation?

• Farms
• Foreign persons, except for foreign persons who
  transport food in the United States
• Restaurants

Source FDA overview presentation
6
What is a Mixed Facility Farm?

• If you do the following you are a Mixed Facility
  Farm AND MUST TRACE.
• Your animals, birds or fish enter the food chain
• Sold live to another farm / business
• Slaughtered and yield not destroyed
• Yield sold to outside businesses (e.g., eggs)
• You mix forage with feed premix in a feed wagon

Source FDA Guidance Documents
7
FDA Definitions

• Manufacturing/processing
• Making a food from one or more ingredients
• Synthesizing, preparing, treating, modifying, or
  manipulating food, including food crops or
  ingredients
• E.g., cutting, peeling, trimming, washing,
  waxing, eviscerating, rendering, cooking, baking,
  freezing, cooling, pasteurizing, homogenizing,
  mixing, formulating, bottling, milling, grinding,
  extracting juice, distilling, labeling, or
  packaging

Source FDA overview presentation
8
Records You Must Establish And Maintain -Who
you got it from.

• Date food or ingredient was received or purchased
• If you manufacture, process, or pack food, the
  lot or code number or other identifier
• Quantity and how the food is packaged
• Who transported the product / ingredient (company
  name, email, fax, address and license / trailer
  number)
• Even if it is your own truck!

Source FDA overview presentation
9
What you did with it.

• Link inbound shipments of product / ingredient to
  out bound shipment of product / ingredient
• Establish and maintain records of all specific
  ingredients (by unique identifier number) used in
  processing individual batches
• For dairy operations would include all separation
  and where resulting products went.
• Must trace all food contact packaging by specific
  lot into production batch

Source FDA overview presentation
10
Who you sold it to.

• Date food or ingredient was released or sold
• Who transported the product / ingredient (company
  name, email, fax, address and license / trailer
  number)
• For persons who manufacture, process, or pack
  food, lot or code number or other identifier
  (scale ticket)

Source FDA overview presentation
11
New Compliance Facts

• Linking all potential sources (Q29.3)
• Tracking lot code, not item descriptions (Q29.4)
• Detailed product descriptions (Q30.2)
• Tracing all blending activities (Q29.1)
• Inter-company tracing One 24-hour window for
  entire chain of custody (Q41.2)
• Source FDA Documents

12
Solve the problem regardless of the facility type!

• PathTracer can be incorporated into all facility
  operations!
• Does NOT rely on complex accounting systems
• Provides means to maintain records of
• What you did with it (blend / co-mingled)
• What you added to it
• Multifunctional
• Liquid or dry
• Bagged or bulk
• ALL FOOD animal or human

13
Lets Look at the Solution!

• PathTracer is ready today to meet the FDA record
  keeping requirements!
• Links all facilities together
• PathTracer is patent pending
• Delivers accurate tracing for all bulk or bagged
  food / commodities
• WEB Based- hosted solution

14
PathTracer
Providing, Timely, Accurate Information

• But, we do require you to keep some specificity
  and thats part of why we look at the date
  received, and we do expect some due diligence as
  to what actually is occurring on a day by day
  basis, as to what actually is there for your
  reasonably available records.
• Dr. Lesyle Fraser, FDA Director
  Regulations and Policy

Source FDA Q A Transcript
15
Separating Fact from Fiction
FACT
FICTION

• FDA verified that Universities must comply
• Compliance date has passed - December 9, 2005
• Farms, most often are mixed facilities
• Must maintain records for up to 2 years

• Farms are completely exempt
• FDA will be lenient
• Universities are exempt as a state operation
• I can trust my students to maintain accurate
  written records

16
Separating Fact from Fiction
FACT
FICTION

• University will not defend an employee in
  violation of Federal Law
• FDA will use all options available
• Civil action in Federal Court
• Criminal action in Federal Court
• Shut facilities down until violation aspects are
  remedied.

• University will accept, I did not know.
• The dean will take the fall for me.
• Cost is too prohibitive
• Paperwork too burdensome
• We are capturing all required records now

17
PathTracer YOUR ONLY TRUE SOLUTION
PRODUCT FEATURES

• Establishes proper habits
• Data encryption plus multi-level security
  features
• Bioterrorism tracing

• Web based
• Report visibility
• global, regional, local
• Facility to facility linking

License cost - 300 per month per geographical
campus
18
PathTracer
PRODUCT FEATURES

• On-line training allows for new users to be
  easily trained on the system
• Custom features allows setup to mirror facility
• Allows for benchmarking between semesters
  measures results
• Provides discipline for faculty and students to
  capture required FDA mandated information
• Helps manage all inventory, ingredients
  packaging
• Provides FDA ONLY mandated information nothing
  more

19
PathTracer
Next Steps

• Ag department meeting to identify
• Which facilitates need to comply
• University system Administrator
  (need 1 go to person)
• Project begin date (remember you are NOT in
  compliance with the FDA at this time)
• Step 2
• Identify key manager / user for each facility
• Identify all users for facility
• Begin online training

20
PathTracer YOUR ONLY TRUE SOLUTION

• PathTracer is a solution for -
• Your University
• Your arm to aid and help in industry education
  through extension services
• Industry compliance
• Bolstering your Ag Departments budget

21
(No Transcript)