The Power of New Information in Risk-Based Decision Making

The Power of New Information in Risk-Based Decision Making

Don L. Zink, Ph.D.Center for Food Safety and Applied Nutrition

U.S. Food and Drug AdministrationCollege, Park, MD

Some Observations on New Information

• “True genius resides in the capacity for evaluation of uncertain, hazardous, and conflicting information.” – Winston Churchill

• “Information is not knowledge.” – Albert Einstein• “I was brought up to believe that the only thing worth

doing was to add to the sum of accurate information in the world.” – Margaret Mead

• Information is new when you find it or figure out how to use it – even if its been right under your nose all along.

Using Old Information in New Ways

• Castleberry botulism Outbreak– The first low acid canned

food botulism outbreak due to commercially canned foods in more than 30 years

– Caused by under-processing on a retort system that is technically sophisticated

– The outbreak led FDA to find new ways to use some old databases to identify potentially problem canners

Crateless Retort*

* Graphic image from http://www.maloinc.com/photo-retort.htm

Crateless Retort*

* Graphic image from http://www.maloinc.com/crateless-process.htm

Awash in Information!

• The case of “whole genome sequencing” (WGS)– We can now sequence the

bacterial genome quickly and cheaply

– Each sequence amounts to 4 – 5 million base pairs– The sequence is the key to all the bacterium can do:

its virulence, antibiotic resistance, serotype, phage type and even its family tree

Using Genomics Information

• Will WGS ultimately replace strain identification technologies such as serotyping and even PFGE?

• Can we use WGS to augment epidemiological investigations?

• Can use WGS to tell us where bacterial strains originate?

• Can we use WGS data to design molecular probes that will let us more rapidly detect specific pathogens?

Summary• Our world is changing

faster than ever before and large databases and powerful software analytical tools will drive this change.

• We need to spend more time discussing how we can share and use data

• We cannot let technological capability get far ahead of ability to analyze the data