Technical Aspects of Commercial-Scale Oyster Irradiation

8/10/2019 Technical Aspects of Commercial-Scale Oyster Irradiation

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Richard G. Hunter, Ph.D.President/CEO

TECHNICAL ASPECTS OFCOMMERCIAL-SCALEOYSTER IRRADIATION


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Who We Are

Founded in 1985

Single Gamma Plant in Mulberry Floridabegin operating in 1992. Replacementcost about $12 million.

Irradiate medical, food and consumer goods todestroy pathogens and spoilageorganisms

NASDAQ listed 2.8 million sharesoutstanding

Fourteen employeesImproving Quality with Science


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Where We Are


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What is Irradiation?

Irradiation means exposing something toradiation.

Typically gamma rays from Cobalt 60 sourcesor X-rays or electron beams fromgenerating machines.

Energy from the rays kills living organisms bybreaking chemical bonds in DNA.Safe, reliable process that is used to sterilize

over 50% of single-use medical products.

Cannot cause items to become radioactive just as a dental x-ray cannot make yourteeth radioactive


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Attributes of Gamma Irradiation

Energy is contained in sealed sources of Cobalt 60

that emit gamma rays.


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Attributes of Gamma Irradiation

Gamma Rays penetrate several feet of product

At a known source strength, time is only processvariable.

Cold process at low doses for food does notraise product temperature.

Product travels through process in carrier or totesand dwells at stations in radiation cell.

Length of time at each station controls the doseand is termed cycle time.

Carriers are typically full or half pallet and can beloaded via fork lift. Totes are smaller andgenerally hand-loaded.


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Wet Pool Gamma Irradiator


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Product Path Through Irradiator

ProductUnload

ProductLoad


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Pallet Carrier


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Loading a Pallet Carrier


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Loading a Tote


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Gamma Facility Interior


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Irradiation and Vv

Vv has a very low d-value (dose to reduce by 1-log) as compared to other bacterial food-bornepathogens.

Pathogen 1-log reduction

dose (kGray)5-log reductiondose (kGray)

Campylobacter 0.20 1.00Toxoplasma cysts 0.25 1.25E. coli 0157 0.30 1.50Listeria 0.45 2.25Salmonella 0.70 3.50Vibrio vulnificus 0.015 0.75

Irradiation dose to decrease selected pathogens at35 F by 1 decimal log (90%) and 5 decimal logs.


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FDA Regulation of Oyster Irradiation

Food irradiation is classified as a food additive

due to U.S. law passed in 1950s. Despitefact nothing is added, FDA wanted torequire the strictest approval process

Classes of food, dose and purpose mustspecifically be approved by FDA.

Process begins with a petition demonstratingsafety and efficacy of irradiation that isevaluated by FDA

FDA approved molluscan shellfish for irradiationin August, 2005 with maximum dose of 5.5kGy


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FDA Regulation of Oyster Irradiation

Specific PHPs must be validated and approved.

FDA and DACS approved in December 2008


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Overview of FTSI Oyster Irradiation

Goal is to kill Vv (and Vp) without changing taste

or palatability.UF/FTSI study determined 0.82 kGy provided

required log reduction. Max. dose isproprietary but does not impact taste.

Rapid process Truckload (~37,000 pounds) ofoysters can be irradiated in ~2 hours

FTSI charges 8 to 12 cents per pound for shell-

stock oyster irradiationWe have not yet set process parameters or

established a price for shucked meats.


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Keys to Oyster Irradiation

Dose

Maintain cold chain Approved Food-contact Packaging (not

applicable to in-shell oyster irradiation)Proper Labeling

The above must be done while maintaining anemphasis on safety and quality.


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Dose

You must be able to accurately measure the dose

range the product received. Dose expressed inkilogray (kGy)FTSI uses alanine dosimeters for oyster irradiation.

Alanine dosimeters are small pellets or strips thatcreate a free radical upon irradiation. Theamount of free radical is measured as the doseusing an instrument calibrated using standardsdirectly traceable to NIST.

Best practice is to use dosimeters in first and lastproduct in run and have product withdosimeters in irradiator at all times during run.


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Alanine Dosimeter


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Alanine Dosimetry System


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Dose Uniformity

Because irradiation decreases rapidly with

distance, any irradiation process results in adose range throughout the product.

This means you will have a minimum dose atsome point in the product and a maximumdose at another point.

The minimum dose is set to have the desiredeffect (achieve required log reduction of Vv).

The maximum dose is set so that product quality ismaintained. Maximum dose used may belower than the maximum dose set byregulation.


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Measure dose

The dose range and the location of the minimum

and maximum dose points are dependent onthe product dimensions and density. It doesnot change from one pallet of the sameproduct to another if dimensions are same.

The location of the minimum and maximumdoses are found by a dose map, which isplacing dosimeters in a 3-dimensionalpattern throughout the product.

Once those points are known, dosimeters are onlyused at the minimum and maximum points.


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Dose Mapping

The location of each dose pointis designated by arow-plane-columncoordinate, e.g.

4-A-2

Dose mappingidentifies thecoordinate of the minimum dosepoint and of themaximum dosepoint


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Maintaining Cold Chain (contd)

Typical semi holds 48 half-pallets and each carrier

that moves product through the processholds 2 half-pallets

FTSI breaks a truck load into 2 separate irradiationruns of 24 half-pallets in 12 carriers tominimize out of refrigeration time.

Each run is about 55 minutes total process timeis about 2 hours.


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Labeling of Irradiated Food

Radura and Statement required for retail sales.

May be on individual product box or ondisplay label/hanger.

Restaurant sales, etc. only require label onmaster container

Pending FDA rule would eliminate requirementfor most foods.

Treated by Irradiation


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Pre-labeled ProductFTSI can apply sticker labels meeting irradiation

and PHP requirements.If producer desires to pre-label product then

controls are required between point ofproduction and FTSI. These include truckseals to be removed at FTSI facility.


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Documentation

FTSI maintains a Quality System that meets

requirements for medical devices sterilizationand food irradiation. We have an approvedHACCP plan for oyster irradiation.

FTSI produces a complete quality package for eachrun documenting how and when the irradiationwas performed, dosimetry results, etc. that ismaintained and furnished as requested.


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Summary

Irradiation is a highly-effective and low-cost PHP for

oysters that produces an excellent product.FTSI is working with producers to commercialize the

process.We recognize that transportation costs are also

important and reflect this in our pricing. As demand increases, we are open to locating a

facility in the Gulf region.


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863-425-0039

WWW.FTSI.US

Richard G. Hunter, Ph.D.

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Technical Aspects of Commercial-Scale Oyster Irradiation