1. 1 Expect The Best Regulatory Designs for International Trade in Irradiated Horticultural Products Robert Griffin Plant Epidemiology and Risk Analysis Laboratory Center for Plant Health Science and Technology USDA, APHIS, PPQ Raleigh, North Carolina

2. 2 Expect The Best What are regulatory designs? The process and approach used to implement regulatory requirements. Done well… –Facilitate safe trade (adequate protection) –Maximize resources Done poorly… –Create unjustified technical barriers to trade –Reduce efficiency and effectiveness

3. 3 Expect The Best Why are reg. designs important? Establish or extend legal authority Promote transparency Describe a process or system Transmit scientific and technical info. Communicate programmatic details Provide a relatively static reference

4. 4 Expect The Best Traditional approach for treatments 1.Evaluate efficacy data 2.Evaluate phytotoxicity data (optional) 3.Determine scope of application a)Pest b)Commodity 4.Determine application parameters 5.Provide pest/commodity specific authorization

5. 5 Expect The Best For example: APHIS Treatment Schedule T 101-a-1 Fumigation with methyl bromide at NAP 2 lbs. for 2 hours applied at 70-79 o F Tarp or chamber For external feeders (mortality) On apple and pear fruit

6. 6 Expect The Best Why is irradiation different? Dose is not commodity specific –Based on Dmin for the pest –Dmin is established through dose mapping –Dmin is assured through dosimetry No immediately observable effect on pest Options for desired response

7. 7 Expect The Best Options for desired response Mortality (not necessary for Q-security) Sterility or limited fertility Limited development Non-emergence Devitalization (of seed) Inactivation (of microorganisms) Sprout inhibition

8. 8 Expect The Best Reg. design for irradiation treatments Generic doses are possible: –For any pest across all commodities* –For groups of pests Regulations on a pest/commodity basis are therefore artificially limiting Regulations requiring commodity by commodity evaluation for food safety are unjustified *provided commodities tolerate the dose

9. 9 Expect The Best Non-target pests No different than other treatments Partial data may be available Proxy data may be available “Extrapolation” may be applied Combination treatments may be effective Less than probit 9 efficacy may be accepted

10. 10 Expect The Best Food versus non-food The FDA limit of 1 kGy does not apply to treatments for non-food commodities such as: –Cut flowers –Wood products –Soil –Straw, hay –Bags, tobacco, cotton

11. 11 Expect The Best Out of [phytosanitary] bounds Food safety Nuclear regulatory concerns Quality (except where phytotoxicity makes a treatment impractical) Consumer labeling (except to the extent that phytosanitary treatments require such labeling under other authorities)

12. 12 Expect The Best PRA: part of the reg. process Pest risk analysis may be facilitated by identifying irradiation as the measure of choice in advance. The process only requires a pest list to determine which pests or groups of Q- pests will not be adequately treated with the chosen dose.

13. 13 Expect The Best APHIS regulations Generic 150 Gy fruit fly dose –Lower doses for specific fruit flies Generic 400 Gy insect dose –Excludes Lepidoptera adults/pupae Hawaii regs (7 CFR 318.13) allows irradiation as a alternative to other treatments Import regs (7 CFR 330) allow treatment on entry

14. 14 Expect The Best Conclusions NPPOs should: –Consider different regulatory approaches –Implement generic authorizations NPPOs should not –Assume traditional processes are appropriate –Require unjustified information or procedures –Exceed phytosanitary authority

15. 15 Expect The Best Thank you Glow-in-the-dark fruit (not irradiated)