Regulatory Designs for International Trade in Irradiated Horticultural Products Robert Griffin Plant

1
Regulatory Designs for International Trade in
Irradiated Horticultural Products Robert
GriffinPlant Epidemiology and Risk Analysis
LaboratoryCenter for Plant Health Science and
TechnologyUSDA, APHIS, PPQRaleigh, North
Carolina
2
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
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
Traditional approach for treatments

• Evaluate efficacy data
• Evaluate phytotoxicity data (optional)
• Determine scope of application
• Pest
• Commodity
• Determine application parameters
• Provide pest/commodity specific authorization

5
For example

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

6
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
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
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
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
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
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
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
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
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
Thank you
Glow-in-the-dark fruit (not irradiated)