Section 18 Final Rule Overview

1. Section 18 Final Rule Overview Presentation originally given by EPA at Emergency Exemption Process Revisions Workshop, revised by Laura Quakenbush

2. New Rule Introduction • New Section 18 Rule Revisions became effective on 3/28/06 • Intention is to streamline and improve process without compromising protections for human health and the environment • Allows re-certification for certain repeat requests • Tiered approach for substantiating significant economic loss (SEL)

3. Re-certificationWhat is it? • Regulation changes allow submission of an abbreviated application for eligible repeat requests, certifying : • Emergency continues to exist • Use pattern remains unchanged • No previously submitted information has changed • EPA will advise states of eligible requests via website and approval letters

4. EPA Review ofRe-certification Applications • Re-certification applications are not automatically granted as exemptions • The agency will consider • Information included in the applications • Other factors, which include whether: • Alternative controls have become available • Prior health and environmental risk assessments remain valid • Adequate progress made toward registration of use

5. Eligibility forRe-certification Application • The emergency situation can reasonably be expected to continue for longer than one year, e.g. • Loss of a previously relied-upon pesticide • Expansion of pest’s range • Documented pest resistance development. • Examples of emergency situations not expected to continue are: • Temporary supply problem of a registered product • Isolated weather event, or • Sporadic pest outbreak.

6. Not Eligible forRe-certification Application • The request is not eligible if uses warrant heightened review and enhanced public involvement and transparency. For example, • New chemical, • First food use, • Chemical under Special Review • Cancelled or suspended chemicals, including those voluntarily cancelled • EPA has final discretion on eligibility

7. Tiered Process for Significant Economic Loss (SEL)

8. New Approach for SEL • Same thresholds for all crops and States • Uses a 3-tiered approach for SEL determination • Compares estimated loss due to the emergency to measures of producer income without the emergency • Does not requite 5-year average to establish without emergency (baseline) scenario

9. New Thresholds for SEL • Tier 1:Yield Loss of 20% • Tier 2: Loss of 20% of Gross Revenue • Tier 3 : Loss of 50% of Net Operating Revenue • Net Operating Revenue = Gross Revenue – Variable Operating Costs • Essentially equivalent standard as before

10. Tier 1 • Yield Loss of at least 20% • Yield loss comparing non-emergency situation with emergency situation • Emergency situation must be estimated with the use of the best available alternative control (chemical or non-chemical) • Average per-acre loss, not worst-case scenario

11. Tier 2 • Loss of at least 20% of Gross Revenue % Yield loss from Tier 1 and • Price reduction (by end market); • Quality loss (e.g., shift in grade or price reduction); • Added production costs (e.g., sorting or repacking costs, additional pest control costs)

12. Tier 3 • Loss of at least 50% of Net Operating Revenue • Net Operating Revenue = Gross Revenue – Variable Operating Costs

13. Data Quality • EPA recognizes that it is not always possible to submit comprehensive data • If such data are not available, EPA may consider using qualitative information in making its decision. • If an SEL is found on the basis of qualitative data, EPA may require that substantiating data be generated to support any future requests

14. Other Regulatory Changes

15. Crisis ExemptionWhat’s Changed • States must notify EPA of intent to declare crisis • States must wait to receive verbal notice of no objections before using chemical • Goal is response within 36 hours

16. Crisis ExemptionsWhat’s Not Changed • Crisis exemptions for unpredictable emergencies • States should use crisis provisions rarely • Assurance needed that • Tolerance can be established • No other immediate concerns/objections seen

17. Other Regulatory Changes • Presumption of reasonable progress toward registration extended to 5 years for uses supported by IR-4 (previously 3 years) • Revised definition of first food use • Clarified control of “invasive species” is acceptable use of quarantine exemption • Opportunity for necessary pest management of new high-impact pests, e.g. soybean rust

18. Tribal Nations andEmergency Exemptions • Tribal Nations not recognized under FIFRA as able to apply for emergency exemptions • Reserved for state and federal agencies only • Long-standing interest in examining this gap • Two recent rulings overcome this limitation

19. Endangered Species Actand Emergency Exemptions • No changes due to new Section 18 rule on endangered species • Risks to endangered species must be considered in Section 18 decision • Approaches can vary – state-by-state • Partners Workshop on Endangered Species Planned for this Year

20. Endangered Species Actand Emergency Exemptions • Application should provide information regarding proposed use area and application details • Application should provide input to potential mitigation measures – Collaborative Process • Open issues can delay the regulatory decision

21. Advertising andEmergency Exemptions • Pesticides authorized for emergency pest problem only • Advertising needs to be factual and caveat limitations of exemption • Registrants may NOT add new pest claims or advertise secondary benefits of Section 18 products in marketing literature or promotions

22. Pest Resistance andEmergency Exemptions • EPA seriously evaluated approaches for supporting resistance management initiatives under Section 18 rule • Ultimate decision was future pesticide resistance is not a reason for an emergency exemption • Documented field failures due to resistance development can fall within the definition of emergency