Section 18 Final Section 18 Final Rule OverviewRule OverviewPresentation originally given by Presentation originally given by EPA at Emergency Exemption EPA at Emergency Exemption Process Revisions Workshop, Process Revisions Workshop, revised by Laura Quakenbushrevised by Laura Quakenbush

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New Rule IntroductionNew 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)

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Re-certificationRe-certificationWhat is it?What 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

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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

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Eligibility forEligibility forRe-certification Re-certification

ApplicationApplication 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.

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NotNot Eligible for Eligible forRe-certification Re-certification

ApplicationApplication 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

Tiered Process Tiered Process forfor

Significant Significant Economic Loss Economic Loss

(SEL)(SEL)

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New Approach for SELNew 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

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New Thresholds for SELNew Thresholds for SEL

Tier 1:Tier 1: Yield Loss of 20%Yield Loss of 20% Tier 2:Tier 2: Loss of 20% of Gross Revenue Loss of 20% of Gross Revenue Tier 3 :Tier 3 : Loss of 50% of Net Loss of 50% of Net

Operating RevenueOperating Revenue Net Operating Revenue = Net Operating Revenue =

Gross Revenue – Variable Operating CostsGross Revenue – Variable Operating Costs Essentially equivalent standard as Essentially equivalent standard as

beforebefore

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Tier 1Tier 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

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Tier 2Tier 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)

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Tier 3Tier 3

Loss of at least 50% of Net Operating Revenue Net Operating Revenue =

Gross Revenue – Variable Operating Costs

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Data QualityData 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

Other Regulatory Other Regulatory ChangesChanges

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Crisis ExemptionCrisis ExemptionWhat’s ChangedWhat’s Changed

States must notify EPA of States must notify EPA of intentintent to to declare crisisdeclare crisis

States must wait to receive verbal States must wait to receive verbal notice of no objections before using notice of no objections before using chemicalchemical Goal is response within 36 hoursGoal is response within 36 hours

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Crisis ExemptionsCrisis ExemptionsWhat’s Not ChangedWhat’s Not Changed

Crisis exemptions for Crisis exemptions for unpredictableunpredictable emergenciesemergencies

States should use crisis provisions States should use crisis provisions rarelyrarely

Assurance needed thatAssurance needed that Tolerance can be establishedTolerance can be established No other immediate concerns/objections No other immediate concerns/objections

seenseen

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Other Regulatory Other Regulatory ChangesChanges

Presumption of reasonable progress Presumption of reasonable progress toward registration extended to 5 years toward registration extended to 5 years for uses supported by IR-4 (previously 3 for uses supported by IR-4 (previously 3 years)years)

Revised definition of first food useRevised definition of first food use Clarified control of “invasive species” is Clarified control of “invasive species” is

acceptable use of quarantine exemptionacceptable use of quarantine exemption Opportunity for necessary pest management Opportunity for necessary pest management

of new high-impact pests, of new high-impact pests, e.g.e.g. soybean rust soybean rust

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Tribal Nations andTribal Nations andEmergency ExemptionsEmergency Exemptions

Tribal Nations not recognized under Tribal Nations not recognized under FIFRA as able to apply for emergency FIFRA as able to apply for emergency exemptionsexemptions

Reserved for state and federal agencies Reserved for state and federal agencies onlyonly

Long-standing interest in examining Long-standing interest in examining this gapthis gap

Two recent rulings overcome this Two recent rulings overcome this limitationlimitation

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Endangered Species ActEndangered Species Actand Emergency and Emergency

ExemptionsExemptions No changes due to new Section 18 rule No changes due to new Section 18 rule

on endangered specieson endangered species Risks to endangered species must be Risks to endangered species must be

considered in Section 18 decisionconsidered in Section 18 decision Approaches can vary – state-by-state Approaches can vary – state-by-state Partners Workshop on Endangered Partners Workshop on Endangered

Species Planned for this Year Species Planned for this Year

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Endangered Species ActEndangered Species Actand Emergency and Emergency

ExemptionsExemptions Application should provide Application should provide

information regarding proposed use information regarding proposed use area and application details area and application details

Application should provide input to Application should provide input to potential mitigation measures – potential mitigation measures – Collaborative ProcessCollaborative Process

Open issues can delay the Open issues can delay the regulatory decision regulatory decision

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Advertising andAdvertising andEmergency ExemptionsEmergency Exemptions

Pesticides authorized for Pesticides authorized for emergency pest problem onlyemergency pest problem only

Advertising needs to be factual and Advertising needs to be factual and caveat limitations of exemptioncaveat limitations of exemption

Registrants may NOT add new pest Registrants may NOT add new pest claims or advertise secondary claims or advertise secondary benefits of Section 18 products in benefits of Section 18 products in marketing literature or promotionsmarketing literature or promotions

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Pest Resistance andPest Resistance andEmergency ExemptionsEmergency Exemptions

EPA seriously evaluated approaches EPA seriously evaluated approaches for supporting resistance management for supporting resistance management initiatives under Section 18 ruleinitiatives under Section 18 rule

Ultimate decision was future pesticide Ultimate decision was future pesticide resistance is not a reason for an resistance is not a reason for an emergency exemptionemergency exemption

Documented field failures due to Documented field failures due to resistance development can fall within resistance development can fall within the definition of emergencythe definition of emergency