Section 18 Final Rule Overview Presentation originally given by EPA at Emergency Exemption Process...
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Transcript of Section 18 Final Rule Overview Presentation originally given by EPA at Emergency Exemption Process...
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