Pesticide Registration Improvement Act Reauthorization Update

Transcription

1 Pesticide Registration Improvement Act Reauthorization Update Steven J. Goldberg Vice President, Regulatory Law and Government Affairs BASF Corporation 6/21/2017 1

2 Background PRIA has been in place since FY Provides for stable funding of EPA through Maintenance fees: per product fees funding reregistration and registration review Registration fees, per application Fees intended to supplement, not replace, appropriated dollars PRIA 4 represents the third reauthorization of the program 2

3 PRIA 4 PESTICIDE REGISTRATION ENHANCEMENT ACT 3

4 PRIA 4 PESTICIDE REGISTRATION ENHANCEMENT ACT PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF

5 Maintenance Fees Increase to $31M in fees Remains flat through the life of PRIA IV Increase in per product fee from $3472 to $3875. Caps increased 12% 5

6 Maintenance Fees 4(2)(k) provision removed Precluding EPA from spending fees collected unless congress appropriates matching funds 6

7 Maintenance Fees Set aside for development of guidance on efficacy testing requirements for public health pesticides Set aside for supplementing resources for Good Laboratory Practices inspections Removal of set aside for IT enhancements 7

8 Registration Fees Categories remain in the statute Two 5% increases over life of PRIA 4 8

9 Registration Fees Categories remain in the statute Two 5% increases over life of PRIA 4 Continued set asides for worker protection, pesticide education 9

10 Registration Fees Categories remain in the statute Two 5% increases over life of PRIA 4 Continued set asides for worker protection, pesticide education Appropriations Trigger continues to be at $128M 10

11 Registration Fees Key Provisions Categories remain in the statute Two 5% increases over life of PRIA 4 Continued set asides for worker protection, pesticide education Appropriations Trigger continues to be at $128M Removes eligibility for small business waiver for requests for Gold Seal letters 11

12 Accountability/Reporting Transparency on worker protection grants Engagement of stakeholders on grant applications Measurement of results 12

13 Accountability/Reporting Transparency on worker protection grants Engagement of stakeholders on grant applications Measurement of results Priority review and approval of new pesticides to control invertebrate public health pests that can transmit vector-born diseases 13

14 Accountability/Reporting Transparency on worker protection grants Engagement of stakeholders on grant applications Measurement of results Priority review and approval of new pesticides to control invertebrate public health pests that can transmit vector-born diseases Accountability for new set asides 14

15 Timing 15

16 Timing Seven-year bill 16

17 Timing Seven-year bill Six year bill 17

18 Chart Updates Antimicrobial Division Added categories for EUP and MUP products 18

19 Chart Updates Antimicrobial Division Added categories for EUP and MUP products Added category for placement of Design for the Environment logo on pesticide product labels 19

20 Chart Updates Antimicrobial Division Added categories for EUP and MUP products Added category for placement of Design for the Environment logo on pesticide product labels Added category for voluntary assessment of substantial similarity 20

21 Chart Updates Antimicrobial Division Added categories for EUP and MUP products Added category for placement of Design for the Environment logo on pesticide product labels Added category for voluntary assessment of substantial similarity Added categories for voluntary determination of FIFRA eligibility, treated articles and pesticide devices 21

22 Chart Updates Antimicrobial Division Added categories for EUP and MUP products Added category for placement of Design for the Environment logo on pesticide product labels Added category for voluntary assessment of substantial similarity Added categories for voluntary determination of FIFRA eligibility, treated articles and pesticide devices Added efficacy categories based on number of data volumes (instead of per registration) 22

23 Chart Updates Antimicrobial Division Adjustment of fees and timelines 23

24 Chart Updates Antimicrobial Division Adjustment of fees and timelines Clarified language on use patterns, tolerances/exemptions 24

25 Chart Updates Antimicrobial Division Adjustment of fees and timelines Clarified language on use patterns, tolerances/exemptions Changed language to meet all new EPA guidelines (Part 158W Rule category designation and use sites) 25

26 Registration Division (Conventionals) 20% fee increase for categories with reduced risk counterpart (new ai and food use categories). No increase in corresponding reduced risk fee New categories for safeners Non-FIFRA regulated determination Conditional ruling pre-application on product substantial similarity Label Amendment to add Design for the Environment Logo 26

27 Politics and Pathway End of Obama administration and start of Trump Administration has made bill path a bit of a challenge 27

28 Politics and Pathway End of Obama administration and start of Trump Administration has made bill path a bit of a challenge H.R passed unanimously in House (Suspension) 28

29 Politics and Pathway End of Obama administration and start of Trump Administration has made bill path a bit of a challenge H.R passed in House Senate? 29

30 Politics and Pathway Trump Administration Challenges 30

31 Politics and Pathway Trump Administration Challenges NGO, Worker Protection 31

32 Politics and Pathway Trump Administration Challenges NGO, Worker Protection Trump Budget and Presidential signature 32

33 Questions? 6/21/