PPQ Organism Permitting

Transcription

1 PPQ Organism Permitting Focus on Biological Control Robert Tichenor Sr. Entomologist PPQ, Plant Health Programs (PHP) Registrations, Identification, Permits and Plant Safeguarding (RIPPS) Pest Permitting Branch USDA, APHIS International Workshop on Tamarixia Species February 2-4, 2010

2 PPQ Biocontrol Permitting Policies APHIS PPQ 526 permits required Importation of all biological control agents Environmental release of all biological control agents into areas where they are not established or no prior releases occurred in the past Interstate movement of biological control agents of weeds Interstate movement of all biocontrol organisms between containment facilities

3 Title 7 Code of Federal Regulations 330 Subparts 200 and 300 Part 330: Federal Plant Pest Regulations; General; Plant Pests; Soil, Stone, and Quarry Products; Garbage Amendments: Subpart 200: Movement of Plant Pests Subpart 300: Movement of Soil, Stone, and Quarry Products

4 Revision History There have not been substantive amendments to 7 CFR and 300 since the 1970s Permitted organism regulations have not been modified since passage of the Plant Protection Act of 2000 which contains specific language on Biological control organisms 2001: APHIS published a rule proposing amendments, and more than 2000 comments were received 2001: The events of 9/11 required a major shift in PPQ permitting policies, and the comments of the 2001 proposed rule were not immediately addressed

5 Pest Permitting Board of Advisors 2005: Pest Permitting underwent an extensive internal review 2006: The Pest Permitting Board of Advisors consisting of representatives from Federal Agencies was established 2007: A Regulatory Change Working Group was established

6 Regulatory Change Working Group Reviewed the existing regulation and pest permitting policy Reviewed the comments received following publication of the 2001 proposed rule Considered new policies that were implemented since 9/11 Provided regulatory change recommendations to the Pest Permitting Board of Advisors in 2007

7 Proposed Plant Pest Regulatory Policy Amendments Related to Biological Control Exemption of certain organisms from interstate movement permit requirements Biocontrol organisms: tiered approach will be used to formulate permit conditions for their movement and release Biocontainment facilities: application, inspection, approval and maintenance processes

8 Biocontrol Proposed Administrative Categories: Bio-A: present in the U.S., wide-spread use, previously assessed. No permit required for interstate movement or release. Bio-B: Environmental assessment complete and a Finding of No Significant Impact has been published. Limited environmental release. Permit required for movement and releases. Bio-C: Environmental assessment not complete. No environmental release permitted.

9 Notice and Comment Rulemaking The Administrative Procedures Act requires that the Agency provide the public with an opportunity to review and comment on proposed rules. Comment periods are typically days, and all public comments are reviewed and considered prior to publication of a final rule.

10 and now for something a little different

11 Permitting Process for Biocontrol Organisms New to North America t Topics Steps in the permitting Process (Review) The Petition (TAG or NAPPO) Review of the Petition Recommendation to APHIS APHIS evaluation The NEPA process FONSI and release permit

12 Steps in the permitting Process (Importation of Biocontrol Organism into containment) 1) Review application for completeness (1 wk +) 2) Inspect containment facility and determine if facility is adequate (1-8 wks) 3) Evaluate pest risk and prepare draft permit (1-4 wks) 4) Review by State Plant Regulatory Official (1-4 weeks) 5) Review by applicant (1-4 weeks) 6) Issue permit

13 Environmental Documents Required by APHIS for First Time Environmental Release of Biocontrol Organisms 1. Petition the North American Plant Protection Organization (NAPPO) to release a biological control agent of an arthropod 2. Recommendation from the NAPPO to release a biological control agent of an arthropod 3. Environmental Assessment (EA) 4. Endangered Species Act Section 7 effects determination 5. Finding of No Significant Impact

14 The Environmental Process for Organisms New to North America 1. Receipt, Review and Forwarding of NAPPO Petition to NAPPO Biological Control Review Committee Chair 2. Receipt and Review of Recommendation and comments from the NAPPO Biological Control Review Committee 3. Preparation of Biological Assessment* for Section 7 Consultation with Fish and Wildlife Services 4. Tribal Review* 5. Preparation of Environmental Assessment* continue

15 The Environmental Process for Organisms New to North America continued 6. Publication of EA in the Federal Register 7. Evaluate and respond to public comments 8. Preparation of Final Environmental Assessment 9. Reach a Finding of no significant Impact? 10. Preparation and signing of FONSI 11. Continue processing of Permit

16 Steps in the permitting Process (Importation of Biocontrol Organism into containment) 1) Review application for completeness (1 wk +) 2) Inspect containment facility and determine if facility is adequate (1-8 wks) 3) Evaluate pest risk (incl. ESA and NEPA process) and prepare draft permit 4) Review by State Plant Regulatory Official (1-4 weeks) 5) Review by applicant (1-4 weeks) 6) Issue permit

17 APHIS Regulations for National Environmental Policy Act (NEPA) Title 7 CFR Part 372 National Environmental Policy Act Implementing Procedures Part Classification of Actions (b) Actions normally requiring environmental assessments but not environmental impact statements. characterized by limited scope (particular sites, species, or activities and potential effect (impacting relatively few environmental values or systems).

18 APHIS Regulations for NEPA Title 7 CFR Part Classification of Actions (b) Actions in this class include: (4) Approvals and issuance of permits for proposals involving genetically engineered or nonindigenous species, except for actions that are categorically excluded

19 APHIS Regulations for NEPA Title 7 CFR Part Classification of Actions (c) Categorically Excluded Actions These differ from actions requiring an EA in that the means through which adverse environmental impacts may be avoided or minimized have actually been built right into the actions themselves

20 APHIS Regulations for NEPA Title 7 CFR Part (c) Categorically Excluded Actions (3) Licensing and Permitting (iii) Permitting of: (A) Importation of nonindigenous species into containment facilities, (B) Interstate movement of nonindigenous species between containment facilities, or (C) Releases into a State s environment of pure cultures of organisms that are either native or established introductions

21 Information for the NAPPO Petition (RSPM No. 12) 1. Proposed Action (Purpose, need, methods, etc) 2. Target Pest Information 3. Biological Control Agent Information 4. Environmental & Economic Impacts of Proposed Releases 5. Post Release Monitoring

22 Information for the NAPPO Petition (RSPM No. 12): Highlights (3) Biological Control Agent Information 3.1 &3.2 Taxonomy 3.4 Natural and Expected (US) Geographic Range 3.5 Source (including where originally collected) 3.6 & 3.7 Biology and life history information 3.8 Known host range from literature, records, etc.

23 Information for the NAPPO Petition (RSPM No. 12): Highlights (4) Environmental and Economic Impacts of the Proposed Release 4.1 Known impact on vertebrates including humans. 4.2 Implications of not releasing this biological control agent (e.g., pesticide use, physical controls). 4.3 Direct impact of the biological control agent on target pest and non-target species.

24 Information for the NAPPO Petition (RSPM No. 12): Highlights (4) Environmental and Economic Impacts of the Proposed Release 4.1 Known impact on vertebrates including humans. 4.2 Implications of not releasing this biological control agent (e.g., pesticide use, physical controls). 4.3 Direct impact of the biological control agent on target pest and non-target species.

25 Information for the NAPPO Petition (RSPM No. 12): Highlights (4) Environmental and Economic Impacts of the Proposed Release 4.4 Effects on physical environment (e.g., water, soil and air resources). 4.5 Indirect effects (e.g., potential impacts on organisms that depend on the target pest and non-target species, including potential competition with resident biological control agents). 4.6 Possible direct, or indirect effects on threatened and endangered species in North America

26 Information for the NAPPO Petition (RSPM No. 12): Highlights (4) Environmental and Economic Impacts of the Proposed Release 4.4 Effects on physical environment (e.g., water, soil and air resources). 4.5 Indirect effects (e.g., potential impacts on organisms that depend on the target pest and non-target species, including potential competition with resident biological control agents). 4.6 Possible direct, or indirect effects on threatened and endangered species in North America

27 Information for the NAPPO Petition (RSPM No. 12): Highlights (4) Environmental and Economic Impacts of the Proposed Release 4.4 Effects on physical environment (e.g., water, soil and air resources). 4.5 Indirect effects (e.g., potential impacts on organisms that depend on the target pest and non-target species, including potential competition with resident biological control agents). 4.6 Possible direct, or indirect effects on threatened and endangered species in North America

28 Information for the NAPPO Petition (RSPM No. 12): Highlights (5) Post-Release Monitoring 5.1 Establishment and spread 5.2 Changes in density of Biocontrol Organism and pest 5.3 Host specificity/attack rates on the target pest and selected non-target species for which potential impacts are identified 5.4 Changes in the target pest and in the growth, survival, and reproduction of selected non-target species. 5.5 Changes in species diversity and community structure.

29 Biocontrol Proposed Administrative Categories: Bio-A: present in the U.S., wide-spread use, previously assessed. No permit required for interstate movement or release. Bio-B: Environmental assessment complete and a Finding of No Significant Impact has been published. Limited environmental release. Permit required for movement and releases. Bio-C: Environmental assessment not complete. No environmental release permitted.

30

31 Administrative Category BioA Petition process for inclusion of additional BioA organisms Federal Register notification will be published following completion of the evaluation of a petition(s), and comments will be requested Lists will be maintained on the APHIS web site Organisms may be removed from the list based new evidence of unanticipated adverse effects

32 Alternate Host testing and other data Positive controls for each trial run (and negative?) No Choice and choice trials Variety of experimental conditions, as feasible, including varying the age and condition of parasite and hosts and how presented Please include detailed methods with each data set More is better (but how much is enough?) Non-target feeding, attention, oviposition, etc. = the need for more robust data Anything that can address the field (what will it really do?)