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Regulating Plant-Incorporated Protectants (PIPs) A State and National Perspective

Regulating Plant-Incorporated Protectants (PIPs) A State and National Perspective. Western Region Pesticide Meeting May 12-14, 2004 Spokane, Washington Robert Boesch, HIDA Karen Heisler, USEPA R9. Topics of Discussion. Coordinated Framework for Biotech PIP Compliance Issues

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Regulating Plant-Incorporated Protectants (PIPs) A State and National Perspective

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  1. Regulating Plant-Incorporated Protectants (PIPs)A State and National Perspective Western Region Pesticide Meeting May 12-14, 2004 Spokane, Washington Robert Boesch, HIDA Karen Heisler, USEPA R9

  2. Topics of Discussion • Coordinated Framework for Biotech • PIP Compliance Issues • State Perspective and Roles • One (Experienced) State Perspective • Case Examples • Next Steps

  3. Coordinated Framework • USDA – Plant Protection Act • FDA – Federal Food Drug, and Cosmetic Act • EPA – FIFRA and TSCA • Intent of the framework was to use existing statutes to regulate biotechnology. • Emphasis to be on the product, not the process.

  4. FIFRA: key elements • Evaluate pesticide prior to registration for sale/use • Develop and communicate rules responsibly in order to sustain a credible program • Compliance oversight and response:A key feedback loop for regulatory efficacy

  5. First registered PIP in 1995 (Bt potato) Rules specific to PIPs: Part 174 promulgated August 2001 defines Plant-Incorparated Protectants specifics of data requirements and compliance to follow PIP Regulation

  6. Plant Incorporated Protectants • Plant incorporated protectants (PIPs) are pesticidal substances produced and used by the living plant. • Hawaii’s experience with PIPs. • The focus on process not product (a story of three identical corn plants): • Pesticide Production (seed growers) • Pesticide Use (Farmers) • Treated article (food or feed produced by farmers for consumption).

  7. EUPs Small-scale Oversight by govt. Research plan as basis of conditions May not yet be licensed for food (no tolerance) EUPs clearly “use” Section 3 registrations Commercial product Oversight by industry Restrictions related to IRM Tolerance or exemption granted Planting PIP not clearly “use” PIP Regulation

  8. FIFRA – Experimental Use Permits • Trigger of ten (10) acres. • Registrant notifies State of issuance. State advises registrant of State requirements (if any). • Need temporary tolerance if out-crossing to food or feed is possible. • Enforcement through 7 USC 136j(H) or primacy.

  9. PIP Compliance Issues • Access to CBI-protected information for EUPs • PIP definition confounds meaning of FIFRA terms (use, distribution, production) • If planting could be “use”, then oversight authority at field for Sec. 3 reg may be lacking • Section 7 framework not clear (what is reported by whom) • How to address contamination and liability; containment and confinement not clearly defined

  10. Potential outcomes of non-compliance • More risk than is allowed by law • Actual human health or eco-impact • Limit provision of public information as required by law • Compromise Agency function • Penalties and legal action

  11. Chemical Biological Potential Impacts

  12. One State Program - Hawaii • Requires that the Department of Health be notified when biotechnology notification is provided to a Federal Agency. • USDA consults with Plant Quarantine Program. • Pesticide program treats Plant Incorporated Protectants as treated articles. • State Resources: No new staff or equipment for biotechnology regulation.

  13. Real Life – Case Example • March 2002 – EPA inspector conducts EUP inspections of PIP’s. • July 2002 – Letter to EPA explaining that Hawaii considers PIP’s as treated articles. Deferring enforcement to EPA. • December 2002 – EPA Issues Enforcement actions [issues: isolation, changed field locations, border row characteristics]. Stipulated penalties added.

  14. PIP EUP Workshop 1/04 • A stakeholder meeting with EPA, registrants, USDA, public interest groups, FDA, consultants and States to discuss PIP EUP’s. • EPA Office of Regulatory Enforcement stated that the enforcement of PIP EUP’s was handled by States under primacy. • National compliance strategy is lacking

  15. Next Steps • SFIREG has two IP’s concerning enforceability of grower guides as labeling. The last in 1995. • Is regulating PIPs considered State lead (use primacy), if so, when will guidance on regulating PIP production and use be issued? • Hawaii agrees to conduct inspections of PIP EUPs and refer cases and any samples for analysis to EPA. (Only 3 permits). • Regulatory fixes needed (terminology, EUP < 10 acres)? • Legislative fixes needed?

  16. More Steps • Hawaii had about 20 bills introduced relating to regulating genetically modified organisms. • A visible, credible, coordinated effort at the Federal level is needed to bolster citizen confidence in the coordinated framework.

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