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 State Perspective and Roles One (Experienced) State Perspective Case Examples Next Steps

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.

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

PIP Regulation 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

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).

PIP Regulation 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”

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.

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

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

Potential Impacts ChemicalBiological

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.

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.

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

Next Steps SFIREG has two IP’s concerning enforceability of grower guides as labeling. The last in 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?

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.