Regulating PlantIncorporated Protectants PIPs A State and National Perspective

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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

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Topics of Discussion

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

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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.

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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

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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

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Plant Incorporated Protectants

• Plant incorporated protectants (PIPs) are
  pesticidal substances produced and used by the
  living plant.
• Hawaiis 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).

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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

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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.

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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

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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

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Potential Impacts

• Chemical

• Biological

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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.

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Real Life Case Example

• March 2002 EPA inspector conducts EUP
  inspections of PIPs.
• July 2002 Letter to EPA explaining that Hawaii
  considers PIPs as treated articles. Deferring
  enforcement to EPA.
• December 2002 EPA Issues Enforcement actions
  issues isolation, changed field locations,
  border row characteristics. Stipulated
  penalties added.

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PIP EUP Workshop 1/04

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

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Next Steps

• SFIREG has two IPs 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 lt 10
  acres)?
• Legislative fixes needed?

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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.