Regulatory Processes for Pesticides Mark Hartman Antimicrobials Division (AD) Office of Prevention,...

Regulatory Processes for Pesticides

Mark HartmanAntimicrobials Division (AD)

Office of Prevention, Pesticides and Toxic SubstancesUnited States Environmental Protection Agency

Program Goals

Protect public health and the environment from pesticide risks.

Ensure pesticide users have access to appropriate tools.

Main Statutes

Federal Insecticide, Fungicide and Rodenticide Act (FFIRA)

Food Quality Protection Act (FQPA)

Federal Food, Drug and Cosmetic Act (FFDCA)

Pesticide Registration Improvement Act (PRIA)

Regulatory Framework

Registration

Reregistration

Registration Review

Registration Gateway to the marketplace Granting license necessary to use a pesticide in the

U.S.• New active ingredients• New uses• New products• Amended products

Goal – Ensure that new pesticides/use patterns do not pose risk of concern to human health or the environment

Pesticide Reregistration

Ensures older pesticides meet today’s standards

Scope – Pesticides initially registered before November 1984

Goal – Mitigate risks of concern without disrupting agriculture, public health, other vital uses

Registration Review

15-year review cycle for all pesticides

Implementation projected to begin in 2007

General Process

Data Collection

Risk Assessment

Risk Management

Regulatory Decision

Data

EPA has authority under FIFRA to require data to support a registration– Toxicity

– Product and Residue Chemistry

– Ecological Effects

– Environmental Fate

– Exposure

– Efficacy

Other available data is also reviewed

FIFRA Framework

Consider wide range of risks– Food– Occupational– Water resources– Residential – Terrestrial and aquatic organisms– Endangered species

Acceptable risk standard (“unreasonable adverse effects”)

FQPA Framework

FQPA introduced new safety standard, “reasonable certainty of no harm”

Consider and assess:– Aggregate exposure– Cumulative effects of pesticides with a

common mechanism of toxicity– Effects on infants and children– Endocrine effects (program in early stages)

Public Participation Process

Provides framework for stakeholder and public involvement in reregistration

Offers consistent, defined, predictable opportunities for public involvement

Gives EPA flexibility to tailor the process to each pesticide’s uses and risks

Tailored Approach

6-phase full process for pesticides with complex uses and issues; significant risk mitigation needed

4-phase modified process for pesticides with limited uses and risks; nominal risk mitigation needed

Low risk process for pesticides requiring little or no risk mitigation

Public Process: Phases 1-3

Phase 1: Registrant "Error Only" Review

Phase 2: EPA Considers Error Comments

Phase 3: Release of Risk Assessment for Public Comment

Phase 4

EPA considers public comments received during Phase 3, revises the risk assessments as necessary, prepares a preliminary benefits characterization (if needed) and works on risk reduction options

With input from other EPA offices, other agencies and stakeholders, EPA develops a risk management decision

Get Involved Early

EPA encourages stakeholders and the public to use our schedules and the public participation process

Plan to get involved early in reviews of pesticides of interest

See EPA’s website for pesticide information and contacts

Triclosan as a Pesticide

First registered in 1969 22 currently registered products Major use patterns

– Hard surface disinfection and sanitization– Materials preservatives (textiles etc.)– Coatings– Swimming pool water systems

Triclosan Process

Tentative Reregistration Decision Date of 9/07

Data review and risk assessment development to begin late in 2006

Information on EPA Website

EPA Office of Pesticide Programs www.epa.gov/pesticides/