Regulation and Management of Pest Control Products in the U.S. An Introduction to EPA

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Regulation and Management of Pest Control
Products in the U.S.An Introduction to EPAs
Pesticide Programs

• Anne Lindsay
• Deputy Director
• Office of Pesticide Programs
• U.S. Environmental Protection Agency
• January, 2007

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Briefing Goals

• Outline U.S. system of pesticide regulation, with
  particular emphasis on food safety issues
• Review key policies toward Codex Alimentarius and
  Organization for Economic Cooperation and
  Development (OECD) pesticide work
• Provide links to key information

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Part I OverviewU.S. Regulatory System
Fundamentals

• Definitions, scope of coverage
• Legal texts
• Standards for health and environmental protection
• Major regulatory tools and programs

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EPA/OPP Mission

• The mission of the Environmental Protection
  Agency is to protect human health and the natural
  environment.
• The mission of the Office of Pesticide Programs
  is to protect human health and the environment
  from unreasonable risks associated with pesticide
  use and to ensure that pesticide residues in food
  are safe. Over 900 staff, wide range of expertise.

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Definitions What is a pesticide?

• A pesticide is any substance or mixture
  intended to prevent, destroy, repel or mitigate
  any pest or intended for use as a plant
  regulator, defoliant or dessicant.

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Definitions What is a pest?

• Any insect, rodent, nematode, fungus, weed, or
• Any other form of terrestrial or aquatic plant or
  animal life or virus, bacteria, or other
  micro-organism (except microbes on or in living
  man or animals)
• that EPA declares to be a pest under the law.

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Examples of pesticides

• Algicides, antifouling agents, antimicrobials,
  attractants, disinfectants, fungicides,
  fumigants, herbicides, insecticides, miticides,
  microbials, pheromones, repellents, rodenticides,
  termiticides, plant incorporated protectants
  (PIPs)

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Scope of Regulation

• Over 1000 active ingredients in 16,000 products,
  over 10,000 tolerances (MRLs)
• Used in agriculture, parks, forests, homes,
  businesses, hospitals, schools, food service
  establishments, roadways, etc.

• 20 major producers
• 100 small producers
• 2500 formulators
• 29,000 distributors
• 40,000 pest control firms

• 2-3 million agricultural workers
• 2.1 million farms
• gt1 million certified applicators
• 104 million households

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Key Legal Texts

• Federal Insecticide, Fungicide, and Rodenticide
  Act (FIFRA)
• --registration/licensing and reregistration of
  pesticide products
• Federal Food, Drug, and Cosmetic Act (FFDCA)
• --tolerances/MRLs for residues in foods

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Legal Standards for Health and Environmental
Protection

• FIFRA Standard for initial registration and for
  re-registration
• no unreasonable adverse effects on the
  environment (includes human health)
• FFDCA Standard for food use pesticides
• a reasonable certainty of no harm to consumers

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Major Regulatory Tools and Programs

• Pre-market Approval/Registration and
  Re-registration
• Enforcement, Compliance Assistance and Field
  Programs (state and tribal partnerships)
• Communications, Outreach and Extension

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Major Regulatory Tools and Programs(1)

• Pre-market approval/registration
• --data requirements
• --labeling
• -- other conditions of registration

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Labeling the Label is the Law

• Label elements include
• Product identification and ingredient information
• Signal word and symbol if required
• Keep out of the reach of children
• Restricted Use Statement (if required)
• Precautionary Statements, including first aid and
  hazards to humans and domestic animals
• Storage and disposal statements
• Directions for use, and/or referral to
  supplemental labeling
• New global system (GHS) would mean some changes

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Other Conditions of Registration

• EPA may impose additional conditions when
  approving a registration, for example
• Use restricted to trained and certified
  applicators
• Personal protective equipment
• Pre-harvest and re-entry intervals
• Well set-backs, buffer zones, refugia
• Requirements for additional follow-up/monitoring
  data

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Re-registration

• EPA is in the process of reviewing older
  pesticides to ensure they meet current scientific
  and safety standards
• Re-registration Eligibility Decisions (REDs)
  contain a wealth of detailed scientific and
  technical information
• After EPA completes the current round of
  re-registration reviews, periodic review for all
  pesticides in the future (15 year cycle, unless
  earlier action is warranted by new scientific
  information)

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Major Regulatory Tools and Programs(2)

• Pre-market Approval/Registration and
  Re-registration
• Enforcement, Compliance Assistance and Field
  Programs (state and tribal partnerships)
• Applicator Certification and Training
• Worker Protection Standard
• Endangered Species and ground water protection
  requirements

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Major Regulatory Tools and Programs (3)

• Pre-market Approval/Registration and
  Re-registration
• Enforcement, Compliance Assistance and Field
  Programs (state and tribal partnerships)
• Communications, Outreach and Extension
• IPM emphasis
• Pesticide Environmental Stewardship Program (PESP)

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Part 2 OverviewPesticide Residues in Food

• Review of legal texts
• Import tolerances
• Standards for tolerance (MRL) setting
• Data requirements
• Procedures, public participation and transparency
• Codex and WTO Agreements
• OECD work sharing vision

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Review of Legal Texts

• Under FIFRA, EPA is responsible for
  registering(licensing) pesticides before they may
  be sold or distributed for use in the U.S.
• Under FFDCA, EPA sets tolerances, or maximum
  legally permissible residue limits for pesticide
  residues in or on food or animal feed.

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Effect of a tolerance/MRL

• Applies equally to domestically produced and
  imported foods
• Must be established for a specific crop or crop
  group
• Generally, tolerances are established for raw
  agricultural commodities and apply to processed
  foods derived from that commodity
• Any food with pesticide residues not covered by a
  tolerance, or in excess of the tolerance, may not
  be legally sold or distributed in the U.S.,
  unless EPA has granted a specific exemption from
  the tolerance requirement

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Import tolerances

• EPA will not register a pesticide for use on a
  food crop in the U.S. unless EPA also establishes
  a tolerance or exemption for the residue on the
  crop or crop group.
• EPA will establish a tolerance even if there is
  no registration for use in the U.S., if data
  demonstrate that food safety standards are met
• This is often called an import tolerance

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Enforcement

• EPAs pesticide residue tolerances/MRLs are
  enforced by
• The Food and Drug Administration (FDA) for most
  foods
• The U.S. Department of Agriculture Food Safety
  and Inspection Service (FSIS) for meat, poultry,
  and some egg products

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Pesticide Food Safety Standard

• EPA is responsible for establishing
  tolerances/MRLs at levels that protect the public
  health
• U.S. law sets a single, health-based standard a
  reasonable certainty of no harm to consumers
• EPA must also ensure that tolerances/ MRLs
  continue to be protective over time

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Specific Determinations Required

• To reach a conclusion on whether the standard of
  a reasonable certainty of no harm is met, EPA
  must consider
• Aggregate non-occupational exposure (including
  all food uses, drinking water, residential use)
• Cumulative effects from pesticides with a common
  mechanism or mode of toxicity (e.g., all
  organophosphates)
• Infants, children and other potentially sensitive
  subpopulations
• Potential estrogenic or other endocrine effects

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Data Requirements

• Acute and chronic toxicity studies in animals
• Residue chemistry studies
• Processing and animal feeding studies
• Field trial data under varying growing conditions
• Food consumption and other exposure data,
  including analyses by age, region, etc.

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Three Simple Questions

• What is the residue?
• How much residue is there?
• Is the residue safedoes it meet the standard of
  a reasonable certainty of no harm to consumers?

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Procedures Public Participation and Transparency

• Proposals to establish, modify or revoke
  tolerances/MRLs are subject to public notice
• Notices include detailed data summaries and the
  bases for EPA action
• Decisions are notified to the World Trade
  Organization
• Data requirements are subject to peer review and
  published in the Code of Federal Regulations(CFR)
• Tolerances are published in the Federal Register
  and the CFR

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Other Key FFDCA Provisions

• Tolerance reassessment, mandated by 1996 Food
  Quality Protection Act
• Over 9700 existing tolerances
• Accounts for large number of WTO notices
• August 2006 completion
• Means up to date risk assessments available for
  use by other regulatory authorities, public
• Data call-in authority
• Under FIFRA, or FR notice if no U.S. registration
• If no-one commits to provide the required data,
  tolerance revoked
• Tolerances for FIFRA Section 18 emergency
  exemptions
• --Require same safety findings under FFDCA

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What is Codex?

• The Codex Alimentarius Commission is part of the
  joint UN Food and Agriculture Organization/World
  Health Organization Food Standards Program
• Establishes international food standards,
  including maximum residue limits (MRLs) for
  pesticides
• Twin goals protect consumer health and ensure
  fair practices in the food trade
• Over 170 member countries, many non-government
  observer organizations
• EPA and Japan have both taken leadership roles on
  important Codex issues

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Relationship to World Trade Organization
Agreements

• Agreement on the Application of Sanitary and
  Phytosanitary Measures
• --calls on WTO members to base their SPS
  measures on international standards
• --specifically recognizes Codex as
  international standards-setting organization for
  food safety
• Agreement on Technical Barriers to Trade
• --calls for harmonization of standards and
  technical regulations on as wide a basis as
  possible and for participation in international
  standards bodies
• --does not name specific organizations
• Pesticide MRLs are SPS measures

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EPA Policies toward Codex

• EPA supports and participates actively in Codex,
  leading U.S. delegation to CCPR
• We harmonize our tolerances with Codex MRLs when
  possible, consistent with U.S. food safety
  standardsits in our law
• Very often, however, there is no Codex MRL when
  EPA makes its decision
• Lengthy Codex process has impeded access to
  newer, safer pesticides
• Work in CCPR to expedite MRLs, using accelerated
  procedures (if there are no dietary risk
  concerns) significant progress

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OECD Work Sharing Vision

• Adopted at 2005 OECD workshop in Washington
• To make work-sharing in the review of
  agricultural pesticides a routine practice,
  coordinate timing and decisions
• Japan and the U.S. are both active in OECD work,
  and we expect the relationship to continue to grow

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Why work sharing?

• Pesticides are developed and marketed
  internationally
• All industrialized countries have regulatory
  systems to review old and new pesticides
• Tremendous opportunities to collaborate across
  countries
• Some health and environmental protection issues
  can only be effectively addressed globally

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Examples of on-going projects

• OECD work on study templates
• Templates are harmonized electronic formats for
  study reviews
• Facilitate work sharing and help streamline
  electronic submission and review processes
• Harmonized OECD test guidelines
• Support mutual acceptance of data generated in
  OECD countries and others participating in the
  program
• Conserve scientific resources, promote common
  data base for decisions

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Fundamentals of Work Sharing

• Availability of chemical reviews and schedules
• Harmonization of data requirements
• Hope to develop more comprehensive work-sharing
  relationship with Japanese authorities to share
  information and reduce review burdens

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Information Resources (1)

• www.epa.gov/pesticides
• Legal texts www.epa.gov/pesticides/regulating/law
  s.htm
• Regulations, proposed regulations and notices
• www.epa.gov/pesticides/regulating/laws.htmregula
  tions
• Registration information
• www.epa.gov/pesticides/regulating/registering/dat
  a_sources.htm
• Re-registration information
• http//cfpub.epa.gov/oppref/rereg/status.cfm?show
  rereg
• Worker protection
• http//www.epa.gov/pesticides/health/worker.htm

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Information Resources (2)

• Pesticide Environmental Stewardship Program
• www.epa.gov/oppbppd1/PESP/
• Commodity definitions and crop groupings
  http//www.access.gpo.gov/nara/cfr/waisidx_04/40cf
  r180_04.html
• Data requirements http//www.access.gpo.gov/nara
  /cfr/waisidx_04/40cfr158_04.html
• Import tolerance policy
• www.epa.gov/fedrgstr/EPA-PEST/2000/June/Day-01/p
  13708.htm

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Other references

• International Portal on Food Safety, Animal and
  Plant Health (FAO/WHO), includes Codex MRLs
• www.ipfsaph.org
• International Maximum Residue Limit Database (for
  specialty crops)
• http//mrldatabase.com/