Regulation and Management of Pest Control Products in the U.S. An Introduction to EPA’s Pesticide Programs Anne Lindsay Deputy Director Office of Pesticide Programs U.S. Environmental Protection Agency January, 2007

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

Part I Overview: U.S. Regulatory System Fundamentals  Definitions, scope of coverage  Legal texts  Standards for health and environmental protection  Major regulatory tools and programs

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.

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. 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.

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.

Examples of pesticides Algicides, antifouling agents, antimicrobials, attractants, disinfectants, fungicides, fumigants, herbicides, insecticides, miticides, microbials, pheromones, repellents, rodenticides, termiticides, “plant incorporated protectants” (PIPs)

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 >1 million certified applicators 104 million households

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

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”

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

Major Regulatory Tools and Programs(1)  Pre-market approval/registration -- data requirements -- labeling -- other conditions of registration

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

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

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)

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

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)

Part 2 Overview: Pesticide 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

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.

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

‘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 ’

Enforcement EPA’s 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

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

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

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.

Three Simple Questions  What is the residue?  How much residue is there?  Is the residue safe—does it meet the standard of a reasonable certainty of no harm to consumers?

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

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

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

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

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 standards—it’s 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

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

Why work sharing? Pesticides are developed and marketed internationally +Pesticides are developed and marketed internationally + All industrialized countries have regulatory systems to review old and new pesticides =All industrialized countries have regulatory systems to review old and new pesticides = Tremendous opportunities to collaborate across countriesTremendous opportunities to collaborate across countries Some health and environmental protection issues can only be effectively addressed globallySome health and environmental protection issues can only be effectively addressed globally

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

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

Information Resources (1) Legal texts: Regulations, proposed regulations and notices: Registration information: s.htm s.htm Re-registration information: Worker protection:

Information Resources (2)  Pesticide Environmental Stewardship Program  Commodity definitions and crop groupings html html html  Data requirements html html html  Import tolerance policy 01/p13708.htm

Other references  International Portal on Food Safety, Animal and Plant Health (FAO/WHO), includes Codex MRLs  International Maximum Residue Limit Database (for “specialty crops”)