1. FIFRA 101 Karl Arne May 17, 2010 Karl Arne May 17, 2010

2. Pesticide Laws  Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)  Federal Food, Drug, and Cosmetic Act (FFDCA)  Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)  Federal Food, Drug, and Cosmetic Act (FFDCA)

3. Purpose  To regulate the marketing of economic poisons and devices, and for other purposes.

4. Other Laws  Endangered Species Act  Clean Water Act  Occupational Safety and Health  National Environmental Policy Act  Safe Drinking Water Act  Endangered Species Act  Clean Water Act  Occupational Safety and Health  National Environmental Policy Act  Safe Drinking Water Act

5. Revisions to FIFRA  1959 nematicides, plant regulators, defoliants, and desiccants added to the definition of a pesticide  1964 registration numbers; signal words (i.e., Warning, Caution, Danger). Emergency suspensions  1972; restricted use; certification; “no unreasonable adverse effects”  1975 Notification of USDA; consider the impact of pesticide cancellations on production and costs of agricultural commodities; establish a Scientific Advisory Panel  1978 conditional registrations allowed  1988 reregistration timeline  1996 FQPA timeline for reregistration; additional safety; cumulative; aggretate  2003 and 2007 PRIA  1959 nematicides, plant regulators, defoliants, and desiccants added to the definition of a pesticide  1964 registration numbers; signal words (i.e., Warning, Caution, Danger). Emergency suspensions  1972; restricted use; certification; “no unreasonable adverse effects”  1975 Notification of USDA; consider the impact of pesticide cancellations on production and costs of agricultural commodities; establish a Scientific Advisory Panel  1978 conditional registrations allowed  1988 reregistration timeline  1996 FQPA timeline for reregistration; additional safety; cumulative; aggretate  2003 and 2007 PRIA

6. Section 2- Definitions  (a) Active ingredient.  (b) Administrator.  (c) Adulterated.  (d) Animal.  (e) Certified applicator, etc.  (1) Certified applicator.  (2) Private applicator.  (3) Commercial applicator.  (4) Under the direct supervision of a certified applicator.  (f) Defoliant.  (g) Desiccant.  (h) Device.  (i) District court.  (j) Environment.  (k) Fungus.  (l) Imminent hazard.  (m) Inert ingredient.  (n) Ingredient statement.  (o) Insect.  (p) Label and labeling.  (a) Active ingredient.  (b) Administrator.  (c) Adulterated.  (d) Animal.  (e) Certified applicator, etc.  (1) Certified applicator.  (2) Private applicator.  (3) Commercial applicator.  (4) Under the direct supervision of a certified applicator.  (f) Defoliant.  (g) Desiccant.  (h) Device.  (i) District court.  (j) Environment.  (k) Fungus.  (l) Imminent hazard.  (m) Inert ingredient.  (n) Ingredient statement.  (o) Insect.  (p) Label and labeling.  (q) Misbranded  (r) Nematode.  (s) Person.  (t) Pest.  (u) Pesticide.  (v) Plant regulator.  (w) Producer and produce.  (x) Protect health and the environment.  (y) Registrant.  (z) Registration.  (aa) State.  (bb) Unreasonable adverse effects on the environment.  (cc) Weed  (dd) Establishment.  (ee) To use any registered pesticide in a manner inconsistent with its labeling.  (ff) Outstanding data requirement.  (gg) To distribute or sell.

7. UNREASONABLE ADVERSE EFFECTS ON THE ENVIRONMENT  The term ‘‘unreasonable adverse effects on the environment’’ means (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.

8. 2(ee) Uses  The term ‘‘to use any registered pesticide in a manner inconsistent with its labeling’’ means to use any registered pesticide in a manner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage, concentration, or frequency, (2) applying a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling,

9. Section 3- Registration  DATA IN SUPPORT OF REGISTRATION  The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time.  DATA IN SUPPORT OF REGISTRATION  The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time.

10. Data Requirements  Described in 40 CFR 158  Additional guidelines describe how to conduct studies  Data requirements necessarily do not address newer concerns  Following slides show toxicology data requirements  Described in 40 CFR 158  Additional guidelines describe how to conduct studies  Data requirements necessarily do not address newer concerns  Following slides show toxicology data requirements

14. Risk Assessment  Standards of protection  Reasonable certainty of no harm (FFDCA)  No unreasonable adverse effects (FIFRA)  Standards of protection  Reasonable certainty of no harm (FFDCA)  No unreasonable adverse effects (FIFRA)

15. Reasonable Certainty of No Harm  Applies to dietary exposure  Risk determined through estimates of hazard and exposure  Reference Dose Concept  Because this standard is in FFDCA, not FIFRA, benefits are not as important  Applies to dietary exposure  Risk determined through estimates of hazard and exposure  Reference Dose Concept  Because this standard is in FFDCA, not FIFRA, benefits are not as important

16. Hazard  Determined by tox studies  No observable adverse effect (NOAEL) level determined (usually from long term studies)  NOAEL is basis of reference dose  For non-threshold effects such as cancer, it is presumed that any level of exposure results in a possibility of disease.  Determined by tox studies  No observable adverse effect (NOAEL) level determined (usually from long term studies)  NOAEL is basis of reference dose  For non-threshold effects such as cancer, it is presumed that any level of exposure results in a possibility of disease.

17. Dietary Exposure Estimates  Requires estimates of food consumption and residue levels  Food Consumption Estimates based on USDA Decennial Food Surveys  Residue levels are based on tolerance or other reliable data  Requires estimates of food consumption and residue levels  Food Consumption Estimates based on USDA Decennial Food Surveys  Residue levels are based on tolerance or other reliable data

18. Allowable Dietary Exposure  Generally one-hundreth of a level that is found to produce no observable adverse effects  Additional safety factor is added for children if needed  Includes cumulative and aggregate exposures  Generally one-hundreth of a level that is found to produce no observable adverse effects  Additional safety factor is added for children if needed  Includes cumulative and aggregate exposures

19. No Unreasonable adverse Effects  Attempt is made to limit exposure to 1% of the NOAEL (e.g., for farmworkers, pesticide applicators)  Margin of Exposure (MOE) concept  But if this isn’t achieved, then the pesticide may still be used, provided the benefits are sufficient.  Attempt is made to limit exposure to 1% of the NOAEL (e.g., for farmworkers, pesticide applicators)  Margin of Exposure (MOE) concept  But if this isn’t achieved, then the pesticide may still be used, provided the benefits are sufficient.

20. Example: Azinphos-methyl  Organophosphate  Risk from dietary exposure considered acceptable (reasonable certainty of no harm standard).  MOEs for handlers, applicators, and farm workers are unacceptable, i.e., in some cases much less than 100  Since benefits are high, use was allowed to continue for several years  Organophosphate  Risk from dietary exposure considered acceptable (reasonable certainty of no harm standard).  MOEs for handlers, applicators, and farm workers are unacceptable, i.e., in some cases much less than 100  Since benefits are high, use was allowed to continue for several years

21. Plants and Animals  “no unreasonable adverse effects” standard also applies to plants and animals  Level of protection is, in general, designed to protect populations, not individuals.  Risk Quotient Concept  “no unreasonable adverse effects” standard also applies to plants and animals  Level of protection is, in general, designed to protect populations, not individuals.  Risk Quotient Concept

22. Animals  Level of concern is, in general, one half of the LC 50  For Endangered Species, acceptable exposure is usually one tenth of the LC 50  Level of concern is, in general, one half of the LC 50  For Endangered Species, acceptable exposure is usually one tenth of the LC 50

23. Example: Organophosphates and ESA  Because EPA’s risk quotient approach may not be protective of individual animals, it falls short of the protection required by the Endangered Species Act.

24. Plants  Level of concern is EC 25  Not necessarily protective of Endangered Species  Also uses the risk quotient approach  Level of concern is EC 25  Not necessarily protective of Endangered Species  Also uses the risk quotient approach

25. Example: Picloram  Extremely Phytotoxic Herbicide  Groundwater Contaminant  Reregistered in 1995  Groundwater monitoring required as condition of reregistration  Very high risk quotients  Extremely Phytotoxic Herbicide  Groundwater Contaminant  Reregistered in 1995  Groundwater monitoring required as condition of reregistration  Very high risk quotients

26. Example: Sulfonylurea Herbicides  Low dose herbicides  Plant Reproductive effects  Effects at undetectable levels  High risk quotients  Two SUs have been reregistered  Low dose herbicides  Plant Reproductive effects  Effects at undetectable levels  High risk quotients  Two SUs have been reregistered

27. 3c2b  ADDITIONAL DATA.—(i) If the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person.

28. Section 3,cont  Conditional Registration  Expedited Registration  Classification of Pesticides  Labels  Conditional Registration  Expedited Registration  Classification of Pesticides  Labels

29. Sections 4-9  4- Reregistration  5- Experimental Use Permits  6- Administrative Review; Suspension  - 6(a)(2) Reporting of new information  7- Registration of Establishments  8- Books and Records  9- Inspection of Establishments; Use of Restricted use Pesticides  4- Reregistration  5- Experimental Use Permits  6- Administrative Review; Suspension  - 6(a)(2) Reporting of new information  7- Registration of Establishments  8- Books and Records  9- Inspection of Establishments; Use of Restricted use Pesticides

30. Sections 10-15  10- Trade Secrets  11- Restricted Use Pesticides  12-Unlawful Acts  13-Stop Sale, Use, Removal, and Seizure  14- Penalties  15- Indemnities  10- Trade Secrets  11- Restricted Use Pesticides  12-Unlawful Acts  13-Stop Sale, Use, Removal, and Seizure  14- Penalties  15- Indemnities

31. Sections 16-20  16- Administrative Review  17- Imports and Exports  18- Exemption of State Agencies  19- Storage and Disposal  20- Research and Monitoring  16- Administrative Review  17- Imports and Exports  18- Exemption of State Agencies  19- Storage and Disposal  20- Research and Monitoring

32. Sections 21-25  21- Solicitation of Comments  22- Delegation and Cooperation  23- State Cooperation, Aid, and Training  24- Authority of States  25- Authority of Administrator  21- Solicitation of Comments  22- Delegation and Cooperation  23- State Cooperation, Aid, and Training  24- Authority of States  25- Authority of Administrator

33. Sections 26-32  26- State Primary Enforcement Responsibility  27- Failure of State Enforcement  28- Identification of Pests  29- Annual Report  30- Minimum Requirements for Training of Applicators  31 and 32- Minor Use Programs  26- State Primary Enforcement Responsibility  27- Failure of State Enforcement  28- Identification of Pests  29- Annual Report  30- Minimum Requirements for Training of Applicators  31 and 32- Minor Use Programs

34. Issues  Shortcomings of Science  Lack of Timeliness  Risk Benefit standard  Weak analysis of alternatives  Resources  Shortcomings of Science  Lack of Timeliness  Risk Benefit standard  Weak analysis of alternatives  Resources

35. Resources  FIFRA  http://agriculture.senate.gov/Legislation/Compila tions/Fifra/FIFRA.pdfRainbow Report  Pesticide Registration Notices  http://www.epa.gov/PR_Notices/  40 CFR Part 158  Reregistration Elegibility Documents  http://www.epa.gov/pesticides/reregistration/status.htm http://www.epa.gov/pesticides/reregistration/status.htm  FIFRA  http://agriculture.senate.gov/Legislation/Compila tions/Fifra/FIFRA.pdfRainbow Report  Pesticide Registration Notices  http://www.epa.gov/PR_Notices/  40 CFR Part 158  Reregistration Elegibility Documents  http://www.epa.gov/pesticides/reregistration/status.htm http://www.epa.gov/pesticides/reregistration/status.htm