ENTOM 558Pesticide Regulation

Allan FelsotDepartment of Entomology, WSU-TCFood & Environmental Quality Labafelsot@tricity.wsu.eduLecture 11-3-03

Part I: Benefits & Utility

Why Use Pesticides???– Non-pesticide technologies are ready, “off-

the-shelf” technologies– IPM means less pesticide use

Complexity of AgroecosystemsPublic health pests

Definitions: ‘Fertilizer’

Macro & trace nutrients added to soil (sometimesplant foliage) to maximize crop production/qualityNot regulated by EPA with regards to labeling,application rates, applicator licensing– Federal regulation intercedes when

environmental hazard arises• For example, water pollution

Regulated by states– Labeling to protect against adulteration– Heavy metal content (Canada and Washington

State)

Definitions: ‘Pesticide’

Defined by law, Federal Insecticide, Fungicide, &Rodenticide Act (FIFRA, 1947)Any substance or mixture intended forpreventing, destroying, repelling, or mitigatingany pestPest: insect, rodent, plant, virus, bacteria, fungi– Exempted: microbes living on or in humans– Includes: whatever the EPA administrator rules to be

a pest

Includes plant growth regulators, defoliants,pheromones, desiccants, disinfectants

Have You Used a PesticideRecently????

Natural vs. Agroecosystems

Natural Ecosystems– Diversity rich– Plant nutrients stored &

recycled– Infrequent perturbations– Dominated by native

species– Good natural control

Agroecosystems– Diversity poor– Plant nutrients

depleted– Frequent perturbations– Invaded by exotic

species– Poor natural control

Agroecosystems DemandManagement

Easier for one species to become dominantNutrients are continually removed by annualharvestingPest can be native or imported– pests are opportunists– consider presence or absence of mortality

factors as limiting or enhancing factor

Conflict among economic value of crop, itssusceptibility to damage from pests, and removalof nutrients demands management of both thepest and the crop.

Historical Role of Pesticides1000 BC: Sulfur used as fumigant100 BC: Hellebore (lily containing alkaloids) for controlof rodents & insects70 AD: Report of Greek use of gall of green lizard forprotection against caterpillars & rot!!!!!900 AD: Chinese use arsenic1690 AD: Tobacco extracts1787: Soap mentioned as insecticide; turpentineemulsion as repellant1800 AD: Persian louse powder (pyrethrum); sprays oflime and sulfur; whale oil for scales1848 AD: Rotenone1867 AD: Paris Green (aceto-meta-arsenite of copperfor Colorado potato beetle; mosquitoes)1892 AD: Lead arsenate for gypsy moth; dinitrophenols

Ware 1984

cropproduction

index

crop acresharvested

farm acres

population

Crop Production Index Increases Independently of Acreage

Hayes 1991

306,299,000

3,644,000

307,839,000

1,352,000

56 382

Total PrincipalCrops (acres)

Potatoes (acres)

Potato Yield PerAcre (cwt)

1910 2000Year

More People, Less AcresMore Production/Acre

National Agricultural Statistics Service

Corn Yield

HybridSeed Use

Fertilizer

Insecticide

Significant Increase in YieldAssociated with Fertilizer & Insecticide Use

Hayes 1991

Effect of Weeds onthe Production of Corn and Soybeans

Corn

Soybeans

Hayes 1991

Knutson et al 1993

fresh processedvegetables

fresh processed fruit

-80

-60

-40

-20

0

% YieldReduction

� 50% reduction � zero use

Estimated Effects of Reduction in Pesticide Use

Anopheline mosquitoes/monthfrom capturing stations

Malaria cases/1000 inhabitants

DDT Spraying Post 1945--Latina Province, Italy

Public Health Benefits

Hayes 1991

Pest Management Tools

Cultural practices

Mechanical control

Plant resistance

Parasitoids & Predators

Pesticides

Advantages of Pesticides

Many times they are the only practicalor available technologyRapid action– can be used in an emergency– biodegradable (modern pesticides)

Wide range of properties, uses, andmethods of application– broad spectrum to selective

MarketValue

Total Production Expenses

Labor Fertilizer Pesticides0

50000

100000

150000

2000001992

1997

Farming Costs & Returns

USDA Database

Economic return-cost ratio favorable– $4 - $29 returned per $1 spent– However,

• Ratio goes down when– price of crop decreases but pesticide cost is

fixed;– a product is used and pest populations are not

at a level that will cause economic damage– development costs for a new product are high

Advantages of Pesticides

Are We On a Treadmill?

Costs of Research & Development areextremely high– $70 million– It may take 15 years to recover a positive

cash flow

Is pesticide use rising significantly?

US Corn Pesticide Use

76.2 79.3 3.1

94 97 3210.5 165.0 -45.5

30 29 -120.9 9.8 -12.7

Acres Planted x 106

Herbicides-% Area Applied

Pounds x 106

Insecticides -% Area Applied

Pounds x 106

1991 2000 ChangeCorn

US Potato Pesticide Use

1.2 1.2 0

792.2

932.2

140

913.1

932.8

2

-0.3

692.7

957.8

265.1

45

39

45

108

0

69

Acres Planted X 106

Herbicides-% Area Applied

Pounds X 106

Insecticides-% Area Applied

Pounds X 106

Fungicides-% Area Applied

Pounds x 106

Other-% Area Applied

Pounds x 106

1991 1999 ChangePotatoes

US Apple Pesticide Use

0.35 0.37 0.02

420.31

600.42

180.11

9912.7

978.9

-2-3.8

834.7

855.3

20.7

Acres Planted X 106

Herbicides-% Area AppliedPounds X 106

Insecticides-% Area AppliedPounds X 106

Fungicides-% Area Applied

Pounds x 106

1991 1999 ChangeApple

What Pesticide Use StatisticsCannot Tell Us

Nothing about hazard nor riskNothing about implementation of IPM norsustainable agricultural systems

What Pesticide Use Statistics Can Tell Us

Trends in use of particular productsAdoption of new productsTrends in outbreaks of certain pests

The Down Side of Pesticides

Worker exposure & poisoningPest resistanceReduction of natural enemiesPotential for adverse environmentalhealth effectsPotential for human health effects

Reconciliation

Integrated Control ConceptIntegrated Pest ManagementEcologically Based Pest ManagementSustainable Agriculture

Pesticide RegulationIn the Beginning

Pure Food & Drug Act(1906)

Insecticide Act(1910)

Prohibit Misbranding and Adulteration

Health Protection Ensure Efficacious Product

The adulteration standard placed the laws in conflict!!

Early Evolution of Pesticide Laws

Pure Food & Drug Act(1906)

Insecticide Act(1910)

Federal Food, Drug &Cosmetic Act (FFDCA ‘38)

Federal InsecticideFungicide & Rodenticide

Act (FIFRA ‘47)

Residue Tolerances Registration, Labeling

Safety Testing Not Mandatory!!

FDA USDA

Putting Some Teeth into FFDCA

Pure Food & Drug Act(1906)

Federal Food, Drug &Cosmetic Act (FFDCA 1938)

Residue Tolerances

Miller Amendment(1954) Food Additives Act

Delaney Amendment(1958)

New & Improved FFDCA Tolerance before registration

Manufacturer petitions for tolerance– Name & chemical composition– Application procedures– Safety data– Residue tests– Method for removing excess residue– Proposed tolerance

Manufacturer obtains certificate of usefulnessfrom USDA or exemptionFood sold with residues above toleranceconsidered adulterated

New & Improved FFDCANo Carcinogens

Raw agricultural commodity vs. processed foodIf concentration of residues in processed foodabove raw ag. commodity– Then must obtain tolerance specifically for

processed foodIf chemical caused cancer in lab rats, then noprocessed food allowed tolerance– Paradoxically, A-OK for raw commodity if

benefits outweighed risk

Silent SpringDrives Environmental Concern

Mrak Commission Report, 1969– Study of effects of pesticides on environment

Pesticide regulation responsibilities removedfrom USDA to newly created EPA (1970)FEPCA (Federal Environmental PesticideControl Act, 1972)

– Manufacturer must demonstrate that aproduct could be used without“unreasonable adverse effects on theenvironment.”

FEPCARegistrant had to show that a pesticide could perform itsintended function without unreasonable adverse effectson the environment– Use in violation of product label becomes a crime

Classification of Pesticides– Restricted Use

• Pesticide could cause unreasonable adverseeffects to environment or applicator if additionalregulatory restrictions were not imposed

• Muse be certified to buy– Initiated training and certification programs by

the states– General Use (no license required; available to public)

Shared ResponsibilitiesBut EPA In Charge

EPA(1970) FEPCA (1972)

FFDCA Amended(1954, 1958)

FIFRA(1947)

Food Residues Monitoring(FDA)

Eggs, Meat Residues(USDA)

Re-Registration

FIFRA had historically intended that all productsbe reviewed periodically, i.e., re-registeredFEPCA reiterated this goal (within four yr)Many amendments to FIFRA to extend the initialdeadline under FEPCA– By 1988, 600 active ingredients required re-

registration– Amended FIFRA in 1988 to new 1997 deadline

Re-Registration Rationale

Only products registered prior to 1984 requiredre-assessment and re-registration– Perceived need to require newer tests under

more modern testing and safety standards– Need for implementation of GLPs (Good

Laboratory Practices Standards)• Systematic data tracking and auditing• Requires documentation of standard

operating procedures, protocols, in-progress inspections, data & report audits

Re-Registration

EPA updates and examines database toprioritize information needsCompanies submit new information and/orconducts new studies to fill data gapsEPA can cancel product or require changein label language– Note that the product label is the law!!!

The Pesticide LabelIt’s the Law

All registered active ingredients formulated intocommercial products– All individual products must be registered, but

registration not given until label developed andapproved

The label is the governing law– Identification of active ingredient and contents– Legal uses (crops, maybe specific pests)– Rates of application; application methods– Personal protective equipment– Restrictions on use (no drift; no application near water;

sometimes region-restricted)– Directions for disposal

Paradox of Delaney Amendment

No residues of animal carcinogens (zerotolerance) in processed food, but OK in raw food– EPA maneuvered around by using de minimis

standard• 1 in 1,000,000 risk of additional cancer ok

Advocacy groups sue to have Delaney strictlyenforcedIndustry Concerns over implementation plans forDelaney Amendment following Federal courtruling for strict implementation– If processed commodity affected by Delaney, then so

would be raw commodity

New ConcernsAbout Pesticide Regulation

Where are the children????– Pesticides in the Diets of Infants and Children

• 1993 National Academy of Sciences report• Questioned adequacy of regulations to protect

children• Never concluded that pesticides were unsafe or

harming children

Birth of theFood Quality Protection Act (1996)

Industry wanted Delaney AmendmentrepealedAdvocacy groups wanted childrenprotected and many pesticides scrutinizedunder a risk only perspective

Mandate of the FQPA

Tolerances will be “safe,” i.e., “areasonable certainty that no harm willresult from aggregate exposure”All tolerances will be reassessed by2006

Tolerances (legal limits for residues) hadbeen based on dietary exposure– Represented a residue level somewhat

above highest levels expected in field trials– Sum total of all tolerances for all registered

uses adjusted for food consumption andbody weight could not exceed ReferenceDose (RfD)

• Initial screening uses the Theoretical MaximumResidue Contribution (TMRC) concept (allresidues at the tolerance level)

Basis for the Tolerance

Determination of the Reference Dose (RfD =mg residue/kg body weight/day)– The dose at which there is a reasonable

certainty of no harm for either a single (acute) ordaily lifetime (chronic) exposure

– Rat & dog toxicity tests used to determine adose causing no effect

• No observable effect level (NOEL)

– NOEL divided by a safety factor of 100 = RfD

A Theoretically Safe Dose

What Is a Safe Tolerance?

Infants & ChildrenThreshold vs. Non-threshold EffectEndocrine DisruptionAggregate Exposure AssessmentCumulative Exposure Assessment

Factors To Consider

“Old” Risk Cup

Food

Home & LawnWater

FQPA Risk Cup

FoodReference

Dose

All exposures are aggregated together. The risk cup represents the maximum exposure.

This exposure equals the Reference Dose (RfD)for acute (daily) or chronic (lifetime) exposures

(milligrams of pesticide per kilogram body wt. per day)

Aggregate Exposure

The Shrinking RfDIf enhanced susceptibility of children;If endocrine disrupter;If non-threshold,……THEN

–Apply extra safety factor &–reduce the RfD

FoodFood

Home & LawnWater

“Old” Risk Cup FQPA Risk Cup

Food

Home & LawnWater

FQPA Risk Cup w/ Child

Endocrine,Cancer Hazard

The Changing Size of the Risk Cup

The size of the risk cup, i.e., the EPA Reference Dose(RfD) depends on the nature and degree of the hazard.

Child Sensitivity--A Double Whammy for the Risk Cup

If fetal and newborn rats are moresensitive at a given dose than adult rats,then up to an extra 10-fold safety factormay be applied to the RfD

The RfD divided by this FQPA SafetyFactor is called the

– Population Adjusted Dose (PAD)

NOEL

100= Reference Dose (RfD)

RfD

10= Population Adjusted Dose (PAD)

Is It Safe Enough???

Food

Home & Lawn

Water

Overflowing FQPA Risk Cup

What determines the size of the cup?How is the cup filled?If the cup overflows, EPA freaks, but isthat really hazardous?

Exposure > 100%of RfD or PAD

Food

Secrets of the FQPA

As written, the FQPA deals with consumerprotection– Nothing is stated about worker and ecological

protection– Risk based assessment

However, the process of tolerancereassessment places all hazards on the table(by virtue of FEPCA!!!)– EPA issues a RED (Re-registration Eligibility Decision

document)

Registration Eligibility Decision Documents(REDs)

EPA’s analyses leading to a determination ofeligibility for registrationInput from– HED (Health Effects Division)– EFED (Ecological Fate & Effects Division)

Chapters are typical risk assessment process– Hazard & Dose-Response Assessment– Dietary, Drinking Water, Residential & Worker

Exposure– Nontarget Organism Exposure– Risk Characterization

The Cat Is Out of the Bag

In late 1999, the NRDC (Natural ResourcesDefense Council) and several otherenvironmental advocacy groups sued EPAclaiming failure to properly implement theFQPA– The main issue was failure to consider cumulative

exposure

Consent Decree signed Spring, 2001– Provisions to ensure cumulative exposure

assessment and publication of determinations

– Provisions to include worker exposureand ecological effects

Caveats of Pesticide RiskAssessment

The assessment of risk to consumers isnow guided by the mandates of theFQPA– No benefits consideration (with one

exception)The assessment of risk to workers andthe environment is pretty much thesame as before the FQPA– But, benefits of pesticide use can be

considered

U.S. Pesticide Law 101

FIFRA(1947)

FFDCA(1938)

Tolerance (“MRL”)

FEPCA(1972)

Labeling Registration

Risk Assessment

FQPA(1996)

Miller (1954)Delaney (1958)

Consequences of the FQPA

More transparency in EPA riskassessment policies and decision makingBlazing new trails in risk assessmentmethodologyOP insecticide uses being curtailed andeven cancelled in urban sectorsLabel changes to protect workers; lessoften the environmentTolerance reductions