About

California Environmental Protection Agency

|- Department of Pesticide Regulation

|--- Registration and Evaluation Division

|----- Human Health Assessment Branch

Today’s Topics

An evolution in pesticide regulation

A law for regulated pesticide residue in food

An appraoch for pesticide exposure assessment

What Is a Pesticide?

The term "pesticide" means

• any substance or mixture of substances intended for

  • preventing, destroying, repelling, or mitigating any pest.

  • use as a plant regulator, defoliant, or desiccant

• any nitrogen stabilizer

First Pesticide

California’s first law, passed in 1901, was concerned only with preventing consumer fraud in sales of Paris green.

First Law

Until 1910, Congress passed the first federal law, Federal Insecticide Act, to regulate its sales.

1906

The Jungle published

Food and Drug Administration formed

Pure Food and Drug Act

Meat Inspection Act

First Standard

1919 — Boston inspector finds arsenic dust on pears

1925 — British illnesses linked to American apple imports

1927 — First federal tolerances set for arsenic on apples & pears

1938

President Franklin Roosevelt signed Federal Food, Drug, and Cosmetic Act (FFDCA).

The Food and Drug Administration has the authority to set food "standards".

1947

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was established.

The U.S. Department of Agriculture (USDA) was required to ensure the "quality and effectiveness" of products.

1970

The official birthday of EPA is December 2, 1970 ... But pollution alone does not an agency make. Ideas are needed--better yet a whole world view--and many environmental ideas first crystallized in 1962.

1972

Congress amended the FIFRA, requiring EPA to measure

• every pesticide's "risks" to man and environement against its potential benefits.

and

• any human "dietary risk" from residues that result from use of a pesticide in or on any food inconsistent with the standard under section 408 of the FFDCA.

1983

1996

FQPA

FQPA requires EPA to find "a reasonable certainty of no harm", including

• Aggregate risk — food, water, air, and other sources

• Cumulative risk — chemicals sharing a common mechanism of toxicity

• Extra protection for infants and children

Uncertainty Factor Safety Factor

RfD & PAD can build from No observed adverse effect level (NOAEL) or Lowest observed adverse effect level (LOAEL)

Residue Monitoring

US FDA Residue Monitoring Program (1987–)

USDA Pesticide Data Program (1991–)

CDPR California Pesticide Residue Monitoring Program (2003–)

USDA Pesticide Data Program

• For consumer exposure assessment only

  • Focuses on pesticides used on the selected commodities, including pesticides without U.S. tolerances but used abroad on imported products.

  • Samples are taken closer to the point of consumer purchase and are prepared the way consumers use them.

  • Laboratories focus on detecting very low pesticide residue levels

US FDA Residue Monitoring Program

• Enforces tolerances on imported & domestic products

• Targeted sampling

  • consumption frequency
  • violation history

• Also runs the Total Diet Study (~800 contaminants monitored)

California Pesticide Residue Monitoring Program

CDPR focuses on sampling high-risk commodities:

• Highly consumed by infants & children
• Treated with Prop 65-listed carcinogens/reproductive toxins
• Reflective of ethnic & socioeconomic consumption patterns
• History of illegal residues (commodity or origin)

Dietary Exposure Assessment

The basic model

Pesticide Ingested = Residue Concentration x Foods Consumed

Children vs. Adults

60 kg adult, 60 g apple/day → 1 g/kg

20 kg child, 60 g apple/day → 3 g/kg

! Same intake, 3× the exposure per body weight

Acute & Chronic Exposure

Acute — extreme exposure scenario

Tier 1: Tolerance

Tier 2: Max detect

Chronic — mean consumption × mean residue

Tier 3: Mean or ½ LOD

Food Consumption Database

Continuing Survey of Food Intakes by Individuals (CSFII, USDA)
1989–91, 1994–96, 1998

What We Eat In America (WWEIA, CDC)
1999–

Food Commodity Intake Database (FCID, EPA)
Convert reported food consumption into food commodity intakes

Exposure Assessment

Deterministic

— regulatory tolerance decisions

Stochastic

— exposure distribution, biomonitoring comparison

Neither is "more correct" — the tiered framework matches refinement to the decision

Exposure Models

Deterministic

• DEEM-FCID — regulatory workhorse for dietary assessment used by both EPA and CDPR

Stochastic

• SHEDS — simulates a population of individuals (activity, body weight, diet, etc.,)

Take Away

Evolution — from quality assurance to safety assurance

Law — a health risk-centric framework to protect children

Approach — integration of data and model

Take Away

Evolution — from quality assurance to safety assurance

Law — health risk-centric framework to protect children

Approach — integration of data and model

Thank You

Questions?