Briefing for Acting EPA Administrator(Your Name Here)

Background on the Alar SituationJanuary 2003

Richard Wilsonbased upon an analysis by John Graham

and George Gray

Alar

• Alar is trade name for daminozide - primary manufacturer is Uniroyal Chemical Company

• Toxicological concern due to Alar as well as breakdown product and metabolite unsymmetrical dimethylhydrazine (UDMH)

• Alar functions as growth regulator - major use is apples

• ripe apples stay on tree longer• easier to harvest entire crop at once• improves appearance of apples

Pesticide Residue Regulation• EPA registration under the Federal Insecticide,

Fungicide and Rodenticide Act (FIFRA) is necessary for pesticide use

• Registration determines which crops pesticide can be used and under what conditions

• Use conditions determined to stay within tolerance for that crop

• Tolerances set through comparison of efficacy and risk

• Stated goal of pesticide regulation is to protect public health while considering the need for "an adequate, wholesome, and economical food supply"

Registration Under FIFRA at EPA

• Registration is required before a pesticide can be sold or used in the U.S.

• Manufacturer must submit efficacy and toxicological data which is used in setting tolerance - burden of proof on manufacturer of pesticide to demonstrate "safety”

• Final output of process is legally binding label for the product indicating on which crops, in what amounts, and when it can be used

• FIFRA established a Scientific Advisory Panel (SAP) to review EPA's evaluations of pesticide risks to human health and the environment - nonbinding review

Reregistration andthe Data Call-in Program

• FIFRA 1972 amendments require that all currently registered ("grandfathered") pesticides be reregistered with up to date and modern toxicological data

• EPA instituted the Data Call-in Program to get the required toxicity and residue chemistry data to support reregistration

Actions Under Reregistration

• Continue registration

• Request more data

• Initiate Special Review process • change terms of registration• cancel some or all uses of pesticide• continue registration as is

• Declare imminent hazard and suspend use

• In all cases of change in registration the burden in on the Agency to demonstrate "unreasonable risk"

Summary of Alar Situation

• Alar was first registered in 1963, registration for apples in 1968

• Tolerance for raw apples set at 30 ppm of Alar

• 1980 - EPA announces plans for Special Review of Alar in light of Toth et al. animal bioassays - Special review called off after private discussions with Uniroyal (according to Congressional Research Service)

• July, 1984 - EPA issues Notice of Initiation of Special Review after litigation by NRDC

Summary of Alar Situation

• September, 1985 - EPA sends Draft Preliminary/Final Determination and Draft Cancellation Notice to Science Advisory Panel. SAP determines that scientific data from Toth cancer studies inappropriate for estimation of cancer risk due to excessive doses and high mortality in treated animals

• EPA allows continued use of Alar pending new toxicology data from Uniroyal

Summary of Alar Situation

• Lowers tolerance from 30 ppm to 20 ppm and sets tolerance expiration date of July 31, 1987

• July 1987 - EPA extends tolerance until January, 1989

• January, 1989 - EPA receives interim report from Uniroyal bioassay - excessive doses and high mortality

• January 31, 1989 - extension of tolerance for Alar expires. Uniroyal is asking for another extension until bioassay data complete

NRDC's Intolerable Risk Report

• Examination of risks of pesticide residues on fruits and vegetables with emphasis on risk to young children

• Conclude that preschoolers are "exposed to hazardous levels of pesticides in fruits and vegetables.”

• Report singles out UDMH as the "greatest source of cancer risk" in study

• "The average preschooler's UDMH exposure during the first six years of life alone is estimated to result in a cancer risk of approximately 1 case for every 4200 preschoolers exposed."

Estimating Risks of Alar

• EPA estimate cancer risk due to Alar residues on food at:4.5 x 10-5 for life time exposure to UDMH1.5 x 10 -5 during the first 5 years of life

assuming a linear dose-response

• Remember that we call these "plausible upper limits" to the risk and the risk may be as low as zero

• NRDC estimates risk at:2 x 10-4 during first 5 years of life for average consumers9 x 10-4 during first 5 years of life for high consumers

• NRDC risk estimates ~ 50 times higher than EPA

The Questions You Must Face

• What factors in addition to the scientific facts must you consider in your decision-making concerning ALAR?

• Should you appear on 60 Minutes? Should you reveal the regulatory decision on 60 Minutes?

• If you agree to the interview how should you prepare?

• In addition to "Why hasn't EPA banned Alar?" and "Is the current law adequate to protect the public from the risks of pesticides?" what other questions should you anticipate?