The OP Pilot Public Participation Process

The organophosphates are a group of

related pesticides that affect the functioning of the

nervous system. They are among EPA’s highest

priority for review under the Food Quality

Protection Act. 

EPA is encouraging the public to

participate in the review of the OP pesticides. 

Through a six-phased pilot public participation

process, the Agency is releasing for review and

comment its preliminary and revised scientific risk

assessments for individual OPs. (Please contact

the OP Docket, telephone 703-305-5805, or see

EPA’s web site, www.epa.gov/pesticides/op .)

EPA is exchanging information with

stakeholders and the public about the OPs, their

uses, and risks through Technical Briefings,

stakeholder meetings, and other fora. USDA is

coordinating input from growers and other OP

pesticide users. 

Based on current information from

interested stakeholders and the public, EPA is

making interim risk management decisions for

individual OP pesticides, and will make final

decisions through a cumulative OP assessment.

United States Prevention, Pesticides EPA 738-F-00-010

Environmental Protection and Toxic Substances October 2000

Agency (7508C)

 

 Fenitrothion Facts

EPA has assessed the risks of fenitrothion and completed a “Report on FQPA Tolerance

Reassessment Progress and Interim Risk Management Decision for Fenitrothion” for this

organophosphate (OP) pesticide. Without risk mitigation, fenitrothion fits into its own “risk cup”-- its

individual, aggregate risks are within acceptable levels. Fenitrothion also is eligible for reregistration,

pending a full reassessment of the cumulative risk from all OPs. 

In July 1995 a RED was issued for

fenitrothion. Most uses were canceled during the

RED process or subsequent to the issuance of the

RED. Currently used in Australia on stored wheat 

and in the U.S. in containerized ant and roach baits in

child resistant packaging, fenitrothion residues in

food do not pose risk concerns and exposure

resulting from use of the containerized ant and roach

baits is expected to be insignificant. Without

mitigation fenitrothion fits into its own “risk cup.” 

EPA’s next step under the Food Quality

Protection Act (FQPA) is to complete a cumulative

risk assessment and risk management decision

encompassing all the OP pesticides, which share a

common mechanism of toxicity. The interim

decision on fenitrothion cannot be considered final

until this cumulative assessment is complete. Further

risk mitigation may be required at that time. 

EPA is reviewing the OP pesticides to

determine whether they meet current health and

safety standards. Older OPs need decisions about

their eligibility for reregistration under FIFRA. OPs

with residues in food, drinking water, and other nonoccupational exposures also must be reassessed to

make sure they meet the new FQPA safety standard. 

The fenitrothion interim decision was made through the OP pilot public participation process,

which increases transparency and maximizes stakeholder involvement in EPA’s development of risk

assessments and risk management decisions. EPA worked extensively with affected parties to reach
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the decisions presented in this interim decision document, which concludes the OP pilot process for

fenitrothion. 

Uses

• An insecticide/acaricide, fenitrothion is used in Australia on stored wheat and there is a U.S.

tolerance for imported wheat gluten. The only registered use in the U.S. is for containerized

ant and roach baits in child resistant packaging.

• Annual domestic use is low. Annual U.S. consumption of wheat gluten by the food industry is

about 250 million pounds; currently approximately 26% (65 million pounds) is imported from

Australia. No data are available on percent crop treated in Australia. 

Health Effects

• Fenitrothion can cause cholinesterase inhibition in humans; that is, it can overstimulate the

nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,

accidents or major spills), respiratory paralysis and death. 

Risks 

• Dietary exposures from consuming wheat gluten treated with fenitrothion are below the level

of concern for the entire U.S. population, including infants and children. Drinking water is not

a source of exposure. 

• Risks are not of concern for the use of fenitrothion in containerized ant and roach baits in child

resistant packaging. Exposure is expected to be insignificant because the material is not

available through the dermal and oral routes; and, due to the small amount of material which

would be available through volatilization, inhalation exposure is expected to be minimal.

Risk Mitigation

• No risk mitigation is necessary at this time. 

Next Steps

• Numerous opportunities for public comment were offered as this decision was being

developed. The fenitrothion IRED therefore is issued as final (see

www.epa.gov/pesticides/op), without a formal public comment period. The docket remains

open, however, and any comments submitted in the future will be placed in this public docket. 
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• When the cumulative risk assessment for all organophosphate pesticides is completed, EPA

will issue its final tolerance reassessment decision for fenitrothion and may require further risk

mitigation measures. The Agency will amend the only tolerance for fenitrothion now. The

tolerance for wheat gluten imported from Australia will be lowered to 3 ppm and the tolerance

expression will be modified to include only the parent compound. For all OPs, raising and/or

establishing tolerances will be considered once a cumulative assessment is completed.