UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: 5/9/ 13 

SUBJECT: Fenhexamid. Human Health Assessment Scoping Document in Support of 

Registration Review. 

PC Code: 090209 

Decision No.: t.J7g.13tf 

Petition No.: N/A 

DP Barcode: D407943 

Registration No.: N/A 

Regulatory Action: Registration Review 

Scoping Document 

Risk Assessment Type: N/ A 

TXRNo.: N/A 

Case No.: 7027-1 

CAS No.: 126833-17-8 

MRID No.: N/A 40 CFR: 180.553 

FROM: 

THRU: 

TO: 

Monica Hawkins, Environrnentalj-lealth Scientist/Risk Assessor Jl~ %.wY~ P. Yvonne Barnes, Chemist ~~..,...__. ~etL~ 

N~ncy McCarro!l, Se~ior ~oxicologist -Aia.-L./Itc ~~ Bndgett Bobowtec, BIOl ogtst~~Jh 7~7 Risk Assessment Branch VI - . -;]"' 

Health Effects Division (7509P) 1--

Felecia Fort, Branch Chief ~~~C{ta -;j(JJ~ Risk Assessment Branch VI ')JJ' 

Health Effects Division (7509P) 

Joel Wolf, Chemical Review Manager 

Risk Management and Implementation Branch II 

Product Re-Evaluation Division (7508P) 

Attached is HED's human health risk assessment scoping document for fenhexamid to support 

Registration Review. 

Executive Summary 

Page 1 of22 
Fenhexamid Registration Review Human Health Scoping Document 

The most recent human health risk assessment for fenhexamid, which is a fungicide, was 

completed in 2007 for use on asparagus (B. Hanson, D347171 , 12/05/2007). HED has 

evaluated the status of all previous risk assessments for fenhexarnid to determine whether 

sufficient data are available and whether any updates are needed to support Registration Review. 

The previous risk assessments were evaluated with respect to fenhexamid's toxicity, exposure, 

usage databases, and the most updated Agency science policy and risk assessment methodologies 

to determine the scope of work necessary to support Registration Review. 

Fenhexamid is a water dispersible granule that is applied on a variety of agricultural and 

ornamental crops in the field, greenhouses, and in post-harvest production. HED's Metabolism 

Assessment Review Committee (MARC) concluded that only the parent fenhexamid needs to be 

included in the tolerance expression and used for dietary and drinking water risk assessments. 

Only parent fenhexamid is of regulatory concern. 

The toxicology database for fenhexamid is incomplete but sufficient for registration review. In 

accordance with the revised 2007 toxicology data requirements, the neurotoxicity battery and 

immunotoxicity studies are required. Additionally, a sub chronic inhalation toxicity study is 

required if there is likelihood of repeated inhalation exposure to pesticide chemical. HED's 

Hazard Science Policy Council (HASPOC) evaluated all of the available hazard and exposure 

information for fenhexamid and concluded that the sub chronic inhalation is not required based 

on: the low acute inhalation toxicity (Toxicity Category IV); lack of systemic toxicity when 

exposed at 1.092 mg/L for 5-days and the the composition of the formulated product (waterdispersible granules containing 50% a.i.); the low application rate (maximum of 0.5-0.75 lb 

ai/Napplication) and application method (ground spray, ground boom and airblast). The Council 

also concluded that a sub chronic inhalation study is not required since there was no evidence of 

neurotoxicity at the Limit Dose in an acute neurotoxicity study, there is no evidence of 

neurotoxicity in the subchronic and chronic oral toxicity studies, and the Point of Departure 

(POD) use for risk assessment is based most sensitive endpoint (hematopoietic toxicity) observed 

in the most sensitive species (dog) and therefore, a sub chronic will not be useful in the 

Agency's evaluation of risk. OPP has published the findings of an independent retrospective 

analysis of 170 immunotoxicity studies submitted to the Agency. The retrospective analysis 

showed that the submitted immunotoxicity studies have not yet resulted in PODs that are lower 

than the PODs selected from other available guideline experimental toxicology studies. As a 

result, the currently available immunotoxicity studies have not impacted the Agency's risk 

assessments. HED is in the process of developing guidance on data waiver considerations. In the 

interim, HED recommends that immunotoxicity studies continue to be required for registration 

and registration review chemicals. 

The residue chemistry database for fenhexamid is complete. However, the chemistry database 

indicates that the registrant has, as a condition of registration, submitted three studies: (MRID 

45720101) two additional field trials required to support an individual tolerance on prunes; 

(MRID 45720102) a processing study required for dried prune matrices; and (MRID 45720103) 

a method validation study required to support dried prune residue data collection. These 

documents have not yet been reviewed. The most recent unrefined dietary risk assessment 

included an updated drinking water assessment for fenhexamid. An acute reference dose (RID) 

has not been established for fenhexarnid aRd it is classified as a "not likely" human carcinogen. 

Neither an acute nor a cancer dietary risk assessment is required. For chronic, the chronic 

dietary exposure is below the level of concern. 

Page 2 of22 
Fenhexamid Registration Review Human Health Scoping Document

Page 3 of 22

There are currently no registered residential uses for fenhexamid; therefore, no short- and 

intermediate-term aggregate risk assessments are required.

The occupational exposure database is adequate to support the registration review process for 

fenhexamid. Updated occupational handler exposure assessments may be required under 

Registration Review based upon revisions to the Agency’s scenario-specific handler exposure

data. New exposure monitoring data may be incorporated, as necessary, during Registration 

Review. Updated occupational post-application exposure assessments may be required under 

Registration Review based upon revisions to the Agency’s post-application exposure data and to 

incorporate chemical-specific data, as necessary. In addition, revised occupational handler and 

post-application assessments may be needed if toxicological endpoints change or other new data 

are received by the Agency that impact exposure estimates.

Introduction

Fenhexamid is currently registered for field application on almonds, asparagus, bushberries, 

caneberries, ginseng (except California), grapes, pear and oriental pear, pistachios, stone fruit, 

and strawberries. The chemical is currently registered for transplant production and greenhouse 

production on the following crops; cilantro (except California), cucumber, fruiting vegetables, 

tomatoes, leafy greens (except spinach), and nursery grown ornamentals. Fenhexamid also has 

post-harvest application registered uses on the following crops: cherries, kiwi, pear and oriental 

pear, pomegranate, and stone fruit. 

Information on the chemical identify of fenhexamid is included in Attachment 1.

Hazard Identification/Toxicology

The Toxicology Profile Tables are presented in Attachment 2, Table A 2.2. In general, the 

toxicology studies conducted on fenhexamid demonstrate that it has few or no biologically 

significant toxic effects at relatively low doses in many animal studies and only mild or no toxic 

effects at high doses, which often approach or exceed the limit dose. In subchronic and chronic 

oral studies, the most toxicologically significant effects were anemia in dogs, decreased body 

weights, increased food consumption and mild liver and/or kidney effects in rats and mice. 

Fenhexamid is not acutely toxic, neurotoxic, carcinogenic or mutagenic and is not a 

developmental or reproductive toxicant. There was no evidence of increased susceptibility 

following in utero exposure to rats or rabbits. There was evidence for increase qualitative 

susceptibility following pre/post natal exposure in the two generation reproduction study. 

Offspring toxicity manifested as severe decreases in the body weight of pup in both the F1 and 

F2 generations at the same dose that caused parental toxicity characteristic of hepatotoxicity. 

HED’s Hazard Identification Assessment Review Committee (HIARC) determined that there is 

low concern for pre- and/or postnatal toxicity resulting from exposure to fenhexamid (Tarplee, 

2003). The rationale for this decision was based on the evidence showing no increased 

susceptibility in the offspring in either the rat or rabbit developmental toxicity studies and that a

clear No Observed Adverse Effect Level (NOAEL) and a well-characterized dose response for 

offspring effects was observed in the presence of maternal toxicity. Accordingly, the doses 
Fenhexamid Registration Review Human Health Scoping Document

Page 4 of 22

selected for the risk assessment would be protective of the susceptibility of the young. HIARC 

also determined that no FQPA safety factor is needed (i.e. 1X) since there are no residual 

uncertainties for pre and/or postnatal toxicity. In addition the HIARC concluded that there is not 

a concern for developmental neurotoxicity resulting from exposure to fenhexamid. Minimal or 

no toxic effects were observed in studies in which fenhexamid was administered by the dermal 

or inhalation routes of exposure. 

In a battery of five mutagenicity studies (with and without metabolic activation, as appropriate 

for the specific study), technical grade fenhexamid was negative for genotoxicity. 

Based on the lack of evidence of carcinogenicity in male and female rats as well as in male and 

female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies, 

fenhexamid is classified as a “not likely” human carcinogen according to the EPA Proposed 

Guidelines for Carcinogen Risk Assessment (April 10, 1996).

The fenhexamid endpoints, points of departure (POD), and uncertainty/safety factors (UF/SFs) 

are summarized in Attachment 3, Tables A 3.1 and A 3.2. HED concluded that an aRfD was not 

selected for the acute dietary risk assessment because no appropriate toxicological endpoint 

attributable to a single exposure was identified in the available toxicology studies, which 

included an acute neurotoxicity study in rats and developmental studies in rats and rabbits 

(Hansen, 2007). Since that time, no new studies have been submitted. 

The chronic Reference Dose (cRfD) of 0.17 mg/kg/day was based on toxicological findings in 

the 1-year chronic dog feeding study of decreased RBCs, decreased hemoglobin and hematocrit, 

and increased Heinz bodies in males and females, as well as increased adrenal weights and 

intracytoplasmic vacuoles in females at the Lowest Observed Adverse Effect Level (LOAEL) of 

124 mg/kg/day (See Attachment 3, Table A 3.1). An uncertainty factor of 100 (10X for 

interspecies and 10X for intraspecies variations) was applied to the NOAEL of 17 mg/kg/day.

Since there are no residential exposures, endpoints were not selected for incidental oral (shortand intermediate-term), dermal (short-, intermediate- or long- term) or inhalation (short-, 

intermediate- or long- term) scenarios.

Occupational exposure via the dermal route is expected. Accordingly, the 21-day dermal 

toxicity study was selected for the short- and intermediate-term dermal risk assessments, based 

on the NOAEL of 1000 mg/kg/day (HDT, Limit dose). HIARC (TXR No. 0051704, 3/26/2003) 

justified this selection because the results of this study were consistent with those of the oral 

developmental toxicity study in rabbits in which maternal effects (decreased body weight gain 

and decreased food consumption) were observed, particularly during the first week of dosing at 

the LOAEL of 300 mg/kg/day (See Attachment 3, Table A 3.2). The NOAEL for maternal 

toxicity in this study was 100 mg/kg/day. Using the 20% dermal absorption factor (See

Attachment 2, Table A 2.2) derived from the submitted dermal absorption study, the oral 

LOAEL (300 mg/kg/day) is equivalent to a dermal LOAEL of 1500 mg/kg/day. Therefore, since 

treatment-related effects were observed at an equivalent dermal dose, the dermal NOAEL of 

1000 mg/kg/day would be appropriate. Long-term dermal exposure is not expected.

Based on the low acute inhalation toxicity (Toxicity Category IV) (See Attachment 2, Table A 

2.1), the low 5-day subchronic toxicity (no systemic toxicity at 1.092 mg/L), the composition of 

the formulated product (water-dispersible granules containing 50% a.i.), the application rate 
Fenhexamid Registration Review Human Health Scoping Document

Page 5 of 22

(maximum of 0.5 - 0.75 lb ai/A/application), and acceptable MOEs, HASPOC determined that a 

subchronic inhalation study is not required.

HASPOC, nevertheless, chose to examine the short- and intermediate-term inhalation exposure 

for possible risks to workers because of the various application scenarios including high pressure 

hand held equipment in enclosed areas, such as greenhouses. Accordingly, the two-generation 

reproduction study in rats (MRID 44346803) with a NOAEL of 38 mg/kg/day and a LOAEL of 

406 mg/kg/day was chosen for this assessment. Inhalation and oral absorption were assumed to 

be equivalent. The level of concern (LOC) for the occupational exposures was a margin of 

exposure (MOE) >1000, which is considered the benchmark for granting an inhalation waiver. 

Based on this analysis, inhalation exposure scenarios were found to have MOEs >1000 and are 

not of concern.

Long-term inhalation exposure is not expected. 

Conclusions

The toxicology database for fenhexamid is incomplete but sufficient for registration review. 

Although the 21/28-day subchronic inhalation study, the 90-day neurotoxicity study, and the 

immunotoxicity study are required in accordance with new data requirements for conventional 

pesticide registration (40 CFR Part 158), HASPOC waived both the 21/28-day subchronic 

inhalation and the 90-day neurotoxicity studies; the immunotoxicity study remains a data 

requirement. 

Endocrine Disruption

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its reregistration decision, EPA reviewed these data and selected 

the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard 

database. However, as required by FFDCA section 408(p), fenhexamid is subject to the 

endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 
Fenhexamid Registration Review Human Health Scoping Document

Page 6 of 22

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Fenhexamid is 

not among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for fenhexamid. For further information 

on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the 

test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

Dietary Exposure

The residue chemistry database for fenhexamid is complete and sufficient for registration review. 

Adequate nature of the residue studies is available for plants and livestock. The only residue of 

concern, used to establish tolerances and used for risk assessment purposes in plants and 

livestock, is the parent fenhexamid. The Agency previously concluded that a 30-day plant-back 

interval should appear on the label and apply to all crops without a registered use. The Elevate 

50 WDG registered label specifies a 30-day plant-back restriction for non-label crops. The label 

plant-back interval is adequate; no additional data are required relative to rotational crops. 

An adequate analytical method for enforcing tolerances in plant and livestock matrices is 

available. Data validation studies (MRID 45720103) for data collection of prune matrices is also 

available and requires scheduling for evaluation during the registration review process. Field 

trial data generated using acceptable data collection methods for all other commodities and 

supported by adequate storage stability data are available for each registered crop. The required 

dried prune processing study (MRID 45720102) is available and requires scheduling for 

evaluation during the registration review process. Additionally, two field trial studies (MRID 

45720101) in support of an individual tolerance on dried plums is available and will require 

scheduling for analysis during the registration review process. Adequate livestock feeding 

studies are available for fenhexamid. The Agency previously concluded that there is no 

reasonable expectation of finite residues [40 CFR §180.6(a)(3)] in milk or ruminant tissues as a 

result of the currently proposed uses.

A chronic dietary assessment was conducted assuming tolerance-level residues for all 

commodities with existing and proposed tolerances and 100% crop treated (CT). For the U.S. 

population the exposure for food and water utilized 10% of the cPAD. The chronic dietary risk 

estimate for the highest reported exposed population subgroup, children 1-2 years old, is 27% of 

the cPAD. 

The Environmental Fate and Effects Division (EFED) conducted a drinking water assessment 

(DP#: 338651, C. Sutton, 07/26/2007), which modeled separately the estimated drinking water 

concentrations (EDWCs) for fenhexamid residues of concern. However, the residue of concern 
Fenhexamid Registration Review Human Health Scoping Document

Page 7 of 22

was identified as only the parent (Herndon 1999), EFED may revisit this determination in 

Registration Review. If no new relevant data regarding the environmental fate, toxicity, or uses 

of parent fenhexamid is submitted, the EDWCs from the most current drinking water assessment 

may be used in the registration review risk assessment. The Agency previously conducted an 

unrefined chronic risk assessment for fenhexamid. The dietary assessment included the use of 

field trial data and empirical processing factors, as well as modeled drinking water values. 

Conclusions

The residue chemistry database is complete and sufficient for registration review. However, 

there are studies previously submitted, as a condition of registration, which require scheduling 

for evaluation during the registration review process: two field trial studies on plums (MRID 

45720101), dried prune processing study (MRID 45720102) and data validation study (MRID 

45720103). Pending the results of these three studies, the database currently indicates that all 

other data requirements for residue chemistry are adequate. 

Also, a new dietary assessment may be needed if one or more of the following occur: new data 

are identified which impact dietary exposure estimates, including those from drinking water; new 

toxicological points of departure are identified, including revisions to the FQPA SF; Office of 

Pesticide Program dietary exposure policies and procedures are revised. HED has updated its 

dietary model to incorporate more recent consumption data from the National Health and 

Nutrition Examination Survey (NHANES). The newer version of the model will be used during 

registration review if a new dietary assessment is needed.

Residential Exposure and Risk

There are no residential uses for fenhexamid; therefore, a residential exposure assessment will 

not be required.

Residential bystander inhalation exposures resulting from off-site transport (e.g., spray drift or 

volatilization) may occur as a result of applications of fenhexamid. The Agency is in the process 

of evaluating these types of exposures and will examine the need for spray drift and 

volatilization assessments for fenhexamid during registration review.

Aggregate Risk Assessment

There are currently no registered residential uses, nor are any proposed for fenhexamid. 

Therefore, at this time, dietary (food + water) exposure is the only component of an aggregate 

exposure analysis and risk assessment. 

Conclusions for Aggregate Exposure and Risk Assessment

Updated aggregate exposure and risk assessments may be required under registration review 

based on the need for directly incorporating drinking water estimates into the dietary assessment. 

These revised aggregate exposure and risk assessments may also reflect any toxicological 

endpoint changes or other new data are received by the Agency that may impact exposure 

estimates.
Fenhexamid Registration Review Human Health Scoping Document

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Occupational Exposure

As noted above, fenhexamid is registered for field application to almonds, asparagus, 

bushberries, caneberries, ginseng (except California), grapes, pear and oriental pear, pistachios, 

stone fruit, and strawberries. The chemical is also currently registered for transplant production 

and greenhouse production on the following crops; cilantro (except California), cucumber, 

fruiting vegetables, tomatoes, leafy greens (except spinach), and nursery grown ornamentals. 

Lastly, fenhexamid uses include post-harvest application on the following crops; cherries, kiwi, 

pear and oriental pear, pomegranate, and stone fruit. The Agency has determined that there is a 

potential for occupational handler and post-application exposures resulting from the registered 

uses of fenhexamid. 

Occupational Handlers

In 2006, HED evaluated a number of occupational handler scenarios that represented the major 

fenhexamid occupational handler scenarios for field-based application equipment based on the 

water dispersible granular formulation type. The assessment indicated that occupational handler 

scenarios resulted in no risks of concern for the highest expected dermal exposure scenarios 

(e.g., mixer/loaders using open pour loading of granules and applicators using open-cab, groundboom spray equipment). Application sites including greenhouses and post-harvest packing 

plants were last reviewed in 2006. The assessment also indicated that there were no risks of 

concern for the highest expected dermal exposure scenarios associated with transplant, 

greenhouses, and packing plants, (e.g., mixer/loaders using open pour loading of granules, 

applicators using high pressure hand sprayers in enclosed situations such as a greenhouse, and 

ground boom spray equipment). Groundboom equipment is not an expected application method, 

due to the estimated size of transplant beds in greenhouses, but was included in the assessment 

due to the lack of specific bed data. The post-harvest fruit treatment is assumed to be an 

automated process in which the fruit passes along a “line” and is either dipped or sprayed in an 

automatic hooded situation. Therefore, only occupational loaders were assessed for the postharvest packing plant application sites.

Occupational Post-application

Previous assessments were conducted for occupational post-application scenarios associated with 

fenhexamid uses, including post-harvest applications in packing plants. Dislodgeable foliar 

residue (DFR) data are available for fenhexamid, and were used in all of the previous 

assessments, except for post-harvest treatment, which used default assumptions. In general, 

there were no risk estimates of concern for any of the post-application activities assessed (MOEs 

≥ 100).

Technical fenhexamid is currently classified as toxicity category IV for acute dermal toxicity, 

primary eye, and skin irritation. The restricted-entry interval was set to 12-hours for use of 

fenhexamid on asparagus and other field grown crops. 

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment has not been performed for fenhexamid to date. However, there are multiple 
Fenhexamid Registration Review Human Health Scoping Document

Page 9 of 22

potential sources of inhalation exposure to individuals performing post-application activities in 

previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice 

and input on issues related to volatilization of pesticides from its FIFRA SAP in December 2009, 

and received the SAP’s final report on March 2, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The Agency is in the 

process of evaluating the SAP report as well as available post-application inhalation exposure 

data generated by the Agricultural Reentry Task Force and may, as appropriate, develop policies 

and procedures, to identify the need for and, subsequently, the way to incorporate occupational 

post-application inhalation exposure into the Agency's risk assessments. If new policies or 

procedures are put into place, the Agency may revisit the need for a quantitative occupational 

post-application inhalation exposure assessment for fenhexamid.

Conclusions for Occupational Exposure and Risks

The occupational exposure database is adequate to support the registration review process for 

fenhexamid. Updated occupational handler exposure assessments may be required under 

Registration Review based upon revisions to the Agency’s scenario-specific surrogate handler 

exposure data (http://www.epa.gov/pesticides/science/handler-exposure-table.pdf). HED will 

incorporate new exposure monitoring data, as necessary, during Registration Review. Updated 

occupational post-application exposure assessments may also be required under Registration 

Review based upon revisions to the Agency’s post-application exposure data. HED will 

incorporate all available chemical-specific data, as appropriate, into the occupational exposure 

assessment for Registration Review. Additionally, revised occupational handler and postapplication assessments may also be needed if toxicological endpoints change or other new data 

are received by the Agency that impact exposure estimates.

Human Studies

The previous fenhexamid risk assessments relied in part on data from studies in which adult 

human subjects were intentionally exposed to a pesticide or other chemical. Studies such as the 

Pesticide Handlers Exposure Database, Outdoor Residential Exposure Task Force, and 

Agricultural Handler Exposure Task Force have been reviewed by the Agency and found on the 

basis of available evidence to have been neither fundamentally unethical nor significantly 

deficient relative to standards of ethical research conduct prevailing when they were conducted. 

There is no barrier in EPA's "Protection of Human Subjects" Regulation to reliance on these 

studies.

Public Health and Pesticide Epidemiology Data 

The Agency has reviewed the available incident data for fenhexamid (D407943, S. Recore, 

2/21/13) and concludes that based on the low frequency and severity of incident cases reported 

for fenhexamid, there does not appear to be a concern at this time that would warrant further 

investigation. The Agency will continue to monitor the incident information and if a concern is 

triggered, additional analysis will be included in the risk assessment.
Fenhexamid Registration Review Human Health Scoping Document

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Tolerance Assessment and International Harmonization

Tolerances for fenhexamid are established under 40 CFR §180.553, only the parent is of 

regulatory concern.

According to HED’s Interim Guidance on Tolerance Expressions (05/27/2009, S. Knizner), the 

tolerance expression for fenhexamid on plant and animal commodities should be revised to state:

Tolerances are established for residues of fenhexamid, including its metabolites and 

degradate, in or on the commodities as listed in 40 CFR §180.553. Compliance with the 

tolerance levels specified below is to be determined by measuring only fenhexamid (N2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide).

At this time, there are no pending requests to establish a new fenhexamid tolerance.

The International Residue Limit Status Sheets are appended to the end of this document as 

Attachment 4, Table A 4.1 (i.e. Harmonized MRLs). There are US, Codex and Canada 

maximum residue limits (MRLs) established for plant and/or animal commodities but there are 

no Mexico MRLs. The U.S. plant residue definition is harmonized with Canada. Also included 

in Attachment 4, is Table A 4.2 that lists the commodities for which there are tolerance 

differences among the US, Canadian and Codex MRLs.

Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in the 

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

http://www.eh.doe.gov/nepa/tools/guidance/Volume1/2-6-EO_12898envjustice.pdf). The Office 

of Pesticide Programs (OPP) typically considers the highest potential exposures from the legal 

use of a pesticide when conducting human health risk assessments, including, but not limited to, 

people who obtain drinking water from sources near agricultural areas, the variability of diets 

within the U.S., and people who may be exposed when harvesting crops. Should these highest 

exposures indicate potential risks of concern, OPP further refines the risk assessments to ensure 

that the risk estimates are based on the best available information.

Cumulative Risk Assessment

The Food Quality Protection Act (FQPA) requires the Agency to consider the cumulative risks of 

chemicals sharing a common mechanism of toxicity. The Agency determined that there was 

insufficient evidence to suggest fenhexamid shares a common mechanism of toxicity with other 

chemical substances. For information regarding EPA’s efforts to determine which chemicals 

have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, 

see the policy statements released by EPA’s Office of Pesticide Program concerning common 

mechanism determinations and procedures for cumulating effects from substances found to have 

a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.
Fenhexamid Registration Review Human Health Scoping Document

Page 11 of 22

Data Requirements

The following toxicity studies are required to support the registration review of fenhexamid: 

Toxicology

Immunotoxicity study (870. 7800)

Residue Chemistry

No outstanding residue chemistry data are required to support the registration review of 

fenhexamid.

Occupational/Residential Exposure

None

References

Table 1. HED Memoranda Relevant to Registration Review

Author Barcode/TXR # Date Title

John 

Redden

D329137 6/ 14/ 2006 Human Health Risk 

Assessment for Fenhexamid –

IR-4 Tolerance Requests on 

Cilantro (Transplant / 

Greenhouse), Non-Bell Pepper

(Transplant) and Pomegranate

(Post-Harvest).

G. Jeffrey 

Herndon

D253792 03/11/1999 Fenhexamid. Results of the 

HED Metabolism Assessment 

Review Committee Meeting 

Held on 3/2/99.

Breann 

Hanson

D347171 12/05/2007 Fenhexamid. Chronic Dietary 

Exposure Assessment for the 

Interregional Research Project 

No. 4 (IR-4) Petition Proposing 

Tolerances for Residues of 

Fenhexamid on Asparagus 

(PP# 7E7187).

Breann

Hanson

D340304 12/31/2007 Fenhexamid: Human Health 

Risk Assessment for a 

Proposed Section 3 

Registration for Use on 

Asparagus 
Fenhexamid Registration Review Human Health Scoping Document

Page 12 of 22

Table 1. HED Memoranda Relevant to Registration Review

Author Barcode/TXR # Date Title

Brenda 

Tarplee

TXR No. 0051704 03/26/2003 Fenhexamid: 2nd Report of the 

Hazard Identification 

Assessment Review 

Committee

G. Jeffrey 

Herndon

D244844 and D249061 03/25/1999 PP# 7F04890. Fenhexamid on 

Grapes and Strawberries. 

Review of Residue Data and 

Analytical Methodology.

MRID# 443467-56 thru -67

443665-08 thru -12

445140-02 thru -04

Rury, K TXR No. 01/29/2013 Fenhexamid: Summary of 

Hazard and Science Policy of 

January 24, 2013: 

Recommendations on the Need 

for a Subchronic Neurotoxicity 

and 90-day Inhalation Toxicity 

Studies 

Mark I. 

Dow

D328715 05/17/2006 Fenhexamid: Exposure/Risk 

Assessment for Fenhexamid 

Used as Post-Harvest 

Treatment of Pomegranate 

Fruit, Cilantro, and Non-Bell 

Pepper Transplants

Margarita 

Collantes

D292433 08/01/03 Occupational and Residential 

Exposure Assessment for 

Section 3 Registration of 

Fenhexamid on Stone Fruits, 

Kiwis, Fruiting Vegetables, 

Cucumbers, Leafy Greens

Attachments

Attachment 1. Chemical Identity

Attachment 2. Toxicity Profile Tables

Attachment 3. Endpoint Tables

Attachment 4. Fenhexamid International Residue Limits Table 

Attachment 1 
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Table A1.1. Fenhexamid Nomenclature.

Compound

Common name Fenhexamid

Company experimental name KBR 2738

IUPAC name 2,3-dichloro-4-(1-methylcyclohexyl-carbonylamine)-phenol

CAS name N-(2,3-dichloro-4-hydroxyphenyl)-1-methyl-cyclohexanecarboxamide

CAS registry number 126833-17-8

End-use products (EP) ELEVATE 50 WDG Fungicide

Table A 1.2. Physicochemical Properties of the Technical Grade Fenhexamid 

Parameter Value Reference

Melting point/range 153 oCFenhexamid: Pesticide 

Fact Sheet (May 20, 

1999)

Fenhexamid (KBR 

2738)-a Botryticide from 

a New Chemical Class, 

PflanzenschutzNachrichten Bayer 

52/1999, 2

pH 8.3 in 1% solution of water

Density 1.34 g/mL @ 20 oC

Water solubility ( 20 C) 20 mg/L 

Solvent solubility (mg/L at 20 

C)

dichloromethane: 31000, 

2-propanol: 91000, 

n-hexane: < 100, 

Toluene: 5700

Vapor pressure at 25 C 7x10-9 Torr

Dissociation constant (pKa) 7.3

Octanol /water partition 

coefficient Log(KOW)

3.51 (pH 7, 20 oC )

UV/visible absorption 

spectrum

245 nm and 290 nm 

(wavelengths of maximum absorption)
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Attachment 2

Table A 2. 1. Acute Toxicity of Fenhexamid Technical 1

GDLN STUDY TYPE MRID RESULTS TOX CATEGORY

81-1 Acute Oral

Rats

44346769 M: LD50 >5000 mg/kg

F: LD50 >5000 mg/kg

IV

81-2 Acute Dermal

Rats

44346770 M: LD50 >5000 mg/kg

F: LD50 >5000 mg/kg

IV

81-3 Acute Inhalation

Rats

44366513 DUST

M: LC50 >5.057 mg/L

F: LC50 >5.057 mg/L

DUST

IV

81-4 Primary Eye Irritation

Rabbits

44346771 Not an eye irritant IV

81-5 Primary Skin Irritation

Rabbits

44346771 Not a dermal irritant IV

81-6 Dermal Sensitization

Guinea Pigs

44346772

44346773

Not a dermal sensitizer N/A

1

All studies were conducted on technical grade fenhexamid, 95.5% purity.

Table A 2. 2. Toxicity Profile of Fenhexamid Technical

Guideline No./ Study Type MRID No. (year)/

Classification/Doses

Results

28-Day Oral (Gavage) – Rat

(Range-Finding)

44346774(1995) 

Acceptable

0, 100, 300, 1000 

mg/kg

Male: NOAEL = 1000 mg/kg/day (HDT)

LOAEL = Not established

Female: NOAEL = 1000 mg/kg/day (HDT)

LOAEL = Not established 

870.3100

13-Week Feeding - Rat

44346775 (1994)

Acceptable/guideline

0, 2500, 5000, 10,000, 

20,000 ppm

0, 202, 415, 904, 1904 

mg/kg/day (M)

0, 270, 549, 1132, 

2824 mg/kg/day (F)

Male: NOAEL = 415 mg/kg/day

LOAEL = 904 mg/kg/day, based on decreased 

body weight and body weight gain; increased food 

consumption; decreased food efficiency; and 

increased serum alanine aminotransferase.

Female: NOAEL = 1132 mg/kg/day

LOAEL = 2824 mg/kg/day, based on increased 

food consumption; decreased food efficiency; 

decreased liver weights; and mild 

histopathological effects on the liver 

870.3100

14-Week Feeding - Mouse

(Range-Finding) 

44346778 (1993) 

Acceptable/guideline

0, 100, 100, 10,000, 

ppm

0, 26.5, 266.5, 3283.5 

mg/kg 

(M)

0, 51.6, 453.9, 5151.1 

NOAEL = 267/454 mg/kg/day (M/F)

LOAEL = 3284/5151 mg/kg/day (M/F), based on 

increased water consumption, increased serum 

creatinine, increased cholesterol and bilirubin 

decreased kidney weights, histopathological 

changes in the kidney. Additionally, increased 

food consumption; decreased food efficiency; and 

decreased glycogen in hepatocytes (M). 
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Table A 2. 2. Toxicity Profile of Fenhexamid Technical

Guideline No./ Study Type MRID No. (year)/

Classification/Doses

Results

mg/kg 

(F)

870.3150

13-Week Feeding - Dog

44346779 (1995)

Acceptable/guideline

0, 34, 239, 1748 

mg/kg (M)

0, 37, 261, 1866 

mg/kg (M)

Male: NOAEL = 34 mg/kg/day

LOAEL = 239 mg/kg/day, based on increased 

Heinz bodies

Female: NOAEL = 37 mg/kg/day

LOAEL = 261 mg/kg/day, based on increased 

Heinz bodies

870.3200

21-Day Dermal Toxicity - Rabbit

44346780 (1995)

Acceptable/guideline

0, 1000 mg/kg/day (M 

& F)

NOAEL (systemic) = 1000 mg/kg/day (HDT)

LOAEL (systemic) = Not established

 

NOAEL (dermal) = 1000 mg/kg/day (HDT)

LOAEL (dermal) = Not established 

5-Day Inhalation – Rat

DUST

(Range-Finding)

44366514 (1996)

Acceptable

0, 11.8, 97.7, 1092.6 

mg/m3(0, 0. 012, 

0.098, 1.093 mg/L (M 

& F)

NOAEL = 0.098 mg/L

LOAEL = 1.093 mg/L (M & F) 

870.3465

21/28-Day Inhalation 

HASPOC has waived this study (Rury, 2013).

870.4100a

2-Year Chronic Toxicity/ 

Carcinogenicity - Rat

44346806 (1996) 

Acceptable/guideline

0, 500, 5000, 20,000 

ppm

0, 28, 292, 1280 

mg/kg/day (M)

0, 40, 415, 2067 

mg/kg/day (F)

Male: NOAEL = 28 mg/kg/day

LOAEL = 292 mg/kg/day, based on increased 

splenic extramedullary hematopoietic & increased 

cecal mucosal hyperplasia

Female: NOAEL = 40 mg/kg/day

LOAEL = 415 mg/kg/day, based on decreased 

body weight (only after 60 weeks), decreased 

body weight gain (only after 39 weeks), decreased 

food efficiency, and bone marrow hyperplasia.

No evidence of carcinogenicity in either sex.

870.4100b

2-Year Carcinogenicity - Mouse 

44346805(1996) 

Acceptable/guideline

0, 800, 2400, 7000 

ppm

0, 247.4, 807.4, 

2354.8 mg/kg/day (M)

0, 364.8, 1054.5, 

3178.2 mg/kg/day (F)

Male: NOAEL = 247 mg/kg/day

LOAEL = 807.4 mg/kg/day, based on decreased 

kidney weights, & decreases in sex-specific 

vacuolation of the proximal tubules in the kidneys.

Female: NOAEL = 1054.5 mg/kg/day

LOAEL = 3178.2 mg/kg/day, based on increased 

water consumption, decreased kidney weights, & 

renal histopathology (increased incidence of 

basophilic cortical tubules)

No evidence of carcinogenicity in either sex.

870.4100b

1-Year Chronic Feeding - Dog

44346804(1996)

Acceptable/guideline

0, 500, 3500, 25,000 

ppm

(0, 17.4, 124.3, 917.8 

mg/kg/day M) 

NOAEL = 17.4/19.2 mg/kg/day

LOAEL = 124.3/132.7 mg/kg/day, based on 

decreased RBCs, Hb and Hct and increased Heinz 

bodies (M & F) & increased adrenal weight (F), 

and presence of intracytoplasmic vacuoles in the 

adrenal cortex (M).
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Table A 2. 2. Toxicity Profile of Fenhexamid Technical

Guideline No./ Study Type MRID No. (year)/

Classification/Doses

Results

(0, 19.2,132.7, 947.1 

mg/kg/day F)

870.3700a 

Developmental Toxicity - Rat 

44346781 (1994) 

Acceptable/guideline

0,1044 mg/kg/day

Maternal: NOAEL = <1044 mg/kg/day

LOAEL = 1044 mg/kg/day (HDT), based 

on decreased body weight gain (-12%) 

during gestation days 6-16 & decreased 

food consumption (10%) 

Developmental: NOAEL = 1044 mg/kg/day 

(HDT)

LOAEL = Not established

870.3700b

Developmental Toxicity - Rabbit

44346801(1995)

Acceptable/guideline 

0, 100, 300, 1000 

mg/kg/day

Maternal: NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day, based on alterations of 

excretory products (discolored urine & small

scybala)

Developmental: NOAEL = 300 mg/kg/day

LOAEL = 1000 mg/kg/day based on decreased 

male fetal body weight & evidence of delayed 

ossification

870.3800 

2-Generation Reproductive 

Toxicity - Rat 

44346803 (1996) 

Acceptable/guideline

0, 100, 500, 5000, 

20,000 ppm

0, 7.6, 38.2, 406, 1814 

mg/kg/day (M)

0, 9.0, 44.8, 477, 2043 

mg/kg/day (F)

Parental/Systemic: 

Males: NOAEL = 38 mg/kg/day

LOAEL = 406 mg/kg/day, based on increased 

creatinine (P gen only), increased alkaline 

phosphatase, decreased absolute & relative liver 

weights, decreased absolute & relative kidney 

weights

Females: NOAEL = 45 mg/kg/day 

LOAEL = 477 mg/kg/day, based on increased 

alkaline phosphatase & a small increase in GGT

Reproductive:

NOAEL = 1841/2043 mg/kg/day (M/F) (HDT)

Offspring: NOAEL = 38/45 mg/kg/day (M/F)

LOAEL = 406/477 mg/kg/day (M/F), based on 

dose-related decreased pup body weights on 

lactation days 7, 14, & 21 days for F1 (6-11%) & 

for F2 (9-11%); effect is considered severe.

870.5100 

Reverse Gene Mutation –

Salmonella typhimurium

44346807 (1991)

Acceptable/guideline

0, 62.5, 125, 250, 500, 

1000, 2000, 5000 

μg/plate +/-S9

Non-mutagenic (±) activation up to insoluble and 

cytotoxic concentrations (≥ 2000 μg/plate).

870.5300

Forward Gene Mutation –

Chinese hamster ovary (CHO) 

cells

44346810 (1994) 

Acceptable/guideline

0, 25, 50, 75, 100, 

125, 150 μg/mL +/-S9

Non-mutagenic up to cytotoxic concentrations 

(150 μg/mL ± activation)
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Table A 2. 2. Toxicity Profile of Fenhexamid Technical

Guideline No./ Study Type MRID No. (year)/

Classification/Doses

Results

870.5375

Chromosome Aberration - CHO 

cells

44346809 (1995) 

Acceptable/guideline

0, 6, 30, 150 μg/mL -

S9 & 0, 2, 20, 120 

μg/mL +S9 with 8, 24 

& 30 hr. cell harvests

Non-mutagenic up to cytotoxic concentrations 

(150 μg/mL –S9; 120 μg/mL +S9) 

870.5395

Micronucleus Assay – Mice

44346811 (1993) 

Acceptable/guideline

0, 750 mg/kg (IP 

injection) & bone 

marrow cell harvests 

at 16, 24, & 48hrs. 

Negative at a dose showing clinical signs of overt 

toxicity. 

870.5550

Unscheduled DNA Synthesis -

Rat Hepatocytes

44346812 (1992) 

Acceptable/guideline

0, 2.5, 5.0, 10.0, 15.0, 

30.0, 40.0 μg/mL 

Non-genotoxic up to a cytotoxic concentration 

(40.0 μg/mL).

870.6200a

Acute Neurotoxicity - Rat

44346813 (1996)

Acceptable/guideline

0, 200, 630, 2000 

mg/kg

Male: NOAEL = 630 mg/kg/day

LOAEL = 2000 mg/kg/day (HDT), based on lower 

body temperature.

Female: NOAEL = 2000 mg/kg/day (HDT)

LOAEL = Not established

870.6200b

90-Day Neurotoxicity Screening 

Battery - Rat

HASPOC waived this study (Rury, 2013).

870.7485

Metabolism - Rat 

44346814 (1996)

Acceptable/guideline

Very rapidly and completely absorbed and 

excreted (<48 hours). Pronounced enterohepatic 

circulation. Metabolite in bile was glucuronide. 

Major route of excretion was feces (mostly 

parent); lesser amounts in urine (mostly 

glucuronide).

870.7600

Dermal Absorption – Rat

44346815(1997)

Acceptable/guideline

At 10 hours, mean dermal absorption was 20% 

(low dose group) 

870.7800

Immunotoxicity 

Not available
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Attachment 3

Table A 3. 1. Summary of Toxicological Doses and Endpoints for Fenhexamid for Use in the Dietary and NonOccupational Human Health Risk Assessments

Exposure

Scenario

Point of 

Departure

Uncertainty/ 

FQPA Safety 

Factors

RfD/PAD

Study and Toxicological Effects

Acute Dietary

(General Population 

including infants and 

children)

Not selected. No appropriate toxicological endpoint attributable to a single exposure was identified in the

available toxicology studies.

Chronic Dietary

(All populations)

NOAEL = 17 mg 

ai/kg/day

UF = 100

Chronic RfD = 

0.17 mg/kg/day

UFA 10X

UFH 10X

FQPA 1X

Total UF 100

cRfD = .17

mg/kg/day

cPAD = 

0.17

mg/kg/day

1-Year Feeding Study (dog)

MRID 44346804 

LOAEL = 124 mg/kg/day, based on decreased 

RBC counts, hemoglobin and hematocrit and 

increased Heinz bodies in males and females; 

increased adrenal weights and intracytoplasmic 

vacuoles in adrenal cortex in females

Short-Term 

(1 - 30 days), 

Intermediate-Term (1 -

6 months) and LongTerm (>6 months)

Dermal and Inhalation

Not selected. There are no residential exposures (see TXR NO. 013258). 

Cancer (oral) Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor 

increases in two adequate rodent carcinogenicity studies.

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and used to 

mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. 

NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = 

extrapolation from animal to human (interspecies). UFA = extrapolation from animal to human (interspecies). UFH = potential 

variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA safety factor. MOE = 

margin of exposure. LOC = level of concern. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose, 

MOE = margin of exposure, LOC = level of concern
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Table A 3. 2. Summary of Toxicological Doses and Endpoints for Fenhexamid for Use in the Occupational 

Human Health Risk Assessments

Exposure

Scenario

Point of 

Departure

Uncertainty/ 

FQPA Safety 

Factors

RfD/PAD

Study and Toxicological Effects

Short-Term 

(1 - 30 days) and 

Intermediate-Term (1 -

6 months)

Dermal

NOAEL = 1000 mg 

ai/kg/day

UFA = 10

UFH = 10

FQPA SF = 1X 

Residential

MOE = NA

Occupational

MOE = 100

21-Day Dermal-Rabbit.

MRID 44346780 

LOAEL = 1000 mg/kg/day 

Consistent with the findings of the 

developmental toxicity study in rabbits 

(MRID 44346801) showing decreased body 

weight gain and food consumption at LOAEL 

of 300 mg/kg/day; the NOAEL in this study 

is 100 mg/kg/day. The dermal equivalent 

dose, using 20% dermal absorption factor, the 

NOAEL would be 500 mg/kg/day and the 

LOAEL would be 1500 mg/kg/day.

Long-Term Dermal 

(>6 months)

None Residential

MOE = NA

Occupational

MOE = NA

Not selected. It was determined that no longterm exposure would occur (see TXR NO. 

013258).

Short-Term 

(1 - 30 days), 

Intermediate-Term (1 -

6 months) and 

Inhalation 

None Residential

MOE = NA

Occupational

MOE = NA

Not selected. Based on low acute toxicity, 

the composition of the formulated product, 

and the application methods, HED 

determined that there is a minimal concern 

for potential inhalation exposure (see TXR 

NO. 0051704). HASPOC reaffirmed this 

decision (Rury, 2013).

Long-Term (>6 

months)

Inhalation

None Residential

MOE = NA

Occupational

MOE = NA

Not selected. It was determined that no longterm exposure would occur (see TXR NO. 

013258).

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and used to 

mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. 

NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = 

extrapolation from animal to human (interspecies). UFA = extrapolation from animal to human (interspecies). UFH = potential 

variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA safety factor. MOE = 

margin of exposure. LOC = level of concern. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose, 

MOE = margin of exposure, LOC = level of concern. Dermal absorption factor = 20% (see MRID 44346815)
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Attachment 4. Fenhexamid International Residue Limits Table

Table A 4.1. Summary of US and International Tolerances and Maximum Residue Limits for all registered 

commodities

Residue Definition:

US Canada Mexico1 Codex2

40 CFR 180.553

fenhexamid (N-2,3-dichloro-4-

hydroxyphenyl)-1-methyl 

cyclohexanecarboxamide) 

N-2,3-dichloro-4-hydroxyphenyl)-

1-methyl 

cyclohexanecarboxamide

Fenhexamid

The residue is fat 

soluble.

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico1 Codex2

Almond, hulls 2.0 2

Almond 0.02 0.02 almond nuts 0.02 (*)

Asparagus 0.02

Bushberry subgroup 13B

5.0 4.0 blueberries, currant, 

elderberries, gooseberries, 

huckleberries

5.0 bilberry, 

blueberries, currants, 

black, red, white, 

elderberry, gooseberry

Caneberry subgroup 13A

20.0 20 blackberries, loganberries, 

raspberries

15 blackberries, 

dewberries (including 

boysenberry and 

loganberry), raspberry

Cilantro, leaves 30.0

Cucumber 2.0 1.0 

Fruit, stone, group 12, 

except plum, prune, fresh, 

postharvest

10.0 6.0 apricots, cherries, nectarines, 

peaches

0.5 plums

7.0 cherries

10 apricots, nectarine, 

peach

1.0 plums (including 

prunes)

Ginseng 0.3 0.3 ginseng roots

Grape 4.0 4.0 15.0 

Grape, raisin

6.0 6.0 raisins 25.0 dried grapes 

(=currants, raisins and 

sultanas)

Juneberry 5.0 5.0

Kiwifruit, postharvest 15.0 15.0 kiwifruit

Leafy greens subgroup 4A, 

except spinach

30.0 23.0 lettuce, head, leaf lettuce 30.0 lettuce, head and 

leaf

Lingonberry 5.0

Pear 10

Pepper, nonbell 0.02 2.0 peppers

Pistachio 0.02

Plum, prune, dried 2.5

Plum, prune, fresh 1.5 0.5 plums 1.0 plums (including 

prunes)

Pomegranate 2.0

Salal 5.0

Strawberry 3.0 3.0 10

Vegetable, fruiting, group 

8, except nonbell pepper

2.0 1.0 tomatoes 2.0 eggplant, tomato, 

peppers

MRLs with No US Equivalent

Edible offal (mammalian) 0.05

Gherkin 1
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Table A 4.1. Summary of US and International Tolerances and Maximum Residue Limits for all registered 

commodities

Residue Definition:

US Canada Mexico1 Codex2

Meat (from mammals other 

than marine mammals)

Milks 0.01 (*) F

Squash, summer 1

Completed: M. Negussie; 01/14/2013

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

2 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = 

processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on 

the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Table A 4.2. Summary Maximum Residue Limits (Not Harmonized)

Residue Definition:

US, Fenhexamid, 40 CFR 180.553 Canada Mexico1 Codex2

(N-2,3-dichloro-4-hydroxyphenyl)-1-methyl 

cyclohexanecarboxamide) 

N-2,3-dichloro-4-

hydroxyphenyl)-1-

methyl 

cyclohexanecarbox

amide

Fenhexamid

The residue is fat 

soluble.

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico1 Codex2

Bushberry subgroup 13B

5.0 4.0 blueberries, 

currant, 

elderberries, 

gooseberries, 

huckleberries

5.0 bilberry, 

blueberries, 

currants, black, red, 

white, elderberry, 

gooseberry

Caneberry subgroup 13A

20.0 20.0 blackberries, 

loganberries, 

raspberries

15.0 blackberries, 

dewberries 

(including 

boysenberry and 

loganberry), 

raspberry

Cucumber 2.0 1.0

Fruit, stone, group 12, except 

plum, prune, fresh, postharvest

10.0 6.0 apricots, 

cherries, 

nectarines, 

peaches

0.5 plums

7.0 cherries

10.0 apricots, 

nectarine, peach

1.0 plums 

(including prunes)

Grape 4.0 4.0 15.0

Grape, raisin

6.0 6.0 raisins 25.0 dried grapes 

(=currants, raisins 

and sultanas)

Leafy greens subgroup 4A, 

except spinach

30.0 23.0 lettuce, head, 

leaf lettuce

30.0 lettuce, head 

and leaf
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Table A 4.2. Summary Maximum Residue Limits (Not Harmonized)

Residue Definition:

US, Fenhexamid, 40 CFR 180.553 Canada Mexico1 Codex2

Pepper, nonbell 0.02 2.0 peppers

Plum, prune, fresh 1.5 0.5 plums 1.0 plums 

(including prunes)

Strawberry 3.0 3.0 10.0 

Vegetable, fruiting, group 8, 

except nonbell pepper

2.0 1.0 tomatoes 2.0 eggplant, 

tomato, peppers

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

2 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest 

treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs 

indicated as proposed have not been finalized by the CCPR and the CAC.