Methyl Eugenol (ME) 

PC Code: 203900 

Preliminary Work Plan and Summary Document 

Registration Review: Initial Docket 

March 2016 

Case # 6203 

Approved by: 

Biope

Pollution 

RobertsticideE~: Prevention 

s and 

Di

~ vision 

Date: 
Methyl Eugenol (ME) 

T ABLE OF CONTENTS 

EPA-HQ-OPP-20 15-0547 

www.regulations.gov 

I. PRELIMINARY WORK PLAN ........................................ .................................. ................................ 4 

A. Overview .................................................................... .................................................................. 4 

B. Statutory and Regulatory Authority ............................................................................................ .4 

C. Background and Regulatory Information .................................................................................... 5 

D. A nticipated Data Needs and Risk Assessments ..................................................................... ..... 8 

E. Risk to Threatened and Endangered Species ............................................................ ................ 14 

F. Endocrine Effects .................................................................... ................................................... 16 

G. Incidents ..................................................................................................................................... 17 

H. Timeline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............... 17 

I. Guidance fo r Commenters ...................................................... ................................................... 18 

J. Next Steps .... ............................................................................................................. ................. 19 

II. BIBLIOGRAPHY ................................................................. ............................................................. 20 

A. Studies Supporting Registration Review of Methyl Eugenol ................................................... 20 

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ACRONYMS AND ABBREVIATIONS 

AI or a.i. Active Ingredient 

BPPD The EPA's Biopesticides and Pollution Prevention Division 

C.F.R. Code of Federal Regulations 

DCI Data Call-In 

EDSP Endocrine Disruptor Screening Program 

EPA U.S. Environmental Protection Agency 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

FWP Final Work Plan 

IDS Incident Data System 

MRIDNo. Master Record Identification Number: The EPA's system of recording and tracking studies 

submitted to the Office of Pesticide Programs. 

MRL Maximum Residue Limit 

OPP The EPA's Office of Pesti cide Programs 

PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals. 

PWP Preliminary Work Plan 

TGAI Technical grade of the active ingredient 

TMDL Total Maximum Daily Load 

us United States 

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Methyl Eugenol (ME) 

I. PRELIMINARY WORK PLAN 

A. Overview 

EP A-HQ-OPP-20 15-054 7 

www.regulations.gov 

The docket (EPA-HQ-OPP-20 15-0 173) for Methyl Eugenol (ME) is now open, initiating the first public 

comment period for this registration review (case number 6203). Three end use products containing 

Methyl Eugenol are registered. 

This preliminary work plan (PWP) explains what the U.S. Environmental Protection Agency's (EPA) 

Office of Pesticide Programs (OPP) knows about Methyl Eugenol, highlighting anticipated data and 

assessment needs, identifies types of information that would be especially useful to the EPA in 

conducting the review, and provides an anticipated timeline for completing the registration review 

process for Methyl Eugenol. 

The registration review process was designed to include a public participation component to solicit input 

from interested stakeholders. The EPA intends, by sharing this information in the docket, to inform the 

public of what it knows about Methyl Eugenol, and what types of new data or other information would 

be helpful for the Agency to receive as it moves toward a decision on this compound. The EPA 

encourages all interested stakeholders to review the PWP and to provide comments and additional 

information that will help the EPA's decision-making process fo r this biochemical pesticide. In addition 

to general areas on which persons may wish to comment, there are some areas identified in the PWP 

about which the EPA specifically seeks comments and information. Interested stakeholders could 

include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural 

labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large. 

The PWP begins by describing the statutory and regulatory authorities for registration review. Next, it 

provides background on Methyl Eugenol, which includes a descri ption of its mode of action, currently 

registered pesticide products, application rates and methods, use sites, and tolerance exemption 

information. Then, it lists the anticipated data needs and risk assessments, and a projected registration 

review timeline for this case. Finally, the PWP provides guidance for cornrnenters, explains the next 

steps EPA will be taking, summarizes background information, and lists supporting studies, risk 

assessments, and other documents available for the registration review of Methyl Eugenol. 

Further information about this case, including background and supporting documents, is available at 

http://www.regulations.gov (under "SEARCH for: Rules, Comments, Adjudications or Supporting 

Documents," enter the docket identification number, which is indicated above). 

B. Statutory and Regulatory Authority 

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) must generally be registered by the EPA, based 

on scientific data showing that they will not cause unreasonable risks to human health or the 

environment when used as directed on the product labeling. The registration review program is intended 

to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or 

the environment. Changes in science, public policy, and pesticide use practices will occur over time. 

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Through the registration review program, the EPA periodically reevaluates pesticides to make sure that, 

as change occurs, products in the marketplace are safe to use. Information on this program is provided 

on the EPA's website2. The Agency is implementing the registration review program pursuant to Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. 

The regulations governing registration review begin at 40 C.F.R. § 155.40. The Agency will consider 

benefits information and data as required by FIFRA. The public phase of registration review begins 

when the initial docket is opened for each case. The docket is the Agency's opportunity to state what it 

knows about the pesticide and what additional risk analyses and data or information it believes are 

needed to make a registration review decision. After reviewing and responding to comments and data 

received in the docket during this initial comment period, the EPA will develop a final work plan (FWP) 

and the anticipated schedule for the registration review of Methyl Eugenol. 

C. Background and Regulatory Information 

i. Summary of the Active Ingredient, Usage and Associated Pesticide Products 

Methyl Eugenol is a natural constituent in a wide range of plants including many of those consumed as 

food by humans and animals. It has a clove like fragrance and is fo und in cloves, carrots, nutmeg, 

rosemary, basil, laurel, bananas, walnuts, citrus, black pepper tea tree, hyacinth, and snakeroot. Methyl 

Eugenol is approved in the United States for use in natural or synthetic forms as a fl avoring agent in 

foods such as ice cream, cookies, candy, cola soft drinks, gum, and as a fragrance in perfumes and soaps. 

In April 2002, the US Food and Drug Administration (FDA) determined synthetic forms of Methyl 

Eugenol to be "Generally Regarded as Safe (GRAS)" and may be safely used in food in accordance with 

specific conditions. In 2006, the EPA registered Methyl Eugenol for use as an insect attractant. It has a 

non-toxic more of action. End use products (EP) containing Methyl Eugenol are used to attract a range 

of gender specific (male) insects and are formulated into baits, lures, traps, and cones. These delivery 

systems are generally stationed on and around agricultural crops, structures, landscapes, and right-ofways for use in monitoring and eradicating insect populations including the MediteiTanean and Oriental 

Fruit Fly, thrip, leaf miners, spiders, mites, mosquitoes, and ants. Two currently registered products 

contain Methyl Eugenol as the sole active ingredi ent at 58 and 76.9%, respectively, and another 

registered product containing Methyl Eugenol at 51% is combined with spinosad, a conventional 

insecticide based on naturally occurring chemical compounds found in the bacterial species 

Saccharopolyspora spinosa. 

Methyl Eugenol is an important part of the control programs targeting many species of fruit flies (e.g., 

Mediterranean fruit fl y, Oriental fruit fl y, melon fly, solanaceous fruit fly, and Mexican fruit fl y) 

throughout states such as Hawaii, Florida, and California. Certain species of fruit flies can cause 

devastating damage to a wide range of commercially grown fruit and vegetables. When formulated as a 

Jure, methyl eugenol attracts male fruit flies to traps where they die or are removed for monitoring 

purposes. When formulated with the insecticide spinosad, insects (males) attracted by the methyl 

eugenol experience irreversible tremors, prostrate trembling, paralysis, and death from exposure to 

spinosad thereby reducing the amount of pesticides applied directly to plants. The enclosed nature of its 

application (traps, lures, stationary baits, and cones) limits Methyl Eugenol's exposure potential to 

humans as well as to non-targeted and listed organisms. The chemical structure of Methyl Eugenol is: 

2 See http://www2 .epa.gov/pesticide-reevaluation. 

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Methyl Eugenol (ME) 

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Table l.O provides a summary of the chemical facts for Methyl Eugenol: 

Table 1.0 Chemical Facts for Methyl Eugenol 

PC code 203900 

Case Number 6203 

CAS Number 93-15-2 

Year first registered 2006 

Pesticide Type Insect Attractant 

Chemical class Biochemical 

Reregistration Eligibility 

Decision (RED) No 

Tolerance Reassessment December 2004; February 2, 2005 (70FR 5440) 

Eligibility Decision (TRED) 

Cumulative group Not applicable. Methyl Eugenol has not been identified as a 

member of a cumulative group that shares a common mechanism of 

toxicity. 

40 CFR Citation 40 CFR 180.1 067 

(Methyl Eugenol and Malathion combination) 

Non-pesticidal uses Food Flavoring Agent 

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The following table summarizes the use and usage information for Methyl Eugenol: 

Table 2.0 Methyl Eugenol Use and Usage Information 

Summary of Use Insect attractant/lure commonly used in traps and bait stations 

for monitoring and eradicating insect populations. 

Use Sites Agricultural fields and orchards, landscapes, right-of- ways 

Summary of Usage No usage information has been reported. 

Formulation Types Oily liquid, cones 

Application Method Lures, in traps and bait stations 

Technical Registrant Farma Tech International Corp. 

No. of Registrations 3 

Restricted Use None 

Table 3.0 Summ ary of Currently Registered Methyl Eugenol based Pesticide End-Use Products (EPs) 

EPA Product Name 

Registration (%Active Date Registered Application Application Use Sites Number Ingredient; Rates Methods 

Formulation Type) 

FTMETHYL 

Disposable lure in EUGENOL SHORT 81325-3 LURE October 26, 2007 7.75g retrievable trap Tree canopies 

58% 

Cone/lure in Buffer areas and 

36638-41 Sentry Methyl December I, l Og retrievable trap periphery of 

Eugenol Cone 2007 fruit orchards 

76.9% and crop fields 

Non-Crop Sites 

STATIC Spinosad Large droplet liquid Only: stakes 

627 19-592 ME June 13, 2008 3.4 - 6.84 fl spot application posts, fences, 

51% oz./acre non-crop tree 

trunks or limbs, 

telephone poles, 

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ii. Tolerance Actions 

In March, 1982, an exemption from the requirement of a tolerance was established by the Agency for 

Methyl Eugenol-Malathion (3: 1 ratio) combination impregnated on a carrier and used in United States 

Department of Agriculture (USDA) Oriental Fruit Fly Eradication Programs. This exemption was 

modified in April, 2004 to further define the carrier. An Experimental Use Permit (EUP) was granted in 

June, 1990 to the Tropical Fruit and Vegetable Research Laboratory, USDA Agricultural Research 

Station in Honolulu, HI to use Methyl Eugenol and Malathion in plastic traps placed on the periphery of 

fruit orchards to mitigate Oriental Fruit Fly populations. This EUP expired in October, 1992. In April, 

2002, the U.S. Food and Drug Administration (FDA) declared synthetic forms of Methyl Eugenol to be 

Generally Regarded as Safe (GRAS) and may be safely used in food in accordance with specific 

conditions under 21 CFR 172.515. In February, 2005 EPA published a Tolerance Reassessment 

Eligibility Document for Methyl Eugenol and concluded " ... there is a reasonable certainty that no harm 

to any population or subgroup will result from the dietary and water exposure to Methyl Eugenol from 

uses specified in the existing exemption for the requirements for tolerance for Methyl Eugenol under 40 

CFR § 180.1067." Occupational and residential exposure risks were not evaluated in this tolerance 

reassessment. 

D. Anticipated Data Needs and Risk Assessments 

Provided below are tables of the current data requirements for biochemical pesticides as set forth in 40 

C.F.R. § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health 

assessment, and non-target organisms) and descriptions of how the data requirements have been fulfill ed 

or where data have been waived. At this time, no data gaps (anticipated data needs) for Methyl Eugenol 

have been identified. The most recent comprehensive risk assessment for Methyl Eugenol was 

completed September 20,2013, in support of an amendment to add unregistered sources (U.S. EPA, 

2013). Because there are no data gaps for Methyl Eugenol or anticipated data needs, and no additional 

information has been received on this biochemical since this most recent risk assessment, the Agency 

does not anticipate the need to conduct a new risk assessment during registration review. 

i. Product Chemistry (40 C.F.R. § 158.2030) 

Table 4.0 Summary of Product Analysis for Methyl Eugenol 

Harmonized Has Data Requirement MRIDNo. or Guideline Data Requirement 

Number Been Addressed? How? Other Source 

880.1100 Product Identity and Composition Yes- Study 46358403 

880. 1200 Description of Starting Materials, Yes - Study 49008903; 

Production, and Formulation Process 49008901 

880. 1400 Discussion of Formation of Impurities Yes - Study 4774 1901 ; 

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Methyl Eugenol (ME) 

Harmonized 

Guideline 

Number 

830. 1700 

830. 1750 

830. 1800 

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Table 4.0 Summary of Product Analysis for Methyl Eugenol 

Has Data Requirement MRIDNo. or Data Requirement Been Addressed? How? Other Source 

47541903 

Preliminary Analysis Yes - Study 49008902 

Certified Limits Yes - Study 49008902; 

49008904 

Enforcement Analytical Method Yes - Study 49008903 

Table 5.0 Summary of Physical and Chemical Characteristics for Methyl Eugenol 

Harmonized Has Data Requirement MRID No. or Guideline Data Requirement 

Number Been Addressed? How? Other Source 

830.6302 Color Yes - Study 46358403 

830.6303 Physical State Yes - Study 46358403 

830.6304 Odor Yes - Study 46358403 

830.63 13 Stability to Normal and Elevated Yes - Study 46358403 Temperatures, Metals and Metal Ions 

830.7000 pH Yes - Study 46358403 

830.7050 UVNisible Light Absorption Yes - Study 46358403 

830.7200 Melting Point/Melting Range Not required2 

830.7220 Boiling Point/Boiling Range Yes- Study 46358403 

830.7300 Density/Relative Density/Bulk Density Yes - Study 46358403 (Specific Gravity) 

830.7520 Particle Size, Fiber Length, and Not required - substance is a liquid Diameter Distribution 

830.7550 

830.7560 Partition Coefficient (n-Octanol Water) Not required3 

830.7570 

830.7840 Water Solubility Yes - Study 46358403 

2 Per 40 § CFR 158.2030 Test Note 16: Required for organic chemicals unless they di sociate in water or are partially or 

completely soluble in Methyl Eugenol is partially soluble in water. 

3Per 40 § CFR 158.2030 Test Note 16: Required for organic chemicals unless they dissociate in water or are partially or 

completely soluble in water. Methyl eugenol is partially soluble in water. 

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Table 5.0 Summary of Physical and Chemical Characteristics for Methyl Eugenol 

Harmonized Has Data Requirement MRID No. or Guideline Data Requirement 

Number Been Addressed? How? Other Source 

830.7950 Vapor Pressure Yes - Study 46358403 

11. Human Health Assessment (40 C.F.R. § 158.2050) 

Hazard Characterization and Risk 

The toxicological database is considered complete for characterizing hazard and assessing risk from 

Methyl Eugenol. No additional studies are anticipated to be needed for registration review. 

Acute toxicity studies have shown slight toxicity relative to oral (LDso > 1,179 mglkg) and dermal (LDso 

> 2.02 mglkg) routes of exposures (Tox. Category III). The inhalation LCso is greater than 4.8 mg/L with 

no deaths or adverse signs noted (Tox. Category IV). Methyl Eugenol produced skin irritation in a 

primary detmal irritation study but this effect cleared by 72 hours (Tox. Category IV). Significant eye 

irritation was noted in a primary eye irritation study at one hour post application of Methyl Eugenol but 

cleared by 24 hours (Tox. Category IV). Methyl Eugenol is not classified as a skin sensitizer. 

Subchronic toxicity studies conducted with Methyl Eugenol demonstrated increased liver weights in 

both male and female rats. In a prenatal toxicity study, a reduction in the average fetal body weight per 

litter and an increased incidence of unossified sternebra! was noted; increased liver weight was noted in 

the maternal animals. In addition, a reproductive study demonstrated that Methyl Eugenol induced a 

significant increase in testis size. Chronic toxicology studies demonstrate that relatively high-bolus 

doses of Methyl Eugenol administered orally result in hepatic neoplasms in rats and mice. Results of 

mutagenicity studies indicated that Methyl Eugenol caused unscheduled DNA synthesis and Methyl 

Eugenol metabolites formed DNA adducts. 

Methyl Eugenol has been reviewed by the National Toxicology Program (NTP, 2005) and classified as 

"reasonably anticipated to be a human carcinogen". Under the conditions of2 year rat studies, there was 

clear evidence of carcinogeni c activity of Methyl Eugenol with increase incidences of liver neoplasms 

and neuroendocrine tumors of the glandular stomach in male and female rats and the increase incidences 

of kidney neoplasm, malignant mesothelioma, mammary gland fibroadenoma, subcutaneous fibroma 

and fibroma or fibrosarcoma (combined) in male rats. A comparable mouse study also showed that there 

was increase in incidences of liver neoplasms and neuroendocrine tumors of the glandul ar stomach 

related to Methyl Eugenol exposure. However, based on the non-food use of Methyl Eugenol as a lure in 

traps placed in close proximity to food crops (not on food), no dietary, oral, dermal or inhalation risks of 

exposure exists (Farwell, 2004). 

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Methyl Eugenol (ME) 

Dietary and Occupational Exposure and Risk Assessment 

EPA-HQ-OPP-20 15-0547 

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Although there are hazardous effects found in rodent toxicity studies, the potential for human dietary 

exposure to this chemical is below a level of quantitation. The insect attractant, Methyl Eugenol, is not 

applied to any food crops but is only used near orchards. Due to its volatility and because of its use 

patterns, it is considered unlikely for Methyl Eugenol to contaminate food or drinking water. This was 

confirmed by a monitoring study by the California Department of Food and Agricultural, which did not 

detect Methyl Eugenol in fruit collected near sites of Methyl Eugenol traps use (Turner et al., 1989). 

Therefore, there are no risk concerns for Methyl Eugenol used as an insect attractant in insect traps. In 

addition, the retrievable insect traps are available as ready to use items thereby significantly limiting the 

potential for applicator dermal and inhalation exposure. 

The potential for post-application dermal and inhalation exposure resulting from entry into treated areas 

is anticipated to be negligible. The ready to use retrievable traps are used in orchards and require no 

additional post-application treatment or handling other than to remove them for disposal or replacement 

approximately every 3-4 months.4 Furthermore, the Agency has received no incident reports resulting 

from the use of pesticidal products containing Methyl Eugenol. 

Table 6.0 Summary of Human Health Assessment Data for Methyl Eugenol 

Data Requirement Has Data MRIDNo. 

Harmonized Requirement Been Source or Other 

Guideline Addressed? How? Reference 

Number 

Acute Oral Toxicity- Rat Yes - Study U.S. EPA 44906304 

870. 1100 

870. 1200 

Acute Dennal Toxicity Yes- Study U.S. EPA 44906304 

870.1300 Acute Inha lation Toxicity Yes - Study U.S. EPA 44906304 

870.2400 Primary Eye Irritation 

Yes - Study U.S. EPA 44906304 

870.2600 Primary Dennal Sensitization 

Yes - Study U.S. EPA 

44906304 

870.2500 Acute Dennal Irritation 

Yes - Study U.S. EPA 44906304 

870.5 100; Mutagenicity: Moertelmans et Moertelmans 

Bacterial Reverse Mutation Yes- Study a!., (1986) eta/., (1986) 

Test NTP, (2000) NTP, (2000) 

4 Methyl Eugenol Cone label use pattern. 

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Table 6.0 Summary of Human Health Assessment Data for Methyl Eugenol 

Data Requirement Has Data MRID No. Harmonized Requirement Been Source or Other 

Guideline Addressed? How? Reference 

Number 

870.5300 Eukaryotic Reverse Mutation Moertelmans et Moertelmans 

Test Yes- Study a!. , ( 1986) et a!., (1986) 

NTP, (2000) NTP, (2000) 

870.3100 90-day Oral - rat Yes - Study NTP, NTP, (2000) (2000) 

870.3 100 90-day Oral - mouse Yes - Study NTP NTP, (2000) , (2000) 

870.3200 90-day Dermal Yes-Waived 5 4691 8302 

870.3250 90- day Inha lation - rat Yes- Waived 6 4691 8302 

870.3700 Prenatal Developmental- rat Yes - Study Price, (2004) Price, (2004) 

870.3800 Reproductive Toxicity-rat Yes - Study NT NTP, (2000) P, (2000) 

NTP, (2005) 

NTP, (2005) 

Nrn, (2000) 

Carcinogenicity- rat Nrn, (2000) Abdo, K.M. 

870.4200 Abdo, K.M. et eta!., (200 1) 

a!. , (200 1) Auman, J.T., Auman, J.T., el eta!. (2004) Yes - Study a!. (2004) Miller E. C., 

Miller E. C., et eta!., ( 1983) 

a!., ( 1983) Phillips, 

Phillips, D.H., et D.H., et a!., a /., (1984) ( 1984) 

870.4200 Carcinogenicity-mouse NTP, (2005) NTP, (2005) Yes - Study 

880.3550 Genotoxicity 

(lmmunotoxicity) Yes - Study NTP, (2000) NTP, (2000) 

5

The 90 day Dermal study was waived as repeat dermal exposure to Methyl Eugenol Is not expected based on Its use pattern 

as a ready to use retrievable insect trap. 6

The 90 day Inhalation study was waived as repeat inhalation exposure to Methyl Eugenol is not expected based on its use 

pattern as a ready to use retrievable insect trap. 

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iii. Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060) 

Exposure of non-target avian and mammalian species to Methyl Eugenol is highly unlikely because the 

end product is used as a fruit fly attractant that is enclosed in containers or traps for use in orchards (no 

ground or aerial spray), degrades quickly (vapor degrades with half-life of 5 hours), and is applied at a 

maximum rate of I 0 gram AI per hectare, ambient air residue levels were recorded at 142.8 - 34.9 ppt 

on day of application and Day I post application and showed no detectable residues at Day 5 (Turner et 

a/. , 1989). Methyl Eugenol is registered in ready to use retrievable traps, which will significantly limit 

potential exposure to birds, fish, non-target insects, and aquatic organisms. There is no ground or aerial 

spray and, therefore, no potential for runoff or drift to an aquati c area. 

Table 7.0 Summary of Non-target Organism Data for Methyl Eugenol 

Harmonized Has Data Requirement Been Guideline Data Requirement MRID 

Number Addressed? How? 

850.2 100 Avian Acute Oral Toxicity Yes - Waived 7 469 18302 

850.2200 Avian Dietary Toxic ity Yes - Waived 8 469 18302 

850. 1075 Fish Acute Toxicity, Freshwater Yes - Study 44906304 

850. 10 10 Aquatic Invertebrate Acute Yes - Waived 9 46918302 

Toxicity, Freshwater 

850.4100 Terrestrial Plant Toxicity, Yes - Waived 10 469 18302 

Seedling Emergence 

850.4 150 Terrestria l P lant Toxic ity, Yes - Waived 11 469 18302 

Vegetative Vigor 

880.4350 Nontarget Insect Testing Yes - Study 47147604 

7 The Avtan Acute Oral toxtctty study was wa1ved as exposure ts not expected to occur because of Methyl Eugenol use 

pattem as a ready to use retrievable insect trap. 

8 The Avian Dietary toxicity study was waived as exposure is not expected to occur because of Methyl Eugenol use pattem as 

a ready to use retrievable insect trap. 9 The Aquatic Invertebrate Acute toxicity study was waived as exposure is not expected to occur becau e of Methyl Eugenol 

u e pattem as a ready to use retrievable insect trap. 10 The Terrestrial Plant Seedling Emergence toxicity study was waived as exposure is not expected to occur because of 

Methyl Eugenol use pattem as a ready to use retrievable insect trap. 11 The Terrestrial Plant Vegetative Vigor toxicity study was waived as exposure is not expected to occur because of Methyl 

Eugenol use pattem as a ready to use retrievable insect trap. 

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Methyl Eugenol (ME) 

Harmonized 

Guideline 

Number 

850. 1075 

850. 1075 

850. 1010 

850.2200 

850.2 100 

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Table 8.0 Summary of Ecotoxicity Studies for Methyl Eugenol 

Species 

Results MRIDNo. 

Rainbow trout 44906304 

(Oncorhynchus mykiss) 96 hr LCso = 6.0 mg/L (4.9 -7.2 mg/L); Moderate 

toxicity 

Bluegill sunfish 96 hr LCso = 8. 1 mg/L (7.4 -9.0 mg/L) 44906304 

(Lepomis macrochirus) Moderate toxicity 

Daphnia magna Waiver request granted because of low potential exposure to terrestrial 

areas. Product is enclosed in trap/lure.

12 

Avian Dietary Test Waiver request granted because of low potential exposure to terrestrial 

areas. Product is enclosed in trap/lure. 13 

A vi an Acute Oral Waiver request granted because of low potential exposure to terrestrial 

areas. Product is enclosed in trap/lure .

14 

12 Watver request granted because of low potent tal exposure to terrestnal areas. Product ts enclosed tn trap/lure, terrestnal 

exposure not expected. 

13Waiver request granted because of low potential exposure to terrestrial areas. Product is enclosed in trap/lure, terrestrial 

exposure not expected. 14Waiver request granted because of low potential exposure to terrestrial areas. Product is enclosed in trap/lure, terrestrial 

exposure not expected. 

E. Threatened/Endangered Species 

Methyl Eugenol is used as an attractant for fruit flies in orchard bait traps and is also produced naturally 

in many plants. Acute toxicity studies on freshwater fish show that Methyl Eugenol is moderately toxic 

with LCso values ranging from 6.0 - 8. 1 mg/L. Environmental exposure to this compound is expected to 

be limited because the product is to be used only in the manufacture ofbait-traps and lures; and 

therefore most of the requirements for non-targeted test species and other ecological testing were 

waived. The California Department of Food and Agriculture (Turner et al., 1989) monitored residue 

levels of Methyl Eugenol in ambient air around traps at 142.8 - 34.9 ppt on day of application and Day I 

post application and showed no detectable residues at Day 5 (Table 9). Methyl Eugenol vapor rapidly 

degrades in the environment with a half-life of 5 hours. 

Table 9.0 Methyl Eugenol Concentration found in Air during Application of Oriental Fly 

Eradication Program ppt) 

Days After Site 1 Site 2 Site 3 Site 4 

Application 

0 142.8 7 1.9 ND 44.2 

1 34.9 31.9 ND 31.9 

5 ND ND ND ND 

Field studies have also shown that Methyl Eugenol is a kairomone (Metcalf and Metcalf, 1992) and is an 

attractant for many species of the Subfamily Dacinae (i. e. fruit fly subfamily). Uchida et al., (2006) 

concluded that traps with Methyl Eugenol attracted many non-target insects, many of which were 

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scavenger flies. The researchers concluded, however, that the presence of these non-target flies may 

have resulted partially from the lures, as well as decaying insects inside the traps. Because of these 

findings, they concluded that future studies with Methyl Eugenol should include frequent cleaning of 

traps in order to avoid false positive results for evaluating Methyl Eugenol's ability to attract non-target 

insects. Leblanc et al., (2009) also noted that fruit fl y lures (Methyl Eugenol), when used over large 

areas may attract a small number of non-target insects, including pollinators and aphid predators, plant 

feeding Miridae, and Sciaridae, or by secondary attraction of large numbers of saprophagous species to 

the accumulation of dead trapped flies. They further noted that there was a relatively small number of 

insect pollinators (including honeybees) in Methyl Eugenol traps (0.03 to 0.15 per trap per day) 

suggesting that this attraction is likely to occur over short distance and can be minimized by avoiding 

the application of Methyl Eugenol traps to trees during the flowering stage. 

Leblanc et al., (2009) observed that, because most native Hawaiian insect species are rather uncommon 

in highly modified habitats, the risk of attracting large numbers of endemic saprophagous non-targets to 

decaying flies is very low in the non-native and agricultural habitats where the lures are primaril y used. 

This was confirmed in a preliminary comparison (Hawaii) of catches ofDrosophilidae in traps baited 

with decaying fli es in relatively undisturbed native forest, two ecotone forest sites adj acent to na"tive 

forest and non-native forest and agricultural areas. 

On May 9, 2006, in 71 FR 46994-47054, the Fish and Wildlife Service (FWS) of the Department of the 

Interior (DOl), placed 12 species of picture-wing fruit flies from the Hawaiian islands on the endangered 

or threatened list (Drosophila aglaia, D. differens, D. hemipeza, D. heteroneura, D. montgomety i, D. 

mulli, D. musaphilia, D. neoclavisetae, D. obatai, D. ochrobasis, D. substenoptera, and D. 

tarphytrichia). Since Methyl Eugenol is an attractant for fruit fli es, manufacturers of end-use products 

must make certain that products are not used in areas where these flies may be impacted. These listed 

species of fruit fli es and their critical habitat are protected with nine of the species already on forest 

reserves that are protected State Park land, or p1ivate land protected by the Nature Conservancy. The 

remaining species are on sites with no agricultural activity and sites owned and managed by the City and 

County of Honolulu adj acent to State conservation districts (Cook, 2007). A search of the U.S. EPA's 

Environmental Incident Information System (EllS) conducted on January 11 , 201 6, revealed no 

incidents associated with Methyl Eugenol; this database contains information dating back to the 1970s. 

The EPA will consider any incident data or comments submitted in response to this Preliminary Work 

Plan. 

Based upon the results of toxicity tests on non-target species and the low potential for exposure noted 

previously (not likely to attract pollinators), the risks to endangered/threatened species and their 

designated critical habitats, from Methyl Eugenol as an active ingredient in pesticide products are 

expected to be negligible. Therefore, EPA has reached a "No Effect" determination for 

endangered/threatened species and designated critical habitat (Rexrode, 20 15). 

Page 15 of 23 
Methyl Eugenol (ME) 

F. Endocrine Effects 

EPA-HQ-OPP-20 15-0547 

www.regulations.gov 

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 

408(p ), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to 

implement the screening program that is to be used to test all pesticides in order 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." 

FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of 

the Estrogenic Substances Screening Program a biologic substance or other substance if a determination 

is made that the substance is not anticipated to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. 

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

67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening was published on June 14, 2013, and includes some pesticides 

scheduled for registration review and chemicals found in water. Methyl Eugenol was among the group 

of pesticide active ingredients on the lists to be screened under the EDSP. EPA researchers developed 

the Endocrine Disruption Screening Program for the 21st Century Dashboard (EDSP21 Dashboard) to 

provide access to new chemical data on over 1,800 chemicals of interest. The purpose of this is to help 

EPA evaluate chemicals for endocrine-related activity (EDSP21 Dashboard). 

No data are available on the endocrine effects of Methyl Eugenol; however, data are available for 

Eugenol. Because Eugenol is significantly similar to Methyl Eugenol in structure and environmental 

effects, Eugenol EDSP data are used here as a surrogate for Methyl Eugenol data. Eugenol was tested by 

EPA's, Office of Research and Development (ORD), National Health and Environmental Effects 

Research Laboratory (NHEERL), and MED for chemical binding to rainbow trout endocrine receptor 

(ER) as measured in vitro with relative binding affinity that has been estimated to be similar to that of a 

very weak phenol binding. Eugenol was not run in the gene activation assay for confirmation, but the 

observed binding curve was believed to be due to competitive binding for the estrogen receptor based 

upon affirmative binding results for other similar methoxy phenol structures which induced detectable 

vitellogenin (Vtg) gene expression in liver slices of male rainbow trout (Schmieder et. al., 2004). The 

relationship of low binding affinity in vitro and the ability to cause an adverse effect in vivo is not 

known. However, Eugenol was - 1.5 to 2.5 orders of magnitude less in its relative binding affinity for 

ER than chemicals that have been tested and shown to have in vivo effects in MED studies, and similar 

chemicals tested by others (Seki eta!., 2003a, b; Yokota et al. , 2001 ). 

In summary, Eugenol is a very weak binder in vitro; and is unlikely to result in an in vivo effect of 

concern to humans or wildlife given that it is a component of mint, its natural presence in the 

environment, and its long history of use without reported effects. 

The EPA, as part of this Preliminary Work Plan, believes that Methyl Eugenol is a substance that would 

not likely produce any effect in humans similar to an effect produced by a naturally occurring estrogenic 

substance. Results from the EDSP21 Dashboard for Methyl Eugenol (ACso- AR, ACso-ER, and ACsoThR bioassays) showed that the chemical was inactive (did not bind effectively) against estrogenic 

targets. As such, pursuant to Section 408(p) (4), the EPA will detennine in the future whether it can 

Page 16 of 23 
Methyl Eugenol (ME) EPA-HQ-OPP-20 15-0547 

Wlvw.regulations.gov 

exempt Methyl Eugenol from the requirements of the Section 408(p) EDSP. ln the event the EPA does 

determine to exempt this substance from the EDSP, an order will be issued. 

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website at 

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

G. Incidents 

A search of the Office of Pesticide Programs' Incident Data System (IDS) from April 7, 2006, through 

December 2, 20 15, indicated that there are no individual reports of major incidents involving humans 

associated with the use of Methyl Eugenol in insect traps. In addition, a search of OPP's Environmental 

Incident Information System (EllS) conducted on January 11,2016, revealed no incidents associated 

with Methyl Eugenol; this database contains information dating back to the 1970s. The EPA will 

consider any incident data or comments submitted in response to this Preliminary Work Plan. 

H. Timeline 

Below is the projected timeline for Registration Review case 6203: Methyl Eugenol: 

Activities Estimated MonthNear 

Opening the Docket 

Open Docket and 60-Day Public Comment Period for March 2016 

Close Public Comment Period May 2016 

Case Development 

Issue Final Work Plan September 2016 

Issue Data Call-in N/A 

Data Submission N/A 

Open 30-Day Public Comment Period for Draft Risk Assessments N/A 

Close Public Comment Period N/A 

Registration Review Decision 

Open 60-Day Public Comment Period for Proposed Registration March 2017 

Review 

Decision 

Close Public Comment Period May 2017 

Final Decision September 20 17 

*Estimated Total (years) 1 year and 6 months 

* This schedule is subject to revision should unforeseen issues arise during the registration review process. In the 

event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be 

issued at that time that will set forth a new timeline and, if applicable, any new data requirements will be 

included in the amended document and a Data Call-In Notice will be issued. 

Page 17 of 23 
Methyl Eugenol (ME) 

I. Guidance for Commenters 

EP A-HQ-OPP-20 15-054 7 

www.regulations.gov 

The public is invited to comment on the EPA's preliminary work plan and rationale. The areas below 

highlight topics of special interest to the EPA where comments, data submissions, or reference to sources 

of additional information could be of particular use. The EPA will consider all comments, as well as any 

additional infonnation or data provided in a timely manner, prior to issuing a Final Work Plan for this 

case. 

i. Environmental Justice 

The EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, and 

enforcement of environmental laws, regulations, and policies. To help address potential environmental 

justice issues, the EPA seeks information on any groups or segments of the population who, as a result of 

their location, cultural practices, or other factors, may have unusually high exposure to the pesticidal use 

of Methyl Eugenol, compared to the general population. Please comment if you are aware of any 

subpopulations that may have atypical, unusually high exposure compared to the general 

population. 

ii. Water Quality 

Methyl Eugenol is not identified as a cause of impairment for any water bodies listed as impaired under 

Section 303(d) of the Clean Water Act. 15 In addition, no Total Maximum Daily Loads (TMDLs) have 

been developed for Methyl Eugenol. More information on impaired water bodies and TMDLs can be 

found on EPA's website. 16 The EPA invites submission of water quality data for this pesticide. To the 

extent possible, data should conf01m to the quality standards in Appendix A of the Office of Pesticide 

Programs (OPP) Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in Registration Review Risk Assessment and Management Proces 15 to ensure they can be 

used quantitatively or qualitatively in pesticide risk assessments. 

iii. Trade Irritants 

Through the registration review process, the EPA intends to solicit information on trade irritants and, to 

the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize 

tolerance and international Maximum Residue Limits (MRLs), and, if necessary, may modify tolerance 

levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues 

resulting from lack ofMRLs or disparities between U.S. tolerances, including exemptions and MRLs in 

key export markets, providing as much specificity as possible regarding the nature of the concern. 

There are no known MRLs for Methyl Eugenol. Therefore, the EPA does not anticipate that current uses 

of Methyl Eugenol will pose concerns as trade irritants. 

15 This is based on infonnation provided at http://www.epa.gov/owow/tmdl! 16 This document can be found at http://www.epa. gov/oppsrrd //registration review/water qualitv sop.htm 

Page 18 of 23 
Methyl Eugenol (ME) 

iv. Additional Information 

EPA-HQ-OPP-20 15-0547 

\VlVW.regu/arions.gov 

Stakeholders are also specifically asked to provide infom1ation and data that will assist the EPA in 

refining the risk assessments. The EPA is interested in obtaining the following infonnation regarding 

Methyl Eugenol: 

IJi> Confirmation on the following label information: 

- Sites of application 

-Formulations 

- Application methods and equipment 

- Maximum application rates 

- Frequency of application, application intervals, and maximum number of applications 

- Geographic limitations on use 

IJi> Use or potential use distribution (e.g., acreage and geographical distribution of relevant use 

sites) 

1Ji> Median and 901h percentil e reported use rates (lbs active ingredient/! ,000 square feet) from 

usage data- national, state, and county 

1Ji> Application timing (date of first application and application intervals) - national, state, and 

county 

1Ji> Usage/use information for nonagricultural uses 

1Ji> Typical application interval (days) 

IJi> State or local use restrictions 

1Ji> Monitoring data 

1Ji> Foreign technical registrants not listed above who supply technical Methyl Eugenol to the US 

market 

J. Next Steps 

After the 60-day comment period closes, the EPA will review and respond to any comments received in 

a timely manner, then issue a Final Work Plan for Methyl Eugenol. 

Page 19 of 23 
Methyl Eugenol (ME) EPA-HQ-OPP-20 15-0547 

w1vw. regulations. gov 

II. BIBLIOGRAPHY 

A. Studies Supporting Registration Review of Methyl Eugenol 

Abdo, K.M. eta!. , 2001. 14-week toxicity and cell proliferation of Methyl Eugenol administered by 

gavage to F344 rats and B6C3F1 mice Food Chern Toxicol39 (4): 303-16. 

Asquith, A. and Kido, M. 1995. Native Hawaiian insects attracted to the semiochemical Methyl 

Eugenol, used for male annihilation of the oriental fruit fly (Diptera: Tephritidae). Environmental 

Entomology23: 1397-1408. 

Auman, J.T., Fannin, R. D., Sieber, S. 0., Cunningham, M. L., and Paules, R. S. 2004. Early changes in 

hepatic gene expression following exposure to the rodent carcinogen Methyl Eugenol. Toxicologist 78 

(1 -S): 135. 

Beroza, M., Inscoe, M.N., Schwartz, P.H., Keplinger, M.L., and Mastri, C.W. 1975. Acute toxicity 

studies with insect attractants. Toxicology and Applied pharmacology 31: 421-429. (MRID 44906304). 

Cook, P. 2002. Physical and Chemical Properties: FT Methyl Eugenol. Unpublished study prepared by 

Farma Tech International Corp. 47 p. (MRID 46358403). 

Cook, p. 2002. Physical and Chemical Properties Methyl Eugenol. Farma Tech. International. (MRID 

46358403). 

Cook, R. 2005. Supplemental Studies/ Infonnation Submitted as Support for a Non-Target Plant Waiver 

( 40 CFR 158.540): The Environmental Monitoring of Methyl Eugenol, Naled and Dichlorvos During a 

Pest Trapping and Eradication Program: Monitoring of Methyl Eugenol and DDVP in Fruit Near Fruit 

Fly Traps During a Pest Trapping Program: Methyl Eugenol/Naled Monitoring at Fruit Fly Trapping 

Locations. Unpublished study prepared by Farma Tech International Corporation and State of California. 

78 p. (MRID 46671001). 

Cook, R. 2007. Non-Target Insects: FT-Methyl Eugenol Short Lure. Unpublished study prepared by 

Farma Tech International Corp. 130 p (MRID 47147604) 

Cook, P. (2012) FT-Methyl Eugenol: Analysis of Sample: Certified Limits. Unpublished study prepared 

by Farma Tech International Corp. 19p. (MRID 49008902). 

Cook, P. (2012) FT Methyl Eugenol: Analysis of Sample: Certified Limits. Unpublished study prepared 

by Farma Tech International Corp. 16p. (MRID 49008904). 

Farwell, K., (2004). D302237. Risk Assessment for Methyl Eugenol (Methyleugenol). 

Leblanc, 1., Rubinoff, D., and Vargas, R.I. 2009. Attraction ofNontarget Species to Fruit Fly (Diptera: 

Tephritidae) Male Lures and Decaying Fruit Flies in Traps in Hawaii. Environ. Entomol. 38(5): 1446-

1461. 

Page 20 of 23 
Methyl Eugenol (ME) EPA-HQ-OPP-20 15-0547 

www. regulations.gov 

Leblanc, 1., Rubinoff, D and Vargas, R.I. 2009. Attraction ofNontarget Species to Fruit Fly (Diptera: 

Tephritidae) Male Lures and Decaying Fruit Flies in Traps in Hawaii. Environ. Entomol. 38(5): 1446-

1461. 

Metcalf, R. L. and E. R. Metcalf. 1992. Fruit flies of the family Tephritidae, pp. 109- 152. In Metcalf, 

R. L. and E. R. Metcalf, Plant kairomones in insect ecology and control. Chapman and Hall, New 

York, 168 pp. 

Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., Zeiger, E. 1986. Salmonella 

mutagenicity tests: II. Results from the testing of 270 chemicals. Environ Mutagen 8: 1-11 9 National 

Institute of Health. 2000. 

NIH, 2000. Toxicology & Carcinogenesis Studies of Methyl Eugenol in F344/N Rats and B6C3Fl Mice 

p.8-1 0 Technical Report Series No. 491 NIH Publication No. 00-3950 U.S. Department of Health and 

Human Services, National Toxicology Program, National Institute of Environmental Health Sciences, 

Research Triangle Park, NC 27709. 

NTP (National Toxicology Program). 2000. Toxicology and carcinogenesis studies of Methyl Eugenol 

(CAS No. 93-15-2) in F344/N rats and B6C3F1 mice (gavage studies). NTP TR 491. 412 pp. 

NTP (National Toxicology Program). 2005. Eleventh Report on Carcinogens: Methyl Eugenol (93-15-

2). 

OECD, 2009. Report of the Expert Consultation to Evaluate an Estrogen Receptor Binding Affinity 

Model for Hazard Identification. Series on Testing and Assessment, No. 111. August 21, 2009. 

ENV /JM/MON0(2009)33. 

http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jrn/mono(2009)33&doclanguag 

e=en 

Phillips, D. H., Reddy, M.Y., and Randerath, K. 1984. 32P-post-labelling analysis of DNA adducts 

formed in the livers of animals treated with safrole, estragole and other naturally-occurring alkenyl 

benzenes II. Newborn male B6C3F1 mice. Carcinogenesis 5 (12): 1623-8. 

Price, C. 2004. Final Study Report: Developmental toxicity evaluation for Methyl Eugenol (CAS No. 

93-1 5-2) administered by gavage to Sprague-Dawley (CD) rats on gestational days 6 through 19. NTP 

Study No.; TER-97-007 . 1-1 09. 

Rexrode, M., (2015). Registration Review for Methyl Eugenol. 

Rose, R. (2006) Scentry Methyl Eugenol Biochemical Pesticide Registration Data Requirements: 

Waiver Requests. Unpublished study prepared by Scentry Biologicals, Inc. 10 p (MRID 46918302). 

Schmieder, P.K., Tapper, M.A., Denny, J.S., Kolanczyk, R.C., Sheedy, B.R., Henry, T.R., Veith, G.D., 

2004. Use of trout liver sli ces to enhance mechanistic interpretation of estrogen receptor binding for 

cost-effective prioritization of chemicals within large inventories. Environ. Sci. Techno!. 38 (23), 6333-

6342. 

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Methyl Eugenol (ME) EP A-H Q-OPP-20 15-054 7 

www.regulations.gov 

SAP, 2009. See http://www.epa.gov/scipoly/sap/meetings/2009/082509meeting.html: cite both the EPA 

white paper and the SAP report. 

SAP, 2013. See http://www.epa.gov/scipoly/sap/meetings/2013/012913meeting.html, cite both the EPA 

white paper and the SAP report. 

Seki, M., Yokota, H., Matsubara, H., Maeda, M., Tadokoro, H., Kobayashi, K., 2003a. Fish full lifecycle testing for the weak estrogen 4-tert-pentylphenol on medaka (Oryzias latipes). Environ. Toxicol. 

Chern. 22, 1487-1496. 

Seki, M., Yokota, H., Maeda, M., Tadokoro, H., Kobayashi, K., 2003b. Effect of 4-nonylphenol and 4-

tert-octylphenol on the sex differentiation in medaka (Oryzias latipes). Environ. Toxicol. Chern. 22, 

1507- 1516. 

Turner, B., Miller, N., Tran, D. and Powell, S. 1989. The environmental monitoring of Methyl Eugenol, 

naled, and dichlorvos during a pest trapping and eradication program. California Department of Food 

and Agriculture. (MRID 488710-01). 

Uchida, G. K., Mackey, B. E., Vargas, R.I., Beardsley, J. W, Hardy, D. E., Goff, M. L., and Stark, J. D. 

Response of nontarget insects to Methyl Eugenol, cue-lure, trimedlure, and protein bait bucket traps on 

Kauai Island, Hawaiian Islands, USA. Proc. Hawaii Entomol. Soc. 38: 61-72. 2006. 

U.S. EPA (December 16, 2004) Risk Assessment for Methyl Eugenol 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2004-0418-0003. 

U.S. EPA (December 2004) Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment 

Progress and Risk Management Decision (TRED) for Methyl Eugenol 

http:/ I archive. epa. gov /pesti ci des/reregistration/web/pd f/methyl_eugeno l_tred. pdf 

U.S. EPA Approved Label for Scentry Methyl Eugenol Cone, EPA File Symbol 36638-41 , December 11 , 

2007, 

http:/ /ofmpub.epa.gov/apex/pesticides/f?p=PPLS:8: 17148588 153015: :NO: :P8 PUID,P8 RINUM:4860 

12,36638-41 . 

U.S. EPA, 2013. Endocrine Disrupter Screening Program: Final Second List of Chemicals and 

Substances for Tier 1 Screening. EPA-HQ-2009-0477-0074. 

U.S. Environmental Protection Agency Environmental Incident Information System (EllS) Version 

2.1.1. 10114/2015. 

U.S. Environmental Protection Agency Dashboard Overview. Endocrine Disruption Screening Program 

for the 21 st Century. http://actor.epa.gov/edsp21 I 

U.S. Fish and Wildlife Service. 2007. Endangered and threatened wildlife and plants: revised proposed 

designation of critical habitats for 12 species of picture-wing flies from the Hawaiian Islands: proposed 

rule. Fed. Reg. 72: 67427-67522. 

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www.regulations.gov 

Yokota, H., Seki, M., Maeda, M., Oshima, Y., Tadokoro, H., Honjo, T., Kobayashi, K., 2001 . Life-cycle 

toxicity of 4-nonylphenol to medaka (Oryzias latipes). Environ. Toxicol. Chern. 20, 2552- 2560. 

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