BIOPESTICIDES REGISTRATION ACTION DOCUMENT



## Oregano Oil

( Origanum vulgar )


### PC Code 004300

U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division

(last updated June 10 , 2011)

This document is for informational purposes only and is representative of the Agency’s justification in registering products containing this active ingredient. This is not a legal

document.Oregano Oil ( Origanum vulgar ) Page 2 of 19 Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMAR Y

................................ ................................ ................................ ...... 4

II. ACTIVE INGREDIE NT OVERVIEW

................................ ................................ ................ 5

III. REGULATORY BAC KGROUND

................................ ................................ ...................... 5

A. Applications for Pesticide Registration

................................ ................................ ..... 5

B . Food Tolerance Exemptions

................................ ................................ ....................... 5

IV. RISK ASSESSMENT

................................ ................................ ................................ ............ 5

A. Product Chemistry Assessment ( 40 CFR § 158.2030 )

................................ ............. 5

B. Human Health Assessment ( 40 CFR § 158.2050 )

................................ ..................... 5

C. Env ironmental Assessment ( 40 CFR § 158.2060 )

................................ .................... 8

V. RISK MANAGEMENT DECISION

................................ ................................ ..................... 9

A. Determination of Eligibility for Registration

................................ ........................... 9

B. Regulatory Decision

................................ ................................ ................................ .... 9

VI. ENVIRONMENTAL J USTICE

................................ ................................ ........................... 9

V1I. ACTIONS REQUIR ED BY REGISTRANTS

................................ ................................ .. 9

A. Reporting of Adverse Effects

................................ ................................ ................... 10

B. Reporting of Hypersensitivity Incidents

................................ ................................ . 10

APPENDIX A. DATA RE QUIREMENTS (40 CFR P ART 158

— SUBPART U)

............... 11

**REFERENCES**

**... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ...**  **... ..**  **14**Oregano Oil ( Origanum vulgar ) Page 3 of 19 Biopesticides Registration Action Document

Science Reviews

Sadaf Shaukat Russell Jones, Ph.D.

Regulations

Linda A. Hollis, M.S

. Chief, Biochemical Pesticides Branch Leonard S. Cole, Jr., M.S

. Senior Regulatory Action LeaderOregano Oil ( Origanum vulgar ) Page 4 of 19 Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY

O regano Oil is derived from a common species of Or iganum , a genus of the mint family (Lamiaceae). Oregano Oil is also considered an antioxidant with properties t hat assist i n the inhibition of bacterial growth and inhibiting the growth of fungi. Oregano Oil is most commonly

found in Turkey . Oregano Oil is also used for the treatment of several diseases, including

diabetes mellitus. In summary, Oregano Oil is a multi

- purpos e oil with uses that span cooking to general health

.

The Biopesticides and Pollution Prevention Division (BPPD) determined that the data/information submitted for Tier I Acute Toxicity and Product Chemistry for Oregano Oil adequately satisfy current guide line requirements (refer to 40 CFR Subpart U § 158.2000). Nontarget toxicology data requirement s were satisfied by the submission of data waivers for nontarget organism that were granted by BPPD based on the information submitted by the applicant. The su bmitted information demonstrate d no hazards to nontarget species as presented in the scientific literature and rationale for the proposed use of Oregano Oil as a biochemical fungicide

. Based on the information discussed above, the Agency determined that O regano Oil as an active ingredient will have No Adverse Effects (NAE) on threatened and/or endangered species.

Based on the Acute Toxicity and Product Chemistry data available to the Agency, the active ingredient is classified into Toxicity Category III for oral toxicity and Toxicity Category IV for primary eye irritation

, acute dermal, acute inhalation

, and skin irritation

. The Agency determined that no unreasonable adverse effects to the U.S. population will result from the use of the active ingredient when used as directed by the label

. There are no reports of adverse effects following regular human exposure and consumption of Oregano Oil

. Moreover, the pesticidal usage of this biochemical will not have any harmful environmental effects.

The Biope sticides and Pollution Prevention Division (BPPD) reviewed data/information in support of the requirements for granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

. Based on data available, BPPD

det ermined that the data/information submitted adequately satisfy current guideline requirements (please refer to 40 CFR Subpart U § 158.2000)

.

On October 1, 2009, the Agency announced a policy to provide a more meaningful opportunity for the public to par ticipate i n major registration decisions before they occur. A ccording to this policy, the Agency intends to provide a public comment period prior to making a registration decision for, at minimum, the following types of applications: new active ingredients ; first foo d uses; first outdoor uses; first residential uses ; and any registration decisions for which the Agency believes there may be substantial public interest.

Consistent with the policy of making registration actions more transparent, Oregano Oil w as subject to a 30

- day comment period because it is a new active ingredient. During this comment period, no comments were received on the Agency’s preliminary decision to register Oregano Oil. Therefore, the Agency maintained tha t, based upon the risk ass essment and information submitted in support of registration of Oregano Oil, it was in the best interest of the public andOregano Oil ( Origanum vulgar ) Page 5 of 19 Biopesticides Registration Action Document

the environment to issue the registration of this pesticide. The basis for this decision can be

found in the risk assessment for Oreg ano Oil , which is characterized throughout this BRAD.

II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Oregano Oil (from Origanum vulgar )

OPP Chemical Code: 004300

Type of Pesticide: Bio chemical Pesticide/ Biofungicide

III

. REGULATORY BACKGROUND

A. Applications for Pesticide Registration

On August 18, 2007

, Gary Libman of G NL Consultation Services (39 Sage Hill Drive, Placitas, New Mexico 87043) , actin g as the authorized agent for Moss Buster LLC

, (address: 3002 Fair Lane, Mason City, Iowa 50401) , submitted an application to register Oregano Oil (EPA File Symbol 84316

- R ) u nder section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA )

. On February 2 7 , 200 8 , the Agency announced receipt of this application to register a pesticide product containing a new active ingredient ( 7 3 Federal Register [FR] 10435 ) and opened a 30

- day public comment period pursuant to the provisions of FIFRA section 3(c)(4)

. No comments were received following this publication.

B. Food Tolerance Exemptions

Currently, this active ingredient is not proposed for food or feed uses.

IV. RISK ASSESSMENT

A. Pr oduct Chemistry Assessment ( 40 CFR § 158.2 030 )

All product chemistry data requirements for Oregan o Oil are satisfied

. T he applicant must submit the results of one year storage stability and corrosion characteristics studies for the end use product twelve months post registration

. These guideline study requirements are OCSPP

830.6317 , 830.6320).

B. Human Health Assessment ( 40 CFR § 158.2 050 )

1. Toxicity

All toxicology data requirements for Oregano Oil are satisfied

. Acceptable Tier I mammalian toxicology data / information support the registration of Oregano Oil

. Furthermore, Tier II and

Tier III studies w ere not required for Oregano Oil based on the lack of acute toxicity in the Tier I

studies

.Oregano Oil ( Origanum vulgar ) Page 6 of 19 Biopesticides Registration Action Document

For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) identified from studies and/or information on file with the Agency

. The active ingredient is classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the lowest toxicity

. For more information, refer http://www.epa.gov/pesticides/pestla bels/

.

Oregano Oil is classified into category III for oral toxicity, and IV for primary eye irritation, dermal, inhalation and skin irritation.

Adequate mammalian toxicology data/information is available to support registration of Oregano

Oil

. All t oxicology data requirements for Oregano Oil are satisfied.

a. Acute Toxicity

Acute toxicity studies /information submitted in support of the active ingredient, Oregano

Oil are adequate for registration of this active ingredient. Based on the review an d analysis of the information, guideline studies, and submitted literature discussed in this section of the BRAD, no additional toxicity data are required to support the non food use of this active ingredient.

b. Subchronic Toxicity

Tier I information did not trigger subchronic toxicity data.

c. Developmental Toxicity and Mutagenicity

These data were not required because Oregano Oil is being used on roof tops, golf greens, and landscape timbers; therefore, it is not expected to result in significant exposure to human females

.

d

. Effects on the Endocrine System

EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA), to develop a screening program to determine

whether certain su bstances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following

the recomm endations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone syst em

. EPA also adopted EDSTAC’s recommendation that the program include evaluations of potential effects in wildlife

. For pesticide chemicals, the Agency will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the

wildlife evaluations

. As the science develops and resources allow, screening ofOregano Oil ( Origanum vulgar ) Page 7 of 19 Biopesticides Registration Action Document

additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

The Agency is not requi ring information on the endocrine effects of Oregano Oil at this

time

. The Agency has considered, among other relevant factors, available information concerning whether the active ingredient may have an effect on humans similar to an effect produced by na turally occurring estrogen or other endocrine effects

. There is no known metabolite that acts as an endocrine disrupter produced by this active ingredient

. Based on the low potential exposure level associated with the proposed use of the end use products , the Agency expects no incremental adverse effects to the endocrine or immune

systems.

2. Dose Response Assessment

No toxicological endpoints were identified; therefore, a dose response assessment was not required.

3. Drinking Water Exposure and R isk Characterization

No significant exposure via drinking water is expected when Oregano Oil is used according to the product label directions

. The active ingredient is not to be applied directly to water or to areas where surface water is present, and if used as labeled, is not likely to accumulate in drinking water

. In the unlikely event that exposure via drinking water did occur, the health risk would be expected to be minimal, based on the low acute oral toxicity of Oregano Oil.

4. Occupational, Residential, School and Day Care Exposure and Risk

Characterization Occupational Exposure and Risk Characterization

No occupational estimate s are made in this assessment.

5. Residential, School and Day Care Exposure and Risk Characterization

Oregano Oil is considered ubiquitous in nature, and it is widely used in food ; therefore , no risk

characterization was done for incidental oral scenarios

. Should accidental exposure occur, the health risk is expected to be minimal, based on the low acute oral, d ermal, and inhalation toxicity

of Oregano Oil.

6

. Aggregate Exposure from Multiple Routes Including Dermal, Oral,

and Inhalation

There is a reasonable certainty that no harm to the US population will result from aggregate

exposure to Oregano Oil

. The Agency arrived at this conclusion based on the low level of toxicity of Oregano Oil

. Further, Oregano Oil is a food ingredient consumed by the general public without any reported adverse effects on human health.Oregano Oil ( Origanum vulgar ) Page 8 of 19 Biopesticides Registration Action Document

7

. Cumulative Effects

Based on the information available to the Agency, there is no indication that toxic effects associated with exposure to Oregano Oil are of toxicological concern

. Because of the active ingredient’s low toxicity, cumulative effects with other substances that share a common mechanism of toxicity are not expected.

8

. Risk Characterization

The Agency considered human exposure to Oregano Oil in light of the relevant safety factors in FQPA and FIFRA

. A determination was made that no unreasonable adverse effects to t he U.S. population in general, and to infants and children in particular, will result from the use of Oregano Oil when used in accordance with label instructions

.

C. Environmental Assessment ( 40 CFR § 158.20 6 0 )

1. Ecological Hazards

Ecological effects data requirements for Oregano Oil were satisfied by the sub mission of data waiver requests/data pertaining to effects on nont arget organisms

. Based on the waiver rationale, the Agenc y concluded that exposure and risk from the proposed use of Oregano Oil is not expected to occur or pose a threat to nontarget organisms

, including plants

. Oregano Oil was deemed to be practically nontoxic to honeybees with an LC 50 of 331.3 μ g/bee as shown in Table

3 below.

2. Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered because Oregano Oil acute toxicity studies did not trigger any additional Tier I studies.

3. Ecological Exposure a nd Risk Characterization

Based on the information submitted in the data waiver requests for nontarget plants and data for nontarget insects, exposure and risk from the proposed use of Oregano Oil is not expected to

occur for other nontarget organisms.

4. Endangered Species Assessment

Based on the information discussed above, the Agency determined that registered use of Oregano Oil as an active ingredient will have No Adverse Effects (NAE) on threatened and/or endangered species

. When the product is used according to label use directions, there are no concerns for any nontarget organisms.Oregano Oil ( Origanum vulgar ) Page 9 of 19 Biopesticides Registration Action Document

V. Risk Management Decision

A. Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is determined that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materia ls required to be submitted comply with the requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice it will n ot generally cause unreasonable adverse effects on the environment. The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the science assessments supporting products containing Oregano Oil

. Such products ar e not expected to cause unreasonable adverse effects, and are likely to provide protection as claimed when used according to label instructions

. Therefore, Oregano Oil is registered for the labeled

uses.

B. Regulatory Decision

As set forth above, EPA determined that Oregano Oil presents no issues of toxicological, ecological, or environmental concern. Accordingly, EPA granted a registration for Oregano Oil under the provisions of FIFRA § 3(c)( 5) for use as a biochemical fungicide.

Conditional/Unconditional Registration

All data requirements are fulfilled

, and EPA determined that unconditional registration of Oregano Oil is appropriate.

VI

. ENVIRONMENTAL JUSTICE

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies

. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to Oregano Oil compared to the general population

.

V 1 I. ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with the initial registration of Oregano Oil and determined that these data are sufficient to satisfy current registration data requirements. For new uses and/or changes to existing uses, ad ditional data may be required.Oregano Oil ( Origanum vulgar ) Page 10 of 19 Biopesticides Registration Action Document

Not withstanding the information stated in the previous paragraph, it should be clearly understood that certain, specific, data are required to be reported to the Agency as a requirement for maintaining the Federal registra tion for a pesticide product

. In addition, t he applicant must

sub mit the results o f one year storage stability and corrosion characteristics studies for the end use product twelve months post registration. A brief summary of these types of data are listed

below.

A. Reporting of Adverse Effects

Reports of all incidents of adverse effects to the environment must be submitt ed to the Agency under the provisions of Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide

Act

.

B. Reporting of Hypersensitivity Incidents

A ll incidents of hypersensit ivity (including both suspected and confirmed incidents) must be reported to the Agency under the provisions of 40 CFR Part 158.2050 (d).Appendix A. Data Requirements (40 CFR Part 158

— Subpart U)

*NOTE: MRID numbers listed in the following tables are representative of supporting data for the original registration of the product containing this active ingredient

. Subsequent to this registration, there may be additional MRIDs that support registration of other products containing this active ingredient.

TABLE 1. Product Chemistry Data Requirements for Oregano Oil (40 CFR § 158.2030)

OPPTS

Guideline No. Study Results (below are example results)

830.1550 to

830.1670 Produc t identity; Manufacturing process;

Discussion of formation of unintentional

ingredients Submitted data satisfy the requirements for product identity, manufacturing process, and discussion of formation of impurities.

830.1700 Analysis of samples Subm itted data satisfy the requirements for analysis of samples.

830.1750 Certification of limits Limits listed in the CSF are adequate / acceptable.

830.1800 Analytical method Acceptable.

TABLE 2. Physical and Chemical Properties of Oregano Oil ( 40 CFR § 158.2030)

OPPTS

Guideline No. Property Description of Result

830.6302 Color Yellow @ 21oC

830.6303 Physical State Liquid @ 21oC

830.6304 Odor Minty

830.6313 Stability to Normal and Elevated Temperatures, Metals and Metal Ions Stab le at room and elevated temperatures and in the presence

of metals and ions.

830.6314 Oxidation/Reduction: Chemical Incompatibility Dihydronepetalactone was relatively stable in solution with metals and metal salts after 14 days at 25oC, with slight

d ecreases at 54oC after 14 days.

830.6315 Flammability >99oC

830.6317 Storage Stability In short

- term testing at 25 and 54oC, dihydronepetalactone content was relatively stable

. Guideline study is in progress.

830.6319 Miscibility Not applicabl e, product is not to be diluted in petroleum

solvents

830.6320 Corrosion Characteristics Guideline study is in progress

830.7000 pH 3.97 @ 25oC (1% w/w in deionized water)

830.7050 UV/Visible Light Absorption Not applicable

830.7100 Viscosit y 18.09 mm2/s (cSt) @ 22oC

830.7200 Melting Point/Range Not applicable, product is a liquid

830.7220 Boiling Point/Range 266.0 ± 12.0oC

830.7300 Density 1.0334 @ 20.7oCOregano Oil ( Origanum vulgar ) Page 12 of 19 Biopesticides Registration Action Document

OPPTS

Guideline No. Property Description of Result

830.7520 Particle Size, Fiber Length and Diameter

Distribution

830.7 550

830.7560

830.7570 Partition Coefficient (n

Octanol/Water) Not applicable, required only for pure active ingredient

830.7840 Water Solubility 0.254 ± 0.013 g/L @ 30oC

830.7950 Vapor Pressure 591, 707, 907. 1100, 1320, and 1630 Pa @ 20, 25, 30, 35, and 40oC, respectively

TABLE 3. Human Toxicology Data Requirements for Refined Oil of Refined Oil of Oregano

Oil (40 CFR § 158.2050)

Study/OPPTS Guideline No. Results Toxicity Category/Description

Acute oral toxicity (rat) (870.1100) LD 50 = 1750 (95% C.L.455.5

- 9230) mg/kg (females using the Up

- and Down Method) III / MRID 46977401

Acute dermal toxicity (rat) (870.1200) LD 50 > 5000 mg/kg for males, females, and for both

sexes combined. IV / MRID 46977402

Acute inhalation toxicity (rat ) (870.1300) LC 50 > 5.5 mg/L (males, females, and both sexes combined; 4 hour nose

- only exposure) IV / MRID 46977406

Primary eye irritation (rabbit) (870.2400) Corneal opacity persisted for 24 to 48 hours after treatment with clearance by 72 hours

. Iritis was noted at 1 and 24 hours after treatment and cleared by the 48

hour observation

. Conjunctival irritation was noted on one rabbit one hour throughout 48 hours after treatment with clearance by 72 hours

. The maximum average

score was 24.0 at 24 hours after test material instillation

. Hydrogenated Catmint Oil was mildly irritating. III / MRID 46977403

Primary dermal irritation (rabbit) (870.2500) No dermal irritation or clinical signs of toxicity were observed during the study

. The primary irritation index

was 0.0. IV / MRID 46977404

Dermal sensitization (mouse) (870.2600) A local lymph node assay (LLNA) indicated that hydrogenated catmint oil is not a dermal sensitizer. --- / MRID 46977405

90

- Day oral toxicity (rat) (870.3100) Min imal to mild degeneration / regeneration of the olfactory epithelium lining the nasal turbinates of males

and females.

NOAEL = 200 mg/kg

LOAEL = 1000 mg/kg MRID 46977407

90

- Day dermal toxicity (rat) (870.3250) No adverse effects were reported.

NOAE L = 1000 mg/kg

LOAEL > 1000 mg/kg MRID 46977415

Mutagenicity (Bateria) (870.5100, 5300 and 5375) Negative

Doses tested: 0 to 5000 μg/plate with or without metabolic activation (S9 mix) MRID 46977410Oregano Oil ( Origanum vulgar ) Page 13 of 19 Biopesticides Registration Action Document

Study/OPPTS Guideline No. Results Toxicity Category/Description

Developmental toxicity (rat) (870.3700) No adv erse effects were reported.

NOAEL = 1000 mg/kg

LOAEL > 1000 mg/kg MRID 46977408

TABLE 4

. Nontarget Organism Toxicity Requirements for Oregano Oil (40 CFR § 158.2060)

Study/OPPTS Guideline No. Results

Avian acute oral toxicity Colinus virginianus (850.2100) Data Waiver Request submitted

Avian dietary toxicity Colinus virginianus (850.2200) Data Waiver Request submitted

Avian dietary toxicity Anas platyrhynchos (850.2200) Data Waiver Request submitted

Aquatic invertebrate acute toxici ty ( Daphnia magna ) (850.1010) Data Waiver Request submitted

Freshwater fish LC50 ( Oncorhynchus mykiss ) (850.1075) Data Waiver Request submitted

Non

- target plant studies (850.4000

- 4800, as applicable) Data Waiver Request submitted

Non

- target i nsect testing (880.4350) Data Waiver Request submitted

Non

- Target Toxicity

Table 5 . Non t arget Organism Assessment

Study Type/OPPTS Guideline LD 50 or LC 50 Results Toxicity Category MRID

Seedling Emergence (Guideline 850.4100)

Vegetative Vigor ( Guideline 850.4150) Information/rationale

submitted to address data requirement Acceptable N/AOregano Oil ( Origanum vulgar ) Page 14 of 19 Biopesticides Registration Action Document



### REFERENCES

48322103 Libman, G. (2010) Physical and Chemical Characteristics of the TGAI: (Moss Buster). Unpublished study prepared by GNL C onsultation Services. 5 p.

48322104 Libman, G. (2010) Physical and Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.

48322101 Libman, G. (2010) Product Chemistry Test Guidelines: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 7 p.

48322101 Libman, G. (2010) Product Chemistry Test Guidelines: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 7 p.

48322104 Libman, G. (2010) Physical an d Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.

48322104 Libman, G. (2010) Physical and Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepare d by GNL Consultation Services. 5 p.

48322101 Libman, G. (2010) Product Chemistry Test Guidelines: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 7 p.

48322104 Libman, G. (2010) Physical and Chemical Properties Information on Ore gano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.

48322104 Libman, G. (2010) Physical and Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.

48 322104 Libman, G. (2010) Physical and Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements:

Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Cons ultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticid e Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.Oregano Oil ( Origanum vulgar ) Page 15 of 19 Biopesticides Registration Action Document

4809390 1 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochem ical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 4 9 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultatio n Services. 49 p.

48363101 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements NonTarget Plants: Moss Buster. Unpublished study prepared by GNL Consultation Services. 8 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

48363101 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements NonTarget Plants: Moss Buster. Unpublished study prepared by GNL Consultation Services. 8 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data R equirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

48363101 Libman , G. (2010) Waiver Request for Biochemical Pesticide Data Requirements NonTarget Plants: Moss Buster. Unpublished study prepared by GNL Consultation Services. 8 p.Oregano Oil ( Origanum vulgar ) Page 16 of 19 Biopesticides Registration Action Document

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements:

Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48363101 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements NonTarget Plants: Moss Buster. Unpublished study prepared by GNL Consultation Services. 8 p.

4 7557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpubl ished Study Prepared by GNL Consultation Services. 49 p.

48363101 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements NonTarget Plants: Moss Buster. Unpublished study prepared by GNL Consultation Services. 8 p.

47557101 Libman, G . (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepa red by GNL Consultation Services. 49 p.

48363101 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements NonTarget Plants: Moss Buster. Unpublished study prepared by GNL Consultation Services. 8 p.

48093901 Libman, G. (2010) Waiver R equest for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consu ltation Services. 36 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.

4755710 1 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.Oregano Oil ( Origanum vulgar ) Page 17 of 19 Biopesticides Registration Action Document

47557101 Libman, G. (2008) Waiver Reque st for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultati on Services. 49 p.

47247401 Lowe, C. (2007) Primary Eye Irritation Study in Rabbits: Moss Buster. Project Number: 22491, P324. Unpublished study prepared by Product Safety Laboratories. 17 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pe sticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Serv ices. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements:

Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements: Moss Busters. Unpublished study prepared by GNL Consultation Services. 36 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements:

Mo ss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Wai ver Request for Biochemical Pesticide Data Requirements:Oregano Oil ( Origanum vulgar ) Page 18 of 19 Biopesticides Registration Action Document

Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL C onsultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesti cide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

4 8093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements:

Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

48351801 Libman, G. (2011) Waiver R equest for Biochemical Pesticide Data Requirements NonTarget Insects: Moss Buster 84316

- R. Unpublished study prepared by GNL Consultation Services. 5 p.

47276801 Libman, G. (2007) Waiver Request for Biochemical Pesticide Data Requirements:

Moss Bust ers. Unpublished study prepared by GNL Consultation Services. 36 p.

47557101 Libman, G. (2008) Waiver Request for Biochemical Pesticide Data Requirements: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.

48093901 Libman, G. (20 10) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.

47247400 Moss Buster LLC (2007) Submission of Toxicity Data in Support of the Application for Registration of Moss Buster. Tra nsmittal of 1 Study.

47276800 Moss Buster LLC (2007) Submission of Toxicity Data in Support of the Application for Registration of Moss Buster. Transmittal of 1 Study.

47557100 Moss Buster, LLC (2008) Submission of Toxicity and Exposure and Risk Data in Support of the Application for Registration of Moss Buster. Transmittal of 1 Study.

48093900 Moss Buster, LLC (2010) Submission of Toxicity Data in Support of the Application for Registration of Moss Buster. Transmittal of 1 Study.

48322100 Moss Buster, LLC (2010) Submission of Product Chemistry Data in Support of theOregano Oil ( Origanum vulgar ) Page 19 of 19 Biopesticides Registration Action Document

Application for Registration of Moss Buster. Transmittal of 3 Studies.

48339200 Moss Buster, LLC (2011) Submission of Product Chemistry Data in Support of the Application for Registration o f Moss Buster. Transmittal of 1 Study.

48339201 Libman, G. (2010) Additional Product Chemistry Data: Moss Buster. Unpublished study prepared by GNL Consultation Services. 9 p.

48351800 Moss Busters LLC (2011) Submission of Toxicity Data in Support of the Application for Registration of Moss Buster. Transmittal of 1 Study.

48363100 Moss Buster, LLC (2011) Submission of Toxicity Data in Support of the Application for Registration of Moss Buster. Transmittal of 1 Study.

48380801 Journal of Apicultural R esearch and Bee World 48(4): 263

- 269 (2009)

. Gashout

Hanan A. and Guzmán

- Novoa Ernesto.