                  BIOPESTICIDES REGISTRATION ACTION DOCUMENT

                                  Oregano Oil
                               (Origanum vulgar)

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

                               February 10, 2011

                               TABLE OF CONTENTS
I.  EXECUTIVE SUMMARY	4
II.  ACTIVE INGREDIENT OVERVIEW	5
III.  REGULATORY BACKGROUND	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.  Environmental Assessment (40 CFR § 158.2060)	8
V.  Risk Management Decision	9
A.  Determination of Eligibility for Registration	9
B.  Regulatory Decision	9
VI.  ENVIRONMENTAL JUSTICE	9
V1I.  ACTIONS REQUIRED BY REGISTRANTS	9
A.  Reporting of Adverse Effects	10
B.  Reporting of Hypersensitivity Incidents	10
Appendix A.  Data Requirements (40 CFR Part 158 -- Subpart U)	11

                BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

                      Office of Pesticide Programs (OPP)
                Biopesticides and Pollution Prevention Division
                         Biochemical Pesticides Branch

                                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 Leader

I.  EXECUTIVE SUMMARY
Oregano Oil is derived from a common species of Origanum, a genus of the mint family (Lamiaceae). Oregano Oil is also considered an antioxidant with properties that assist in 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-purpose oil with uses of which span from cooking to general health.
The Biopesticides and Pollution Prevention Division (BPPD) has determined that the data/information submitted for Tier I Acute Toxicity and Product Chemistry for Oregano Oil adequately satisfy current guideline requirements (refer to 40 CFR Subpart U § 158.2000).  Nontarget toxicology data requirements 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 submitted information demonstrates 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 has determined that Oregano 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, dermal, inhalation and skin irritation.  The Agency has 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 Biopesticides and Pollution Prevention Division (BPPD) has 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).  It has been determined that the data/information submitted adequately satisfy current guideline requirements (please refer to 40 CFR Subpart U § 158.2000).

II.  ACTIVE INGREDIENT OVERVIEW

    Biological Name:  	Oregano Oil (from Origanum vulgar)

 	OPP Chemical Code: 		004300

	Type of Pesticide:				Biochemical Pesticide/Biofungicide

III.  REGULATORY BACKGROUND

   A.  Applications for Pesticide Registration

On August 18, 2007, Gary Libman of GNL Consultation Services (39 Sage Hill Drive, Placitas, New Mexico  87043), acting 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) under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  On February 27, 2008, the Agency announced receipt of this application to register a pesticide product containing a new active ingredient (73 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 proposed for nonfood or feed uses.

IV.  RISK ASSESSMENT

   A.  Product Chemistry Assessment (40 CFR § 158.2030)

All product chemistry data requirements for Oregano Oil have been satisfied.  However, the applicant must submit the results of one year storage stability and corrosion characteristics studies must be submitted for the end use product twelve months postregistration.  These guideline study requirements are OCSPP 830.6317, 830.6320).

   B.  Human Health Assessment (40 CFR § 158.2050)

   1.  Toxicity

All toxicology data requirements for Oregano Oil have been satisfied.  Acceptable Tier I mammalian toxicology data/information support the registration of Oregano Oil.  Furthermore, Tier II and Tier III studies were not required for Oregano Oil based on the lack of acute toxicity in the Tier I studies.

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/pestlabels/.

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 toxicology data requirements for Oregano Oil have been 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 and 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 nonfood use of this 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 not expected to result in significant exposure to human females, e.g., occupational exposure or repeated application of this product to the skin.

      d.  Effects on the Endocrine System

      EPA is required under the Federal Food, Drug, and Cosmetics Act (FFDCA), as amended by the Food Quality Protection Act (FQPA), to develop a screening program to determine whether certain substances (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 recommendations 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 system.  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 of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

      The Agency is not requiring 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 naturally 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 Risk 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 estimates 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, dermal, 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.

      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 has been made that no unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, will result from the use of Oregano Oil when label instructions are followed.

      C.  Environmental Assessment (40 CFR § 158.2060)

      1.  Ecological Hazards

Ecological effects data requirements for Oregano Oil were satisfied by the submission of data waiver requests/data pertaining to effects on nontarget organisms.  Based on the waiver rationale, the Agency concluded that exposure and risk from the proposed use of Oregano Oil is not expected to occur or pose a threat to nontarget organisms.  Nontarget data requirements were waived by the submissions of data waivers for nontarget plants.  Oregano Oil was deemed to be practically nontoxic to honeybees with an LC50 of 331.3 ug/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 and Risk Characterization

Based on the rationales 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 has 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.

V.  Risk Management Decision

	A.  Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is determined that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials 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 not 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 are 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 eligible for registration for the labeled uses.

      B.  Regulatory Decision

The data submitted fulfill the requirements of registration for use of Oregano Oil for use as a biochemical fungicide.

      Conditional/Unconditional Registration

All data requirements are fulfilled and EPA has 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 origin, 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.  Please comment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general population.

V1I.  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, additional data may be required.

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 registration for a pesticide product.  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 submitted to the Agency under the provisions of Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act.

      B.  Reporting of Hypersensitivity Incidents

All incidents of hypersensitivity (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
Product 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
Submitted 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
Stable 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 decreases 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 applicable, 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
Viscosity
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 @ 20.7ºC
830.7520
Particle Size, Fiber Length and Diameter Distribution

830.7550
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)
LD50 = 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)
LD50 > 5000 mg/kg for males, females, and for both sexes combined.
IV / MRID 46977402
Acute inhalation toxicity (rat)
(870.1300)
LC50 > 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)
Minimal 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.
NOAEL = 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 46977410
Developmental toxicity (rat)
(870.3700)
No adverse 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 toxicity
(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 insect testing
(880.4350)
Data Waiver Request submitted

Non-Target Toxicity

Table 5.  Nontarget Organism Assessment

                          Study Type/OPPTS Guideline

                             LD50 or LC50 Results

                               Toxicity Category
                                     MRID
Seedling Emergence (Guideline 850.4100)

Vegetative Vigor (Guideline 850.4150)

          Information/rationale submitted to address data requirement
                                  Acceptable
                                      N/A

IX. Appendix C.
REFERENCES

48322103
Libman, G. (2010) Physical and Chemical Characteristics of the TGAI: (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.
48322101
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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 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 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.
48322104
Libman, G. (2010) Physical and Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.
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Libman, G. (2010) Physical and Chemical Properties Information on Oregano Oil: (Moss Buster). Unpublished study prepared by GNL Consultation Services. 5 p.
47557101
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48093901
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47557101
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48093901
Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.
47557101
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48093901
Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.
47557101
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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.
47557101
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48093901
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48093901
Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.
48363101
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47557101
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48093901
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48363101
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47557101
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48093901
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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.

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
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48093901
Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.
48363101
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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.
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.
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.

47247401
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47276801
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47557101
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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: Moss Buster. Unpublished study prepared by GNL Consultation Services. 44 p.
48093901
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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.

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.

48351801
Libman, G. (2011) Waiver Request 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 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.
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Libman, G. (2010) Waiver Request for Biochemical Pesticide Data Requirements. Unpublished Study Prepared by GNL Consultation Services. 49 p.
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Moss Buster, LLC (2010) Submission of Product Chemistry Data in Support of the Application for Registration of Moss Buster. Transmittal of 3 Studies.
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Moss Buster, LLC (2011) Submission of Product Chemistry Data in Support of the Application for Registration of Moss Buster. Transmittal of 1 Study.
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48380801  Journal of Apicultural Research and Bee World 48(4): 263-269 (2009). Gashout
                  Hanan A. and Guzmán-Novoa Ernesto.


HUMAN HEALTH RISK ASSESSMENT (HHRA) SUBCOMMITTEE

DRAFT AGENDA

October 31, 2007

11:00 pm – 1:30 pm Eastern Time

Participation by Teleconference Only

11:00-11:10 a.m.	Welcome

	-  Roll Call	Dr. George Daston,

	- Overview of Agenda	Subcommittee Chair

	- Summary of Ongoing Activities

11:10-11:15 a.m.	Administrative Procedures	Ms. Joanna Foellmer,

		Subcommittee DFO

11:15-11:25 a.m. 	Overview of Documentation	Dr. John Vandenberg,

Office of Research and Development (ORD)

11:25-12:55 p.m.	HHRA Research Program:	Dr. Peter Preuss, Director

	- Overview LTG 1	National Center for

	      Key Accomplishments	Environmental Assessment/

	- Overview LTG 2	ORD

	      Key Accomplishments

- Overview LTG 3

      Key Accomplishments

	Program Performance:	Dr. Peter Preuss, Director

	- Use by EPA Programs	National Center for

 	- Milestones	Environmental Assessment/

		ORD

12:55-1:00 p.m.	Public Comment

1:00-1:30 p.m. 	Preparation for Face-to-Face Meeting	Dr. George Daston,

	-  Discuss Poster Review Process	Subcommittee Chair

-  Discuss Draft Report Outline

	-  Charge Questions

	-  Discuss Background Information and

	Additional Requests

1:30 p.m.	Adjourn

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development