BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Tagetes Oil PC Code : 176602

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

February 21, 2012
Tagetes Oil

Page 2 of 22

Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY:................................................................................................. 5

II. ACTIVE INGREDIENT OVERVIEW.............................................................................. 7

III. REGULATORY BACKGROUND.................................................................................... 7

A. Classification ........................................................................................................................ 7

B. Food Clearances/Tolerances............................................................................................... 7

IV. RISK ASSESSMENT ......................................................................................................... 8

A. Active Ingredient Characterization.................................................................................... 8

B. Human Health Assessment.................................................................................................. 8

1. Toxicology ......................................................................................................................................................8

2. Dose Response Assessment .........................................................................................................................11

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization ......................11

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation...........................12

6. Cumulative Effects......................................................................................................................................12

7. Risk Characterization .................................................................................................................................12

C. ENVIRONMENTAL ASSESSMENT.............................................................................. 12

1. Ecological Hazards......................................................................................................................................12

2. Environmental Fate and Ground Water Data..........................................................................................13

3. Ecological Exposure and Risk Characterization ......................................................................................13

4. Endangered Species Assesment..................................................................................................................13

D. EFFICACY DATA............................................................................................................ 13

V. RISK MANAGEMENT DECISION................................................................................. 14

A. Determination of Eligibility for Registration .................................................................. 14

B. Regulatory Decision........................................................................................................... 14

VI. ACTIONS REQUIRED BY REGISTRANTS................................................................. 15

A. Reporting of Adverse Effects............................................................................................ 15

B. Reporting of Hypersensitivity Incidents.......................................................................... 15

VII. APPENDIX A. Data Requirements (40 CFR Part 158) ................................................. 15

VIII. APPENDIX B. Product Specific Information................................................................. 19
Tagetes Oil

Page 3 of 22

Biopesticides Registration Action Document

IX. APPENDIX C. References. ................................................................................................ 19
Tagetes Oil

Page 4 of 22

Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief

Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms

Angela L. Gonzales, Biologist

Regulatory Action Leader

Colin G. Walsh, M.S., Biologist
Tagetes Oil

Page 5 of 22

Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY:

Tagetes oil is a new biochemical pesticide active ingredient intended for use as an 

insecticide/acaricide for the control of mites, whiteflies, aphids, thrips, mealybugs, scales, and 

pyslla on a variety of food crops. The active ingredient is extracted from the flowering herb, 

Tagetes minuta (Muster John Henry or Mexican Marigold). The major constituents of the 

identified components of tagetes oil are terpenes, which are found in a variety of essential oils. 

Tagetes oil, as Tagetes patula L., T. erecta L., or T. minuta L. (T. glandulifera Schrank), is 

approved by the U.S. Food and Drug Administration (FDA) for use in food as a natural flavoring 

substance and natural adjuvant (in the oil form only) under 21 CFR 172.510. Tagetes oil is also 

used in some cosmetics including shampoos, soaps and lotions (EWG, 2010). 

The Biopesticides and Pollution Prevention Division (BPPD) determined that the 

data/information submitted for product chemistry and Tier I acute toxicity for tagetes oil satisfy 

the current guideline requirements. Acceptable scientific rationales were submitted for the 

subchronic [90-day oral (OCSPP 870.3100) and 90-day inhalation (OCSPP 870.3465)], 

developmental (OCSPP 870.3700), and mutagenicity data requirements [in vitro mammalian cell 

assay (OCSPP 870.5300 and 5375)] in lieu of data. BPPD determined that the rationales

submitted were acceptable based on tagetes oil’s toxicological and exposure profiles. Significant 

exposure to humans is not anticipated for tagetes oil based on low application rates, appropriate 

Personal Protective Equipment (PPE) requirements on the product label, and rapid degradation in 

the environment. BPPD granted a waiver from conducting a 90-day dermal study (OCSPP 

870.3250) based on the rapid volatilization of the active ingredient and because prolonged 

dermal exposure is not expected (the product is not purposely applied to the skin and 

handlers/applicators are required to wear appropriate PPE). BPPD received data for the 

mutagencity data requirement [Ames test (OCSPP 870.5100)], which indicated that tagetes oil 

was not mutagenic with or without metabolic activation. Although the data requirements were 

satisfied for the new active ingredient, tagetes oil, BPPD notes that should future intended enduse product (EP) applications result in different anticipated exposures to humans, these data 

requirements may need to be readdressed.

For nontarget organisms and environmental fate data requirements (OCSPP 850.1010 to 

850.4450), the applicant either submitted acceptable data/information for the EPs or the data 

were waived because the guideline study was not applicable. BPPD granted a request to bridge 

the data from the EPs to the active ingredient, tagetes oil, because the applicant indicated that the 

active ingredients in the EPs act synergistically; thus, the combination of these chemicals is more 

potent as an insecticide than each active ingredient alone. Therefore, the toxicological profile of 

the EPs is more relevant to the risk assessment than the toxicological profile of tagetes oil alone. 

Based on the nontarget organism data from the EPs, which indicated that the EPs were

practically nontoxic, and the screening level risk assessment, the Agency determined that 

registered use of tagetes oil in the EPs should not result in adverse effects to birds, fish, aquatic 

invertebrates, plants, or nontarget insects.

Based on the acute toxicity data for tagetes oil, the active ingredient is toxicity category III. EPA 

has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil 

organisms. EPA has no concerns for any nontarget organisms exposed to tagetes oil when used 
Tagetes Oil

Page 6 of 22

Biopesticides Registration Action Document

in accordance with approved label directions. Given that tagetes oil has very low toxicity and 

presents little, if any, risk to nontarget organisms, EPA has concluded that it is in the best 

interests of the public to issue the registration for the EPs, Bug Oil Food Use (EPA File Symbol

No. 85937-E) and Bug Oil Ornamental (EPA File Symbol No. 85937-R), which contain this new 

active ingredient, tagetes oil.

BPPD has reviewed the 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). 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this

policy, EPA provides a public comment period prior to making a registration decision for the 

following types of applications: new active ingredients, first food use, first outdoor use, first

residential use; 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, tagetes oil is subject 

to a 30 day comment period as a “new active ingredient”. The notice for this comment period 

includes the draft Biopesticides Registration Action Document (BRAD) and draft product labels

for the EPs, Bug Oil Food Use and Bug Oil Food Ornamental, which contain this new active 

ingredient, tagetes oil. The docket identification (ID) number is EPA-HQ-OPP-2009-0822. The 

Agency believes that based on the risk assessment and information submitted in support of the 

registration of the EPs containing tagetes oil, it is in the best interests of the public to issue the 

registration for Bug Oil Food Use and Bug Oil Food Ornamental. The basis for this decision can 

be found in the risk assessment for tagetes oil, which is characterized in this BRAD. 
Tagetes Oil

Page 7 of 22

Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Common Name: Tagetes Oil

 Chemical Names: N/A

Trade & Other Names: Marigold Oil

 CAS Registry Number: 8016-84-0

OPP Chemical Code: 176602

Type of Pesticide: Biochemical Pesticide (Insecticide/Acaricide) 

III. REGULATORY BACKGROUND

On September 18, 2009, EPA received an application filed by Exponent, 1150 Connecticut 

Avenue, NW, Suite 1100, Washington, DC 20036, on behalf of Plant Impact plc, 12 South 

Preston Office Village, Cuerden Way, Bamber Bridge, Preston, PR5 6BL, United Kingdom, to 

register the products, Bug Oil Food Use (EPA File Symbol No. 85937-E) and Bug Oil 

Ornamental (EPA File Symbol No. 85937-R) containing the new biochemical active ingredient, 

tagetes oil, and the currently registered active ingredients, canola oil, thyme oil, and wintergreen 

oil. A notice of receipt (NOR) of this application, allowing for a 30-day comment period, was 

published in the Federal Register on December 16, 2009 (74 FR 66639). No comments were 

received following this publication.

A. Classification

On July 6, 2006, the biochemical classification committee determined that tagetes oil is marigold 

oil, which was previously classified as a biochemical in 1997 due to its nontoxic mode of action, 

natural occurrence in the environment, and history of exposure to humans and the environment 

demonstrating minimal toxicity. Tagetes oil is derived from Tagetes spp. (marigolds), 

specifically, African marigold (Tagetes erecta) and Aztec marigold (Tagetes minuta). The mode 

of action is repellency by tagetes oil alone and suffocation by tagetes oil in conjunction with the 

other actives in the proposed EPs, canola oil, thyme oil, and wintergreen oil.

B. Food Clearances/Tolerances 

The applicant filed a petition (PP 9F7619) proposing to establish an exemption from the 

requirement of a tolerance for residues of tagetes oil in or on all food commodities. A notice of 

filing (NOF), allowing for a 30-day comment period, was published in the Federal Register on 

December 16, 2009 (74 FR 66644). No comments were received following this publication. EPA 

determined during the review of the petition that the active ingredient, tagetes oil, is an edible oil 

and is exempt from the requirement of a tolerance as a minimal risk active ingredient under 40 
Tagetes Oil

Page 8 of 22

Biopesticides Registration Action Document

CFR 180.950(c). The petition (PP 9F7619) filed by the applicant is no longer applicable to this 

new active ingredient, tagetes oil.

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

Tagetes Oil is a new biochemical pesticide active ingredient intended for use as an 

insecticide/acaricide for the control of mites, whiteflies, aphids, thrips, mealybugs, scales, and 

pyslla on a variety of food crops. The active ingredient is extracted from the flowering herb, 

Tagetes minuta (Muster John Henry or Mexican Marigold). There are many species within the 

Tagetes genus. The herb is non-native to the United States, but is found in California, Hawaii, 

and in most of the states on the east coast (USDA Plants Database, 2010). It has a widespread 

geographic distribution, but is prevalent in subtropical and tropical climates. The major 

constituents of the identified components of tagetes oil are terpenes, which are found in a variety 

of essential oils. 

Tagetes oil, as Tagetes patula L., T. erecta L., or T. minuta L. (T. glandulifera Schrank) is 

approved by the U.S. Food and Drug Administration (FDA) for use in food as a natural flavoring 

substance and natural adjuvant (in the oil form only) under 21 CFR 172.510. Reported uses of 

tagetes oil as a food additive are in alcoholic beverages, nonalcoholic beverages, baked goods, 

chewing gum, condiments (e.g., relishes), frozen dairy, gelatins (e.g., puddings), hard candy, and 

soft candy (Burdock, 2005). Tagetes oil is also used in some cosmetics including shampoos, 

soaps and lotions (EWG, 2010). 

Descriptions of the product formulation and production process, formation of impurities, and 

physical and chemical characteristics were examined by BPPD and found to be acceptable in 

meeting current guideline standards.

All product chemistry data requirements for registration of tagetes oil have been satisfied. 

For more information regarding product chemistry data requirements, refer to Tables 1 and 2 in 

Appendix A. 

B. Human Health Assessment

1. Toxicology

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. 

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

oil. All toxicology data requirements for tagetes oil have been satisfied.
Tagetes Oil

Page 9 of 22

Biopesticides Registration Action Document

a. Acute Toxicity

Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the 

dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes, and 3) 

determine the potential for skin sensitization (allergic contact dermatitis). 

Tier I acute toxicity studies submitted and reviewed showed that tagetes oil is a toxicity category 

III (slightly toxic) compound via acute dermal route of exposure, based on testing at a limit dose 

of 2000 mg a.i./kg in rats, and is moderately irritating to the skin based on the results of a 

primary dermal irritation study in rabbits. Tagetes oil falls in Toxicity Category IV (not toxic) for 

acute oral toxicity, acute inhalation toxicity, and primary eye irritation. Tagetes oil is minimally 

irritating in the eye and is not a dermal sensitizer. 

For more information regarding acute toxicity data requirements, refer to Table 3 in Appendix A. 

b. Subchronic Toxicity 

Subchronic data are required to determine a no-observed-effect-level (NOEL) and any toxic 

effects associated with repeated or continuous exposure to a test substance for a period of ninety 

days. 

Rationale was submitted for the subchronic [90-day oral (OCSPP 870.3100) and 90-day 

inhalation (OCSPP 870.3465)] in lieu of data. BPPD determined that the rationale submitted was 

acceptable based on the EPs toxicological and exposure profile, summarized below.

i. Tagetes oil is an edible oil and is exempt from the requirement of a tolerance as a 

minimal risk active ingredient under 40 CFR 180.950(c).

ii. Tagetes oil is an edible oil and is already consumed in the human diet as it is used as a 

food additive and FDA has approved the use of the oil (in oil form only) with no 

limitations as a food additive under 21 CFR 172.510. 

iii. Significant exposure to humans is not anticipated based on low application rates and 

rapid degradation in the environment.

iv. Significant repeat exposure of tagetes oil to humans as a gas, vapor, or aerosol is not 

anticipated based on the use pattern.

A waiver requested for the subchronic [90-day dermal (OCSPP 870.3250)] was granted by 

BPPD, based on the EPs toxicological and exposure profile, summarized below.

i. Prolonged dermal exposure is not expected because the product is not purposely applied 

to the skin and handlers/applicators are required to wear appropriate PPE.

ii. Tagetes oil is expected to volatilize rapidly after application.

For more information regarding the subchronic data requirements, refer to Table 3 in Appendix 

A. 
Tagetes Oil

Page 10 of 22

Biopesticides Registration Action Document

 c. Developmental Toxicity and Mutagenicity

A rationale for lack of toxicity was submitted for the developmental toxicity data requirement 

(OCSPP 870.3700) in lieu of data. BPPD determined that the rationale submitted was acceptable 

based on the EPs toxicological and exposure profile, summarized below.

i. Tagetes oil is an edible oil and is exempt from the requirement of a tolerance as a 

minimal risk active ingredient under 40 CFR 180.950(c).

ii. Tagetes oil is an edible oil and is already consumed in the human diet as it is used as a 

food additive and FDA has approved the use of the oil (in oil form only) with no 

limitations as a food additive under 21 CFR 172.510. 

iii. Significant exposure to female humans is not anticipated based on low application rates, 

appropriate PPE requirements on the label, and rapid degradation in the environment. 

The tier I mutagenicity study [Ames test (OCSPP 870.5100)] submitted and reviewed showed 

that tagetes oil concentrations of up to 5,000 ug/plate were not mutagenic with or without 

metabolic activation. Rationale was submitted for the Tier I mutagenicity data requirement [in 

vitro mammalian cell assay (OCSPP 870.5300 and 5375)] in lieu of data. BPPD determined that 

the rationale submitted was acceptable based on the EPs toxicological and exposure profile, 

summarized below.

i. Tagetes oil is an edible oil and is exempt from the requirement of a tolerance as a 

minimal risk active ingredient under 40 CFR 180.950(c).

ii. Tagetes oil is an edible oil and is already consumed in the human diet as it is used as a 

food additive and FDA has approved the use of the oil (in oil form only) with no 

limitations as a food additive under 21 CFR 172.510. 

iii. Significant exposure to humans is not anticipated based on low application rates, 

appropriate PPE requirements on the label, and rapid degradation in the environment. 

For more information regarding developmental and mutagenicity data requirements, refer to 

Table 3 in Appendix A. 

d. Tier II/Tier III 

The data requirements were not required due to the nature of the active ingredient and its 

intended uses in potential new EP products (insecticides and acaricides).

e. Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

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

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

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

Page 11 of 22

Biopesticides Registration Action Document

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

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

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

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

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

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

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

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

group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

Tagetes oil is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA section 408(p) the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all 

pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

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

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

2. Dose Response Assessment

Because no toxicological endpoints were identified for this active ingredient, a dose response 

assessment was not required. 

3. Drinking Water Exposure and Risk Characterization

No significant exposure via drinking water is expected when tagetes oil is used according to the 

product label directions. The active ingredient biodegrades rapidly in the environment (59% 

volatilization in 48 hours), is applied at low application rates and is not directly applied to water; 

therefore, residues of tagetes oil are unlikely to accumulate in drinking water. In the unlikely 

event that exposure via drinking water does occur, the health risk would be expected to be 

minimal based on the low acute oral toxicity of tagetes oil and the fact that tagetes oil is an 

edible oil and is exempt from the requirement of a tolerance as a minimal risk active ingredient 

under 40 CFR 180.950(c).

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

a. Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for tagetes oil, and is not required. 

Appropriate PPE requirements on the label will mitigate any potential exposure to applicators 

and/or handlers. Additionally, no relevant toxicological endpoints have been identified. Based on 
Tagetes Oil

Page 12 of 22

Biopesticides Registration Action Document

the data and information available to the Agency, anticipated exposure is not likely to result in 

unreasonable risk to humans. 

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

Exposure to tagetes oil will be minimal in residential, school, and day care areas, as the product 

containing this active ingredient is intended for use on horticultural and agricultural crops. 

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

There is reasonable certainty that no harm to the U.S. population will result from aggregate 

exposure to tagetes oil. This includes all exposures for which there is reliable information. The 

Agency arrived at this conclusion based on the lack of toxicity of this active ingredient and the 

already widespread exposure without any reported adverse effects on human health. The risks 

from aggregate exposure via oral, dermal and inhalation exposure are a compilation of three lowrisk exposure scenarios and are negligible.

6. Cumulative Effects

Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information 

concerning the cumulative effects of tagetes oil residues and other substances that have a 

common mechanism of toxicity. No toxicological endpoints have been established for exposure 

to tagetes oil; therefore, cumulative effects with other substances that share a common 

mechanism of toxicity are not expected. 

7. Risk Characterization

The Agency considered human exposure to tagetes 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 

tagetes oil when label instructions are followed. 

C. ENVIRONMENTAL ASSESSMENT

1. Ecological Hazards

Adequate nontarget toxicology data/information is available to support registration of tagetes oil

with the submission of nontarget toxicology data on the EPs. All nontarget toxicology data 

requirements for tagetes oil have been satisfied.

The EPs are practically nontoxic to birds, fish and aquatic invertebrates and is not phytotoxic. 

The EPs are practically nontoxic via exposure through contact to nontarget insects.

For more information regarding nontarget organism toxicity data requirements, refer to Table 4

in Appendix A. 
Tagetes Oil

Page 13 of 22

Biopesticides Registration Action Document

2. Environmental Fate and Ground Water Data 

Environmental fate and groundwater data are not required at this time because the results of the 

nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II 

data requirements. 

3. Ecological Exposure and Risk Characterization

Toxicity studies have not been submitted for tagetes oil. A lack of toxicity rationale and data on 

the proposed EPs have been submitted to fulfill these data requirements. According to the 

applicant, the active ingredients act synergistically; thus, the combination of these chemicals is 

more potent as an insecticide than each ingredient alone. Therefore, the toxicological profile of 

the EPs are germane to the risk assessment rather than the toxicological profile of tagetes oil 

alone. For registration of the proposed EPs, the Agency has bridged the nontarget organism 

toxicology data from the EPs to the active ingredient, tagetes oil. The product is a contact 

insecticide that operates through a physical mode of action. The product is practically nontoxic 

to birds, fish and aquatic invertebrates and is not phytotoxic; toxic endpoints have not been 

identified for these species. The product is practically nontoxic via exposure through contact to 

nontarget insects. Based on the data submitted, the Agency has indicated in its review that the 

product may be moderately toxic via oral exposure to nontarget insects; however, no mortality 

was observed at the highest dose tested in the study. Additionally, significant oral exposure is 

not anticipated as the product is a contact insecticide and is expected to degrade rapidly in the 

environment. Toxic endpoints have not been identified for nontarget insects via the oral or 

contact route of exposure. The results of the submitted studies and screening-level risk 

assessment indicate that use of the product according to label instructions should not result in 

adverse effects to birds, fish, aquatic invertebrates, plants or nontarget insects. 

4. Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete endangered species 

determination. The ecological risk assessment planned during registration review will allow the 

Agency to determine whether tagetes oil’s use has “no effect” or “may effect” federally listed 

threatened or endangered species (listed species) or their designated critical habitats. When an 

assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical 

habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine 

Fisheries Services (the Services) as appropriate. 

D. EFFICACY DATA 

Product performance data must be developed for all pesticides to ensure that pesticide products 

will perform as intended and that unnecessary pesticide exposure to the environment will not 

occur as a result of the use of ineffective products. The Agency reserves the right to require on a 

case-by- case basis, submission of efficacy data for any pesticide product registered or proposed 

for registration that are intended to be used to control a pest of significance public health 

importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For 

further guidance on product performance requirement, refer to Pesticide Registration Notice (PR) 
Tagetes Oil

Page 14 of 22

Biopesticides Registration Action Document

Notices 96-7, 2002-1 and Explanation of Statutory Framework for Risk-Benefit Balancing for 

Public Health Pesticides (http://www.epa.gov/PR _Notices/pr1996-7.pdf) 

(http://www.ea.gov/PR_Notices/pr2002-1.pdf) and (http://www.epa.gov/pesticides/health/riskbenefit.htm).

The EPs submitted with this new active ingredient did not list pests of significance public health 

importance or a public health pest as defined in FIFRA section 28(d) and section 2(nn). 

Therefore, product performance (efficacy) was not evaluated. 

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 warrants proposed claims; (B) its labeling and other 

materials 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 the technical grade active ingredient, 

tagetes oil. Such products are not expected to cause unreasonable adverse effects. Therefore, 

tagetes oil as a technical grade active ingredient is eligible for registration for the labeled uses. 

B. Regulatory Decision

The data submitted fulfill the registration requirements of tagetes oil for use as an insecticide and 

acaricide. Refer to Appendix B for product-specific information.

Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA determined that an unconditional registration of 

tagetes oil is appropriate.

C. 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—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. At this time, 

EPA does not believe that use of tagetes oil pesticide products will cause harm or a 

disproportionate impact on at-risk communities. For additional information regarding 

environmental justice issues, please visit EPA’s website at

http://www.epa.gov/compliance/environmentaljustice/index.html.
Tagetes Oil

Page 15 of 22

Biopesticides Registration Action Document

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the tagetes oil pesticide 

products and determined that these data are sufficient to satisfy current registration data 

requirements. At this time, no additional data must be submitted to EPA for these particular 

products. For new uses and/or changes to existing uses, EPA may require additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA 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 

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment 

must be submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Additionally, 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).

VII. Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are 

representative of supporting data/information 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 Tagetes Oil (40 CFR § 158.2030)

OPPTS Guideline No. Study Results MRID

830.1550

to

830.1670

Product identity;

Manufacturing process;

Discussion of formation of 

unintentional ingredients

Acceptable; Confidential Business 

Information (CBI) 47868201

830.1700 Analysis of samples Acceptable; CBI

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

acceptable. 47868201

830.1800 Analytical method Acceptable; CBI
Tagetes Oil

Page 16 of 22

Biopesticides Registration Action Document

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

OPPTS Guideline No. Property Description of Result MRID

830.6302 Color Yellow to orange 47868202

830.6303 Physical State Liquid 47868202

830.6304 Odor Bright, diffusive, fruity-floral 47868202

830.6313

Stability to Normal and Elevated

Temperatures, Metals and Metal

Ions

Stable under normal and elevated 

temperatures for 14 days. No evidence of 

instability under contact with metals and 

metal ions for 14 days at ambient and 

elevated temperatures. Some color and 

physical state changes to the metal ions 

were observed during the study.

48649812

830.6315 Flammability Flashpoint = 63°C

43°C

47868203

47868202

830.6317 Storage Stability Not required for TGAI.

830.6319 Miscibility Not applicable, the product is not to be 

mixed with petroleum solvents.

830.6320 Corrosion Characteristics Not required for TGAI.

830.7000 pH 3.79 (neat oil)

4.43 (1% dilution) 47868203

830.7050 UV/Visible light absorption

UV profiles are similar under all pH 

conditions. No significant molar 

absorbance (ε) at the wavelength range of 

290-750 nm.

Neutral pH:

ε = 44.52, 45.98 at wavelength 237 nm

Basic pH:

ε = 40.13, 44.80 at wavelength 237 nm

Acidic pH:

ε = 45.38, 47.81 at wavelength 237 nm

48649806

830.7100 Viscosity 1.5-4.05 mPa at shear rates of 5-200 rpm 

at 20°C 47868202

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

830.7220 Boiling Point/Range 190°C 47868202

830.7300 Density Specific gravity = 0.870 at 20°C 47868202

830.7370 Dissociation Constant in Water Does not dissociate in water. 47730401

47730409

830.7550

830.7560

830.7570

Partition Coefficient

(n-Octanol/Water)

Values estimated using KOWWIN version 

1.68 (US EPA) were submitted for the 

major components of tagetes oil, as the oil 

itself is not amenable to testing.

Limonene: Log Kow = 4.83

Ocimene: Log Kow = 4.80

Dihydrotagetone Log Kow = 2.92

Linalool Log Kow = 3.38

48649802

830.7840 Water Solubility Insoluble 47868202

830.7950 Vapor Pressure

Approximately 59% volatilization 

(measured via weight loss) in 48 hours in 

laboratory study. 48329208
Tagetes Oil

Page 17 of 22

Biopesticides Registration Action Document

Table 3. Mammalian Toxicology Data Requirements for Tagetes Oil (40 CFR § 158.2050)

Study/OPPTS Guideline No. Results Toxicity 

Category/Description

MRID

Acute oral toxicity (rat)

(870.1100)

LD50 >5,000 mg/kg (females) IV 47868213

Acute dermal toxicity (rats)

(870.1200)

LD50 >2000 mg/kg for males, females, and for 

both sexes combined

III 47868214

Acute inhalation toxicity 

(870.1300)

LC50 > 5.20 mg/L IV 48329203

Primary eye irritation 

(870.2400)

Minimally irritating: positive conjunctival 

irritation and moderate reddening of sclerae 

were noted on 3/3 rabbits one hour postinstillation with clearance by 24 hours.

IV 47868215

Primary dermal irritation (rabbit)

(870.2500)

Moderately irritating: well defined erythema 

on 3/3 rabbits one hour after patch removal 

with clearance on one rabbit by day 7, with 

reduction to very slight erythema on the 

second rabbit by 72 hours and clearance by 

day 7, and with reduction to very slight 

erythema on the third rabbit by day 7 and 

clearance by day 10. Very slight edema on 3/3 

rabbits one hour after patch removal with 

clearance by 24 hours. Scaling on all rabbits 

on day 7 with clearance on two rabbits by day 

14 and persistence on one rabbit through day 

14. 

III 47868216

Dermal sensitization (guinea pig)

(870.2600)

Not a sensitizer. No positive signs of 

reactivity at 24 and 48 hours after challenge in 

test and naïve control animals after three 

consecutive weekly inductions. 

47868217

90-Day oral toxicity 

(870.3100)

Rationale was provided in lieu of a 90-day 

oral study. Tagetes oil is exempt from the 

requirement of a tolerance as a minimal risk 

active ingredient under 40 CFR 158.950(c).

Significant exposure is not expected based on 

low application rates and rapid degradation in 

the environment. Tagetes oil is an edible oil 

and is already consumed in the human diet as 

it is used as a food additive in alcoholic 

beverages, baked goods, condiments, frozen 

dairy, gelatins, puddings, candy, and 

nonalcoholic beverages. 

48339002

90-Day dermal toxicity

(870.3250)

Waived: prolonged dermal exposure not 

anticipated based on use pattern, volatility 

(anticipated volatility-vapor pressure data 

must be submitted) of active ingredient and 

appropriate PPE requirements on label.

90-Day inhalation toxicity

(870.3465)

Rationale was provided in lieu of a 90-day 

inhalation study. Significant repeat exposure 

to humans to tagetes oil as a gas, vapor or 

aerosol is not anticipated based in the use 

pattern. Additionally, significant exposure is 

not expected based on low application rates 

and rapid degradation in the environment. 

48339002
Tagetes Oil

Page 18 of 22

Biopesticides Registration Action Document

Table 3. Mammalian Toxicology Data Requirements for Tagetes Oil (40 CFR § 158.2050)

Study/OPPTS Guideline No. Results Toxicity 

Category/Description

MRID

Mutagenicity (Ames)

(870.5100, 5300 and 5375)

Not mutagenic with or without metabolic 

activation in Salmonella typhimurium strains 

TA 98, TA 1537, TA 100, TA 1535 and 

Escherichia coli strain Wp2uvrA. 

Rationale was provided in lieu of an in vitro

mammalian cell assay. Significant exposure 

to humans is not anticipated based on low 

application rates, appropriate PPE 

requirements on the label, and rapid 

degradation in the environment. Additionally, 

humans are already exposed to tagetes oil in 

the diet, as it is an edible oil and is used as a 

food additive in alcoholic beverages, baked 

goods, condiments, frozen dairy, gelatins, 

puddings, candy, and nonalcoholic beverages. 

48329205

Developmental toxicity

(870.3700)

Rationale was provided in lieu of a 

developmental study. Significant exposure to 

female humans is not anticipated based on 

low application rates, appropriate PPE 

requirements on the label, and rapid 

degradation in the environment. Humans are 

also already exposed to tagetes oil, as it is an 

edible oil and is used as a food additive in 

alcoholic beverages, baked goods, 

condiments, frozen dairy, gelatins, puddings, 

candy, and nonalcoholic beverages. 

48339002

Table 4: Nontarget Organism Toxicity Data Requirements for Bug Oil Food Use (40 CFR § 158.2060)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Avian acute oral toxicity

Colinus virginianus (850.2100)

LD50 > 10,000mg/kg

NOEL = 10,000 mg/kg

Practically non-toxic1 47868219

Avian dietary toxicity

Colinus virginianus

(850.2200)

NOEL = 12,945 mg/kg bw-day (50,000

ppm)

Practically non-toxic1 47868220

Aquatic invertebrate acute toxicity

Daphnia magna

(850.1010)

EC50 > 1000 mg/L Practically non-toxic1 47868223

Freshwater fish LC50

Oncorhynchus mykiss (850.1075)

LC50 > 1000 mg/L Practically non-toxic1 47868222

Non-target plant studies

(850.4000-4800, as applicable)

Adequate information to support data 

requirement: non-phytotoxic to a variety of 

ornamental and edible plants including 

tomato, chrysanthemum, lemon, zucchini, 

lantana, pansy and impatiens in efficacy trials.

Not phytotoxic1 47868237

Non-target insect testing

(880.4350)

Apis millifera (honeybee): oral LD50 > 9.4 μg 

a.i./bee.

Apis millifera (honeybee): contact LD50 >

12.01 μg a.i./bee.

Coccinella septempunctata (ladybird beetle): 

mortality: 12.5% and 20.0% at 2 L/ha and 4 

Moderately toxic to 

honeybees1

47868224

47868225

47868226
Tagetes Oil

Page 19 of 22

Biopesticides Registration Action Document

Table 4: Nontarget Organism Toxicity Data Requirements for Bug Oil Food Use (40 CFR § 158.2060)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

L/ha, respectively; reproduction: decrease in 

viable eggs/female/day at 2 L/ha and increase 

in viable eggs/female/day at 4 L/ha. 

Aphidus rhopalosipi (parasitic wasp): 

mortality: 80.0% and 95.0% at 2 L/ha and 4 

L/ha, respectively at 48-hours. 

Aphidus rhopalosipi (parasitic wasp): 48-hour 

LR50 > 64 L/ha, NOER ≥ 64 L/ha (mortality 

and reproduction), LOER > 64 L/ha (mortality 

and reproduction ).

Typhlodromus pyri (parasitic mite): 

mortality: 98.0% and 99.0% at 2 L/ha and 4 

L/ha, respectively after 7 days. 

Typhlodromus pyri (parasitic mite): 7-day 

LR50 > 64 L/ha, NOER = 32 L/ha (mortality), 

LOER = 64 L/ha (mortality), NOER > 4 L/ha 

(reproduction), LOER = 4 L/ha 

(reproduction).

47828227

47868228

47868229

47868230

Algal Toxicity

(850.5400)

Pseudokirchneriella subcapitata: 96-hour 

EbC50 (biomass), ErC50 (growth rate), and 

EyC50 (yield) > 1000 mg/L, NOEC = 1000 

mg/L

47868231

1 Studies were conducted using the proposed EP. Request to bridge data from EP to tagetes oil is acceptable. 2 Studies were conducted at application rates well below the recommended application rates on 

the proposed EP label (maximum rate on label = 41 L/ha). 

VIII. Appendix B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX.Appendix C.

REFERENCES

Burdock, GA. (2005). Fenaroli’s handbook of flavor ingredients; adapted from the Italian 

language works of Giovanni Fenaroli, 5th edition. Boca Raton, Fl: CRC Press.

Environmental Working Group (EWG) Database. 2010. Products Containing Tagetes

Oil. http://www.cosmeticsdatabase.com.

USDA Plants Database. 2010. Tagetes minuta. U.S. Department of Agriculture Natural 

Resources Conservation Service. http://plants.usda.gov/java/profile?symbol=TAMI3 June 29, 

2010.
Tagetes Oil

Page 20 of 22

Biopesticides Registration Action Document

 

REVIEWS AND OTHER REFERENCES

U.S. EPA. 2010. Memorandum from Angela L. Gonzales to Colin G. Walsh. Science Review In 

Support of the Registration of Bug Oil Food Use containing Canola Oil, Tagetes Oil, Thyme Oil 

and Wintergreen Oil as its active ingredients. U.S. Environmental Protection Agency Office of

Pesticide Programs. August 25, 2010.

U.S. EPA. 2010. Memorandum from Angela L. Gonzales to Colin G. Walsh. Science Review In 

Support of the Registration of Bug Oil Ornamental containing Canola Oil, Tagetes Oil, Thyme 

Oil and Wintergreen Oil as its active ingredients. U.S. Environmental Protection Agency Office 

of Pesticide Programs. August 25, 2010.

U.S. EPA. 2010. Memorandum from Angela L. Gonzales to Colin G. Walsh. Tolerance 

Exemption Petition Review in Support of Tagetes Oil. U.S. Environmental Protection Agency 

Office of Pesticide Programs. August 25, 2010.

U.S. EPA. 2011. Memorandum from Angela L. Gonzales to Colin G. Walsh. Science Review In 

Support of the Registration of Bug Oil Food Use containing Canola Oil, Tagetes Oil, Thyme Oil 

and Wintergreen Oil as its active ingredients. U.S. Environmental Protection Agency Office of 

Pesticide Programs. June 23, 2011.

U.S. EPA. 2011. Memorandum from Angela L. Gonzales to Colin G. Walsh. Science Review In 

Support of the Registration of Bug Oil Ornamental containing Canola Oil, Tagetes Oil, Thyme 

Oil and Wintergreen Oil as its active ingredients. U.S. Environmental Protection Agency Office 

of Pesticide Programs. June 23, 2011.

U.S. EPA. 2012. Memorandum from Angela L. Gonzales to Colin G. Walsh. Science Review In 

Support of the Registration of Bug Oil Food Use containing Canola Oil, Tagetes Oil, Thyme Oil 

and Wintergreen Oil as its active ingredients. U.S. Environmental Protection Agency Office of

Pesticide Programs. January 18, 2012.

U.S. EPA. 2012. Memorandum from Angela L. Gonzales to Colin G. Walsh. Science Review In 

Support of the Registration of Bug Oil Ornamental containing Canola Oil, Tagetes Oil, Thyme 

Oil and Wintergreen Oil as its active ingredients. U.S. Environmental Protection Agency Office 

of Pesticide Programs. January 18, 2012.

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. active ingredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

bw body weight

CBI Confidential Business Information

CFR Code of Federal Regulations
Tagetes Oil

Page 21 of 22

Biopesticides Registration Action Document

cm3 cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EC50 median effective concentration. A statistically derived single concentration in 

environmental medium that can be expected to cause an effect in 50% of the test 

animals when administrated by the route indicated (inhalation). It is expressed 

as a concentration in air or water (e.g. mg/L).

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

ha hectare

kg kilogram

Kow octanol-water partition coefficient

L liter

LC50 median lethal concentration. A statistically derived single concentration in air or 

water that can be expected to cause death in 50% of the test animals when 

administrated by the route indicated (inhalation and environment). It is 

expressed as a concentration in air or water (e.g. mg/L).

LD50 median lethal dose. A statistically derived single dose that can be expected 

to cause death in 50% of the test animals when administered by the route 

indicated (oral and dermal). It is expressed as a weight of 

substance per unit weight of animal (e.g., mg/kg).

MRID No. Master Record Identification Number

mg milligram

mPa millipascal

mL milliliter

MP manufacturing-use product

N/A not applicable

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

nm nanometer

NOEL no-observed-effect-level

NOF notice of filing

NOR notice of receipt

OPP Office of Pesticide Programs

OCSPP Office of Chemical Safety and Pollution Prevention

pa pascal

PPE personal protective equipment
Tagetes Oil

Page 22 of 22

Biopesticides Registration Action Document

PR Notice Pesticide Registration Notice

 TGAI technical grade of the active ingredient

 ug microgram

 USDA United States Department of Agriculture

 UV ultra-violet