BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Sarmentine

PC Code : 373501

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

August 7, 2014
Biopesticides Registration Action Document

Sarmentine

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TABLE OF CONTENTS

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

II. ACTIVE INGREDIENT OVERVIEW ............................................................................................................................. 6

III. REGULATORY BACKGROUND.................................................................................................................................... 6

A. Classification ....................................................................................................................................................................... 6

B. Food Clearances/Tolerances............................................................................................................................................... 6

IV. RISK ASSESSMENT ......................................................................................................................................................... 6

A. Active Ingredient Characterization ................................................................................................................................... 6

1. Toxicology........................................................................................................................................................................ 7

2. Dose Response Assessment ............................................................................................................................................. 9

3. Drinking Water Exposure and Risk Characterization................................................................................................. 9

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization ........................................... 9

5. Risk Characterization................................................................................................................................................... 10

C. ENVIRONMENTAL ASSESSMENT............................................................................................................................. 10

1. Ecological Hazards........................................................................................................................................................ 10

2. Environmental Fate and Ground Water Data ............................................................................................................ 10

3. Ecological Exposure and Risk Characterization......................................................................................................... 10

4. Endangered Species Assessment .................................................................................................................................. 10

D. PRODUCT PERFORMANCE DATA (EFFICACY) .................................................................................................... 10

V. RISK MANAGEMENT DECISION............................................................................................................................... 11

A. Determination of Eligibility for Registration.................................................................................................................. 11

B. Regulatory Decision .......................................................................................................................................................... 11

1. Conditional/Unconditional Registration...................................................................................................................... 11

C. Environmental Justice ...................................................................................................................................................... 11

VI. ACTIONS REQUIRED BY REGISTRANTS ................................................................................................................ 12

A. Reporting of Adverse Effects............................................................................................................................................ 12

B. Reporting of Hypersensitivity Incidents.......................................................................................................................... 12

VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U).......................................................... 12

VIII. APPENDIX B. ................................................................................................................................................................... 15

IX. APPENDIX C.................................................................................................................................................................... 16

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS............................................................................................ 16
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Leonard S. Cole, Jr., M.S. Senior Regulatory Specialist
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Sarmentine

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I. EXECUTIVE SUMMARY

Sarmentine is a new biochemical active ingredient intended for use as an herbicide to control 

grasses and broadleaf weeds in and around crops. It is used as a foliar and spot treatment spray on 

non-food crops in agricultural, residential, and other areas such as golf courses and parks. It is a 

naturally occurring constituent of peppercorns that has been extracted from fruit, foliage and 

roots of a variety of pepper plants. Sarmentine has been characterized in alcohol extracts from a 

variety of edible peppers, including Piper sarmentosum, Piper longnum, and Piper nigrum, the 

source of both common black and white peppers. Sarmentine has also been isolated from vines in 

the Vitus family, which includes grapes. Although the specific mode of action of sarmentine is 

not completely understood, it is believed that the substance damages and degrades the integrity of 

plant cell walls. Based on this information, the Agency considers the mode of action to be nontoxic. 

The Biopesticides and Pollution Prevention Division (BPPD) has reviewed all of the data and 

other information submitted in support of the registration of sarmentine as an herbicide under 

section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and has 

determined that the current data requirements (40 CFR part 158.2010 through 158.2070) for 

registration of a biochemical pesticide have been satisfied. Given that sarmentine is of low 

toxicity and presents little, if any, risks to humans, including infants and children, and the 

environment, the U.S. Environmental Protection Agency (EPA or the Agency) has concluded that

it is in the best interest of the public to issue registrations for the manufacturing-use product 

(MP), MBI-011 TGAI (EPA File Symbol No. 84059-RO), and the end-use product (EP), MBI011 EP (EPA File Symbol No. 84059-EN) which contain this new active ingredient, sarmentine. 

The basis for this decision is described in more detail in section IV of this Biopesticide 

Registration Action Document (BRAD). 

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 new policy of making registration actions more transparent, sarmentine is

subject to a 15 day comment period as a “new active ingredient”. EPA has established a 

comment period of 15 days on the basis of sarmentine’s low toxicity, the determination that 

sarmentine presents low risk of any adverse effects to human health and the environment, and a 

need for this active ingredient. The notice for this comment period includes the draft 

Biopesticides Registration Action Document (BRAD), and a draft product label for the MP, 

MBI-011 and EP, MBI-011, which contain this new active ingredient, sarmentine. The docket ID 

is EPA-HQ-OPP-2014-0003. The Agency believes that based on the risk assessment and 

information submitted in support of the registration of sarmentine, it is in the best interests of the 

public to issue the registration of MBI-011 TGAI and MBI-011 EP. The basis for this decision 

can be found in the risk assessment for sarmentine, which is characterized in this BRAD.
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II. ACTIVE INGREDIENT OVERVIEW

Common Name: Sarmentine

Chemical Names: (E,E)-1-(1-oxo-2,4-decadienyl) pyrrolidine

Trade & Other Names: MBI-011

CAS Registry Number: 78910-33-5

OPP Chemical Code: 373501

Type of Pesticide: Herbicide

III. REGULATORY BACKGROUND

On December 31, 2012, EPA received an application filed by Marrone Bio Innovations, 2121 

Second Street, Suite B107, Davis, California 95618 to register the products, MBI-011 TGAI

(EPA File Symbol 84059-RO) and MBI-011 EP (EPA File Symbol 84059-EN), containing the 

new biochemical active ingredient (E,E)-1-(1-oxo-2,4-decadienyl) pyrrolidine known as 

sarmentine. A notice of receipt of this application, allowing for a 30-day comment period, was 

published in the Federal Register of April 18, 2014 (79 FR 75). No comments were received 

following this publication. 

A. Classification

On October 14, 2010, the Biochemical Classification Committee determined that sarmentine can 

be classified as a biochemical pesticide due to its non-toxic mode of action, natural occurrence in 

the environment, and history of exposure to humans and the environment demonstrating minimal 

toxicity. 

B. Food Clearances/Tolerances 

Currently, sarmentine is not intended for use on food or feed commodities; therefore, a tolerance 

or exemption from the requirement of a tolerance is not relevant. Sarmentine has been 

determined to be a non-food use.

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

The new active ingredient sarmentine (MP, MBI-011) will be formulated as an EP to be used as 

an herbicide on non-food use sites. Sarmentine is a naturally-occurring biochemical isolated from 

pepper fruit, foliage and roots. Sarmentine is naturally occurring and is found in many plants 

within the Piper family, which is the source of the spice “pepper”. Sarmentine has also been 
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isolated from vines in the Vitus family, which includes grapes. Sarmentine has been characterized

in alcohol extracts from a variety of edible peppers, including Piper sarmentosum, Piper 

longnum, and Piper nigrum, the source of both common black and white peppers.

Descriptions of the product formulation and production process, as well as the formation of 

impurities, were examined by BPPD and found to be acceptable in meeting current guideline 

standards. 

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

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 acute Toxicity Category I, II, III or IV where Toxicity Category I is the level of 

highest toxicity and Toxicity Category IV indicates low toxicity. 

Adequate mammalian toxicology data/information are available to support registration of

sarmentine. All toxicology data requirements for sarmentine have been satisfied.

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 sarmentine is a Toxicity

Category II (moderately irritating) compound via primary eye irritation exposure. Sarmentine is a 

Toxicity Category IV for acute inhalation, primary dermal irritation, and acute oral toxicity routes

of exposure. Submitted information confirmed that sarmentine is a dermal sensitizer. 

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

of this document. 

b. Subchronic Toxicity 

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

(if any) associated with repeated or continuous exposure to a test substance for a period of 90 

days.

Data waivers requested for the subchronic [90-day oral (OSCPP 870.3100), 90-day dermal 

(OSCPP 870.3250), and 90-day inhalation (OSCPP 870.3465)] studies were granted by BPPD, 

based on the product’s toxicological and exposure profile below.
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Sarmentine is for non-food use; therefore, repeat oral exposure to humans is not anticipated.

Prolonged exposure to human skin is not anticipated based on the use pattern and the use of 

personal protective equipment is required in occupational settings.

Significant inhalation exposure is not expected based on the use pattern. 

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

A of this document.

 c. Developmental Toxicity and Mutagenicity

Data waivers were granted for Tier I Subchronic, Developmental and Mutagenicity data 

requirements (OSCPP 870.3100 to 870.5375) due to the nature of the A.I. and its intended uses.

Significant exposure to humans is unlikely based on the proposed use pattern of the active 

ingredient. Exposure via the oral route is not anticipated as sarmentine is intended for non-food

uses. Further, applicators and handlers must wear PPE to preclude significant dermal and 

inhalation exposure. Significant residential exposures are also not anticipated because any

exposures would be acute in nature and not prolonged. Further, exposure will be mitigated 

because sarmentine is expected to degrade rapidly into innocuous substances once applied; thus,

significant post-application exposure is not likely.

d. Tier II/Tier III 

Tiers II and III data were not triggered due to low toxicity profile of sarmentine and low exposure 

to humans and non-target species. 

e. Effects on the Endocrine System

As required under Federal Food, Drug, and Cosmetic Act (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 determinations. Tier I 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 I 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 
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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.

Sarmentine 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 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 I screening battery, please visit our website: 

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

2. Dose Response Assessment

There are no available repeat dose studies; therefore, a dose response cannot be established. 

3. Drinking Water Exposure and Risk Characterization

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

product label directions. Sarmentine 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.

Sarmentine is expected to degrade rapidly in the environment once applied, based on the half-life 

of 30-45 minutes. In the unlikely event that exposure via drinking water did occur, the health risk 

would be expected to be minimal based on the rapid degradation of sarmentine.

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 sarmentine. Based on the proposed 

use pattern and toxicity data available to the Agency, expected exposure is not likely to result in 

unreasonable risk to applicators/handlers. Occupational exposure is not anticipated because 

applicators and handlers are required to wear PPE that would mitigate exposure to the active 

ingredient. Additionally, sarmentine is expected to degrade rapidly into innocuous substances 

once applied, which would greatly reduce the potential for post-application exposure. In the 

event that exposure does occur, adverse effects are not expected due to the low toxicity of the 

A.I. 

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

Based on the proposed use pattern and toxicity data available to the Agency, residential exposure 

is not likely to result in unreasonable risk to humans. Although significant exposures are not 

anticipated, any exposures that might occur would be incidental, acute in nature, and not 

prolonged because of the way in which the proposed product is intended for use. That is, as a 

spot treatment to weeds applied via a tank sprayer as a course spray. Further, exposure will also 

be reduced because sarmentine is expected to degrade rapidly into innocuous substances once 
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applied. Thus, post application exposure is not likely. No relevant toxicological endpoints were 

identified and therefore, exposure should it occur, will be appropriately mitigated for the reasons 

stated above in addition and when proper label instructions are followed.

5. Risk Characterization

The Agency considered human exposure to sarmentine after reviewing the available toxicity data.

A determination has been made that no unreasonable exposure to the U.S. population in general, 

and to infants and children in particular, will result from the use of sarmentine when label 

instructions are followed. 

C. ENVIRONMENTAL ASSESSMENT

1. Ecological Hazards

Adequate non-target toxicology data/information are available to support the registration of the 

biochemical pesticide, sarmentine. All non-target toxicology data requirements for sarmentine

have been satisfied. Non-Target Organisms and Environmental Fate data requirements were 

waived or satisfied by data/information submitted by the applicant.

2. Environmental Fate and Ground Water Data 

The need for environmental fate and groundwater data was not triggered because results of the 

acute toxicity studies did not trigger any additional Tier II studies. Further, sarmentine degrades 

rapidly into innocuous substances in the environment once applied.

3. Ecological Exposure and Risk Characterization

Data waivers were granted for non-target plants and non-target insect testing based on 

data/information which demonstrate that sarmentine is non-toxic to ladybugs when applied to the 

beetle’s food source and corn earworn eggs. Appropriate mitigation language on the EP label will 

prevent exposure to desirable or non-target plants. In addition, avian dietary exposure is not 

anticipated based on the use pattern and rapid degradation in the environment.

4. Endangered Species Assessment

Sarmentine is not toxic to non-target organisms, and based on its use pattern EPA has determined 

it will have No Effect on threatened and/or endangered species or any designated critical habitat.

D. PRODUCT PERFORMANCE DATA (EFFICACY)

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 significancant public health 

importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For 
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further guidance on product performance requirement, refer to Pesticide Registration Notice (PR) 

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

The EP submitted with this new active ingredient did not list pests of significant 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 new active ingredients 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 sarmentine. 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, sarmentine is eligible for registration for 

the labeled uses.

B. Regulatory Decision

The data submitted fulfill the requirements of registration for sarmentine for use as an herbicide. 

Refer to Appendix B for product-specific information.

1. Conditional/Unconditional Registration

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

sarmentine 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 sarmentine pesticide products will cause harm of 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. 
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VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all of the data submitted in connection with the initial registration of sarmentine

and determined that these data are sufficient to satisfy current registration data requirements. No 

additional data are required to be submitted to the Agency at this time. 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

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR § 158.2050(d). 

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: 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 Sarmentine (40 CFR § 158.2030)

OPPTS Guideline No. Study 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 acceptable.

830.1800 Analytical method Acceptable.
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TABLE 2. Physical and Chemical Properties of Sarmentine (MBI-011 TGAI) (40 CFR § 158.2030)

OCSPP Guideline Property Description of Result MRID

830.6302 Color Light yellow 49020301

830.6303 Physical State Solid (powder) 49020301

830.6304 Odor None detected 49020301

830.6313 Stability to Normal and Elevated 

Temperatures, Metals and Metal 

Ions

Not expected to be stable at temperatures between 

25°C and 40°C. The active ingredient is not 

anticipated to come in contact with metals or metal 

ions during storage.

49020303

830.6315 Flammability N/A: product does not contain combustible liquids. 49020303

830.6317 Storage Stability A storage stability study is ongoing. 49020303

830.6319 Miscibility N/A: product is not an emulsifiable liquid to be 

diluted with petroleum solvents.

49020303

830.6320 Corrosion Characteristics A corrosion characteristics study is ongoing. 49020303

830.7000 pH 4.34 49020301

830.7050 UV/Visible Light

Absorption

ɛ= 3071 (neutral), 3090 (acidic), 3127 (basic) 49020301

830.7100 Viscosity N/A: test substance is a solid. 49020301

830.7200 Melting Point/Range Method needed

830.7220 Boiling Point/Range >400°C 49020301

830.7300 Bulk Density 1.28 g/ml 49020301

830.7520 Particle Size, Fiber Length and 

Diameter Distribution

5.707μm Unassigne

d MRID

830.7550

830.7560

830.7570

Partition Coefficient (nOctanol/Water) Not required: test substance is partially soluble in 

water.

49020303

830.7840 Water Solubility 1.57 g/100ml 49020302

830.7950 Vapor Pressure Test substance is too unstable for testing. 49020302

Table 3. Mammalian Toxicology Data for Sarmentine (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Acute oral toxicity (rat)

(870.1100) LD50 > 5000 mg/kg (females) IV 49020306

Acute dermal toxicity (rat)

(870.1200) LD50 > 5050 mg/kg (females and males) IV 49020307

Acute inhalation toxicity (rat)

(870.1300) LC50 > 2.22 mg/l (females and males) IV 49020308

Primary eye irritation (rabbit)

(870.2400) Moderately irritating II 49020309

Primary dermal irritation (rabbit)

(870.2500) Slightly irritating IV 49020310

Dermal sensitization (guinea pig)

(870.2600) Is a sensitizer N/A 49020311
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Table 3. Mammalian Toxicology Data for Sarmentine (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

90-Day oral toxicity

(870.3100)

Waived. Sarmentine is for non-food uses only. Uses are not 

anticipated to result in repeat oral exposure to humans.

49020319

49131901

49207902

90-Day dermal toxicity

(870.3250)

Waived. Purposeful application and prolonged exposure to 

the human skin is not anticipated based on the use pattern. 

Applicators and handlers are required to wear appropriate 

PPE. Residential exposures would be incidental and short 

in duration; thus, repeated exposure is not anticipated. 

Additionally, sarmentine degrades rapidly into innocuous 

substances in the environment once applied which further 

mitigates exposure.

49020319

49131901

49207902

90-Day inhalation toxicity

(870.3465)

Waived. Significant repeat inhalation exposure to the active 

ingredient as a gas, vapor or aerosol is unlikely. Applicators 

and handlers are required to wear appropriate PPE. 

Residential exposures would be incidental and short in 

duration; thus, repeated exposure is not anticipated. 

Additionally, sarmentine degrades rapidly into innocuous 

substances in the environment once applied which further 

mitigates exposure.

49020319

49131901

49207902

Mutagenicity-in vitro studies

(870.5100)

Waived. Significant human exposure is unlikely based on 

use pattern. Sarmentine is for nonfood-uses only. 

Applicators and handlers are required to wear appropriate 

PPE. Residential exposures would be incidental and short 

in duration; thus, repeated exposure is not anticipated. 

Additionally, sarmentine degrades rapidly into innocuous 

substances in the environment once applied which further 

mitigates exposure.

49020319

49131901

49207902

Mutagenicity-in vivo micronucleus

assay

(870.5395)

Waived. Significant human exposure is unlikely based on 

use pattern. Sarmentine is for nonfood-uses only. 

Applicators and handlers are required to wear appropriate 

PPE. Residential exposures would be incidental and short 

in duration; thus, repeated exposure is not anticipated. 

Additionally, sarmentine degrades rapidly into innocuous 

substances in the environment once applied which further 

mitigates exposure.

49020319

49131901

49207902

Developmental toxicity

(870.3700)

Waived. Significant exposure to females is unlikely based 

on use pattern. Sarmentine is for non-food uses only. 

Applicators and handlers are required to wear appropriate 

PPE. Residential exposures would be incidental and short 

in duration; thus, repeated exposure is not anticipated. 

Additionally, sarmentine degrades rapidly into innocuous 

substances in the environment once applied which further 

mitigates exposure.

49020319

49131901

49207902
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VIII. Appendix B.

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

TABLE 4. Nontarget Organism Toxicity Requirements for Sarmentine (MBI-011 TGAI) (40 CFR § 158.2060)

Study/OCSPP Guideline No.

/MRID No.

Results Toxicity 

Category/Description

MRID

Avian acute oral toxicity

Colinus virginianus

(850.2100)

LD50 > 2,000 mg/kg Practically non-toxic 49020314

Avian dietary toxicity

Colinus virginianus and Anas 

platyrhynchos

(850.2200)

Waived. Avian dietary exposure is not 

anticipated based on the use pattern. The 

proposed EP containing sarmentine is 

applied as a foliar spray to weeds and is not 

in a granular form that could be attractive to 

birds. Sarmentine is expected to degrade 

rapidly into innocuous substances in the 

environment once applied which would 

further mitigate dietary exposure to birds. 

N/A 49020319

49207902

Freshwater fish LC50

(Oncorhynchus mykiss)

(850.1075)

LC50 = 9.38 mg/l Moderately toxic 49020313

Aquatic invertebrate acute toxicity

(Daphnia magna)

(850.1010)

EL50 = 3.83 mg/l Moderately toxic 49020312

Non-target plant studies-seedling 

emergence

(850.4100)

Waived. Sarmentine is a non-selective 

herbicide that will be applied to weeds. The 

proposed EP label will include language to 

prevent or mitigate exposure to desirable or 

nontarget plants. Exposure to non-target 

plants will be further mitigated because 

sarmentine is expected to degrade rapidly 

into innocuous substances in the 

environment. 

N/A 49020319

49131901

Non-target plant studies-vegetative 

vigor

(850.4150)

Waived. Sarmentine is a non-selective 

herbicide that will be applied to weeds. The 

proposed EP label will include language to 

prevent or mitigate exposure to desirable or 

non-target plants. Exposure to non-target 

plants will be further mitigated because 

sarmentine is expected to degrade rapidly

into innocuous substances in the 

environment.

N/A 49020319

49131901

Nontarget insect testing (Apis mellifera)

(880.4350)

Honey bee: LD50 > 100 μg a.i./bee

Ladybird beetle: practically non-toxic when 

sarmentine was applied to the beetle’s food 

source, corn earworm eggs.

Green lacewing: practically non-toxic when 

sarmentine was applied to the lacewing’s 

food source, corn earworm eggs.

Practically non-toxic

49020315

49020316

49020317
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IX. Appendix C.

REFERENCES

Bernabeu, M., Chinchilla, R. and Najera, C. 1995. (2E,4E)-5-Tosyl-2,4-pentadienamides: New 

Dienic Sulfones for the Stereoselective Synthesis of (2E,4E)-Dienamides, Tetrahedron Letter. 

36: 3901-3904

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X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BRAD Biopesticides Registration Action Document

C.F.R. Code of Federal Regulations

cSt centistokes

EDSP Endocrine Disruptor Screening Program

EP end-use pesticide product

EPA United States Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register

g/cm3grams per cubic centimeter

lb/gal pounds per gallon

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, dermal, or inhalation). It is expressed as a weight of 

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

mg/kg milligrams per kilogram
Biopesticides Registration Action Document

Sarmentine

17

mL milliliter

MP manufacturing-use pesticide product

MPCA microbial pest control agent

MRID No. Master Record Identification Number

NIOSH National Institute for Occupational Safety and Health

OPP Office of Pesticide Programs

PC Code Pesticide Chemical Code

PPE personal protective equipment

TGAI technical grade of the active ingredient

U.S. United States