**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 Docum ent** 

**Sarm entine** 

3 **TABLE OF CONTENTS I.**  **EXECUTIVE SUMMARY ................................**  **................................ ................................**  **................................ .................**  **5 II.**  **ACTIVE INGREDIENT OV ERVIEW**  **................................ ................................**  **................................ .............................**  **6 III.**  **REGULATORY BACKGROUN D**  **................................ ................................**  **................................ ................................**  **.... 6**  **A. Classification**  **................................ ................................**  **................................ ................................**  **................................ .......**  **6 B.**  **Food Clearances/Tolerances ................................**  **................................ ................................**  **................................ ...............**  **6 IV.**  **RISK ASSESSMENT ................................**  **................................ ................................**  **................................ .........................**  **6 A.**  **Active Ingredient Characterization ................................**  **................................ ................................**  **................................ ...**  **6 1.**  **Toxicology ................................**  **................................ ................................**  **................................ ................................**  **........ 7**  **2. Dose Response Assessm**  **ent ................................**  **................................ ................................**  **................................ .............**  **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.**  **Environm ental Fate and Ground Water Data**  **................................ ................................**  **................................ ............**  **10 3.**  **Ecological Exposure and Risk Characterization ................................**  **................................ ................................**  **......... 10**  **4. Endangered Species Assessm**  **ent ................................**  **................................ ................................**  **................................ ..**  **10 D.**  **PRODUCT PERFORMANCE DATA (EFFICACY) ................................**  **................................ ................................**  **.... 10**  **V. RISK MANAGEMENT DECI**  **SION ................................**  **................................ ................................**  **............................... 11**  **A. Determ** **ination of Eligibility for Registration ................................**  **................................ ................................**  **.................. 11**  **B. Regulatory Decision**  **................................ ................................**  **................................ ................................**  **.......................... 11**  **1. Conditional/Unconditional Registration**  **................................ ................................**  **................................ ......................**  **11 C.**  **Environm ental Justice**  **................................ ................................**  **................................ ................................**  **...................... 11**  **VI. ACTIONS REQUIRED BY**  **REGISTRANTS ................................**  **................................ ................................**  **................ 12**  **A. R** **eporting of Adverse Effects ................................**  **................................ ................................**  **................................ ............**  **12 B.**  **Reporting of Hypersensitivity Incidents ................................**  **................................ ................................**  **.......................... 12**  **VII. APPENDIX A. DATA REQ**  **UIREMENTS (40 CFR PA RT 158**  **- SUBPART U)**  **................................ ..........................**  **12 VIII.**  **APPENDIX B. ................................**  **................................ ................................**  **................................ ................................**  **... 15**  **IX. APPENDIX C.**  **................................ ................................**  **................................ ................................**  **................................ ...**  **16 X.**  **GLOSSARY OF ACRONYMS AND ABBREVIATIONS**  **................................ ................................**  **............................ 16** **Biopesticides Registration Action Docum ent** 

**Sarm entine** 

4 **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**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

5 **I. EXE**  **CUTIVE SUMMARY** Sarmentine is a new biochemical active ingredient intended for use as an herbicide to control grasses and broadleaf weeds in and around crops. Itis used as a foliar and spot treatment spray on non - food crops in agricultural , residential , and other areas such as golf courses and parks
. Itis 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 actio n of s armentine 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 non
toxic. The Biopesticides and Pollution Prevention Division (BPPD) has reviewed all of the data and other information submitted in support of the registration of s armentine 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 s armentine 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 Sy mbol No. 84059
- RO), and the end
- use product (EP), MBI
011 EP (EPA File Sy

mbol No. 84059
- EN) which contain this new active ingredient, s armentine. 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 provide s a public comment period prior to making a registration decision for the following ty

pes 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, s armentine 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 s armentine’s low toxicity , the determination th at s armentine 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 include s 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 s armentine, it is in the best interests of the public to issue the registration of MBI
- 011 TGAIand MBI
- 011 EP . The basis for this decision can be found in the risk assessment for s armentine, which is characterized in this BRAD.**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

6 **II. ACTIVE INGREDIENT OVERVIEW**  **Common Name:** Sarmentine **Chemical Names:** (E,E)
- 1
- (1
- oxo - 2,4
- decadienyl) py rrolidine **Trade & Other Names:** MBI
- 0 11 **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 Sy

mbol 84059
- RO) and MBI
- 011 EP (EPA File Sy mbol 84059
- EN) , containing the new biochemical active ingredient (E,E)
- 1
- (1
- oxo - 2,4
- decadienyl) py rrolidine known as s arm entine. 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 s armentine 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 , s armentine 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 s armentine (MP, MBI
- 011 ) will be formulated as an EP to be used as an he rbicide 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**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

7 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 s armentine 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 /informatio n are available to support registration of s armentine

. All toxicology data requirements for s armentine 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 Iacute toxicity

studies submitted and reviewed showed that s armentine is a T oxicity C ategory 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 confirm ed that s arment ine 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 tox ic effects (if any ) associated with repeated or continuous exposure to a test substance for a period of 90 days . Data w aiver s 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.**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

8 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 f or 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
. E xposure via the oral route is not anticipated as s armentine 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 s armentine is expected to degra de rapidly into innocuous substances once applied; thus , s ignificant 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 s armentine and low exposure to humans and non
- targ et 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 wh ether 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 thy roid (E, A, or T) ho rmonal 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 20 10, 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**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

9 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 ini tial 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 s armentine is used according to the product label directions. Sarmentine is not to be app lied 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 s armentine. **4. Occupational, Residential, School and Day Care Exposure and Risk Characterization** 
**a. Occupa**  **tional Exposure and Risk Characterization** An occupational exposure assessment was not conducted for s armentine. 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. O ccupational exposure is not anticipated because applicators and handlers are required to wear PPE that would mitigate exposure to the active ingredient. Additionally, s armentine is expected to degrade rapidly into innocuous substance s once applied , which would greatly reduce the potential for post - application exposure. Inthe event that exposure does occur, adverse effects are not expected due to the low toxicit y of the A.I
. **b. Residential, School and Day Care Exposure and Risk Cha**  **racterization** 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 s ignificant exposures are not anticipated , any exposures that might occur woul d 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 sar

mentine is expected to degrade rapidly into innocuous substances once**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

10 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 s armentine after reviewing the available toxicity data. A determination has been made that no unreason able exposure to the U.S. population in general, and to infants and children in particular, will result from the use of s armentine 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, s armentine

. All non
- target toxicology data requirements for s armentine 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 Tie r II studies. Further, sarmentine degrades rapidly into innocuous substances in the environment once applied. **3. Ecological Exposure and Risk Characterization**  D ata waivers were granted for non
- target plants and non
- target insect testing based on data/inf ormation which demonstrate that sarmentine is non
- toxic to lady bugs 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. Inaddition, avian dietary exposure is not anticipated based on the use pattern and rapid degradation i n the environment
. **4. Endangered Species Assessment** S armentine is not toxic to non
- target organisms , and based on its u se pattern EPA has determined it will have **No Eff**

**ect** 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 unne cessary 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 significanc ant public health importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

11 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/risk
benefit.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. Deter**  **mination 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 require ments 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 s armentine. 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, s armentine is eligible for registration for the labeled uses. **B. Regulatory Decision**  The data submitted fulfill the requirements of registration for s armentine 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 s armentine 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 s armentine pesticide products will cause harm of a disproportionate impact on at
- risk communities. For additional information regarding environmental justice issues, p lease visit EPA’s website at http://www.epa.gov/compliance/environmentaljustice/index.html
.**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

12 **V I**  **. ACTIONS REQUIRED BY REGISTRANTS**  EPA evaluated all of the data submitted in co nnection with the initial registration of s armentine and determined that these data are sufficient to satisfy current registration data requirements. No additional data are required to be submi tted 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 maintainin g the Federal registration for a pesticide product. A brief summary of these ty

pes of data are listed below. **A. R eporting of Adverse Effects**  Additionally , all incidents of hy persensitivity

(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 hy persensitivity

(including both suspected and confirmed incidents) must be reported to the Agency under the pro visions of 40 CFR Part 158.2050(d). **VI I**  **. 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 acti ve ingredient. Subsequent to this registration, there may

be additional MRIDs that support registration of other products containing this active ingredient.

**TABLE 1. Product Chem istry Data Requirem**  **ents for**  **Sarm entine**  **(40 CFR § 158.2030) OPPTS**  **G uideli**  **ne N**  **o .**  **Study R**  **esults** 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 im purities. 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.**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

13

**TABLE 2. Physical and Chem ical P**  **roperties of Sarm entine (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

Tem peratures, 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 Flammabil ity 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 so lid
. 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 83 0.7570 Partition Coefficient (n
Octanol/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. Mam malian Toxicology Data for**  **Sarm entine**  **(40 CFR § 158.2050) Study/OCSPP Guideline No.**  **Results Toxicity**  **Category/Description MRID**  Acute oral toxicity (rat) (870.1100) LD 50 > 5000 mg/kg (females) IV 49020306 Acute dermal toxicity (rat) (870.12 00) LD 50 > 5050 mg/kg (females and males) IV 49020307 Acute inhalation toxicity (rat)

(870.1300) LC 50 > 2.22 mg/l (females and males) IV 49020308 Primary eye irritation (rabbit) (870.2400) Moderately irritating II 49020309 Primary dermal irritation (ra bbit) (870.2500) Slightly irritating IV 49020310 Dermal sensitization (guinea pig)

(870.2600) Is a sensitizer N/A 49020311**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

14

**Table 3. Mam malian Toxicology Data for**  **Sarm entine**  **(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 exp osure 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 P PE. Residential exposures would be incidental and short in duration; thus, repeated exposure is not anticipated. Additionally, s armentine 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, s armentine degrades rapidly into innocuous substances in the environment once applied which further mitigates exposure. 49020319 49131901 49207902

Mutagen icity
- 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 i n duration; thus, repeated exposure is not anticipated. Additionally, s armentine degrades rapidly into innocuous substances in the environment once applied which further mitigates exposure. 49020319 49131901 49207902

Mutagenicity
- in vivo micronucleus

ass ay (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, s armentine degrades rapidly into innocuous substances in the environment once applied which further mitigates exposure. 49020319 49131901 49207902

Developmental toxicity (870.3700) Waived. Significant exp osure 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, s armentine degrades rapidly into innocuous substances in the environment once applied which further mitigates exposure. 49020319 49131901 49207902**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

15 **VII I**  **. Appendix B.**  **For product speci fic information, please refer to**  **http://www.epa.gov/pesticides/pestlabels .**  **TABLE 4. Nontarget Organism Toxicity Requirem**  **ents for Sarm**  **entine (MBI -**  **011 TGAI) (40 CF R § 158.2060)**  **Study/OCSPP Guideline No. /MRID No.**  **Results Toxicity**  **Category/Description MRID**  Avian acute oral toxicity Colinus virginianus (850.2100) LD 50 > 2,000 mg/kg Practically non
- toxic 49020314
Avian dietary toxicity Colinus virginianus and Anas p latyrhynchos (850.2200) Waived. Avian dietary exposure is not anticipated based on the use pattern. The proposed EP containing s armentine 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 LC 50 ( Oncorhynchus mykiss ) (850.1075) LC 50 = 9.38 mg/l Moderately toxic 49 020313 Aquatic invertebrate acute toxicity ( Daphnia magna ) (850.1010) EL 50 = 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 s armentine 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 s armentine is expected to degrade rapidly into innocuous substances in the environment. N/A 49020319 49131901

Nontarget insect testing ( Apis mellifera ) (880.4350) Honey bee : LD 50 > 100 μg a.i./bee Ladybird beetle : practically non
- toxic when s armentine was applied to the beetle’s food source, corn earworm eggs. Green lacewing : practically non
- toxic when s armentine was applied to the lacewing’s food source, corn earworm eggs. Prac tically non
- toxic 49020315 49020316 49020317**Biopesticides Registration Action Docum ent** 

**Sarm entine** 

16 **IX .**  **A ppendix**  **C. REFERENCES**  B ernabeu, M., Chinchilla, R. and Najera, C. 1995. (2E,4E)
- 5
- Tosyl
- 2,4
- pentadienamides: New Dienic Sulfones for the Stereoselective Sy nthesis of (2E,4E)
- Dienamides, Tetrahedron Letter
. 36: 3901
- 3904 Débieux J
- L, & Bochet, CG, 2010. Photoinduced acyl transfe r. J. Physical Organic Chem. 10:1002/poc.1639. HSDB, 2014. Succinic Acid. National Library of Medicine. Hazardous Substances Data Bank (HSDB). May

23, 2014. < http://toxnet.nlm.nih.gov/cgi
- bin/sis/search/f?./temp/~3QhRRm:1> Kiuchi, F., Nakamura, N., Tsud a, Y., Kondo, K and Yoshimura, H. 1988. Studies on Crude Drugs Effective on Visceral Larva Migrans. IV. I solation and I dentification of L arvicidal Principles in Pepper Chemical and Pharmaceutical Bulletin 36: 2452. Li khitwitayawuid, K., Ruangrungsi, N, Lange, G and Decicco, C.. 1987. Structural Elucidation and Sy nthesis of New Components isolated from Piper Samentosum Tetrahedron 43: 3689
- 3694. Trigui M, Pulvin S, Poupin P, Thomas D. 2003. Biodegradation of cyclic amines by a Pseudomonas strain involves an amine mono
- oxygenase. Can J. Microbiol 49: 181
- 188. WHO, 2006. Food Additive Series 56: Aliphatic and Aromatic Amines and Amides. FAO/WHO Joint Expert Committee on Food Additives. http://www.inchem.org/documents/jecfa/jecmono/v56je13.pdf **X. GLOSSAR** 

**Y 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/cm 3 grams per cubic centimeter lb/gal pounds per gallon LD 50 median lethal dose. A statistically derived single dose th at 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 Docum ent** 

**Sarm entine** 

17 mL mi lliliter MP manufacturing
- use pesticide product MPCA microbial pest control agent MRID No. Master Record I dentification Number NI OSH National Institute for Occupational Safety and Health OPP Office of Pesticide Programs PC Code Pesticide Chemical Code PP E personal protective equipment TGAI technical grade of the active ingredient U.S. United States