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Extract of Reynoutria sachalinensis (Giant Knotweed) (055809) Biopesticide Registration Action Document

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Issued: 11/00

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  1. Executive Summary
    1. Idenity
    2. Use/Usage
    3. Risk Assessment
    4. Data Gaps / Labeling Restrictions
  2. Overview
    1. Active Ingredient Overview
    2. Use Profile
    3. Estimated Usage
    4. Data Requirements
    5. Regulatory History
    6. Classification
    7. Food Clearances/Tolerances
  3. Science Assessment
    1. Physical/Chemical Properties Assessment
    2. Human Health Assessment
    3. Environmental Assessment
    4. Efficay Data
  4. Risk Management Decision
    1. Determination of Eligibility for Registration
    2. Regulatory Position
    3. Labeling Rational
    4. Labeling
  5. Actions Required by Registrants
  6. Appendix A

  1. Executive Summary

    1. Idenity

      2. The technical grade active ingredient (TGAI) consists entirely of the dried and ground plant material from harvested Reynoutria sachalinensis (giant knotweed) plants grown for this purpose. The end-use product Milsana® Bioprotectant Concentrate (hereafter referred to as Milsana®) contains 5% of the ethanolic extract of Reynoutria sachalinensis, and is not manufactured by an integrated process. The product chemistry data submitted by the registrant satisfies the requirement for product identity.

    2. Use/Usage

      3. Milsana® is to be used as a spray on greenhouse grown ornamental plants for the purpose of boosting their natural defense mechanisms against certain fungal diseases. The product should be used as a preventive application mainly for the control of powdery mildew. The use is classified as a greenhouse, non-food crop application.

    3. Risk Assessment

      4. No unreasonable adverse effects on humans or the environment are anticipated from aggregate exposure to Milsana®. This includes all anticipated exposures for which there is reliable information.

      1. Human Health Risk Assessment


        1. Toxicological Endpoints

          2. No toxicological endpoints were identified. Mammalian toxicology data requirements have been submitted and adequately satisfy data requirements to support the registration. Submitted data for the TGAI and the end-use product, indicate Toxicity Category IV for acute oral and acute inhalation toxicity. Acute dermal toxicity data indicated a Toxicity Category III. The data reported for primary eye irritation studies showed that the test substance was moderately irritating, and was given a Toxicity Category III when the TGAI was used, and Toxicity Category II when the end use product MilsanaŽ is used as a test material. Exposure to MilsanaŽ produced very slight erythema in animal tests; as a result, a Toxicity Category IV was given for dermal irritation.

        2. Human Exposure

          3. Human exposure would be very low because the product is for use in greenhouses only. Moreover, for workers, the product is Toxicity Category IV for both inhalation and dermal irritation, and the label language will mitigate the eye irritation risks.

        3. Risk Assessment

          4. The Biopesticides and Pollution Prevention Division (BPPD) has not identified any subchronic, chronic, immune, endocrine, or nondietary exposure issues as they may affect children and the general U.S. population. The eye irritation risk to applicators is mitigated as long as the product is used according to label directions. No toxicological endpoints have been identified, and there is limited exposure to this product when used according to the label instructions. The Agency has considered the extract of Reynoutria sachalinensis in light of the relevant safety factors in the Food Quality Protection Act (FQPA) of 1996 and under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and has determined that there will be no unreasonable adverse effects from the use of this product.

      2. Ecological Risk Assessment


        1. Ecological Toxicity Endpoints

          2. No toxic endpoints were identified.

        2. Ecological Exposure

          3. The data requirements for nontarget organisms were waived based on the minimal environmental exposure to the extract of Reynoutria sachalinensis. The use of the end-use product in enclosed areas (greenhouses), minimize the chances of exposure for nontarget avian and aquatic organisms.

        3. Risk Assessment

          4. Risk to nontarget organisms is expected to be minimal, due to the low chances of exposure to the environment. Moreover, the active ingredient is a natural component of a commonly found plant. As a result, BPPD believes that the use of the extract of Reynoutria sachalinensis according to label use directions, should result in no significant adverse effects to wildlife.

    4. Data Gaps / Labeling Restrictions

      5. There are no data gaps or labeling restrictions. Because of MilsanaŽ's Toxicity Category II for eye irritation, some restrictions and precautionary labeling are required to mitigate risks associated with the proposed uses (see Labeling Rationale for details).

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  2. Overview

    1. Active Ingredient Overview


      • Common Name: Giant Knotweed Plant Extract


      • Chemical Name: Extract of Reynoutria sachalinensis


      • Trade and Other Names: MilsanaŽ Bioprotectant Cencentrate


      • OPP Chemical Code: 055809

      Basic Manufacturer:

      KHH BioSci, Inc.
      Centennial Campus/Venture II Building
      920 Main Campus Drive, Suite 400 Raleigh, NC 27606

    2. Use Profile

      3. The following, is information on the proposed uses with an overview of use sites and application methods.

      • Type of Pesticide: Growth Regulator


      • Use Sites: Ornamental Species Grown in Greenhouses.


      • Target: Fungal Diseases (Mainly Powdery Mildew and Gray Mold)


      • Formulation Types: Suspension Concentrate (Liquid)


      • Method and Rates of Application: Applications should be done using conventional ground or foliar application equipment. Mix MilsanaŽ with water at a rate of 2 quarts (0.1 quart of the active ingredient) per 100 gallons of water.


      • Use Practice Limitations: For use only on ornamental non-food greenhouse crops. Make no more than 6 applications per year.


      • Timing: Application should start at the 4-6 leaf stage. Repeat at 7 to 10 day intervals.

    3. Estimated Usage

      4. None used yet since this will be the first registered product.

    4. Data Requirements

      5. The data requirements for granting this registration under Section 3(c)(5) of FIFRA have been reviewed by BPPD. The mammalian toxicology and ecological effects data requirements for the giant knotweed (Reynoutria sachalinensis) plant extract have been fulfilled. Product analysis data requirements are adequately satisfied.

    5. Regulatory History

      6. On May 6, 1999, the Agency received an application from KHH BioScience, Inc. to register Milsana® Bioprotectant Concentrate and the technical grade active ingredient, Reynoutria sachalinensis bioprotectant, containing 5% and 100% of dried and ground giant knotweed (Reynoutria sachalinensis) respectively .

      A notice of receipt of the application for registration of Reynoutria sachalinensis as a new active ingredient was published in the Federal Register on December 28 1999 (64 FR 72658) with a 30-day comment period. No comments were received as a result of this publication.

    6. Classification

      7. In 1996, the Biochemical Classification Committee determined that Milsana® (alcoholic extract of Reynoutria sachalinensis) is a biochemical pesticide because it is naturally occurring and has a non-toxic, indirect mode of action.

    7. Food Clearances/Tolerances

      8. A numeric tolerance or exemption from the requirement of a tolerance is not needed because there are no food uses associated with the registration of MilsanaŽ.

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  3. Science Assessment

    1. Physical/Chemical Properties Assessment

      2. All product chemistry data requirements for the extract of Reynoutria sachalinensis are satisfied.

      1. Product Identity and Mode of Action


        1. Product Identity:

          2. The technical grade active ingredient consists entirely of the dried and ground plant material from harvested Reynoutria sachalinensis (giant knotweed) plants grown for this purpose. The end-use product Milsana® Bioprotectant contains 5% of the ethanolic extract of Reynoutria sachalinensis, and is not manufactured by an integrated process.

        2. Mode of Action:

          3. Reynoutria sachalinensis extract, which is used as a preventive treatment, is believed to induce a non-specific resistance against certain fungal diseases. The active ingredient appears to be a natural elicitor of phytoalexins, which induce the plant's natural "immune system", providing resistance in the host plant.

        3. Food Clearances/Tolerances

          4. There are no food uses associated with this action. As a result, a tolerance establishment/exemption is not required.

        4. Physical And Chemical Properties Assessment

        The physical and chemical characteristics of the TGAI and the end-use product were submitted to support the registration. There are summarized in Table 1.

        GUIDELINE NO. STUDY RESULTS MRID NO.
        151B-10 151B-11 151B-12 Product identity; Manufacturing process; Discussion of formulation of unintentional ingredients TGAI consists of 100% dried and ground knotweed plant material.
        EU contains 5% of the ethanolic extracts of the TGAI and 95% impurities.        		 44821901
        151B-13 Analysis of samples Since this a plant extract, a Bioassay Method (dose response) was used to demonstrate consistent activity in lieu of 5 batch analysis. 44857301
        151B-15 Certification of limits Limits listed in the CSF are adequate 44821901
        151B-16 Analytical method G C / F I D 44857301
        151B-17 PHYSICAL / CHEMICAL PROPERTIES FOR THE TGAI and End-Use Product (EU)
        151B-17(a) Color TGAI: Olive green, brown and cream EU: Not Required 44821902
        151B-17(b) Physical State TGAI: Non-uniform solid EU: Liquid 44821902
        151B-17(C) Odor No odor 44821902
        151B-17(d) Melting point Not Required TGAI is a solid plant extract  
        151B-17(e) Boiling point Not Required; TGAI is a solid plant extract o  
        151B-17(f) Density/Specific gravity TGAI: 0.135 g/ml EU: 1.394g/ml 44821903
        151B-17(g) Solubility Not Required; TGAI is a solid plant extract o  
        151B-17(h) Vapor Pressure Not Required; TGAI is a solid plant extract o  
        151B-17(I) pH EU: 6.84 (@ " 0.03 for 1% solution 44821903
        151B-17(j) Stability Not Required; TGAI is a solid plant extract o  
        151B-17(k) Flammability Not Required; TGAI is a solid plant extract o EU: No flashpoint up to 101.8 EC 44821903
        151B-17(l) Storage stability Not Required; TGAI is a solid plant extract o  
        151B-17(m) Viscosity TGAI: Not Required; TGAI is a solid plant extract o EU: 79.4 cp at 20.1EC 44821903
        151B-17(n) Miscibility TGAI: Not Required; TGAI is a solid plant extract o EU: Not emulsifiable 44821902
        151B-17(o) Corrosion characteristics EU does not contain corrosive ingredients 44821902
        151B-17(p) Octanol/water partition coef. Not Required; TGAI is a solid plant extract o  

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    2. Human Health Assessment

      3. The information submitted in support of the application for registration of Milsana® Bioprotectant Concentrate and the technical grade active ingredient Reynoutria sachalinensis bioprotectant adequately satisfies the requirements set forth in 40 CFR 158.690 (c) for biochemical pesticides for non-food indoor uses. The overall toxicological risk from human exposure to the extract of Reynoutria sachalinensis is considered negligible.

      1. Toxicology Assessment

        2. Adequate mammalian toxicology data are available and support registration of the product containing the active ingredient Reynoutria sachalinensis plant extract.

        1. Acute Toxicity

          2. The registrant submitted acceptable acute toxicity studies. Based on a lack of mortality observed in albino rats, the oral LD50 of the liquid end-use product Milsana®, was >5000 mg/kg; Toxicity Category IV. Based on a lack of mortality observed in albino rabbits dermally dosed with 2000 mg/kg of liquid product, the LD50 was >2000 mg/kg; Toxicity Category III. All the animals exposed to the product for 4 hours, lived and gained weight during the study. The LC50 is >2.6 mg/L; making inhalation a Toxicity Category IV. With a dose of 0.1 ml of liquid Milsana®, the highest Average Ocular Irritation Index was 23.3, recorded one hour after initiation. This classifies Milsana® as moderately irritating with a Toxicity Category II. However, when the TGAI was used as a test material, the highest average ocular irritation recorded was 12.2. As a result, the primary eye imitation for the extract of Reynoutria sachalinensis could be classified as Toxicity Category III. Therefore, it may be safe to believe that product Milsana® contains an eye irritant inert. Dermal application of 0.5 g of liquid product did not cause any dermal irritation symptoms up to 72 hours postdosing; Toxicity Category IV. Based on the data submitted for dermal sensitization, the test substance is not considered to be a contact sensitizer in guinea pigs by the Buehler method.

        2. Mutagenicity, Developmental Toxicity, and Immune Response

          3. Studies to detect genotoxicity are only conditionally required for terrestrial, non-food use biochemical pesticides. 40 CFR 158.690(c)(v) indicates that these studies are required if use is likely to result in significant human exposure, or if the active ingredient or its metabolites are structurally related to a known mutagen or belong to a class of chemical compounds which contains known mutagens. Human exposure to the active ingredient when used in accordance with label instructions in greenhouses on ornamental plants is anticipated to be very low due to the low application rate, re-entry restrictions, and protective wear requirements for greenhouse workers. In addition, the active ingredient is not structurally related to a known mutagen, nor does it belong to a class of known mutagens. Since Reynoutria sachalinensis is found in food and in medicines, and there have been no reports of adverse effects over many years of significant human exposure, these studies were waived.

          Although immune response studies are required under 40 CFR 158.690(c), the test compound did not cause dermal sensitization in guinea pigs when tested by the Buehler method. Thus, along with the low anticipated human exposure from the labeled uses, the presence of the active ingredient as food, animal feed, and medicine in other parts of the world, and no reports of adverse effects in humans after many years of significant human exposure, the immune response study was waived. Any incidents resulting from the labeled uses must be reported in accordance with section 6(a)(2) of FIFRA. If such reports occur, this data may be required at that time.

          Mammalian toxicity data for the extract of Reynoutria sachalinensis, are summarized in Table 2.

          Table 2. Toxicity data requirements
          GUIDELINE NO. STUDY RESULTS MRID NO.
          TIER I
          152-10 Acute oral toxicity in rats LD50 is > 5000 mg/Kg Toxicity Category IV 44821905
          152-11 Acute dermal toxicity in rabbits Both TGAI and EU:

          LC50 is >2000 mg/Kg Toxicity Category III          		 44821907
          152-12 Acute inhalation toxicity in rats Both TGAI and EU:

          LC50 is >2.6 mg/L

          Toxicity Category IV          		 44821908
          152-13 Primary eye irritation in rabbits TGAI: Average ocular irritation index recorded was 12.2

          Toxicity Category III

          EU: Average Ocular Irritation Index was 23.3, recorded one hour after initiation

          Toxicity Category II          		 4482190
          152-14 Primary dermal irritation in rabbits Dermal application of 0.5 g of liquid product did not cause any dermal irritation symptoms up to 72 hours postdosing

          Toxicity Category IV          		 44821911
          152-15 Dermal sensitization in guinea pigs Both TGAI and EU are not considered to be a contact sensitizer in guinea pigs by the Buehler method. 44821914
          152-16 Hypersensitivity incidents No hypersensitivity incidents observed 44821914
          152-17 Genotoxicity - Salmonella typhimurium gene mutation assay Waived  
          152-18 Cellular immune response Waived  
          152-19 Mutagenicity:

          * Mouse Lymphoma forward mutation

          * In vivo mouse micronucleus assay          		 Waived  
        3. Subchronic Toxicity

          4. A 90 - day feeding study was not required because of the non-food use of Milsana®. Moreover, the 90 - day dermal and inhalation toxicity studies are not required because the proposed use pattern does not result in prolonged exposure at concentrations that are likely to be toxic. The immunotoxicity study (cellular immune response study) was waived based on the minimal potential for exposure and the low toxicity of the extract of Reynoutria sachalinensis shown in the studies submitted.

        4. Chronic Exposure and Oncogenicity Assessment

          5. Chronic exposure studies are conditionally required to support non-food uses only if the potential for adverse chronic effects are indicated based on 1) the subchronic effect levels established in Tier I subchronic oral, inhalation, or dermal studies, 2) the pesticide use pattern, or 3) the frequency and the level of repeated human exposure that is expected. Oncogenicity studies are required to support non-food uses only if the active ingredient or any of its metabolites, degradation products, or impurities produce in Tier I studies morphologic effects in any organ that potentially could lead to neoplastic changes. The triggers for chronic exposure and oncogenicity studies were not met.

        5. Effects on the Endocrine Systems

          6. EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen- and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

          Based on the weight of the evidence of available data, no endocrine system-related effects have been identified for the extract of Reynoutria sachalinensis.

      2. Dose Response Assessment

        3. No toxicological endpoints are identified.

      3. Dietary Exposure and Risk Characterization

        4. Dietary exposure is unlikely to occur because of the non-food use of Milsana®. In the absence of any toxicological endpoints, risk from the consumption of residues is not expected for the general population including infants and children.

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

        5. Significant human exposure to Milsana® is not expected in residential, school and day care areas.

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        1. Occupational Exposure

          2. Based on its low toxicity and its use on ornamentals intended for aesthetic purposes, Milsana® is not subject to the Worker Protection Standards (WPS). Moreover, the possibility for dermal, eye and inhalation exposure, is mitigated as long as the product is used according to label directions, which requires the use of protective equipment, the restricted entry interval into treated areas, and allowing proper ventilation time before permitting human activity in the treated areas.

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

          3. No indoor residential, school, or day care uses currently appear on proposed labels. Human exposure to MilsanaŽ should not occur in these areas.

      5. Drinking Water Exposure

        6. Exposure to Milsana® in drinking water is not expected.

      6. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly Infants and Children

        7. There are no food uses associated with the proposed use of the Milsana®. Therefore, the acute dietary risks should be negligible based on the lack of exposure.

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

        8. Aggregate exposure would primarily occur to the applicators via dermal and inhalation routes. Risks associated with dermal and inhalation aggregate exposure are measured via the acute toxicity studies submitted to support registration. Because the inhalation toxicity studies for MilsanaŽ showed no toxicity (Toxicity Category IV), the risks anticipated for this route of exposure are considered minimal. Results of the acute dermal study indicated low toxicity (Toxicity Category III) and no significant dermal irritation (Toxicity Category IV). Based on these results, the anticipated risks from dermal exposure are also considered minimal. Therefore, the risks from aggregate exposure via dermal and inhalation exposure are a compilation of two low risk exposure scenarios and are considered negligible. Temporary eye irritation and injury may occur, because the primary eye irritation study for Milsana7 is Toxicity Category II. However, this risk is mitigated as long as the product is used according to label directions, which requires the use of protective equipment by users, restricted re-entry interval into treated areas, and proper ventilation time before permitting human activity in the treated areas.

      8. Cumulative Effects

        9. The extract of Reynoutria sachalinensis is not toxic and therefore there would be no expected cumulative effects from common mechanisms of toxicity.

      9. Risk Characterization

        10. The Agency has considered the extract of Reynoutria sachalinensis 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 Milsana7

        when label instructions are followed.

    3. Environmental Assessment

      1. Ecological Effects Hazard Assessment

        2. The end use product Milsana® is intended for use in non-food enclosed areas. When applied according to the proposed label, no direct exposure of birds, aquatic organisms and non-target insects to Milsana® is expected to occur. Moreover, the active ingredient is a naturally abundant plant species. Therefore, Milsana®'s potential environmental/ecological effects are likely to be negligible. As a result, non-target organism/ecological effects studies were not required for this particular use of Milsana®.

      2. Environmental Fate and Ground Water Data

        3. The need for environmental fate and groundwater data (Tier II, (40 CFR Section 158.690(d)(2)(vii through xv)) was not triggered because the results from Tier I studies were classifies as practically non-toxic. Risk to nontarget species is minimal due to the lack of exposure, low toxicity, use pattern, and application methods.

      3. Ecological Exposure and Risk Characterization

        4. Minimal potential for exposure exists to nontarget wildlife as a result of Milsana®'s use.

    4. Efficay Data

      5. No efficacy data are required, because no public health uses are involved.

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  4. Risk Management Decision

    1. Determination of Eligibility for Registration

      2. Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is determined that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials required to be submitted comply with the requirements of FIFRA; (c) it will perform its intended function without unreasonable adverse effects on the environment and (D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.

      To satisfy criteria "A" above, the extract of Reynoutria sachalinensis is not expected to cause unreasonable adverse effects when used according to label instructions. Criteria "B" is satisfied by the current label and by the data presented in this document. It is believed that this new pesticidal active ingredient will not cause any unreasonable adverse effects, will extend the life and usefulness of ornamentals as claimed satisfying Criteria "C". Criteria "D" is satisfied by the data submitted and the low exposure to the product when used according to label directions.

      Therefore, the extract of Reynoutria sachalinensis is eligible for registration. Registered use is listed in Table 4, Appendix A.

    2. Regulatory Position



      1. Conditional/Unconditional Registration

        2. All data requirements are fulfilled and BPPD recommends unconditional registration of the extract of Reynoutria sachalinensis.

      2. CODEX Harmonization

        3. There are no Codex harmonization consideration since there is no food use associated with this registration.

      3. Nonfood Re/Registrations

        4. There are no non-food issues at this time. The nonfood uses are listed in Appendix A, Table 4.

      4. Risk Mitigation

        5. There are no significant risk issues. Risks to greenhouse workers are mitigated by protective clothing requirements and re-entry restrictions.

      5. Endangered Species Statement

        6. Currently, the Agency is developing a program (The Endangered Species Protection Program) to identify all pesticides whose use may cause potential adverse impacts on endangered and threatened species and their habitats. To aid in the identification of threatened and endangered species and their habitats, several companies have formed an Endangered Species Task Force (EST) under the direction of the American Crop Protection Association (ACPA). Moreover, the EST will assist in providing species location information at the subcounty level, and particularly if an endangered species occurs in areas where pesticides would be used. This information will be useful once the Endangered Species Protection Program has been implemented.

        Prior to the implementation of the Endangered Species Protection Program, the Agency will not impose specific labeling on those pesticides that may pose risks to threatened and endangered species and their habitats but will defer imposing specific labeling language until implementation of the Program.

    3. Labeling Rational

      4. It is the Agency's position that the labeling for Milsana® Bioprotectant Concentrate and the technical grade active ingredient Reynoutria sachalinensis bioprotectant containing, respectively, 5% and 100% of dried and ground giant knotweed (Reynoutria sachalinensis) complies with the current pesticide labeling requirements.

      1. Human Health Hazard


        1. Human Health Hazard

          2. This product does not come under the provisions of the Worker Protection Standards (WPS).

        2. Non-Worker Protection Standard

          3. There are no non-WPS human health hazard issues.

        3. Precautionary Labeling

          4. The Agency has examined the toxicological data base for Milsana® product and concluded that the proposed precautionary labeling (i.e. Signal Word, Statement of Practical Treatment and other label statements) adequately mitigates any risks associated with the proposed uses.

          End-Use product Precautionary Labeling: For Milsana®, "WARNING". Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses) Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash clothing before reuse.

          Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of twenty four (24) hours.

        4. Spray Drift Advisory

          5. No spray drift advisory statement is necessary for this use

      2. Environmental Hazards Labeling

        3. End-Use Product Environmental Hazards Labeling: Because Milsana® is exclusively intended for greenhouse use, the environmental hazard statement is not required on the end-use product's label.

      3. Application Rate

        4. t is the Agency's position that the labeling for the pesticide product containing Milsana® complies with the current pesticide labeling requirements. The Agency has not stipulated a maximum number of applications for the active ingredient. Applications should be done using conventional ground or foliar application equipments. Mix Milsana® with water at a rate of 2 quarts per 100 gallons of water. Begin applications at 4-6 leaf stage at 7 to 10 day intervals.

    4. Labeling

      1. Product name: Milsana7 Bioprotectant Concentrate

        2. Active Ingredient: Extract of Reynoutria sachalinensis 5.00%

        Other Ingredients 95.57%

        Total 100.00%

      2. Product name: Reynoutria sachalinensis bioprotectant

        3. Active Ingredient: Extract of Reynoutria sachalinensis 100 %

        Other Ingredients 0 %

        Total 100.00%

      Signal word is "WARNING". Eye irritation warning is appropriate.

      The product shall contain the following information:

      - Product Name

      • Ingredient Statement
      • Registration Number
      • "Keep Out of Reach of Children"
      • Signal Word (WARNING)

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  5. Actions Required by Registrants

    6. Reports of incidences of adverse effects to humans or domestic animals under FIFRA, Section 6(a)2 and incidents of hypersensitivity under 40 CFR Part 158.690(c), guideline reference number 152-16. There are no data requirements, label changes and other responses necessary for the reregistration of the end-use product since the product is being registered after November 1984 and is, therefore, not subject to reregistration. There are also no existing stocks provisions at this time.

  6. Appendix A

    7. Milsana® Bioprotectant Concentrate Use Site Greenhouse grown ornamental plants Official date registered:

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