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BIOPESTICIDES REGISTRATION ACTION DOCUMENTCold Pressed Neem OilPC Code 025006U.S. Environmental Protection AgencyOffice of Pesticide ProgramsBiopesticides and Pollution Prevention Division(Last updated October 14, 20009)This document is for informational purposes only and isrepresentative of the Agency’sjustification in registeringproducts containing this active ingredient. This is not a legal document.
Cold Pressed Neem OilPage 2 of 20Biopesticides Registration Action DocumentTABLE OF CONTENTSI. EXECUTIVE SUMMARY: ……………………………………………………………………………………. 5II. ACTIVE INGREDIENT OVERVIEW……………………………………………………………………. 6III. REGULATORY BACKGROUND………………………………………………………………………….6A. Classification ………………………………………………………………………………………………………… 6B. Food Clearances and Tolerances……………………………………………………………………………. 6IV. RISK ASSESSMENT…………………………………………………………………………………………….. 7A. Active Ingredient Characterization ……………………………………………………………………….. 7B. Human Health Assessment ……………………………………………………………………………………. 71. Toxicology………………………………………………………………………………………………………….. 72. Dose Response Assessment………………………………………………………………………………….. 93. Food Quality Protection Act (FQPA) Consideration…………………………………….94.. Occupational, Residential, School and Day Care Exposure and RiskCharacterization ………………………………………………………………………………………………. 115 Cumulative Effects……………………………………………………………………………………………. 116 Risk Characterization………………………………………………………………………………………… 11C. ENVIRONMENTAL ASSESSMENT…………………………………………………………………… 121. Ecological Hazards…………………………………………………………………………………………….122. Environmental Fate and Ground Water Data ……………………………………………………. 123. Ecological Exposure and Risk Characterization ………………………………………………… 124. Endangered Species Assessment……………………………………………………….13D. EFFICACYDATA………………………………………………………………………………………………. 13V. RISK MANAGEMENT DECISION………………………………………………………………………13A. Determination of Eligibility for Registration ………………………………………………………… 13B. Regulatory Decision14C. Environmental Justice 13VI. ACTIONS REQUIRED BY REGISTRANTS………………………………………………………… 14A. Reporting Adverce Effects …………………………………………………………………………………… 14B.Reporting of Hypersensitivity Incidents………………………………………………………………………………15
Cold Pressed Neem OilPage 3 of 20Biopesticides Registration Action DocumentVII. APPENDIX A. Product Specific Information…………………………………………..19VIII. APPENDIX B. Product Specific Information…………………………………………..19IX. APPENDIX C. References……………………………………………………………………………………… 19
Cold Pressed Neem OilPage 4 of 20Biopesticides Registration Action DocumentBIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAMOffice of Pesticide Programs:Biopesticides and Pollution Prevention DivisionBiochemical Pesticides Branch (BPB)Driss Benmhend Regulatory Action LeaderLinda Hollis Branch ChiefRussell Jones Senior BiologistManying Xue Chemist
Cold Pressed Neem OilPage 5 of 20Biopesticides Registration Action DocumentI. EXECUTIVE SUMMARY:The active ingredient Cold Pressed Neem Oil is pressed directly from seeds of the Neem tree(Azadirachta indica), which is a tropical evergreen tree native to India and also found in otherSoutheast Asian and African countries. Cold Pressed Neem Oil has a brown color, a bitter tasteand a garlic/sulfur smell.This application is for use on outdoor and greenhouse agricultural foodand ornamental crops, and as an insect repellent and insect growth regulator.The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data required tosupport the registration of this biochemical active ingredient, under Section 3(c)(5)of theFederal Insecticide, Fungicide and Rodenticide Act (FIFRA). Product chemistry datarequirements were satisfied by acceptable guideline studies. Adequate mammalian toxicologydata/information was submitted to support registration of Cold Pressed Neem Oil. Acceptableacute toxicity guideline studies were submitted, and data waivers were granted by the Agencyfor the remaining toxicity requirements based on the lack of toxicity of the active ingredient.Ecological effects data requirements for Cold Pressed Neem Oil are fulfilled by acceptableguideline studies and additional data/information from the scientific literature sufficient tosupport the remaining Tier I and Tier II requirements.Based on the data available to the Agency, it has been determined that no unreasonable adverseeffects to the U.S. population and the environment will result from the use of the activeingredient when label instructions are followed and good agricultural practices are employed.Laboratory studies indicate that the active ingredient is not toxic following oral, inhalation ordermal exposure. Cold Pressed Neem Oil and neem extracts are widely used in cosmetics (soap,hair products, hand creams, etc.), traditional folk medicine (acne, fevers, rheumatism, diuretics,inflammations, etc.), as an insect repellent, insecticide, nematicide, fungicide, and as a fertilizer.There are no reports of adverse effects following human exposure to Neem Oil. Moreover, thepesticidal usage of this biochemical will not have any harmful environmental effects. Studiesindicate that Cold Pressed Neem Oil will not cause adverse effects to mammals, birds, fish andaquatic invertebrates, other non-target insects, or plants.Due to the negligible risk concerns when used as an insect repellent, Cold Pressed Neem Oilmeets the criteria as specified in §3(c)(5) of the Federal Insecticide, Fungicide and RodenticideAct (FIFRA), as amended, and is thus eligible for unconditional registration. It was determinedthat the data/information submitted adequately satisfy applicable data requirements at 40 C.F.R.Subpart U §158.2000.
Cold Pressed Neem OilPage 6 of 20Biopesticides Registration Action DocumentII. ACTIVE INGREDIENT OVERVIEWCommon Name:Neem OilChemical Names:Cold Pressed Neem OilTrade & Other Names: Cold Pressed Neem OilCAS Registry Number:8002-65-1OPP Chemical Code:025006Type of Pesticide:Insect repellent and anti-feedant.Application rates and methods vary depending on the product. For specific informationregarding the product(s)refer to Appendix B.III.REGULATORY BACKGROUNDOn August 02, 2007, Plasma Power of India, submitted an application for the registration of theend use product (EP) Plasma Neem™ Oil (azadirachtin 3000 ppm) Insecticide (84185-U), andPlasma Neem™ Oil Manufacturing Use Product (84185-G). Both products contain 100% ColdPressed Neem Oil A notice of receipt of the application for registration of Cold Pressed NeemOil as a new active ingredient was published in the Federal Register on October 24, 2007(72 FR60365), with a 30-day comment period. No comments were received following this publication.Consistent with the Agency’s new policy for making pesticide registration actions moretransparent, EPA provided a 30-day public comment period on the decision to register ColdPressed Neem Oil. No comments were received during the 30 day public comment periodA. ClassificationThe Biochemical Classification Committee determined that Cold Pressed Neem Oil is abiochemical pesticide due to its apparent non-toxic mode of action and natural occurrence in theenvironment.B. Food Clearances/TolerancesThe applicant filed a petition (PP 7F7249) proposing to establish an exemption from therequirement of a tolerance for residues of ColdPressed Neem Oil in or on all food commodities.A notice of filing was published on November 2, 2007 (72 FR 62237). On October 13, 2009,EPA promulgated a final rule exempting residues of the biochemical pesticide Cold PressedNeem Oil, from the requirement for tolerance in or on all food commodities.
Cold Pressed Neem OilPage 7 of 20Biopesticides Registration Action DocumentIV. RISK ASSESSMENTA. Active Ingredient CharacterizationCold Pressed Neem Oil is pressed directly from seeds of the Neem tree (Azadirachta indica),which is a tropical evergreen tree native to India and also found in other Southeast Asian andAfrican countries. Cold Pressed Neem Oil has a brown color, a bitter taste and a garlic/sulfursmell. A single seed may contain up to 50 percent oil by weight. Cold Pressed Neem Oil containsvarious compounds that have insecticidal and medicinal properties. It is used in makingshampoos, toothpaste, soaps, cosmetics, mosquito repellents, creams and lotions, and petproducts such as pet shampoo. It also contains vitamin E, other essential amino acids and fattyacids. Cold Pressed Neem Oil is used for treating many skin diseases, including eczema,psoriasis, and skin allergies.Cold Pressed Neem Oil is a mixture of several C26terpenoids that are naturally occurring organiccompounds composed of a five-carbonskeleton (simple terpenoids) or complex terpenoids withstructures that possess between 20 and 40 carbon atoms. Azadirachtin, the most commonterpenoid in Cold Pressed Neem Oil and the most thoroughly characterized, is a federallyregistered active ingredient pesticide. Cold Pressed Neem Oil also contains steroids, fatty acids,and a number of essential oils.The descriptions of the product formulation and production process, as well as the formation ofimpurities, were examined by the Agency and found to meet current standards. A preliminaryanalysis was conducted to determine Cold Pressed Neem Oil content in five batches of theproduct, and the results were determined to be acceptable by the Agency. The analytical methodused to determine the content of the active ingredient is also acceptable. Physical and chemicalproperties were submitted for the active ingredient and are adequate. Refer to Table 1 inAppendix Afor a summary of product chemistry data requirements. Refer to Table 2 inAppendix A for the summary of physical and chemical characteristics for Neem Oil.All productchemistry data requirements for registration of Cold Pressed Neem Oil have been satisfied.B. Human Health Assessment1. ToxicologyToxicity categories are assigned based on thehazard(s) identified from studies and/orinformation on file with the Agency. An active ingredient is classified into Toxicity Category I,II, III or IV, in which Toxicity Category I indicates the highest toxicity and Toxicity CategoryIV indicates the lowest toxicity.Adequate mammalian toxicology data/information is available to support registration of ColdPressed Neem Oil.All toxicology data requirements for Cold Pressed Neem Oil have beensatisfied.
Cold Pressed Neem OilPage 8 of 20Biopesticides Registration Action Documenta. Acute ToxicityAcute toxicity testing is required to 1) determine systemic toxicity from acute exposure via thedermal, 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 toxicity data submitted and reviewed showed that Cold Pressed Neem Oil is a toxicitycategory IV (low toxicity) compound via acuteoral and acute inhalation routes of exposure.Cold Pressed Neem Oil is in Toxicity Category III (slightly toxic) for acute dermal irritation.Cold Pressed Neem Oil is not an eye or skin irritant, and it is not a dermal sensitizer. Noadditional toxicity data are required to support usage of this biochemical.For more information regarding the acute toxicity data requirements, refer to Table 3 inAppendix A.b. Sub-chronic ToxicitySubchronic data is required to determine a no-observed-effect-level (NOEL)and toxic effects (ifany) associated with repeated or continuous exposure to a test substance for a period of 90 days.To address this data requirement, the applicant submitted data obtained from the technical publicliterature in lieu of a guideline study. The study showed that test animals did not exhibit anyclinical signs of toxicity that were statisticallydifferent from untreated controls. There were nosignificant changes in body weight, serum liver damage indicators, direct bilirubin and totalbilirubin, or other blood parameters during the90-day study period. The 90-day oral feedingLD50is higher than 5000 mg crude Cold Pressed Neem Oil/kg body weight. Based on thereview of this data, EPA concluded that no subchronic oral toxicity is expected to occur whenthis compound is used in accordance with good agricultural practices.The 90-day dermal toxicity data requirement was waived by the Agency. Dermal metabolism ofthe product is not expected to differ from its oral metabolism. In the acute guideline studies, theproduct was demonstrated to have no acute dermal toxicity (LD50>4000 mg/kg), was not adermal irritant, and was not a dermal sensitizer. Prolonged human dermal exposure is unlikely.Humans are regularly exposed to this substance in medicinal and cosmetic products, via the oral,inhalation and dermal routes, and at comparatively high levels. These uses are also expected toresult in exposures that are significantly greater than that which would be expected frompesticidal uses. Based on the lack of toxicity (Toxicity Category IV) demonstrated in thesubmitted acute inhalation toxicity study and the anticipated lack of repeated inhalation exposureunder good agricultural usage, the requirement for a 90-day inhalation study was waived by theAgency.For more information regarding the subchronic data requirements, refer to Table 3 in AppendixA.
Cold Pressed Neem OilPage 9 of 20Biopesticides Registration Action Documentc. Developmental Toxicity and MutagenicityStudies from technical public literature were submitted to address the data requirements fordevelopmental toxicity and mutagenicity (OPPTS 870.3700).Based onIn vitroandin vivostudies, and subcutaneous and intravaginal applications of ColdPressed Neem Oil, it seems that developmental toxicity may occur in test animals when exposedto Cold Pressed Neem Oil by intravaginal, intrauterine, subcutaneous injection, or by directexposure to mammalian sperm and eggs inin vitrolaboratory studies. The three generationstudy in rats fed Cold Pressed Neem Oil in the diet, however, demonstrates that chronic oralingestion of food commodities containing Cold Pressed Neem Oil residues does not result in anymammalian developmental toxicity. Taken together, these data demonstrate that nodevelopmental toxicity is expected to occur from the use of Cold Pressed Neem Oil as apesticide.Furthermore,Cold Pressed Neem Oil and its components are not structurally related to knownmutagens, nor do they belong to any chemical class of compounds containing known mutagens.Humans are regularly exposed to this substance via oral exposure (as a traditional folk medicinalproduct) and dermal exposure (when used on skin and hair) at levels that are significantly greaterthan that which would be expected from the product as a pesticide under conditions of use. Inaddition, an extensive literature search of several scientific databases (i.e. ChemIDPlus, HSDB,Toxline, CCCRIS, DART, GENETOX, IRIS, ITER, LactMed, Multi-Database, TRI, HazMap,Household Products, TOXMAP and TOXNET) for the period 1980 to 2008 failed to locate anyother data / information regarding mutagenicity or genotoxicity of Cold Pressed Neem Oil. As aresult, EPA concludes that Cold Pressed Neem Oil is not mutagenic or genotoxic.e. Effects on the Endocrine SystemEPA is required under the Federal Food, Drug, and Cosmetics Act (FFDCA) to develop ascreening program to determine whether certain substances (including all pesticide active andother ingredients) “may have an effect in humans that is similar to an effect produced by anaturally-occurring estrogen, or other such endocrine effects as the Administrator maydesignate.” Following the recommendations of itsEndocrine Disruptor Screening and TestingAdvisory 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 estrogenhormone system. EPA also adopted EDSTAC’s recommendation that the program includeevaluations of potential effects in wildlife.When the appropriate screening and/or testingprotocols being considered under the Agency’sEndocrine Disrupter Screening Program (EDSP)have been developed and vetted, Cold Pressed Neem Oil may be subjected to additionalscreening and/or testing to better characterize effects related to endocrine disruption.2. Dose Response AssessmentNo meaningful toxicological endpoints were identified on Cold Pressed Neem Oil when used asa pesticide; therefore, a dose response assessment was not required.
Cold Pressed Neem OilPage 10 of 20Biopesticides Registration Action Document3. Food Quality Protection Act (FQPA) Considerationa. Dietary Exposure and Risk CharacterizationThe most likely human exposure to Cold Pressed Neem Oil will occur via dietary exposure(consumption) to treated fruits, seeds, or leafy vegetables. EPA modeling (using the TerrestrialExposure model (T-REX; EPA, 2005) of potentialresidues of Cold Pressed Neem Oil followingterrestrial treatments indicated that following 12consecutive applications of 100% Cold PressedNeem Oil at 7-day intervals, the maximum dietary residues present would be approximately 881ppm on broadleaf plant foliage; and approximately 98 ppm on fruits, pods, and seeds. Themodeling indicated that residues would decline rapidly between foliar applications(approximately 245-440 ppm on broadleaf foliage; and 27-49 ppm on fruits, pods, and seeds)and following the final application (see Table 4 in appendix A). As stated in section B (a) of thisdocument, Cold Pressed Neem Oil is a toxicity category IV for oral exposure (LD50= >5000mg/kg). The estimated maximum theoretical residues likely to be present on edible commoditiesare 882 ppm. This residue level is approximately 5-fold less than the highest doses used in acuteand subchronic laboratory testing (5000 mg/kg)and approximately 20-fold less than chroniclaboratory testing (10% in the diet) at which nomortalities or other signs of clinical toxicitywere observed. Therefore, based on a lack ofacute, subchronic, or chronic toxicity inlaboratory testing, estimated maximum residues that are well below the doses used in laboratorytesting, and the rapid degradation of Neem Oil in the environment, it is highly unlikely that thatthere will be any adverse effects to humans resulting from dietary exposure to Neem Oil residue.Moreover, humans are regularly exposed to this compound via consumption of Cold PressedNeem Oil medicinal products, and at levels that are significantly greater than what would beexpected from pesticide applications. EPA has determined that dietary exposure is not a concernbecause of the low toxicity of this active ingredient and the history of its use without any reportsof adverse effects.b. Drinking Water Exposure and Risk CharacterizationNo significant drinking water exposure or residues are expected to result from the pesticidalusage of Cold Pressed Neem Oil. The active ingredient is intended for use as a foliar applicationon food commodities and not to be applied directly to water. If used in accordance with EPA-approved labeling, is not likely to accumulate in drinking water. In the unlikely event thatexposure via drinking water did occur from accidental spraying, the health risk would beexpected to be minimal, based on the low acute oral toxicity and the long history of humanexposure to Cold Pressed Neem Oil without adverse effects.As a result, dietary and drinking water exposure to residue of Cold Pressed Neem Oil areexpected to be minimal.c. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly Infantsand ChildrenFFDCA section 408 provides that the Agency shall apply an additional tenfold margin ofexposure (safety) for infants and children in the case of threshold effects to account for pre- andpost-natal toxicity and the completeness of the database unless the Agency determines that adifferent margin of exposure (safety) will be safe for infants and children. Margins of exposure
Cold Pressed Neem OilPage 11 of 20Biopesticides Registration Action Document(safety) are often referred to as uncertainty (safety) factors. In this instance, based on all theavailable information, the Agency has concluded that there is reasonable certainty that no harmto infants and children or adults will result from the use of Cold Pressed Neem Oil when labelinstructions are followed.4.Occupational, Residential, School and Day Care Exposure and Risk Characterizationa. Occupational Exposure and Risk CharacterizationThe potential for dermal, eye, and inhalation exposure to Cold Pressed Neem Oil for handlersand applicators is mitigated as long as products are used according to label directions. TheAgency will require labels to include the appropriate signal word, re-entry interval andprecautionary statements, including the requirement for personal protective equipment, tomitigate any risk of exposure.b. Residential, School and Day Care Exposure and Risk CharacterizationNo indoor residential, school, or day care usesare currently approved for products containingCold Pressed Neem Oil.Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish anexemption from a tolerance, the Agency consider “available information concerning thecumulative effects of [a particular pesticide’s] residues and other substances that have a commonmechanism of toxicity.” These considerations include the possible cumulative effects of suchresidues on infants and children.5. Cumulative EffectsEPA has considered the potential for cumulative effects of Cold Pressed Neem Oil and othersubstances in relation to a common mechanism of toxicity. However, because of its low toxicityto mammalian systems, the Agency does not expect any cumulative or incremental effects fromexposure to residues of Cold Pressed Neem Oil when applied/used as directed on the label and inaccordance with good agricultural practices.6.Risk CharacterizationThe Agency considered human exposure to Cold Pressed Neem Oil in light of the relevant safetyfactors in FQPA and FIFRA. A determination has been made that no unreasonable adverseeffects to the U.S. population in general, and to infants and children in particular, will result fromthe use of Cold Pressed Neem Oil when label instructions are followed.
Cold Pressed Neem OilPage 12 of 20Biopesticides Registration Action DocumentC. ENVIRONMENTAL ASSESSMENT1. Ecological HazardsAdequate non-target toxicology data/informationare available to support registration of ColdPressed Neem Oil.All non-target toxicology data requirements for Cold Pressed Neem Oil havebeen satisfied.There are no concerns for any non-target organisms when 100% Cold Pressed Neem oil isapplied in accordance with EPA-approved label use directions. No toxic endpoints have beenidentified for non-target birds, non-target plants, and non-target soil organism such asearthworms. Although Cold Pressed Neem Oil is slightly toxic to aquatic organisms inlaboratory testing, as a result of the rapid biodegradation of Neem Oil under approved conditionsof use, calculated Risk Quotients (RQs) for fish and aquatic invertebrates are well below anyLevels of Concern (LOCs) for threatened and endangered species. There are no concerns fornon-target insects. Only insects that feed directly on treated plant foliage or roots will bedirectly exposed to Cold Pressed Neem Oil at levels that will be pesticidal. Honey bees andother pollinators that feed on nectar, and predators of insect pests are unlikely to consumesufficient quantities of Cold Pressed Neem Oil to cause adverse effects. Bees have been reportedto avoid foods that contain >100 ppm Cold Pressed Neem Oil.For more information regarding the non-target toxicity data requirements, refer to Table 4 inAppendix A.2. Environmental Fate and Ground Water DataSince Cold Pressed Neem Oil is a multicomponent mixture, azadirachtin A was used as asurrogate when evaluating environmental fate for all of the insecticidally active liminoidcomponents in 100% Cold Pressed Neem Oil.A number of studies have addressed the degradation of Cold Pressed Neem Oil components inthe environment. In forest environments, azadirachtin A persisted 3 to 6 days in terrestrialmatrices and 8 to 13 days in water (Sundaram et al., 1999). In laboratory studies, azadirachtin Awas shown to have temperature dependent degradation rates in sandy loam soils with half-livesof 43.9 and 19.8 days at 15oC and 25oC, respectively (Stark and Walter, 1995). When the soilwas autoclaved, half-lives increased to 91.2 (15oC) and 31.5 days (25oC), demonstrating thesignificant influence of microbial activity in thedegradation of Cold Pressed Neem Oil. Halflives for azadirachtin B in sandy loam soil were comparable to that of azadirachtin A.Azadirachtin is extremely labile in light with photolysis half lives of 48 min to 3.98 days in thinfilms under UV light, and 2.47 days on leaf surfaces (Johnson et al., 2003). In field trials witholives, azadiractin residues had a half-life of 0.8 days (Caboni et al., 2002).Based on the submitted data, Cold Pressed Neem Oil is readily biodegradable in soil, water andon foliar surfaces. As a result, Cold Pressed Neem Oil and its components are not likely topersist in the environment.
Cold Pressed Neem OilPage 13 of 20Biopesticides Registration Action Document3. Ecological Exposure and Risk CharacterizationThe potential for exposure to non-target wildlife is minimal. Based on the results/informationpresented in the Environmental Fate and Groundwater Data section above, it is highly unlikelythat non-target organisms, particularly aquaticorganisms, would be exposed to potentially toxiclevels of Cold Pressed Neem Oil via runoff and/or movement through the soil. Cold PressedNeem Oil undergoes rapid biodegradation in soil and water, and no unreasonable adverse effectsto the environment are expected from the use of Cold Pressed Neem Oil when label instructionsare followed.4. Endangered Species AssessmentA nontarget organism hazard assessment and an Endangered Species Assessment has beenconducted to support registration of Plasma Neem Oil Manufacturing Use Product and PlasmaNeem Oil Biological Insecticide (an end-use product, EP) (the MP and the EP are identicalformulations). There are no concerns for non-target mammals and birds, including threatenedand endangered species. No toxic endpoints were identified for non-target terrestrial mammals(acute oral and dietary toxicity LD50s >5000 mg/kg and 5000 ppm, respectively) and birds (acuteoral and dietary toxicity LD50s >1000 mg/kg and 12000 ppm, respectively. Moreover, based onsubmitted laboratory studies, no concerns were identified for non-target aquatic organisms,including threatened and endangered species. Calculated Risk Quotients (RQs) fish and aquaticinvertebrates are well below any Levels of Concerns (LOCs) for threatened and endangeredspecies.Based on the fact that Cold Pressed Neem Oil is not toxic to non-target organisms and on its usepattern and use instructions, EPA has determined it will have “No Effect” on any currently listedthreatened or endangered species or any designated critical habitatD. PRODUCT PERFORMANCE DATA (EFFICACY)Submission of product performance data (OPPTS 810.3000) is listed as a requirement for allpesticide products. Customarily, the Agency requires efficacy data to be submitted for reviewonly in connection with the registration of products directly pertaining to the mitigation ofdisease bearing human health organisms and certain designated quarantine pests, i.e., ticks,mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc. For a list oforganisms considered by the Agency as “public health pests”, please refer to PesticideRegistration Notice 2002-1 (http://www.epa.gov/PR_Notices/pr2002-1.pdf).V. Risk Management DecisionA. Determination of Eligibility for RegistrationSection 3(c)(5) of FIFRA provides for the registration of new active ingredients if it isdetermined that (A) its composition is such as to warrant the proposed claims for it; (B) itslabeling 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
Cold Pressed Neem OilPage 14 of 20Biopesticides Registration Action Documentenvironment; and (D) when used in accordance with widespread and commonly recognizedpractice it will not generally cause unreasonable adverse effects on the environment.The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfiedby the science assessments supporting products containing Cold Pressed Neem Oil. Suchproducts are not expected to cause unreasonable adverse effects, and are likely to provideprotection as claimed when used according to label instructions.Therefore, Cold Pressed NeemOil is eligible for registration for the labeled uses.B. Regulatory DecisionEPA has determined that Cold Pressed Neem Oilpresents no issues of toxicological, ecological,or environmental concern. As discussed above, acute toxicity data for Cold Pressed Neem Oildemonstrate that it is either toxicity category IV or III. Cold Pressed Neem Oil does notdemonstrate subchronic or developmental toxicity,and it is not mutagenic or genotixic. EPA hasno concerns for any non-target organisms exposed to Cold Pressed Neem Oil in accordance withapproved label directions. EPA has not identified any toxic endpoints for non-target mammals,birds, plants, aquatic, or soil organisms. Nor are there concerns for any threatened andendangered species. Thus, given that Cold Pressed Neem Oil has very low toxicity and presentslittle if any risk to non-target organisms, EPA concludes that it is in the best interests of thepublic and the environment to issue the registration for Cold Pressed Neem Oil without delay.Consistent with the Agency’s new policy for making these registration actions more transparent,EPA has provided a 30-day public comment periodon the decision to register Cold PressedNeem Oil. No comments were received during the 30 day public comment period.The data submitted fulfill the requirements of registration of Cold Pressed Neem Oil for use inon vegetables, fruits, nuts, outdoor and greenhouseornamental and food crops to control insectsusing ground equipment.Refer to Appendix B for product-specific information.C. Environmental JusticeEPA seeks to achieve environmental justice, thefair treatment and meaningful involvement ofall people, regardless of race, color, national origin, or income, in the development,implementation, and enforcement of environmental laws, regulations, and policies. To helpaddress potential environmental justice issues, the Agency seeks information on any groups orsegments of the population who, as a result of their location, cultural practices, or other factors,may have atypical, unusually high exposure to Cold pressed Neem Oil, compared to the generalpopulation. Please comment if you are aware ofany sub-populations that may have atypical,unusually high exposure compared to the general population.VI. ACTIONS REQUIRED BY REGISTRANTSThe Agency evaluated all of the data submitted inconnection with the initial registration of ColdPressed Neem Oil and determined that these data are sufficient to satisfy current registration datarequirements. No additional data are required to be submitted to the Agency at this time. Fornew uses and/or changes to existing uses, additional data may be required.
Cold Pressed Neem OilPage 15 of 20Biopesticides Registration Action DocumentNot withstanding the information stated in the previous paragraph, it should be clearlyunderstood that certain, specific, data are required to be reported to the Agency as a requirementfor maintaining the Federal registration for a pesticide product. A brief summary of these typesof data are listed below.A. Reporting of Adverse EffectsReports of all incidents of adverse effects to the environment must be submitted to the Agencyunder the provisions stated in FIFRA, Section 6(a)(2).B. Reporting of Hypersensitivity IncidentsAdditionally, 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 forthe original registration of the product containing this active ingredient. Subsequent to thisregistration, there may be additional MRIDs that support registration of other productscontaining this active ingredient.TABLE 1. Product Chemistry Data Requirementsfor Cold Pressed Neem Oil (40 CFR § 158.2030)OPPTS Guideline No. Study (MRID 475387-01) Results830.1550to830.1670Product identity;Manufacturing process;Discussion of formation ofunintentional ingredientsSubmitted data satisfy the requirements for productidentity, manufacturing process, and discussion offormation of impurities.830.1700 Analysis of samples Submitted data satisfy the requirements for analysis ofsamples.830.1750 Certification of limits Limits listed in the CSF are adequate / acceptable.830.1800 Analytical method Acceptable.
Cold Pressed Neem OilPage 16 of 20Biopesticides Registration Action DocumentTABLE 2. Physical and Chemical Properties of Cold Pressed Neem Oil(40 CFR § 158.2030)Guideline Reference No./PropertyDescription of ResultMethods830.6302 ColorYellowish brown830.6303 Physical StateLiquid at 20°C830.6304 OdorStrong, garlic-like830.6313 StabilitybThe study is required since the MPis a TGAI.830.6314 Oxidation/Reduction:Chemical IncompatibilityNot applicable, product is notintended to contact strong oxidizingor reducing agents.830.6315 FlammabilityFlash point >96°C (204°F)830.6316 ExplodabilityThe product does not containexplosive ingredients830.6317 Storage StabilityTo be submitted830.6319 MiscibilityNot applicable; the product is not tobe mixed with petroleum solvents.830.6320 Corrosion CharacteristicsNot applicable830.6321 Dielectric Breakdown VoltageNot applicable, not for use aroundelectrical equipment.830.7000 pH5.3 at 21°C (70°F)830.7050 UV/Visible Absorption215 nm830.7100 Viscosity7.8 cps #2 Spindle at 30 rpm at24°C (75°F)830.7200 Melting RangeNot applicable, product is a liquid830.7220 Boiling RangebThe data is required since the MP isa TGAI.830.7300 Density/Relative Density/BulkDensity0.922 g/mL (8.27 lb/gal) at 22°C(72°F)830.7370 Dissociation Constant in WaterNot applicable, the product does notsubstantially dissociate in water.830.7550 Partition CoefficientbLog Kow =6.26830.7840 Water Solubilityb52.3 mg/L830.7950 Vapor Pressureb2.5 x 10-7mm Hg at 25ºCaData from PR Notice 98-1 submitted for Plasma Neem OilBiological Insecticide and PR Notice 98-1 submitted forPlasma Neem Oil Manufacturing Use Product.bThe studies are required.