Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

**BIOPESTICIDES REGISTRATION ACTION DOCUMENT**



## Humates **(Humic acid; Humic acids, potassium Salts; Humic acids, sodium** 

**salts ; and**  **Humates derived from Leonardite**  **) PC Code**  **s :**  **700132, 800286, and 021818** 

**U.S. Environmental Protection Agency Office of Pesticide Programs**  **Biopesticides and Pollution Prevention Division**

( Last updated March 13, 2014 )Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

i 

### Table of Contents **I. EXECUTIVE SUMMARY**  **................................ ................................**  **................................ 1**  **II. ACTIVE INGREDIENT OV** **ERVIEW ................................**  **................................ ............**  **2 III.**  **REGULATORY BACKGROUN D**  **................................ ................................**  **................... 2**  **A. Application for Pesticide Registration**  **................................ ................................**  **............... 2**  **B. Food Clearances/Tolerances**  **................................ ................................**  **............................... 3**  **IV. RISK ASSESSMENT**  **................................ ................................**  **................................ .........**  **3 A.**  **Product Analysis Assessment (40 CFR § 158.2030) ................................**  **.......................... 3**  **B. Human Health Assessment**  **................................ ................................**  **................................ ..**  **3 1.**  **Tier I Toxicology ................................**  **................................ ................................**  **................................ ...........**  **3 2.**  **Tier II and Tier III Toxicity Studies ................................**  **................................ ................................**  **............ 4**  **3. Endocrine Disruptors**  **................................ ................................**  **................................ ................................**  **.... 4**  **4. Dos**  **e -**  **Response Assessment ................................**  **................................ ................................**  **........................... 5**  **6. Occupational Exposure and Risk Characterization**  **................................ ................................**  **................... 7**  **7. Hum**  **an Health Risk Characterization ................................**  **................................ ................................**  **......... 7**  **C. Environmental Assessment**  **................................ ................................**  **................................ .**  **8 1.**  **Ecological Hazards ................................**  **................................ ................................**  **................................ ........**  **8 2.**  **Environmental Fate and Ground Water Data ................................**  **................................ ............................**  **8 3.**  **Ecological Exposure and Risk Characterization ................................**  **................................ ........................**  **8 4.**  **Endangered Species Assessment ................................**  **................................ ................................**  **.................. 9**  **D. Product Performance Data**  **................................ ................................**  **................................ .**  **9 V.**  **RISK MANAGEMENT DECI SION**  **................................ ................................**  **................ 9**  **A. Determination of Eligibility for Registration**  **................................ ................................**  **.... 9**  **B. Regulatory Decision**  **................................ ................................**  **................................ ...........**  **10 C.**  **Environmental Justice ................................**  **................................ ................................**  **....... 10**  **VI. ACTIONS REQUIRED BY**  **REGISTRANTS ................................**  **............................... 10**  **A. R** **eporting of Adverse Effects ................................**  **................................ ............................**  **11 B.**  **Reporting of Hypersensitivity Incidents ................................**  **................................ ..........**  **11**Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

ii **VII. APPENDIX A. DATA RE**  **QUIREMENTS (40 CFR P ART 158, SUBPART U)**  **....... 12**  **VIII. APPENDIX B. REFERENC**  **ES ................................**  **................................ .......................**  **16 IX.**  **GLOSSARY OF ACRONYMS AND ABBREVIATIONS**  **................................ ...........**  **17**Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

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### BIOPESTICIDES REGISTRATION ACTION DOCUMENT **(BRAD) TEAM**  **Branch Chief** Linda A. Hollis, M.S. **Product Chemistry/ Hum**  **an Health Effects/Nontarget Organisms**  Russell Jones, PhD , Senior Scientist Sadaf Shaukat, Biologist **Regulatory Action Leader**  Menyon Adams, BiologistHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

1 **I. EXECUTIVE SUMMARY**  Humates derived from Leonardite are collectivel y a new biochemical active ingredient (hereaf ter referred to as humates ) intended for use as a plant growth regulator (PGR) to control the vegetative growth and maturation of agricultural and greenhouse crops
. Treatment of plants with humate s enhance s root growth , improve s the uptake of nitrogen, potass ium and phosphate , increases the treated plants’ ability to resist plant disease, and reduce s the need to add soil nutrients and fertilizers during the growing season. Humates are naturall y occurring substances formed by the biodegradation of dead organi c matter , and are often associated with deposits of coal, lignite and mudstone. They are ubiquitous in the environment in soil and water , including agricultural areas where crops are grown for human and animal consumption. Commonly used to condition soil, humates are widel y regarded as being beneficial to plants. From a structural perspective, humates include a complex mixture of compounds, including humic acids and their potassium and so dium salts, fulvic acids, and humins, with humic acids being the major extractable component. In terms of their safety to humans, including infants and children , humates have been previousl y evaluated and well

- characterized by the U.S. Environmental P rotection A gency (EPA or Agency) . They are also listed among those substances that are exempt from the requirement of a tolerance under section 408 of the F ederal F ood, D rug, and C osmetic A ct (FFDCA) as either inert or active ingredient s in a pesticide formulation when used in accordance with good agricultural and/or manufacturing practices (40 CFR Part 180.950 (e)). BPPD has reviewed all of the data and other information submitted in support of the registration of humates as a PGR under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), an d 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 humates are of very

low toxicity

and present little, if any , risk s to humans and the env ironment , EPA has concluded that it is in the best interest of the public to issue registrations for the manufacturing

- use product (MP), PM

- 4300 Organic Acids (EPA File S ymbol No. 82940

- G) and the end

- use product (EP), Phocon (EPA File Sy mbol No. 82940

- E), which contain humates as the active ingredient. The basis for this decision is described in more detail in section IV of this draft B iopesticide Registration A ction D ocument (BRAD)
. On October 1, 2009, EPA announced a policy to provide a more meaningful opportunity for the public to participate in major registration decisions before they occur. According to this policy , EPA provides a public comment period prior to making a registration decision for the foll owing ty pes of applications: new active ingredients; first food uses; first outdoor uses; first residential uses; or any other registration actions for which EPA believes there may be significant public interest. Consistent with the policy of making reg istration decisions more transparent, humates are subject to a 15 day comment period as a “new active ingredient
. ” The notice for this comment period includes the draft BRAD and draft labels for two products (PM

- 4300 Organic Acids (EPA FileHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

2 Sy mbol 82940

- G) and Phocon (EPA File S ymbol 82940

- E )) that contain this new active ingredient. The docket identification (ID) number is EPA
- HQ
- OPP
- 2012
- 025 1
. For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/
. **II. ACTIVE INGREDIENT OVERVIEW**  **Common Name:** N/A **Chemical Names:** Humates Humic Acids, Potassium Salts Humic Acids, Sodium Salts Humates derived form Leonardite **Trade & Other Names:** N/A **CAS Registry Number:**  N/A **OPP Pesticide**  **Chemical Code:** 700132 800286 021818 **Type of Pesticide:** Biochemical Pesticide

– Plant Growth Regulator
**Biochemical Classification**  On February 12 , 2009, the Biochemical Classification Committee classified humates as a biochemical active ingredient , based upon the nontoxic mode of action as a PGR , natural occurrence in the environment, and history of human and animal exposure to humates with no toxi c or other adverse effects
. For more information regarding product chemistry data requirements, please refer to Table s 1, 2 , and 3 in Appendix A of this document. **III. REGULATORY BACKGROUND**  **A. Application for Pesticide Registration**  On December 16 , 2011 , Ann Tillman of Py xis regulatory

Consulting, Inc. , on behalf of Actagro LLC., 4110 136 th St. NW, Gig Harbor, WA 98332 , submitted applications to register an MP, “ PM
- 4300 Organic Acids ” (EPA File S ymbol No. 82940
- G ) , and an EP, “ Phocon ” (EPA File Sy mbol No. 82940

- E) , containing the new biochemical active ingredient, humates , at 18.5% and 12.0% , respectively
. A notice of receipt (NOR) of th e application s was published in the Federal Register o n June 27, 2012 , (7 7 FR 38285 )
. No comments were received during the 30

- day comment period following publication of the NOR.Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

3 **B. Food Clearances/Tolerances**  Residues resulting from the use of humates (humic acid ; humic acid s , potassium salts; humic acids, sodium salts ) as either an inert o r an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemicals, are exempt from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices (40 CFR p art 180.950 (e) )
. ( Ref. 1) **IV. RISK ASSESSMENT**  **A. Product Analysis Assessment (** 40 CFR § 158.2 03 0 **)** Biochemical pesticide product anal ys is data requirements include product chemistry and composition, analy sis and certified limits, and phy sical and chemical characteristics. Product chemistry and composition data include information about the identity of the active ingredient, the manufacturing process, and discussion of the potential for formation of unintentional ingredients. Anal ys is and certified limits data include information on anal ysis of samples and certification of the upper and lower limits for the ingredients in a formulated product . Phy sical and chemical characteristics data describe basic characteristics of the registered pesticide products, including color, phy sical state, odor, stability, miscibility , pH, corrosion characteristics, viscosity and density. EPA’s Office of Pesticide Programs (OPP) has assigned unique pesticide chemical ( PC ) c ode s to humic acid , humic acid s , potassium salts, and humic acids, sodium salts (700132, 800286 and 021818, respectivel y), and all of the product anal ysis data required for an unconditional registration have been fulfilled
. ( S ee Table s 1 and 2 in Appendix A of this document for a summary of product chemistry and composition, anal ys is and certified limits , physical and chemical characteristics data. ) **B. Human Health Assessment**  **1. Tier I**  **Toxicology** All of the toxicology

data requirements have been satisfied and support the proposed registration of humates as a biochemical PGR
. The data and other information submitted are summarized below (see also Table s 3 and 4 in Appendix A of this document).
**a. Acute Toxicity**  **(OCSPP Guideline Nos. 870.1100, 870.1200, 870.1300, 870.2400, 870.2500, and 870.2600; Master Record Identification (MRID) Nos.**  **48711105, 48711106,48711107, 48711108, 48711109, 48711110, 49080301, 48711115**  **):** Acute toxicity

testing of a pesticide active ingredient and/or product is required to: 1) determine sy stemic toxicity

from acute exposure via the dermal, inhalation and oral routes ; 2) determine irritant effects from exposure to the eyes and skin ; and 3) determine the potential for skin sensitization (allergic contact dermatitis). Acute T oxicity C ategories I, II, III, or IV (Toxicity Category Iindicates the highest toxicity, and Toxi city Category IV is the lowest) are assigned toHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

4 an active ingredient and EPs containing that active ingredient, and are based on the hazard(s) identified from studies and/or other information submitted to support an application to register a pesticide in the U.S
. In an acute oral toxicity

test in rats, the LD 50 for a single dose of humic acids was >11,500 mg/kg (EAEMP, 1999). Further, the results from the Tier I acute testing on the MP classify humates in T oxicity C ategory

IV for the dermal, oral, and inhalation routes of exposure, based on the dose s tested in laboratory rats. In addition, minimal eye irritation cleared in less than 24 hours and sl ight dermal irritation resolved within 72 hours in rats, and humates were not dermal sensitizers in guinea pigs. (For the results of these studies ( i.e., LD 50 , LC 50 ) , refer to Table 3 in Appendix A of this document.) **b. Sub**  **c hronic Toxicity, Developmental Toxicity, and Mutagenicity**  **(OCSPP Guideline Nos. 870.3100,**  **870.3250, 870.3465; 870.3700, 870.5100, 870.5300, 870.5375; MRID Nos. 48975101, 48975102):**  The data submitted to fulfill the requirement for a Bacterial Reverse Mutation Test (OCSPP 870.5100) demonstrated that humates did not cause base pair changes or f rame shift mutations, and there was no evidence of cy totoxicity at highest dos e tested
. In lieu of conducting guideline studies, rationale s were submitted to address the following: 90
- Day Oral (OCSPP 870.3100), 90

- Day Dermal (OCSPP 870.3250), 90

- Day Inh alation (OCSPP 870
- 3465) and Prenatal Development (OCSPP 870.3700) toxicity studies, and the in vitro Mammalian Cell Assay

(OCSPP 870.5300/5375). BPPD determined that the rationales are acceptable , based on the results of the studies conducted with humates as the test substance and its presence as a natural component of soil and water with no known adverse effects to humans and the environment. **2. Tier II**  **and Tier III**  **Toxicity Studies** Tier II and Tier III toxicity testing was not required due to humates’ low toxicity and the low levels of human exposure expected from its intended us e as a PGR
. **3. Endocrine Disruptors**  As required b y the Administrator under the Federal Food, Drug, and Cosmetic Act ( FFDCA) section 408(p ), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced b y a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determination is made that the substance is not anticipated to produce any effect in humans similar to an effect produced b y a naturall y oc curring estrogenic substance. Between October 2009 and February 2010, the EPA issued test orders/data call

- ins for the first group of 67 chemicals, which containsHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

5 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identifie d for screening under the EDSP was published on June 14, 2013, and includes some pesticides scheduled for registration review and chemicals found in water. Humates are not among the group of pesticide active ingredients on the lists to be screened under the EDSP. The Agency

believes that humates would not likely produce any effect in humans similar to an effect produced b y a naturally occurring estrogenic substance. As such, and pursuant to Section 408(p)(4), EPA will determine in the future whether it c an exempt humates from the requirements of the Section 408(p) EDSP. Inthe event the EPA does determine to exempt this substance from the EDSP, an order will be issued. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines , and the Tier 1 screening battery , please visit our website at http://www.epa.gov/endo/
. **4. Dose**  **- Response Assessment**  No toxicological endpoints were identified for humates ; therefore, a dose

- response assessment was not required. **5 . Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations**  Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of F FDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable informatio n.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption and to “ensure th at there is a reasonable certainty

that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally , section 408(b)(2)(D) of FFDCA requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity .” EPA performs a number of anal ys es to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and other routes as a result of pesticide use in residential settings. Consistent with section 408(b)(2)(D) of FFDCA, EPA reviewed the available scientific data and other relevant information, and considered its validity , completeness, and reliability, and the relationship of this information to human risk. EPA also considered available information concerning the variability of the sensitivities of maj or identifiable subgroups of consumers,Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

6 including infants and children. Based on the acute toxicity data and information discussed previously

and presented in Table 3 in Appendix A of this document , the data requirements for a human health dietary risk assessment for humates have been fulfilled.
**a. Aggregate Exposure**  In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non

occupational exposures, including drinking water from ground or surface water , pesticide use in gardens, residential and other lawns and landscapes, and buildings (residential and other indoor uses). EPA expects the aggregate exposure to res idues of humates from the PGR use to be negligible when compared to the ordinary , everyday levels to which individuals are already exposed in the natural environment, since humates are commonl y found in soil and water. Th e aggregate exposure potential for humates is discussed below. Food Exposure and Risk Characterization : Since humates are common components of agricultural soil, EPA expects that human dietary exposure to residues of humates resulting from its pesticidal uses would be negligible in compari son to naturally occurring humates. Further, residues of humates from use as a PGR would be very low, since they

are not absorbed by

plants, and rainfall and irrigation would reduce the amount of applied product during the growing season. In the unlikel y event that any residues of the pesticide remain in or on consumed food, no adverse effects would be expected, based on the lack of toxicity demonstrated in the submitted studies and other information described previously and presented in Table 3 in Appendix A of this document. Drinking W

ater Exposure and Risk Characterization : According to the directions for use on the EP label, humates are not to be applied directly to bodies of water. Itis possible , however, that some residues may

reach bodies of water via runoff or spray drift. Since humates are common components of water, EPA expects that human exposure to residues of humates in drinking water resulting from its use as a PGR would be negligible in comparison to naturall y occurring humates. In the unlikely event that any

residues of the pesticide remain in drinking water , no adverse effects would be expected, based on the lack of toxicity demonstrated in the submitted studies and other information described previously and presented in Table 3 in Appendix A of this document. N on - occupational, Residential Exposure and Risk Characterization: The PGR use of this active ingredient is intended only for agricultural environments, so non - occupational and residential exposure s are expected to be minimal to non - existent
. Should exposure occur, the risks to humans is expected to below level of concern , based upon the low toxicity of humates demonstrated in the data and other information s ubmitted and evaluated by the EPA. (Ref. 1 ; see also Section IV.B.1.a of this BRAD). **b**
. **Cumulative Effects from Substances with a Common Mechanism of Toxicity.** Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify , or revoke a tolerance exemption, EPA consider “available information concerning theHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

7 cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity .” Humates are not known to have a common mechanism of toxicity with other substances; therefore, cumulative effects with other substances are not anticipated. For information regarding EPA’s efforts to identify

chemicals that may

have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http://www.epa.gov/pesticides/cumulative

. **c. Determination of Safety for the U.S. Population, Infants and Children**  Based on its analy ses of the submitted toxicity data (refer to Section IV.B.1. a and Table 3 in Appendix A) , EPA concludes that there are no threshold effects of concern to infants, children, or adults when PGR products containing humates as an active ingredient are used as labeled in accordance with good agricultural practices. N o toxicological effects or endpoints were identified in mammalian studies . The Agency does not expect that infants and children will have special sensitivity

to residues of humates . As a result, no additional margin of exposure (safety) is necessary

to protect infants and children and that not adding an additional margin of exposure (safety) will be safe for infants and children. The Agency also concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of humates when used as labeled and in accordance with good a gricultural practices as a PGR . Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA arrived at this conclusion because, considered collectively , the data available on humates do not demonstrate toxic potential to humans , including infants and children. **6. Occupational Exposure and Risk Characterization**  An occupational exposure assessment was not conducted and is not required for b iochemical pesticides (40 CFR part 158.2010 )
. Appropriat e personal protective equipment ( PPE ) requirements on the label will mitigate any unintentional exposure s to applicators and/or handlers. **7. Human Health**  **Risk Characterization** EPA considered human exposure to humates in light of the standard for registration in FIFRA and the relevant safety

factors in FFDCA. Since there were no toxicological effects or endpoints identified in mammalian studies, a determination has been made that no unreasonable adverse effects to the U.S. population in general, an d to infants and children in particular, will result when humate products are used in accordance with EPA

- approved labeling.Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

8 **C. Environmental Assessment**  **1. Ecological Hazards**  Adequate n ontarget toxicology data/information submitted and reviewed by the Agen cy

satisfies the non

- target toxicology data requirements for humates
. **Avian Oral Acute Toxicity , Avian Dietary Toxicity, Fish Acute**  **Toxicity, Freshwater and Marine**  **, and Aquatic Invertebrate Acute Toxicity**  **(OCSPP Guideline Nos. 850.2100, 850.2200,850.1075, and 850.1010)**  (see also Tables 5 and 6 in Appendix A of this document). Humates have historically been applied to soil with no reports of adverse effects to humans , other mammals , or the environment. Since humates are ubiquitous in soil and water, birds, fish, and other living organisms are already naturall y exposed. The data and other information submitted to support the registration of humates as a PGR demonstrate that humates are practicall y nontoxic to birds on a dietary basis ( LC 50 > 5620 ppm), practically nontoxic to fish (L C 50 > 100mg/L), and practicall y nontoxic to aquatic invertebrate s (EC 50 > 100mg/L). **Seedling Emergence and Vegetative Vigor (OCSPP**  **Guidelines Nos. 850.4100 and 850.4150)**  Humates are intended to be applied to growing crops , and are not absorbed by plants when applied to crops or to soil near growing crops. The major component , humic acid s, enriches the soil and stimulates root growth and uptake of nutrients by the treated plants. They

have historically been applied to crops with no reports of adverse effects to the environment. Humates provide benefits to soils and plants, and are considered to have a nontox ic mode of action. **Non -**  **target Insect Testing (OCSPP**  **Guideline 880.4350)**  Humates are intended to be formulated into EP’s and intended for application to growing crops. There have been no reports in the public literature of deleterious effects to honey bees from exposures to humic acid or other hum ic substances. **2. Environmental Fate and Ground Water Data**  Environmental fate and groundwater data are not required at this time because the results of the nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II data requirements. **3. Ecological Exposure and Risk Characteriza**  **tion** Humates are naturall y occurring and ubiquitous in both soil and aquatic environments
. The proposed EP label rates would result in little net increase in the background amount of humates already present in the environment
. Based on the review of this body of information in conjunction with the proposed labeling, the Agency believes that when used in accordance with the label directions, the use of humates should not result in adverse effects to birds, fish, aquatic invertebrates, and plant or n ontarget insects. (Ref
. 1)Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

9 **4. Endangered Species Assessment**  EPA has determined that no adverse effects are anticipated for nontarget species exposed to humates when used as a PGR ; therefore, effects to federally

- listed threatened and endangered species and their designated critical habitats are also not expected. Therefore, a “No Effect” determination is made for direct and indirect effects to federall y- listed endangered and threatened species and their designated critical habitats for the proposed uses of humates as a PGR in agricultural settings. **D. Product Performance Data**  Product performance (efficacy) data must be developed for all pesticides to ensure that the products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. The Agency reserves the right to require , on a case - by

- case basis, the submission of efficacy data for any

pesticide product registered or proposed for registration , but applications to register pe sticide products intended to control a pest of significant public health importance , as defined in FIFRA section 28(d) and section 2(nn) , must include such data . For further guidance on the product performance data requirement, refer to Pesticide Registration (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.ea.gov/PR_Notices/pr2002

- 1.pdf , and http://www.epa.gov/pesticides/health/risk

- benefit.htm). Humates are not intended t o be formulated into products to control publi c health pest s, and product performance was not evaluated b y the Agency. **V. RISK MANAGEMENT DECISION**  **A. Determination of Eligibility for Registration**  Section 3(c)(5) of FIFRA provides for the registration of a pesticide provided that all the following determinations are made: (1) its composition is such as to warrant the claims for it; (2) its labeling and other materials required to be submitted comply with the requirements of FIFRA; (3) it will perform its int ended function without unreasonable adverse effects on the environment; and (4) when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment. To satisfy criterion (1 ), EPA believes the composition the proposed MP and EP warrants the claims made on the labels. Criterion (2) is satisfied, since the proposed product labels, as well as the data and information presented in this document, are in compliance with the requirements of FIFRA. Criterion (3) is satisfied in that humates are expected to function as PGRs without causing unreasonable adverse effects on the environment. Criterion (4) is satisfied in that no unreasonable adverse effects are expected when products containing humates are used in accordance with label directions and commonly recognized agricultural practices. Therefore, PM
- 4300 Organic Acids (EPA File Sy mbol No. 82940

- G), and Phocon (EPA File Sy mbol No.Humates PC Codes 700132, 800286, and 021818

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10 82940
- E ) meet the requirements for registration under FIFRA section 3(c)(5) for use in agricultural settings. **B. Regulatory Decision**  The data submitted fulfill the requirements for the unconditional registration of humates for use as a plant growth regulator
. For product

- specific information, please refer to http://www.epa.gov/pesticides/pestlabels
. **C. Environmental Justice**  For additional information regarding environmental justice issues, please visit EPA ’s website at http://www.epa.gov/compliance/environmentaljustice/index.html
. 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. Fair treatment means that no group of people, including racial, ethnic, or socioeconomic groups, should bear a disproportionate share of the negative environmental consequences resulting from industrial, municipal, and commercial operations or the execution of federal, state, local, and tribal environmental programs and policies. Meaningful involvement means that (1) potentially affected community residents have an appropriate opportunity to participate in decisions about an activity

that wi ll affect their environment and/or health; (2) the public’s contribution can influence the regulatory

agency ’s decision; (3) the concerns of all participants involved will be considered in the decision

- making process; and (4) the decision

- makers seek out and facilitate the involvement of those potentially affected. EPA has this goal for all communities and persons across the U.S. At this time, EPA does not believe that use of humates pesticide products will cause harm or a disproportionate impact on at

- ri sk communities; however, p lease comment if you are aware of any groups or segments of the population who, as a result their location, cultural practices, or other factors, may

have aty pical, unusuall y high exposure to humates compared to the general population
. For additional information regarding environmental justice issues, please visit EPA’s web site at http://www.epa.gov/compliance/environmentaljustice/index.html
. **VI. ACTIONS**  **REQUIRED BY REGISTRANTS** EPA evaluated all data submitted in connection with the registration of the new active ingredient, humates , and determined that these data are sufficient to satisfy current registration data requirements. At this time, no additional data must be submitted to EPA for these particular products. For new uses and/or changes to existing uses, EPA may require additional data. Notwithstanding the information stated in the previous paragraph, it should be clearly understood that b efore releasing the registered products for shipment, the registrant will be required toHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

11 provide appropriate final printed labeling to EPA. Further, certain specific data, briefl y described below, are required to be reported to EPA , as a requirement for maintaining the federal registration for all pesticide products. **A. R** **eporting of Adverse Effects** Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment must be submitted to EPA. **B. Reporting of Hypersensitivity**  **Incidents** Under the provisions of 40 CFR p art 158.2050(d) , all incidents of hy persensitivity

(including both suspected and confirmed incidents) must be reported to the Agency
.Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

12 **VII. APPENDIX A.**  **Data Requirements (40 CFR Part 158 ,**  **Subpart U)** Master Record Id entification (MRID) numbers listed in the following tables are representative of supporting data/information for the original registration of the product containing this active ingredient. Subsequent to this registration, there may be additional MRIDs that support registration of other products containing this active ingredient.
**TABLE 1. Product Identify**  **, Composition, Analysis**  **and Certified Limits for PM**  **- 4300 Organic Acids**  **(40 CFR 158.2030) OPPTS**  **Guideline Reference**  **No. Study**  **Results**
830.1550 to 830.1670 Product identity; Manufacturing process; Discussion of formation of unintentional

ingredients Acceptable; Confidential Business Information (CBI)
830.1700 Analysis of samples Acceptable; CBI 830.1750 Certification of limits Acceptable ; CBI 830.1800 Analytical method Acceptable; CBIHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

13 **T ABLE 2. Physical and Chemical Properties for PM**  **- 4300 Organic Acids**  **(40 CFR 158.2030) MRID Nos. 48711101**  **- 48711104 and 49080300**  **Property/OCSPP Guideline**  **Description of Result Methods**  Color / 830.6302 Black Munsell N1 1/N Visual inspection at 21.4°C Physical State/ 830.6303 Liquid Visual inspection at 21.5°C Odor /830.6304 Mild, alcoholic Olfactory inspection at 21.5°C
Stability /830.6313 Stable for 14 days at ambient and elevated (54 ± 2°C) temperature in HDPE containers. Stability to metals and metal ions is not applicable, since the product will not be stored or packaged in metal containers. OCSPP 830.1637

Oxidation/Reduction: Chemical Incompatibility

/830.6314 Not applicable, the product does not contain oxidizing ingredients. N/A Flammability

/830.6315 Not applicable, the product is 70% water and contains no flammable ingredients. >100°C b N/A Explodability

/830.6316 Not applicable, the product is 70% water and contains no explosive ingredients. N/A Storage Stability

/830.6317 Study is ongoing. Results will be submitted upon completion. N/A Miscibility

/830.6319 Not applicable, the product is not an em ulsifiable liquid to be diluted with petroleum solvents. N/A
Corrosion Characteristics /830.6320 Study is ongoing. Results will be submitted upon completion. N/A Dielectric Breakdown Voltage/830.6321 Not applicable, the product is not for use around electrical equipment. N/A pH/830.7000 10.67 ± 0.005(1% solution in CO 2 - free water at 21.1°C) pH meter Maxxam SOP 91
- M
- 014 Viscosity /830.7100 3.01 ± 0.00 mm2/s (cSt) at 19.8°C 2.53 ± 0.00 mm2/s (cSt) at 39.9°C Ubbelohde viscometer M elting Range/830.7200 Not applicable ; the product is a liquid. N/A Boiling Range/830.7220 102.6 ± 0.1°C Ebulliometric method Density/Relative Density/Bulk Density /830.7300 1.14 ± 0.00 g/mL OECD 109 Dissociation Constant in Water /830.7370 Not applicable, the product is 70% water. N/A Partition Coefficient/830.7550 Not applicable, the product is 70% water and the components are not expected to partition into octanol. N/A Water Solubility

/830.7840 Not applicable, the product is 70% water. N/A Vapor Pressure/830.7950 Not applicable, the product is 70% water and contains non

- volatile solutes. N/AHumates PC Codes 700132, 800286, and 021818

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14

**TABLE 3. Acute Toxicity**  **Data for PM**  **- 4300 Organic**  **Acids (40 CFR 158.2050)**  **Study Type/ OCSPP**  **Guideline LD**  **50 /LC**  **50 /Results**  **Toxicity Category**  **MRID** Ac ute Oral Toxicity

/ 870.1100 >5,000 mg/kg IV 48711105 Ac ute Dermal Toxicity/870.1200 > 5,000 mg/kg IV 48711106 Ac ute Inhalation Toxicity870.1300 >2.05 mg/L IV 48711107 Ac ute Eye Irritation/870.2400 Minimal effects clearing in less than 24 hours IV 48711108
Ac ute Dermal Irritation/870.2500 Slight irritation resolved within 72 hours IV 48711109 Skin Sensitization/870.2600 Not a sensitizer N/A 48711110
Bacterial Reverse Mutation Testing/ 870.5100 PM
- 4300 did not cause gene mutations by base pair changes or frame shifts; no evidence of cy totoxicity at highest does tested; non

mutagenic /Acceptable N/A 49080301

In vitro Mammalian Cell Assay/870.5300/5375 Rationale/Acceptable N/A 48711115 90
- Day Oral Toxicity/870.3100 Rationale/Acceptable N/A 48711115 90
- Day Dermal Toxicity/870.3250 Rationale/Acceptable N/A 48711115 90
- Day Inhalation Toxicity/870.3465 Rationale/Acceptable N/A 48711115 Prenatal Development/870.3700 Rationale/Acceptable N/A 49080301

The request to bridge acute toxicity data produced for PM

- 4300 (TGAI/MP) to Phocon was acceptable
. **TABLE 4. Acute Toxicity Data for P hocon**  **(40 CFR 158.2050)**

Acute Oral Toxicity Rationale

- acceptable Acute Dermal Toxicity Rationale

- acceptable Primary Eye Irritation Minimal irritation: IV Primary Dermal Irritation Rationale

- acceptable Dermal Sensitization Rationale

- acceptable Acute Inhalation Toxicity Rationale

- acceptableHumates PC Codes 700132, 800286, and 021818

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15

**TABLE 6**  **. Ecological Toxicity Data Requirements for Phocon (40 CFR 158.2060) Study Type/OCSPP Guideline**  **Results/ Toxicity Category**  **MRID Study Conclusion**  Avian Acute Oral/ 850.2100 Information submitted to justify rationale Acceptable 49080203 Avian Dietary/850.2200 Information submitted to justify rationale Acceptable 48711116 Freshwater Fish L C 50/ 850.1075 Information submitted to justify rationale Acceptable 48711116 Freshwater Invertebrate/ 850.1010 Information submitted to justify rationale Acceptable 48711116
Non
- target Plants/850.4100 Pre
- emergence application at 24 qt/A did not reduce by 25% or greater any of the 21

- day growth endpoints for species tested Acceptable 48710906

Non
- target Plants/850.4150 Foliar application at 24 qt/A did not reduce by 25% or greater any of the grow th endpoints for species tested at 21 days post application Acceptable 48710907

Non
- target Insects/850.3020 48
- hr contact LD 50 >100μg/bee; relatively nontoxic to honey bee Acceptable 48710908 and 49080203 **TABLE 5. Ecological Toxicity Data Requirements for PM**  **- 4300 Organic Acids**  **(40 CFR 158.2060) Study Type/OCSPP Guideline**  **Results MRID**  Avian Acute Oral/850.2100 Rationale/Acceptable 49080302 Avian Dietary/850.2200 96 hour LC 50 > 5620ppm; Practically Nontoxic 48711112
Freshwater Fish LC 50/850.1075 96 hour LC 50 > 100 mg/L; Practically Nontoxic 48711113
Freshwater Invertebrate/850.1010 48 hour EC 50 > 100 mg/L Practically Nontoxic 48711114 Non
- target Plants/850.4100/4150 Rationale/Acceptable 48711116 Non
- target Insects/850.3020 Rationale/Acceptable 48711116Humates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

16 **VIII. APPENDIX**  **B. R** **eferences** 1. U.S. EPA, 2012 . Memorandum from Sadaf Shaukat to Menyon Adams
. Science Review in support of the Registration of PM

- 4300 Organic Acids Containing 18.5% Organic Acids derived from Leonardite as its Active Ingredient. U.S. Environmental Protection Agency , Office of Pesticide Programs. December 18, 2012. 2. U.S. EPA, 2013. Memorandum from Sadaf Shaukat to Menyon Adams. Science Review in support of the Registration of PM

- 4300 Organic Acids Containing 18.5% Organic Acids derived from Leonardite as its Active Ingredient. U.S. Environmental Protection Agency , Office of Pesticide Programs. September 6, 2013. 3. U.S. EPA, 2012. Memorandum from Sadaf Shaukat to Menyon Adams. Science Review in support of the Registration of Phocon Containing 12.0% Organic Acids derived from Leonardite as its Active Ingredient. U.S. Environmental Protection Agency , Office of Pesticide Programs. December 22, 2012. 4. U.S. EPA, 2013. Memorandum from Sadaf Shaukat to Menyon Adams. Science Review in suppo rt of the Registration of Phocon Containing 12.0% Organic Acids derived from Leonardite as its Active Ingredient. U.S. Environmental Protection Agency , Office of Pesticide Programs. January 23, 2013. 5. U.S. EPA, 2013. Memorandum from Sadaf Shaukat to Menyo n Adams. Science Review in support of the Registration of Phocon Containing 12.0% Organic Acids derived from Leonardite as its Active Ingredient. U.S. Environmental Protection Agency , Office of Pesticide Programs. September 6, 2013. 6. OECD. 2004. SIDS Ini tial Assessment Report. Gluconic Acid and its Derivatives. Paris, France. 7. Pena
- Mendez, E. M., Havel, J., Patocka, J. 2005. J. Applied Biomedicine. 3: 13

- 24. 8. Thurman EM. 1985. Organic Geochemistry of Natural Waters. Kluwer, Boston, MA, USA. 9. (40 CFR §180. 950 (e)). 10. ASA Analy

tics. 2010. Natural organic matter (NOM) in water. http://www.anaanal ytics.com/natural

- organic

- matter.phpHumates PC Codes 700132, 800286, and 021818

**Biopesticides Registration Action Document**

17 **IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS**  a.i. active ingredient BPPD Biopesticides and Pollution Prevention Division BRAD Biopesticide Registration Action Document bw body

weight CBI Confidential Business Information CFR Code of Federal Regulations cm 3 cubic centimeter CSF Confidential Statement of Formula °C degrees Celsius EC 50 median effective concentration. A statistically derived single concentration in environmental medium that can be expected to cause an effect in 50% of the test animals when administrated by the route indicated (inhalation). It is e xpressed as a concentration in air or water (e.g. mg/L). EDSP Endocrine Disruptor Screening Program EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee EP end

- use product EPA Environmental Protection Agency (the “Agency”) FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FR Federal Register g gram ha hectare kg kilogram Kow octanol

- water partition coefficient L liter LC 50 median lethal concentration. A statistically derived single concentration in air or water that can be expected to cause death in 50% of the test animals when administrated by

the route indicated (inhalation and environment). It is expressed as a concentration in air or water (e.g. mg/L). LD 50 median lethal dose. A statistically derived single dose that can be expected to cause death in 50% of the test animals when administered by the route indicated (oral and dermal). It is expressed as a weight of substance per unit weight of animal (e.g., mg/kg). MRID No. Master Record Identification Number mg milligram mPa millipascal mL milliliter MP manufacturing

- use product N/A not applicable NE “No Effect” NI OSH National Institute for Occupational Safety and Health nm nanometerHumates PC Codes 700132, 800286, and 021818

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18 NOEL no - observed

- effect
- level NOF notice of filing NOR notice of receipt OPP Office of Pesticide Programs OCSPP Office of Chemical Safety and Pollution Prevention pa pascal PPE personal protective equipment PR Notice Pesticide Registration Notice TGAI technical grade of the active ingredient ug microgram USDA United States Department of Agriculture UV ultra

- violet