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 Codes: 700132, 800286, and 021818

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

(Last updated March 13, 2014)
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Table of Contents

I. EXECUTIVE SUMMARY................................................................................................ 1

II. ACTIVE INGREDIENT OVERVIEW............................................................................ 2

III. REGULATORY BACKGROUND................................................................................... 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. Dose-Response Assessment...........................................................................................................................5

6. Occupational Exposure and Risk Characterization...................................................................................7

7. Human 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 DECISION ................................................................................ 9

A. Determination of Eligibility for Registration .................................................................... 9

B. Regulatory Decision........................................................................................................... 10

C. Environmental Justice ....................................................................................................... 10

VI. ACTIONS REQUIRED BY REGISTRANTS............................................................... 10

A. Reporting of Adverse Effects............................................................................................ 11

B. Reporting of Hypersensitivity Incidents.......................................................................... 11
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VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158, SUBPART U)....... 12

VIII. APPENDIX B. REFERENCES....................................................................................... 16

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS........................................... 17
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief

Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms

Russell Jones, PhD, Senior Scientist

Sadaf Shaukat, Biologist

Regulatory Action Leader

Menyon Adams, Biologist
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I. EXECUTIVE SUMMARY

Humates derived from Leonardite are collectively a new biochemical active ingredient (hereafter

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 

humates enhances root growth, improves the uptake of nitrogen, potassium and phosphate, 

increases the treated plants’ ability to resist plant disease, and reduces the need to add soil 

nutrients and fertilizers during the growing season. 

Humates are naturally occurring substances formed by the biodegradation of dead organic 

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 widely regarded 

as being beneficial to plants. From a structural perspective, humates include a complex mixture 

of compounds, including humic acids and their potassium and sodium 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 previously 

evaluated and well-characterized by the U.S. Environmental Protection Agency (EPA or 

Agency). They are also listed among those substances that are exempt from the requirement of a 

tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) as either 

inert or active ingredients in a pesticide formulation when used in accordance with good 

agricultural and/or manufacturing practices (40 CFR Part180.950 (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), and has determined that the current data requirements (40 CFR part 158.2010 

through 158.2070) for registration of a biochemical pesticide have been satisfied. Given that 

humates are of very low toxicity and present little, if any, risks to humans and the environment, 

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 Symbol No. 82940-G) and 

the end-use product (EP), Phocon (EPA File Symbol 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 Biopesticide Registration Action Document (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 following 

types 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 registration 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 File 
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Symbol 82940-G) and Phocon (EPA File Symbol 82940-E)) that contain this new active 

ingredient. The docket identification (ID) number is EPA-HQ-OPP-2012-0251. 

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 

toxic or other adverse effects.

For more information regarding product chemistry data requirements, please refer to Tables 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 Pyxis regulatory Consulting, Inc., on behalf of Actagro

LLC., 4110 136th St. NW, Gig Harbor, WA 98332, submitted applications to register an MP, 

“PM-4300 Organic Acids” (EPA File Symbol No. 82940-G), and an EP, “Phocon” (EPA File 

Symbol No. 82940-E), containing the new biochemical active ingredient, humates, at 18.5% and 

12.0%, respectively. A notice of receipt (NOR) of the applications was published in the Federal 

Register on June 27, 2012, (77 FR 38285). No comments were received during the 30-day

comment period following publication of the NOR.
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B. Food Clearances/Tolerances 

Residues resulting from the use of humates (humic acid; humic acids, potassium salts; humic 

acids, sodium salts) as either an inert or 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 part 180.950 (e)). (Ref.1)

IV. RISK ASSESSMENT

A. Product Analysis Assessment (40 CFR § 158.2030)

Biochemical pesticide product analysis data requirements include product chemistry and 

composition, analysis and certified limits, and physical 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. Analysis and certified limits data include information on analysis of samples and

certification of the upper and lower limits for the ingredients in a formulated product. Physical 

and chemical characteristics data describe basic characteristics of the registered pesticide 

products, including color, physical state, odor, stability, miscibility, pH, corrosion characteristics, 

viscosity and density.

EPA’s Office of Pesticide Programs (OPP) has assigned unique pesticide chemical (PC) codes to 

humic acid, humic acids, potassium salts, and humic acids, sodium salts (700132, 800286 and 

021818, respectively), and all of the product analysis data required for an unconditional

registration have been fulfilled. (See Tables 1 and 2 in Appendix A of this document for a 

summary of product chemistry and composition, analysis 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 Tables 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 

systemic 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 Toxicity Categories I, II, III, or IV (Toxicity

Category I indicates the highest toxicity, and Toxicity Category IV is the lowest) are assigned to 
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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 LD50 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 

Toxicity Category IV for the dermal, oral, and inhalation routes of exposure, based on the doses

tested in laboratory rats. In addition, minimal eye irritation cleared in less than 24 hours and 

slight 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., LD50, LC50), refer to Table 3 in Appendix A

of this document.)

b. Subchronic 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 frame shift mutations, 

and there was no evidence of cytotoxicity at highest dose tested.

In lieu of conducting guideline studies, rationales were submitted to address the following: 90-

Day Oral (OCSPP 870.3100), 90-Day Dermal (OCSPP 870.3250), 90-Day Inhalation (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 use as a PGR.

3. Endocrine Disruptors

As required by 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 by 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 by a naturally occurring estrogenic substance. Between October 2009 and February

2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 
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58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified 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 by a naturally occurring estrogenic substance. As such, and pursuant to Section 

408(p)(4), EPA will determine in the future whether it can exempt humates from the 

requirements of the Section 408(p) EDSP. In the 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 FFDCA 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 information.” 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 that 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 analyses 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 major identifiable subgroups of consumers, 
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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 nonoccupational 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 residues 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 commonly found in soil and water. The

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 comparison 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 unlikely 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 Water 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. It is 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 naturally 

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.

Non-occupational, Residential Exposure and Risk Characterization: The PGR use of this 

active ingredient is intended only for agricultural environments, so non-occupational and 

residential exposures 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 submitted 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 the 
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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 analyses 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. No 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 agricultural 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 biochemical 

pesticides (40 CFR part 158.2010). Appropriate personal protective equipment (PPE)

requirements on the label will mitigate any unintentional exposures 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, and to infants and children in particular, will result 

when humate products are used in accordance with EPA-approved labeling.
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C. Environmental Assessment

1. Ecological Hazards

Adequate nontarget toxicology data/information submitted and reviewed by the Agency 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 naturally exposed. The data and other information

submitted to support the registration of humates as a PGR demonstrate that humates are 

practically nontoxic to birds on a dietary basis (LC50 > 5620 ppm), practically nontoxic to fish 

(LC50 > 100mg/L), and practically nontoxic to aquatic invertebrates (EC50 > 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 acids, 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 nontoxic 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 humic 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 Characterization

Humates are naturally 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 nontarget insects. (Ref. 1)
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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 federally-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 pesticide 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 to be formulated into products to control public health pests, and 

product performance was not evaluated by 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 intended 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 Symbol No. 82940-G), and Phocon (EPA File Symbol No. 
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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 will 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-risk communities; however, please 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 atypical, unusually 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 before releasing the registered products for shipment, the registrant will be required to 
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provide appropriate final printed labeling to EPA. Further, certain specific data, briefly described 

below, are required to be reported to EPA, as a requirement for maintaining the federal 

registration for all pesticide products.

A. Reporting 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 part 158.2050(d), all incidents of hypersensitivity (including 

both suspected and confirmed incidents) must be reported to the Agency.
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VII. APPENDIX A. Data Requirements (40 CFR Part 158, Subpart U)

Master Record Identification (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; CBI
Humates PC Codes 700132, 800286, and 021818

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TABLE 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°Cb

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 

emulsifiable 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 CO2-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

Melting 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/A
Humates PC Codes 700132, 800286, and 021818

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TABLE 3. Acute Toxicity Data for PM-4300 Organic Acids (40 CFR 158.2050)

Study Type/OCSPP Guideline LD50/LC50/Results Toxicity 

Category

MRID

Acute Oral Toxicity/870.1100 >5,000 mg/kg IV 48711105

Acute Dermal Toxicity/870.1200 > 5,000 mg/kg IV 48711106

Acute Inhalation Toxicity870.1300 >2.05 mg/L IV 48711107

Acute Eye Irritation/870.2400 Minimal effects clearing in less 

than 24 hours

IV 48711108

Acute 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 

cytotoxicity at highest does 

tested; nonmutagenic/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 Phocon (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-acceptable
Humates PC Codes 700132, 800286, and 021818

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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 LC50/

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 growth 

endpoints for species tested at 21 days post 

application

Acceptable

48710907

Non-target Insects/850.3020 48-hr contact LD50 >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 LC50 > 5620ppm; Practically 

Nontoxic

48711112

Freshwater Fish LC50/850.1075

96 hour LC50 > 100 mg/L; 

Practically Nontoxic

48711113

Freshwater Invertebrate/850.1010 48 hour EC50 > 100 mg/L Practically 

Nontoxic

48711114

Non-target Plants/850.4100/4150 Rationale/Acceptable 48711116

Non-target Insects/850.3020 Rationale/Acceptable 48711116
Humates PC Codes 700132, 800286, and 021818

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VIII. APPENDIX B. References

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 

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. January 23, 2013. 

5. U.S. EPA, 2013. 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. September 6, 2013. 

6. OECD. 2004. SIDS Initial 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 Analytics. 2010. Natural organic matter (NOM) in water. 

http://www.anaanalytics.com/natural-organic-matter.php
Humates PC Codes 700132, 800286, and 021818

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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

cm3cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EC50 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 expressed 

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

LC50 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).

LD50 median lethal dose. A statistically derived single dose that can be expected 

to cause death in 50% of the test animals when administered by the route 

indicated (oral 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”

NIOSH National Institute for Occupational Safety and Health

nm nanometer
Humates PC Codes 700132, 800286, and 021818

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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