Document ID: EPA-HQ-OPP-2018-0152-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-05-18T04:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: [insert name and telephone number with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Nutri AG Inc.
4740 N. Interstate 35 E 
Waxahachie, Texas  75165     
IN-11102

	EPA has received a pesticide petition (IN-11102) from Nutri AG Inc., 4740 N. Interstate 35 E, Waxahachie, Texas  75165   requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

	 to establish an exemption from the requirement of a tolerance for

	Fulvic Acid (CAS Reg. No. 479-66-3) under 40 CFR §180.910 when used as an inert ingredient used pre- and post-harvest. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry
Fulvic Acid will be exempted from the requirement of a tolerance in 40 CFR §180.910 when used as an inert ingredient used pre- and post-harvest. Thus, residue data are not required.  

	1. Plant metabolism. Not Applicable - Remove

	2. Analytical method. Not Applicable - Remove

	3. Magnitude of residues. Not Applicable - Remove

B. Toxicological Profile

The Nutri Ag Fulvic Acid is derived from a carbohydrate source. Humic substances and specifically fulvic acid are ubiquitous, essentially found wherever it has been analyzed for its presence.  Natural background levels are quite high, thus fulvic acid exposures to soil and aquatic organisms is constant and found at relatively high concentrations. 

In soils, humic substances are the largest constituent of organic matter (∼60%) and are considered as a key component of the terrestrial ecosystem, being responsible for many complex chemical reactions in soil.  In waters of the United States, the average concentration of dissolved humic substances is 2.2 mg C/L or 4.4 mg/L expressed as humic substances and moreover, approximately 90% of the humic substances US surface waters are fulvic acids.

Due to its ubiquity, the US population is exposed to continuous and relatively high concentrations of fulvic acid on a regular basis.  

	1. Acute toxicity.  [In acute studies, exposure to fulvic acid resulted in no observable or minimal toxicity.  The acute oral LD50 in rats is >5,000 mg/kg.  Minimal eye irritation ws observed with New Zealand Albino Rabbits.  Minimal dermal irritation was observed in an acute dermal study with New Zealand Albino Rabbits.  No Indications of sensitization has been observed in hypersensitivity studies.]

	2. Genotoxicty. [Mutagenic activity was determined by the Ames test procedures using Salmonella typhimurium TA100 and TA98. Humic acid was not found to be mutagenic, nor did it decrease sponta­neous mutations. Moreover, fulvic acid has also shown to have desmutagenic effects with several known mutagens]

	3. Reproductive and developmental toxicity. [In a teratogenicity experiment, 10 pregnant rats received fulvic acid by gavage 3 days before fertilization to 14 days of pregnancy a dosage of 100mg/kg body weight diluted to an equal amount of distilled water. None of the animals died in the teratogenicity study, and no abnormalities were observed in the puppies. The weight growth patterns of the females during the pregnancy period between the groups were almost identical (results not shown). The report concluded that there was no indication of any developmental defects or pathological anatomical abnormalities were associated with fulvic acid treatment.]

	4. Subchronic toxicity. [Two separate oral exposure studies with male and female rats (by gavage) using 100 mg/kg body weight/day suggested that the product was nontoxic with regards to liver and kidney function in rats over a period of 6 months, when administered orally. Fulvic acid did cause a significant increase in serum AST levels after 6 weeks. However, this increase was not apparent upon completion of the trial at 6 months. 

In a 30-day dermal toxicity and hypersensitivity study with female Balb C mice were topically exposed 400 mg/kg body weight of fulvic acid, twice a day for 30 days. The data suggested that fulvic acid, when applied topically, did not produce any hypersensitivity reactions and was nontoxic with regards to liver and kidney function in mice over a period of one month.]

	5. Chronic toxicity. [Insert text.]

	6. Animal metabolism. 

      7. Metabolite toxicology. Not Applicable  -  Remove
      
	8. Endocrine disruption. [Insert text.]

C. Aggregate Exposure

	1. Dietary exposure. .
	i. Food. 
	ii. Drinking water. 
	2. Non-dietary exposure. 
D. Cumulative Effects

	[Insert text.]

E. Safety Determination
[Due to its ubiquity and high background levels particularly in soil and water, the US population is continuously exposed to high concentrations of humic substances including fulvic acid.  The proposed uses of fulvic acid as an inert in pesticide are well below background levels. Moreover, the low to non-toxic effects in the available public literature support an exemption from the requirement of a tolerance. ]

	1. U.S. population. 
	2. Infants and children. [
]

F. International Tolerances

	[Insert text.]