Document ID: EPA-HQ-OPP-2017-0574-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-02-27T05:00Z

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

EPA Registration Division contact: Janet Whitehurst 703-305-6129

Nutri AG Inc.
4740 N. Interstate 35 E 
Waxahachie, Texas  75165     
 IN 11059

	EPA has received a pesticide petition (IN 11059) 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

   
   	1.  to amend establish an exemption from the requirement of a tolerance for

	Amend the zinc oxide exemption from the requirement of a tolerance in 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.

The present exemption for zinc oxide use as an inert ingredient under 40 CFR §180.910 is for its use as "coating agent." Nutri AG Inc. proposes to add a new use of zinc oxide as a "stabilizer." 

A. Residue Chemistry
Zinc oxide is 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

	1. Acute toxicity.  Data indicates that zinc oxide has an acute toxicity category IV for acute oral (rat). It is a not a skin irritant (acute toxicity category IV) and only a mild eye irritant (acute toxicity category III).

The FDA considers zinc oxide and zinc sulfate GRAS for use in foods under 21 CFR 182.8991 and 182.8997, respectively. The FDA also considers zinc oxide and zinc sulfate GRAS for use in nutrients under 21 CFR 182.5985 and 182.5997, respectively. 

Zinc is ubiquitous in the environment and occurs in the earth's crust at an average concentration of approximately 70 mg/kg. This ion exists in the form of zinc salts such as zinc sulfide, zinc carbonate, and zinc oxide. Zinc is also an essential nutrient in the body. For toxicological concerns, there are adequate toxicology studies in the zinc database to evaluate incidental oral exposures. At high levels, oral exposure to zinc in animal studies may result in toxic effects such as pancreatic and renal lesions as well as histological alterations in the pituitary and adrenal glands. However, based on the on the use of zinc oxide as an inert, exposure to zinc is not anticipated to be high. Zinc is widely distributed in plants and animals, and is normally present in food. Zinc is also a normal part of metabolism in all living organisms. Based on this information, no toxicological endpoints were selected.

	2. Genotoxicty. [Insert text.]

	3. Reproductive and developmental toxicity. [Insert text.]

	4. Subchronic toxicity. [Insert text.]

	5. Chronic toxicity. [Insert text.]

	6. Animal metabolism. Regarding effects on metabolism, zinc is an essential element in human nutrition and is part of the nutrition of all plants and animals. It is
an essential component of several enzymes involved in human metabolism, and is present in every cell. In laboratory feeding studies, most of the zinc eaten by test animals was excreted. Ingesting large amounts of zinc salts does cause changes in metabolism; however, people usually are not exposed to such large amounts of zinc through the diet.	

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

C. Aggregate Exposure

	1. Dietary exposure. The primary source of information for this assessment is the 1992 Zinc Salts RED. Toxicity endpoints for zinc and zinc salts were not originally selected in the RED because zinc is ubiquitous in the environment and occurs in the earth's crust at an average concentration of approximately 70 mg/kg. Zinc is also an essential nutrient in the body and is GRAS in food as dietary supplements. When used as an inert, exposure to zinc oxide is not likely to be higher than that which is found in ambient levels and at levels of zinc nutrient which are required by the human body.

	i. Food. The FDA considers zinc oxide and zinc sulfate GRAS for use in foods under 21 CFR 182.8991 and 182.8997, respectively. The FDA also considers zinc oxide and zinc sulfate GRAS for use in nutrients under 21 CFR 182.5985 and 182.5997, respectively.

	ii. Drinking water. The FDA considers zinc and zinc chloride generally recognized as safe (GRAS) for use in foods and nutrients under 21 CFR 182.8985 and 21 CFR 182.5991. The FDA also considers zinc oxide and zinc sulfate as GRAS for use in foods under 21 CFR 182.8991 and 182.8997, respectively. The FDA also considers zinc oxide and zinc sulfate as GRAS for use in nutrients under 21 CFR 182.5985 and 182.5997, respectively. Therefore, no dietary or drinking water assessment is needed for zinc and zinc salts.

	2. Non-dietary exposure. An occupational and/or residential exposure assessment is needed for an active ingredient if (1) certain toxicological criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For zinc and zinc salts, the toxicological criteria are not triggered. Given the lack of concern for toxicity, and low potential for occupational and residential exposure, mixer/loader/applicator and post application occupational and residential risks from the existing uses of zinc salts are considered inconsequential and are not of concern. Additional occupational and residential risk assessments are not needed.

D. Cumulative Effects

	[Insert text.]

E. Safety Determination

	1. U.S. population. As mentioned in the toxicology section, zinc is ubiquitous in the environment and occurs in the earth's crust at an average concentration of approximately 70 mg/kg. Zinc is also an essential nutrient in the body and is GRAS in food as dietary supplements. At registered application rates, exposure to zinc oxide when sued as an inert is not likely to be higher than that which is found in ambient levels and at levels of zinc nutrient which are required by the human body.

	2. Infants and children. [Insert text.]

F. International Tolerances