BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Natamycin

PC Code: 051102

U.S. Environmental Protection Agency 

 Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

(last updated November 7, 2014) 

 
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Table of Contents

I. EXECUTIVE SUMMARY .................................................................................................. 5

II. ACTIVE INGREDIENT OVERVIEW .............................................................................. 7

III. REGULATORY BACKGROUND...................................................................................... 7

A. Application for Pesticide Registration ............................................................................... 7

B. Food Clearances/Tolerances ............................................................................................... 8

IV. RISK ASSESSMENT ........................................................................................................... 8

A. Product Analysis Assessment (40 CFR § 158.2030) .......................................................... 8

B. Human Health Assessment.................................................................................................. 9

1. Tier I Toxicology ........................................................................................................................................... 9

2. Tier II and Tier III Toxicity Studies .......................................................................................................... 10

3. Effects on the Endocrine System ................................................................................................................ 10

4. Dose Response Assessment ......................................................................................................................... 11

5. Drinking Water Exposure and Risk Characterization ............................................................................ 11

6. Occupational, Residential, School and Day Care Exposure and Risk Characterization ...................... 11

a. Occupational Exposure and Risk Characterization ................................................................................. 11

b. Residential, School and Day Care Exposure and Risk Characterization ............................................... 11

7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation ........................... 11

a. Food Exposure ............................................................................................................................................. 12

b. Drinking Water Exposure .......................................................................................................................... 12

c. Other Non-occupational Exposure ............................................................................................................ 12

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity ..................................... 12

9. Determination of Safety for United States Population, Infants and Children ....................................... 12

10. Risk Characterization ................................................................................................................................. 13

C. Environmental Assessment ............................................................................................... 13

1. Ecological Hazards ...................................................................................................................................... 13

2. Environmental Fate and Ground Water Data .......................................................................................... 13

3. Ecological Exposure and Risk Characterization ...................................................................................... 13

4. Endangered Species Assessment ................................................................................................................ 14

D. Product Performance Data ............................................................................................... 14

V. RISK MANAGEMENT DECISION ................................................................................. 14

A. Determination of Eligibility for Registration .................................................................. 14

B. Regulatory Decision ........................................................................................................... 14
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C. Environmental Justice ....................................................................................................... 15

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 15

A. Reporting of Adverse Effects ............................................................................................ 15

B. Reporting of Hypersensitivity Incidents .......................................................................... 15

VII.  APPENDIX A: DATA TABLES ....................................................................................... 16

VIII.  APPENDIX B: REFERENCES ....................................................................................... 18

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 23
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM 

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Biochemical Pesticides Branch 

Linda A. Hollis, M.S., Branch Chief 

Russell Jones, Ph.D., Senior Scientist 

Miachel Rexrode, Ph.D., Senior Scientist 

Cheryl Greene, Regulator Action Leader 

Gina Burnett, M.S., Regulatory Action Leader 

 
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I. EXECUTIVE SUMMARY 

Natamycin is a biochemical pesticide active ingredient intended for use as a fungistat to control 

the germination of mold and yeast spores in the growth media of mushrooms produced in 

enclosed mushroom production facilities and on pineapples. Natamycin is a naturally-occurring 

antimycotic compound derived from the common soil microorganisms Streptomyces natalensis, 

Streptomyces lydicus, and Streptomyces chattanoogensis. It is commercially produced by a 

submerged oxygen-based fermentation of Streptomyces natalensis cells, which are then lysed by 

increasing the temperature in the fermentation vessel thereby causing the release of natamycin 

from the cell solids. Natamycin was originally discovered in Streptomyces natalensis in South 

Africa in the early 1950s, and was subsequently discovered to also occur naturally in North 

America in Streptomyces lydicus and Streptomyces chattanoogensis. Natamycin has a non-toxic 

mode of action and functions as a fungistat, preventing the germination of fungal spores. It has 

no effects on fungal mycelia. Development of antibiotic resistance to Natamycin has not been 

reported during its entire history of use. 

Natamycin has been used as a food preservative worldwide for over 40 years and is approved as 

a food additive/preservative by the European Union, the World Health Organization and 

individual countries for use as a fungistat to suppress mold on cheese, meats and sausage. In the 

United States, natamycin is approved by The Food and Drug Administration (FDA) as a direct 

food additive/preservative for the inhibition of mold and yeast on the surface of cheeses (21 CFR 

§ 172.155) and as an additive to the feed and drinking water of broiler chickens to retard the 

growth of specific molds (21 CFR § 573.685). Natamycin is also FDA approved for use as a 

treatment to suppress fungal eye infections such as blepharitis, conjunctivitis, and keratitis. On 

August 17, 2007, the EPA’s Biochemical Classification Committee classified Natamycin as a 

Biochemical Pesticide active. Streptomyces lydicus (the source of natamycin) is currently 

registered by the Agency under Registration Nos. 73314-1, -2, and -4 as a microbial pesticide for 

greenhouse, nursery, turfgrass, agricultural, and seed treatment uses. Natamycin is currently 

registered by the Agency under Registration Nos. 87485-1 and -2 for use in enclosed mushroom 

production facilities. The pending product registration for natamycin is EPA File Symbol 87485-

G; this product is intended for use post-harvest, indoors, on pineapples. 

The Agency has concluded that adequate product chemistry and mammalian toxicology data are 

available to support natamycin (U.S. EPA, 2010; U.S. EPA, 2011a; U.S. EPA, 2011b; U.S. EPA 

2011c; U.S. EPA, 2014). Acute toxicity studies on natamycin (98.17% and 98.27% pure), 

confirm a low toxicity profile. The acute toxicity data show virtual nontoxicity for all routes of 

exposure (Toxicity Category III for acute oral toxicity and primary eye irritation; Toxicity 

Category IV for acute dermal toxicity, acute inhalation toxicity, and primary dermal irritation; 

not a dermal sensitizer). A 90-Day Oral study on natamycin indicated no adverse effects up to 

the highest dose tested, which was 2,000 milligrams (mg) per kilogram (kg) body weight (bw) 

per day. No 90-Day Dermal or 90-Day Inhalation studies were submitted and none are required 

since products containing natamycin will be used indoors only by applicators wearing 

appropriate Personal Protective Equipment (PPE), as stated on the product labels. A prenatal 

developmental toxicity study showed no effects up to the highest dose tested, which was 50 

mg/kg bw/day. Submitted studies indicate that natamycin is non-mutagenic. Therefore, the 

Agency concludes that this active ingredient is not likely to result in adverse human health 
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effects, based upon available reports and information. 

Tier I studies were not submitted for non-target organisms and environmental fate data 

requirements for natamycin and such studies are not required. Based on its use pattern and use 

instructions as a fungistat intended solely for use indoors (in enclosed mushroom production 

facilities or in packaging facilities on pineapples), natamycin exposure to non-target organisms is 

not expected. Further, EPA has determined that natamycin will have "No Effect" on any 

currently listed threatened or endangered species or any designated critical habitat based on its 

use pattern. 

On October 1, 2009, the U.S. Environmental Protection Agency (EPA or the Agency) 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, the public is 

provided 15 days in which to submit comments to the Agency regarding its pending decision to 

register a product containing natamycin for use on pineapples post-harvest, indoors. The 

following documents are available for comment in the docket, identification number EPA-HQOPP-2014-0352: a draft of this Biopesticides Registration Action Document (BRAD) and the 

draft product label for Zivion P (EPA File Symbol 87485-G). 

Altogether, the Agency believes that, based on the existing information in the Agency’s database 

on natamycin and the recent information submitted in support of the registration of a pesticide 

product containing natamycin for use on pineapples, post-harvest, indoors, it is in the best 

interest of the public to issue the registration for Zivion P (EPA File Symbol 87485-G). The 

basis for this decision can be found in the science review memorandums for these products (U.S. 

EPA, 2010; U.S. EPA, 2011a; U.S. EPA, 2011b; U.S. EPA 2011c; U.S. EPA, 2014) and the 

existing information in the Agency’s database on natamycin, all of which are characterized in 

this BRAD. 

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/. 

= 
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II. ACTIVE INGREDIENT OVERVIEW 

Common Name: Natamycin

Chemical Names: IUPAC Chemical Name: 

(1R,3S,5R,7R,8E,12R,14E,16E,18E,20E,22R,24S,25R,26S)-

22-[(3-amino-3,6-dideoxy-β-D-mannopyranosyl)oxy]-

1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-

trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-

pentaene-25-carboxylic acid

Trade & Other Names: Natamycin L 

 Pimaricin 

 Tennectin 

 Delvocid 

CAS Registry Number: 7681-93-8 

OPP Chemical Code: 051102 

Type of Pesticide: Biochemical Pesticide – Fungistat 

Biochemical Classification 

On August 17, 2007, EPA’s Biochemical Classification Committee classified natamycin as a 

Biochemical Pesticide active ingredient. 

III. REGULATORY BACKGROUND 

A. Application for Pesticide Registration 

On May 20, 2010, EPA received an application filed by Keller and Heckman, 1001 G Street, 

N.W., Suite 500 West, Washington, D.C.20001 on behalf of DSM Food Specialties B.V. 

(hereafter referred to as “DSM” or “applicant”), Alexander Fleminglaan 1, Delft, The 

Netherlands 2613AX to register the products Natamycin TGAI (EPA Reg. No. 87485-1), and 

Natamycin L (EPA Reg. No. 87485-2) containing the new biochemical active ingredient 

natamycin. The application was submitted to both EPA and The Health Canada Pest 

Management Regulatory Agency (PMRA) along with a request for a North American Free Trade 

Agreement (NAFTA) Joint Review of the applications. Concurrent with these applications, DSM 

filed a petition for a tolerance exemption for residues of natamycin on mushrooms when used as 

a fungistat in enclosed mushroom producing facilities. No comments were received following 

publication of the notice. On November 24, 2010, EPA published in the Federal Register (76 FR 

22067) a Notice of Receipt (NOR) announcing receipt of the applications, and on April 20, 2011 

EPA published in the Federal Register (76 FR 22067) a Notice of Filing (NOF) announcing 

receipt of the petition. 
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On January 6, 2014, Becker Underwood, on behalf of DSM, submitted an application to register 

a biochemical pesticide product, Zivion P (EPA File Symbol 87485-G), containing natamycin as 

its active ingredient. Zivion P is intended for use as a fungistat applied to pineapples post-harvest 

in indoor packages facilities. In the Federal Register of August 1, 2014 (79 FR 44729), a NOF 

announced the pesticide tolerance petition (PP 4F8233) by DSM. The petition requested that 40 

CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for 

residues of natamycin post-harvest, indoors, on pineapples. There were no comments received in 

response to this NOF.

B. Food Clearances/Tolerances 

Natamycin is exempt from the requirement of a tolerance as stated at 40 CFR § 180.1315: 

40 CFR § 180.1315 Natamycin; exemption from the requirement of a tolerance. 

An exemption from the requirement of a tolerance is established for residues of natamycin in or on 

mushrooms when applied as a fungistat to prevent the germination of fungal spores on mushrooms 

produced in enclosed mushroom production facilities.

 

The proposed end-use product, Zivion P (EPA File Symbol 87485-G), will be used post-harvest 

on pineapples inside packaging facilities (indoor use only). With the registration of this product, 

the Agency will also amend the tolerance exemption at 40 CFR § 180.1315 to read as follows: 

40 CFR § 180.1315 Natamycin; exemption from the requirement of a tolerance. 

An exemption from the requirement of a tolerance is established for residues of natamycin in or on 

mushrooms when applied as a fungistat to prevent the germination of fungal spores on mushrooms 

produced in enclosed mushroom production facilities, and in or on pineapples when applied as a fungistat 

in accordance with label directions and good agricultural practices 

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 limits. 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. 

All product chemistry data requirements have been satisfied for the active ingredient (natamycin) 

and the proposed product, Zivion P (EPA File Symbol 87485-G). Refer to Appendix A for a 

summary of natamycin product chemistry data. 
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B. Human Health Assessment 

1. Tier I Toxicology 

All applicable mammalian toxicology data requirements an exemption from the requirement of a 

tolerance for residues of natamycin when used on mushrooms in enclosed production facilities 

and on pineapples, indoors, post-harvest have been fulfilled with data submitted by the 

petitioner. These data indicate that the active ingredient is of low acute toxicity and is not a 

developmental toxicant, a mutagen, or toxic via repeat oral exposure. 

The following is a summary of EPA’s review of the toxicity profile of this biochemical: 

 

Acute Toxicity: Acute toxicity studies on natamycin (98.17% and 98.27% pure), confirm a low 

toxicity profile. The acute toxicity data show virtual nontoxicity for all routes of exposure. 

Therefore, it can be concluded that any dietary risks associated with this biochemical would be 

negligible. 

1. The acute oral median lethal dose (LD50) in rats was greater than 2,000 milligrams per 

kilogram (mg/kg) bodyweight. There were no observed toxicological effects on the test 

subjects in the acute oral study submitted (MRID No. 48105505). Natamycin is classified 

as Toxicity Category III for acute oral toxicity. 

2. The acute dermal LD50 in rats was greater than 5,050 mg/kg body weight (MRID 

48105506). Natamycin is classified as Toxicity Category IV for acute dermal toxicity. 

3. The acute inhalation median lethal concentration (LC50) was greater than 2.39 

milligrams per liter (mg/L) in rats and showed no significant inhalation toxicity (MRID 

48105507). Natamycin is classified as Toxicity Category IV for acute inhalation toxicity. 

4. A primary eye irritation study on rabbits indicates that natamycin is severely irritating to 

the eye but with no effects observed at 24 hours after treatment (MRID 48015508). 

Natamycin is classified as Toxicity Category III for primary eye irritation. 

5. A skin irritation study on rabbits indicates that natamycin is slightly irritating (MRID 

48105509). Natamycin is classified as Toxicity Category IV for primary skin irritation. 

6. Data indicate that natamycin is not a dermal sensitizer (MRID 48105510). 

Mutagenicity: Two mutagenicity studies, using natamycin (98.17% and 98.27% pure) as the test 

substance, were performed. These studies are sufficient to confirm that there are no expected 

dietary or non-occupational risks of mutagenicity with regard to food use of natamycin. 

1. A Bacterial Reverse Gene Mutation Test (MRID No. 48105513) investigating doses of test 

substance up to those that were cytotoxic, both with and without metabolic S9 activation, found 

no incidences of a 2-fold or greater increase in the number of revertants compared to the 

corresponding solvent control in two independently repeated experiments. Therefore, natamycin 
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is considered to be non-mutagenic under the conditions of this assay. 

2. An in vitro Mammalian Cell Chromosome Aberration Test (MRID No. 48105514) tested 

natamycin genotoxicity on cultured peripheral human lymphocytes in the presence and absence 

of metabolic S9 activation. Natamycin did not induce a statistically significant or biologically 

relevant increase in the number of cells with chromosome aberrations in the absence and in the 

presence of S9-mix, in two independently repeated experiments. In addition, all of the negative, 

solvent, and positive controls gave appropriate responses. Therefore, under the conditions of this 

assay, natamycin is considered to be non-mutagenic and does not cause chromosome aberrations. 

Subchronic Toxicity: In a subchronic oral toxicity study using natamycin (98.17% and 98.27% 

pure) as the test substance, doses of 125 and 500 mg/kg/day showed no treatment related 

findings. The highest concentration level, 2,000 mg/kg/day, showed reduced weight for both 

male and female rats (MRID 48105511). The Agency does not consider the temporary decrease 

in body weight or food intake observed in the 2,000 mg/kg bw/day test group to be an adverse 

effect, as this is likely due to the palatability of the food containing this high dose of test 

substance. Therefore, the Agency establishes the NOAEL (No Observed Adverse Effect Level) 

for this study as 2,000 mg/kg bw/day. A LOAEL (Lowest Observed Adverse Effect Level) was 

not identified, suggesting that the test animals could have tolerated a higher dose. 

Developmental Toxicity: A developmental toxicity study using natamycin (98.17% and 98.27% 

pure) as the test substance (MRID 48105512) showed no discernable effects on growth, 

reproduction, teratological or mutagenic responses, or on gross and microscopic pathology, at 

concentration levels 0, 5, 15 and 50 mg/kg bw/day. 

2. Tier II and Tier III Toxicity Studies 

The biochemical pesticide Human Health Assessment data requirements for Tier II and Tier III 

were not required due to the low toxicity of the active ingredient and the low levels of exposure 

expected from its intended uses in EP products. 

3. Effects on the Endocrine System 

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) 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.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

 
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Between October 2009 and February 2010, EPA issued test orders and data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors. 

 

Natamycin is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA section 408(p), the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP test orders and data call-ins for all 

pesticide active ingredients. 

 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/. 

4. Dose Response Assessment 

No toxicological endpoints have been identified for natamycin; therefore, a dose-response 

assessment was not required. 

5. Drinking Water Exposure and Risk Characterization 

Exposure of humans to natamycin in drinking water is not expected because natamycin is 

approved for application indoors only (enclosed mushroom houses or pineapple packing 

facilities). 

6. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization 

a. Occupational Exposure and Risk Characterization 

Occupational exposure to registered pesticide products containing natamycin is not expected due 

to mitigation through precautionary language and personal protective equipment (PPE) on the 

label. 

b. Residential, School and Day Care Exposure and Risk Characterization 

Natamycin is intended for use only in enclosed mushroom houses and in indoor packaging 

facilities on pineapples. No indoor residential, school, or day care uses are currently approved for 

products containing natamycin. 

7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation 

There is reasonable certainty of no harm to U.S. populations, including infants and children, 

from aggregate exposures to residues of natamycin when used as proposed. This includes all 

anticipated dietary exposures and all other exposures for which there is reliable information. 
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Moreover, potential non-occupational inhalation and dermal exposure is not likely to pose any 

adverse effects to exposed populations via aggregate and cumulative exposure. 

a. Food Exposure 

Dietary exposure to residues of natamycin is expected to be insignificant, even in the event of 

exposure. The lowest NOEL (No observed effect level) for natamycin is 50 mg/kg/day. The 

application of natamycin on pineapples produces residues in the edible portions (meat and juice) 

in the range < 0.01 – 0.07 ppm. A human adult exposure threshold was calculated at 30 mg/day

(NOEL/uncertainty factor x 60kg; 50 mg/kg/day/100 x 60 kg = 30 mg/day). Oral exposure to 

children (1-2 years old, 11.2 kg) was found at 5.6 mg/day (50 mg/kg/day/100 x 11.2 kg = 5.6 

mg/day). Therefore, expected residue levels on natamycin on pineapple meat and juice are about 

three orders of magnitude below the adult and children exposure threshold (EPA, 2014). 

Furthermore, the active ingredient is of low acute toxicity and is not a developmental toxicant, a 

mutagen, or toxic via repeat oral exposure 

b. Drinking Water Exposure 

Exposure of humans to natamycin in drinking water is not expected because natamycin is 

approved for application indoors only (enclosed mushroom houses or pineapple packing 

facilities). 

c. Other Non-occupational Exposure 

Non-occupational exposure is not expected because natamycin is not approved for residential 

uses. The active ingredient is applied directly to commodities and degrades rapidly. 

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity 

 

The EPA has not found natamycin to share a common mechanism of toxicity with any other 

substances, and natamycin does not appear to produce a toxic metabolite produced by other 

substances. For the purposes of this tolerance action, therefore, the EPA has assumed that 

natamycin does not have a common mechanism of toxicity with other substances. Following 

from this, the EPA concludes that there are no cumulative effects associated with natamycin that 

need to be considered. For information regarding the EPA’s efforts to determine chemicals that 

have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, 

see the EPA’s website at http://www.epa.gov/pesticides/cumulative. 

9. Determination of Safety for United States Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or 

tolerance exemption for a pesticide chemical residue, the EPA shall assess the available 

information about consumption patterns among infants and children, special susceptibility of 

infants and children to pesticide chemical residues, and the cumulative effects on infants and 

children of the residues and other substances with a common mechanism of toxicity. In addition, 
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FFDCA section 408(b)(2)(C) provides that the EPA shall apply an additional tenfold (10X) 

margin of safety for infants and children in the case of threshold effects to account for prenatal 

and postnatal toxicity and the completeness of the database on toxicity and exposure, unless the 

EPA determines that a different margin of safety will be safe for infants and children. This 

additional margin of safety is commonly referred to as the Food Quality Protection Act Safety 

Factor. In applying this provision, the EPA either retains the default value of 10X, or uses a 

different additional or no safety factor when reliable data are available to support a different 

additional or no safety factor. 

Because there are no threshold effects associated with this biochemical, an additional margin of 

safety for infants and children is not necessary. 

EPA has determined that there are no foreseeable dietary risks to the U.S. population, including 

infants and children, from the use of natamycin as a pesticide (fungicide) on mushrooms in 

enclosed mushroom facilities and post-harvest, indoors, on pineapples when label instructions 

and good agricultural practices are followed. The available data and information indicate that the 

chemical is of low toxicity and not a developmental toxicant. Therefore, EPA 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 natamycin when it is used as labeled 

and in accordance with good agricultural practices. Such exposure includes all anticipated 

dietary exposures and all other exposures for which there is reliable information. EPA has 

arrived at this conclusion because the data and information available on natamycin do not 

demonstrate significant toxic potential to mammals, including infants and children. 

10. Risk Characterization 

The Agency considered human exposure to natamycin in light of the relevant safety factors in 

FQPA and FIFRA. 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 from the use of 

products containing natamcyin when label instructions are followed. 

C. Environmental Assessment 

1. Ecological Hazards 

Tier I studies were not submitted but are not required. However, based on its use pattern and use 

instructions as a fungistat intended solely for use in indoors, exposure to non-target organisms is 

not expected. 

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 
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Exposure and risk from the registered and proposed uses of natamycin are expected to be 

minimal for nontarget organisms because all uses are indoors only. 

4. Endangered Species Assessment 

Based on its use pattern and use instructions, EPA has determined that natamycin will have "No 

Effect" on any currently listed threatened or endangered species or any designated critical 

habitat. 

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 significance 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 Notice (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). 

Natamycin is not intended to be formulated into products to control public health pests as 

defined in FIFRA section 28(d) and section 2(nn), and product performance (efficacy) was not 

evaluated by the Agency. 

V. RISK MANAGEMENT DECISION 

A. Determination of Eligibility for Registration 

Section 3(c)(5) of FIFRA provides for pesticide product registration if it is determined that: (A) 

its composition warrants proposed claims; (B) its labeling and other materials comply with the 

requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse 

effects on the environment; and (D) when used in accordance with widespread and commonly 

recognized practice, it will not generally cause unreasonable adverse effects on the environment. 

The four eligibility criteria have been satisfied for the proposed pesticide product containing the 

active ingredient natamycin (and for all previous registered pesticide products containing 

natamycin). 

B. Regulatory Decision 

The data submitted fulfill the requirements for the unconditional registration of Zivion P (EPA 

File Symbol 87485-G) as an EP for use on pineapples, post-harvest, indoors, and EPA believes it 

is in the best interest of the public to grant this registration. For product-specific labels and 
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information on other product containing natamycin, please refer to 

http://www.epa.gov/pesticides/pestlabels. 

C. Environmental Justice 

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. At this time, 

EPA does not believe that products containing the active ingredient natamycin, or the use of 

natamycin on pineapples post-harvest, indoors, will cause harm or a disproportionate impact on 

at-risk communities. For additional information regarding environmental justice issues, please 

visit EPA’s website 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 natamycin and 

determined that these data are sufficient to satisfy current registration data requirements for 

Zivion P (EPA File Symbol 87485-G). At this time, no additional data must be submitted to 

EPA. 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 certain specific data are required to be reported to EPA as a requirement for maintaining the 

federal registration for a pesticide product. A brief summary of these types of data are listed 

below. 

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: Product Chemistry Data Tables 

TABLE 1. Product Chemistry Data Requirements for Natamycin Technical (40 CFR § 158.2030) 

OSCPP Guideline 

No. Study Results MRID No. 

880.1100 

880.1200 

880.1400 

Product identity; 

Manufacturing process; 

Discussion of formation of 

impurities 

Submitted data satisfy the 

requirements for product 

identity, manufacturing 

process, and discussion of 

formation of impurities. 

48105401 

48105501 

47206713 

47760931 

830.1700 Analysis of samples Submitted data satisfy the 

requirements for analysis of 

samples. 

48105502

830.1750 Certification of limits Limits listed in the 

confidential statement of 

formula are acceptable 

48105402 

830.1800 Analytical method Acceptable 48105403 

TABLE 2. Physical and Chemical Properties of Natamycin Technical (40 CFR § 158.2030)

OCSPP 

Guideline No. 

Property Description of Results MRID 

830.6302 Color Colourless 48105503 

830.6303 Physical State Viscous liquid 48105503

830.6304 Odor Odorless 48105503

830.6313 

Stability to Normal and 

Elevated Temperatures, 

Metals and Metal Ions 

Natamycin was found stable at 

54°C for 14 days. Storage stability 

studies supporting pharmaceutical 

uses found acceptable stability in 

tests of 2 to 5 years in duration. 

Natamycin is degraded by contact 

with most metals and metal ions. 

However, the product is never 

packaged in metal containers. 

48105504

830.6315 Flammability Does not contain any flammable 

components. Consists of ~ 80% 

water. 

48105503 

830.6317 Storage Stability The product is stable when stored 

for 12 and 18 months in HDPE 

plastic bottles at 25o

C. 

8105405 

48439301 

48544501 

830.6320 Corrosion Characteristics The product is not corrosive. 48105405 

48439301 

48544501 

830.7000 pH 6.5 (1% aqueous solution) 

6.5 (1% aqueous solution). May 

vary between 5 to 7.5

48105503? 

830.7100 Viscosity ~2200 mPa.s, Brookfield Test 

Method: 

RPM-20, Axe=3, T=20°C. 

48105503

830.7220 Boiling Point/Range N/A The product is a solid. 48105503

830.7300 Density Loose bulk density 0.3 g/mL 

Tapped bulk density 0.59 g/mL
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TABLE 2. Physical and Chemical Properties of Natamycin Technical (40 CFR § 158.2030)

OCSPP 

Guideline No. 

Property Description of Results MRID 

830.7560 

830.7570 

Octanol/water partition 

coefficient (Kow) 

Log Kow = – 3.67 48105503 

830.7840 Water Solubility 30-50 ppm @ 20-25°C and pH 5- 

7.5; very soluble at pH ≥ 10 or 

pH ≤ 2 but rapidly degrades.

8105503

830.7950 Vapor Pressure NA The product is a solid 48105503 

 Formulation Type Suspension (SU) 48105501 

 Container Material and 

Description 

HDPE plastic bucket, jerry can, 

drum or jumbo container (5 to 1000 

Litres) 

48105501

830.7000 pH 6.5 (1% aqueous solution) 

6.5 (1% aqueous solution). May 

vary between 5 to 7.5 

48105503

830.6314 Oxidizing or Reducing Action Not applicable. Does not contain 

oxidizing or reducing chemicals. 

48105503

830.6316 Explodability Not applicable. Does not contain 

any substance capable of exploding. 

48105503

830.6319 Miscibility Not formulated to be mixed with 

petroleum solvents. 

48105503

830.6321 Dielectric Breakdown 

Voltage 

Not applicable. Not intended to be 

used around electrical equipment. 

48105503

1

 A = Acceptable; N = Unacceptable (see Deficiency); N/A = Not applicable. 2

 For example, “brown” for 830.6302; “1.021” for 830.7300. 

3.There was a slight shift in the retention time (close to a minute) for the active ingredient based on the 

chromatograms provided for the 18-month storage stability study. The applicant provided a rationale indicating 

that there was a change in the column packing material (new batch). The applicant provided additional 

chromatograms for the controls (standard sample) for the 6- and 18-month to confirm the slight shift in the 

retention times for the active. The rationale is accepted. 

 
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VIII. Appendix B. References 

EPA Science Review Memos 

U.S. EPA, 2010. Jones, Russell, Ph.D. Science Review in Support of Natamycin Technical, 

Containing 91.02% Natamycin as Its Active Ingredient. United States Environmental Protection 

Agency (U.S. EPA) Memorandum dated 10/15/2010. 

 

U.S. EPA, 2011a. Jones, Russell, Ph.D. Science Review in Support of Natamycin Technical, 

Containing 91.02% Natamycin as Its Active Ingredient. United States Environmental Protection 

Agency (U.S. EPA) Memorandum dated 04/04/2011. 

 

U.S. EPA, 2011b. Jones, Russell, Ph.D. Science Review in Support of Natamycin Technical, 

Containing 91.02% Natamycin as Its Active Ingredient. United States Environmental Protection 

Agency (U.S. EPA) Memorandum dated 07/11/2011. 

U.S. EPA, 2011c. Jones, Russell, Ph.D. Science Review in Support of Natamycin Technical, 

Containing 91.02% Natamycin as Its Active Ingredient. United States Environmental Protection 

Agency (U.S. EPA) Memorandum dated 12/13/2011. 

U.S EPA, 2014. Rexrode, Miachel, Ph.D., Request for new food use (post-harvest treatment of 

pineapples) to the active ingredient, Natamycin. United States Environmental Protection Agency 

(U.S. EPA) Memorandum dated 10/01/2014. 

Data Volumes Submitted to the Agency on Natamycin 

MRID Citation Reference 

59399 American Cyanamid Company (1959) Antibiotic A-5283, Myprozine: Acute 

Toxicity to Rats; Subacute Toxicity to Rats and Dogs: Re- port No. 59-4. 

(Unpublished study received on unknown date un- der unknown admin. no.; 

CDL:223651-A) 

59400 American Cyanamid Company (1963) Pimaricin (Myprozine^(R)I): Report on 

Two-Year Toxicity Studies. Summary of studies 223651-C through 223651-H. 

(Unpublished study received on unknown date under unknown admin. no.; 

CDL:223651-B) 

59401 American Cyanamid Company (1963) Pimaricin: Two-Year Feeding to Dogs: 

Report No. 63-6. (Unpublished study received on unknown date under unknown 

admin. no.; CDL:223651-C) 

59402 American Cyanamid Company (1963) Pimaricin: Two-Year Feeding to Rats: 

Report No. 63-7. (Unpublished study, including report no. 63-8, received on 

unknown date under unknown admin. no.; CDL: 223651-D) 

59403 Levinskas, G.J.; Bushey, C.; Kunde, M.L.; et al. (1963) Pimaricin: Successive 

Generation Studies: Report No. 63-9. (Unpublished study received on unknown 
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date under unknown admin. no.; submit- ted by American Cyanamid Co., 

Princeton, N.J.; CDL:223651-E) 

59404 Shirk, R.J.; Lovesky, R.L. (1963) A Gross Examination of the Fecal Flora of Rats 

Sustained for Two Years on Diets Containing from 0 to 1000 ppm. Pimaricin: 

Report FS 3. Progress rept., Jun 21, 1962 to Aug 1, 1962. (Unpublished study 

received on unknown date under unknown admin. no.; submitted by American 

Cyanamid Co., Princeton, N.J.; CDL:223651-F) 

59405 Shirk, R.J. (1963) The Fecal Excretion and Non-absorption of Pima- ricin in 

Animals: Report FS 3. Progress rept. (Unpublished study received on unknown date 

under unknown admin. no.; submit- ted by American Cyanamid Co., Princeton, 

N.J.; CDL:223651-G) 

48105400 DSM Food Specialties B.V. (2010) Submission of Product Chemistry, Residue, 

Toxicity, and Exposure and Risk Data in Support of the Application for 

Registration of Natamycin L and the Petition for Tolerance of Netamycin for Use 

on Mushrooms. Transmittal of 11 Studies. 

48105401 van der Lee, J.; Jovanovich, A. (2010) Natamycin L: Product Identity, Composition, 

and Formulation. Unpublished study prepared by Keller and Heckman LLP. 48 p. 

48105402 van der Lee, J.; Jovanovich, A. (2010) Natamycin L: Certified Limits. Unpublished 

study prepared by Keller and Heckman LLP. 9 p. 

48105403 van Hilten, P. (2010) Natamycin L: Enforcement Analytical Method. Unpublished 

study prepared by Keller and Heckman LLP. 18 p. 

48105404 van der Lee, J.; Jovanovich, A. (2010) Natamycin L: Summary of 

Physical/Chemical Properties and Self-Certification. Unpublished study prepared 

by Keller and Heckman LLP. 32 p. 

48105405 van der Lee, J.; Jovanovich, A. (2011)(Sic) Natamycin L: Interim Report for 

Storage Stability and Corrosion Characteristics. Project Number: 

STAB/SLD/09/008. Unpublished study prepared by DSM Food Specialties B.V. 24 

p. 

48105406 Jovanovich, A. (2010) Residue Data: Chemical Identity and Directions for Use for 

Natamycin L. Unpublished study prepared by Keller and Heckman LLP. 9 p. 

48105407 Marin, J. (2010) Development and Validation of an Analytical Method for the 

Determination of Natamycin in Mushrooms and Mushroom Compost, Casing and 

Casing plus Innoculum. Project Number: 1869W. Unpublished study prepared by 

PTRL West, Inc. 73 p. 

48105408 Marin, J. (2009) Magnitude of the Residue of Natamycin in Mushrooms. Project 

Number: 1915W. Unpublished study prepared by PTRL West, Inc. 165 p. 

48105409 Wilms, L.; Jovanovich, A. (2010) Natamycin L: Request for Waiver of 5 Acute 

Toxicity Tests. Unpublished study prepared by Keller and Heckman LLP. 16 p. 
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48105410 Kuhn, J. (2009) Natamycin Liquid Formulation: Acute Eye Irritation Study in 

Rabbits: Final Report. Project Number: 12753/09. Unpublished study prepared by 

Stillmeadow, Inc. 20 p. 

48105411 Wach, M. (2010) Natamycin L: Descriptions of Human Activity for Natamycin L. 

Unpublished study prepared by Keller and Heckman LLP. 10 p. 

48105500 DSM Food Specialties B. V. (2010) Submission of Product Chemistry and Toxicity 

Data in Support of the Application for Registration of Natamycin TGAI and the 

Petition for Tolerance of Natamycin for Use on Mushroom. Transmittal of 14 

Studies. 

48105501 Zuur, P.; Hee, P.; Roghoenath, D.; et al. (2010) Natamycin TGAI: Product Identity, 

Composition, and Production. Unpublished study prepared by Keller and Heckman 

LLP. 252 p. 

48105502 Zeeman, M.; Boogers, I.; Van der Lee, J.; et al. (2010) Natamycin TGAI: 

Preliminary Analysis and Certified Limits. Unpublished study prepared by Keller 

and Heckman LLP. 140 p. 

48105503 Van der Lee, J.; Jovanovich, A. (2010) Natamycin TGAI: Physical and Chemical 

Properties. Unpublished study prepared by Keller and Heckman LLP. 9 p. 

48105504 Van der Lee, J.; Jovanovich, A. (2010) Stability to Normal and Elevated 

Temperatures, Metals, and Metals Ions. Unpublished study prepared by Keller and 

Heckman LLP. 27 p. 

48105505 Kuhn, J. (2008) Natamycin TGAI: Acute Oral Toxicity Study (UDP) in Rats: Final 

Report. Project Number: 11403/07. Unpublished study prepared by Stillmeadow, 

Inc. 12 p. 

48105506 Kuhn, J. (2008) Natamycin TGAI: Acute Dermal Toxicity Study in Rat: Final 

Report. Project Number: 11404/07. Unpublished study prepared by Stillmeadow, 

Inc. 13 p. 

48105507 Crutchfield, V. (2008) Natamycin TGAI: Acute Inhalation Toxicity Study in Rats: 

Final Report. Project Number: 11405/07. Unpublished study prepared by 

Stillmeadow, Inc. 19 p. 

48105508 Kuhn, J. (2008) Natamycin TGAI: Acute Eye Irritation Study in Rabbits: Final 

Report. Project Number: 11406/07. Unpublished study prepared by Stillmeadow, 

Inc. 18 p. 

48105509 Kuhn, J. (2008) Natamycin TGAI: Acute Dermal Irritation Study in Rabbits: Final 

Report. Project Number: 11407/07. Unpublished study prepared by Stillmeadow, 

Inc. 13 p. 

48105510 Kuhn, J. (2008) Natamycin TGAI: Skin Sensitization: Local Lymph Node Assay in 

Mice: Final Report. Project Number: 11408/07. Unpublished study prepared by 

Stillmeadow, Inc. 13 p. 
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48105511 Otterdijk, F. (2003) Natamycin TGAI: 90 Day Oral Toxicity Study with Natamycin 

in the Rat. Project Number: NOTOX/PROJECT/339323, 002019. Unpublished 

study prepared by Notox B.V. 220 p. 

48105512 Knickerbocker, M. (1979) Natamycin TGAI: Teratologic Evaluation of Pimaricin in 

Dutch-Belted Rabbits. Project Number: 5906. Unpublished study prepared by Food 

& Drug Research Laboratories, Inc. 290 p. 

48105513 Verspeek, C. (2002) Natamycin TGAI: Evaluation of the Mutagenic Activity of 

Natamycin in the Salmonella typhimurium Reverse Mutation Assay and the 

Escherichia coli Reverse Mutation Assay (with Independent Rat). Project Number: 

NOTOX/PROJECT/339345. Unpublished study prepared by Notox B.V. 29 p. 

48105514 Meerts, I. (2002) Natamycin TGAI: Evaluation of the Ability of Natamycin to 

Induce Chromosome Aberrations in Cultured Peripheral Human Lymphocytes. 

Project Number: NOTOX/PROJECT/339356. Unpublished study prepared by 

Notox B.V. 28 p. 

48439300 DSM Food Specialties (2011) Submission of Product Chemistry Data in Support of 

the Application for Registration of Natamycin L. Transmittal of 1 Study. 

48439301 van der Lee, J.; Jovanovich, A. (2011) 12-Month Interim Report for Storage 

Stability and Corrosion Characteristics: Natamycin L. Project Number: 

STAB/SLD/09/008. Unpublished study prepared by DSM Food Specialties B.V. 38 

p. 

48544501 van der Lee, J.; Jovanovich, A. (2011) 18-Month Final Report for Storage Stability 

and Corrosion Characteristics: Natamycin L. Project Number: STAB/SLD/09/008. 

Unpublished study prepared by DSM Food Specialties B.V. 41p. 

48593400 DSM Food Specialties B.V. (2011) Submission of Toxicity Data in Support of the 

Application for Registration of Natamycin L. Transmittal of 1 Study. 

48593401 Cox, G.; Bailey, D. (1973) Natamycin TGAI Rat Development Toxicity Study. 

Project Number: 1052. Unpublished study prepared by Food & Drug Research 

Laboratories, Inc. 495p. 

48613501 Thate, C.; Jovanovich, A. (2011) Natamycin TGAI: Request for Waiver of 

Teratology Study Data Requirement. Unpublished study prepared by Keller and 

Heckman LLP and DSM Food Specialities. 177p. 

48966100 DSM Food Specialties (2012) Submission of Exposure/Risk Data in Support of the 

Amended Registration of Zivion M. Transmittal of 1 Study. 

48966101 Novak, M. (2012) Scientific Justification for Shortening the Restricted Entry 

Interval (REI) From 12 Hours to 4 Hours: Zivion M. Unpublished study prepared 

by Keller and Heckman LLP. 14p. 

49188300 DSM Food Specialties (2013) Submission of Residue Data in Support of the 

Amended Registration of Natamycin L. Transmittal of 1 Study. 
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49188301 Cassidy, P. (2013) Natamycin Residue Analysis in Mushrooms, Compost and 

Casing: Amended Report. Project Number: 029035/1/1, 029035. Unpublished study 

prepared by Ricerca Biosciences, LLC. 101p. 

49254800 DSM Food Specialties B.V. (2013) Submission of Product Chemistry Data in 

Support of the Amended Registration of Zivion M. Transmittal of 1 Study. 

49254801 Graham, D. (2013) Measurements Viscosity, Density and pH: (Zivion M). 

Unpublished study prepared by DSM Food Specialties B.V. 30p. 

49292400 DSM Food Specialties B.V. (2014) Submission of Product Chemistry, Toxicity and 

Residue Data in Support of the Application for Registration of Zivion P, the 

Amended Registration of Natamycin TGAI and the Petition for Tolerance of 

Natamycin for Use on Pineapple. Transmittal of 5 Studies. 

49292401 Ramdjielal, J.; Graham, D. (2013) Product Identity, Compostion, and Formulation: 

Zivion P. Unpublished study prepared by DSM Food Specialties B.V. 32p. 

49292402 Ramdjielal, J.; Graham, D. (2013) Summary of Physical/Chemical Properties and 

Self-Certification: Zivion P. Unpublished study prepared by DSM Food Specialties 

B.V. 6p. 

49292403 Devine, J.; Maryann C. (2013) Magnitude of Residues of Natamycin in PostHarvest Treated Pineapples (Decline, Processing). Project Number: 

197SRUS12R/1, 029653/1, 029653. Unpublished study prepared by SynTech 

Research. 204p. 

49292405 Ramdjielal, J. (2013) Descriptions of Human Activity for Zivion P. Unpublished 

study prepared by DSM Food Specialties B.V. 5p. 

 
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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 

cm3 cubic 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 
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nm nanometer 

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