Document ID: EPA-HQ-OPP-2008-0021-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-02-19T05:00Z

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 
(1/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: [insert
name and telephone number with area code]>

 

<INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
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Please do not remove or alter these comment notes or change the margins,
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appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.>

<SUBMISSION: E-mail the completed template to: hollis.linda@epa.gov.>

<TEMPLATE:>

<[BioSafe Systems, LLC]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([insert petition number) from
BioSafe Systems, LLC, 22 Meadow St. East Hartford, CT 06108 proposing,
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.>

<(Options (pick one)>

<	

	

< to establish an amendment/expansion of an existing tolerance exemption
for the>

<(Options (pick one)>

<>

<	 biochemical pesticide peroxyacetic acid

>

	

<	>

<	Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, BioSafe
Systems, LLC has submitted the following summary of information, data,
and arguments in support of their pesticide petition. This summary was
prepared by BioSafe Systems, LLC and EPA has not fully evaluated the
merits of the pesticide petition. The summary may have been edited by
EPA if the terminology used was unclear, the summary contained
extraneous material, or the summary unintentionally made the reader
conclude that the findings reflected EPA’s position and not the
position of the petitioner.>

<I. BioSafe Systems, LLC Petition Summary>

<	[Insert petition number]>

<A. Product Name and Proposed Use Practice

Peroxyacetic Acid>

<	For use to control plant pathogenic and horticultural diseases in
soil, on plants, turf, seeds, food crops and commodities, post harvest
commodities, greenhouse surfaces and other agricultural, horticultural
and commercial use sites. For use as a bactericide/fungicide/algaecide
on hard, non-porous surfaces, tools, equipment, and structures in
agricultural settings, greenhouses and post harvest packinghouse
applications.  For use in treatment of agricultural spray water,
livestock water, irrigation water, and water treatment in packinghouse
applications.>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. 

Residues of peroxyacetic acid are not expected because peroxyacetic acid
reacts immediately on contact with materials such as food, reducing
agents and catalysts, and is degraded to moieties which present no
toxicological concern (Reregistration Eligibility Decision, Peroxy
Compounds, U.S. EPA 738-R-93-030). The ultimate degradation products of
peroxyacetic acid are acetic acid (which is generally regarded as safe
in food up 0.15 %, 21 CFR 184.1,005), water and oxygen. The degradation
products of peroxyacetic acid are not of toxicological concern.

Finally, it is noted that the Food and Drug Administration (FDA) has
approved peroxyacetic acid for direct food contact for use in wash water
or to assist in the peeling of fruits and vegetables (21 CFR 173.315),
and is also approved as a sanitizer on food contact surfaces (21CFR
178-1010). Co-products hydrogen peroxide (21 CFR 582.1366) and acetic
acid (21 CFR 582.1005) are listed as FDA GRAS in animal feeds.

>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. Not Applicable.>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. Due to the fact an
exemption from the requirement of a tolerance without numerical
limitation on residue levels is granted for peroxyacetic acid, an
enforcement analytical method is not needed. Peroxyacetic acid is used
in low concentrations and rapidly degrades into acetic acid, oxygen and
water. >

<C. Mammalian Toxicological Profile>

<	Peroxyacetic acid at a concentration of 2.0% has a pH of 0.82, and at
5.0% has a pH of 0.74, at which concentration the Agency assumes a
Toxicity Category I for eye and skin irritation.  BioSafe Systems has
submitted toxicology information for aqueous solutions containing
peroxyacetic acid concentrations between 0.15% and 15%. The 2.0%
peroxyacetic acid concentrate is diluted prior to use according to label
directions, a minimum of 1:32 (12 ounces to 3 gallons, or 384 oz) with
water The 5.0% peroxyacetic acid concentrate is diluted prior to use
according to label directions, a minimum of 1:500 (3 gallons to 1500
gallons) with water.  Thus, the greatest concentration of peroxyacetic
acid in the 2.0% product at the time of application would contain a
maximum of approximately 0.07% peroxyacetic acid, and the greatest
concentration of peroxyacetic acid in the 5.0% product at the time of
application would contain a maximum of approximately 0.01% peroxyacetic
acid.   

 

Information reported by The European Centre for Ecotoxicology and
Toxicology of Chemicals (ECETOC) demonstrated that a solution of 5.6 %
peroxyacetic acid has an acute oral LD50 of 3,622 mg/kg, in female and
male rats together (toxicity category III), a solution of 4.89%
peroxyacetic acid has an acute dermal LD50 of 1,040 mg/kg in rabbits
(toxicity category II), and a solution of  4.5% peroxyacetic acid has an
 LC50 of > 5,350 mg/m3 (5.35 mg/L) in rats (toxicity category IV). The
ECETOC Task Force determined that solutions containing peroxyacetic acid
at concentrations of 0.2% and higher were severely irritating or
corrosive to the eye. A solution containing 0.15 % peroxyacetic acid
caused mild irritation in the rabbit eye study, and a concentration of
0.034 resulted in very slight irritation.  

Peroxyacetic acid is currently EPA registered as a pesticide for
antimicrobial use against viruses, bacteria, and fungi. Peroxyacetic
acid is also EPA registered for use in dairy/cheese processing plants,
agricultural premises, and food establishments, on food processing
equipment and in pasteurizers in breweries, wineries, and beverage
plants.  Per the Final Rule published for the current peroxyacetic acid
tolerance exemption at 40 CFR Part 180.1196 (FR Volume 65, Number 232,
Pages 75168 -75173, December 1, 2000) that covers those uses, there are
acceptable acute generic data referenced in the Reregistration
Eligibility Document (RED) for Peroxy Compounds (December 1993, Case
4072, EPA 738-R-93-030). Peroxyacetic acid was found to be corrosive and
severely irritating to the eyes, skin, and mucous membranes but only
when high concentrations were used. The proposed use patterns involve
low concentrations and are expected to result in a lack of any residues
of toxicological concern. The RED document waived all other non-acute
toxicology data requirements for peroxyacetic acid.

Per the December 2000 Final Rule, no data exists for the subchronic,
chronic, carcinogenicity, mutagenicity, developmental and reproductive
toxicity of peroxyacetic acid. However, peroxyacetic acid shares similar
chemical characteristics with hydrogen peroxide which has a more
extensive toxicology data base. For example, peroxyacetic acid and
hydrogen peroxide both decompose into two identical degradates that do
not pose any toxicological concern. These two degradates are oxygen and
water.  Acetic acid is also a degradate of peroxyacetic acid and does
not pose any toxicological concern. 

Peroxyacetic acid and hydrogen peroxide also show similar chemical
characteristics for corrosivity, pH, rapid peroxide bond dissociation,
and production of oxygen molecules. Because of these similar chemical
characteristics, and low expected exposures with the proposed uses, the
dose-response toxicology relationships (i.e. adverse effects experienced
only at very high doses) shown by the data for hydrogen peroxide, can
also be expected with peroxyacetic acid. The remaining toxicology
testing requirements for peroxyacetic acid were waived in the RED
because of the similar chemical characteristics, similar expected dose-
response relationships with hydrogen peroxide, low exposure levels under
the proposed uses, and for the reasons given above. 

As stated, residues of peroxyacetic acid are not expected because
peroxyacetic acid reacts immediately on contact with materials such as
food, reducing agents and catalysts, and is degraded to moieties which
present no toxicological concern (Reregistration Eligibility Decision,
Peroxy Compounds, U.S. EPA 738-R-93-030). The ultimate degradation
products of peroxyacetic acid are acetic acid (which is generally
regarded as safe in food up 0.15 %, 21 CFR 184.1,005), water and oxygen.
The degradation products of peroxyacetic acid are not of toxicological
concern.

Finally, it is noted that the Food and Drug Administration (FDA) has
approved peroxyacetic acid for direct food contact for use in wash water
or to assist in the peeling of fruits and vegetables (21 CFR 173.315),
and is also approved as a sanitizer on food contact surfaces (21CFR
178-1010). Co-products hydrogen peroxide (21 CFR 582.1366) and acetic
acid (21 CFR 582.1005) are listed as FDA GRAS in animal feeds. >

<D. Aggregate Exposure>

<	1. Dietary exposure. 

>

<

	i. Food. U.S. EPA has previously established an exemption from the
requirement of a tolerance for residues of peroxyacetic acid as an
antimicrobial pesticide, in or on raw agricultural commodities, in
processed commodities, when such residues result from the lawful use of
peroxyacetic acid as an antimicrobial agent on fruits, vegetables, tree
nuts, cereal grains, herbs, and spices up to 100 ppm. 

	According to the 1993 RED, peroxyacetic acid is used in dairy/cheese
processing plants, on food-processing equipment and in pasteurizers in
breweries, wineries and beverage plants. While some contact may occur
between treated equipment and food, no residues are expected since only
trace amounts would come in contact with food having contacted treated
equipment and the compound degrades rapidly in air and in contact with
organic materials to acetic acid (which is generally regarded as safe in
food up 0.15 %, see 21 CFR 184.1005), oxygen and water. In addition,
peroxyacetic acid may be safely used on food-processing equipment,
utensils, and other food-contact articles according to the Food and Drug
Administration (FDA) (21 CFR 178.1010, Sanitizing Solutions).   

	This petition proposes including use of peroxyacetic acid as a
biochemical pesticide to control plant diseases in horticultural,
commercial and agricultural areas. The ingredient would be applied to
soil, plants, turf, seeds, food crops and commodities, post harvest
commodities, surfaces, tools, equipment and structures in agricultural
settings, agricultural spray water, livestock water, and irrigation
water.   Dietary exposure from these uses is possible; however,
peroxyacetic acid reacts immediately upon contact with materials such as
food and degrades to moieties which present no toxicological concern.
The addition to dietary aggregate exposure of peroxyacetic acid as
described in this petition is expected to be zero.>

<	ii. Drinking water. At the proposed application rates, the use of
peroxyacetic acid to treat agricultural food commodities will result in
minimal transfer of residues to potential drinking water supplies. This
is due to the low application rate and rapid degradation of peroxyacetic
acid into acetic acid, oxygen and water, none of which are of
toxicological concern. 

	In addition, the degradation products of peroxyacetic acid in aqueous
solutions are acetic acid (which is generally regarded as safe in food
up 0.15%, see 21 CFR 184.1005), water and oxygen. These degradation
products are not of toxicological concern.>

<	2. Non-dietary exposure. According to the 1993 RED, the compound, in
the form of a soluble concentrate/liquid, is used in industrial and
commercial settings.  Peroxyacetic acid is highly reactive and
short-lived because of the inherent instability of the peroxide bond
(O-O bond) and, because the peroxide bond is weak, transformation to
acetic acid, water and oxygen is very highly favored thermodynamically
(1993 RED). The degradation products of peroxyacetic acid in aqueous
solutions are acetic acid (which is generally regarded as safe in food
up 0.15%, see 21 CFR 184.1005), water and oxygen. The degradation
products of peroxyacetic acid are not of toxicological concern.  

	The potential for any non-occupational exposure under the use proposed
in this petition to the general population (including children) is
unlikely. Peroxyacetic acid  is proposed in this petition to be used
only at horticultural, commercial and agricultural establishments
(including farms) and is not proposed for use in or around the home.>

<E. Cumulative Effects>

<	When used as proposed, peroxyacetic acid decomposes quickly; there is
no reasonable expectation that residues of these compounds will remain
in human food items in accordance with 40 CFR 180.3. The mode of action
of this pesticide is oxidation. Other chemicals that may share a similar
mode of action are hydrogen peroxide and potassium peroxymonosulfate
sulfate as listed in the 1993 RED. Combining exposures to these
compounds could be appropriate; however, each degrades rapidly (due to
the peroxy bond, the O-O bond) into compounds that are not
toxicologically significant (including water, oxygen, and carbon
dioxide).>

<F. Safety Determination>

<	1. U.S. population. Peroxyacetic acid naturally degrades to acetic
acid (which is generally regarded as safe in food up 0.15%, see 21 CFR
184.1005), water and oxygen which would not pose a health risk to the
U.S. general population. These degradation products are not of
toxicological concern.>

<	2. Infants and children. Peroxyacetic acid naturally degrades to
acetic acid (which is generally regarded as safe in food up 0.15%, see
21 CFR 184.1005), water and oxygen which would not pose a health risk to
the U.S. population subgroup of infants and children. These degradation
products are not of toxicological concern. Residues of peroxyacetic acid
are not expected on food from use of peroxyacetic acid as a biochemical
pesticide on agricultural commodities. Therefore, exposure of the
pesticide chemical (from the use proposed in this petition) to the U.S.
general population should not occur.  There is a reasonable certainty of
no harm to consumers, including infants and children, from aggregate
exposure to peroxyacetic acid.>

<G. Effects on the Immune and Endocrine Systems>

<	Peroxyacetic acid is not structurally similar to any known chemical
capable of producing adverse effects on the endocrine system.  Per the
Final Rule published for the current peroxyacetic acid tolerance
exemption at 40 CFR Part 180.1196 (FR Volume 65, Number 232, Pages 75168
-75173, December 1, 2000), the currently available animal data suggest
no significant endocrine effects from exposure to peroxyacetic acid.>

<H. Existing Tolerances>

<	US EPA Tolerance –

40 CFR Part 180.1196 - Peroxyacetic acid; exemption from the requirement
of a

tolerance.

    (a) An exemption from the requirement of a tolerance is established
for residues of peroxyacetic acid in or on raw agricultural commodities,
in processed commodities, when such residues result from the use of
peroxyacetic acid as an antimicrobial treatment in solutions containing
a diluted end use concentration of peroxyacetic acid up to 100 ppm per
application on fruits, vegetables, tree nuts, cereal grains, herbs, and
spices.

    (b) An exemption from the requirement of a tolerance is established
for residues of peroxyacetic acid, in or on all raw and processed food
commodities when used in sanitizing solutions containing a diluted end-
use concentration of peroxyacetic acid up to 500 ppm, and applied to
tableware, utensils, dishes, pipelines, tanks, vats, fillers,
evaporators, pasteurizers, aseptic equipment, milking equipment, and
other food processing equipment in food handling establishments
including, but not limited to dairies, dairy barns, restaurants, food
service operations, breweries, wineries, and beverage and food
processing plants.

>

<I. International Tolerances>

<	International –There is no Codex Alimentarium Commission Maximum
Residue Level (MRL) for peroxyacetic acid.>