Document ID: EPA-HQ-OPP-2008-0561-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-19T05:00Z

<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: [Driss
Bhenmhend 703-308-9525]>

 

<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 and brackets, i.e., “[insert
company name],” with the information specific to your action.>

<SUBMISSION: E-mail the completed template to: duggard.mari@epa.gov.>

<TEMPLATE:>

<[SummerSet Products]>

<[8F7319]>

<	EPA has received a pesticide petition ([8F7319]) from [SummerSet
Products], [130 Columbia Court, Chaska, MN, 55318] 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)>

<	1. by establishing a tolerance for residues of – NA-Remove>

<	2. to establish an exemption from the requirement of a tolerance for -
NA-Remove>

	

<	3. to establish an amendment/expansion of an existing tolerance
exemption for the>

<(Options (pick one)>

<	1. microbial pesticide  [NA - Remove]>

<	2. biochemical pesticide [acetic acid]>

	

<	3. plant-pesticide [NA - Remove] in or on [all raw agricultural
commodities].>

<	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [SummerSet
Products] has submitted the following summary of information, data, and
arguments in support of their pesticide petition. This summary was
prepared by [SummerSet Products c/o SciReg, Inc., 12733 Director’s
Loop, Woodbridge, VA., 22192] 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. [SummerSet Products]  Petition Summary>

<	[84069-R]>

<A. Product Name and Proposed Use Practices>

<	[SummerSet AllDown Herbicide with acetic acid as an active ingredient
will be used undiluted at 1 gallon/1000 sq. ft. as a post-emergence
herbicide in flowerbeds, vegetable gardens, around trees and shrubs,
along fence lines, patios, driveways, sidewalks, fruit trees, vines, and
other areas where weed control is desired.]>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [Acetic acid
is a naturally-occurring chemical commonly found as an integral part of
basic metabolic pathways in mammals and plants. Acetic acid, as vinegar,
is also commonly consumed in a multitude of human and animal food
products. No residues are expected.]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [No magnitude of residue (MOR) studies have been
conducted on acetic acid, as it is a naturally-occurring chemical
commonly found as an integral part of basic metabolic pathways in
mammals and plants. As a tolerance exemption is being sought, no
magnitude of the residue studies or residue analytical methods are being
submitted.]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [A tolerance
exemption is being sought for acetic acid.]

>

<C. Mammalian Toxicological Profile>

<	[Acute Oral Toxicity – Reported LD50s for acetic acid range between
3000 mg/Kg of body weight (bwt) to greater than 4000 mg/Kg bwt, placing
acetic acid in Toxicity Category III.>    

 

Acute Dermal Toxicity – The acute dermal LD50 for acetic acid is
reported as 1060 mg/Kg bwt universally (Toxicity Category II).

Acute Inhalation Toxicity – Data reporting inhalation toxicity are
reported several ways. Two sources reported slightly different
inhalation information. The first reported an inhalation LC50 of 5620
ppm/one hour.  The other reported that at 11.4 mg/Liter for one hour,
acetic acid was classified as Toxicity Category III (no clear
explanation was offered how this classification was determined).
Concentrated acetic acid affects mucous membranes and would be expected
to have an impact if directly inhaled. 

Acute Eye Irritation – It is common knowledge that vinegar (acetic
acid) is irritating to the eye. Acetic acid is irritating and corrosive
to rabbit eyes and is classified in Toxicity Category I.         

 

Acute Dermal Irritation – Reports on tests with acetic acid on rabbit
skin all indicate that concentrated acetic acid may cause pain,
irritation and burns, especially to mucous membranes. Although not
specified, these studies likely place concentrated acetic acid into
Toxicity Category I or II. 

Skin Sensitization – Sensitization may result from repeated exposure,
but is a rare consequence of exposure.   

Genotoxicity – Mutagenicity assays (Ames testing) with acetic have
been reported as negative through TOXNET. 

Reproductive and Developmental Toxicity –  Reports of three studies
that examined the effects of acetic acid on development and reproduction
of mice, rats, and rabbits. 

“No effects on nidation or maternal or fetal survival were observed at
doses up to 1600 mg/kg bw/day. The number of abnormalities seen in
either soft or skeletal tissues of the test groups did not differ from
the number occurring in the controls.” 

Results were identical for all three studies. 

Subchronic Toxicity – Acetic acid is a naturally occurring food acid
found in plants and animals. Acetic acid (as vinegar) is ingested with a
wide variety of foods and used as a food additive (e.g., salad
dressing). Starting materials in AllDown herbicide are food grade and as
such can be used in or on food. The concentration of acetic acid in the
formulated herbicide product (8.0 %) falls within the range of 3-8%
normally associated with concentrations of acetic acid found in vinegar.
Nothing in the literature indicates that acetic acid will have any
adverse toxicological effects, and no subchronic effects are expected
from exposure to this active ingredient. 

Chronic Toxicity – No chronic toxicity has been associated with
consumption of or exposure to acetic acid (vinegar) at concentrations
between three and eight percent. Chronic effects would not be expected
in view of the probable lack of subchronic effects discussed above. 

Carcinogenicity – The National Toxicology Program (NTP) does not list
acetic acid as a known or anticipated carcinogen. IARC has not
classified acetic acid as a carcinogen. There are no other known
literature sources that suggest that acetic acid may be carcinogenic. 

Animal Metabolism/Metabolite Toxicology – Acetic acid is an inherent
part of the Krebs/Citric Acid Cycle in both plants and animals. It is an
integral part of the pathway found in living organisms that breaks down
sugars, fats and proteins to release the energy they store. Metabolites
of acetic acid would be expected to be incorporated into the normal
metabolism of the exposed organism. Toxic metabolites or breakdown
products of toxicological concern would not be produced.]

<D. Aggregate Exposure>

<	1. Dietary exposure. [Acetic acid is a food acid and occurs naturally
in plants and animals. It is commonly consumed, rapidly metabolized, and
is part of the normal metabolic pathways of both plants and animals.
Therefore, it is unlikely that exposure to acetic acid would have any
negative impact on human health.]>

<	i. Food. [This acid plays a key role in allowing living organisms to
access acquired energy stored in the form of fats, proteins, and
carbohydrates. Acetic acid combines with a coenzyme “CoA” as it
enters the Krebs/Citric acid metabolic pathway. The Krebs Cycle plays a
key role in generating energy-charged organic molecules used by all
cells to carry on life functions. The general population encounters
acetic acid in the form of vinegar at concentrations between 3% and 8%.
FDA designates acetic acid as a chemical that is generally recognized as
safe (GRAS) when added to foods (21 CFR 184.1005). 

With AllDown (used as directed), acetic acid is applied at a
concentration of 8.0%. 

At the application rate of 1 gal/1000 sq. ft. of spray solution, the
expected acetic acid rate per square inch of weed plant surface will be
0.026 ml of product, or 0.0021 ml of acetic acid. AllDown is a contact
herbicide, and herbicide application to non-target plants must be
avoided. Therefore, only accidental application or extremely small
amounts of spray drift are anticipated on any desirable crop, especially
agricultural crops. Dietary exposure to acetic acid, when used according
to label directions, will not pose a threat to mammals, humans or the
environment. Residues, if they were present, are not of toxicological
significance. Further, it is expected that acetic acid will rapidly
break down in the environment.]>

<	ii. Drinking water. [Acetic acid is not considered to be a risk to
drinking water. Acetic acid is rapidly broken down and metabolized by
organisms and municipal treatment of drinking water would reduce or
eliminate the possibility of exposure through drinking water. Typical
agricultural practices are carried out such that spray drift is
minimized. This is especially true with AllDown as it is a contact
herbicide and will cause damage to desirable plants if sprayed. Although
possible minimal spray drift may contact drinking water, natural and
water treatment steps would further reduce or eliminate the possibility
of exposure via potable water. The end-use product, SummerSet AllDown
Herbicide, is prohibited by the label from direct application to water
and, therefore, is not expected to be present at significant
concentrations in aquatic environments.]>

<	2. Non-dietary exposure. [Non-dietary exposure to acetic acid will
come through use of vinegar as a cleaner, and through inadvertent
exposure during application. At spray application concentrations,
precautions to be taken are the same as would be taken when handling
grocery store vinegar. Acetic acid is not totally benign (see toxicology
discussion above).  All appropriate and required precautionary
statements are found on the product label that are necessary to protect
residential and commercial applicators. Based on the use patterns, the
potential for exposure for the general population (including children)
is negligible. 

Application equipment will include handheld spray bottles, hand-wand
sprayers, and small field sprayers. Application of herbicides through
this type of equipment is not known to have a high potential for
operator exposure. In addition, protective clothing is required in
accordance with the regulations based on Toxicity Category
classifications.]>

<E. Cumulative Effects>

<	[Exposure of the general population (estimated at higher than 99%) to
acetic acid will come through ingestion of vinegar in their diet.
Minimal exposure comes from non-food uses, such as those associated with
use of acetic acid as a surface cleaner. As discussed earlier, no acetic
acid metabolites of concern have been characterized since the active
ingredient is part of the normal metabolism of higher organisms. No
effects of repeated exposure are anticipated, and nothing in the
literature has been reported regarding a concern with cumulative
exposure to acetic acid.]>

<F. Safety Determination>

<	1. U.S. population. [Since acetic acid is a normal component of
metabolism in humans, and acetic acid is consumed as both a food
ingredient, as well as a food additive, no adverse effects are probable
or anticipated from the herbicidal use of acetic acid.]>

<	2. Infants and children. [Acetic acid is a normal component of
mammalian metabolism. It is not expected that infants and children will
be at greater risk than the general population. Nothing in the
literature leads one to conclude otherwise. 

It is not anticipated that use of acetic acid as a contact herbicide
will result in adverse dietary or non-dietary exposure of either the
general population or the subgroup of infants and children.]>

<G. Effects on the Immune and Endocrine Systems>

<	[Acetic acid does not act like a hormone and has no activity on
hormones. Acetic acid has no structural relationship to any known
hormone or to any known endocrine disruptor. Nothing in the literature
points to any known impact acetic acid has on the endocrine system.]>

<H. Existing Tolerances>

<	[An exemption from the requirement for tolerance for acetic acid used
as a post-harvest treatment of grain and hay is published in the Federal
Register (see 40 CFR part 180.1258).]>

<I. International Tolerances>

<	[There are no known international tolerances for residues of acetic
acid in food or animal products.]>

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