Document ID: EPA-HQ-OPP-2009-0107-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-04T05:00Z

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

(7/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: [Leonard
Cole 703-305-5412]>

 

<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.>

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

<TEMPLATE:>

<[Organic Works]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([8E7446]) from [Organic Works/
BioNet International Corp. c/o], [Interregional Research Project Number
4, 500 College Road East, Princeton, NJ  08540] 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 180.1258>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of>

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

	

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

<(Options (pick one)>

<	1. microbial pesticide  [insert name of active ingredient]>

<	2. biochemical pesticide [Acetic acid]>

	

<	3. plant-pesticide [insert name of active ingredient] in or on [insert
commodity].>

<	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Organic
Works c/o BioNet International Corp.] has submitted the following
summary of information, data, and arguments in support of their
pesticide petition. This summary was prepared by [Interregional Research
Project Number 4,  IR-4] 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. [Organic Works ]  Petition Summary>

<	[8E7446]>

<A. Product Name and Proposed Use Practices>

<	[ Weed Works Weed & Grass Killer is a horticultural vinegar to manage
weeds. Use patterns will include pre plant and post plant directed
applications. Since this product is non-selective the product will be
applied either when the crop is not present or the application will be
directed away from the crop. In addition , applications will be made to
remaining vegetation after the crop has been harvested. The product is
not intended for any direct application to any harvested portion the
crop.]>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [The active
ingredient is acetic acid. Product chemistry data was submitted as MRID
46958301.]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [Since this product is a non-selective herbicide
the product will be applied either when the crop is not present or the
application will be directed away from the crop. The product is not
intended for any direct application to the crop therefore only a minor
amount of  inadvertent residues could occur. Acetic acid is a naturally
occurring substance found in all  plants therefore inadvertent residues 
would be indistinguishable from acetic acid already in the crop.  The
petition is for an exemption from tolerance on all food commodities
therefore the magnitude and method of residue analysis is not
applicable.  A review of residue data supporting this petition was
submitted (MRID 46944103)]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [There are no known
analytical studies which have determined residue magnitudes on plant
tissues following the herbicidal application of acetic acid.  At the
upper application rate of 55 pounds of active ingredient per acre  the
resulting concentrations should be well below the 1 to 1.5% levels
predicted when acetic acid is applied to hay or grain, a use for which
acetic acid has gained an exemption from the requirements of a tolerance
40 CFR 180.1258. Since this product is a non-selective herbicide the
product will be applied either when the crop is not present or the
application will be directed away from the crop. The product is not
intended for any direct application to the crop therefore only a minor
amount of  inadvertent residues could occur. Acetic acid is a naturally
occurring substance found in all  plants therefore inadvertent residues
would be indistinguishable from acetic acid already in the crop.  

The petition is for an exemption from tolerance on all food commodities
therefore the magnitude and method of residue analysis is not
applicable.]>

<C. Mammalian Toxicological Profile>

<	[The toxicological profile of acetic acid was submitted in MRID
46944102 and 46944105.  Acetic acid is a naturally occurring compound in
plants and animals with a fundamental role in cell metabolism,
particularly in the tricarboxylic acid cycle (also know as the citric
acid or Kreb’s cycle)” which is carried out in the mitochondria.  A
key feature is that “three of these food acids (citric, fumaric and
malic) are used over and over again in the production” of ATP, carbon
dioxide and water.  As it enters this catabolic cycle, the>  acetyl
molecule (acetic acid) is broken down and serves as the source of energy
transformed into ATP, the carbon converted into carbon dioxide and the
hydrogen present in the production of water molecules.   Toxicology data
was collected from information in the public literature. 

) ACUTE ORAL TOXICITY  indicated that the Rat LD50 = 3310 mg/kg and the 
Mouse LD50 = 4960 mg/kg

ACUTE DERMAL TOXICITY Rabbit LD50  = 1060 mg/kg (b.w.) 

ACUTE INHALATION TOXICITY Mouse LC50  (1 h) = 5620 ppm/h 

                                                    Rat LC50  (4 h) =
11.4 mg/l   			

ACUTE EYE IRRITATION Rabbit open irritation test to eye  – severe
irritation 

ACUTE DERMAL IRRITATION Rabbit open administration to skin – severe
irritation effects 

RABBIT SUBCUTANEOUS INJECTION, lowest reported lethal concentration =
1200 mg/kg ,                

                                                                    
Mouse intravenous injection, LD50 =  525 mg/kg (b.w.) BACTERIAL REVERSE
MUTATION	Ames Test - Bacterial Reverse Mutation assay -  No genotoxic
effects with or without metabolic activation. 

Standard Ames Test - Bacterial Reverse Mutation assay -  No genotoxic
effects with or without metabolic activation 

	Ames Test - Bacterial Reverse Mutation assay -  No genotoxic effects
with or without metabolic 



CONTINUOUS INHALATION TEST	Rat continuous inhalation (3 to 35 days) at
11- 35 ppm: decreased activity, behavioural changes and reduced work
capacity 

TERATOGENICITY 	Mouse Developmental Toxicity/Teratogenicity (17 days)
– doses up to 		1600 mg/kg bw/day – No effects on nidation or on
maternal or fetal survival 

                                                                        
                                       Rat Developmental
Toxicity/Teratogenicity (10 days) – doses up to 1600   

                                             mg/kg bw/day – No effects
on nidation or on maternal or fetal survival 

		Rabbit Developmental Toxicity/Teratogenicity (23 days) – doses up to
				1600 mg/kg bw/day – No effects on nidation or on maternal or fetal
				survival 

Insert text.]

<D. Aggregate Exposure>

<	1. Dietary exposure. [The product is not intended for any direct
application to the crop therefore only a minor amount of  inadvertent
residues could occur. Acetic acid is a naturally occurring substance
found in all  plants therefore inadvertent residues  would be
indistinguishable from acetic acid already in the crop. Acetic acid is
found in vinegar which is a widely consumed product . The use of Acetic
acid as a herbicide is not anticipated to significantly increase the
margin of exposure to acetic acid.   .]>

<	i. Food. [The product is not intended for any direct application to
the crop therefore only a minor amount of  inadvertent residues could
occur. Acetic acid is a naturally occurring substance found in all 
plants therefore inadvertent residues  would be indistinguishable from
acetic acid already in the crop.  Acetic acid is found in vinegar which
is a widely consumed product  .]>

<	ii. Drinking water. [Acetic acid is not intended for use in aquatic
environment. It is not labeled for application to any body of water]>

<	2. Non-dietary exposure. [Insert text  .]>

<E. Cumulative Effects>

<	[Insert text .]>

<F. Safety Determination>

<	1. U.S. population. [Acetic acid is naturally occurring as the acid in
apple cider vinegar and other fruit-derived products. It and several of
its salts are commonly used as food additives (e.g., as flavor
enhancers) and are listed as Generally Recognized as Safe (GRAS) by the
USFDA. Given the lack of significant toxicity, the natural occurrence in
both plants and animals, and the common use in foods, there is adequate
data available to determine that establishment on an exemption from
tolerance for acetic acid would not have any adverse effects.acid.]>

<	2. Infants and children. [Acetic acid is naturally occurring as the
acid in apple cider vinegar and other fruit-derived products. It and
several of its salts are commonly used as food additives (e.g., as
flavor enhancers) and are listed as Generally Recognized as Safe (GRAS)
by the USFDA. Given the lack of significant toxicity, the natural
occurrence in both plants and animals, and the common use in foods,
there is adequate data available to determine that establishment on an
exemption from tolerance for acetic acid would not have any adverse
effects .]>

<G. Effects on the Immune and Endocrine Systems>

<	[Acetic acid is not known to be an endocrine disruptor]>

<H. Existing Tolerances>

<	[In 40 CFR 180.1258 acetic acid has existing exemption from the
requirements of a tolerance when applied to hay or grain as a desiccant.

 ]>

<I. International Tolerances>

<	[There are no known international tolerances]>

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