Document ID: EPA-HQ-OPP-2008-0172-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-19T04:00Z

<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: [Driss
Benmhend, 703-308-9525]>

 

<[Stratacor, Inc.]>

<[8F7317]>

<	EPA has received a pesticide petition ([8F7317]) from [Stratacor,
Inc.], [1315 So. 46th Street, Bldg 154, Richmond, CA  94804] 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.>

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

<	2. biochemical pesticide [octanoic acid, nonanoic acid and decanoic
acid]>

<	3. in or on [Cattle and Horses].>

<	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Stratacor,
Inc.] has submitted the following summary of information, data, and
arguments in support of their pesticide petition. This summary was
prepared by [Stratacor, Inc.] 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. [Stratacor Inc.]  Petition Summary>

<	[8F7317]>

<A. Product Name and Proposed Use Practices>

<	[Octanoic, Nonanoic, and Decanoic Acids in formulations to be applied
to livestock (cattle and horses) to repel insects]>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [The C8, C9,
and C10 n-carboxylic acids (fatty acids) are naturally occuring,
well-understood compounds that are essential components of energy
production in vertebrate systems.  The compounds are closely associated,
readily interconverted in energy production, metabolized similarly, and
have similar toxicological profiles.  Because of the natural and normal
metabolism of these compounds and their close chemical structures, they
can be considered together.  These C8-10 fatty acids are saturated and
are considered to be mid-chain in length, compared to the longer C12-18
fatty acids.  However, all these fatty acids are well-known and
understood and all are metabolized by oxidation for production of energy
in animals and humans.  .]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [No residues that exceed those normally occurring
are expected to be present in livestock at the time of slaughter or in
livestock products.]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [Because an
exemption from the requirements of a tolerance are requested, a residue
analytical method is not needed.]>

<C. Mammalian Toxicological Profile>

<Acute toxicity.  A formulated product containing these active
ingredients identifies that the acute oral toxicity (rats) is >5000
mg/kg bw, the acute dermal toxicity (rats) is > 5000 mg/kg bw, acute
inhalation toxicity (rats) is > 2.15 mg/L.  The formulated product is
mildly irritating to the eye and moderately irritating to the skin.  The
formulated product is not a dermal sensitizer.>

Genotoxicity.  Published results of mutagenicity studies have
demonstrated that C8-C10 n-carboxylic acids are not mutagenic or
genotoxic.  The free fatty acids, which occur naturally in living
systems, are not genotoxic in living systems.

Reproductive and developmental toxicity.  There is no evidence in the
literature nor any expectation that C8-C10 n-carboxylic acids are
reproductive or developmental toxicants.  The long history of safe use
as food and feed additives, along with the natural occurrence of these
fatty acids in animal systems, supports that there will be no adverse
toxicological effects.

Subchronic toxicity.  Published literature shows no adverse effects from
oral dosing at limit doses with free fatty acids.  The long history of
safe use of the C8-C10 n-carboxylic acids as food and feed additives,
along with the natural occurrence of these fatty acids in animal
systems, supports that there will be no adverse toxicological effects.

Chronic toxicity.  There is no evidence of chronic toxicity in the
public literature.  The long history of safe use of the C8-C10
n-carboxylic acids as food and feed additives, along with the natural
occurrence of these fatty acids in animal systems, supports that there
will be no adverse toxicological effects.

Carcinogenicity.  There is no evidence of carcinogenicity in the public
literature. The long history of safe use of the C8-C10 n-carboxylic
acids as food and feed additives, along with the natural occurrence of
these fatty acids in animal systems, supports that there will be no
adverse toxicological effects.

Endocrine effects.  A review of information from public sources,
including the World Health Organization, the Agency of Toxic Substances
and Disease Registry, and the Environmental Protection Agency indicate
that potential endocrine effects from exposure to C8-C10 n-carboxylic
acids have not been studied.  To the best of our knowledge, nothing in
the available literature suggests that C8-C10 n-carboxylic acids are
endocrine disruptors or have any intrinsic hormonal activity.

<D. Aggregate Exposure>

<	1. Dietary exposure. [The C8-C10 n-carboxylic acids are normal and
essential constituents of man, plants, and animals, and are a
significant part of the normal daily diet as part of dietary fats. 
Residues from the pesticide uses of these fatty acids are not likely to
exceed levels of naturally occurring fatty acids in commonly consumed
foods.]>

<	i. Food. [NA]>

<	ii. Drinking water. [The potential for exposure in drinking water is
unlikely.]>

<	2. Non-dietary exposure. [The potential for significant
nonoccupational exposure to the general population (including children)
is unlikely.]>

<E. Cumulative Effects>

<	[No cumulative adverse effects are expected from long-term exposure to
C8-C10 n-carboxylic acids.  These compounds are members of a much larger
class of naturally occurring and essential compounds, all of which are
dealt with by all vertebrate systems as food rather than toxicants. 
There is no evidence that these compounds have a common mechanism of
toxicity with any other substance.]>

<F. Safety Determination>

<	1. U.S. population. [It is doubtful harm will result from aggregate
exposure to residues of these fatty acids.  This is based on the long
history of safe use of the C8-C10 n-carboxylic acids as food and feed
additives, along with the natural occurrence of these fatty acids in
animal systems.]>

<	2. Infants and children. [There are no concerns for potential
sensitivity to infants and children.  The C8-C10 n-carboxylic acids are
essential to mammalian systems and normal consitituents of the daily
diet.]>

<G. Effects on the Immune and Endocrine Systems>

<	[A review of information from public sources, including the World
Health Organization, the Agency of Toxic Substances and Disease
Registry, and the Environmental Protection Agency indicate that
potential endocrine effects from exposure to C8-C10 n-carboxylic acids
have not been studied.  To the best of our knowledge, nothing in the
available literature suggests that C8-C10 n-carboxylic acids are
endocrine disruptors or have any intrinsic hormonal activity.]>

<H. Existing Tolerances>

<	[The following are the current tolerances for the three n-carboxylic
acids of interest

Basic ID	C8 Octanoic Acid	C9 Nonanoic acid	C10 Decanoic Acid

CAS RN	124-07-2	112-05-0	334-48-5

Other names	Caprylic Acid

n-Octoic acid	Pelargonic acid	Capric acid

1-nonanecarboxylic acid

Current specific exemptions in 40 CFR*	180.940 (sanitizing solution)

180.910 (inert)	180.1159 (herbicide, pgr, sanitizing solution)

180.940 (sanitizing solution)

180.910 (inert)	180.1225 (sanitizing solution)

180.940 (sanitizing solutions)

180.910 (inert)

FDA clearances under 21 CFR as food additives	172.210

172.860

173.315

173.340

173.370

184.1025	172.515

173.315	172.210

172.860

173.340

*NOTE:  40 CFR 180.940 also lists a mixture of n-carboxylic acids, not
less than 56% octanoic and not less than 40% decanoic acids.

The C8-C10 FFA are considered as GRAS direct food and feed additives by
FDA.

The C8, C9, and C10 FFA are well-known components of both animal and
plants and are, by definition “edible fats derived from either plants
or animals.”  Current regulations at 40 CFR 180.950 exempt from the
requirements of a tolerance certain general types of substances, as well
as certain specific substances, based on a determination that those
substances are of minimal risk to humans.  Those substances may be
either active or inert components of pesticide products used on food and
feed commodities without any need to establish any tolerance or
tolerance exemption for food and feed uses.  If a substance falls within
one of the groupings identified under (a), (b), (c), unless specifically
excluded, that substance does not have to be specifically named under
(e) or be subject to a separate regulation under 40 CFR Part 180.  The
C8, C9, and C10 FFA may already be addressed under 40 CFR 180.950(c) as
edible fats and oils, where “Edible fats and oils means all edible
(food or feed) fats and oils, derived from either plants or animals,
whether or not commonly consumed.”]>

<I. International Tolerances>

<	[No Codex Alimentarius maximum residue levels have been established
for C8-C10 n-carboxylic acids.]>

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