Document ID: EPA-HQ-OPP-2007-0571-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-26T04:00Z

FQPA Publicly Releasable Summary of the Petition for the Establishment
of a Exemption from the Requirement of a Tolerance on all Raw
Agricultural Commodities

A. Introduction

Falcon Lab, LLC, 1103 Norbee Drive, Wilmington, DE 19803, has submitted
to the EPA a petition to exempt, pursuant to 408(d) of the FFDCA, from
the requirement of a tolerance ammonium salts of higher fatty acids
[C8-C18 saturated and C8-C12 unsaturated] on all food uses.  This
petition is being submitted after the failure to finalize a proposed
rule to exempt ammonium salts of higher fatty acids, originally
published in 1996 (61FR10233-36).  The final rule is to be published at
40 CFR 180.1166.

The petition contains data or information regarding the elements set
forth in 408(d)(2) of the FFDCA; however EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition.

B. Residue Chemistry

Residue Chemistry.  There have been no analytical procedures conducted
to ascertain residual ammonium salts of fatty acids on treated food
crops.  Ammonium salts of fatty acids have been used on food crops since
1982 with no adverse effects.  Naturally occurring fatty acids
constitute a significant part of the normal daily diet and are of low
toxicity when taken orally and pose no known health risks.  The residues
of these salts of fatty acids from pesticide use are not likely to
exceed levels of naturally occurring fatty acids in commonly eaten
foods.  Salts of fatty acids are generally recognized as safe (GRAS) by
the U.S. Food and Drug Administration and potassium salts of fatty acids
have been previously exempted from the requirement of a tolerance (40
CFR 180.1068).

			 

C. Toxicological Profile

In the 1992 Reregistration Eligibility Document (RED): Soap Salts, the
Agency concluded that the soap salt toxicological database on file was
adequate to support reregistration.  This conclusion is supported by the
extensive study and summary data for fatty acids, fatty acid salts
(potassium) and esters of fatty acids.  Because the toxicity of ammonium
salts of fatty acids is low, no exposure data was required by the
Agency.  Even though exposure could be expected to be significant to
applicators, because of the low toxicity of ammonium salts of fatty
acids, pesticide use in accordance with label directions will not
present a hazard.  Protective eyewear is required for ammonium salts of
fatty acids to mitigate potential ocular exposure and irritation.

Acute Toxicity.  A battery of acute studies on fatty acids (nonanoic
acid, C9), fatty acid esters, an end use product containing ammonium
salts of fatty acids resulted in acute oral and acute dermal LD50 >5000
mg/kg, respectively.  Fatty acids and their ammonium salt-containing
product were mild to moderately irritating on rabbit skin.  Nonanoic
acid was severely irritating to human skin, while an end-use product
containing ammonium nonanoate was moderately irritating to rabbit skin
when 20 mg was applied for 4 hours.  The ammonium salt of nonanoic acid
was severely irritating to rabbit eyes.  As described in the 1992 RED,
and supported with data and summaries of data, the acute toxicity
effect/categories for ammonium salts of fatty acids are: Acute Oral,
Category IV; Acute Dermal, Category IV; Primary Eye Irritation, Severely
Irritatating;  Primary Skin, Mild-Moderate Irritation; and Acute
Inhalation, Category III. 

Subchronic toxicity.   A waiver has been requested for the 90-day
feeding study.  A 14-day range finding study with nonanoic acid (C9)
found no systemic toxicity with either sex at the high dose tested
(20,000 ppm, or 1,834 mg/kg/day), and no adverse effects were observed
with respect to survival, clinical signs, body weight gain, food
consumption, hematology, clinical chemistry or gross pathology.   Based
on these results of the range finding study, and the natural occurrence
of fatty acids in the human diet, the Agency waived the requirement for
the 90-day feeding study.   Naturally occurring fatty acids constitute a
significant part of the normal daily diet and are of low toxicity when
taken orally and pose no known health risks.  The residues of these
salts of fatty acids from pesticide use are not likely to exceed levels
of naturally occurring fatty acids in commonly eaten foods.  Fatty acids
are normally metabolized by the cells, where they are oxidized to simple
compounds for use as energy sources and as structural components
utilized in all living cells.  Potassium, sodium and ammonium are
normally part of the body’s metabolism and electrolyte balance.

	

Chronic Toxicity/Oncogenicity.   Not required due to the evidenced low
toxicity of ammonium salts of fatty acids. 

Reproductive and Developmental Toxicity  A waiver has been requested for
the teratogenicity study based on published findings of a developmental
toxicity study with nonanoic acid: “In a developmental toxicity study
in rats, MRID 43843508 the treatment had no adverse effects on clinical
signs, body weights, weight gain, or food/water consumption.  No fetal
toxicity was observed between the treated or the untreated controls. 
Moreover, the mean number of viable fetuses, early or late resporptions,
implantation sites, corpora lutea, pre- and post-implantation losses,
sex ratios and fetal body weights were comparable to those of the
control group.  The no observed effect level (NOEL) for maternal and
developmental toxicity was 1,500 mg/kg/day with the lowest observed
toxicity level (LOEL) greater than 1,500 mg/kg/day.

DNA inhibition was reported with 600 μmol/l of the sodium salt of
caprylic acid, tested with guinea pig kidney cells.  Unscheduled DNA
synthesis was found in mouse cells with 35 mg/kg of oleic acid. 
Cytogenetic analysis was positive for 2500 μg/l of oleic acid with
hamster fibroblasts and for 100 mg/l with Saccaromyces cerevisiae.  

Animal metabolism.  Fatty acids are normally metabolized by the cells,
where they are oxidized to simple compounds for use as energy sources
and as structural components utilized in all living cells.  Potassium,
sodium and ammonium are normally part of the body’s metabolism and
electrolyte balance.

	

D. Aggregate Exposure

Dietary exposure. Salts of fatty acids are food additives (21 CFR
172.863).  Residue chemistry data requirements are not applicable to the
proposed tolerance exemption.  While there are registered food uses of
for ammonium salts of fatty acids, there is neither a tolerance nor a
tolerance exemption under 40 CFR 180.  In the 1991 RED the Agency
pledged to correct this discrepancy by proposing a tolerance exemption. 
This action was carried out in 1996 (61FR19233-36) but the proposed rule
was never finalized even though no comments were received from the
public.  The herewith submitted petition to exempt ammonium salts of
fatty acids, from the requirement of a tolerance for all food uses,
seeks to re-propose and finalize this tolerance exemption.

4.  Non-Dietary Exposure.  The only non-dietary exposure to ammonium
salts of fatty acids will be occupational and residential exposure. 
Ammonium salts of fatty have been, or are currently used as a rabbit and
deer repellent on forage and grain crops; vegetables and field crops,
non-crop areas, nursery stock and ornamentals, flowers, roses shrubs,
fruit trees and vines.  The labels for products whose active ingredient
is a higher soap salt of a fatty acid bear the signal word “WARNING”
due to potential eye irritation and require that users wear protective
eyewear, i.e. glasses, goggles, or faceshield, to protect against ocular
exposure.  The products may also cause allergic skin reactions in some
individuals, however, no measures are recommended to reduce skin
exposure because the Agency believes the allergic reactions are uncommon
and transient.

E.  Cumulative Effects

	

Cumulative effects from substances with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether
to establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' Studies of fatty acids and fatty acid
salts previously submitted to the Agency, indicate that the half-life of
fatty acids is less than one (1) day (MRID 00157476).  As can be
expected, there is very rapid microbial degradation of fatty acids in
soil.  Fatty acids and their salts are excellent substrates for
microbial growth, serving both as carbon sources and energy sources. 
The active ingredient cannot totally dissipate from soil, because there
is a natural content of fatty acids in soil resulting from plant
metabolism and by formation of microbial organisms.  Fatty acids
constitute a significant portion of the normal daily diet of mammals
(including humans, birds, and invertebrates since they are found in
large amounts in the form of lipids in all living tissues (including
seeds).  Microbial metabolism of fatty acids has the effect of either
converting the degradates to CO2 and ester (if used as an energy source)
or converting the carbon content of the fatty acid to any of the
thousands of naturally occurring organic substances produced by the soil
microflora (if used as a carbon source).  Based on these known facts of
the role of fatty acids in the environment and in food and feed, there
should be no concern for cumulative effects of ammonium salts of fatty
acids used as pesticides.

F. Safety Determination

U.S. Population.  As described above in D., fatty acids are a necessary
and normal component of the human diet.  Dietary exposure from
pesticidal use would be very low compared to the everyday normal dietary
exposure.

   

Infants and children. Fatty acids are a necessary and normal part of the
diet of infants and children.  For the same reasons as for the general
U.S. population, dietary exposure to ammonium salts of fatty acids due
to pesticidal use would be of minimal concern.

G. Proposed Tolerance Exemption

Falcon Lab, LLC, is requesting that the Agency grant and exemption from
the requirement of a tolerance for ammonium salts of higher fatty acids
[C8-C18, saturated, and C8-C12, unsaturated].  This action is consistent
with the Agency’s pledge to formalize food use approval for ammonium
salts of fatty acids as stated in the 1992 RED: Soap Salts, by exempting
ammonium salts of higher fatty acids from the requirement of a
tolerance.  The Agency began this process in 1996 with the publication
of a proposed rule to exempt ammonium salts of fatty acids from the
requirement of a tolerance: “the Agency is now proposing to establish
an exemption from the requirement of a tolerance for all food uses under
FFDCA section 408 for ammonium soap salts of fatty acids because a
tolerance is not needed to protect the public health.”  The Agency
proposed to establish the exemption from the requirement of a tolerance
at 40 CFR 180.1166.  Although no comments were received during the
public comment period, the rule was not finalized, and has languished
since.  Falcon Lab is now petitioning the Agency to establish a
permanent exemption from the requirement of a tolerance for all food
uses for ammonium salts of higher fatty acids due to the demonstrated,
very low acute oral and dermal toxicity of these ammonium salts and
because residues from pesticide uses are not likely to exceed levels of
naturally occurring or intentionally added fatty acids in commonly
consumed foods.  In the 1992 RED, and the recently published
Biopesticide Registration Document for Ammonium Nonanoate, the agency
found that the risks to applicators and consumers of treated foods with
ammonium salts of fatty acids to be negligible.

				

H. International Tolerances

š

›

²

Ã

™

š

›

°

±

²

@

@

h

h

 h

h

@

@

There are no international tolerances or exemptions from the
requirement of a tolerance for residues of ammonium salts of fatty acids
in food or animal feed.  Therefore, harmonization is not an issue.