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.

1.  *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 LD~50~ \>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.

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1.  *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.

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

3.  *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.

4.  *Genotoxicity.* A mutagenic response was not observed when bacteria
    were tested with nonanoic acid (C9) at any dose or in confirmatory
    studies, leading to the conclusion that fatty acids are not
    mutagenic. It can be extended that ammonium salts of fatty acids are
    not mutagenic due to the similarity in chemical structure and
    behavior and near-identical toxicity profile they share with their
    fatty acid counterparts. In the 1992 RED, it was reported that 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*.

5.  *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

1.  *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.*]{.mark} 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.

[]{.mark}

## [E. Cumulative Effects]{.mark}

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 CO~2~ 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.

[]{.mark}

## [F. Safety Determination]{.mark}

[]{.mark}

> [*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.]{.mark}

[]{.mark}

> [*Infants and children*.]{.mark} 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]{.underline}**

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]{.underline}." 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.

[]{.mark}

## H. International Tolerances

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.