ENVIRONMENTAL PROTECTION AGENCY

\[OPP-2006-xxxx; FRL-xxxx-x\]

Ammonium Salts of Higher Fatty Acids; Notice of Filing a Pesticide
Petition to Exempt from the

Requirement of a Tolerance a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

SUMMARY: This notice announces the filing of pesticide

petition \[PPxxxxxx\] proposing to amend the regulations in 40 CFR
§180.1166 to exempt from the requirement of a tolerance for the residues
of the biochemical pesticide ammonium salts of higher fatty acids
\[C8-C18 saturated; C8-C12 unsaturated\] in or on all food uses.

DATES: Comments, identified by docket \[ID\] number OPP-2006-xxxx, must
be

received on or before \[date\].

ADDRESSES: Comments may be submitted electronically, by mail, or through

hand delivery/courier. Follow the detailed instructions as

provided in Unit I. of the \'\'SUPPLEMENTARY INFORMATION.\'\'

FOR FURTHER INFORMATION CONTACT: By mail: Denise Geenway,

Biopesticides and Pollution Prevention Division (7511C), Office of

Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:

(703)308-8263; e-mail address: greenway.denise@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

Potentially affected by this action but are not limited to:

•[ Crop production (NAICS code 111)]{.underline}

•[ Animal production (NAICS code 112) ]{.underline}

•[ Food manufacturing (NAICS code 311)]{.underline}

•[ Pesticide manufacturing (NAICS code 32532)]{.underline}

This listing is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining whether
this action might apply to certain entities. If you have any questions
regarding the applicability of this action to a particular

entity, consult the person listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1\. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2006-xxxx. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket is
the collection of materials that is available for public viewing at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1801 South Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-5805.

2\. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the \`\`Federal
Register\'\' listings at . An electronic version of the public docket is
available through EPA\'s electronic public docket and comment system,
EPA Dockets. You may use EPA Dockets at to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select \`\`search,\'\' then key in the
appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA\'s electronic
public docket. EPA\'s policy is that copyrighted material will not be
placed in EPA\'s electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA\'s electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the document
is available for viewing in EPA\'s electronic public docket. Although,
not all docket materials may be available electronically, you may still
access any of the publicly available docket materials through the docket
facility identified in Unit I.B. EPA intends to work towards providing
electronic access to all of the publicly available docket materials
through EPA\'s electronic public docket.

For public commenters, it is important to note that EPA\'s policy is
that public comments, whether submitted electronically or on paper, will
be made available for public viewing in EPA\'s electronic public docket
as EPA receives them and without change, unless the comment contains
copyrighted material, CBI, or other information whose disclosure is
restricted by statute. When EPA identifies a comment containing
copyrighted material, EPA will provide a reference to that material in
the version of the comment that is placed in EPA\'s electronic public
docket. The entire printed comment, including the copyrighted material,
will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered
to the docket will be transferred to EPA\'s electronic public docket.
Public comments that are mailed or delivered to the docket will be
scanned and placed in EPA\'s electronic public docket. Where practical,
physical objects will be photographed, and the photograph will be placed
in EPA\'s electronic public docket along with a brief description
written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked \`\`late.\'\' EPA is not required to
consider these late comments. If you wish to submit CBI or information
that is otherwise protected by statute, please follow the instructions
in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or
information protected by statute.

1\. Electronically. If you submit an electronic comment as prescribed in
this unit, EPA recommends that you include your name, mailing address,
and an e-mail address or other contact information in the body of your
comment. Also, include this contact information on the outside of any
disk or CD ROM you submit, and in any cover letter accompanying the disk
or CD ROM. This ensures that you can be identified as the submitter of
the comment and allows EPA to contact you in case EPA cannot read your
comment due to technical difficulties or needs further information on
the substance of your comment. EPA\'s policy is that EPA will not edit
your comment, and any identifying or contact information provided in the
body of a comment will be included as part of the comment that is placed
in the official public docket, and made available in EPA\'s electronic
public docket. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.

i.  EPA Dockets. Your use of EPA\'s electronic public docket to submit
    comments to EPA electronically is EPA\'s preferred method for
    receiving comments. Go directly to EPA Dockets at , and follow the
    online instructions for submitting comments. Once in the system,
    select \`\`search,\'\' and then key in docket ID number
    OPP-2006-xxxx. The system is an \`\`anonymous access\'\' system,
    which means EPA will not know your identity, e-mail address, or
    other contact information unless you provide it in the body of your
    comment.

ii. E-mail. Comments may be sent by e-mail to , Attention: Docket ID
    number OPP-2006-xxxx.. In contrast to EPA\'s electronic public
    docket, EPA\'s e-mail system is not an \`\`anonymous access\'\'
    system. If you send an e-mail comment directly to the docket without
    going through EPA\'s electronic public docket, EPA\'s e-mail system
    automatically captures your e-mail address. E-mail addresses that
    are automatically captured by EPA\'s e-mail system are included as
    part of the comment that is placed in the official public docket,
    and made available in EPA\'s electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that
     you mail to the mailing address identified in Unit I.C.2. These
     electronic submissions will be accepted in WordPerfect or ASCII
     file format. Avoid the use of special characters and any form of
     encryption.

2\. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2006-xxxx.

3\. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1801 South Bell St., Arlington, VA, Attention: Docket ID number
OPP-2006-xxxx. Such deliveries are only accepted during the docket\'s
normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically
through EPA\'s electronic public docket or by e-mail. You may claim
information that you submit to EPA as CBI by marking any part or all of
that information as CBI (if you submit CBI on disk or CD ROM, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the disk or CD ROM the specific information that is CBI).
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket and EPA\'s
electronic public docket. If you submit the copy that does not contain
CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly
that it does not contain CBI. Information not marked as CBI will be
included in the public docket and EPA\'s electronic public docket
without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the person listed under FOR
FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your
comments:

1\. Explain your views as clearly as possible.

2\. Describe any assumptions that you used.

3\. Provide copies of any technical information and/or data you used
that support your views.

4\. If you estimate potential burden or costs, explain how you arrived
at the estimate that you provide.

5\. Provide specific examples to illustrate your concerns.

6\. Make sure to submit your comments by the deadline in this notice.

7\. To ensure proper receipt by EPA, be sure to identify the docket ID
number assigned to this action in the subject line on the first page of
your response. You may also, provide the name, date, and Federal
Register citation.

II\. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA
has determined that this petition contains data or information regarding
the elements set forth in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the petition. Additional data may
be needed before EPA rules on the petition.

List of Subjects

Environmental protection, Agricultural commodities, Feed additives, Food
additives, Pesticides and pests, Reporting and recordkeeping
requirements.

\[Dated: xxxxxxxxxx xx, 2006. \]

Janet Anderson, Director, Biopesticides and Pollution Prevention
Division, Office of Pesticide Programs.

Summary of Petition

The petitioner summary of the pesticide petition is printed below as
required by section 408(d)(3) of the FFDCA. The summary of the petition
was prepared by the petitioner and represent the views of the
petitioner. EPA is publishing the petition summary verbatim without
editing it in any way. The petition summary announces the availability
of a description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an

explanation of why no such method is needed.

**Falcon Lab, LLC**

\[PP xxxxxx\]

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.

## A. 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).

## B. 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 20mg 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.

2.  *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.

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

2.  *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.

3.  *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 ìmol/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 ìg/l of oleic acid with
    hamster fibroblasts and for 100 mg/l with *Saccaromyces cerevisiae*.

4.  *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.

## C. 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.* 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.

## D. 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 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.

## E. 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.

F. 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]{.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, the agency found that the risks to
applicators and consumers of treated foods with ammonium salts of fatty
acids to be negligible.

## G. 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.