[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6495]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Ammonium Salts of Fatty Acids (C8-C18
Saturated); Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ammonium salts of fatty acids
(C8-C18 saturated) applied pre- and post-harvest
on all raw agricultural commodities when applied/used as a surfactant.
Falcon Lab, LLC. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of ammonium salts of
fatty acids (C8-C18 saturated).
DATES: This regulation is effective March 24, 2010. Objections and
requests for hearings must be received on or before May 24, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0652. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
FOR FURTHER INFORMATION CONTACT: Deirdre Sunderland, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0851; e-mail address:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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
B. How Can I Access Electronic Copies of This Document?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0652 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before May 24, 2010.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0652, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 5, 2008 (73 FR 51817) (FRL-
8380-4), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by the Food Quality Protection ACT (FQPA)
(Public Law 104-170), announcing the filing of a pesticide petition (PP
8E7402) by Falcon Lab, LLC, 1103 Norbee Drive, Wilmington, DE 19803.
The petition requested that 40 CFR 180.910 be amended by establishing
an exemption from the requirement of a tolerance for residues of
ammonium salts of fatty acids (C8-C18 saturated)
when used as an inert ingredient in pesticide formulations applied pre-
and post-harvest. A request for a tolerance exemption under 40 CFR
180.950 was withdrawn by the company. That notice included a summary of
the petition prepared by the petitioner. There were no comments
received in response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene ploymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
IV. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by
ammonium salts of fatty acids (C8-C18 saturated)
are discussed in this unit. The following provides a brief summary of
the risk assessment and conclusions for the Agency's review of ammonium
salts of fatty acids (C8-C18 saturated). The
Agency's full decision document for this action is available in the
Agency's electronic docket (regulations.gov) under the docket ID number
Ammonium salts of fatty acids are mineral salts of naturally
occurring fatty acids found in the environment. Fatty acids play a
significant role in the normal diet of humans, animals, and plants and
currently have Food and Drug Administration and EPA approved uses in
food products. They are naturally present in commonly eaten fats and
oils, accounting for approximately 30 to 40% of the caloric intake in
the U.S. diet (~ 90 grams/day). They are also found in cosmetics and
household cleaning products.
Ammonium salts of fatty acids have shown to be of low toxicity via
the oral and dermal routes of exposure, Toxicity category IV and III,
respectively (40 CFR 156.62). When applied for long periods of time,
they have the potential to be dermal irritants. In addition, ammonium
salts of fatty acids are eye irritants and have the potential to cause
permanent eye injury. Limited data are available regarding the
inhalation toxicity of soap salts; however, they are anticipated to be
irritating via the inhalation route of exposure.
A subchronic range finding study did not see any significant
systemic toxicity from nonanoic acid (C9 saturated) given to
rats at doses up to 1,834 milligrams/kilograms/day (mg/kg/day).
Ammonium salts of fatty acids are not believed to be mutagenic or
carcinogenic. When used at very high doses, potassium salts of fatty
acids (a chemical belonging to the same chemical group) caused
reproductive effects (post-implantation mortality at 6,000 mg/kg/day (6
times the limit dose of 1,000 mg/kg/day) on days 2 to 13 of pregnancy
and musculo-skeletal abnormalities observed at 600 mg/kg/day); however,
studies on ammonium salts of fatty acids did not show developmental or
mutagenic effects in rats at doses up to 1,500 mg/kg/day. In addition,
no signs of neurotoxicity or carcinogencity were observed. Although
reproductive/developmental effects were seen at very high doses in a
study on a structurally similar chemical, these effects were not
observed in studies on the actual inert ingredient at doses up to 1,500
mg/kg/day. Based on the available evidence the Agency does not believe
that ammonium salt of fatty acids (C8-C18
saturated) when used as an inert ingredient in pesticide products will
cause reproductive or developmental effects. Due to the low toxicity of
ammonium soap salts and the natural occurrence of fatty acids in the
environment and food products, a chronic study was not required.
V. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Fatty acids are an essential component of the mammalian diet and
the body is able to metabolize these soap salts and use them as an
energy source. Due to the self-limiting nature of these chemicals (e.g.
unpleasant taste and odor, herbicidal properties), their natural
occurrence in the environment, their rapid environmental degradation
and low toxicity, and their presence in commonly eaten foods (both
naturally and intentionally added), a quantitative exposure assessment
was not performed. The anticipated exposure from the use of ammonium
salts of fatty acids as inert ingredients in pesticide products is
expected to be minimal and is not anticipated to significantly increase
the overall exposure to all populations including infants and children.
Because of their strong soil adsorption and the rapid degradation
of ammonium salts of fatty acids they are not expected to reach surface
water via runoff nor are they expected to leach into ground water.
Based on the physical/chemical properties, volatilization from soils
and water is not expected. There is no expected translocation into
plants. Ammonium salts of fatty acid are not likely to persist in the
environment and are expected to be indistinguishable from naturally
occurring ammonium ions and fatty acids already present in the
environment as a result of plant metabolism and formation by soil
VI. Cumulative Effects
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to ammonium salts of fatty
acids (C8-C18 saturated) and any other
substances, and these chemicals do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that these chemicals
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism of toxicity on EPA's website at http://ww.epa.gov/pesticides/cumulative/.
VII. Additional Safety Factor for the Protection of Infants and
Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold margin of exposure (safety) for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA determines
that a different margin of exposure (safety) will be safe for infants
and children. There was no evidence of systemic toxicity or
developmental toxicity in rats at doses up to 1,500 mg/kg/day in a
developmental toxicity study (Master Record Identification Number
43843508) on pelargonic acid (nonanoate acid). The study showed no
adverse effect of treatment on clinical signs, body weights, weight
gain, or food/water consumption. No fetal toxicity attributed to the
effects of treatment was observed between the
treated (1,500 mg/kg/day) or the untreated controls. Similarly, no
systemic toxicity was observed at doses up to and including 1,837 mg/
kg/day in a 14-day toxicity study in rats. No clinical signs of
neurotoxicity were seen in any of the repeat dose studies. Since there
was no hazard identified to adults and developing fetuses EPA did not
use a safety factor analysis in assessing risks to ammonium salts of
fatty acids (C8-C18 saturated). For similar
reasons, EPA determined that an additional safety factor to protect
infants and children is not needed.
VIII. Determination of Safety for U.S. Population
As noted in Unit IV, ammonium salts of fatty acids are not expected
to pose an acute risk. Because of the low oral and dermal toxicity, the
rapid degradation of the chemical, and the natural presence of fatty
acids in the environment, the Agency concluded that aggregate exposure
will result in minimal risk to all subpopulations, including infants
and children. Since the inhalation route is not a likely exposure
pathway the anticipated risk from inhalation exposure is also
Taking into consideration all available information on ammonium
salts of fatty acids (C8-C18 saturated), it has
been determined that there is a reasonable certainty that no harm to
any population subgroup, including infants and children, will result
from aggregate exposure to this chemical. Therefore, the exemption from
the requirement of a tolerance for residues of ammonium salts of fatty
acids (C8-C18 saturated) (CAS Reg. No. 5972-76-9,
63718-65-0, 16530-70-4, 32582-95-9, 2437-23-2, 191799-95-8, 16530-71-5,
93917-76-1, 5297-93-8, 94266-36-1, 1002-89-7), when used as inert
ingredient in pre- and post-harvest applications, under 40 CFR 180.910
can be considered safe under section 408(q) of the FFDCA.
IX. Other Considerations
A. Analytical Method
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Existing Exemptions
Ammonium stearate (C18 saturated; CAS Reg. No. 1002-89-
7), one of the soap salts, has been approved as an inert ingredient
under 40 CFR 180.910. In addition, 40 CFR 180.1284 established an
exemption from the requirement of a tolerance for residues of the
active ingredient ammonium salts of higher fatty acids (C8-
C18 saturated; C8-C12 unsaturated) in
or on all food commodities when applied for the suppression and control
of a wide variety of grasses and weeds.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
ammonium salts of fatty acids (C8-C18 saturated)
nor have any CODEX Maximum Residue Levels (MRLs) been established for
any food crops at this time.
Therefore, a tolerance exemption is established for Ammonium salts
of fatty acids (C8-C18 saturated) (CAS Reg. No.
5972-76-9, 63718-65-0, 16530-70-4, 32582-95-9, 2437-23-2, 191799-95-8,
16530-71-5, 93917-76-1, 5297-93-8, 94266-36-1, 1002-89-7) when used as
inert ingredient in pesticide formulations applied to pre- and post-
harvest crops only.
XI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
XII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: March 11, 2010.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.910, in the table add alphabetically the following inert
ingredient to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Inert ingredients Limits Uses
* * * * * * *
Ammonium salts of fatty acids Surfactant
(C8-C18 saturated) (CAS Reg.
No. 5972-76-9, 63718-65-0,
16530-70-4, 32582-95-9, 2437-23-
2, 191799-95-8, 16530-71-5,
93917-76-1, 5297-93-8, 94266-36-
* * * * * * *
[FR Doc. 2010-6495 Filed 3-23-10; 8:45 am]
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