[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19450]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Sweet Orange Peel Tincture; Exemption From the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sweet orange peel tincture when used as
an inert ingredient not to exceed 10% (weight/weight) in pesticide
formulations for use as a surfactant, fragrance, and adjuvant on all
pre- and post-harvest food commodities. This regulation eliminates the
need to establish a maximum permissible level for residues of sweet
orange peel tincture.
DATES: This regulation is effective August 15, 2014. Objections and
requests for hearings must be received on or before October 14, 2014,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0444, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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. 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-2013-0444 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 14, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0444, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of July 19, 2013 (78 FR 43117) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10547) by
AG-Chem Consulting (12208 Quinque Lane, Clifton VA 21024), on behalf of
Oro-Agri, Inc., 990 Trophy Club Drive, Trophy Club, TX 76262. The
petition requested that 40 CFR 180.910 be amended by establishing an
exemption from the requirement of a tolerance for residues of sweet
orange peel tincture when used as an inert ingredient when used as a
surfactant, fragrance and adjuvant up to 10% (weight/weight)
concentration in pesticide products applied to all pre- and post-
harvest food commodities. That document referenced a summary of the
petition prepared by AG-Chem Consulting, the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
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 polymers 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. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(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,
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 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.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sweet orange peel tincture
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with sweet
orange peel tincture follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by sweet orange peel tincture as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
Sweet orange peel tincture and sweet orange peel oil are chemically
the same (EINECS No. 232-433-8; CAS 8028-48-6). The only difference is
the method of extraction. Sweet orange peel tincture is extracted in
alcohol and the extraction process leads to the formation of a
``tincture''. Sweet orange peel oil is extracted by cold press
expression. Both are extracted from the same plant, Citrus sinensis
family Rutaceae. Both forms of the sweet orange peel extract contain d-
limonene as its primary component (>90%) and lesser amounts of myrcene.
The EPA has conducted a ``Screening-Level Hazard Assessment'' of a
class of compounds called monoterpene hydrocarbons, d-limonene and
myrcene are among the monoterpene hyrdrocarbons assessed. The chemical
class was ``based on structural similarity, similar molecular weights
and functional groups and the expectation that inherent
physicochemical, environmental and toxicological properties are
predicted to be similar''. That analysis also included a review of data
on sweet orange peel oil since it is a complex mixture containing
greater than 90% monoterpene hydrocarbons (including d-limonene and
myrcene), and is expected to have ``physicochemical, environmental and
toxicological properties similar to the major components . . . limonene
and myrcene''. Therefore, the Agency assessed the potential toxicity of
sweet orange peel tincture based on the available toxicity data for
sweet orange peel oil, and where data for sweet orange peel oil is
missing, relied upon available data for the monoterpene hydrocarbons
The acute oral and dermal toxicity of sweet orange peel oil is low.
The oral LD50 was >5,000 milligram/kilogram (mg/kg) in rats
and rabbits, respectively.
In a 28-day study with sweet orange peel oil, lesions in the non-
glandular stomach and clinical chemistry were observed at 1,500 mg/kg/
day (above the limit dose of 1,000 mg/kg/day) in rats. Lesions in the
non-glandular stomach is attributed to the irritating property of the
chemical. The NOAEL was 600 mg/kg/day.
In a combined reproductive/developmental toxicity screening test
with sweet orange peel oil, stillbirths and pup mortality were observed
at 1,500 mg/kg/day. The offspring NOAEL was 750 mg/kg/day. Signs of
toxicity were not observed in maternal rats, the NOAEL was 1,500 mg/kg/
Evidence of mutagenicity was not observed in the Ames test.
Although evidence of mutagenicity was observed in mouse lymphoma assay,
it was noted that cytotoxic concentrations were not reported and this
could contribute to an inflated mutation rate. In addition, d-limonene
was not mutagenic in an Ames test, mouse lymphoma, sister chromatid
exchange nor in chromosome aberrations in Chinese hamster ovary cells
assays. Therefore, based on the weight of evidence sweet orange peel
tincture is not expected to be mutagenic.
Evidence of immunotoxicity was not observed. Sweet orange peel oil
exhibited no effects on cell-mediated or humoral immune response at
doses up to 2,500 mg/kg/day in a plaque-forming cell assay in mice.
Although a carcinogenicity study was not available for sweet orange
peel tincture, carcinogenicity studies were available in the rat and
mouse for d-limonene. An increased incidence of tumor formation was not
observed in a 2 year carcinogenicity study on female rats or in male
and female mice treated with d-limonene up to 1,000 mg/kg/day. An
increased incidence of tubular cell hyperplasia, adenomas, and
adenocarcinomas of the kidney was observed in the male rat. However,
these lesions are related to the accumulation of the alpha 2u-globulin
protein which is specific to the male rat and is not relevant for human
risk assessment. Based on this available information and the data
supporting EPA's conclusion that sweet orange peel tincture is not
expected to be mutagenic, EPA concludes that sweet orange peel tincture
is not likely to be carcinogenic.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that sweet orange peel
tincture has low toxicity. Since no endpoint of concern was identified
for sweet orange peel tincture, a qualitative risk assessment is
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sweet orange peel tincture, EPA considered exposure under
the proposed exemption from the requirement of a tolerance (40 CFR
180.910 as an inert ingredient used in pesticide formulations applied
to growing crops). EPA assessed dietary exposures from sweet orange
peel tincture in food as follows:
Dietary exposure can occur from eating foods containing residues of
sweet orange peel tincture. Because no hazard endpoint of concern was
identified for the acute and chronic dietary assessment (food and
drinking water), a quantitative dietary exposure risk assessment was
2. Dietary exposure from drinking water. Sweet orange peel tincture
residues may be found in drinking water. However, since an endpoint of
concern was not identified for the dietary assessment (food and
drinking water), a quantitative dietary exposure risk assessment was
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). Sweet
orange peel tincture is used as an inert ingredient in pesticide
products that could result in short- and intermediate-term residential
exposure. However, based on the lack of toxicity, a quantitative
exposure assessment from residential exposures was not performed.
4. 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.''
EPA has not found sweet orange peel tincture to share a common
mechanism of toxicity with any other substances and sweet orange peel
tincture does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that sweet orange peel tincture does not 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
EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
Based on an assessment of sweet orange peel oil, EPA has concluded
that there are no toxicological endpoints of concern for the U.S.
population, including infants and children, and has conducted a
qualitative assessment. As part of its qualitative assessment, the
Agency did not use safety factors for assessing risk, and no additional
safety factor is needed for assessing risk to infants and children.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate point of departure (PODs)
to ensure that an adequate MOE exists.
Based on the lack of any endpoints of concern, EPA concludes that
there is a reasonable certainty that no harm will result to the general
population or to infants and children from aggregate exposure to sweet
orange peel tincture residues.
V. Other Considerations
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.
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for sweet orange peel tincture (CAS
Reg. No. 8028-48-6) when used as an inert ingredient in pesticide
formulations for use as a surfactant, fragrance and adjuvant up to 10%
(weight/weight) on all pre- and post-harvest food commodities.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) 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 FFDCA section 408(d), such as the exemption to the
requirement of a tolerance 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: August 7, 2014.
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, the table is amended by alphabetically adding
entry for ``Sweet orange peel tincture * * *'' after the entry for
``Sulfuric acid * * * '' to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Pesticide chemical Limits Uses
* * * * * * *
Sweet orange peel tincture Not to exceed 10% Surfactant,
(CAS Reg. No. 8028-48-6). (weight/weight) in fragrance,
pesticide formulation. related
* * * * * * *
[FR Doc. 2014-19450 Filed 8-14-14; 8:45 am]
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