[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17630]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Distillates, (Fischer-Tropsch), Heavy, C18-
C50, Branched, Cyclic and Linear; 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 distillates, (Fischer-Tropsch), heavy,
C18-C50, branched, cyclic and linear when used as
an inert ingredient (solvent, diluent and/or dust suppressant) in
pesticide formulations applied to growing crops and raw agricultural
commodities after harvest. On behalf of Pennzoil-Quaker State Company,
Wagner Regulatory Associates, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of distillates, (Fischer-Tropsch), heavy, C18-
C50, branched, cyclic and linear.
DATES: This regulation is effective July 17, 2015. Objections and
requests for hearings must be received on or before September 15, 2015,
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-2012-0585, 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), West William Jefferson Clinton 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: Susan Lewis, Director, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email 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.
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-2012-0585 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
September 15, 2015. 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-2012-0585, 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.html.
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 February 27, 2013 (78 FR 13295) (FRL-
9380-2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 2E8049) by
Wagner Regulatory Associates, P.O. Box 640, 7217 Lancaster Pike, Suite
A, Hockessin, DE 19707 on behalf of Pennzoil-Quaker State Company, 700
Milam Street, Houston, TX 77002. The petition requested that 40 CFR
180.910 be amended by establishing an exemption from the requirement of
a tolerance for residues of distillates, (Fischer-Tropsch), heavy,
C18-C50, branched, cyclic and linear (CAS Reg.
No. 848301-69-9) when used as an inert ingredient as a solvent, diluent
and/or dust suppressant in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest. That document
referenced a summary of the petition prepared by Wagner Regulatory
Associates on behalf of the Pennzoil-Quaker State Company, 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,
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 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 distillates, (Fischer-Tropsch),
heavy, C18-C50, branched, cyclic and linear
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
distillates, (Fischer-Tropsch), heavy, C18-C50,
branched, cyclic and linear 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 distillates, (Fischer-Tropsch), heavy,
C18-C50, branched, cyclic and linear (also known
as GTL petroleum distillates) 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 this unit.
The acute oral lethal dose (LD)50 is 5,000 milligrams/
kilograms (mg/kg) in rats. An acute dermal toxicity study was not
conducted. There were no available dermal irritation data. It is not
irritating to the rabbit eye. It is not a skin sensitizer in the guinea
In a 90-day oral toxicity study, GTL petroleum distillates
administered by gavage resulted in a statistically significant increase
in the incidence and severity of alveolar macrophage accumulations and
increased vacuolation of alveolar macrophages in the lung in rats at
the lowest observed adverse effect level (LOAEL) 200 mg/kg/day. The No
Observed Adverse Effect Level (NOAEL) was 50 mg/kg/day.
In a 2-generation reproductive toxicity study via gavage in rats,
GTL petroleum distillates caused maternal and offspring toxicity at
1,000 mg/kg/day. Toxicity was manifested as chronic interstitial/
alveolus inflammation in the lungs. The NOAEL for parental toxicity was
50 mg/kg/day since animals in the mid dose (250 mg/kg/day) group were
not analyzed. The reproduction NOAEL was 1,000 mg/kg/day, the highest
Based upon subsequent studies conducted to evaluate the lung
effects, the Agency determined that the effects observed in the 90-day
oral toxicity study and 2-generation reproductive toxicity study were
caused by gavage administration error and were not test material (dose)
related. In a 28-day oral feeding study in rats at doses up to 1,256
mg/kg/day, no adverse effects were observed. In a prenatal
developmental toxicity study in the rat (by oral gavage) at doses up to
1,000 mg/kg/day, no adverse toxicological effects were seen. The
results of these two more recent studies alleviated the Agency's
concern for the lung effects seen in the 90-day oral toxicity study and
the 2-generation reproduction study.
GTL petroleum distillates were evaluated for mutagenic potential
the Ames test, micronucleus assay, and gene mutation in mammalian
cells. These studies were negative for the induction of mutations and
aberrations. Therefore, GTL petroleum distillates are considered non-
A neurotoxicity study was not conducted with GTL petroleum
distillates. However, signs of neurotoxicity were not observed in acute
toxicity tests at doses up to 5,000 mg/kg body weight (bw)/day.
Evidence of neurotoxicity was not observed in the 90-day oral toxicity
study in rats and in the 28-day oral feeding study in rats.
An immunotoxicity study was not conducted with GTL petroleum
distillates. However, alveolar macrophage accumulations and increased
vacuolation of alveolar macrophages in the lung was observed in rats at
>200 mg/kg/day in both the 90-day oral and 2-generation reproduction
toxicity studies. However, these effects were determined to be caused
by gavage technique error rather than effects attributable to the test
There are no data specific to the absorption, metabolism,
distribution and elimination of GTL petroleum distillates, however, the
absorption of other mixtures of normal, branched and cyclic petroleum
derived hydrocarbons is inversely related to carbon chain length and is
independent of isomeric form, preparation process or type of product.
Consequently, when administered orally, Fischer-Tropsch derived
hydrocarbons in the range of C18-C50 are likely
to be unabsorbed and excreted in the feces.
Carcinogenicity studies with GTL petroleum distillates are not
available for review. However, based on the lack of carcinogenicity of
related linear, branched, and cyclic alkanes and the negligible
absorption of GTL petroleum distillates, lack of systemic toxicity at
the limit dose, lack of mutagenic concerns, GTL petroleum distillates
are not expected to be carcinogenic.
B. Toxicological Points of Departure/Levels of Concern
There were no adverse effects in repeat dose toxicity,
reproductive, and developmental studies with GTL petroleum distillates
at or above limit dose levels to either parental animals or their
offspring. Thus, due to the low potential hazard and lack of hazard
endpoint, the Agency has determined that a quantitative risk assessment
using safety factors applied to a point of departure protective of an
identified hazard endpoint is not appropriate for GTL petroleum
C. Exposure Assessment
1. Dietary exposure from food and feed uses and drinking water. In
evaluating dietary exposure to GTL petroleum distillates, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance. Dietary exposure to GTL petroleum distillates can occur
when eating food treated with pesticide formulation containing this
inert ingredient. Since an endpoint for risk assessment was not
identified, a quantitative dietary exposure assessment for GTL
petroleum distillates was not conducted.
2. 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).
GTL petroleum distillates may be used as an inert ingredient in
agricultural pesticide products that could result in short- and
intermediate-term residential exposure. Residential exposure can occur
via dermal and inhalation routes of exposure to residential applicator.
Dermal and inhalation exposure can occur from the use of consumer
products and foods/food additives containing GTL petroleum distillates.
Since an endpoint for risk assessment was not identified, a
quantitative residential exposure assessment for GTL petroleum
distillates was not conducted.
3. 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 distillates, (Fischer-Tropsch), heavy,
C18-C50, branched, cyclic and linear to share a
common mechanism of toxicity with any other substances, and the
category does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that distillates, (Fischer-Tropsch), heavy,
C18-C50, branched, cyclic and linear do 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
1. In general. 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 Safety Factor (FQPA 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 different factor.
At this time, there is no concern for potential sensitivity to
infants and children resulting from exposures to GTL petroleum
distillates. There is no reported quantitative or qualitative evidence
of increased susceptibility of rat fetuses to in utero exposure to GTL
petroleum distillates in developmental toxicity studies in rats. No
quantitative or qualitative evidence of increased susceptibility has
been reported following the pre/postnatal exposure to rats in 2-
generation reproduction toxicity studies in rats. Given the lack of
adverse toxicological effects at limit dose levels, a safety factor
analysis has not been used to assess the risk. For these reasons the
additional tenfold safety factor is unnecessary.
E. Aggregate Risks and Determination of Safety
In examining aggregate exposure, EPA takes into account the
available and reliable information concerning exposures to pesticide
residues in food and drinking water, and non-occupational pesticide
exposures. Dietary (food and drinking water) and non-dietary
(residential) exposures of concern are not anticipated for GTL
petroleum distillates because of its low toxicity based on animal
studies showing toxicity at or above the limit dose of 1,000 mg/kg/day.
Taking into consideration all available information on GTL petroleum
distillates, EPA has determined that there is a reasonable certainty
that no harm to any population subgroup, including infants and
children, will result from aggregate exposure to GTL petroleum
distillates under reasonably foreseeable circumstances. Therefore, the
establishment of an exemption from
tolerance under 40 CFR 180.910 for residues of GTL petroleum
distillates when used as an inert ingredient (solvent, diluent and/or
dust suppressant) in pesticide formulations applied to growing crops
and raw agricultural commodities after harvest is safe under FFDCA
V. Other Considerations
A. Analytical Enforcement Methodology
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. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for distillates, (Fischer-
Tropsch), heavy, C18-C50, branched, cyclic and
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 910 for distillates, (Fischer-Tropsch),
heavy, C18-C50, branched, cyclic and linear (CAS
Reg. No. 848301-69-9) when used as an inert ingredient (solvent,
diluent and/or dust suppressant) in pesticide formulations applied to
growing crops or raw agricultural commodities after harvest.
VII. Statutory and Executive Order Reviews
This action establishes 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: July 2, 2015.
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, add alphabetically the inert ingredient
``Distillates, (Fishcher-Tropsch), heavy, C18-
C50, branched, cyclic and linear (CAS Reg. No. 848301-69-
9)'' to the table 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
* * * * * * *
Distillates, (Fishcher-Tropsch), ............. Solvent, diluent and/or
heavy, C18-C50, branched, dust suppressant.
cyclic and linear (CAS Reg. No.
* * * * * * *
[FR Doc. 2015-17630 Filed 7-16-15; 8:45 am]
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