80 FR 42400 - Distillates, (Fischer-Tropsch), Heavy, C18

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 137 (July 17, 2015)

Page Range		42400-42404
FR Document		2015-17630

This regulation establishes an exemption from the requirement of a tolerance for residues of distillates, (Fischer-Tropsch), heavy, C<INF>18</INF>-C<INF>50</INF>, 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, C<INF>18</INF>- C<INF>50</INF>, branched, cyclic and linear.

Federal Register, Volume 80 Issue 137 (Friday, July 17, 2015)

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
[Pages 42400-42404]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-17630]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0585; FRL-9929-27]

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.

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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:
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

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
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please

[[Page 42401]]

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
ingredients.

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
pig.
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
dose tested.
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
using

[[Page 42402]]

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-
mutagenic.
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
substance.
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
distillates.

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

[[Page 42403]]

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
section 408.

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
linear.

VI. Conclusions

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
recordkeeping requirements.

Dated: July 2, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

0
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.
848301-69-9).

* * * * * * *
------------------------------------------------------------------------

[[Page 42404]]

[FR Doc. 2015-17630 Filed 7-16-15; 8:45 am]
BILLING CODE 6560-50-P

42400 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations

§ 180.242 Thiabendazole; tolerances for its metabolites and degradates, in or on only the sum of thiabendazole (2-(4-
residues. the specified agricultural commodities, thiazolyl)benzimidazole) and its
* * * * * resulting from use of the pesticide metabolite benzimidazole (free and
(b) Section 18 emergency exemptions. pursuant to FIFRA section 18 conjugated), calculated as the
Time-limited tolerances specified in the emergency exemptions. Compliance stoichiometric equivalent of
following table are established for with the tolerance levels specified thiabendazole. The tolerances expire on
residues of the thiabendazole, including below is to be determined by measuring the date specified in the table.

Parts per
Commodity Expiration date
million

Pea, succulent shelled .................................................................................................................................... 0.02 December 31,
2018.

* * * * * Office of Pesticide Programs Regulatory www.ecfr.gov/cgi-bin/text-
[FR Doc. 2015–17681 Filed 7–16–15; 8:45 am] Public Docket (OPP Docket) in the idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
BILLING CODE 6560–50–P Environmental Protection Agency 40tab_02.tpl.
Docket Center (EPA/DC), West William
C. How can I file an objection or hearing
Jefferson Clinton Bldg., Rm. 3334, 1301
ENVIRONMENTAL PROTECTION request?
Constitution Ave. NW., Washington, DC
AGENCY 20460–0001. The Public Reading Room Under FFDCA section 408(g), 21
is open from 8:30 a.m. to 4:30 p.m., U.S.C. 346a, any person may file an
40 CFR Part 180 Monday through Friday, excluding legal objection to any aspect of this regulation
[EPA–HQ–OPP–2012–0585; FRL–9929–27] holidays. The telephone number for the and may also request a hearing on those
Public Reading Room is (202) 566–1744, objections. You must file your objection
Distillates, (Fischer-Tropsch), Heavy, and the telephone number for the OPP or request a hearing on this regulation
C18-C50, Branched, Cyclic and Linear; Docket is (703) 305–5805. Please review in accordance with the instructions
Exemption From the Requirement of a the visitor instructions and additional provided in 40 CFR part 178. To ensure
Tolerance information about the docket available proper receipt by EPA, you must
AGENCY: Environmental Protection at http://www.epa.gov/dockets. identify docket ID number EPA–HQ–
Agency (EPA). FOR FURTHER INFORMATION CONTACT: OPP–2012–0585 in the subject line on
Susan Lewis, Director, Registration the first page of your submission. All
ACTION: Final rule.
Division (7505P), Office of Pesticide objections and requests for a hearing
SUMMARY: This regulation establishes an Programs, Environmental Protection must be in writing, and must be
exemption from the requirement of a Agency, 1200 Pennsylvania Ave. NW., received by the Hearing Clerk on or
tolerance for residues of distillates, Washington, DC 20460–0001; main before September 15, 2015. Addresses
(Fischer-Tropsch), heavy, C18-C50, telephone number: (703) 305–7090; for mail and hand delivery of objections
branched, cyclic and linear when used email address: RDFRNotices@epa.gov. and hearing requests are provided in 40
as an inert ingredient (solvent, diluent SUPPLEMENTARY INFORMATION: CFR 178.25(b).
and/or dust suppressant) in pesticide In addition to filing an objection or
formulations applied to growing crops I. General Information hearing request with the Hearing Clerk
and raw agricultural commodities after A. Does this action apply to me? as described in 40 CFR part 178, please
harvest. On behalf of Pennzoil-Quaker submit a copy of the filing (excluding
State Company, Wagner Regulatory You may be potentially affected by any Confidential Business Information
Associates, submitted a petition to EPA this action if you are an agricultural (CBI)) for inclusion in the public docket.
under the Federal Food, Drug, and producer, food manufacturer, or Information not marked confidential
Cosmetic Act (FFDCA), requesting pesticide manufacturer. The following pursuant to 40 CFR part 2 may be
establishment of an exemption from the list of North American Industrial disclosed publicly by EPA without prior
requirement of a tolerance. This Classification System (NAICS) codes is notice. Submit the non-CBI copy of your
regulation eliminates the need to not intended to be exhaustive, but rather objection or hearing request, identified
establish a maximum permissible level provides a guide to help readers by docket ID number EPA–HQ–OPP–
for residues of distillates, (Fischer- determine whether this document 2012–0585, by one of the following
Tropsch), heavy, C18-C50, branched, applies to them. Potentially affected methods:
entities may include:
cyclic and linear.
• Crop production (NAICS code 111). • Federal eRulemaking Portal: http://
DATES: This regulation is effective July www.regulations.gov. Follow the online
• Animal production (NAICS code
17, 2015. Objections and requests for 112). instructions for submitting comments.
hearings must be received on or before • Food manufacturing (NAICS code Do not submit electronically any
September 15, 2015, and must be filed 311). information you consider to be CBI or
in accordance with the instructions • Pesticide manufacturing (NAICS other information whose disclosure is
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provided in 40 CFR part 178 (see also code 32532). restricted by statute.
Unit I.C. of the SUPPLEMENTARY • Mail: OPP Docket, Environmental
INFORMATION). B. How can I get electronic access to Protection Agency Docket Center (EPA/
ADDRESSES: The docket for this action,
other related information? DC), (28221T), 1200 Pennsylvania Ave.
identified by docket identification (ID) You may access a frequently updated NW., Washington, DC 20460–0001.
number EPA–HQ–OPP–2012–0585, is electronic version of 40 CFR part 180 • Hand Delivery: To make special
available at through the Government Printing arrangements for hand delivery or
http://www.regulations.gov or at the Office’s e-CFR site at http:// delivery of boxed information, please

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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations 42403

tolerance under 40 CFR 180.910 for VII. Statutory and Executive Order ‘‘Federalism’’ (64 FR 43255, August 10,
residues of GTL petroleum distillates Reviews 1999) and Executive Order 13175,
when used as an inert ingredient This action establishes a tolerance entitled ‘‘Consultation and Coordination
(solvent, diluent and/or dust under FFDCA section 408(d) in with Indian Tribal Governments’’ (65 FR
suppressant) in pesticide formulations response to a petition submitted to the 67249, November 9, 2000) do not apply
applied to growing crops and raw Agency. The Office of Management and to this action. In addition, this action
agricultural commodities after harvest is Budget (OMB) has exempted these types does not impose any enforceable duty or
safe under FFDCA section 408. of actions from review under Executive contain any unfunded mandate as
Order 12866, entitled ‘‘Regulatory described under Title II of the Unfunded
V. Other Considerations Planning and Review’’ (58 FR 51735, Mandates Reform Act (UMRA) (2 U.S.C.
A. Analytical Enforcement Methodology October 4, 1993). Because this action 1501 et seq.).
has been exempted from review under This action does not involve any
An analytical method is not required Executive Order 12866, this action is technical standards that would require
for enforcement purposes since the not subject to Executive Order 13211, Agency consideration of voluntary
Agency is establishing an exemption entitled ‘‘Actions Concerning consensus standards pursuant to section
from the requirement of a tolerance Regulations That Significantly Affect 12(d) of the National Technology
without any numerical limitation. Energy Supply, Distribution, or Use’’ (66 Transfer and Advancement Act
FR 28355, May 22, 2001) or Executive (NTTAA) (15 U.S.C. 272 note).
B. International Residue Limits Order 13045, entitled ‘‘Protection of VIII. Congressional Review Act
Children from Environmental Health
In making its tolerance decisions, EPA Pursuant to the Congressional Review
Risks and Safety Risks’’ (62 FR 19885,
seeks to harmonize U.S. tolerances with Act (5 U.S.C. 801 et seq.), EPA will
April 23, 1997). This action does not
international standards whenever contain any information collections submit a report containing this rule and
possible, consistent with U.S. food subject to OMB approval under the other required information to the U.S.
safety standards and agricultural Paperwork Reduction Act (PRA) (44 Senate, the U.S. House of
practices. EPA considers the U.S.C. 3501 et seq.), nor does it require Representatives, and the Comptroller
international maximum residue limits any special considerations under General of the United States prior to
(MRLs) established by the Codex Executive Order 12898, entitled publication of the rule in the Federal
Alimentarius Commission (Codex), as ‘‘Federal Actions to Address Register. This action is not a ‘‘major
required by FFDCA section 408(b)(4). Environmental Justice in Minority rule’’ as defined by 5 U.S.C. 804(2).
The Codex Alimentarius is a joint Populations and Low-Income List of Subjects in 40 CFR Part 180
United Nations Food and Agriculture Populations’’ (59 FR 7629, February 16,
Organization/World Health 1994). Environmental protection,
Organization food standards program, Since tolerances and exemptions that Administrative practice and procedure,
and it is recognized as an international are established on the basis of a petition Agricultural commodities, Pesticides
food safety standards-setting under FFDCA section 408(d), such as and pests, Reporting and recordkeeping
organization in trade agreements to the tolerance in this final rule, do not requirements.
which the United States is a party. EPA require the issuance of a proposed rule, Dated: July 2, 2015.
the requirements of the Regulatory Susan Lewis,
may establish a tolerance that is
Flexibility Act (RFA) (5 U.S.C. 601 et
different from a Codex MRL; however, Director, Registration Division, Office of
seq.), do not apply. Pesticide Programs.
FFDCA section 408(b)(4) requires that This action directly regulates growers,
EPA explain the reasons for departing food processors, food handlers, and food Therefore, 40 CFR chapter I is
from the Codex level. retailers, not States or tribes, nor does amended as follows:
The Codex has not established a MRL this action alter the relationships or
for distillates, (Fischer-Tropsch), heavy, distribution of power and PART 180—[AMENDED]
C18-C50, branched, cyclic and linear. responsibilities established by Congress
■ 1. The authority citation for part 180
in the preemption provisions of FFDCA
VI. Conclusions continues to read as follows:
section 408(n)(4). As such, the Agency
has determined that this action will not Authority: 21 U.S.C. 321(q), 346a and 371.
Therefore, an exemption from the
have a substantial direct effect on States 2. In § 180.910, add alphabetically the
requirement of a tolerance is established ■
or tribal governments, on the inert ingredient ‘‘Distillates, (Fishcher-
under 40 CFR 180. 910 for distillates,
relationship between the national Tropsch), heavy, C18-C50, branched,
(Fischer-Tropsch), heavy, C18-C50, government and the States or tribal
branched, cyclic and linear (CAS Reg. cyclic and linear (CAS Reg. No. 848301–
governments, or on the distribution of 69–9)’’ to the table to read as follows:
No. 848301–69–9) when used as an inert power and responsibilities among the
ingredient (solvent, diluent and/or dust various levels of government or between § 180.910 Inert ingredients used pre- and
suppressant) in pesticide formulations the Federal Government and Indian post-harvest; exemptions from the
applied to growing crops or raw tribes. Thus, the Agency has determined requirement of a tolerance.
agricultural commodities after harvest. that Executive Order 13132, entitled * * * * *
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Inert ingredients Limits Uses

* * * * * * *
Distillates, (Fishcher-Tropsch), heavy, C18-C50, branched, cyclic .............. Solvent, diluent and/or dust suppressant.
and linear (CAS Reg. No. 848301–69–9).

* * * * * * *

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42404 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations

[FR Doc. 2015–17630 Filed 7–16–15; 8:45 am] at protecting lives and new construction met prior to the effective suspension
BILLING CODE 6560–50–P from future flooding. Section 1315 of date. Since these notifications were
the National Flood Insurance Act of made, this final rule may take effect
1968, as amended, 42 U.S.C. 4022, within less than 30 days.
DEPARTMENT OF HOMELAND prohibits the sale of NFIP flood National Environmental Policy Act.
SECURITY insurance unless an appropriate public This rule is categorically excluded from
body adopts adequate floodplain the requirements of 44 CFR part 10,
Federal Emergency Management management measures with effective Environmental Considerations. No
Agency enforcement measures. The environmental impact assessment has
communities listed in this document no been prepared.
44 CFR Part 64 longer meet that statutory requirement Regulatory Flexibility Act. The
for compliance with program Administrator has determined that this
[Docket ID FEMA– 2015–0001; Internal regulations, 44 CFR part 59.
Agency Docket No. FEMA–8387] rule is exempt from the requirements of
Accordingly, the communities will be the Regulatory Flexibility Act because
Suspension of Community Eligibility suspended on the effective date in the the National Flood Insurance Act of
third column. As of that date, flood 1968, as amended, Section 1315, 42
AGENCY: Federal Emergency insurance will no longer be available in U.S.C. 4022, prohibits flood insurance
Management Agency, DHS. the community. We recognize that some coverage unless an appropriate public
ACTION: Final rule. of these communities may adopt and body adopts adequate floodplain
submit the required documentation of management measures with effective
SUMMARY: This rule identifies legally enforceable floodplain enforcement measures. The
communities where the sale of flood management measures after this rule is communities listed no longer comply
insurance has been authorized under published but prior to the actual with the statutory requirements, and
the National Flood Insurance Program suspension date. These communities after the effective date, flood insurance
(NFIP) that are scheduled for will not be suspended and will continue will no longer be available in the
suspension on the effective dates listed to be eligible for the sale of NFIP flood communities unless remedial action
within this rule because of insurance. A notice withdrawing the takes place.
noncompliance with the floodplain suspension of such communities will be
Regulatory Classification. This final
management requirements of the published in the Federal Register.
In addition, FEMA publishes a Flood rule is not a significant regulatory action
program. If the Federal Emergency under the criteria of section 3(f) of
Management Agency (FEMA) receives Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Executive Order 12866 of September 30,
documentation that the community has 1993, Regulatory Planning and Review,
adopted the required floodplain Areas (SFHAs) in these communities.
The date of the FIRM, if one has been 58 FR 51735.
management measures prior to the
published, is indicated in the fourth Executive Order 13132, Federalism.
effective suspension date given in this
column of the table. No direct Federal This rule involves no policies that have
rule, the suspension will not occur and
financial assistance (except assistance federalism implications under Executive
a notice of this will be provided by
pursuant to the Robert T. Stafford Order 13132.
publication in the Federal Register on a
Disaster Relief and Emergency Executive Order 12988, Civil Justice
subsequent date. Also, information
Assistance Act not in connection with a Reform. This rule meets the applicable
identifying the current participation
flood) may be provided for construction standards of Executive Order 12988.
status of a community can be obtained
from FEMA’s Community Status Book or acquisition of buildings in identified Paperwork Reduction Act. This rule
(CSB). The CSB is available at http:// SFHAs for communities not does not involve any collection of
www.fema.gov/fema/csb.shtm. participating in the NFIP and identified information for purposes of the
for more than a year on FEMA’s initial Paperwork Reduction Act, 44 U.S.C.
DATES: The effective date of each
FIRM for the community as having 3501 et seq.
community’s scheduled suspension is
flood-prone areas (section 202(a) of the List of Subjects in 44 CFR Part 64
the third date (‘‘Susp.’’) listed in the
Flood Disaster Protection Act of 1973,
third column of the following tables. Flood insurance, Floodplains.
42 U.S.C. 4106(a), as amended). This
FOR FURTHER INFORMATION CONTACT: If prohibition against certain types of Accordingly, 44 CFR part 64 is
you want to determine whether a Federal assistance becomes effective for amended as follows:
particular community was suspended the communities listed on the date
on the suspension date or for further shown in the last column. The PART 64—[AMENDED]
information, contact Bret Gates, Federal Administrator finds that notice and
Insurance and Mitigation public comment procedures under 5 ■ 1. The authority citation for Part 64
Administration, Federal Emergency U.S.C. 553(b), are impracticable and continues to read as follows:
Management Agency, 500 C Street SW., unnecessary because communities listed Authority: 42 U.S.C. 4001 et seq.;
Washington, DC 20472, (202) 646–4133. in this final rule have been adequately Reorganization Plan No. 3 of 1978, 3 CFR,
SUPPLEMENTARY INFORMATION: The NFIP notified. 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
enables property owners to purchase Each community receives 6-month, 3 CFR, 1979 Comp.; p. 376.
Federal flood insurance that is not 90-day, and 30-day notification letters
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§ 64.6 [Amended]
otherwise generally available from addressed to the Chief Executive Officer
private insurers. In return, communities stating that the community will be ■ 2. The tables published under the
agree to adopt and administer local suspended unless the required authority of § 64.6 are amended as
floodplain management measures aimed floodplain management measures are follows:

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Document Created: 2018-02-23 09:21:03
Document Modified: 2018-02-23 09:21:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation		80 FR 42400
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements