C.I. Pigment Red 112; Exemption From the Requirement of a Tolerance, 49245-49248 [2014-19742]
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Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Rules and Regulations
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0757; FRL–9914–14]
C.I. Pigment Red 112; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of C.I. Pigment
Red 112 (CAS Reg. No. 6535–46–2)
when used as an inert ingredient seed
treatment pigment not to exceed 10%
weight/weight (w/w) in pesticide
formulations. Clariant Corporation
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 C.I.
Pigment Red 112.
DATES: This regulation is effective
August 20, 2014. Objections and
requests for hearings must be received
on or before October 20, 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–2013–0757, 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: Lois
Rossi, 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:
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SUMMARY:
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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/textidx?&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–2013–0757 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 20, 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–
2013–0757, by one of the following
methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the online
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49245
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
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
21, 2014 (79 FR 9870) (FRL–9904–98),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (IN–10631) by Exponent, 1150
Connecticut Ave. NW., Washington, DC
20036, on behalf of Clariant
Corporation, 4000 Monroe Road,
Charlotte, NC 28205. The petition
requested that 40 CFR 180.920 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of C.I. Pigment Red 112 (CAS
Reg. No. 6535–46–2) when used as an
inert ingredient seed treatment pigment
not to exceed 10% w/w in pesticide
formulations. That document referenced
a summary of the petition prepared by
Exponent, on behalf of Clariant
Corporation, 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
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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 C.I. Pigment Red
112 including exposure resulting from
the exemption established by this
action. EPA’s assessment of exposures
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and risks associated with C.I. Pigment
Red 112 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 C.I. Pigment Red 112 as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
Based on the physical and chemical
properties of C.I. Pigment Red 112 it is
unlikely that C.I. Pigment Red 112 will
be absorbed in the body and therefore,
it is unlikely that C.I. Pigment Red 112
becomes systemically bioavailable after
exposure. It is expected that C.I.
Pigment Red 112 will pass though the
body and be excreted in the feces.
Acute studies revealed low oral and
dermal toxicity. When tested on rabbits,
the chemical was shown to be nonirritating to the skin and eyes.
Skin sensitization testing of C.I.
Pigment Red 112 (containing 3%
Naphtol AS–D, a manufacturing
impurity) was performed on guinea pigs
according to the Buehler method. The
study portion for erythma was
performed with a 20% pigment
composition (due to the red coloring of
the chemical). Based on the results of
this study, the chemical and the 20%
mixture were not considered to be a
dermal sensitizer. In addition, two Local
Lymph Node Assays were conducted
with up to 20% C.I. Pigment Red 112;
one study had <0.01% Naphtol AS–D
and the other claimed 4.1% Naphtol
AS–D. The second test substance
containing what the petitioner claimed
was 4.1% Naphtol AS–D was positive
for skin sensitization whereas the test
with 0.01% Naphtol AS–D was not,
indicating that skin sensitization is
possible when Naphtol AS–D is present
at sufficiently high concentrations. The
percent of Napthol AS–D in the second
study could not be confirmed with the
study data available. However, the two
negative skin sensitization studies did
have documented proof of the Napthol
AS–D content at up to 3%. The
manufacturing process for C.I. Pigment
Red 112 that will be used as a seed
treatment inert ingredient is specifically
manufactured to contain less than 1%
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Naphtol AS–D which, based on the
study results, would not result in skin
sensitization. Therefore, the C.I.
Pigment Red 112 manufactured for use
as a seed treatment inert ingredient is
not considered a skin sensitizer.
In a 28-day oral toxicity study in rats
no treatment-related changes were noted
in neurological evaluations, body
weights, food consumption, hematology
or clinical chemistry analyses, or organ
weights at the limit dose of 1,000
milligram/kilogram/day (mg/kg/day).
Although there were no reproductive or
developmental toxicity studies available
for C.I. Pigment Red 112, the 28-day oral
study in rats included endpoints
specific to reproductive toxicity
including organ weights, gross
pathology and histopathology. No
adverse effects were seen at doses up to
1,000 mg/kg/day (highest dose tested).
In addition, DEREK modeling was
conducted and did not indicate any
structural alerts for reproductive
toxicity or endocrine-related toxicity.
There was also no indication from the
blood parameters, organ weights, or
histopathology of an immunotoxic effect
at 1,000 mg/kg/day.
No neuropathological changes or
effects were reported in the 28-day
study (i.e., hearing ability, pupillary
reflex, static righting reflex, grip
strength, and motor activity testing);
therefore, the Agency does not believe
C.I. Pigment Red 112 will be neurotoxic.
Also, there was no evidence of
cytotoxicity or mutagenicity in any of
the reviewed studies: A reverse gene
mutation study, an in vitro cell
mutagenicity study, and a Chinese
hamster cell in vitro study.
Although no carcinogenicity studies
are available for C.I. Pigment Red 112,
C.I. Pigment Red 112 is unlikely to be
carcinogenic. This conclusion is based
on the lack of any evidence of
mutagenicity in the available
mutagenicity studies and the physical/
chemical properties of the substance
(e.g., high molecular weight making
absorption unlikely and low water
solubility).
B. Toxicological Points of Departure/
Levels of Concern
No endpoint of concern was
identified for any of the acute studies
conducted. In addition, no endpoint of
concern was determined in the 28-day
study up to the limit dose of 1,000 mg/
kg/day (highest dose tested).
C. Exposure Assessment
Since no endpoint of concern was
identified in acute and subchronic
studies a quantitative exposure
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assessment for C.I. Pigment Red 112 was
not conducted.
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to C.I. Pigment Red 112, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from C.I.
Pigment Red 112 in food as follows:
Although there is potential dietary
exposure from consuming foods grown
from the seeds that were treated with
pesticide products containing the inert
ingredient, the potential is very low
because C.I. Pigment Red 112 will be
used on treated seeds only and any
pigment that is released into the soil is
expected to be tightly bound to the soil
and therefore, not expected to be taken
up by the plant. There will not be
dietary exposure from the treated seeds
themselves since seeds that have been
chemically treated may not be used for
food, feed, or oil processing. Even if any
chemical residue was accessible to the
plant a quantitative dietary risk
assessment would not be necessary
because no endpoint of concern was
identified in the available data.
2. Dietary exposure from drinking
water. Dietary exposure from drinking
water is unlikely because C.I. Pigment
Red 112 has low water solubility and
therefore, runoff from pesticides
containing the inert ingredient is not
likely to occur.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables). The proposed use of C.I.
Pigment Red 112 as a seed treatment/
dye under 40 CFR 180.920 is not
expected to result in residential
exposure to this chemical. Although
there are no reliable data to quantify
non-pesticidal exposure, it could occur
due to the use of C.I. Pigment Red 112
as an industrial colorant in paints,
plastics, and inks. However, there is no
safety concern because of the low
toxicity of the chemical and the lack of
an endpoint of concern in the database.
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 C.I. Pigment Red 112 to share a
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common mechanism of toxicity with
any other substances, and C.I. Pigment
Red 112 does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that C.I. Pigment Red 112 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
No endpoint of concern was
identified for any of the acute studies
conducted. In addition, no endpoint of
concern was determined in the 28-day
study up to the limit dose of 1,000 mg/
kg/day (highest dose tested). The
toxicity database does not contain a
carcinogenicity study or an
immunotoxicity study but for the
reasons stated in Unit IV.A., the Agency
has concluded that there are no
concerns for carcinogenicity,
immunotoxicity, or neurotoxicity for
this chemical. No developmental or
reproductive effects were seen in the
available studies and DEREK modeling
did not indicate any structural alerts for
reproductive toxicity or endocrinerelated toxicity. Since no endpoint of
concern was identified in acute and
subchronic studies and because C.I.
Pigment Red 112 is not expected to be
absorbed by the body, a qualitative risk
assessment for C.I. Pigment Red 112 was
performed. Due to the lack of toxicity of
C.I. Pigment Red 112, the Agency
determined that a quantitative risk
assessment using safety factors was not
necessary for assessing risk. For the
same reason, no additional safety factor
is needed for assessing risk to infants
and children.
E. Aggregate Risks and Determination of
Safety
Taking into consideration all available
information on C.I. Pigment Red 112
when used as an inert ingredient in seed
treatment pesticide formulations at not
more that 10% w/w, EPA has
determined that there is a reasonable
certainty that no harm to any population
subgroup will result from aggregate
exposure to C.I. Pigment Red 112 under
reasonable foreseeable circumstances.
Therefore, the establishment of an
exemption from tolerance under 40 CFR
180.920 for residues of C.I. Pigment Red
112 when used as an inert ingredient in
pesticide formulations as a seed
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49247
treatment pigment at 10% w/w is safe
under FFDCA section 408.
V. 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. EPA
is establishing a limitation on the
amount of C.I. Pigment Red 112 that
may be used in pesticide formulations.
The limitation will be enforced
through the pesticide registration
process under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. EPA will
not register any seed treatment, use
pesticide for sale or distribution with
concentrations of C.I. Pigment Red 112
exceeding 10% by weight of the
formulation.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.920 for C.I. Pigment
Red 112 (CAS Reg. No. 6535–46–2)
when used as an inert ingredient seed
treatment pigment not to exceed 10%
w/w in pesticide formulations.
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
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the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of 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 recordkeeping
requirements.
Dated: August 14, 2014.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, the table is amended
by alphabetically adding an entry for
‘‘C.I. Pigment Red 112’’ after the entry
for ‘‘C.I. Pigment Green #7’’ to read as
follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
*
*
*
C.I. Pigment Red 112 (CAS Reg. No. 6535–46–2) ..
*
*
*
Seed treatment use only. Limited to 10% w/w of pesticide formulation
*
*
*
*
Uses
*
*
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Agencies
[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Rules and Regulations]
[Pages 49245-49248]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19742]
[[Page 49245]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0757; FRL-9914-14]
C.I. Pigment Red 112; 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 C.I. Pigment Red 112 (CAS Reg. No. 6535-
46-2) when used as an inert ingredient seed treatment pigment not to
exceed 10% weight/weight (w/w) in pesticide formulations. Clariant
Corporation 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 C.I. Pigment Red
112.
DATES: This regulation is effective August 20, 2014. Objections and
requests for hearings must be received on or before October 20, 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-2013-0757, 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: Lois Rossi, 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-2013-0757 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 20, 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-2013-0757, 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 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 21, 2014 (79 FR 9870) (FRL-
9904-98), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (IN-10631)
by Exponent, 1150 Connecticut Ave. NW., Washington, DC 20036, on behalf
of Clariant Corporation, 4000 Monroe Road, Charlotte, NC 28205. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of C.I.
Pigment Red 112 (CAS Reg. No. 6535-46-2) when used as an inert
ingredient seed treatment pigment not to exceed 10% w/w in pesticide
formulations. That document referenced a summary of the petition
prepared by Exponent, on behalf of Clariant Corporation, 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
[[Page 49246]]
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 C.I. Pigment Red 112 including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with C.I. Pigment Red 112
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 C.I. Pigment Red 112 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.
Based on the physical and chemical properties of C.I. Pigment Red
112 it is unlikely that C.I. Pigment Red 112 will be absorbed in the
body and therefore, it is unlikely that C.I. Pigment Red 112 becomes
systemically bioavailable after exposure. It is expected that C.I.
Pigment Red 112 will pass though the body and be excreted in the feces.
Acute studies revealed low oral and dermal toxicity. When tested on
rabbits, the chemical was shown to be non-irritating to the skin and
eyes.
Skin sensitization testing of C.I. Pigment Red 112 (containing 3%
Naphtol AS-D, a manufacturing impurity) was performed on guinea pigs
according to the Buehler method. The study portion for erythma was
performed with a 20% pigment composition (due to the red coloring of
the chemical). Based on the results of this study, the chemical and the
20% mixture were not considered to be a dermal sensitizer. In addition,
two Local Lymph Node Assays were conducted with up to 20% C.I. Pigment
Red 112; one study had <0.01% Naphtol AS-D and the other claimed 4.1%
Naphtol AS-D. The second test substance containing what the petitioner
claimed was 4.1% Naphtol AS-D was positive for skin sensitization
whereas the test with 0.01% Naphtol AS-D was not, indicating that skin
sensitization is possible when Naphtol AS-D is present at sufficiently
high concentrations. The percent of Napthol AS-D in the second study
could not be confirmed with the study data available. However, the two
negative skin sensitization studies did have documented proof of the
Napthol AS-D content at up to 3%. The manufacturing process for C.I.
Pigment Red 112 that will be used as a seed treatment inert ingredient
is specifically manufactured to contain less than 1% Naphtol AS-D
which, based on the study results, would not result in skin
sensitization. Therefore, the C.I. Pigment Red 112 manufactured for use
as a seed treatment inert ingredient is not considered a skin
sensitizer.
In a 28-day oral toxicity study in rats no treatment-related
changes were noted in neurological evaluations, body weights, food
consumption, hematology or clinical chemistry analyses, or organ
weights at the limit dose of 1,000 milligram/kilogram/day (mg/kg/day).
Although there were no reproductive or developmental toxicity studies
available for C.I. Pigment Red 112, the 28-day oral study in rats
included endpoints specific to reproductive toxicity including organ
weights, gross pathology and histopathology. No adverse effects were
seen at doses up to 1,000 mg/kg/day (highest dose tested). In addition,
DEREK modeling was conducted and did not indicate any structural alerts
for reproductive toxicity or endocrine-related toxicity. There was also
no indication from the blood parameters, organ weights, or
histopathology of an immunotoxic effect at 1,000 mg/kg/day.
No neuropathological changes or effects were reported in the 28-day
study (i.e., hearing ability, pupillary reflex, static righting reflex,
grip strength, and motor activity testing); therefore, the Agency does
not believe C.I. Pigment Red 112 will be neurotoxic. Also, there was no
evidence of cytotoxicity or mutagenicity in any of the reviewed
studies: A reverse gene mutation study, an in vitro cell mutagenicity
study, and a Chinese hamster cell in vitro study.
Although no carcinogenicity studies are available for C.I. Pigment
Red 112, C.I. Pigment Red 112 is unlikely to be carcinogenic. This
conclusion is based on the lack of any evidence of mutagenicity in the
available mutagenicity studies and the physical/chemical properties of
the substance (e.g., high molecular weight making absorption unlikely
and low water solubility).
B. Toxicological Points of Departure/Levels of Concern
No endpoint of concern was identified for any of the acute studies
conducted. In addition, no endpoint of concern was determined in the
28-day study up to the limit dose of 1,000 mg/kg/day (highest dose
tested).
C. Exposure Assessment
Since no endpoint of concern was identified in acute and subchronic
studies a quantitative exposure
[[Page 49247]]
assessment for C.I. Pigment Red 112 was not conducted.
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to C.I. Pigment Red 112, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from C.I. Pigment Red 112 in food as follows:
Although there is potential dietary exposure from consuming foods
grown from the seeds that were treated with pesticide products
containing the inert ingredient, the potential is very low because C.I.
Pigment Red 112 will be used on treated seeds only and any pigment that
is released into the soil is expected to be tightly bound to the soil
and therefore, not expected to be taken up by the plant. There will not
be dietary exposure from the treated seeds themselves since seeds that
have been chemically treated may not be used for food, feed, or oil
processing. Even if any chemical residue was accessible to the plant a
quantitative dietary risk assessment would not be necessary because no
endpoint of concern was identified in the available data.
2. Dietary exposure from drinking water. Dietary exposure from
drinking water is unlikely because C.I. Pigment Red 112 has low water
solubility and therefore, runoff from pesticides containing the inert
ingredient is not likely to occur.
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). The
proposed use of C.I. Pigment Red 112 as a seed treatment/dye under 40
CFR 180.920 is not expected to result in residential exposure to this
chemical. Although there are no reliable data to quantify non-
pesticidal exposure, it could occur due to the use of C.I. Pigment Red
112 as an industrial colorant in paints, plastics, and inks. However,
there is no safety concern because of the low toxicity of the chemical
and the lack of an endpoint of concern in the database.
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 C.I.
Pigment Red 112 to share a common mechanism of toxicity with any other
substances, and C.I. Pigment Red 112 does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that C.I. Pigment Red 112
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
No endpoint of concern was identified for any of the acute studies
conducted. In addition, no endpoint of concern was determined in the
28-day study up to the limit dose of 1,000 mg/kg/day (highest dose
tested). The toxicity database does not contain a carcinogenicity study
or an immunotoxicity study but for the reasons stated in Unit IV.A.,
the Agency has concluded that there are no concerns for
carcinogenicity, immunotoxicity, or neurotoxicity for this chemical. No
developmental or reproductive effects were seen in the available
studies and DEREK modeling did not indicate any structural alerts for
reproductive toxicity or endocrine-related toxicity. Since no endpoint
of concern was identified in acute and subchronic studies and because
C.I. Pigment Red 112 is not expected to be absorbed by the body, a
qualitative risk assessment for C.I. Pigment Red 112 was performed. Due
to the lack of toxicity of C.I. Pigment Red 112, the Agency determined
that a quantitative risk assessment using safety factors was not
necessary for assessing risk. For the same reason, no additional safety
factor is needed for assessing risk to infants and children.
E. Aggregate Risks and Determination of Safety
Taking into consideration all available information on C.I. Pigment
Red 112 when used as an inert ingredient in seed treatment pesticide
formulations at not more that 10% w/w, EPA has determined that there is
a reasonable certainty that no harm to any population subgroup will
result from aggregate exposure to C.I. Pigment Red 112 under reasonable
foreseeable circumstances. Therefore, the establishment of an exemption
from tolerance under 40 CFR 180.920 for residues of C.I. Pigment Red
112 when used as an inert ingredient in pesticide formulations as a
seed treatment pigment at 10% w/w is safe under FFDCA section 408.
V. 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. EPA is establishing a
limitation on the amount of C.I. Pigment Red 112 that may be used in
pesticide formulations.
The limitation will be enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. EPA will not register any seed treatment,
use pesticide for sale or distribution with concentrations of C.I.
Pigment Red 112 exceeding 10% by weight of the formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for C.I. Pigment Red 112 (CAS Reg. No.
6535-46-2) when used as an inert ingredient seed treatment pigment not
to exceed 10% w/w in pesticide formulations.
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
[[Page 49248]]
the exemption in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of 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
recordkeeping requirements.
Dated: August 14, 2014.
G. Jeffrey Herndon,
Acting 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. 180.920, the table is amended by alphabetically adding an
entry for ``C.I. Pigment Red 112'' after the entry for ``C.I. Pigment
Green 7'' to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
C.I. Pigment Red 112 (CAS Reg. No. 6535- Seed treatment use only. Limited to 10% w/w Coloring agent
46-2). of pesticide formulation.
* * * * * * *
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[FR Doc. 2014-19742 Filed 8-19-14; 8:45 am]
BILLING CODE 6560-50-P