[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Rules and Regulations]
[Pages 49245-49248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19742]



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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.

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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: [email protected].

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

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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 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

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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 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

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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]

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.

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           Inert ingredients                                Limits                               Uses
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                                                  * * * * * * *
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