Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Rules and Regulations 49245 

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/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 

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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49246 Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Rules and Regulations 

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-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% 

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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Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Rules and Regulations 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 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 

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 

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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49248 Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Rules and Regulations 

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 Uses 

*******

C.I. Pigment Red 112 (CAS Reg. No. 6535–46–2) .. Seed treatment use only. Limited to 10% w/w of pesticide formulation Coloring agent 

* * * * * * * 

[FR Doc. 2014–19742 Filed 8–19–14; 8:45 am] 

BILLING CODE 6560–50–P 


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