### 73218 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations

hexythiazox, in or on beet, sugar, root at 0.15 ppm. This tolerance expires on December 31, 2019. VII. Statutory and Executive Order Reviews

This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C.

1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: December 3, 2014. Susan Lewis, 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 § 180.448, revise paragraph (b) to read as follows:

**§ 180.448 Hexythiazox; tolerance for residues.** 

* * * * *

(b) Section 18 emergency exemptions. A time-limited tolerance specified in the following table is established for residues of hexythiazox and its metabolites containing the (4- chlorophenyl)-4-methyl-2-oxo-3- thiazolidine moiety, calculated as the stoichiometric equivalent of hexythiazox, in or on the specified agricultural commodity, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerance expires on the date specified in the table.

Commodity Parts per million Expiration date

Beet, sugar, root ... 0.15 12/31/19 * * * * * [FR Doc. 2014–28935 Filed 12–9–14; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 180**

**[EPA–HQ–OPP–2013–0695; FRL–9919–34]**

**Diisopropanolamine; 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 diisopropanolamine when used as an inert ingredient (neutralizer or stabilizer) at no more than 10% in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. United Phosphorus, Inc. 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 diisopropanolamine.

**DATES :**  This regulation is effective December 10, 2014. Objections and requests for hearings must be received on or before February 9, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the

**SUPPLEMENTARY INFORMATION** ).

**ADDRESSES :**  The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0695, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available

at http://www.epa.gov/dockets.

**FOR FURTHER INFORMATION CONTACT :**  Susan T. Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone


### 73219 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations

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–2013–0695 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 February 9, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2013–0695, 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 August 1, 2014 (79 FR 44729) (FRL–9911–67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10626) by United Phosphorus, Inc., 630 Freedom Business Center Suite 402, King of Prussia, PA 19406. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of diisopropanolamine (CAS Reg. No. 110–97–4) when used as an inert ingredient neutralizer or stabilizer in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at not more than 10% by weight in a pesticide formulation. That document referenced a summary of the petition prepared by Pyxis Regulatory Consulting, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. III. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .’’

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for


### 73220 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations

diisopropanolamine including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with diisopropanolamine 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 diisopropanolamine 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.

The acute oral toxicity of diisopropanolamine is low. The acute oral Lethal Dose (LD) 50 s in rats are all >2,000 milligram/kilogram body weight (mg/kg bw). The acute dermal toxicity in rats and rabbits is >8,000 mg/kg bw. Diisopropanolamine is an eye irritant based on a primary eye irritation study in rabbits. Diisopropanolamine is dermally irritating based on a primary skin irritation study in rabbits with erythema after 24 hours and scaling after 8 days. Diisopropanolamine is not a dermal sensitizer.

Two subchronic oral toxicity studies using diisopropanolamine on rats wereavailable. In the 14-day study the noobserved-adverse-effect-level (NOAEL) was 600 mg/kg/day in males and females based on decreased body weight gain and relative kidney weight increases at 1,200 mg/kg/day. In the 90- day study the NOAEL was 100 mg/kg/ day (males) based on increased absolute and relative kidney weights at 500 mg/ kg/day and 500 mg/kg/day (females) based on increases in absolute and relative kidney weights at 1,000 mg/kg/ day. There was also a 28-day dermal toxicity study with diisopropanolamine in which the NOAEL was the limit dose of 750 mg/kg/day for systemic effects.

In a developmental toxicity study in rats with diisopropanolamine, no observed adverse effects were seen at the limit dose of 1,000 mg/kg/day for both maternal and developmental toxicity.

In an in vitro mammalian cell gene mutation test, two bacterial reverse mutation tests and an in vitro mammalian chromosomal aberration test, results for mutagenicity and genotoxicity were negative for diisopropanolamine.

In a carcinogenicity study in rats dosed at 1% (

∼ 1,000 mg/kg/day) diisopropanolamine for 94 weeks, no increase in incidence of tumors over controls was observed under the conditions of the study.

No immunotoxicity or neurotoxicity studies on diisopropanolamine were available in the database. However, evidence of immunotoxicity or neurotoxicity was not observed in the submitted studies.

A dermal metabolism and dermal absorption study on diisopropanolamine were provided. Based on the study, i.v. administration of radioactive labeled diisopropanolamine rapidly decreased in plasma and was undetectable at 18 and 24 hours. 96.8% of the administered dose of diisopropanolamine was excreted in urine and none was detectable in the feces. The dermal administration portion of the study determined that

∼ 20% was absorbed within 48 hours. Most of the radiolabeled diisopropanolamine was excreted in urine. The application site contained 49% of the applied diisopropanolamine. Little diisopropanolamine was observed in the feces. The total recovered dose was 69.2%. The absolute dermal absorption of diisopropanolamine was calculated to be 12%.
B. Toxicological Points of Departure/ Levels of Concern

Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors (U/SF) are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safemargin of exposure (MOE). For nonthreshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/pesticides/factsheets/ riskassess.htm.

A summary of the toxicological endpoints for diisopropanolamine used for human risk assessment is shown in Table 1 of this unit.



### TABLE 

### 1—S UMMARY OF 

### TOXICOLOGICAL 

### D OSES AND 

### E NDPOINTS FOR 

### D IISOPROPANOLAMINE FOR 

### U SE IN 

### H UMAN 

### R ISK 

### A SSESSMENT

Exposure/scenario Point of departure and uncertainty/

safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects

Acute dietary (General population including infants and children). An acute effect was not found in the database therefore an acute dietary assessment is not necessary.

Chronic dietary (All populations) NOAEL = 100 mg/ kg/day. UF A = 10x UF H = 10x FQPA SF = 1x Chronic RfD = 100 mg/kg/day. cPAD = 1.0 mg/kg/

day 90-day oral toxicity—rat.LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight.


### 73221 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations

TABLE 

### 1—S UMMARY OF 

### TOXICOLOGICAL 

### D OSES AND 

### E NDPOINTS FOR 

### D IISOPROPANOLAMINE FOR 

### U SE IN 

### H UMAN 

### R ISK 

### A SSESSMENT

### —Continued

Exposure/scenario Point of departure and uncertainty/

safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects

Incidental oral short-term (1 to

30 days). NOAEL = 100 mg/ kg/day. UFA = 10x UF H = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity—rat.LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight.

Incidental oral intermediateterm (1 to 6 months). NOAEL = 100 mg/ kg/day. UFA = 10x UF H = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity—rat.LOAEL = 500 mg/kg/day based on increase in relative and absolute kidney weight.

Dermal short- and intermediateterm. Dermal exposure was not assessed because no systemic toxicity was identified at the limit dose of 750 mg/kg/ day in a dermal toxicity study.

Inhalation short-term (1 to 30

days). oral study NOAEL =100 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x UF H = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity—rat.LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight.

Inhalation (1 to 6 months) ......... oral study NOAEL =100 mg/kg/day (inhalation absorption rate = 100%). UF A = 10x UF H = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity—rat.LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight.

Cancer (Oral, dermal, inhalation). Based on the lack of increased incidence of tumor formation compared to controls in a carcinogenicity study and the lack of mutagenicity, diisopropanolamine is considered not likely to be carcinogenic.

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to diisopropanolamine, EPA considered exposure under the proposed exemption from the requirement of a tolerance (40 CFR 180.910 as an inert ingredient used in pesticide formulations applied to growing crops). EPA assessed dietary exposures from diisopropanolamine in food as follows:

Because an acute endpoint of concern was not identified, an acute dietary exposure assessment is unnecessary. The chronic dietary exposure assessment for this inert ingredient utilizes the Dietary Exposure Evaluation Model Food Commodity Intake Database (DEEM–FCID), Version 3.16, EPA, which includes food consumption information from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, ‘‘What We Eat in America’’, (NHANES/ WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model which assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled ‘‘Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.’’ (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA–HQ–OPP–2008–

0738.

2. Dietary exposure from drinking

water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for diisopropanolamine, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term ‘‘residential exposure’’ is used inthis 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).

Diisopropanolamine is used as an inert ingredient in pesticide products that could result in short- and intermediate-term residential exposure,


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and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to diisopropanolamine. Possible routes of exposure include dermal and/or inhalation exposure to outdoor lawn and turf use (i.e. low pressure handwand, hose end sprayer and trigger sprayers).

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 diisopropanolamine to share a common mechanism of toxicity with any other substances, and diisopropanolamine does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that diisopropanolamine 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

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Fetal susceptibility was not observed in developmental studies with rats administered diisopropanolamine. Treatment with diisopropanolamine had no effect on body weight gain or food consumption during the dosing period, kidney or liver weights, gravid uterine weight, number of corpora lutea, implantations or resorptions, percent pre- and post-implantation loss, mean fetal weight or males or females, fetal sex ratio or the number of viable fetuses. There were no statistically significant increases in abnormalities (external, visceral or skeletal) in any treatment group compared to the control.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for diisopropanolamine contains the following acceptable studies: Subchronic, developmental, and chronic/carcinogenicity studies, several mutagenicity studies, and a dermal metabolism and absorption study. No repeated dose inhalation toxicity study is available in the database, however all inhalation MOEs, which are based on the POD from the 90-day oral toxicity study, are greater than 15,000. The Agency does not believe that any inhalation study would provide a POD so substantially different from the POD in the 90-day oral toxicity study to result in a risk of concern from inhalation exposure; therefore, there is no need to include an additional uncertainty factor to account for the lack of inhalation data.

ii. There is no indication that diisopropanolamine is a neurotoxic chemical. Although no neurotoxicity studies were available in the database, no clinical signs of neurotoxicity were observed in the available subchronic and chronic studies. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. Based on the discussion above, there is no concern that diisopropanolamine results in increased susceptibility in the prenatal developmental studies.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to diisopropanolamine in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by diisopropanolamine. E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, diisopropanolamine is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to diisopropanolamine from food and water will utilize 14.1% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Diisopropanolamine is currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to diisopropanolamine.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2,600 for both adult males and females respectively. EPA has concluded the combined short-term aggregated food, water, and residential exposure results in an aggregate MOE of 680 for children. Children’s residential exposure includes total exposures associated with contact with treated surfaces (hand-to-mouth exposure). Because EPA’s level of concern for diisopropanolamine is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic


### 73223 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations

exposure to food and water (considered to be a background exposure level). Diisopropanolamine is currently used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to diisopropanolamine.

Using the exposure assumptionsdescribed in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 2,600 for adult males and females. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 690 for children. Children’s residential exposure includes total exposures associated with contact with treated surfaces (hand-to-mouth exposure). Because EPA’s level of concern for diisopropanolamine is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in adequate rodent carcinogenicity study, diisopropanolamine is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to diisopropanolamine residues. 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.

VI. Conclusions

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for diisopropanolamine (CAS Reg. No. 110– 97–4) when used as an inert ingredient (neutralizer or stabilizer) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at not more than 10% by weight in pesticide formulations. VII. Statutory and Executive Order Reviews

This action 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 action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children From Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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 action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination With Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: November 26, 2014. Susan Lewis, 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 § 180.910, add alphabetically the inert ingredient to the table to read as follows:

**§ 180.910 Inert ingredients used pre- and post-harvest; exemptions from the**  **requirement of a tolerance.**

* * * * *

Inert ingredients Limits Uses

******* Diisopropanolamine (CAS Reg. No. 110–97–4) ............. Not to exceed 10% by weight of pesticide formulation .. Neutralizer or sta bilizer.

*******


### 73224 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations

[FR Doc. 2014–28955 Filed 12–9–14; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 180**

**[EPA–HQ–OPP–2014–0122; FRL–9919–40]**

**C.I. Pigment Yellow 1; 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 Yellow 1 (butanamide, 2- (4-methyl-2- nitrophenyl) azo -3-oxo-N-phenyl-) when used as an inert ingredient as a colorant in seed treatment formulations not to exceed 10% weight(wt)/wt under 40 CFR 180.920. Exponent Inc. on behalf of 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 Yellow 1.

**DATES :**  This regulation is effective December 10, 2014. Objections and requests for hearings must be received on or before February 9, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the

**SUPPLEMENTARY INFORMATION** ).

**ADDRESSES :**  The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0122, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available

at http://www.epa.gov/dockets.

**FOR FURTHER INFORMATION CONTACT :**  Susan T. Lewis, 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–2014–0122 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 February 9, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2014–0122, 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 October 24, 2014 (79 FR 63594) (FRL–9916–03), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10661) by Exponent, Inc. (1150 Connecticut Ave. NW., Suite 1100, 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 Yellow 1 (butanamide, 2- (4-methyl-2- nitrophenyl) azo -3-oxo-N-phenyl-) (CAS Reg. No. 2512–29–0) when used as an inert ingredient as a colorant in pesticide formulations applied as a seed treatment not to exceed 10% wt/wt. That document referenced a summary of the petition prepared by Exponent, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit V.C. 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;