Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Rules and Regulations 41443 

significant deterioration requirements 

related to section 110(a)(2)(C), (D)(i)(II), 

and (J), and the state board requirements 

of (E)(ii). We will address these 

requirements in a separate action. 

[FR Doc. 2014–16553 Filed 7–15–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0590; FRL–9911–54] 

Coco alkyl dimethyl amines; 

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 coco alkyl 

dimethyl amines (CAS Reg. No. 61788– 

93–0) when used as an inert ingredient 

(emulsifier) in pesticide formulations 

applied to crops preharvest at a 

concentration not to exceed 0.5% by 

weight. Technology Sciences Group 

Inc., 1150 18th St. NW., Suite 1000, 

Washington, DC 20036, 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 coco 

alkyl dimethyl amines. 

DATES: This regulation is effective July 

16, 2014. Objections and requests for 

hearings must be received on or before 

September 15, 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–2013–0590, 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), EPA West 

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; telephone number: 

(703) 305–7090; email address: 

RDFNotices@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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2013–0590 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 15, 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– 

2013–0590, 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 25, 

2013 (78 FR 63938) (FRL–9901–96), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–10622) by Technology 

Sciences Group Inc., 1150 18th St. NW., 

Suite 1000, Washington, DC 20036. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of coco alkyl 

dimethyl amines (CAS Reg. No. 61788– 

93–0) when used as an inert ingredient 

(emulsifier) in pesticide formulations 

applied to crops preharvest at a 

concentration not to exceed 0.5% by 

weight. 

That document referenced a summary 

of the petition prepared by Technology 

Sciences Group Inc., the petitioner, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

approved of the use of coco alkyl 

dimethyl amines at a maximum 

concentration not to exceed 0.5% by 

weight in the final end-use formulation. 

This limitation is based on the Agency’s 


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risk assessment which can be found at 

http://www.regulations.gov in document 

Coco Alkyl Dimethyl Amines: CASRN 

61788–93–0 Decision Document for the 

Proposed Use of Coco Alkyl Dimethyl 

Amines as an Inert Ingredient in 

Pesticide Formulations Under 40 CFR 

180.920 in docket ID number EPA–HQ– 

OPP–2013–0590. 

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 coco alkyl 

dimethyl amines, including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with coco alkyl dimethyl 

amines 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 coco alkyl dimethyl amines 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. 

In 2004, the Agency’s High 

Production Volume (HPV) reviewed 23 

fatty nitrogen derived amines. Coco 

alkyl dimethyl amines was among the 

group of fatty nitrogen derived amines. 

In instances where complete data sets 

were not available, the American 

Chemistry Council (ACC), as part of the 

High Production Volume (HPV) Test 

Challenge Program for Fatty Nitrogen 

Derivatives, utilized data derived from 

structurally closely related compounds. 

The predominant alkyl species in coco 

alkyl dimethyl amines is the dodecyl 

(C12) group with the other alkyl species 

being the tetradecyl (C14), hexadecyl 

(C16), and octadecyl (C18) groups. N,Ndimethyl-1-dodecanamine (CAS Reg. 

No. 112–18–5) is a closely related 

substance in that the chemical structure 

is similar, the carbon chain length is 

similar and its physical/chemical 

properties are similar. N,N-dimethyl-1- 

dodecanamine and other related alkyl 

dimethyl amines were used in assessing 

coco alkyl dimethyl amines (CADA). 

The coco alkyl dimethyl amines 

exhibit low toxicity via the acute oral, 

dermal, and inhalation routes of 

exposure. In rats the acute oral LD50 is 

> 1,000 milligrams/kilogram body 

weight/day (mg/kg bw/day). The acute 

dermal LD50 is > 3,385 mg/kg bw/day in 

rabbits. It is corrosive to the skin and 

irritating to the eyes of rabbits. An acute 

inhalation study was not available with 

the coco alkyl dimethyl amines, 

however, data are available for an 

acceptable surrogate compound, ntallow alkyl derivatives of 2,2’-iminobis 

ethanol (CAS Reg. No. 61791–44–4). 

The acute inhalation LC50 is > 0.6 

milligram/Liter (mg/L) in rats. 

A 28-day toxicity study was 

conducted using Sprague-Dawley rats 

which received an oral gavage dose of 

0, 50, 150, or 300 mg/kg bw/day. At 150 

mg/kg bw/day, animals displayed mild 

adverse behavior, including snout 

rubbing. A NOAEL of 50 mg/kg bw/day 

was observed in this study. 

There was no evidence of 

mutagenicity in the Ames test for N,Ndimethyl 1-tetradecanamine (CAS Reg. 

No. 112–75–4), N,N-dimethyl 1- 

hexadecanamine (CAS Reg. No. 112–69– 

6), and N,N-dimethyl 1-octadecanamine 

(CAS Reg. No. 124–28–7). N,Ndimethyl-1-dodecanamine (CAS Reg. 

No. 112–18–5) was not clastogenic in an 

in vivo mammalian erythrocyte 

micronucleus test. 

A gavage reproductive/developmental 

toxicity screening study was conducted 

where N,N-dimethyl-1-dodecanamine 

(CAS Reg. No. 112–18–5) was 

administered to Sprague-Dawley rats. At 

150 mg/kg bw/day, mortality, increased 

mean implantation loss, decreased mean 

viability index and abnormal maternal 

behavior was observed in the dams and 

reduced weight in pups. The maternal, 

developmental and reproduction 

NOAEL was 50 mg/kg bw/day. 

None of the amines discussed in the 

American Chemistry Council High 

Production Volume challenge document 

were mutagenic. As noted in the HPV 

challenge, ‘‘The vast majority of the in 

vitro and in vivo genotoxicity tests gave 

no indication of genotoxic potential for 

primary aliphatic amines’’ (which 

includes coco alkyl diethyl amines). The 

available feeding study for 

cyclohexylamine and 2-year feeding 


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studies with sec-butylamine and 

octadecylamine showed no tumorigenic 

potential.’’ 

In addition, the Agency conducted 

additional review of coco alkyl dimethyl 

amines using DEREK software analysis 

to determine if there were any alerts for 

carcinogenicity or other chronic 

toxicity. The results of the DEREK 

analysis indicated that there were no 

‘‘ALERTS’’ for carcinogenicity. Based on 

the lack of concern regarding 

mutagenicity and lack of carcinogenicity 

in animal studies for surrogate 

chemicals and lack of any 

carcinogenicity alerts in the DEREK 

analysis, the EPA concluded that coco 

alkyl diethyl amines are unlikely to 

pose a carcinogenic risk. 

No dermal toxicity or dermal 

absorption studies are available for coco 

alkyl diethyl amines. A dermal 

absorption study is available for 1- 

dodecanamine which is structurally 

closely related. The dermal absorption 

of 1-dodecanamine was determined to 

be 60%. The coco alkyl diethyl amine 

is a larger molecule than 1- 

dodecanamine, therefore, it is not 

expected to be absorbed at a greater rate. 

No studies were found specific to the 

metabolic pathway or toxicokinetic 

properties of coco alkyl dimethyl 

amines in mammalian systems. 

However, based on the knowledge of 

metabolism of structurally similar 

compounds in mammals, hepatic 

dealkylation readily occurs with 

secondary and tertiary amines, with the 

methyl groups leaving preferentially. 

Oxidation of the alpha carbon via 

cytochrome P450, forms a 

carbinolamine intermediate that will 

spontaneously cleave to form a 

secondary amine and a carbonyl 

compound. Subsequent, dealkylation of 

the secondary amine will take place at 

a slower rate. In a more minor pathway, 

hydroxylation of the nitrogen atom by 

hepatic oxidases may take place. Fatty 

acids are primarily excreted as CO2. 

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 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 safe margin 

of exposure (MOE). For non-threshold 

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. 

No acute endpoint of concern was 

identified in the available database, 

therefore N,N-dimethyl-1-dodecanamine 

is not expected to pose an acute hazard. 

The chronic reference dose was based 

on data from co-critical studies, a 28- 

day oral toxicity study and a 

reproduction and developmental 

screening study on N,Ndimethyldodecylamine (CAS Reg. No. 

112–18–5). In the 28-day repeat dose 

feeding study in rats, all animals 

showed rubbing of the snouts in the 

bedding material between test days 2 

and 28, immediately after dosing for a 

duration of approximately 5 minutes. In 

a reproduction and developmental 

screening studies in rats, mortality, 

increased mean implantation loss, 

decreased mean viability index, reduced 

pup weight and abnormal maternal 

behavior were observed at 150 mg/kg 

bw/day. The NOAEL was 50 mg/kg bw/ 

day in both studies. The uncertainty 

factor of 1,000X was used for chronic 

dietary assessment (10X for intraindividual variability, 10X for 

interspecies extrapolation and 10X Food 

Quality Protection Act Safety Factor 

(FQPA SF). No appropriate dermal or 

inhalation toxicity studies are available 

for the exposure assessment. However, 

the FQPA SF of 10X is retained due to 

the lack of guideline long-term 

study(ies) and lack of a 28-day 

inhalation toxicity study. Dermal 

absorption was assumed to be 60% and 

inhalation absorption is assumed to be 

100% oral equivalent. The acceptable 

MOEs for dermal and inhalation 

exposure are 1,000. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to coco alkyl dimethyl amines, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from coco 

alkyl dimethyl amines in food as 

follows: 

Because an acute endpoint of concern 

was not identified, an acute dietary 

exposure assessment is not necessary. In 

conducting the chronic dietary exposure 

assessment using the Dietary Exposure 

Evaluation Model DEEM–FCID TM, 

Version 3.16, EPA used 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. The 

Inert Dietary Exposure Evaluation 

Model (I–DEEM) is a highly 

conservative model with the assumption 

that the residue level of the inert 

ingredient would be no higher than the 

highest tolerance for 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 coco alkyl 

dimethyl amines, 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 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). 


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Based upon the requested use pattern 

coco alkyl diethyl amines as an 

emulsifier that aids in the spray 

application of pesticides, EPA does not 

expect non-occupational (i.e., 

residential) pesticide handler exposures. 

However, if it is used in pesticide 

formulations in residential setting then 

it could result in short- and 

intermediate-term residential exposure 

and EPA has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to coco alkyl diethyl amines. 

It is possible that non-dietary exposure 

(primarily dermal) could occur as a 

result of non-pesticidal uses of coco 

alkyl dimethyl amines such as use in 

detergents, fabric softeners or anti-static 

agents. The dietary assessment indicates 

3.8% of the RfD for the total U.S. 

population and 14.1% for children 1–2 

years of age (the population most at 

risk). In light of the highly conservative 

dietary exposure assessment, the 

relatively low amount of projected 

dietary exposure compared to the RfD, 

and the primary route for non-dietary 

exposure (dermal), the EPA believes 

exposure from non-dietary sources will 

not exceed the Agency’s level of 

concern. In addition, the combined 

dermal and inhalation MOEs from 

possible pesticidal residential uses are 

in the range of 13,000 to 1,666,000. 

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 coco alkyl 

dimethyl amines to share a common 

mechanism of toxicity with any other 

substances, and coco alkyl dimethyl 

amines does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that coco alkyl dimethyl 

amines 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. 

In a reproductive toxicity/

developmental screening study in rats, 

neither qualitative nor quantitative fetal 

susceptibility was observed. Maternal 

toxicity (mortality and abnormal 

maternal behavior), developmental and 

reproduction toxicity (increased 

implantation loss, decreased mean 

viability index, reduced pup weight) 

effects were observed at the same dose, 

150 mg/kg bw/day. The NOAEL was 50 

mg/kg/day. 

3. Conclusion. EPA has determined 

that it lacks reliable data to apply an 

additional safety for the protection of 

infants and children lower than 10X. 

The decision is based on the following 

findings: 

i. The toxicity database for coco alkyl 

diethyl amines is incomplete. The 

following acceptable studies are 

available: 28-day Oral toxicity study in 

rats Reproduction/Developmental 

Screening study in rats. 

EPA has retained a FQPA factor of 

10X due to lack of a long term study 

conducted evaluating all current 

guideline parameters, the limited 

number of animals used in the 

reproductive/developmental study and 

the lack of an inhalation toxicity study. 

ii. Neurotoxicity and immunotoxicity 

studies were not available for review. 

However, evidence of neurotoxicity or 

immunotoxicity was not observed in the 

submitted studies. Therefore, an 

immunotoxicity study or a 

developmental neurotoxicity study is 

not required at this time. 

iii. There is no evidence that coco 

alkyl dimethyl amines results in 

increased susceptibility in in utero rats. 

In a reproductive toxicity/

developmental screening study in rats, 

neither qualitative nor quantitative fetal 

susceptibility was observed. 

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 coco alkyl 

diethyl amines 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 coco alkyl dimethyl 

amines. 

Given the relatively low toxicity 

demonstrated by coco alkyl dimethyl 

amines and the very conservative 

exposure assessment used, EPA has 

determined that, despite the 

incompleteness of the toxicity database, 

an additional SF of 10X will be 

protective of infants and children. 

E. Aggregate Risks and Determination of 

Safety Determination of Safety Section 

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, coco alkyl diethyl 

amines 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 coco alkyl 

dimethyl amines from food and water 

will utilize 14.1% of the cPAD for 

children 1–2 years of age, the 

population group receiving the greatest 

exposure. There are no residential uses 

for coco alkyl dimethyl amines. Based 

on the explanation in this unit, 

regarding residential use patterns, 

chronic residential exposure to residues 

of coco alkyl diethyl amines is not 

expected. 

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 


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Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Rules and Regulations 41447 

exposure level). The quantitative shortterm aggregate risk assessment is not 

necessary because the total dietary 

exposure for the U.S. population is 

3.8% of the cPAD, and any possible 

short-term residential exposure from 

handler use would not be a significant 

contributer to overall risk nor exceed 

levels of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). The 

quantitative intermediate-term aggregate 

risk assessment is not necessary because 

the total dietary exposure for the U.S. 

population is 3.8% of the cPAD, the 

Agency believes any possible 

intermediate-term residential exposure 

from handler use would not be a 

significant contributor to overall risk 

nor exceed levels of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity, coco alkyl 

dimethyl amines 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 coco alkyl 

dimethyl amines residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of coco alkyl 

dimethyl amines in or on any food 

commodities. EPA is establishing a 

limitation on the amount of coco alkyl 

dimethyl amines 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 pesticide for sale or 

distribution that contains greater than 

0.5% of coco alkyl dimethyl amines in 

the pesticide formulation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for coco alkyl dimethyl amines. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for coco alkyl 

diethyl amines (CAS Reg. No. 61788– 

93–0) when used as an inert ingredient 

(emulsifier) in pesticide formulations 

applied pre-harvest to growing crops at 

a maximum not to exceed 0.5% by 

weight in the final pesticide 

formulation. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this 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 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This 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: July 3, 2014. 

Lois Rossi, 

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: 


ehiers on DSK2VPTVN1PROD with RULES
41448 Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Rules and Regulations 

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

■ 2. In § 180.920, the table is amended 

by alphabetically adding the following 

inert ingredient after the entry for ‘‘Cisisomer * * *’’ to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Coco alkyl dimethyl amines (CAS Reg. No. 61788–93–0) Not to exceed 0.5% in pesticide formulation .................. Emulsifier. 

*******

[FR Doc. 2014–16463 Filed 7–15–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 27 

[WT Docket No. 03–66; FCC 14–76] 

Facilitating the Provision of Fixed and 

Mobile Broadband Access, 

Educational and Other Advanced 

Services in the 2150–2162 and 2500– 

2690 MHz Bands 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission adopted rules that relax the 

out-of-band emissions (OOBE) limits for 

Broadband Radio Service (BRS) and 

Educational Broadband Service (EBS) 

digital mobile stations (broadband 

mobile devices) operating in the 2496– 

2690 MHz radio frequency (RF) band 

(2.5 GHz band). These changes will 

enable operators to use BRS and EBS 

spectrum more efficiently and provide 

higher data rates to consumers. These 

changes will also promote greater 

consistency between the Commission’s 

BRS/EBS technical rules and global 

standards for broadband mobile devices 

in the 2.5 GHz band, potentially making 

equipment more affordable and 

furthering the proliferation of 

broadband mobile devices, such as 

smartphones and tablets that operate in 

the 2.5 GHz band. 

DATES: Effective August 15, 2014. 

ADDRESSES: Federal Communications 

Commission, 445 12th Street SW., 

Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: 

Nancy M. Zaczek, Broadband Division, 

Wireless Telecommunications Bureau, 

at (202) 418–0274 or Nancy.Zaczek@

fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Fifth 

Report and Order, FCC–14–76, adopted 

on June 6, 2014, and released on June 

9, 2014. The full text of this document 

is available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center, 

Room CY–A257, 445 12th Street SW., 

Washington, DC 20554. The complete 

text may be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc. (BCPI), 

Portals II, 445 12th Street SW., Room 

CY–B402, Washington, DC 20554, (202) 

488–5300, facsimile (202) 488–5563, or 

via email at fcc@bcpiweb.com. The 

complete text is also available on the 

Commission’s Web site at http://

fjallfoss.fcc.gov/edocs_public/

attachmatch/FCC-14-76A1.docx. To 

request materials in accessible formats 

for people with disabilities (Braille, 

large print, electronic files, audio 

format), send an email to fcc504@fcc.gov 

or call the Consumer & Governmental 

Affairs Bureau at 202–418–0530 (voice), 

202–418–0432 (tty). 

I. Introduction 

1. In this Fifth Report and Order 

(BRS/EBS OOBE R&O), the Commission 

relaxed the OOBE limits for Broadband 

Radio Service (BRS) and Educational 

Broadband Service (EBS) digital mobile 

stations (broadband mobile devices) 

operating in the 2496–2690 MHz radio 

frequency band (2.5 GHz band). These 

changes will enable operators to use 

BRS and EBS spectrum more efficiently 

and provide higher data rates to 

consumers. These changes will also 

promote greater consistency between 

the Commission’s BRS/EBS technical 

rules and global standards for 

broadband mobile devices in the 2.5 

GHz band, potentially making 

equipment more affordable and 

furthering the proliferation of 

broadband mobile devices, such as 

smartphones and tablets that operate in 

the 2.5 GHz band. 

II. Background 

2. General: To enable commercial 

operators to develop and deploy new 

and innovative wireless services, in 

2004, the Commission fundamentally 

transformed the licensing and technical 

rules for the BRS and EBS. The 

Commission reconfigured the 2.5 GHz 

band into upper and lower-band 

segments (UBS and LBS, respectively) 

for new two-way low-power operations, 

such as mobile and fixed wireless 

broadband services, and a mid-band 

segment (MBS) for legacy one-way video 

high-power operations, such as longdistance learning. In addition, the 

Commission reallocated and assigned an 

additional 5 megahertz to the BRS/EBS 

band at 2495–2500 MHz, and permitted 

BRS and EBS services to share the 

2495–2500 MHz portion of the band on 

a co-primary basis with operators in the 

part 25 Mobile Satellite Service (MSS), 

as well as grandfathered part 74 

Broadcast Auxiliary Service (BAS) and 

part 90 mobile service (MS) and part 

101 fixed service (FS) stations. Under 

the new band plan, BRS Channel 1 

(BRS1) was relocated to 2496–2502 MHz 

from 2150–2156 MHz. BRS1 was the 

channel most affected by the 

Commission’s decision to allow BRS/

EBS operators and MSS, BAS channel 

A10, MS, and FS radio services to share 

the 2496–2500 MHz portion of the 2.5 

GHz band. To reduce the potential for 

harmful interference to operations above 

and below 2495 MHz, the Commission 

created a one megahertz guard band at 

2495–2496 MHz. 

3. To protect against adjacent channel 

interference and to facilitate mobile 

operations in the band, the 

Commission’s 2004 decision also 

revised the OOBE limits for BRS and 

EBS licensees operating in the LBS and 

UBS, consistent with a proposal made 

by a coalition of organizations 

representing BRS and EBS licensees. 

The Commission retained the existing 

OOBE limits for MBS analog operations, 

but applied the new OOBE limits to 

MBS digital operations with the result 

that all digital operations throughout the 

2.5 GHz band would be subject to the 

same OOBE limits. For mobile 

broadband devices, the Commission 


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