Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Rules and Regulations 72747 

additional flexibility for transmix 

processors who produce locomotive and 

marine diesel fuel, and allowed solvent 

yellow 124 marker to transition out of 

the distribution system. We stated in the 

direct final rule that if EPA received 

timely adverse comment or a hearing 

request on the rule or any specific 

portion of the rule, we would publish a 

withdrawal of the rule or a specific 

portion of the rule in the Federal 

Register informing the public that the 

rule or portions of the rule with adverse 

comment will not take effect. We 

subsequently received adverse comment 

on the RFS heating oil amendments and 

the diesel transmix amendments. We 

did not receive adverse comment on the 

yellow marker amendments to 40 CFR 

80.510, 80.598, 80.610, or the RFS 

requirement for RIN generation, as 

amended in 40 CFR 80.1426. Therefore, 

EPA is withdrawing the direct final rule 

with respect to the RFS heating oil 

amendments and the diesel sulfur 

transmix amendments, but leaving in 

place the direct final rule with respect 

to 40 CFR 80.510, 80.598, 80.610, and 

80.1426. Those regulatory amendments 

will take effect on December 10, 2012. 

EPA intends to address all comments 

received on the RFS heating oil and 

diesel transmix amendments in 

subsequent final actions, which will be 

based on the parallel proposed rule also 

published on October 9, 2012 (77 FR 

61313). As stated in the direct final rule 

and the parallel proposed rule, we will 

not institute a second comment period 

on this action. 

Dated: November 30, 2012. 

Lisa P. Jackson, 

Administrator. 

Accordingly, the regulatory 

amendments to 40 CFR 80.511, 80.513, 

80.572, 80.597, 80.1401, 80.1450, 

80.1451, 80.1453, 80.1454, and 80.1460 

published on October 9, 2012 (77 FR 

61281) are withdrawn. The regulatory 

amendments to 40 CFR 80.510, 80.598, 

80.610, and 80.1426 will take effect on 

December 10, 2012. 

[FR Doc. 2012–29512 Filed 12–5–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0106; FRL–9369–2] 

Alkyl(C8-C18) 

dimethylamidopropylamines; 

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 the N-alkyl(C8- 

C18) dimethylamidopropylamines where 

the alkyl group is linear and may be 

saturated and/or unsaturated when used 

as an inert ingredient at levels not to 

exceed 20% in herbicide formulations 

applied to growing crops. Dow 

AgroSciences, LLC, 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 the N-alkyl(C8-C18) 

dimethylamidopropylamines. 

DATES: This regulation is effective 

December 6, 2012. Objections and 

requests for hearings must be received 

on or before February 4, 2013, 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–2012–0106, 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: 

William Cutchin, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7990; email address: 

cutchin.william@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:// 

ecfr.gpoaccess.gov/cgi/t/text/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–2012–0106 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 4, 2013. 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 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 nonCBI copy of your objection or hearing 

request, identified by docket ID number 

mstockstill on DSK4VPTVN1PROD with 

72748 Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Rules and Regulations 

EPA–HQ–OPP–2012–0106, 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 

Confidential Business Information (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.htm. 

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 May 2, 2012 

(77 FR 25957) (FRL–9346–1), EPA 

issued a notice pursuant to FFDCA 

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

the filing of a pesticide petition (PP 

1E7949) by Dow AgroSciences, LLC, 

9330 Zionsville Rd., Indianapolis, IN 

46268. The petition requested that 40 

CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of the N-alkyl(C8-C18) 

dimethylamidopropylamines where the 

alkyl group is linear and may be 

saturated and/or unsaturated (9- 

octadecenamide, N-[3- 

(dimethylamino)propyl]-,(9Z)-, CAS 

Reg. No. 109–28–4; dodecanamide, N- 

[3-(dimethylamino)propyl], CAS Reg. 

No. 3179–80–4; octadecanamide, N-[3- 

(dimethylamino)propyl], CAS Reg. No. 

7651–02–7; octanamide, N-[3- 

(dimethylamino)propyl], CAS Reg. No. 

22890–10–4; decanamide, N-[3- 

(dimethylamino)propyl], CAS Reg. No. 

22890–11–5; hexadecanamide, N-[3- 

(dimethylamino)propyl], CAS Reg. No. 

39669–97–1; tetradecanamide, N-[3- 

(dimethylamino)propyl], CAS Reg. No. 

45267–19–4; amides, coco, N-[3- 

(dimethylamino)propyl], CAS Reg. No. 

68140–01–2; N-[3- 

(dimethylamino)propyl]-C12-C18(even 

numbered)-alkylamide, CAS Reg. No. 

1147459–12–8; amides, C8-C18 and C18- 

unsatd., N-[3-(dimethylamino)propyl], 

CAS Reg. No. 146987–98–6) when used 

as an inert ingredient at levels not to 

exceed 20% in herbicide formulations 

applied to growing crops. That notice 

referenced a summary of the petition 

prepared by Dow AgroSciences, LLC, 

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 the N-alkyl(C8- 

C18) dimethylamidopropylamines 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with of the N-alkyl(C8-C18) 

dimethylamidopropylamines 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 the N-alkyl(C8-C18) 

dimethylamidopropylamines 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. 

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 

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Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Rules and Regulations 72749 

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. 

The toxicity database for the Nalkyl(C8-C18) 

dimethylamidopropylamines includes 

acute toxicity studies, in vitro 

genotoxicity assays and a repeat dose 

developmental/reproductive screening 

test (OECD 422) toxicity study on a 

representative N-alkyl(C8-C18) 

dimethylamidopropylamine member, 

Amides, coco, N-[3-(dimethylamino) 

propyl]; CAS Reg. No. 68140–01–2 (also 

referred to as CADPMA). The database 

is augmented by analogue information 

in the public domain and EPA’s High 

Production Volume (HPV) program. 

CAPDMA is included in subcategory 3 

of Category I amides within the 2004 

HPV submission for Fatty Nitrogen 

Derived Amides class. CAPDMA has 

moderate acute oral toxicity with an 

LD50 of 300 milligrams/kilogram/body 

weight (mg/kg/bw) or greater and is 

corrosive to the skin and eye, 

respectively. CAPDMA and its broader 

class of HPV analogues are negative for 

genotoxicity across a series of in vitro 

assays. A combined repeated dose 

toxicity and reproduction and 

developmental toxicity screening test 

was conducted in rats with CAPDMA 

via oral gavage under OECD 422 

guidelines. No treatment-related effects 

were observed in the reproductive or 

developmental parameters examined. 

No systemic toxicity was observed in 

this study. The NOAEL for repeat dose 

toxicity was 15 mg/kg/bw based on 

localized gastric irritation due to the 

irritation and corrosive nature of the 

material, typical of surfactants seen at 

the LOAEL of 45 mg/kg/day. The 

NOAEL for reproductive and mg/kg/day 

developmental toxicity was the highest 

dose tested (HDT), 45 mg/kg/day. 

CAPDMA was negative for mutagenicity 

in the Ames assay and in vitro 

mammalian chromosome aberration 

assay. No chronic studies are available 

for the N-alkyl(C8-C18) 

dimethylamidopropylamines but 

negative findings for genotoxicity and 

no preneoplastic lesions were observed 

in the OECD 422 study on CAPDMA 

that would suggest no potential for 

carcinogenicity for the N-alkyl(C8-C18) 

dimethylamidopropylamines. The 

Agency used a qualitative structure 

activity relationship (SAR) database, 

DEREK Version 11, to determine if there 

were structural alerts suggestive of 

carcinogenicity. No structural alerts 

were identified for the N-alkyl(C8-C18) 

dimethylamidopropylamines Neither 

IARC nor other authoritative bodies 

have classified the N-alkyl(C8-C18) 

dimethylamidopropylamines as 

carcinogens based on the SAR analysis, 

negative findings in both the 

mutagenicity and clastogenicity studies 

along with the lack of evidence of 

specific target organ toxicity. The 

Agency concluded that these inert 

ingredients are unlikely to pose a cancer 

risk to humans. No evidence of 

immunotoxicity or neurotoxicity was 

observed in the available database. 

A summary of the toxicological 

endpoints for the N-alkyl(C8-C18) 

dimethylamidopropylamines used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THE N-ALKYL(C8-C18) DIMETHYLAMIDOPROPYLAMINES

FOR USE IN HUMAN RISK ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effect 

Acute dietary (General population including infants and 

children and Females 13–50 

years of age).

No POD identified ... None ........................ No endpoint of concern following a single exposure was identified in the data base. 

Chronic dietary (All populations) NOAEL = 15 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.15 

mg/kg/day.

cPAD = 0.15 mg/kg/ 

day. 

MRID 48621602 Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat, NOAEL 15 mg/kg/day based on localized 

gastric irritation seen at the LOAEL of 45 mg/kg/day. 

All Inhalation Exposure Scenarios.NOAEL = 15 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

100% inhalation absorption is assumed. 

MOE = 100 .............. MRID 48621602 Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat, NOAEL. 

15 mg/kg/day based on localized gastric irritation seen at the 

LOAEL as of 45 mk/kg/day. 

Cancer (Oral, dermal, inhalation).There is no evidence for carcinogenic concern for the N-alkyl(C8-C18) dimethylamidopropylamines. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the N-alkyl(C8-C18) 

dimethylamidopropylamines, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from the Nalkyl(C8-C18) 

dimethylamidopropylamines in food as 

using the I–Dietary Exposure Evaluation 

Model (I–DEEM). I–DEEM is a highly 

conservative model that is based on the 

assumption that the residue level of the 

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72750 Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Rules and Regulations 

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. 

Model estimates were calculated for oral 

exposure from the use of the N-alkyl(C8- 

C18) dimethylamidopropylamines at a 

maximum concentration of 20% in 

herbicidal formulations for all crops 

(every food eaten by a person each day 

has tolerance-level residues; D361707, 

S. Piper, 2/25/09). 

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 the Nalkyl(C8-C18) 

dimethylamidopropylamines a 

conservative drinking water 

concentration value of 100 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). 

The N-alkyl(C8-C18) 

dimethylamidopropylamines are not 

currently used, and are not proposed for 

use as inert ingredients in residential 

pesticide products. For the general 

population some exposure to the Nalkyl(C8-C18) 

dimethylamidopropylamines could 

occur via cosmetic use (at very low 

concentrations) including hair care dye 

kits. There is also potential for exposure 

to these chemicals through the use of 

personal soaps and shampoos. 

Incidential oral exposure to N-alkyl(C8- 

C18) dimethylamidopropylamines 

resulting from cosmetic uses is not 

expected. Therefore, a quantitative oral 

risk assessment was not conducted. 

Since reliable data are not available, a 

quantitative dermal/inhalation exposure 

assessment was not conducted. The 

current dietary risk assessment is highly 

conservative and protective of any uses 

potential exposure via consumer 

products because the exposed 

population, children 1–2 years old 

utilize only 53% of the cPAD leaving 

about 47% of the cPAD for exposure via 

consumer products. 

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 the N-alkyl(C8-C18) 

dimethylamidopropylamines to share a 

common mechanism of toxicity with 

any other substances, and the Nalkyl(C8-C18) 

dimethylamidopropylamines do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that the Nalkyl(C8-C18) 

dimethylamidopropylamines do 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 Safety Factor (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. 

No evidence of developmental or 

reproductive toxicity was observed at 

doses up to 45 mg/kg/day in the 

Reproduction/Developmental Toxicity 

Screening Test in Rats (OECD 422 

study). The corrosive nature of these 

chemicals precluded testing at higher 

doses. 

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 the Nalkyl(C8-C18) 

dimethylamidopropylamines is 

adequate for FQPA assessment. The 

available data included acute toxicity 

studies, mutagenicity and the 

Reproduction/Developmental Toxicity 

Screening Test in rats (OECD 422). The 

available OECD 422 study evaluated 

reproductive parameters and 

developmental toxicity parameters in 

rats. In addition, it also evaluated 

hematology, clinical chemistry, organ 

weights and histopathological 

parameters. No effects on these 

parameters were observed at the HDT. 

ii. No effects on Functional 

Observation Battery and motor activity 

parameters were observed in the 

Reproduction/Developmental Toxicity 

Screening Test in rats (OECD 422). 

Since there is no indication that the Nalkyl(C8-C18) 

dimethylamidopropylamines are 

neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional uncertainty factor to 

account for neurotoxicity. 

iii. There is no evidence that the Nalkyl(C8-C18) 

dimethylamidopropylamines result in 

increased susceptibility of infants and 

children based on the results of the 

Reproduction/Developmental Toxicity 

Screening Test in rats, in in utero rats 

or rabbits in the prenatal developmental 

studies. 

iv. There is no evidence of 

immunotoxicity in the available 

database. Therefore, there is no need for 

the immunotoxicity study or additional 

uncertainty factor. 

v. Although the duration of exposure 

was short in the OECD 422 study, there 

is no need for an additional uncertainty 

factor because the effects observed were 

related to local irritation due to 

corrosive nature of these chemicals. 

Based on the lack of progression of 

severity of effects with time along with 

the considerable similarities of effects 

across the species tested and the 

observation that the vast majority of the 

effects observed were related to local 

irritation and corrosive effects, EPA has 

previously concluded that an additional 

uncertainty factor for extrapolation from 

subchronic toxicity study to a chronic 

exposure scenario would not be needed 

for highly irritating substances. As a 

result, the typical 100-fold uncertainty 

factor is sufficiently protective since it 

is not expected that humans’ response 

to local irritation/corrosiveness effects 

would be markedly different based on 

duration of exposure. 

vi. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

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Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Rules and Regulations 72751 

were performed using the highly 

conservative I–DEEM model. EPA also 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to the N-alkyl(C8-C18) 

dimethylamidopropylamines in 

drinking water and with regard to 

potential residential exposures. These 

assessments will not underestimate the 

exposure and risks posed by the Nalkyl(C8-C18) 

dimethylamidopropylamines. 

E. Aggregate Risks and Determination of 

Safety 

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, the N-alkyl(C8-C18) 

dimethylamidopropylamines are 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 N-alkyl(C8-C18) 

dimethylamidopropylamines from food 

and water will utilize 16.5% of the 

cPAD for the general population, and 

53% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit IV.C.3., regarding 

residential use patterns, chronic 

residential exposure to N-alkyl(C8-C18) 

could occur via cosmetic use. While the 

lack of reliable exposure data precluded 

the ability to perform a quantitative risk 

assessment for these uses, the highly 

conservative nature of the chronic 

dietary risk assessment would be 

protective of any uses potential chronic 

exposure via consumer uses. 

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). A short-term adverse 

effect was identified; however, the Nalkyl(C8-C18) 

dimethylamidopropylamines are not 

currently used as an inert ingredient in 

pesticide products that are registered for 

any use patterns that would result in 

short-term residential exposure. Based 

on the explanation in Unit IV.C.3., 

regarding residential use patterns, shortterm residential exposure to N-alkyl(C8- 

C18) could occur via cosmetic use. While 

the lack of reliable exposure data 

precluded the ability to perform a 

quantitative risk assessment for these 

uses, the highly conservative nature of 

the chronic dietary risk assessment 

would be protective of any uses 

potential short-term residential 

exposure via consumer uses, and EPA 

has determined that there are no 

concerns for short-term aggregate risk 

for the N-alkyl(C8-C18) 

dimethylamidopropylamines. 

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). An 

intermediate-term adverse effect was 

identified; however, the N-alkyl(C8-C18) 

dimethylamidopropylamines are not 

currently used as an inert ingredient in 

pesticide products that are registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Based on the explanation in Unit 

IV.C.3., regarding residential use 

patterns, intermediate-term residential 

exposure to N-alkyl(C8-C18) could occur 

via cosmetic use. While the lack of 

reliable exposure data precluded the 

ability to perform a quantitative risk 

assessment for these uses, the highly 

conservative nature of the chronic 

dietary risk assessment would be 

protective of any intermediate-term 

residential exposure via consumer uses 

and EPA has determined that there are 

no concerns for intermediate-term 

aggregate risk for the N-alkyl(C8-C18) 

dimethylamidopropylamines. 

5. Aggregate cancer risk for U.S. 

population. Based on the SAR analysis, 

negative findings in both the 

mutagenicity and clastogenicity studies 

along with the lack of evidence of 

specific target organ toxicity, the 

Agency concluded that the N-alkyl(C8- 

C18) dimethylamidopropylamines are 

unlikely 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 the Nalkyl(C8-C18) 

dimethylamidopropylamines 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 the N-alkyl(C8- 

C18) dimethylamidopropylamines in or 

on any food commodities. EPA is 

establishing a limitation on the amount 

of the N-alkyl(C8-C18) 

dimethylamidopropylamines that may 

be used in pesticide formulations. That 

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 20% of the Nalkyl(C8-C18) 

dimethylamidopropylamines by weight 

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 the N-alkyl(C8-C18) 

dimethylamidopropylamines. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for the Nalkyl(C8-C18) 

dimethylamidopropylamines when used 

as an inert ingredient in herbicide 

formulations applied to growing crops 

at levels not to exceed 20% of the 

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 

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72752 Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Rules and Regulations 

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: November 21, 2012. 

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: 

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

■ 2. In § 180.920, alphabetically add the 

following inert ingredients to the table 

to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

N-alkyl(C8-C18) dimethylamidopropylamines where the alkyl group is linear and may 

be saturated and/or unsaturated (CAS Reg. Nos. 109–28–4, 3179–80–4, 7651– 

02–7, 22890–10–4, 22890–11–5, 39669–97–1, 45267–19–4, 68140–01–2, 

1147459–12–8, 146987–98–6).

Not to exceed 20% by 

weight in herbicide formulations.

Surfactants, related adjuvants of surfactants. 

* * * * * * * 

[FR Doc. 2012–29106 Filed 12–5–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 8 

RIN 0930–AA14 

Opioid Drugs in Maintenance and 

Detoxification Treatment of Opiate 

Addiction; Proposed Modification of 

Dispensing Restrictions for 

Buprenorphine and Buprenorphine 

Combination as Used in Approved 

Opioid Treatment Medications 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Department of Health and 

Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

federal opioid treatment program 

regulations by modifying the dispensing 

requirements for buprenorphine and 

buprenorphine combination products 

approved by the Food and Drug 

Administration (FDA) for opioid 

dependence and used in federally 

certified and registered opioid treatment 

programs. In particular, this rule would 

allow opioid treatment programs more 

flexibility in dispensing take-home 

supplies of buprenorphine—removing 

restrictions on the time a patient needs 

to be in treatment in order to receive 

take-home supplies—after the 

assessment and documentation of a 

patient’s responsibility and stability to 

receive opioid addiction treatment 

medication. Opioid treatment programs 

that use these products in the treatment 

of opioid dependence will continue to 

adhere to all other federal treatment 

standards established for methadone. 

DATES: This rule is effective January 7, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Reuter, Center for Substance 

Abuse Treatment (CSAT), Division of 

Pharmacologic Therapies, SAMHSA, 1 

Choke Cherry Road, Room 2–1063, 

Rockville, MD 20857, (240) 276–2716, 

email: 

Nicholas.Reuter@samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Purpose of the Regulatory Action 

This final rule will modify the way 

that the narcotic treatment medication 

buprenorphine will be dispensed by 

treatment programs to individuals who 

are dependent on heroin or on certain 

prescription pain relievers by reducing 

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