582 Federal Register / Vol. 79, No. 3 / Monday, January 6, 2014 / Rules and Regulations 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: December 12, 2013. 

Karl Brooks, 

Regional Administrator, Region 7. 

Chapter I, title 40 of the Code of 

Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart AA—Missouri 

■ 2. Amend § 52.1320 by: 

■ a. Revising in paragraph (c) the entry 

for ‘‘10–5.455’’; 

■ b. Revising paragraph (e)(55). 

The revisions read as follows: 

§ 52.1320 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED MISSOURI REGULATIONS

Missouri citation Title 

State 

effective 

date 

EPA approval date Explanation 

* * * * * * * 

10–5.455 .......................................... Control of Emissions from Industrial 

Solvent Cleaning Operations.

08/30/2011 1/6/2014 [insert Federal Register 

page number where the document begins].

* * * * * * * 

* * * * * (e) * * * 

EPA-APPROVED MISSOURI NONREGULATORY SIP PROVISIONS

Name of non-regulatory SIP revision Applicable geographic or nonattainment area 

State submittal date EPA approval date Explanation 

* * * * * * * 

(55) VOC RACT Requirements for 

the 8-hour ozone NAAQS.

St. Louis ........................................... 1/17/2007, 

6/01/2011, 

8/30/2011 

1/23/2012, 77 FR 3144 1/6/2014 

[insert Federal Register page 

number where the document begins].

* * * * * * * 

* * * * * 

[FR Doc. 2013–31566 Filed 1–3–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0874; FRL–9904–57] 

Dimethyl Esters of Glutaric Acid (i.e., 

Dimethyl Glutarate), Succinic Acid (i.e., 

Dimethyl Succinate), and Adipic Acid 

(i.e., Dimethyl Adipate); 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 dimethyl esters 

of glutaric acid (i.e., dimethyl glutarate), 

succinic acid (i.e., dimethyl succinate), 

and adipic acid (i.e., dimethyl adipate), 

herein referred to as DMEGSA, when 

used as inert ingredients (as solvents/cosolvents) in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest. 

SciReg, Inc., on behalf of Rhodia, 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 

DMEGSA. 

DATES: This regulation is effective 

January 6, 2014. Objections and requests 

for hearings must be received on or 

before March 7, 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–2012–0874, 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: 

RDFRNotices@epa.gov 

SUPPLEMENTARY INFORMATION: 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 3 / Monday, January 6, 2014 / Rules and Regulations 583 

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–2012–0874 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 March 7, 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– 

2012–0874, 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.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 January, 16, 

2013 (78 FR 3377) (FRL–9375–4), EPA 

issued a document pursuant to FFDCA 

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

the filing of a pesticide petition (IN– 

10520) by SciReg Inc. 12733 Director’s 

Loop, Woodbridge, VA 22192, on behalf 

of Rhodia Inc., CN 7500, 8 Cedar Brook 

Drive, Cranbury NJ, 08512–7500. The 

petition requested that 40 CFR 180.910 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of dimethyl esters 

of glutaric acid (i.e., dimethyl glutarate, 

CAS Reg. No. 1119–40–0), succinic acid 

(i.e., dimethyl succinate, CAS Reg. No. 

106–65–0), and adipic acid (i.e., 

dimethyl adipate, CAS Reg. No. 627– 

93–0) when used as an inert ingredient 

as solvents/co-solvents in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest. That document referenced a 

summary of the petition prepared by on 

SciReg Inc., on behalf of Rhodia, 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. 

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 


sroberts on DSK5SPTVN1PROD with RULES
584 Federal Register / Vol. 79, No. 3 / Monday, January 6, 2014 / Rules and Regulations 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for DMEGSA 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with DMEGSA 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 DMEGSA as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

Acute toxicity studies demonstrate 

low acute oral and dermal toxicity 

(Office of Chemical Safety and Pollution 

Prevention (OCSPP) 870.1100 and 

870.1200, respectively) with minimal 

eye irritation (OCSPP 870.2400) and no 

dermal irritation (OCSPP 870.2500). 

Results from a dermal sensitization 

study were negative (OCSPP 870.2600). 

The repeat dose database contains 

oral, dermal, and inhalation studies. 

Due to their prevalence in commercial 

paint strippers, polishes, and lacquer 

thinners, the majority of the studies 

were conducted via inhalation, the most 

expected route of exposure from nonpesticidal uses. 

Animals in a 14-day oral dietary study 

showed reduced weight gain and food 

consumption at 1,684 mg/kg/day 

(LOAEL) but showed no adverse effects 

at 842 mg/kg/day (NOAEL). Animals in 

a one month oral gavage study showed 

no adverse effects at the limit dose of 

1,000 mg/kg/day. In addition, a 14-day 

dermal study was conducted and 

although mild skin irritation was noted 

in rats at doses equal to and greater than 

100 mg/kg/day, the effects were 

reversible and no systemic effects were 

observed at any dose tested up to the 

limit dose of 1,000 mg/kg/day. 

To support the safety finding as it 

relates to oral exposure, oral studies on 

the metabolites were also evaluated. 

Available repeat dose oral studies on the 

metabolites include a 13-week study on 

succinic acid, two 90-day studies on 

glutaric acid and a two year study on 

adipic acid. Succinic acid was shown to 

cause decreased body weight gain in 

rats at and above 2,500 mg/kg/day. 

Glutaric acid also caused a decrease in 

body weight gain in both rats and dogs 

at 1,000 and 750 mg/kg/day, 

respectively. Similarly, adipic acid was 

seen to cause decreased body weight 

gain and food consumption in rats at 

2,250 mg/kg/day. The results of these 

studies indicate that the metabolites of 

DMEGSA are of low toxicity via the oral 

route of exposure. 

The majority of the repeat dose and 

reproductive/developmental studies 

conducted on dibasic esters (DBE, CAS 

Reg. No. 95481–62–2- a chemical 

mixture of approximately 55–75% 

dimethyl glutarate, 15–27% dimethyl 

succinate, and 10–25% dimethyl 

adipate) and/or the individual 

chemicals are via the inhalation route of 

exposure. The available database 

includes three 90-day inhalation studies 

in rats, one conducted with DMEGSA 

and two with DBE. In the first study rats 

were exposed to DMS and DMA at doses 

of 0 or 0.4 mg/L and DMG at doses of 

0, 0.01, 0.05, or 0.4 mg/L. Degeneration 

of the olfactory epithelium was 

observed for all chemicals at and above 

0.05 mg/L with the severity of the local 

effect being dose dependent. Exposed 

animals also showed microscopic 

alterations in the liver (males) and lung 

(females). The hormonal changes 

observed in these studies with DMS, 

DMA, and DMG were: An increase in 

sperm counts (2/3 studies), a decrease in 

testosterone levels (1/3 studies), and a 

decrease in leutenizing hormone levels 

(1/3 studies) in males and a decrease in 

estradiol levels in females (1/3 studies). 

The significance of these findings is 

unclear because the decrease in male 

hormone levels should result in a 

decrease in sperm counts, yet the 

opposite effect was observed. The single 

study showing changes in estradiol was 

not observed in the other two studies. 

Furthermore, there were no functional 

parameters such as estrous cycle and 

sperm motility or morphology affected. 

In addition, a reproductive study was 

conducted with DBE and there were no 

effects on fertility, viability of pups at 

birth, and the ability of the mothers to 

lactate. 

Two other 90-day rat studies (OCSPP 

870.3465), tested DBE and again, 

degeneration of the olfactory epithelium 

was noted at all doses tested (0.02–1.0 

mg/L). In both studies decreases in liver 

weight were observed but no 

histopathological findings were evident. 

Similarly, when rats were exposed to 1 

mg/L DBE slight increases in relative 

heart and testes weights in males and a 

slight decrease in absolute spleen 

weight in females were observed. These 

slight organ weight changes were not 

accompanied by any histopathological 

changes and are therefore, considered of 

minimal biological significance. No 

other significant effects were observed. 

Repeat dose inhalation studies have 

demonstrated the chemicals potential to 

affect the olfactory mucosa in the nasal 

passage of rats. These local effects are 

believed to be related to the hydrolysis 

of DMEGSA by carboxylesterases 

located in the nasal/olfactory 

epithelium to the dicarboxylic acid 

metabolites. These effects on the 

olfactory epithelium are expected to be 

of much lower impact in humans due to 

major anatomical and physiological 

differences between rats and humans. 

See Unit VI.B for further discussion. 

Depressed pup weights were observed 

in a one-generation reproduction 

inhalation toxicity study with DBE at 

1.0 mg/L but were only seen in the 

presence of maternal toxicity. Two 

developmental inhalation toxicity 

studies (OCSPP 870.3700) were 

conducted, one testing DBE on rats and 

with DMG on rabbits. In both studies no 

developmental effects were observed at 

doses up to and including 1.0 mg/L. 

Similarly, no adverse developmental 

effects were observed in oral studies on 

the metabolites glutaric acid (rat and 

rabbit) and adipic acid (rat and mice) at 

doses up to and including 1,300 mg/kg/ 

day. 

An Ames test conducted with DBE 

was negative; however, a chromosome 

aberration study conducted with DBE 

was positive at high concentrations in 

the presence of S9 metabolic activation 

(negative without S9 activation) in 

lymphocytes from female donors. This 

result is not consistent with what is 

known about the hydrolysis products of 

the methyl esters. Methanol is not 

clastogenic or genotoxic. Glutaric acid, 

succinic acid, and adipic acid are all 

endogenous and not considered to be 

clastogenic or genotoxic; a chromosome 

aberration study conducted with adipic 

acid was negative. As such, it is possible 

that, in the presence of S9 metabolic 

activation, the esters were hydrolyzed 

and the acids released, affecting the pH, 

making it more acidic. This is known to 

cause false positive effects in 

cytogenicity assays. Therefore, an in 

vivo genotoxicity assay on somatic cells 

was performed. A bone marrow 

micronucleus assay was performed in 

mice following a single inhalatory noseonly exposure to DBE for six hours. 

There were no statistically significant 

differences in the proportion of 

micronucleated polychromatic 

erythrocytes between mice of all groups 

including controls at any sampling time 

up to 72 hours following exposure up to 

a very high concentration of 19 mg/L, 

illustrating the absence of clastogenicity 


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Federal Register / Vol. 79, No. 3 / Monday, January 6, 2014 / Rules and Regulations 585 

of the test substance in vivo. In addition, 

a rat micronucleus study conducted 

with DMG was negative. 

No neuropathological changes or 

effects on the functional observation 

battery parameters were reported in any 

of the studies. The agency does not 

believe DMEGSA will be neurotoxic. 

Chronic/carcinogenicity studies could 

not be identified for DMEGSA. A 

DEREK evaluation for DMG and DMS 

was conducted and did not show any 

special alerts. In addition, 

carcinogenicity studies were conducted 

with adipic acid and monosodium 

succinate in rats and no carcinogenic 

effects were observed. Therefore, the 

agency does not expect DMEGSA to be 

carcinogenic in humans. 

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. 

Various inhalation studies with 

DMEGSA show local effects (likely a 

result of irritation at the point of contact 

in the nasal region) as well as some 

changes in hormone levels that, 

although consistently observed, are not 

considered to be toxicologically 

significant. The effects on the olfactory 

epithelium are expected to be of much 

lower impact in humans due to major 

physiological differences between rats 

and humans (e.g., rats have a larger 

surface of nasal epithelium and different 

air flow and breathing pattern (e.g., rats 

are obligate nose breathers) and greater 

carboxylesterase activity in nasal/

olfactory epithelium than do humans) 

so the local exposure will be 

significantly lower in humans. In vitro 

experiments with human nasal tissue 

homogenates suggest that DBE 

metabolism in human nasal tissue is 100 

to 1000 times less active than rat nasal 

tissue. Therefore, humans are expected 

to be much less sensitive. In the absence 

of other systemic toxicity along with the 

expected decrease in sensitivity of 

humans to olfactory responses, EPA 

concluded that these effects were not 

sufficiently adverse to be used as an 

endpoint for risk assessment. 

As noted in Unit VI. A. above, 

exposed animals in repeat dose 

inhalation studies showed microscopic 

organ changes and hormonal changes in 

studies with DMS, DMA, and DMG. The 

significance of these findings is unclear 

because for example, the decrease in 

male hormone levels should result in a 

decrease in sperm counts, yet the 

opposite effect was observed. The single 

study showing changes in estradiol was 

not observed in the other two studies. 

Furthermore, there were no functional 

parameters such as estrous cycle and 

sperm motility or morphology affected. 

In addition, a reproductive study was 

conducted with DBE and there were no 

effects on fertility, viability of pups at 

birth, and the ability of the mothers to 

lactate. For these reasons the point of 

departure for the risk assessment for 

chronic oral routes of exposure was 

from the 14-day oral toxicity study in 

rats. The NOAEL was 842 mg/kg/day 

and the LOAEL was 1684 mg/kg/day 

based on reduced weight gain and food 

consumption. A 1000 fold uncertainty 

factor was used for the chronic exposure 

(10X interspecies extrapolation, 10X for 

intraspecies variability and 10X FQPA 

safety factor)). 

The dermal study did not result in an 

endpoint of concern. Adverse local 

olfactory effects were observed in 

inhalation toxicity studies; however, 

due to anatomical and physiological 

difference between study animals and 

humans, the effects are likely to be less 

severe in humans and subsequently of 

minimal toxicological concern. No 

systemic endpoint of concern was 

identified in the available inhalation 

toxicity studies; therefore, 

quantification of inhalation risk is not 

necessary. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to DMEGSA, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

DMEGSA in food as follows: 

Because no acute endpoint of concern 

was identified, a quantitative acute 

dietary exposure assessment is 

unnecessary. In conducting the chronic 

dietary exposure assessment using the 

Dietary Exposure Evaluation Model 

DEEM–FCIDTM, 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 DMEGSA, 

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). 


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The majority of the current pesticidal 

uses (e.g., use in paints and wood 

products) of DMEGSA are for industrial 

and commercial settings; however, 

DMEGSA are approved for use in 

textiles, as paper coatings, and in and 

around homes and landscapes. There 

are no approved antimicrobial uses of 

DMEGSA. Neither the dermal nor 

inhalation studies resulted in an 

endpoint of concern; therefore, there 

was no need to quantify dermal or 

inhalation exposure. Since there is 

potential for use of this chemical in and 

around homes, residential exposure was 

evaluated using agency approved 

models to estimate high end postapplication oral exposures to children 

from treated lawns. The residential and 

aggregate level of concern (LOC) is for 

margins of exposure (MOE) that are less 

than 1000 and is based on 10X 

interspecies extrapolation, 10X for 

intraspecies variability, and 10X FQPA 

safety factor. 

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 DMEGSA to share 

a common mechanism of toxicity with 

any other substances, and DMEGSA 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that DMEGSA 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 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 increased susceptibility 

was seen in the available developmental 

and reproductive toxicity studies for 

DMEGSA and its metabolites. Depressed 

pup weights were observed in a onegeneration reproduction inhalation 

toxicity study with DBE at 1.0 mg/L but 

were only seen in the presence of 

maternal toxicity. Two developmental 

inhalation toxicity studies were 

conducted, one testing DBE on rats and 

with DMG on rabbits. In both studies no 

developmental effects were observed at 

doses up to and including 1.0 mg/L; 

while maternal toxicity was observed at 

doses of 0.3 mg/L and above. Similarly, 

no adverse developmental effects were 

observed in oral studies on the 

metabolites glutaric acid (rat and rabbit) 

and adipic acid (rat and mice) at doses 

up to and including 1,300 mg/kg/day. 

3. Conclusion. EPA concludes that the 

FQPA safety factor of 10X for DMEGSA 

should be retained because of the need 

to extrapolate from a subchronic study 

for a chronic risk assessment. In making 

this determination, EPA considered the 

following factors: 

i. The toxicity database for DMEGSA 

and their metabolites includes several 

subchronic and chronic studies, several 

developmental and reproductive 

toxicity studies, and mutagenicity 

studies. No chronic studies are available 

on DBEs; however, chronic toxicity 

studies on metabolites are available to 

characterize long term toxicity potential 

of DBEs. 

ii. Increased incidence of delayed 

renal papillary development and 

decreased pup weights were observed in 

reproductive/developmental inhalation 

toxicity studies at 1000 mg/m3; 

however, these effects were only 

observed in the presence of depressed 

maternal body weight. In addition, there 

were no systemic effects seen in oral 

studies at doses up to and including the 

limit dose of 1000 mg/kg/day indicating 

no evidence of increased susceptibility. 

iii. There is no indication that 

DMEGSA are neurotoxic chemicals. 

Although no neurotoxicity studies are 

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. 

vi. The dietary food exposure 

assessment utilizes proposed tolerance 

level or higher residues and 100% CT 

information for all commodities. By 

using these screening-level assessments, 

chronic exposures/risks will not be 

underestimated. 

Based on the absence of reproductive 

and developmental toxicity for 

DMEGSA in inhalation studies at 

maternally toxic doses, the high 

developmental NOAEL for glutaric acid, 

and the lack of neurotoxicity, there is no 

concern for increased sensitivity to 

infants and children to DMEGSA when 

used as an inert ingredients in pesticide 

formulations. However, due to the lack 

of a chronic oral toxicity study the 10X 

FQPA safety factor has been retained to 

protect infants and children. 

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, DMEGSA 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 DMEGSA from 

food and water will utilize 83.9% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no current or 

proposed residential uses for DMEGSA 

at this time. Based on the explanation in 

this unit, regarding residential use 

patterns, chronic residential exposure to 

residues of DMEGSA 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 

exposure level). A short-term adverse 

effect was identified; however, 

DMEGSA is 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. They may, 

however, be used in the future as an 


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Federal Register / Vol. 79, No. 3 / Monday, January 6, 2014 / Rules and Regulations 587 

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 DMEGSA. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential oral exposures result in 

aggregate MOEs for children of 1450 for 

hand-to-mouth exposure to treated 

lawns. Because EPA’s level of concern 

for DMEGSA is a MOE of 1000 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 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, DMEGSA is 

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. 

They may, however, be used in the 

future 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 oral 

exposures to DMEGSA. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs for children of 1500 

for hand-to-mouth exposure to treated 

lawns. Because EPA’s level of concern 

for DMEGSA is a MOE of 1000 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 available 

studies of the metabolites of the subject 

chemicals and a DEREK assessment of 

DMEGSA which revealed no alerts, 

DMEGSA 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 DMEGSA 

residues. 

V. Other Considerations 

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 dimethyl 

glutarate (CAS Reg. No. 1119–40–0), 

dimethyl succinate (CAS Reg. No. 106– 

65–0), and dimethyl adipate (CAS Reg. 

No. 627–93–0) when used as inert 

ingredients (solvent/co-solvent) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest. 

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: December 23, 2013. 

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 § 180.910, alphabetically add the 

following inert ingredient(s) to the table 

to read as follows: 


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588 Federal Register / Vol. 79, No. 3 / Monday, January 6, 2014 / Rules and Regulations 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

Dimethyl adipate (CAS no. 627–93–0) ................................ None ............................ Solvent/co-solvent 

* * * * * * * 

Dimethyl glutarate (CAS no. 1119–40–0) ........................... None ............................ Solvent/co-solvent 

* * * * * * * 

Dimethyl succinate (CAS no. 106–65–0) ............................ None ............................ Solvent/co-solvent 

* * * * * * * 

[FR Doc. 2013–31582 Filed 1–3–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1, 2, 27 and 90 

[PS Docket Nos. 12–94, 06–229, WT Docket 

No. 06–150; FCC 13–137] 

Consolidated Service Rules for the 

758–769 and 788–799 MHz Bands 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Communications 

Commission (Commission) adopts a 

Second Report and Order that 

establishes consolidated service rules 

for the 758–769 and 788–799 MHz 

bands, the 700 MHz spectrum licensed 

to the First Responder Network 

Authority (FirstNet) for purposes of 

establishing a nationwide public safety 

broadband network. The Second Report 

and Order also lifts the suspension on 

the certification of equipment for 

operation in this band and directs the 

Office of Engineering and Technology to 

commence such certification, consistent 

with the service rules adopted therein. 

DATES: Effective January 6, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Erika Olsen, Senior Legal Counsel, 

Public Safety and Homeland Security 

Bureau, (202) 418–2868 or 

erika.olsen@fcc.gov; Brian Hurley, 

Attorney Advisor, Public Safety and 

Homeland Security Bureau, (202) 418– 

2220 or brian.hurley@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Second 

Report and Order, FCC 13–137; PS 

Docket Nos. 12–94, 06–229, WT Docket 

No. 06–150; adopted and released 

October 28, 2013. The full text of this 

document is available for public 

inspection during regular business 

hours in the FCC Reference Center, 

Room CY–A257, 445 12th Street SW., 

Washington, DC 20554, or online at 

http://www.fcc.gov/document/700-mhzpublic-safety-broadband-service-rulesreport-and-order. This document will 

also be available via ECFS at http:// 

fjallfoss.fcc.gov/ecfs/. Documents will 

be available electronically in ASCII, 

Microsoft Word, and/or Adobe Acrobat. 

The complete text may be purchased 

from the Commission’s copy contractor, 

445 12th Street SW., Room CY–B402, 

Washington, DC 20554. Alternative 

formats are available for people with 

disabilities (Braille, large print, 

electronic files, audio format), by 

sending an email to fcc504@fcc.gov or 

calling the Commission’s Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Paperwork Reduction Act of 1995 

This document contains no new or 

modified information collection 

requirements subject to the Paperwork 

Reduction Act of 1995 (PRA), Public 

Law 104–13. 

I. Introduction 

1. In the Second Report and Order 

(Second R&O) we adopt consolidated 

rules, primarily technical service rules, 

for the 758–769/788–799 MHz band, 

which is licensed to the First Responder 

Network Authority (FirstNet) on a 

nationwide basis. We also direct the 

Office of Engineering and Technology 

(OET) to accept and process 

applications for equipment certification 

in this band consistent with the newly 

consolidated rules. Our adoption of the 

Second R&O will further ‘‘facilitate the 

transition’’ of spectrum to FirstNet to 

enable its deployment of a nationwide 

public safety broadband network as 

prescribed by statute. We also focus on 

these technical matters in order to 

expedite the availability of equipment 

for use in this band, which will fulfill 

‘‘the imminent need’’ FirstNet cites ‘‘for 

authorized equipment to meet the needs 

of jurisdictions that may deploy early’’ 

in its licensed spectrum. 

2. The rules we adopt today will 

provide a necessary foundation for 

FirstNet’s operations and expedite the 

availability of equipment for use in this 

band. As noted below, in light of the 

urgent need to resume our process for 

certifying equipment for use in 

promoting more effective public safety 

operations in this band, and because 

that process cannot be resumed in the 

absence of governing technical service 

rules, we find good cause to make the 

Second R&O effective immediately 

upon publication in the Federal 

Register. 

II. Background 

3. The Middle Class Tax Relief and 

Job Creation Act of 2012, enacted 

February 22, 2012, provides for the 

deployment of a nationwide public 

safety broadband network in the 700 

MHz band. The Act established FirstNet 

as an independent authority within the 

National Telecommunications and 

Information Administration (NTIA), and 

required the Commission to grant a 

license to FirstNet for the use of both 

the existing public safety broadband 

spectrum (763–768/793–798 MHz) and 

the spectrally adjacent D Block (758– 

763/788–793 MHz), a commercial 

spectrum block that the statute required 

the Commission to reallocate for public 

safety use. The Act charges FirstNet 

with the responsibility for establishing 

and overseeing ‘‘a nationwide, 

interoperable public safety broadband 

network’’ operated in this spectrum by 

taking ‘‘all actions necessary to ensure 

the building, deployment, and operation 

of the . . . network, in consultation 

with Federal, State, tribal, and local 


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