9778 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0249; FRL–9942–43] 

D-Glucitol, 1-deoxy-1-(methylamino)-, 

N-C8-10 acyl derivatives; 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 D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives (CAS Reg. No. 1591782–62– 

5) when used as an inert ingredient 

(surfactant) applied to growing crops 

and raw agricultural commodities after 

harvest at a concentration not to exceed 

40% by weight under 40 CFR 180.910. 

Keller & Heckman LLP on behalf of the 

Clariant Corporation submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Dglucitol, 1-deoxy-1-(methylamino)-, 

N-C8-10 acyl derivatives. 

DATES: This regulation is effective 

February 26, 2016. Objections and 

requests for hearings must be received 

on or before April 26, 2016, 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–2015–0249, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2015–0249 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 April 26, 2016. 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– 

2015–0249, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of August 26, 

2015 (80 FR 51762) (FRL–9931–74), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10792) by Keller & 

Heckman LLP (1001 G Street NW., Suite 

500 West, Washington, DC 20001), on 

behalf of the Clariant Corporation (4000 

Monroe Road, Charlotte, NC 28205). The 

petition requested that 40 CFR 180.910 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives (CAS Reg. No. 1591782–62– 

5) when used as an inert ingredient 

(surfactant) in pesticide formulations 

applied to growing crops and raw 

agricultural commodities at a 

concentration in formulations not to 

exceed 40% by weight. That document 

referenced a summary of the petition 

prepared by Keller & Heckman on behalf 

of the Clariant Corporation, the 

petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

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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 D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives 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 D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in this unit. 

D-Glucitol, 1-deoxy-1-(methylamino)-, 

N-C8-10 acyl derivatives exhibits low 

acute toxicity. The oral lethal dose 

(LD)50 in the rat is 500 milligram/

kilogram (mg/kg) and above. The dermal 

LD50 in rats and rabbits was determined 

to be >2,000 mg/kg. The inhalation 

lethal concentration (LC)50 value for 

Wistar rats is greater than 1 milligram 

per Liter (mg/L). A primary skin 

irritation test with the rabbit indicates it 

is not irritating to rabbit’s skin. An eye 

irritation test with New Zealand white 

rabbits indicates it to be moderately 

irritating. Two skin sensitization tests 

with Hartley guinea pigs show it is not 

a sensitizer to the guinea pig. 

A 28-day repeat dose oral toxicity 

study was conducted with Wistar rats. 

In this study, rats were treated via 

gavage with D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 derivatives at 

doses up to 500 milligram/kilogram/day 

(mg/kg/day). At the 500 mg/kg/day 

dose, mortality was observed as well as 

toxicity reflected as microscopic 

findings in the GI tract, trachea, lung, 

spleen and bone marrow. The NOAEL 

was 250 mg/kg/day. 

In a reproduction/developmental 

toxicity screening test, rats were dosed 

for 54 days with D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 derivatives at 

doses up to 312.5 mg/kg/day. Neither 

parental, developmental nor 

reproduction toxicity was observed at 

312.5 mg/kg/day, the highest dose tested 

(HDT). 

A gene reverse mutation study with 

Salmonella, an in vitro mammalian cell 

gene mutation study with Chinese 

hamster V 79 cells, a mammalian 

micronucleus mutagenicity test of 

micronuclei in polychromatic 

erythrocytes in the mouse bone marrow, 

a mammalian micronucleus test with 

murine peripheral blood cells, a 

mutagenesis assay using L5178Y TK+/- 

mouse lymphoma cells, an in vivo rat 

bone marrow cytogenicity study all 

were negative for mutagenic and 

clastogenic effects. 

There were no neurotoxicity data per 

se however there were no indications of 

neurotoxic effects in the functional 

observation battery in the 28-day oral 

toxicity study in the rat. In addition, the 

DEREK predictive modeling system did 

not identify any alerts for potential 

neurotoxicity. 

There were no data regarding 

immunotoxicity. However evidence of 

potential immunotoxicity was observed 

in the 28-day oral toxicity study in the 

rat. In this study, atrophy is seen in the 

spleen and bone marrow at 500 mg/kg/ 

day. These effects will be protected 

since the established chronic reference 

dose (cRfD) is 1.04 mg/kg/day. 

There were no study data presented 

specifically addressing metabolism. 

Modeling data using the DEREK (Nexus) 

and METEOR modeling systems 

indicate 80% absorption via the 

gastrointestinal system and less than 1% 

via dermal absorption. The major route 

of excretion is via the urine. 

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 the NOAEL and the 

LOAEL are identified. 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 

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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. 

An acute effect was not found in the 

database therefore an acute dietary 

assessment is not necessary. The 

reproduction/developmental toxicity 

screening study in the rat was selected 

for the toxicological endpoint for use in 

the chronic dietary risk assessment. In 

this study, no effects are observed up to 

312.5 mg/kg/day. The standard 

uncertainty factors (100X) are applied 

for intra-and interspecies variation and 

an additional uncertainty factor (3X) is 

applied to account for extrapolation 

from subchronic to chronic exposures. 

EPA identified the uncertainty factor of 

3X as protective rather than 10X is 

because there was no toxicity observed 

at doses up to 312.5 mg/kg/day in an 

Organization for Economic Cooperation 

and Development (OECD) 422 study. 

Dermal and inhalation absorption are 

assumed to be 100%. For all short- and 

intermediate-term residential risk 

assessments, the toxicological endpoint 

selected for use in the assessment is 

taken from the reproduction/

developmental toxicity screening study 

in the rat. In this study, no effects are 

observed up to 312.5 mg/kg/day. The 

level of concern for residential risk 

assessments is for MOEs of less than 

300. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 derivatives, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from Dglucitol, 1-deoxy-1-(methylamino)-, NC8-10 derivatives, in food as follows: 

Dietary exposure (food and drinking 

water) to D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 derivatives can 

occur following ingestion of foods with 

residues from treated crops. An acute 

dietary risk assessment was not 

conducted because no endpoint of 

concern following a single exposure was 

identified in the available studies. A 

chronic dietary exposure assessment 

was completed and performed using the 

Dietary Exposure Evaluation Model 

DEEM–FCIDTM, Version 3.16, which 

includes food consumption information 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat In America’’, (NHANES/

WWEIA). This dietary survey was 

conducted from 2003 to 2008. In the 

absence of actual residue data, the inert 

ingredient evaluation is based on a 

highly conservative model that assumes 

that the residue level of the inert 

ingredient would be no higher than the 

highest established tolerance for an 

active ingredient on a given commodity. 

Implicit in this assumption is that there 

would be similar rates of degradation 

between the active and inert ingredient 

(if any) and that the concentration of 

inert ingredient in the scenarios leading 

to these highest of tolerances would be 

no higher than the concentration of the 

active ingredient. The model assumes 

100 percent crop treated (PCT) for all 

crops and that every food eaten by a 

person each day has tolerance-level 

residues. A complete description of the 

general approach taken to assess inert 

ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts’’ (D361707, S. 

Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for Dglucitol, 1-deoxy-1-(methylamino)-, NC8-10 derivatives, 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). 

D-Glucitol, 1-deoxy-1-(methylamino)-, 

N–C8-10 derivatives may be used in inert 

ingredients in products that are 

registered for specific uses that may 

result in residential exposure, such as 

pesticides used in and around the home. 

The Agency conducted an assessment to 

represent worst-case residential 

exposure by assessing D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10

derivatives in pesticide formulations 

(outdoor scenarios) and in disinfectanttype uses (indoor scenarios). 

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 D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives to share a common 

mechanism of toxicity with any other 

substances, and D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives 

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 

Food Quality Protection Act Safety 

Factor (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. 

There is no evidence of increased 

susceptibility in the OECD 422 study 

based on lack of systemic toxicity in the 

maternal animals and offspring at doses 

up to 312.5 mg/kg/day; the HDT. 

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 3X. That decision is 

based on the following findings: 

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Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 9781 

i. The toxicity database for D-glucitol, 

1-deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives contains the following 

studies that are adequate to evaluate the 

potential toxicity of D-glucitol, 1-deoxy1-(methylamino)-, N-C8-10 acyl 

derivatives for infants and children: The 

database contains a 28-day repeat dose 

oral toxicity study, a reproduction/

developmental toxicity screening study 

and several mutagenicity studies. 

ii. There were no neurotoxicity data 

per se however there were no 

indications of neurotoxic effects in the 

functional observation battery in the 28- 

day oral toxicity study in the rat. 

iii. There were no data regarding 

immunotoxicity. However evidence of 

potential immunotoxicity was observed 

in the 28-day oral toxicity study in the 

rat. In this study, atrophy is seen in the 

spleen and bone marrow at 500 mg/kg/ 

day. These effects will be protected 

since the established cRfD is 1.04 mg/ 

kg/day. 

iv. There was no evidence of 

increased susceptibility of infants and 

children in the OECD 422 study. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 percent 

crop treated (PCT) and tolerance-level 

residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives 

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 D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives 

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, D-glucitol, 1-deoxy1-(methylamino)-, N-C8-10 acyl 

derivatives 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 D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives from food and water will 

utilize 54.4% of the cPAD for children 

1–2 years old, the population group 

receiving the greatest exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

D-glucitol, 1-deoxy-1-(methylamino)-, 

N-C8-10 acyl derivatives may be used as 

inert ingredients in pesticide products 

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 D-glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives. 

Using the exposure assumptions 

described above, EPA has concluded 

that the combined short-term aggregated 

food, water, and residential exposures 

result in MOEs of 490 for both adult 

males and females respectively. Adult 

residential exposure combines high-end 

dermal and inhalation handler exposure 

from indoor hard surface, mopping, 

wiping and trigger-pump spray. As the 

level of concern is for MOEs that are 

lower than 300, this MOE is not of 

concern. EPA has concluded the 

combined short-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 420 for children 

As the level of concern is for MOEs that 

are lower than 300, this MOE is 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). DGlucitol, 1-deoxy-1-(methylamino)-, NC8-10 acyl derivatives may be used as 

inert ingredients in pesticide products 

that could result in intermediate -term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives. Using the exposure 

assumptions described above, EPA has 

concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 490 for adult 

males and females. Adult residential 

exposure combines indoor hard surface, 

wiping with a high end post application 

dermal exposure from contact with 

treated lawns. As the level of concern is 

for MOEs that are lower than 300, this 

MOE is not of concern. EPA has 

concluded the combined intermediateterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 420 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated surfaces (dermal and handto-mouth exposures). As the level of 

concern is for MOEs that are lower than 

300, this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on a DEREK 

structural alert analysis and the lack of 

mutagenicity, D-Glucitol, 1-deoxy-1- 

(methylamino)-, N-C8-10 acyl derivatives 

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 D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives 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 D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives in or on any food 

commodities. EPA is establishing a 

limitation on the amount of D-glucitol, 

1-deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives that may be used in 

pesticide formulations applied to 

growing crops. 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 

formulation for use on growing crops for 

sale or distribution that exceed 40% of 

D-glucitol, 1-deoxy-1-(methylamino)-, 

N-C8-10 acyl derivatives. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for D-glucitol, 1- 

deoxy-1-(methylamino)-, N-C8-10 acyl 

derivatives when used as an inert 

ingredient (surfactant) in pesticide 

formulations applied to growing crops 

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9782 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 

and raw agricultural commodities at a 

concentration not to exceed 40% by 

weight. 

VII. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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 action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 18, 2016. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910 add alphabetically the 

following inert ingredient to the table to 

read as follows: 

§ 180.910 Inert Ingredients use pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

D-Glucitol, 1-deoxy-1-(methyl-amino)-, N-C8-10 acyl derivatives (CAS 

Reg. No. 1591782–62–5).

Not more than 40% by weight in 

pesticide formulation.

Surfactant 

* * * * * * * 

[FR Doc. 2016–04071 Filed 2–25–16; 8:45 am] 

BILLING CODE 6560–50–P 

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