Document ID: EPA-HQ-OPP-2015-0249-0004
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivatives
Posted Date: 2016-02-26T05:00Z

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Rules and Regulations]
[Pages 9778-9782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04071]

[[Page 9778]]

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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.

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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 D-glucitol, 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/text-idx?&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

[[Page 9779]]

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-adverse-
effect-level (NOAEL) and the lowest-observed-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

[[Page 9780]]

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 D-
glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 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-FCID\TM\, 
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 D-glucitol, 1-deoxy-
1-(methylamino)-, N-C8-10 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 non-occupational, 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 disinfectant-type 
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:

[[Page 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-deoxy-
1-(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 post-application 
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-deoxy-1-(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). D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 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 intermediate-term 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 hand-to-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

[[Page 9782]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.910 add alphabetically the following inert ingredient 
to the table to read as follows:

Sec.  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-    Not more than 40%   Surfactant
 amino)-, N-C8-10 acyl             by weight in
 derivatives (CAS Reg. No.         pesticide
 1591782-62-5).                    formulation.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-04071 Filed 2-25-16; 8:45 am]
 BILLING CODE 6560-50-P