[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: [email protected].
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
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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 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