[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13189]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Diisopropyl Adipate; Exemption From the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of diisopropyl adipate when used as an
inert ingredient (solvent) in pesticide formulations applied to pre-
and post-harvest crops under EPA regulations at no more than 40% in
formulated products intended for mosquito control. Wellmark
International submitted a petition prepared by Technology Sciences
Group Inc. 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 diisopropyl adipate.
DATES: This regulation is effective June 5, 2013. Objections and
requests for hearings must be received on or before August 5, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0469, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: David Lieu, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: 703-305-0079; email address: [email protected].
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. To access the OCSPP test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0469 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
August 5, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0469, 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
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 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 2E8031) by Wellmark
International, Central Life Sciences, 1501 East Woodfield Road, Suite
200 West, Schaumburg, IL 60173. The petition requested that 40 CFR
180.920 be amended by establishing an exemption from the requirement of
a tolerance for residues of diisopropyl adipate (CAS Reg. No. 6938-94-
9) when used as an inert ingredient (solvent) in pesticide formulations
applied to growing crops only at no more than 40% in formulated
products intended for mosquito control. That document referenced a
summary of the petition prepared by Technology Sciences Group Inc., the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing. Based upon review of the data supporting the
petition, EPA has modified the exemption requested to include an
exemption from the requirement of a tolerance for residues of
diisopropyl adipate (CAS Reg. No. 6938-94-9) under 40 CFR 180.910 when
used as an inert ingredient in pesticide formulations applied to
growing crops or to raw agricultural commodities after harvest at no
more than 40% in formulated products intended for mosquito control. The
reason for these changes is explained in Unit V.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
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
aggregate exposure for diisopropyl adipate including exposure resulting
from the exemption established by this action. EPA's assessment of
exposures and risks associated with diisopropyl adipate 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 diisopropyl adipate 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
The acute oral toxicity of diisopropyl adipate in rodents, as
expressed as an LD50, ranges from 1,500 mg/kg to 8,800 mg/
kg. In the guinea pig, the acute oral toxicity of diisopropyl adipate
is about 6,600 mg/kg and in the rabbit, 5,000 mg/kg. In the dog, the
acute oral LD50 of diisopropyl adipate is greater than 8,000
mg/kg. Diisopropyl adipate is minimally irritating to the eyes and skin
The potential for toxicity following repeat dose exposure to
diisopropyl adipate was evaluated based on toxicity studies with
diisopropyl adipate as well as toxicity data on the two primary
metabolites of diisopropyl adipate, adipic acid (CAS Reg. No. 124-04-9)
and isopropyl alcohol (CAS Reg. No. 67-63-0). Isopropyl alcohol was
previously assessed in the U.S. EPA inert reassessment document titled,
Inert Reassessment--n-Propanol; CAS Reg. No. 71-23-8, dated August 24,
2005 and no end points of concern were identified. In addition,
toxicity data from two structural analogues of diisopropyl adipate,
dipropyl adipate and diisobutyl adipate, were also considered. These
substances would be expected to have toxicological properties similar
to diisopropyl adipate and can be used to supplement the available
toxicity data on diisopropyl adipate. The studies summarized below were
either performed with diisopropyl adipate, adipic acid, dipropyl
adipate or diisobutyl adipate.
In a 5 week study, guinea pigs that were administered adipic acid
orally showed no adverse effects up to doses of 1000 mg/kg/day. In a 90
day oral toxicity study, male rats were given 0, 0.1, 1 or 5% adipic
acid and female rats were given 0 or 1% adipic acid. The NOAEL was 1%
(1000 mg/kg/day) and a LOAEL of 5% (5000 mg/kg/day) based on growth
retardation in males. In a 19 week oral toxicity study in rats, each
rat was given 0, 50, 100, 200 or 400 mg adipic acid/rat/day. The NOAEL
was 200 mg adipic acid/rat/day (equivalent to 1700 mg/kg/day) and the
LOAEL was 400 mg adipic acid/rat/day (equivalent to 3,400 mg/kg/day)
was based on slight effects on liver and irritation of the intestine.
In a 33 week subchronic oral toxicity study on groups of 13-15 male and
female rats at doses of 0, 400, 800 mg/rat/day or approximately 0, 1600
and 3200 mg/kg bw/day adipic acid produced a LOAEL of 400 mg/rat/day
(equivalent to 1600 mg/kg bw/day) based on slight liver effects and
inflammation of the intestine and no NOAEL was observed. In a 3 week
inhalation toxicity study, rats were exposed to 0.126 mg/L adipic acid
for 6 hr periods daily for five days a week for a total of 15
exposures. No signs of toxicity were seen, blood tests gave normal
values and autopsy results revealed all organs to be normal.
The mutagenic potential of adipic acid was evaluated in a Host-
Mediated Assay, in an in vivo cytogenetics test, and a dominant lethal
assay. These tests were negative.
An OECD SIDS Initial Assessment Report on Adipic Acid (2004)
concluded that adipic acid was not carcinogenic in a limited two-year
feeding study where groups of twenty male rats were dosed with food
containing 0, 0.1, 1, 3 and 5% (equivalent to 0, 75, 750, 2250 or 3750
mg/kg/day) adipic acid, and female rats were dosed with 0% (n=10) and
1% (n=19) adipic acid, respectively. The incidences of tumors observed
in the adipic acid treated groups were observed at the same levels as
in the control groups.
Developmental studies (FDRL 1972) via oral gavage using adipic acid
on mice, rats, hamsters and rabbits showed no maternal or developmental
toxicity. The NOAELs for mice, rats and hamsters were 263, 288 and 205
mg/kg/day, respectively. These studies were not conducted at the limit
dose. However, the concern for developmental toxicity of diisopropyl
adipate is low because no systemic toxicity was seen in chronic studies
at doses near the limit dose. In addition, the developmental toxicity
studies conducted with two analogue substances (dipropyl adipate and
diisobutyl adipate) via intraperitoneal route showed no developmental
toxicity at doses around 700 mg/kg/day.
An immunotoxicity study from the OECD SIDS 2004 IUCLID Data Set
stated that the lymphocyte mitogenesis test was used to test for
immunotoxicity in vitro. In this test lymphocytes were stimulated by a
polyclonal mitogen specific for either B or T cells. Neither B nor T
lymphocyte mitogenesis was inhibited by adipic acid at concentrations
up to 0.3%.
There were no neurotoxicity studies available in the database.
However, there were no clinical signs of neurotoxicity observed in the
There are no published metabolism studies on diisopropyl adipate
specifically, but the metabolic pathways of diisopropyl adipate are
proposed based on the characteristic molecular structure of diisopropyl
adipate and the known metabolic pathways for structurally similar
compounds. Diisopropyl adipate is a linear fatty acid diester that has
an isopropyl group bound to the oxygen atom on each end of the
molecule. Given these structural groups, diisopropyl adipate metabolism
is almost certainly catalyzed by carboxylesterase enzymes that are
ubiquitous throughout the body to produce adipic acid plus two
molecules of isopropyl alcohol.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
The rational of the toxicological endpoints for diisopropyl adipate
used for human risk assessment is as follows.
The chronic toxicity/carcinogenicity study in rats was selected for
all exposure scenarios and durations for this risk assessment. The
NOAEL in this study was 750 mg/kg/day. The LOAEL was 2,250 mg/kg/day
based on body weight retardation. The rationale for selecting this
study is as follows. The lowest NOAEL (205 mg/kg/day) in the database
was observed in a developmental study in hamsters. In this study 205
mg/kg/day was the highest dose tested. This study was not selected
because maternal and developmental toxicity were not observed at doses
as high as 263 and 288 mg/kg/day in mice and rats, respectively. Also,
in a developmental toxicity study where rats were treated via
intraperitoneal injection of adipic acid esters, maternal and
developmental toxicity were not observed at doses as high as 727 mg/kg/
day. The developmental LOAEL was 1,211 mg/kg/day based on increased
resorptions and a slight but significant increase in gross
abnormalities. However, these studies are not useful for endpoint
selection because they were conducted via intraperitoneal route which
is not relevant for the dietary, dermal or inhalation risk assessment.
Also, the 19 and 33 weeks and 2 years oral toxicity studies showed no
evidence of toxicity at doses as high as 750 mg/kg/day. Therefore, the
chronic toxicity study in rats with the NOAEL of 750 mg/kg/day provided
a good basis for establishing the chronic reference dose (cRfD). The
NOAEL is considered extremely conservative because the extrapolation
from adipic acid to diisopropyl adipate was not performed in order to
keep the toxicity endpoint selection more conservative. Diisopropyl
adipate is a large molecular weight compound compared to adipic acid.
Converting adipic acid to diisopropyl adipate in a 1 to 1 molar ratio
(one molecule of diisopropyl adipate contains 1 molecule of adipic
acid) would mean the NOAEL and LOAEL values would be increased
proportionately to the molecular weight ratios, 230 g/mol for
diisopropyl adipate and 146 g/mol for adipic acid (e.g. The NOAEL of
750 mg/kg/day for adipic acid would become 1,181 mg/kg/day if converted
to diisopropyl adipate). The uncertainty factor of 100x was used for
10x intraspecies variability and 10x for interspecies extrapolation.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to diisopropyl adipate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from diisopropyl adipate in food as follows:
Because no acute endpoint of concern was identified, a quantitative
acute dietary exposure assessment is unnecessary.
In conducting the chronic dietary exposure assessment using the
Dietary Exposure Evaluation Model DEEM-FCID\TM\, Version 3.16, EPA used
food consumption information from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, What we eat in
America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to
2008. The Dietary Exposure Evaluation Model (DEEM) is a highly
conservative model with the assumption that the residue level of the
inert ingredient would be no higher than the highest tolerance for a
given commodity. Implicit in this assumption is that there would be
similar rates of degradation between the active and inert ingredient
(if any) and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient. The model assumes 100
percent crop treated (PCT) for all crops and that every food eaten by a
person each day has tolerance-level residues. A complete description of
the general approach taken to assess inert ingredient risks in the
absence of residue data is contained in the memorandum entitled ``Alkyl
Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food
and Drinking Water) Dietary Exposure and Risk Assessments for the
Inerts.'' (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for diisopropyl adipate,
a conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
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).
Diisopropyl adipate may be used in inert ingredients in pesticide
products that are registered for specific uses that may result in
outdoor residential exposures. A screening level post-application
residential exposure and risk assessment was performed using high-end
exposure scenarios for outdoor residential uses based on end-use
product application methods and highest labeled application rates
submitted for two sample product labels containing diisopropyl adipate
as inert ingredients submitted by the registrant.
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 diisopropyl adipate to share a common mechanism
of toxicity with any other substances, and it does not produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that diisopropyl adipate
does not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
2. Prenatal and postnatal sensitivity. Fetal susceptibility was not
observed in rats, mice, rabbits or hamsters in any of the developmental
studies with adipic acid, a metabolite of diisopropyl
adipate. Maternal and developmental toxicity was not observed at doses
as high as 288 mg/kg/day. Also, in a developmental toxicity study in
rats treated with dipropyl adipate or diisobutyl adipate, analogues of
diisopropyl adipate, maternal and developmental toxicity was not
observed at >= 1,130 mg/kg/day. A 2-generation reproduction toxicity
study in rodents is not available in the database. However, the concern
for the lack of this study is low because maternal and offspring
toxicity was not observed at or above the limit dose (at levels up to
1,211 mg/kg/day) in rats and the lack of any effects on reproductive
indices in mice, rats and rabbits. In addition, there was no evidence
of histopathological changes in reproductive organs in chronic toxicity
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X SF. That decision is based on the following
i. The toxicity database for diisopropyl adipate includes several
subchronic and chronic studies, several developmental toxicity studies,
a chronic/carcinogenicity study, a mutagenicity study, and an
immunotoxicity study. In addition, the metabolism of structurally
similar compounds has been characterized, and that data supports the
proposed metabolic pathways of diisopropyl adipate. No two-generation
reproduction study is available for diisopropyl adipate; however, the
degree of concern for the lack of this study is low for the reasons
provided in Unit III.D.2.
ii. There is no indication that diisopropyl adipate is a neurotoxic
chemical. Although no neurotoxicity studies are available in the
database, no clinical signs of neurotoxicity were observed in the
available subchronic and chronic studies. Therefore, there is no need
for a developmental neurotoxicity study or additional UFs to account
iii. There was no evidence that diisopropyl adipate results in
increased susceptibility in rats, mice or hamsters in the prenatal
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to diisopropyl
adipate 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 diisopropyl adipate.
E. Aggregate Risks and Determination of Safety
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
diisopropyl adipate 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
diisopropyl adipate from food and water will utilize 1.9% of the cPAD
for children 1-2 years old, the population group receiving the greatest
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). Diisopropyl
adipate is currently used as an inert ingredient in pesticide products
that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to diisopropyl adipate.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 14,400 for both
adult males and females and 4,400 for children. Because EPA's level of
concern for diisopropyl adipate is a MOE of 100 or below, these MOEs
are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Diisopropyl adipate is currently used as an inert ingredient in
pesticide products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to diisopropyl
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 16,600 for both adult males and females and 4,800 for
children. Because EPA's level of concern for diisopropyl adipate is a
MOE of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in a 2 year rodent carcinogenicity study,
diisopropyl adipate is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to diisopropyl adipate 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
diisopropyl adipate in or on any food commodities.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for diisopropyl adipate.
C. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, the proposed
use patterns may results in applications of pesticides post-harvest.
Therefore EPA believes a more appropriate exemption would be under 40
CFR 180.910. EPA has modified the exemption requested to include an
exemption from the requirement of a tolerance for residues of
diisopropyl adipate (CAS Reg. No. 6938-94-9) under 40 CFR 180.910 when
used as an
inert ingredient in pesticide formulations applied to growing crops or
to raw agricultural commodities after harvest.
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for diisopropyl adipate (CAS Reg. No.
6938-94-9) when used as an inert ingredient (solvent) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: May 29, 2013.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.910 is amended by alphabetically adding the inert
ingredient ``Diisopropyl adipate'' to the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Inert ingredients Limits Uses
* * * * * * *
Diisopropyl adipate (CAS Reg. No. 6938- 40% in mosquito control Solvent, co-solvent.
* * * * * * *
[FR Doc. 2013-13189 Filed 6-4-13; 8:45 am]
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