Diisopropyl Adipate; Exemption From the Requirement of a Tolerance, 33748-33754 [2013-13189]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33748-33754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13189]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0469; FRL-9387-8]


Diisopropyl Adipate; 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 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 https://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 https://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: Lieu.David@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

[[Page 33749]]

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 https://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 https://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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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, https://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 
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

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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 
unit.
    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 
of rabbits.
    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 
available studies.
    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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.

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    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 https://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 
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).
    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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not 
observed in rats, mice, rabbits or hamsters in any of the developmental 
studies with adipic acid, a metabolite of diisopropyl

[[Page 33752]]

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 
studies.
    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 
findings:
    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 
for neurotoxicity.
    iii. There was no evidence that diisopropyl adipate results in 
increased susceptibility in rats, mice or hamsters in the prenatal 
developmental studies
    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 
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). 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 
adipate.
    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

[[Page 33753]]

inert ingredient in pesticide formulations applied to growing crops or 
to raw agricultural commodities after harvest.

VI. Conclusions

    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 
recordkeeping requirements.

    Dated: May 29, 2013.
Lois Rossi,
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. 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.
 94-9).                                    formulations.
 
                                                  * * * * * * *
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[FR Doc. 2013-13189 Filed 6-4-13; 8:45 am]
BILLING CODE 6560-50-P