[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Rules and Regulations]
[Pages 20721-20727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8195]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0604; FRL-9342-5]


2-Ethyl-1-hexanol; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

[[Page 20722]]

SUMMARY: This regulation amends an exemption from the requirement of a 
tolerance for residues of 2-ethyl-1-hexanol (CAS no. 104-76-7) to 
increase the maximum use level for residues from 2.5% to 10% in final 
pesticide formulations, when used as an inert ingredient as a 
cosolvent, defoamer, solvent in pesticide formulations, inert 
ingredients used pre- and post-harvest, and inert ingredients applied 
to animals. Cognis submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting an amendment to the existing 
exemption for 2-ethyl-1-hexanol.

DATES: This regulation is effective April 6, 2012. Objections and 
requests for hearings must be received on or before June 5, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0604. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; 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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0604 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 
June 5, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0604, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 1E7893) by 
Cognis Corporation, c/o Lewis & Harrison LLC, 122 C St. NW., Suite 740, 
Washington, DC 20001. The petition requested that 40 CFR 180.910 and 
180.930 be amended by modifying an exemption from the requirement of a 
tolerance for residues of 2-ethyl-1-hexanol (CAS Reg. No. 104-76-7) to 
increase the maximum use level from 2.5% to 20% in final pesticide 
formulations when used as an inert ingredient as a cosolvent, defoamer, 
solvent in pesticide formulations applied to agricultural growing crops 
or to raw agricultural commodities after harvest and direct application 
to animals. That notice referenced a summary of the petition prepared 
by Cognis Corporation, c/o Lewis & Harrison LLC, 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 
increased the maximum use limit for 2-ethyl-1-hexanol under 40 CFR 
180.910 and 180.930 to 10% and not 20% as requested by the petitioner 
due to aggregate risk concern. This limitation is based on the Agency's 
risk assessment which can be found at http://www.regulations.gov in the 
document ``Decision Document for Petition Number 1E7893:2-Ethylhexanol; 
Human Health Risk Asseessment and Ecological

[[Page 20723]]

Effects Assessment for Proposed Exemption from Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations,'' 
in docket ID number EPA-HQ-OPP-2011-0604.

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 aggregate exposure for 2-ethyl-1-hexanol including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with 2-ethyl-1-hexanol 
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 2-ethyl-1-hexanol 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 available toxicity studies for 2-ethyl-1-hexanol are 
summarized in detail in the Decision Document for Petition Number 
1E7893: ``2-Ethylhexanol; Human Health Risk Assessment and Ecological 
Effects Assessment for Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations.''
    The Agency has determined that 2-ethyl-1-hexanol is of low acute 
toxicity by the oral and dermal routes. Studies in rats and mice have 
LD50s ranging from 2,000 to 6,400 milligrams/kilogram (mg/
kg) of body weight. 2-Ethyl-1-hexanol is moderately irritating to the 
skin and severely irritating to the eye. Eleven subacute and subchronic 
studies have been performed with 2-ethyl-1-hexanol.
    All the studies show that repeated exposure to 2-ethyl-1-hexanol 
has low potential for toxicity. The major target organ for 2-ethyl-1-
hexanol is the liver with peroxisome proliferation as the major hepatic 
endpoint. The lowest NOAEL was observed in rats at 100 mg/kg/day based 
on liver weights and liver peroxisomes at the LOAEL of 320 mg/kg/day. 
No neurotoxic effects, even at high doses, were observed in the 
subchronic or chronic studies, so there is no reason to assume 2-ethyl-
1-hexanol has neurotoxic potential.
    Numerous genotoxicity studies have been conducted with 2-ethyl-1-
hexanol, including five Ames tests, an in vitro cell transformation 
assay, an 8-azaguanine resistance assay, a mouse micronucleus test, a 
mouse lymphoma assay, a Rec-assay, a CHO mutation assay, an unscheduled 
DNA synthesis assay, an in vivo dominant lethal assay and an in vivo 
chromosomal aberration assay. The results of all in vitro assays except 
the 8-azaguinine resistance assay were negative and all in vivo studies 
were negative as well. The genotoxicity data clearly indicate that 2-
ethyl-1-hexanol is not mutagenic.
    Carcinogenicity studies in both rats and mice were conducted. In 
the mouse study, male and female mice were gavaged with 2-ethyl-1-
hexanol at doses of 0, 50, 200 or 750 mg/kg/day for 18 months. No 
substance-related changes were seen at 50 or 200 mg/kg/day. At 750 mg/
kg/day, reduced body weight gain related to decreased food consumption 
and increased mortality was noted. Treatment-related hematological 
changes were seen, and slight but not statistically significant 
increases were noted in focal hyperplasia of the epithelium of the 
forestomach. No statistically significant increases in tumor incidence 
were noted in mice. In the rat study, male and female rats were gavaged 
five days/week for 24 months at 0, 50, 150 or 500 mg/kg/day. Dose-
related reduced body weight gain was noted at 150 mg/kg/day and higher. 
Clinical findings included poor general condition, labored breathing, 
and piloerection. Increased mortality occurred in females at 500 mg/kg/
day. No increase in tumor incidence was noted. Based on the results of 
the rat and mice studies and lack of mutagenicity concerns, it can be 
reasonably concluded that 2-ethyl-1-hexanol is not likely to be 
carcinogenic.
    Developmental toxicity studies have been performed with 2-ethyl-1-
hexanol; and a reproductive study has been performed using diethylhexyl 
adipate (DEHA) that readily metabolizes to 2-ethyl-1-hexanol in 
mammals. EPA concluded that none of the studies

[[Page 20724]]

showed any developmental or reproductive toxicity associated with 2-
ethyl-1-hexanol, even at high dose levels.

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.
    Several subchronic, chronic/carcinogenicity studies are available 
for 2-ethyl-1-hexanol. No endpoint of concern for acute exposure was 
identified in the available database. The NOAEL, from the 
carcinogenicity study in rat was 50 mg/kg/day based on dose-related 
reduced body weights at the LOAEL of 450 mg/kg/day. The chronic RfD is 
0.5 mg/kg/day using a hundredfold uncertainty factor (10X intraspecies 
and 10X interspecies variation). The population adjusted dose is equal 
to chronic RfD (0.5 mg/kg/day) since the FQPA factor is reduced from 
10X to 1X. This endpoint of concern was used for all exposure durations 
in order to be conservative in the risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 2-ethyl-1-hexanol EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from 2-ethyl-1-hexanol in food as follows: The I-
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 (every food eaten by a person each day has tolerance-level 
residues).
    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 2-ethyl-1-hexanol, 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).
    There are no current residential uses known to the Agency and thus 
no residential exposures are expected. Therefore, a residential 
exposure assessment was not conducted.
    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 2-ethyl-1-hexanol to share a common mechanism of 
toxicity with any other substances, and 2-ethyl-1-hexanol does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
2-ethyl-1-hexanol 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 
factor.
    2. Prenatal and postnatal sensitivity. There are several 
developmental toxicity studies available in mice and rats by the gavage 
route. One developmental toxicity study in rats via inhalation and a 
dermal developmental toxicity study in mice are also available. In one 
developmental toxicity study in mice via oral route, no developmental 
toxicity was observed at the highest dose of 1,525 mg/kg/day. In a 
separate developmental toxicity study in mice via oral route, no 
developmental effects were observed at doses up to 135 mg/kg/day (the 
highest dose tested, HDT). In a rat developmental toxicity study via 
oral routes, the NOAEL for developmental and maternal toxicity was 800 
mg/kg/day based on hydronephrosis and tail abnormalities seen at the 
LOAEL of 1,600 mg/kg/day above the limit dose of 1,000 mg/kg/day. No 
developmental toxicity was seen in rats (inhalation) and mice (dermal) 
at doses up to 850 mg/m\3\ and 2,520 mg/kg/day, respectively. The 
available data on developmental toxicity studies with 2-ethyl-1-hexanol 
clearly indicate no evidence of increased susceptibility for infants 
and children. No two generation reproduction study is available in the 
database for 2-ethyl-1-hexanol, however, no effects on sperm and other 
reproductive parameters were observed in rats at doses up to 1,080 mg/
kg/day when fed on diets containing diethylhexyl adipate (DEHA). In 
mammals, DEHA is readily metabolized to 2-ethyl-1-hexanol. None of the 
studies showed any developmental or reproductive toxicity associated 
with 2-

[[Page 20725]]

ethyl-1-hexanol, even at high dose levels.
    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. That decision is based on the following 
findings:
    i. The toxicity database for 2-ethyl-1-hexanol includes several 
subchronic, chronic/carcinogenicity studies, mutagenicity studies, 
metabolism studies, and developmental studies. No two generation 
reproduction study is available in the database for 2-ethylhexanol, 
however, no effects on sperm and other reproductive parameters were 
observed in rats at doses up to 1,080 mg/kg/day when fed on diets 
containing diethylhexyl adipate (DEHA). In mammals, DEHA is readily 
metabolized to 2-ethylhexanol.
    ii. There is no indication that 2-ethyl-1-hexanol is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity. 
No neurotoxicity studies are available in the database, however, no 
clinical signs of neurotoxicity were observed in the available 
subchronic and chronic studies. Therefore, the developmental 
neurotoxicity study is not necessary at this time.
    iii. No immunotoxicity study is available, however, there were no 
effects on the thymus or spleen indicated in the available database. 
Therefore, an immunotoxicity study is not required.
    iv. There is no evidence that 2-ethyl-1-hexanol results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in the 2-generation reproduction study with a 
surrogate chemical.
    v. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. The food exposure assessments are considered 
to be highly conservative as they are based on the use of the highest 
tolerance level from the surrogate pesticides for every food and 100% 
crop treated is assumed for all crops. EPA also made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to 2-ethyl-1-hexanol in drinking water. These 
assessments will not underestimate the exposure and risks posed by 2-
ethyl-1-hexanol.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population adjusted dose (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, 
2-ethyl-1-hexanol 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 
2-ethyl-1-hexanol from food and water will utilize 7.7% of the cPAD for 
U.S. population and 25% for children age 1 to 2 years, the population 
group receiving the greatest exposure. There are no residential uses 
for 2-ethyl-1-hexanol. Based on the explanation in this unit, regarding 
residential use patterns, chronic residential exposure to residues of 
2-ethyl-1-hexanol is not expected.
    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). A short-term 
adverse effect was identified; however, 2-ethyl-1-hexanol is not 
currently used as an inert ingredient in pesticide products that are 
registered for any use patterns that would result in short-term 
residential exposure. Short-term risk is assessed based on short-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short-term risk is necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term risk for 
2-ethyl-1-hexanol.
    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).
    An intermediate-term adverse effect was identified; however, 2-
ethyl-1-hexanol is not currently used as an inert ingredient in 
pesticide products that are registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for 2-ethyl-1-hexanol.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies and lack of mutagenicity concerns, 2-ethyl-1-hexanol 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 2-ethyl-1-hexanol 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 2-
ethyl-1-hexanol in or on any food commodities. EPA is establishing a 
limitation on the amount of 2-ethyl-1-hexanol that may be used in 
pesticide formulations. 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 for sale or distribution that contains 
greater than 10% of 2-ethyl-1-hexanol in food use pesticide 
formulations.

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

[[Page 20726]]

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 2-ethyl-1-hexanol.

VI. Conclusions

    Therefore, the exemptions from the requirement of a tolerance for 
2-ethyl-1-hexanol (CAS Reg. No. 104-76-7) at 40 CFR 180.910 and 180.930 
are amended to increase the maximum use level from 2.5% to 10% in final 
pesticide formulations.

VII. Statutory and Executive Order Reviews

    This final rule amends an exemption from the requirement for 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 Governmentsx'' (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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: March 27, 2012.
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. In Sec.  180.910 revise the entry for 2-Ethyl-1-hexanol to read as 
follows:


Sec.  [emsp14]180.910  Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------
 
                              * * * * * * *
2-Ethyl-1-hexanol (CAS Reg.   Not more than 10% of  Solvent, adjuvant of
 No. 104-76-7).                pesticide.            surfactants.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930 revise the entry for 2-Ethyl-1-hexanol to read as 
follows:


Sec.  [emsp14]180.930  Inert Ingredients applied to animals; exemptions 
from the requirement of a tolerance.

* * * * *

[[Page 20727]]



------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------
 
                              * * * * * * *
2-Ethyl-1-hexanol (CAS Reg.   Not more than 10% of  Solvent adjuvant of
 No. 104-76-7).                pesticide.            surfactants.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2012-8195 Filed 4-5-12; 8:45 am]
BILLING CODE 6560-50-P