[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Rules and Regulations]
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
2-Ethyl-1-hexanol; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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)
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:
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
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
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
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
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
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
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
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
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
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
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
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-
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
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
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
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
The Codex has not established a MRL for 2-ethyl-1-hexanol.
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
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: March 27, 2012.
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. In Sec. 180.910 revise the entry for 2-Ethyl-1-hexanol to read as
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.
* * * * * * *
3. In Sec. 180.930 revise the entry for 2-Ethyl-1-hexanol to read as
Sec. [emsp14]180.930 Inert Ingredients applied to animals; 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.
* * * * * * *
[FR Doc. 2012-8195 Filed 4-5-12; 8:45 am]
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