Acetone; Exemption From the Requirement of a Tolerance, 28266-28270 [2012-11623]
Download as PDF
28266
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Mark Dow, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5533; email address:
dow.mark@epa.gov.
SUPPLEMENTARY INFORMATION:
continues to meet the 24-hour 2006
PM2.5 NAAQS.
[FR Doc. 2012–11184 Filed 5–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0039; FRL–9344–2]
Acetone; Exemption From the
Requirement of a Tolerance
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of acetone (67–
64–1) when used as an inert ingredient
as a solvent or co-solvent, 40 CFR
180.930, in pesticides products applied
to animals. Whitmire Micro-Gen (now
affiliated with BASF Corp.; 3568 Tree
Court Industrial Blvd., St. Louis, MO
63112) submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of acetone.
DATES: This regulation is effective May
14, 2012. Objections and requests for
hearings must be received on or before
July 13, 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).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0039. All documents in the
docket are listed in the docket index
available at https://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
https://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,
emcdonald on DSK29S0YB1PROD with RULES
ADDRESSES:
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
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 https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&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
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0039 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 July 13, 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–2008–0039, by one of
the following methods:
• Federal eRulemaking Portal: https://
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 February 6,
2008 (73 FR 6966) (FRL–8350–9), EPA
issued a notice pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
7E7239) by Whitmire Micro-Gen (now
affiliated with BASF Corp.; 3568 Tree
Court Industrial Blvd., St. Louis, MO
63112). The petition requested that 40
CFR 180.930 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of acetone (Cas Reg. No. 67–64–1) when
used as an inert ingredient as a solvent
or co-solvent in pesticide formulations
applied to animals. That notice
referenced a summary of the petition
prepared by Whitmire Micro-Gen (now
affiliated with BASF Corp.; 3568 Tree
Court Industrial Blvd., St. Louis, MO
63112), the petitioner, which is
available in the docket, https://
E:\FR\FM\14MYR1.SGM
14MYR1
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit V.C.
emcdonald on DSK29S0YB1PROD with RULES
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
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
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 acetone
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with acetone 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 acetone as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in this unit.
The toxicity data base for acetone
includes data relative to acetone per se
as well as to isopropanol. Since
isopropanol readily metabolizes to
acetone in the body, the Agency has
concluded that the data regarding
isopropanol may be used in conjunction
with the data regarding acetone to
characterize the toxicity of acetone.
Acetone has low acute toxicity. It is
not a skin irritant or sensitizer but is a
defatting agent to the skin. Acetone is an
eye irritant.
The toxicity of acetone was evaluated
in several subchronic toxicity studies in
mice and rats via drinking water, gavage
and inhalation. The most notable
findings in subchronic studies were
increased liver and kidney weights, and
decreased spleen weights. In mice
administered acetone via drinking
water, adverse effects (liver and kidney
toxicity) were observed at doses ≥1,600
milligrams/kilogram/bodyweight/day
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
28267
(mg/kg/bw/day). Rats treated with
acetone via gavage for 90 days exhibited
decreased body weight and increased
relative kidney and liver weights,
hemosiderosis of the spleen and an
increased incidence and severity of
nephropathy at 1,700 mg/kg/day. The
NOAEL in rats was 900 mg/kg/day. In
a subchronic toxicity study in rats via
gavage, acetone resulted in kidney
weight changes and lesions at 500 mg/
kg/day. The NOAEL in this study was
100 mg/kg/day. Male Sprague-Dawley
rats were exposed to acetone via
inhalation at a concentration of 19,000
ppm (45,106 mg/m3) for 3 hours/day, 5
days/week, for 8 weeks. Groups were
sacrificed after 2, 4, and 8 weeks and 2
weeks post-exposure. No treatment
related effects were observed in this
study at exposure concentrations of
19,000 ppm (equal to 11,703 mg/kg/
day). No dermal toxicity studies were
available.
Acetone was evaluated in a
reproduction screening test with mice
via gavage at a dose of 3,500 mg/kg/day
and controls receiving no test
compound. Toxicity was manifested as
decreased reproductive index, increased
gestation length, reduced birth weights,
decreased neonatal survival and
increased neonatal weight gain at 3,500
mg/kg/day. In a 2-generation
reproduction study conducted in rats
with isopropanol, the maternal NOAEL
was 500 mg/kg/day based on increased
in liver and kidney weights (absolute
and relative) seen at the LOAEL of 1,000
mg/kg/day. The offspring toxicity
NOAEL was 500 mg/kg/day based on
reduced pup body weights and a slight
increase in pup mortality seen at the
LOAEL of 1,000 mg/kg/day. No
reproductive parameters were altered at
doses up to 1,000 mg/kg/day. Two
developmental toxicity studies in
rodents exposed to acetone via the
inhalation route of exposure were also
available for review. In mice, maternal
(increased incidence of late resorptions)
and fetal (reduced weight) toxicities
were observed at the same dose, 6,600
ppm (approximately 4,066 mg/kg/day).
No teratogenic effects were observed in
mice. The NOAEL was 2,200 ppm
(equivalent to 1,348 mg/kg/day). In rats,
maternal (reduction in body weight,
uterine weight and extra-gestational
weight gain) and fetal (malformations)
toxicities were observed at the same
dose, 11,000 ppm (approximately 6,773
mg/kg/day). The NOAEL was 2,200 ppm
(equivalent to 1,348 mg/kg/day). In a
developmental toxicity study in rats via
gavage with isopropanol, the NOAELs
for maternal and developmental
toxicities were 400 mg/kg/day based on
E:\FR\FM\14MYR1.SGM
14MYR1
emcdonald on DSK29S0YB1PROD with RULES
28268
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
slightly increased mortality at 800 mg/
kg/day and reduced gestational body
weight and reduced gravid uterine
weights at 1,200 mg/kg/day. Reduced
fetal body weights were observed at 800
and 1,200 mg/kg/day. There was also a
developmental toxicity study in rabbits
treated with isopropanol via gavage.
Maternal toxicity was manifested as
reduced body weight and food
consumption at 480 mg/kg/day. The
NOAEL was 240 mg/kg/day. There were
no treatment related effects observed in
fetuses up to the highest dose tested
(480 mg/kg/day). In a developmental
neurotoxicity study in rats with
isopropanol, no developmental
neurotoxicity was observed at doses up
to 1,200 mg/kg/day.
Subchronic neurotoxicity studies
were available in rats administered
acetone via the inhalation or dietary
routes of exposure. Repeated daily
exposures up to 14,240 mg/m3 of
acetone produced an inhibition of
avoidance behavior but did not produce
any signs of motor imbalance. Following
acetone administered via inhalation,
rats exhibited transient ataxia at >28,480
ppm (approximately 17,544 mg/kg/day).
When acetone was administered in the
diet for 14 weeks, neurotoxicity was not
observed at concentrations up to 1.0%
(approximately 5,000 mg/kg/day).
Information on the carcinogenicity of
acetone is available from dermal studies
performed with acetone used as a
vehicle. An increased incidence of
tumor formation was not observed up to
0.2 milliliter (ml) of acetone in mice.
Carcinogenicity studies in rodents
administered isopropanol via
inhalation, did not exhibit an increased
incidence of tumor formation up to
5,000 ppm (approximately 3,086 mg/kg/
day).
Acetone is normally eliminated
mainly by enzymatic metabolism (70–
80% of the total body burden) or
excreted via urine or exhaled following
inhalation exposure (human volunteer
study). The first step includes the
oxidation to acetol by acetone
monooxygenase, associated with
cytochrome P450IIE1. This step is
followed by two different pathways that
both lead to the formation of pyruvate
which—as a key product of
intermediary metabolism—can enter
various pathways, e.g. gluconeogenesis
or the citric acid cycle. Acetone is
excreted mainly via the lung both
unchanged and, following metabolism,
as carbon dioxide.
Specific information on the studies
received and the nature of the adverse
effects caused by acetone as well as the
NOAEL and the LOAEL from the
toxicity studies can be found at https://
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
www.regulations.gov in the document
‘‘Acetone—Decision Document for
Pesticide Petition 7E7239, Acetone, CAS
No. 67–64–1; PC Code 844101’’, in
docket ID number EPA–HQ–OPP–2008–
0039.
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.
Acetone is currently permitted for use
as an inert ingredient in pesticide
formulations applied pre and post
harvest under 40 CFR 180.910. Acetone
occurs or is found in a variety of foods
and consumer products. Acetone has
been approved by FDA as a secondary
direct food additive (21 CFR 173.210).
The available toxicity studies indicate
that acetone has very low toxicity. The
NOAELs were 900 mg/kg/day and above
except one 90-day toxicity study in rats
via gavage in which the NOAEL of 100
mg/kg/day was based on kidney toxicity
seen at the LOAEL of 500 mg/kg/day.
Differences in the observed effect level
between the drinking water/dietary
study and the gavage study may relate
to the metabolism of acetone. EPA’s
Integrated Risk Information System
(IRIS) concluded that the drinking water
route is considered to more closely
mimic potential long-term human
exposure scenarios. For this reason, EPA
concluded that the results of gavage
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
study in the case of acetone may not be
appropriate for the long term risk
assessments. As indicated in this Unit,
the lowest NOAEL identified in the
database is 900 mg/kg/bw/day. For all
practical purposes, that is the Agency’s
identified limit dose. For materials that
show no signs of toxicity at or above the
limit dose, quantitative risk assessment
is not necessary. Since no endpoint of
concern was identified for the acute and
chronic dietary exposure assessment
and short and intermediate dermal and
inhalation exposure, a quantitative risk
assessment for acetone is not necessary.
C. Exposure Assessment
No hazard endpoint of concern was
identified for the acute and chronic
dietary assessment (food and drinking
water), or for the short, intermediate,
and long term dermal and inhalation
residential assessments, therefore, acute
and chronic dietary and short-,
intermediate-,and long-term dermal and
inhalation residential exposure
assessments are not necessary.
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 acetone to share a
common mechanism of toxicity with
any other substances, and acetone does
not appear to produce a toxic metabolite
produced by other substances, however,
isopropanol is readily metabolized to
acetone in humans. For both
isopropanol and its metabolite, acetone,
no endpoint of concerns were identified
for various dietary and non-dietary
exposure scenarios. For the purposes of
this tolerance action, therefore, EPA has
assumed that acetone 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
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
E:\FR\FM\14MYR1.SGM
14MYR1
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
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.
The toxicity database is sufficient for
acetone and potential exposure is
adequately characterized given the low
toxicity of the chemical. In terms of
hazard, there are no concerns and no
residual uncertainties regarding prenatal
and/or postnatal toxicity. The lowest
NOAEL identified in the database for
risk assessment is 900 mg/kg/day. No
evidence of increased susceptibility was
observed in the available reproduction
studies, developmental studies and
developmental neurotoxicity study
(isopropanol). In these studies
developmental toxicity was observed in
the presence maternal toxicity and at or
above the limit dose of 1,000 mg/kg/day.
Therefore, a safety factor analysis has
not been used to assess risk.
Accordingly, there is no reason to apply
an additional safety factor to protect
infants and children.
E. Aggregate Risks and Determination of
Safety
Given the lack of concern for hazard
posed by acetone, EPA concludes that
there are no dietary or aggregate dietary/
non-dietary risks of concern as a result
of exposure to acetone in food and water
or from residential exposure. As
discussed in this unit, EPA expects
aggregate exposure to acetone to pose no
appreciable dietary risk given that the
data show a lack of systemic toxicity at
doses ≥900 mg/kg/day and a lack of any
increased susceptibility of infants and
children. Taking into consideration of
all available information on acetone,
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
acetone residues.
V. Other Considerations
emcdonald on DSK29S0YB1PROD with RULES
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
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 acetone.
C. Response to Comments
The Agency received one comment
from a private citizen who opposed the
proposed exemption. The Agency
understands the commenter’s concerns
and recognizes that some individuals
believe that no residue of pesticides
should be allowed. However, under the
existing legal framework provided by
section 408 of the FFDCA, EPA is
authorized to establish pesticide
tolerances or exemptions where persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
the statute.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.930 for acetone (67–
64–1) when used as an inert ingredient
(as solvent or co-solvent) in pesticide
formulations applied to animals.
VII. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirements 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,
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
28269
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) (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
E:\FR\FM\14MYR1.SGM
14MYR1
28270
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
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
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 2, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
Therefore, 40 CFR chapter I is
amended as follows:
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
Environmental protection,
Administrative practice and procedure,
*
*
*
*
Inert ingredients
Limits
*
*
*
*
*
Acetone (Cas Reg. No. 67–64–1) .................................................................................................
*
......................................
*
*
*
[FR Doc. 2012–11623 Filed 5–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0421; FRL–9346–7]
Fluxapyroxad; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fluxapyroxad
in or on multiple commodities which
are identified and discussed later in this
document. BASF Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
14, 2012. Objections and requests for
hearings must be received on or before
July 13, 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).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0421. All documents in the
docket are listed in the docket index
available at https://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
emcdonald on DSK29S0YB1PROD with RULES
ADDRESSES:
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
*
*
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://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: Olga
Odiott, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9369; email address:
odiott.olga@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. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• 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 to provide 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
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
*
Uses
*
*
solvent or cosolvent.
*
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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://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
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–2010–0421 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 July 13, 2012. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
E:\FR\FM\14MYR1.SGM
14MYR1
Agencies
[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28266-28270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11623]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0039; FRL-9344-2]
Acetone; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of acetone (67-64-1) when used as an inert
ingredient as a solvent or co-solvent, 40 CFR 180.930, in pesticides
products applied to animals. Whitmire Micro-Gen (now affiliated with
BASF Corp.; 3568 Tree Court Industrial Blvd., St. Louis, MO 63112)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of acetone.
DATES: This regulation is effective May 14, 2012. Objections and
requests for hearings must be received on or before July 13, 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-2008-0039. All documents in the
docket are listed in the docket index available at https://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 https://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: Mark Dow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-5533; email address: dow.mark@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.
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 https://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 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-2008-0039 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
July 13, 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-2008-0039, by one of the following methods:
Federal eRulemaking Portal: https://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 February 6, 2008 (73 FR 6966) (FRL-8350-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 7E7239) by Whitmire
Micro-Gen (now affiliated with BASF Corp.; 3568 Tree Court Industrial
Blvd., St. Louis, MO 63112). The petition requested that 40 CFR 180.930
be amended by establishing an exemption from the requirement of a
tolerance for residues of acetone (Cas Reg. No. 67-64-1) when used as
an inert ingredient as a solvent or co-solvent in pesticide
formulations applied to animals. That notice referenced a summary of
the petition prepared by Whitmire Micro-Gen (now affiliated with BASF
Corp.; 3568 Tree Court Industrial Blvd., St. Louis, MO 63112), the
petitioner, which is available in the docket, https://
[[Page 28267]]
www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit V.C.
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 acetone including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with acetone 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 acetone 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 toxicity data base for acetone includes data relative to
acetone per se as well as to isopropanol. Since isopropanol readily
metabolizes to acetone in the body, the Agency has concluded that the
data regarding isopropanol may be used in conjunction with the data
regarding acetone to characterize the toxicity of acetone.
Acetone has low acute toxicity. It is not a skin irritant or
sensitizer but is a defatting agent to the skin. Acetone is an eye
irritant.
The toxicity of acetone was evaluated in several subchronic
toxicity studies in mice and rats via drinking water, gavage and
inhalation. The most notable findings in subchronic studies were
increased liver and kidney weights, and decreased spleen weights. In
mice administered acetone via drinking water, adverse effects (liver
and kidney toxicity) were observed at doses >=1,600 milligrams/
kilogram/bodyweight/day (mg/kg/bw/day). Rats treated with acetone via
gavage for 90 days exhibited decreased body weight and increased
relative kidney and liver weights, hemosiderosis of the spleen and an
increased incidence and severity of nephropathy at 1,700 mg/kg/day. The
NOAEL in rats was 900 mg/kg/day. In a subchronic toxicity study in rats
via gavage, acetone resulted in kidney weight changes and lesions at
500 mg/kg/day. The NOAEL in this study was 100 mg/kg/day. Male Sprague-
Dawley rats were exposed to acetone via inhalation at a concentration
of 19,000 ppm (45,106 mg/m\3\) for 3 hours/day, 5 days/week, for 8
weeks. Groups were sacrificed after 2, 4, and 8 weeks and 2 weeks post-
exposure. No treatment related effects were observed in this study at
exposure concentrations of 19,000 ppm (equal to 11,703 mg/kg/day). No
dermal toxicity studies were available.
Acetone was evaluated in a reproduction screening test with mice
via gavage at a dose of 3,500 mg/kg/day and controls receiving no test
compound. Toxicity was manifested as decreased reproductive index,
increased gestation length, reduced birth weights, decreased neonatal
survival and increased neonatal weight gain at 3,500 mg/kg/day. In a 2-
generation reproduction study conducted in rats with isopropanol, the
maternal NOAEL was 500 mg/kg/day based on increased in liver and kidney
weights (absolute and relative) seen at the LOAEL of 1,000 mg/kg/day.
The offspring toxicity NOAEL was 500 mg/kg/day based on reduced pup
body weights and a slight increase in pup mortality seen at the LOAEL
of 1,000 mg/kg/day. No reproductive parameters were altered at doses up
to 1,000 mg/kg/day. Two developmental toxicity studies in rodents
exposed to acetone via the inhalation route of exposure were also
available for review. In mice, maternal (increased incidence of late
resorptions) and fetal (reduced weight) toxicities were observed at the
same dose, 6,600 ppm (approximately 4,066 mg/kg/day). No teratogenic
effects were observed in mice. The NOAEL was 2,200 ppm (equivalent to
1,348 mg/kg/day). In rats, maternal (reduction in body weight, uterine
weight and extra-gestational weight gain) and fetal (malformations)
toxicities were observed at the same dose, 11,000 ppm (approximately
6,773 mg/kg/day). The NOAEL was 2,200 ppm (equivalent to 1,348 mg/kg/
day). In a developmental toxicity study in rats via gavage with
isopropanol, the NOAELs for maternal and developmental toxicities were
400 mg/kg/day based on
[[Page 28268]]
slightly increased mortality at 800 mg/kg/day and reduced gestational
body weight and reduced gravid uterine weights at 1,200 mg/kg/day.
Reduced fetal body weights were observed at 800 and 1,200 mg/kg/day.
There was also a developmental toxicity study in rabbits treated with
isopropanol via gavage. Maternal toxicity was manifested as reduced
body weight and food consumption at 480 mg/kg/day. The NOAEL was 240
mg/kg/day. There were no treatment related effects observed in fetuses
up to the highest dose tested (480 mg/kg/day). In a developmental
neurotoxicity study in rats with isopropanol, no developmental
neurotoxicity was observed at doses up to 1,200 mg/kg/day.
Subchronic neurotoxicity studies were available in rats
administered acetone via the inhalation or dietary routes of exposure.
Repeated daily exposures up to 14,240 mg/m\3\ of acetone produced an
inhibition of avoidance behavior but did not produce any signs of motor
imbalance. Following acetone administered via inhalation, rats
exhibited transient ataxia at >28,480 ppm (approximately 17,544 mg/kg/
day). When acetone was administered in the diet for 14 weeks,
neurotoxicity was not observed at concentrations up to 1.0%
(approximately 5,000 mg/kg/day).
Information on the carcinogenicity of acetone is available from
dermal studies performed with acetone used as a vehicle. An increased
incidence of tumor formation was not observed up to 0.2 milliliter (ml)
of acetone in mice. Carcinogenicity studies in rodents administered
isopropanol via inhalation, did not exhibit an increased incidence of
tumor formation up to 5,000 ppm (approximately 3,086 mg/kg/day).
Acetone is normally eliminated mainly by enzymatic metabolism (70-
80% of the total body burden) or excreted via urine or exhaled
following inhalation exposure (human volunteer study). The first step
includes the oxidation to acetol by acetone monooxygenase, associated
with cytochrome P450IIE1. This step is followed by two different
pathways that both lead to the formation of pyruvate which--as a key
product of intermediary metabolism--can enter various pathways, e.g.
gluconeogenesis or the citric acid cycle. Acetone is excreted mainly
via the lung both unchanged and, following metabolism, as carbon
dioxide.
Specific information on the studies received and the nature of the
adverse effects caused by acetone as well as the NOAEL and the LOAEL
from the toxicity studies can be found at https://www.regulations.gov in
the document ``Acetone--Decision Document for Pesticide Petition
7E7239, Acetone, CAS No. 67-64-1; PC Code 844101'', in docket ID number
EPA-HQ-OPP-2008-0039.
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.
Acetone is currently permitted for use as an inert ingredient in
pesticide formulations applied pre and post harvest under 40 CFR
180.910. Acetone occurs or is found in a variety of foods and consumer
products. Acetone has been approved by FDA as a secondary direct food
additive (21 CFR 173.210). The available toxicity studies indicate that
acetone has very low toxicity. The NOAELs were 900 mg/kg/day and above
except one 90-day toxicity study in rats via gavage in which the NOAEL
of 100 mg/kg/day was based on kidney toxicity seen at the LOAEL of 500
mg/kg/day. Differences in the observed effect level between the
drinking water/dietary study and the gavage study may relate to the
metabolism of acetone. EPA's Integrated Risk Information System (IRIS)
concluded that the drinking water route is considered to more closely
mimic potential long-term human exposure scenarios. For this reason,
EPA concluded that the results of gavage study in the case of acetone
may not be appropriate for the long term risk assessments. As indicated
in this Unit, the lowest NOAEL identified in the database is 900 mg/kg/
bw/day. For all practical purposes, that is the Agency's identified
limit dose. For materials that show no signs of toxicity at or above
the limit dose, quantitative risk assessment is not necessary. Since no
endpoint of concern was identified for the acute and chronic dietary
exposure assessment and short and intermediate dermal and inhalation
exposure, a quantitative risk assessment for acetone is not necessary.
C. Exposure Assessment
No hazard endpoint of concern was identified for the acute and
chronic dietary assessment (food and drinking water), or for the short,
intermediate, and long term dermal and inhalation residential
assessments, therefore, acute and chronic dietary and short-,
intermediate-,and long-term dermal and inhalation residential exposure
assessments are not necessary.
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 acetone to share a common mechanism of toxicity
with any other substances, and acetone does not appear to produce a
toxic metabolite produced by other substances, however, isopropanol is
readily metabolized to acetone in humans. For both isopropanol and its
metabolite, acetone, no endpoint of concerns were identified for
various dietary and non-dietary exposure scenarios. For the purposes of
this tolerance action, therefore, EPA has assumed that acetone 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
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
[[Page 28269]]
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.
The toxicity database is sufficient for acetone and potential
exposure is adequately characterized given the low toxicity of the
chemical. In terms of hazard, there are no concerns and no residual
uncertainties regarding prenatal and/or postnatal toxicity. The lowest
NOAEL identified in the database for risk assessment is 900 mg/kg/day.
No evidence of increased susceptibility was observed in the available
reproduction studies, developmental studies and developmental
neurotoxicity study (isopropanol). In these studies developmental
toxicity was observed in the presence maternal toxicity and at or above
the limit dose of 1,000 mg/kg/day. Therefore, a safety factor analysis
has not been used to assess risk. Accordingly, there is no reason to
apply an additional safety factor to protect infants and children.
E. Aggregate Risks and Determination of Safety
Given the lack of concern for hazard posed by acetone, EPA
concludes that there are no dietary or aggregate dietary/non-dietary
risks of concern as a result of exposure to acetone in food and water
or from residential exposure. As discussed in this unit, EPA expects
aggregate exposure to acetone to pose no appreciable dietary risk given
that the data show a lack of systemic toxicity at doses >=900 mg/kg/day
and a lack of any increased susceptibility of infants and children.
Taking into consideration of all available information on acetone, 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 acetone residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
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 acetone.
C. Response to Comments
The Agency received one comment from a private citizen who opposed
the proposed exemption. The Agency understands the commenter's concerns
and recognizes that some individuals believe that no residue of
pesticides should be allowed. However, under the existing legal
framework provided by section 408 of the FFDCA, EPA is authorized to
establish pesticide tolerances or exemptions where persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by the statute.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.930 for acetone (67-64-1) when used as an
inert ingredient (as solvent or co-solvent) in pesticide formulations
applied to animals.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirements 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) (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
[[Page 28270]]
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: May 2, 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. 180.930, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Acetone (Cas Reg. No. 67-64-1)........... ............................ solvent or cosolvent.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[FR Doc. 2012-11623 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P