Document ID: EPA-HQ-OPP-2008-0039-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Acetone
Posted Date: 2012-05-14T04:00Z

[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]

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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.

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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 http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: 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 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-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: 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 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, http://

[[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 http://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 http://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 http://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