28266 Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 

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 

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 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/textidx?&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:// 


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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-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 

(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 


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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 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 


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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 


emcdonald on DSK29S0YB1PROD with RULES
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 

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] 

■ 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: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0421; FRL–9346–7] 

Fluxapyroxad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: 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). 

ADDRESSES: 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 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: 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 

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 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 

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–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). 


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