36342 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 

the telephone number for the Air Docket 

Center is (202) 566–1741. 

In addition to being available in the 

docket, an electronic copy of this 

Federal Register notice is also available 

on the World Wide Web at http:// 

www.epa.gov/climatechange/emissions/ 

ghgrulemaking.html. 

List of Subjects in 40 CFR Part 98 

Environmental Protection, 

Administrative practice and procedures, 

Air pollution control, Monitoring, 

Reporting and recordkeeping. 

Dated: June 15, 2011. 

Lisa P. Jackson, 

Administrator. 

For the reasons discussed in the 

preamble, title 40, chapter I, of the Code 

of Federal Regulations is amended as 

follows: 

PART 98—[AMENDED] 

■ 1. The authority citation for part 98 

continues to read as follows: 

Authority: 42 U.S.C. 7401–7671q. 

Subpart I—[Amended] 

■ 2. Section 98.94 is amended as 

follows: 

■ a. By revising paragraph (a)(1) 

introductory text. 

■ b. By revising paragraph (a)(3) 

introductory text. 

■ c. By revising paragraph (a)(3)(i). 

■ d. By revising paragraph (a)(4)(i). 

§ 98.94 Monitoring and QA/QC 

requirements. 

(a) * * * 

(1) Best available monitoring 

methods. From January 1, 2011 through 

September 30, 2011, owners or 

operators may use best available 

monitoring methods for any parameter 

that cannot reasonably be measured 

according to the monitoring and QA/QC 

requirements of this subpart. The owner 

or operator must use the calculation 

methodologies and equations in § 98.93, 

but may use the best available 

monitoring method for any parameter 

for which it is not reasonably feasible to 

acquire, install, or operate a required 

piece of monitoring equipment in a 

facility, or to procure necessary 

measurement services by January 1, 

2011. Starting no later than October 1, 

2011, the owner or operator must 

discontinue using best available 

monitoring methods and begin 

following all applicable monitoring and 

QA/QC requirements of this part, except 

as provided in paragraphs (a)(2), (a)(3), 

or (a)(4) of this section. Best available 

monitoring methods means any of the 

following methods specified in this 

paragraph: 

* * * * * 

(3) Requests for extension of the use 

of best available monitoring methods in 

2011 for recipe-specific utilization and 

by-product formation rates for the 

plasma etching process type under 

§ 98.93(a)(2)(ii)(A). The owner or 

operator may submit a request to the 

Administrator under this paragraph 

(a)(3) to use one or more best available 

monitoring methods to estimate 

emissions that occur between October 1, 

2011 and December 31, 2011 for recipespecific utilization and by-product 

formation rates for the etching process 

type under § 98.93(a)(2)(ii)(A). 

(i) Timing of request. The extension 

request must be submitted to EPA no 

later than September 30, 2011. 

* * * * * 

(4) * * * 

(i) Timing of request. The extension 

request must be submitted to EPA no 

later than September 30, 2011. 

* * * * * 

[FR Doc. 2011–15650 Filed 6–21–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0330; FRL–8875–9] 

2-methyl-2,4-pentanediol; 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 2-methyl-2,4- 

pentanediol (CAS Reg. No. 107–41–5) 

when used as an inert ingredient as a 

solvent in pesticide formulations 40 

CFR 180.910 and 180.930 for use on 

crops (pre-harvest and post-harvest) and 

for direct application on animals 

without limitations. 2-methyl-2,4- 

pentanediol is commonly referred to as 

‘‘hexylene glycol’’. The FB Sciences, 

Inc., 153 N. Main Street, Suite 100, 

Collierville, TN 38017 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 2- 

methyl-2,4-pentanediol. 

DATES: This regulation is effective June 

22, 2011. Objections and requests for 

hearings must be received on or before 

August 22, 2011, 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–2010–0330. 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; e-mail 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 


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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:// 

www.gpoaccess.gov/ecfr. 

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–2010–0330 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 August 22, 2011. 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–2010–0330, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

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 June 8, 2010 

(75 FR 32466) (FRL–8827–8), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

0E7693) by FB Sciences, Inc., 153 N. 

Main Street, Ste. 100, Collierville, TN 

38017. The petition requested that 40 

CFR 180.910 and 180.930 be amended 

by establishing an exemption from the 

requirement of a tolerance for residues 

of 2-methyl-2,4-pentanediol (CAS Reg. 

No.107–41–5) when used as an inert 

ingredient as a solvent in pesticide 

formulations applied to crops preharvest and post-harvest and to animals 

without limitations. That notice 

referenced a summary of the petition 

prepared by FB Sciences, Inc., the 

petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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 section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 2-methyl-2,4- 

pentanediol including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 2-methyl-2,4- 

pentanediol follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by 2-methyl-2,4-pentanediol as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 


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toxicity studies are discussed in this 

unit. 

2- methyl-2,4-pentanediol (CAS Reg. 

No. 107–41–5) is an aliphatic alcohol 

also known as: Hexylene glycol; 

diolane; and 1,1,3- 

trimethyltrimethylene-diol. Nonpesticidal uses of 2-methyl-2,4- 

pentanediol include use as a chemical 

intermediate, a selective solvent in 

petroleum refining, a component of 

hydraulic fluids, a solvent for inks, as 

an additive to cement, textile dye 

vehicles, a lubricant and fuel additive, 

and as an ingredient in cosmetics and 

hair care products. The Food and Drug 

Administration (FDA) has approved of 

the use of 2-methyl-2,4-pentanediol as 

an indirect food additive such as in 

adhesives in contact with food under 21 

CFR parts 175–178. 

2-methyl-2,4-pentanediol is not 

acutely toxic to rats via the oral route of 

exposure. An Organization for 

Economic Cooperation and 

Development (OECD)–SIDS (2001) 

report indicates LD50 ranges from 2–4.47 

g/kg. Acute dermal toxicity is low with 

dermal doses up to 2,000 milligrams/ 

kilogram (mg/kg) that did not cause 

death (as cited in OECD–SIDS, 2001). It 

is irritating to the skin and eyes, but not 

a skin sensitizer in guinea pigs. It has 

low inhalation toxicity, with an LC50 of 

160 parts per million (ppm) (0.772 mg/ 

L), which is in excess of the saturated 

vapor concentration. 

In a 90-day subchronic toxicity study, 

2-methyl-2,4-pentanediol was 

administered by oral gavage to rats at 

dose levels of 50, 150, or 450 mg/kg/bw/ 

day. In this study the functional 

observational battery, blood chemistry, 

hematological parameters and 

histopathological examinations were 

conducted. A functional observational 

battery test gave no indication of 

neurotoxicity. In both sexes, 

hyperplasia, hyperkeratosis, 

inflammatory cell infiltration and 

edema of the mucosa and submucosa of 

the stomach were observed starting at 

150 mg/kg/day. These changes were 

indicative of a local irritative effect 

resulting from the oral gavage 

procedure. Hepatocellular hypertrophy 

with increased liver weight was 

observed at 450 mg/kg/day in both 

sexes, and in males at 150 mg/kg/day. 

In the absence of degenerative or 

necrotic changes these findings were 

considered to be adaptive responses. At 

150 and 450 mg/kg/day, increased 

kidney weights and increased incidence 

of acidophilic globules in the tubular 

epithelium in males were suggestive of 

male rat specific alpha-2-microglobulin 

nephropathy, which is not considered 

as an effect relevant to humans. 

Observed changes were either fully or 

partially reversible over the 4-week 

recovery period. There were no adverse 

effects on the reproductive organs. No 

effects were observed at 50 mg/kg/day. 

A NOAEL of 450 mg/kg/day was 

determined for systemic toxicity 

because the effects described were 

either produced by irritation from the 

oral gavage procedure, or were 

considered adaptive responses. A rangefinding 14-day study gave similar 

results. 

No guideline reproduction studies 

were available for assessment, however, 

no adverse effects on reproductive 

organs (including testes, prostate, 

seminal vesicles, epididymis, ovaries, 

vagina, and uterus) were observed in the 

90-day gavage study in which rats were 

administered 2-methyl-2,4-pentanediol 

at doses up to 450 mg/kg/day. 

Therefore, OECD SIDS concluded that 

no additional studies are required under 

the SIDS program regarding fertility. 

EPA agrees with this conclusion by the 

OECD. 

In a developmental toxicity study, 

pregnant rats were administered 30, 

300, or 1,000 mg/kg/bw/day of 2- 

methyl-2,4-pentanediol by gavage in 5 

mL/kg of vehicle on gestation days (GD) 

6–15. The NOAEL for maternal toxicity 

was 300 mg/kg/day based on a 

statistically significant reduction in 

group mean body weight gain and food 

consumption at 1,000 mg/kg/day. There 

was a marginal, non-statistically 

significant reduction in fetal body 

weight at 1,000 mg/kg/day. Marginally 

higher incidences of fetal variations, 

some of which were statistically 

significant (occipitals incompletely 

ossified, 21.6%; extra thoracolumbar 

ribs, 18.7%; and hyoid arch not ossified, 

18%), occurred at 1,000 mg/kg/day. A 

delay in the normal ossification process 

was also observed in fetuses, but this 

was considered by the study authors to 

be related to reduced maternal body 

weight gain at this dose level. The 

NOAEL and LOAEL for maternal and 

fetal developmental toxicity were 

determined to be 300 and 1,000 mg/kg/ 

day, respectively. 

In another developmental toxicity 

study, pregnant rats received 500, 1,200, 

or 1,600 mg/kg/bw/day of 2-methyl-2,4- 

pentanediol by gavage in 10 mL/kg of 

vehicle on GD 6–17. At 1,200 and 1,600 

mg/kg/day, dams had ataxia and 

reductions in mean weight gain and 

food consumption. At the 1,600 mg/kg/ 

day, pregnant rats had mean weight 

loss, and one female aborted prior to the 

end of the study. Maternal toxicity at 

these levels corresponds to decreased 

fetal body weights and gravid uterine 

weights. Additionally, at 1,600 mg/kg/ 

day, there was one abortion and one 

whole litter resorption. However, the 

number of fetal malformations, such as 

increased incidence of skeletal 

variations (delayed ossification, extra 

ribs), was not significantly different 

from controls. A maternal NOAEL of 

500 mg/kg/day was determined by the 

Agency, and the same NOAEL was 

determined in the study for fetal 

toxicity. These results support the 

results of a study described in this unit 

and indicate that 2-methyl-2,4- 

pentanediol has low potential for 

developmental toxicity. 

2-methyl-2,4-pentanediol is not 

genotoxic in either mammalian or nonmammalian cells ‘‘in vitro.’’ It was 

negative for mutagenicity in the Ames 

test, yeast cell assay and hamster ovary 

cell assay. 

Ten rats and a rabbit exposed to an 

aerosol of 2-methyl-2,4-pentanediol at a 

concentration of 0.7 mg/L (about 145 

ppm) for 7 hr/day for 9 days survived 

with mild upper respiratory irritation. 

No histopathological effects were 

reported. 

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. 

No acute endpoint of concern was 

identified in the available toxicity 

studies. The endpoint of concern for the 


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chronic reference dose (cRfD) was 

identified from the developmental 

toxicity study in rats. In this study, the 

NOAEL (500 mg/kg/day) was based on 

increased incidence of clinical signs, 

reductions in mean body weight gain 

and food consumption seen at the 

LOAEL of 1,200 mg/kg/day and above. 

This NOAEL was supported by the 90- 

day gavage toxicity study in rats 

(NOAEL 450 mg/kg/day; highest dose 

tested). There was a lower NOAEL (300 

mg/kg/day) observed in the range 

finding study in rats based on a 

statistically significant reduction in 

group mean body weight gain and food 

consumption, and marginally higher 

incidences of fetal variations seen at the 

LOAEL of 1,000 mg/kg/day. The 

differences between the NOAELs of the 

range finding study and the 

developmental toxicity study in rats 

were considered due to artifacts of dose 

selection. An uncertainty factor 100X 

(10X for intraspecies variability and 10X 

interspecies extrapolation) was applied 

to the NOAEL. No additional 

uncertainty factor is necessary for use of 

the subchronic to chronic study because 

the effects were observed at the limit 

dose of 1,000 mg/kg/day and above. The 

FQPA factor for increased susceptibility 

of infant and children was reduced to 

1X. Therefore, the cRfD is equal to 

population adjusted dose (cPAD). This 

endpoint and the dose was also used for 

dermal and inhalation exposure 

assessment for all exposure scenarios. 

Inhalation and dermal absorption was 

assumed to be 100%. This approach 

would provide a highly conservative 

estimate of risk via the dermal and 

inhalation routes of exposure. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2-METHYL-2,4-PENTANEDIOL FOR USE IN HUMAN

RISK ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and children).No acute endpoint of concern was identified in the available database. 

Chronic dietary (All populations) ......................

Incidental oral short-term and intermediate 

term.

NOAEL = 500 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 500 

mg/kg/day.

cPAD = 500 mg/kg/ 

day. 

Developmental Toxicity Study—rats LOAEL = 

1,200 mg/kg/day based on reduced body 

weights in maternal animals, reduced fetal 

body weights. 

Dermal short and intermediate term ................ 100% absorption via 

dermal and inhalation routes; LOC 

MOE..

Inhalation short and intermediate term ............ 100.

Cancer (Oral, dermal, inhalation) ..................... No evidence of carcinogenicity. SAR analysis negative for carcinogenic alerts. Not mutagenic in 

mammalian and non-mammalian mutagenicity assays. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 2-methyl-2,4-pentanediol, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 2- 

methyl-2,4-pentanediol in food as 

follows: 

No acute endpoint of concern was 

identified in the database. Therefore, a 

quantitative acute dietary exposure 

assessment was not conducted. 

i. Chronic exposure. In conducting the 

chronic dietary exposure assessments, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

[1994–1996 and 1998] Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, no residue data were submitted 

for 2-methyl-2,4-pentanediol. In the 

absence of specific residue data, EPA 

has developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts.’’ 

(D361707, S. Piper, 2/25/09) and can be 

found at http://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentration of 

active ingredient in agricultural 

products is generally at least 50% of the 

product and often can be much higher. 

Further, pesticide products rarely have 

a single inert ingredient; rather there is 

generally a combination of different 

inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. 


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Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100% of all foods 

are treated with the inert ingredient at 

the rate and manner necessary to 

produce the highest residue legally 

possible for an active ingredient. In 

summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

ii. Cancer. Chronic and 

carcinogenicity studies were not 

available on 2-methyl-2,4-pentanediol. 

There is no evidence that 2-methyl-2,4- 

pentanediol is carcinogenic. The 

Agency used a qualitative structure 

activity relationship (SAR) database, 

DEREK Version 11, to determine if there 

were structural alerts. No structural 

alerts were identified. In addition, it is 

negative for mutagenicity in mammalian 

and non-mammalian mutagenicity 

assays. 2-methyl-2,4-pentanediol is 

rapidly metabolized and excreted as 

glucuronates. Based on weight-ofevidence and low toxicity mentioned in 

this unit, 2-methyl-2,4-pentanediol is 

not expected to be carcinogenic. Since 

the Agency has not identified any 

concerns for carcinogenicity relating to 

2-methyl-2,4-pentanediol, a dietary 

exposure assessment to evaluate cancer 

risk was not performed. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for 2-methyl2,4-pentanediol, a conservative drinking 

water concentration value of 100 ppb 

based on screening level modeling was 

used to assess the contribution to 

drinking water for the chronic dietary 

risk assessments for parent compound. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). No residential uses as a 

pesticide inert ingredient have been 

requested and none are expected. 

Although 2-methyl-2,4-pentanediol is 

used in cosmetics and hair care 

products, the Agency believes exposure 

and risk from these routes of exposure 

to be negligible. The FDA includes 2- 

methyl-2,4-pentanediol (i.e., hexylene 

glycol) in its list of Indirect Additives 

Used in Food Contact Subtances. The 

exposure to 2-methyl-2,4-pentanediol 

through hair color use is considered 

minimal because it is a volatile 

chemical, treatment times are very short 

and absorption through the scalp is 

limited. Based on these considerations, 

the Agency concluded that there is no 

need to conduct aggregate exposure 

through use of consumer products. 

Further, there are no reliable data with 

which to estimate such exposures. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found 2-methyl-2,4- 

pentanediol to share a common 

mechanism of toxicity with any other 

substances, and 2-methyl-2,4- 

pentanediol does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that 2-methyl-2,4-pentanediol 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The maternal and developmental effects 

were only observed at the limit dose of 

1,000 mg/kg/day and above in the 

developmental toxicity study in rats. 

Maternal and fetal toxicity were mainly 

manifested as decreases in body 

weights. Marginally higher incidences 

of fetal variations were also observed at 

the limit dose or above. There were no 

guideline reproduction studies available 

on 2-methyl-2,4-pentanediol; however, 

no adverse effects on reproductive 

organs (including testes, prostate, 

seminal vesicles, epididymis, ovaries, 

vagina, and uterus) were observed at 

doses up to 450 mg/kg/day in a 90-day 

toxicity study in rats. In addition, the 

reproductive indices were not affected 

in the two available developmental 

toxicity studies in rats. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 2-methyl2,4-pentanediol is not complete but 

considered as adequate for FQPA 

assessment given the low toxicity of 2- 

methyl-2,4-pentanediol. No guideline 

reproduction studies were available for 

assessment; however, no adverse effects 

on reproductive organs (including 

testes, prostate, seminal vesicles, 

epididymis, ovaries, vagina, and uterus) 

were observed in the 90-day gavage 

study in which rats were administered 

2-methyl-2,4-pentanediol at doses up to 

450 mg/kg/day. Therefore, OECD SIDS 

concluded that no additional studies are 

required under the SIDS program 

regarding fertility. EPA is in agreement 


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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 36347 

with the OECD conclusion. Chronic 

studies are also not available, but the 

concern for chronic toxicity is low given 

the low toxicity of 2-methyl-2,4- 

pentanediol. 

ii. No evidence of clinical signs of 

neurotoxicity was observed in the 

available database. No evidence of 

neurobehavioral or neuropathology was 

seen in a 90-day toxicity study in rats. 

There is no indication that 2-methyl-2,4- 

pentanediol is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 2- 

methyl-2,4-pentanediol results in 

increased susceptibility in rats (as 

described in this unit). 

iv Immunotoxicity studies for 2- 

methyl-2,4-pentanediol were not 

available for review. However, there was 

no evidence of immunotoxicity in the 

available database. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 percent 

crop treated (PCT) and tolerance-level 

residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to 2-methyl-2,4- 

pentanediol in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 2-methyl2,4-pentanediol. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute (aPAD) and 

chronic (cPAD). For linear cancer risks, 

EPA calculates the lifetime probability 

of acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, 2-methyl-2,4- 

pentanediol is not expected to pose an 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 2-methyl-2,4- 

pentanediol from food and water will 

utilize 3.8% of the cPAD for the U.S. 

population and Children 1–2 yrs of age 

12.5% cPAD, the population group 

receiving the greatest exposure. Based 

on the explanation in this unit, 

regarding residential use patterns, 

chronic residential exposure to residues 

of 2-methyl-2,4-pentanediol is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

A short-term adverse effect was 

identified; however, 2-methyl-2,4- 

pentanediol is not currently used as an 

inert ingredient in pesticide products 

that are registered for any use patterns 

that would result in short-term 

residential exposure. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure resulting from use 

as an inert ingredient in pesticidal 

formulations and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 2-methyl2,4-pentanediol. 

For the reasons discussed in Unit 

IV.C.3., short-term aggregate exposure 

assessment was not conducted for nonpesticidal uses. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, 2-methyl-2,4- 

pentanediol is not currently used as an 

inert ingredient in pesticide products 

that are registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 2- 

methyl-2,4-pentanediol. For the reasons 

discussed in Unit IV.C.3., intermediate 

term aggregate exposure assessment was 

not conducted for non-pesticidal uses. 

5. Aggregate cancer risk for U.S. 

population. 2-methyl-2,4-pentanediol is 

not expected to pose a cancer risk to 

humans. Therefore, aggregate cancer 

risk was not performed. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 2-methyl2,4-pentanediol 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 U.N. 

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 2-methyl-2,4-pentanediol. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and § 180.930 for 

2-methyl-2,4-pentanediol. (CAS Reg. 

No. 107–1–41–5) when used as an inert 

ingredient in pesticide formulations 

applied to crops and food animals 

without limitations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA 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 


jlentini on DSK4TPTVN1PROD with RULES
36348 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 

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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 

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: June 10, 2011. 

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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Insert ingredients used preharvest and post-harvest; exemptions from 

the requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

2-methyl-2,4-pentanediol (CAS Reg. ......................................................

No.–107–41–5) .......................................................................................

Without limitation ........................... Growing crops and food animals 

* * * * * * * 

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Insert ingredients applied to 

animals: exemption from the requirement of 

a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

2-methyl-2,4-pentanediol (CAS Reg. No.–107–41–5) ............................ Without limitation ........................... Growing crops and food animals 

*******


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 36349 

[FR Doc. 2011–15466 Filed 6–21–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0474; FRL–8877–1] 

Diethylene Glycol MonoEthyl Ether 

(DEGEE); 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 Diethylene 

Glycol MonoEthyl Ether (DEGEE) when 

used as an inert ingredient as a solvent, 

stabilizer and/or antifreeze within 

pesticide formulations/products, for 

preharvest use on growing crops and 

raw agricultural commodities, without 

limitation. Huntsman, Dow 

AgroSciences L.L.C., Nufarm Americas 

Inc., BASF, Stepan Company, Loveland 

Products Inc., and Rhodia Inc. 

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 DEGEE 

on growing crops and raw agricultural 

commodities. 

DATES: This regulation is effective June 

22, 2011. Objections and requests for 

hearings must be received on or before 

August 22, 2011, 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–2008–0474. 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@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:// 

www.gpoaccess.gov/ecfr. 

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–2008–0474 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 August 22, 2011. 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–2008–0474, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

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 July 9, 2008 

(73 FR 39291) (FRL–8371–2), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

8E7355) by Huntsman, 10003 Woodloch 

Forest Drive, The Woodlands, TX 

77380; Dow AgroSciences L.L.C., 9330 

Zionsville Road, Indianapolis, Indiana 

46268; Nufarm Americas Inc., 150 

Harvester Drive, Suite 220, Burr Ridge, 

Illinois, 60527; BASF, 26 Davis Drive, 

Research Triangle Park, NC 27709; 

Stepan Company, 22 W. Frontage Road, 

Northfield, IL 60093; Loveland Products 

Inc., PO Box 1286, Greeley, CO 80632; 

and Rhodia Inc., CN 1500, Cranbury, 

New Jersey, 08512. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of DEGEE (CAS Reg. No. 111– 

90–0) when used as an inert ingredient, 

as a solvent, stabilizer and/or antifreeze 


jlentini on DSK4TPTVN1PROD with RULES