38026 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 

DELEGATION STATUS FOR NEW SOURCE PERFORMANCE STANDARDS FOR SHASTA COUNTY AIR QUALITY MANAGEMENT

DISTRICT, SISKIYOU COUNTY AIR POLLUTION CONTROL DISTRICT, SOUTH COAST AIR QUALITY MANAGEMENT DISTRICT, AND TEHAMA COUNTY AIR POLLUTION CONTROL DISTRICT—Continued 

Subpart 

Air Pollution Control Agency 

Shasta 

County 

AQMD 

Siskiyou 

County 

APCD 

South Coast 

AQMD 

Tehama 

County 

APCD 

BBB ... Rubber Tire Manufacturing Industry ................................................................. .................... X X ....................

CCC .. (Reserved) ........................................................................................................ .................... .................... .................... ....................

DDD .. Volatile Organic Compounds (VOC) Emissions from the Polymer Manufacturing Industry..................... .................... X ....................

EEE ... (Reserved) ........................................................................................................ .................... .................... .................... ....................

FFF ... Flexible Vinyl and Urethane Coating and Printing ........................................... .................... .................... X ....................

GGG Equipment Leaks of VOC in Petroleum Refineries .......................................... .................... .................... X ....................

GGGa Equipment Leaks of VOC in Petroleum Refineries for Which Construction, 

Reconstruction, or Modification Commenced After November 7, 2006.

.................... .................... .................... ....................

HHH .. Synthetic Fiber Production Facilities ................................................................ .................... .................... X ....................

III ....... Volatile Organic Compound (VOC) Emissions From the Synthetic Organic 

Chemical Manufacturing Industry (SOCMI) Air Oxidation Unit Processes.

.................... .................... X ....................

JJJ .... Petroleum Dry Cleaners ................................................................................... .................... .................... X ....................

KKK ... Equipment Leaks of VOC From Onshore Natural Gas Processing Plants ..... .................... .................... X ....................

LLL .... Onshore Natural Gas Processing: SO2 Emissions ......................................... .................... .................... X ....................

MMM (Reserved) ........................................................................................................ .................... .................... .................... ....................

NNN .. Volatile Organic Compound (VOC) Emissions From Synthetic Organic 

Chemical Manufacturing Industry (SOCMI) Distillation Operations.

.................... .................... X ....................

OOO Nonmetallic Mineral Processing Plants ............................................................ .................... .................... X ....................

PPP ... Wool Fiberglass Insulation Manufacturing Plants ............................................ .................... .................... X ....................

QQQ VOC Emissions From Petroleum Refinery Wastewater Systems ................... .................... X X ....................

RRR .. Volatile Organic Compound Emissions from Synthetic Organic Chemical 

Manufacturing Industry (SOCMI) Reactor Processes.

.................... .................... X ....................

SSS ... Magnetic Tape Coating Facilities ..................................................................... .................... X X ....................

TTT ... Industrial Surface Coating: Surface Coating of Plastic Parts for Business 

Machines.

.................... X X ....................

UUU .. Calciners and Dryers in Mineral Industries ...................................................... .................... .................... X ....................

VVV ... Polymeric Coating of Supporting Substrates Facilities .................................... .................... .................... X ....................

WWW Municipal Solid Waste Landfills ........................................................................ .................... .................... X ....................

AAAA Small Municipal Waste Combustion Units for Which Construction is Commenced After August 30, 1999 or for Which Modification or Reconstruction is Commended After June 6, 2001.X X X ....................

CCCC Commercial and Industrial Solid Waste Incineration Units for Which Construction Is Commenced After November 30, 1999 or for Which Modification or Reconstruction Is Commenced on or After June 1, 2001..................... .................... X ....................

EEEE Other Solid Waste Incineration Units for Which Construction is Commenced 

After December 9, 2004, or for Which Modification or Reconstruction is 

Commenced on or After June 16, 2006.

.................... .................... X ....................

GGGG (Reserved) ........................................................................................................ .................... .................... .................... ....................

IIII ...... Stationary Compression Ignition Internal Combustion Engines ....................... .................... .................... X ....................

JJJJ ... Stationary Spark Ignition Internal Combustion Engines .................................. .................... .................... .................... ....................

KKKK Stationary Combustion Turbines ...................................................................... .................... .................... X ....................

* * * * * 

[FR Doc. 2011–16462 Filed 6–28–11; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0474; FRL–8876–5] 

Diethylene Glycol Mono Butyl Ether; 

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 mono butyl ether (CAS Reg. No. 

112–34–5) when used as a pesticide 

inert ingredient as a solvent, stabilizer 

and/or antifreeze within pesticide 

formulations/products without 

limitation under 40 CFR 180.920. 

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 an 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of diethylene glycol mono 

butyl ether. 

DATES: This regulation is effective June 

29, 2011. Objections and requests for 

hearings must be received on or before 

August 29, 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, 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 38027 

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. To access the 

harmonized 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–2008–0474 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 29, 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 diethylene glycol mono 

butyl ether (CAS Reg. No. 112–34–5) 

when used as an inert ingredient 

solvent, stabilizer and/or antifreeze 

without limitation in pesticide 

formulations applied to pre-harvest 

crops. That notice referenced a 

summary of the petition prepared by 

Huntsman, Dow AgroSciences L.L.C., 

Nufarm Americas Inc., BASF, Stepan 

Company, Loveland Products Inc., and 

Rhodia Inc., which is available in the 

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

Agency received one comment 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 

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38028 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 

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 diethylene glycol 

mono butyl ether including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with diethylene glycol mono 

butyl ether 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 diethylene glycol mono butyl ether 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in this unit. 

Diethylene glycol mono butyl ether 

(DEGBE) has low acute toxicity via the 

oral and dermal routes. It is a slightly 

irritating to the skin and moderately 

irritating to the eyes. It is a skin not a 

sensitizer. 

Oral subchronic studies with DEGBE 

were available in the rat. In a study in 

F344 rats, toxicity was mainly 

manifested as an increase in creatinine 

levels at >51 mg/kg/day. Confidence in 

this study is low because of the high 

unexplained mortality. Also, in other 

studies in rats, toxicity was observed at 

doses >210 mg/kg/day. These effects 

included increased absolute relative 

liver weight; and hepatic cytochrome 

P450’s and UGT levels; decreased total 

protein, cholesterol, and aspartate 

aminotransferase, very slight hepatocyte 

hypertrophy and increased individual 

hepatocyte degeneration in females 

only, decreased RBC count; hemoglobin 

(Hgb); and hematocrit (Hct) and 

increased absolute and relative kidney 

weights with an equivocal increase in 

minor histopathologic changes typical 

of early spontaneous nephropathy. In a 

well conducted 90-day toxicity study in 

rats via drinking water, rats were 

exposed to DEGBE at 0, 50, 250, or 1000 

mg/kg/day. The NOAEL in this study 

was 250 mg/kg/day based on kidney, 

liver and blood effects seen at the 

LOAEL of 1000 mg/kg/day. In this 

study, no adverse treatment-related 

effects were observed on functional 

observational battery (FOB) parameters. 

Liver toxicity (including liver enzymes), 

kidney toxicity and blood parameters 

were affected at the limit dose of 1000 

mg/kg/day. 

There was one developmental toxicity 

study in Wistar rats conducted via the 

oral route of exposure. In this study, 

there were no maternal or 

developmental effects at doses up to 633 

mg/kg/day. In a developmental toxicity 

study in mice via gavage, DEGBE did 

not produce any malformations at doses 

up to 2050 mg/kg/day. The maternal 

and developmental NOAEL in mice was 

500 mg/kg/day. A developmental study 

in rabbits via the dermal route of 

exposure was available for review. In 

this study, maternal and developmental 

toxicity was not observed at doses up to 

1000 mg/kg/day. 

There were 2 oral reproduction 

toxicity studies in rats available for 

review. In both studies rats were 

exposed to DEGBE via gavage at doses 

of 0, 250, 500 or 1000 mg/kg/day. In one 

study fetal susceptibility was not 

observed. Maternal (mortality) and 

offspring (reduced mean pup weight) 

toxicity occurred at the same dose (1000 

mg/kg/day). The maternal and 

developmental NOAELs in this study 

were 500 mg/kg/day. In a second study 

quantitative fetal susceptibility was 

observed. Parental toxicity was not 

observed at doses up to 1,000 mg/kg/ 

day. Offspring toxicity (decreased 

bodyweight) was observed at 1000 mg/ 

kg/day. The offspring NOAEL was 500 

mg/kg/day. Reproductive toxicity was 

not observed in either study. A 

reproductive toxicity study in rats with 

exposure via the dermal route was also 

available for review. Parental, offspring 

and reproduction toxicity was not 

observed at doses up to 2000 mg/kg/day. 

Dermal toxicity studies with DEGBE 

were available in the rat and rabbit. In 

a 13-week dermal toxicity study in the 

Sprague-Dawley (SD) rat, systemic 

toxicity was not observed at doses up to 

2,000 mg/kg/day. In a separate 13-week 

dermal toxicity study in SD rats, the 

NOAEL was 580 mg/kg/day based on 

renal tubular epithelium degeneration 

seen at the LOAEL of 1900 mg/kg/day. 

In a neurotoxicity study via the dermal 

route of exposure, degeneration of the 

renal tubular epithelium was observed 

at 2000 mg/kg/day. The NOAEL was 600 

mg/kg/day. No effects on FOB 

parameters, motor activity or 

neuropathology were observed at doses 

up to 2000 mg/kg/day following dermal 

treatment. No local or systemic effects 

were observed in the New Zealand 

white rabbit. 

Several inhalation toxicity studies 

with DEGBE were available for review 

in rats. Perivascular and peribronchial 

infiltrate were observed in Wistar male 

and female rats and decreased spleen 

weights in males at doses > 100 mg/m3. 

In addition, liver toxicity, kidney 

toxicity and blood effects were 

identified as the target organs in 

inhalation studies. 

Immunotoxicity studies for DEGBE 

were not available for review. However, 

DEGBE belongs to the glycol ethers class 

of chemicals. Immunotoxicity studies 

were available for ethylene glycol mono 

butyl ether, also a glycol ether differing 

in only one ethyl group from DEGBE. 

These data were used to assess the 

immunotoxic potential of DEGBE. Signs 

of potential immunotoxicity were not 

observed in any of the available studies 

with the surrogate chemical. Nor was 

there evidence of immunotoxicity 

potential in any of the studies submitted 

for DEGBE. Therefore, DEGBE is not 

expected to be immunotoxic. 

Mutagenicity studies (Ames test, 

mammalian gene mutation, mouse 

lymphoma, chromosome aberration and 

unscheduled DNA synthesis) with 

DEGBE were available for review. All 

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Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 38029 

the tests were negative with the 

exception of the mouse lymphoma assay 

in which cells were weakly positive in 

the absence of S–9, while it was 

negative in the presence of S–9. 

Chronic and carcinogenicity studies 

were not available on DEGBE. However, 

DEGBE belongs to the glycol ether class 

of chemicals which include structurally 

similar chemicals ethylene glycol and 

diethylene glycol. Therefore, 

carcinogenicity data available on these 

chemicals were used to assess DEGBE’s 

potential to cause cancer. Based on the 

lack of evidence of carcinogenicity 

potential for ethylene glycol and 

diethylene glycol and the lack of 

mutagenic concerns for DEGBE, it is not 

expected to be carcinogenic to humans. 

Metabolism studies demonstrated that 

DEGBE was absorbed rapidly, 

metabolized and primarily eliminated 

via the urine. The major metabolite was 

identified as 2-(2-butoxyethoxy) acetic 

acid. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by the diethylene glycol 

mono butyl ether, as well as, the no 

observed adverse effect level (NOAEL) 

and the lowest observed adverse effect 

level (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in the document 

042203, Diethylene glycol mono butyl 

ether; Human Health Risk Assessment 

and Ecological Effects Assessment to 

Support Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations at pp. 6–21 and pp. 19–22 

in EPA–HQ–OPP–2008–0474. 

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. 

A summary of the toxicological 

endpoints for diethylene glycol mono 

butyl ether used for human risk 

assessment is shown in Table 1 of this 

unit. 

No acute endpoint of concern for 

general population was identified in the 

available data base. 

The 90 day oral toxicity study in rats 

via drinking water was selected to 

establish the chronic reference dose 

(cRfD). The NOAEL in this study was 

250 mg/kg/day and the LOAEL was 

1000 mg/kg/day based on kidney, liver, 

and blood effects. Although 51 mg/kg/ 

day was the lowest LOAEL in the 

database, confidence in this study was 

low due to the observed unexplained 

mortality. A lower NOAEL (94 mg/kg/ 

day) was also observed in a 30 day oral 

toxicity study in the rat. The LOAEL 

(210 mg/kg/day) was based on 

decreased water consumption, growth 

retardation, and abnormalities in 

various organs. However, there is more 

confidence in the 90 day oral toxicity 

study in rats because it is a more recent 

study, was well conducted, tested more 

animals, provided more detailed 

information, provided data on all 

parameters measured in the 30-day 

study, has a well established NOAEL 

(250 mg/kg/day) and none of the 

aforementioned effects were observed. 

Therefore, the point of departure of 250 

mg/kg/day was selected to establish the 

cRfD. 

The point of departure selected for the 

dermal exposure scenario is from the 13 

week neurotoxicity screening battery in 

rats. The NOAEL in this study was 600 

mg/kg/day and the LOAEL was 2,000 

mg/kg/day based on mild degeneration 

of renal tubular epithelium in males. 

This endpoint and dose for dermal 

exposure assessment was further 

supported by a 90-day dermal toxicity 

study in rats with a NOAEL of 580 mg/ 

kg/day based renal tubular degeneration 

seen at the LOAEL of 1900 mg/kg/day. 

For the inhalation scenarios, 94 mg/m3 

(∼27 mg/kg/day) from an inhalation 

toxicity study in Wistar rats was 

selected for the point of departure. 

Although, 39 mg/m3 (∼11 mg/kg/day) 

from an inhalation toxicity study in 

F344 rats represents the lowest NOAEL 

in the database for this scenario it was 

not selected because the observed liver 

changes were minor and occurred at the 

high dose (117 mg/m3). In addition, the 

selected study was more recent and one 

would expect changes to occur in the 

liver since animals in this study were 

treated for a longer duration. However, 

liver toxicity was not observed in the 

selected study. Therefore, 94 mg/m3 

(∼27 mg/kg/day) was selected for the 

point of departure for all inhalation 

scenarios. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIETHYLENE GLYCOL MONO BUTYL ETHER 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 (Females 13–50 years of age) An acute endpoint was not identified in the database. 

Chronic dietary (All populations) .................. NOAEL= 250 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 2.5 mg/kg/ 

day 

cPAD = 2.5 mg/kg/day 

90 Day Oral Toxicity Study LOAEL = 

1000 mg/kg/day based on kidney, 

liver, and blood effects. 

Incidental oral short-term (1 to 30 days) ...... NOAEL= 250 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 00 90 Day Oral Toxicity Study LOAEL = 

1000 mg/kg/day based on kidney, 

liver, and blood effects. 

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38030 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIETHYLENE GLYCOL MONO BUTYL ETHER FOR

USE IN HUMAN RISK ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Incidental oral intermediate-term (1 to 6 

months).

NOAEL= 250 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90 Day Oral Toxicity Study LOAEL = 

1000 mg/kg/day based on kidney, 

liver, and blood effects. 

Dermal short-term (1 to 30 days) ................. NOAEL = 600 mg/kg/day 

(UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 13 week Neurotoxicity Screening 

Battery LOAEL = 2000 mg/kg/day 

based on [mild degeneration of 

renal tubular epithelium in males. 

Dermal intermediate-term (1 to 6 months) ... NOAEL = 600 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 13 week Neurotoxicity Screening 

Battery LOAEL = 2000 mg/kg/day 

based on mild degeneration of 

renal tubular epithelium in males. 

Inhalation short-term (1 to 30 days) ............. NOAEL= 27 mg/kg/day (inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 5 week Subchronic Inhalation Toxicity Study LOAEL was not established. 

Inhalation (1 to 6 months) ............................ NOAEL= 27 mg/kg/day (inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 5 week Subchronic Inhalation Toxicity Study LOAEL was not established. 

Cancer (Oral, dermal, inhalation) ................. Not likely to be carcinogenic based on lack of evidence of carcinogenicity in structurally similar 

chemicals, ethylene glycol and diethylene glycol and the lack of mutagenicity. 

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 diethylene glycol mono 

butyl ether, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

diethylene glycol mono butyl ether in 

food as follows: 

No acute endpoint of concern was 

identified in the database. Therefore, 

acute dietary risk 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 the diethylene glycol mono butyl 

ether. 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 led 

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 percent 

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. 

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 percent 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. 

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Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 38031 

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. For the reasons discussed 

above, the Agency has not identified 

any concerns for carcinogenicity 

relating to diethylene glycol mono butyl 

ether. Accordingly, 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 

diethylene glycol mono butyl ether, 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). 

DEGBE may be used in inert 

ingredients in products that are 

registered for specific uses that may 

result in residential exposure. A 

screening level residential exposure and 

risk assessment was completed for 

products containing DEGBE as inert 

ingredients. The DEGBE inerts may be 

present in consumer personal (care) 

products and cosmetics (at 

concentrations up to 30%) (http:// 

hpd.nlm.nih.gov/index.htm). The 

Agency conducted exposure 

assessments based on end-use product 

application methods and labeled 

application rates. The Agency 

conducted an assessment to represent 

worst-case residential exposure by 

assessing DEGBE in pesticide 

formulations used in crack and crevice 

applications. The Agency conducted an 

assessment to represent worst-case 

residential exposure by assessing post 

application exposures and risks from 

DEGBE in pesticide formulations. 

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 diethylene glycol 

mono butyl ether to share a common 

mechanism of toxicity with any other 

substances, and diethylene glycol mono 

butyl ether does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that diethylene glycol mono 

butyl ether 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. 

Fetal susceptibility was not observed in 

either of the developmental toxicity 

studies with rats or rabbits. There were 

no toxic effects observed in parents or 

offspring in either study at the highest 

doses tested, 633 and 1000 mg/kg/day, 

respectively. No developmental effects 

were observed in mice at doses up to 

2050 mg/kg/day. In a reproduction 

toxicity study in the rat, quantitative 

fetal susceptibility was observed. 

Parental toxicity was not observed at 

doses up to 1,000 mg/kg/day. However, 

offspring toxicity (decreased 

bodyweight) occurred at 1000 mg/kg/ 

day. There was a well established 

NOAEL in this study protecting fetuses. 

Therefore, the concern for increased 

fetal susceptibility is low and there are 

no residual concerns. 

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 diethylene 

glycol mono butyl ether is adequate. 

The following acceptable studies are 

available: 

Developmental toxicity in rodents (3 

oral) 

Developmental toxicity in rabbits (1 

dermal) 

Reproduction toxicity study in rats (2 

oral, 1 dermal) 

ii. Signs of neurotoxicity were not 

observed in the neurotoxicity screening 

battery administered via the dermal 

route. Nor were signs of neurotoxicity 

observed in a 90 day oral toxicity 

(drinking water) in rats. In addition, 

signs of neurotoxicity were not observed 

in any of the other submitted studies. 

Therefore, EPA concluded that the 

developmental neurotoxicity study is 

not required. 

iii. Immunotoxicity studies for DEGBE 

were not available for review. However, 

DEGBE belongs to the glycol ethers class 

of chemicals. Immunotoxicity studies 

were available for ethylene glycol 

monobutyl ether, also a glycol ether 

differing only in one ethyl group. This 

data was used to assess the 

immunotoxic potential of DEGBE. Signs 

of potential immunotoxicity were not 

observed in any of the available studies 

with DEGBE and the surrogate chemical. 

Therefore, DEGBE is not expected to be 

immunotoxic. 

iv. Evidence of increased 

susceptibility was observed in a 

reproduction toxicity study in the rat. 

However, the concern for this increased 

susceptibility was low because there 

was a well established NOAEL of 500 

mg/kg/d in this study. Also, the 

established cRfD (250 mg/kg/day) is 

protective of the fetal effects. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed using very conservative 

assumptions. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to DEGBE in drinking 

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38032 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by DEGBE. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute PAD (aPAD) and chronic 

PAD (cPAD). For linear cancer risks, 

EPA calculates the lifetime probability 

of acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. No adverse effects 

attributable to a single exposure of 

DEGBE were seen in the toxicity 

databases. Therefore, DEGBE 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 DEGBE from 

food and water will utilize 0.08% for 

the U.S. population and 0.25% of the 

cPAD for children 1–2 yrs old, the 

population group receiving the greatest 

exposure. 

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). 

DEGBE is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

DEGBE. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 102 for both adult males and 

females respectively. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

liquids/trigger sprayer/home garden use 

with a high end post application dermal 

exposure from contact with treated 

lawns. As the level of concern is for 

MOEs that are lower than 100, this MOE 

is not of concern. EPA has concluded 

that the combined short-term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 163 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). Because EPA’s level of 

concern for DEGBE is a MOE of 100 or 

below, these MOEs are not of concern. 

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). 

DEGBE is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to DEGBE. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 550 for adult 

males and females. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

liquids/trigger sprayer/home garden use 

with a high end post application dermal 

exposure from contact with treated 

lawns. EPA has concluded the 

combined intermediate-term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 230 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). Because EPA’s level of 

concern for DEGBE is a MOE of 100 or 

below, these MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to DEGBE. 

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 DEGBE 

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 an 

MRL for diethylene glycol mono butyl 

ether. 

C. Response to Comments 

The comment was received from a 

private citizen who opposed the 

authorization to sell any pesticide that 

leaves a residue on food. 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 Federal Food, Drug 

and Cosmetic Act (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. 920 for diethylene 

glycol mono butyl ether when used as 

an inert ingredient (pesticide inert 

ingredient as a solvent, stabilizer and/or 

antifreeze within pesticide 

formulations/products without 

limitation) in pesticide formulations 

applied to pre-harvest crops. 

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 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

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Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Rules and Regulations 38033 

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 20, 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. 920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

Inert ingredients Limits Uses 

*******

Diethylene glycol mono butyl ether (CAS Reg. No. 112– 

34–5).

Without limitation ................ Pesticide inert ingredient as a solvent, stabilizer and/or 

antifreeze 

* * * * * * * 

[FR Doc. 2011–16188 Filed 6–28–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0980; FRL–8877–2] 

Cloquintocet-mexyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

established tolerance expression for 

residues of cloquintocet-mexyl and its 

acid metabolite on wheat forage, wheat 

grain, wheat hay, and wheat straw to 

cover residues in or on these 

commodities when cloquintocet-mexyl 

is used as an inert ingredient (safener) 

in pesticide formulations containing the 

active ingredient, dicamba. BASF 

Corporation requested this tolerance 

amendment under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

29, 2011. Objections and requests for 

hearings must be received on or before 

August 29, 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–2010–0980. 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. 

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