Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations 31471 

hour fax-on-demand service, tel.: 202/ 

622–0077. 

Background 

On July 4, 1999, the President issued 

Executive Order 13129 (64 FR 36759, 

July 7, 1999), invoking the authority of, 

inter alia, the International Emergency 

Economic Powers Act (50 U.S.C. 1701 et 

seq.) (‘‘IEEPA’’) and the National 

Emergencies Act (50 U.S.C. 1601 et seq.) 

(the ‘‘NEA’’). In Executive Order 13129, 

the President determined that the 

actions and policies of the Taliban in 

Afghanistan, in allowing territory under 

its control in Afghanistan to be used as 

a safe haven and base of operations for 

Usama bin Ladin and Al-Qaida, 

constituted an unusual and 

extraordinary threat to the national 

security and foreign policy of the United 

States and declared a national 

emergency to deal with that threat. In 

response to this national emergency, the 

President, in Executive Order 13129, 

ordered the blocking of all property and 

interests in property of the Taliban and 

of persons determined to be owned or 

controlled by, or to act for or on behalf 

of, the Taliban, or to provide financial, 

material, or technological support for, or 

services in support of, any of the 

foregoing. In addition, Executive Order 

13129 imposed a trade embargo against 

the Taliban, any persons designated 

pursuant to the order, and the territory 

of Afghanistan controlled by the 

Taliban. On January 11, 2001, the 

Department of the Treasury’s Office of 

Foreign Assets Control (‘‘OFAC’’) issued 

the Taliban (Afghanistan) Sanctions 

Regulations, 31 CFR part 545, to 

implement Executive Order 13219 (66 

FR 2726, January 11, 2001). 

On September 23, 2001, the President 

issued Executive Order 13224 (66 FR 

49079, September 25, 2001), invoking 

the authority of, inter alia, IEEPA, the 

NEA, and section 5 of the United 

Nations Participation Act of 1945, as 

amended (22 U.S.C. 287c). In Executive 

Order 13224, the President determined 

that grave acts of terrorism and threats 

of terrorism committed by foreign 

terrorists, including the terrorist attacks 

in New York, Pennsylvania, and the 

Pentagon committed on September 11, 

2001, and the continuing and immediate 

threat of further attacks on United States 

nationals or the United States constitute 

an unusual and extraordinary threat to 

the national security, foreign policy, and 

economy of the United States and 

declared a national emergency to deal 

with that threat. Executive Order 13224 

blocks the property and interests in 

property of foreign persons listed in the 

Annex to the order or determined to 

have committed or to pose a significant 

risk of committing acts of terrorism that 

threaten U.S. nationals or the United 

States, as well as of, inter alia, persons 

determined to be owned or controlled 

by, to act for or on behalf of, or to 

provide financial, material, or 

technological support for, or financial or 

other services to or in support of, such 

acts of terrorism or those persons listed 

in the Annex or determined to be 

subject to the order. On June 6, 2003, 

OFAC issued the Global Terrorism 

Sanctions Regulations, 31 CFR part 594 

(68 FR 34196, June 6, 2003) (the 

‘‘GTSR’’), to carry out the purposes of 

Executive Order 13224. 

On July 2, 2002, the President issued 

Executive Order 13268 (67 FR 44751, 

July 3, 2002), determining that the 

situation that gave rise to the 

declaration of a national emergency in 

Executive Order 13129 of July 4, 1999, 

with respect to the Taliban was 

significantly altered. As a result, the 

President terminated the national 

emergency declared in Executive Order 

13129 with respect to the actions and 

policies of the Taliban in Afghanistan 

and revoked that order. In addition, 

Executive Order 13268 amended the 

Annex to Executive Order 13224 of 

September 23, 2001, by adding the 

Taliban and one individual who had 

previously been listed in the Annex to 

Executive Order 13129, Mohammed 

Omar, the leader of the Taliban. As a 

result, transactions involving the 

Taliban remain subject to the GTSR. 

Accordingly, OFAC is removing the 

Taliban (Afghanistan) Sanctions 

Regulations, 31 CFR part 545, from 31 

CFR chapter V. Pursuant to section 202 

of the NEA and section 4 of Executive 

Order 13268, removal of this part does 

not affect ongoing enforcement 

proceedings or prevent the initiation of 

enforcement proceedings based on an 

act committed prior to the date of 

Executive Order 13268 where the 

relevant statute of limitations has not 

run. 

Public Participation 

Because the Taliban (Afghanistan) 

Sanctions Regulations involve a foreign 

affairs function, the provisions of 

Executive Order 12866 of September 30, 

1993, as amended, and the 

Administrative Procedure Act (5 U.S.C. 

553), requiring notice of proposed 

rulemaking, opportunity for public 

participation, and delay in effective date 

are inapplicable. Because no notice of 

proposed rulemaking is required for this 

rule, the Regulatory Flexibility Act (5 

U.S.C. 601–612) does not apply. 

List of Subjects in 31 CFR Part 545 

Administrative practice and 

procedure, Afghanistan, Banks, 

Banking, Blocking of assets, Foreign 

investments in the United States, 

Foreign trade, Penalties, Reporting and 

recordkeeping requirements, Taliban, 

Travel restrictions. 

For the reasons set forth in the 

preamble, and under the authority of 50 

U.S.C. 1701–1706 and Executive Order 

13268, 31 CFR chapter V is amended by 

removing part 545. 

Dated: May 25, 2011. 

Adam J. Szubin, 

Director, Office of Foreign Assets Control. 

[FR Doc. 2011–13581 Filed 5–31–11; 8:45 am] 

BILLING CODE 4810–AL–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0361; FRL–8870–7] 

Ethylene Glycol; 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 ethylene glycol 

(CAS Reg. No. 107–21–1) when used as 

a pesticide inert ingredient as a solvent, 

stabilizer and/or antifreeze within 

pesticide formulations/products without 

limitation. Huntsman, et. al, 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 

ethylene glycol. Also, this regulation 

establishes an exemption from the 

requirement of a tolerance for residues 

of ethylene glycol (CAS Reg. No. 107– 

21–1) when used as an inert ingredient 

as an encapsulating agent for pesticides 

being applied post-harvest as residual, 

and crack and crevice sprays in and 

around food and nonfood areas of 

residential and nonresidential 

structures, including food handling 

establishments, with no limit. The 

Sumitomo Chemical Company 

submitted a petition to EPA under 

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 

ethylene glycol. 


jlentini on DSK4TPTVN1PROD with RULES
31472 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations 

DATES: This regulation is effective June 

1, 2011. Objections and requests for 

hearings must be received on or before 

August 1, 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 these actions under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0361. 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–2011–0361 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 1, 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–2011–0361, 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 

EPA received two petitions requesting 

that 40 CFR 180.910 and 40 CFR 

180.920 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of ethylene glycol. 

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 ethylene glycol (CAS Reg. 

No. 107–21–1) when used as an inert 

ingredient solvent, stabilizer and/or 

antifreeze without limitation in 

pesticide formulations applied to preharvest 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. 

Also, in the Federal Register of 

August 4, 2004 (69 FR 47149) (FRL– 

7367–7), EPA issued a notice pursuant 

to section 408 of FFDCA, 21 U.S.C. 

346a, announcing the filing of a 

pesticide petition (PP 4E6828) by the 

Sumitomo Chemical Company, Ltd., 5– 

33 Kitahama, 4-chrome, chuo-ku, Osaka 

541–8550 Japan. The petition requested 

that 40 CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of ethylene glycol (CAS Reg. No. 107– 

21–1) when used as an inert ingredient 

in encapsulating agents for pesticides 

being applied post-harvest as residual, 

and crack and crevice sprays in and 

around food and nonfood areas of 

residential and nonresidential 

structures, including food handling 

establishments, with no limit. That 

notice referenced a summary of the 

petition prepared by the Sumitomo 

Chemical Company, which is available 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations 31473 

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 

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 ethylene glycol 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with ethylene glycol 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 ethylene glycol as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

Acute oral toxicity in rodents, as 

expressed as a lethal dose (LD)50, ranges 

from 1,500 milligram/kilogram (mg/kg) 

to 8,800 mg/kg. In the guinea pig, the 

acute oral toxicity is about 6,600 mg/kg 

and in the rabbit, 5,000 mg/kg. In the 

dog, the acute oral LD50 is greater than 

8,000 mg/kg. It is minimally irritating to 

the eyes and skin of rabbits. Acute 

inhalation and dermal toxicity data 

were not identified. However, given the 

vapor pressure of undiluted ethylene 

glycol (0.092 millimeter (mm) mercury 

(Hg) @ 25 °C) acute inhalation concerns 

are not expected. According to the 

National Institute of Occupational 

Safety and Health (NIOSH) (1999), a 

‘‘harmful contamination of the air will 

be reached rather slowly on evaporation 

of this substance at 20 °C.’’ 

In subchronic and chronic testing, rats 

were more sensitive to the effects of 

ethylene glycol treatment than mice at 

comparable dose levels. Among rats, 

males appeared to be more sensitive 

than females. In subchronic toxicity 

testing in rats and mice, the kidney was 

adversely affected in all studies 

considered. Effects common to all 

studies include increased kidney 

weights, formation of lesions, and 

formation of oxalate crystals. In the rat, 

NOAELs range from 71 to 4,000 mg/kg/ 

day and in the mouse the NOAELs range 

from 1,000 to 3,230 mg/kg/day. In 

chronic testing in rats, kidney effects 

similar to those seen in subchronic 

testing were observed. In addition, 

effects to the liver were seen (i.e., 

decreased liver weight; fatty changes). 

The lowest NOAEL (71 mg/kg/day) in 

the toxicity database occurred in a 

subchronic toxicity study in rats. The 

LOAEL in this study was 180 mg/kg/day 

based on kidney effects. In chronic 

studies, the lowest NOAEL of 150 mg/ 

kg/day was observed in rats, the most 

sensitive species. 

Developmental toxicity testing was 

conducted in rats, mice, and rabbits. 

Overall, fetal toxicity was exhibited as 

increased fetal deaths, skeletal and 

external malformations, and reduced 

body weight. Maternal toxicity was 

manifested as decreased body weight 

gain, kidney effects (lesions, increased 

organ weight), and liver effects 

(decreased organ weight). The relative 

sensitivities of these species in terms of 

developmental toxicity during 

organogenesis are: Mice are the most 

sensitive and rabbits are the least 

sensitive. For maternal toxicity per se 

the sensitivity is: Rats are the most 

sensitive and rabbits are the least 

sensitive. 

In rabbits, statistically-significant fetal 

developmental toxicity was not 

observed; however, maternal toxicity 

was seen at 2,000 mg/kg/day; it was 

manifested as renal toxicity (lesions, 

oxalate formation). In rats, fetal toxicity 

was seen at doses ranging from 1,000 

mg/kg/day to 2,500 mg/kg/day. It 

manifested as decreased viability (2,250 

mg/kg/day); decreased body weight gain 

and decreased pup weight (1,000 to 

2,500 mg/kg/day); and skeletal effects 

and malformations (1,000 to 2,500 mg/ 

kg/day). The skeletal effects and 

malformations included: Poorly ossified 

and unossified vertebral centra; 

decrease in total ossification; 

hydrocephaly; and pup malformation. 

Maternal toxicity in rats was manifested 

as: Decreased body weight gain (1,250 to 

2,500 mg/kg/day); decreased liver 

weight (5,000 mg/kg/day); and kidney 

effects such as lesions and increased 

weight (1,250 to 2,500 mg/kg/day). In 

mice, fetal toxicity was seen at doses 

ranging from 500 to 1,500 mg/kg/day. 

As with rats it manifested as decreased 


jlentini on DSK4TPTVN1PROD with RULES
31474 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations 

fetal body weight and/or weight gain 

(750 to 1,500 mg/kg/day) and skeletal 

effects (500 to 1,500 mg/kg/day) which 

included: Pup malformations, fused ribs 

and arches, poor ossification in thoracic 

and lumbar centra, and increased 

occurrence of an extra 14th rib. The 

lowest developmental NOAEL in mice 

was 150 mg/kg/day. Maternal toxicity 

was demonstrated as decreased weight 

gain (1,500 mg/kg/day) and decreased 

liver weight (1,500 mg/kg/day). 

The reproductive toxicity of ethylene 

glycol was studied in rats and mice. In 

rats, no reproductive toxicity was noted. 

In mice, reproductive toxicity was seen 

at doses ranging from 897 to 2,826 mg/ 

kg/day. It manifested as: Decreased 

numbers of live implants and increased 

number of dead implants; sperm effects 

(abnormal sperm, decreased motility, 

decreased sperm count); testicular 

lesions; and decreased testes weight. 

Ethylene glycol is not known to be 

mutagenic. In a standard battery of in 

vitro genotoxicity assays conducted by 

the National Toxicology Program; 

Health and Human Services (NTP; HHS 

1993), all results were negative. 

Ethylene glycol is not considered to be 

carcinogenic. In carcinogenicity testing 

conducted by the NTP in rats and mice, 

no evidence of carcinogenic potential 

was noted. Therefore, based on the lack 

of mutagenicity and lack of 

carcinogenicity in rodents, ethylene 

glycol is not expected to pose a 

carcinogenic risk in humans. 

Metabolism studies demonstrated that 

ethylene glycol was rapidly absorbed, 

metabolized and excreted. It is primarily 

metabolized via the liver and kidneys. 

Ethylene glycol and metabolites 

(glycolic acid and oxalic acid) are 

primarily excreted in the urine within 

12–18 hours after administration. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by the ethylene glycol, as 

well as, the NOAEL and the LOAEL 

from the toxicity studies can be found 

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

document ‘‘800009, Ethylene Glycol; 

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,’’ pp. 7–24 in EPA–HQ– 

OPP–2008–0474 and EPA–HQ–OPP– 

2004–0207. 

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 (LOC) 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 the NOAEL and the 

LOAEL are identified. 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)(acute 

= a and chronic = c) 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 ethylene glycol used for 

human risk assessment is shown in the 

Table of this unit. 

No acute endpoint of concern for 

general population was identified in the 

available data base. However, the 

endpoint of concern for females 13 plus 

age was identified in a developmental 

toxicity study in mice with a NOAEL of 

150 mg/kg/day and LOAEL of 500 mg/ 

kg/day based on an increased incidence 

of total malformations and bilateral 

extra rib14. 

The endpoint selected for the cRfD 

was based on a chronic toxicity study in 

rats. The NOAEL in this study was 150 

mg/kg/day based on kidney lesions and 

mortality observed at 300 mg/kg/day. 

Although 71 mg/kg/day is the lowest 

NOAEL in the database identified in a 

subchronic study in rats, the confidence 

in this subchronic study is low because 

subchronic and chronic studies support 

the NOAEL of 150 mg/kg/day and 

above. The NOAEL 150 mg/kg/day 

selected for the cRfD is protective of any 

developmental effects. Therefore, the 

Agency selected the point of departure 

of 150 mg/kg/day to establish the cRfD. 

The EPA Integrated Risk Information 

System (IRIS) established a oral cRfD 

based on the NOAEL of 200 mg/kg/day 

and uncertainty factor 100. The 

currently chosen endpoint and the dose 

used for this risk assessment provide the 

most conservative assessment. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHYLENE GLYCOL 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).

NOAEL = 150 mg/kg/day ..........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.5 mg/kg/day .......

aPAD = 1.5 mg/kg/day 

Developmental toxicity study—mice. 

LOAEL = 500 mg/kg bw/day, based on increased incidence of total malformations and 

bilateral extra rib 14. 

Chronic dietary (All populations).NOAEL = 150 mg/kg/day ..........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 1.5 mg/kg/day ....

cPAD = 1.5 mg/kg/day 

Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 

Incidental oral shortterm (1 to 30 days).NOAEL = 150 mg/kg/day ..........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .................. Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 

Incidental oral intermediate-term (1 to 6 

months).

NOAEL = 150 mg/kg/day ..........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .................. Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHYLENE GLYCOL 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 

Dermal short-term (1 to 

30 days).

NOAEL = 150 mg/kg/day (dermal absorption rate = 25%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .................. Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 

Dermal intermediateterm (1 to 6 months).NOAEL = 150 mg/kg/day (dermal absorption rate = 25% 

when appropriate).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .................. Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 

Inhalation short-term (1 

to 30 days).

NOAEL = 150 mg/kg/day (inhalation absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .................. Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 

Inhalation (1 to 6 

months).

NOAEL = 150 mg/kg/day (inhalation absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .................. Chronic toxicity study. 

LOAEL = 300 mg/kg/day based on kidney lesions and death in males. 

Cancer (Oral, dermal, 

inhalation).

Not expected to be carcinogenic based on the lack of mutagenicity and lack of carcinogenicity in rodents. 

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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to ethylene glycol, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

ethylene glycol in food as follows: 

i. Acute and chronic exposure. In 

conducting the acute and 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 ethylene glycol. 

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 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. 

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 


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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. Ethylene glycol is not 

expected to be carcinogenic since it was 

negative for carcinogenicity in mice and 

rats in the available published studies 

and there was a negative response for 

mutagenicity. Since the Agency has not 

identified any concerns for 

carcinogenicity relating to ethylene 

glycol, a dietary exposure assessment to 

evaluate cancer risk was not performed. 

iii. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for ethylene glycol. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

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 ethylene 

glycol, a conservative drinking water 

concentration value of 100 parts per 

billion (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). 

Ethylene glycol 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 ethylene glycol as 

inert ingredients. The ethylene glycol 

inerts may be present in consumer 

personal (care) products and cosmetics 

(at concentrations up to 1%) (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 ethylene glycol 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 

ethylene glycol 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 ethylene glycol to 

share a common mechanism of toxicity 

with any other substances, and ethylene 

glycol does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that ethylene glycol 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 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. 

In the case of the ethylene glycol, some 

of the available studies suggest 

increased susceptibility to the offspring 

of rodents following pre-natal and postnatal exposure. However, the effects 

(described in this unit) occurred at 

doses that were > 500 mg/kg/day. The 

established cRfD of 1.5 mg/kg/day will 

be protective of these effects. 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 ethylene 

glycol is adequate. The following 

acceptable studies are available: 

Developmental toxicity studies in 

rodents (6); 

Multi-generation reproduction studies 

in rodents (4); 

Subchronic toxicity studies in 

multiple species; 

Inhalation and dermal toxicity 

studies; 

Chronic/carcinogenicity studies in 

rodents (5). 

ii. Signs of neurotoxicity (when 

observed) occurred at high doses and at 

doses above that which produced 

kidney toxicity. The established cRfD of 

1.5 mg/kg/day (NOAEL = 150 mg/kg/ 

day) is protective of kidney toxicity and 

is therefore protective of neurotoxic 

effects. Also, the International 

Programme on Chemical Safety Concise 

International Chemical Assessment 

Document 45 Ethylene Glycol: Human 

Health Aspects (IPCS CICAD 2002) 

concluded that ‘‘data are limited, results 

of identified toxicity studies conducted 

(via oral, inhalation, or dermal routes) 

in rodents, rabbits, and monkeys do not 

indicate that neurological effects are 

critical end-points for ethylene glycol.’’ 

IPCS (2002) also states that generally 

neurotoxicity effects occur at a dose 

higher than the dose producing kidney 

toxicity. Since the current cRfD is 

protective of kidney toxicity, the 

concern for neurotoxicity is low to 

none. Therefore, EPA concluded that 

the developmental neurotoxicity is not 

required. 

iii. Evidence of potential 

immunotoxicity was observed in a 

subchronic toxicity study in rats. 

Decreased relative thymus weights were 

observed at 4,000 mg/kg/day. Again, 

this effect occurred at a high dose and 

at a dose above that which produced 

kidney toxicity. The established cRfD of 

1.5 mg/kg/day (NOAEL = 150 mg/kg/ 

day) is protective of kidney toxicity and 

is approximately 2,600 times lower than 

the dose where decreased relative 

thymus weights were observed. 

Therefore, the cRfD will be protective of 

this immunotoxicity effects. The IPCS 

CICAD for ethylene glycol finds that 

although ‘‘data are limited, results of 


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identified toxicity studies conducted 

(via oral, inhalation, or dermal routes) 

in rodents, rabbits, and monkeys do not 

indicate that immunological effects are 

critical end-points for ethylene glycol.’’ 

(IPCS 2002). 

iv. Evidence of increased 

susceptibility was not observed in the 

developmental toxicity study in the 

rabbit. However, evidence of increased 

susceptibility was observed following 

prenatal exposure to ethylene glycol in 

mice. An increased incidence of total 

malformations and bilateral extra rib 14 

were observed at 500 mg/kg/day. These 

effects occurred in the absence of 

maternal toxicity. In a developmental 

study in rats, there was evidence of 

qualitative fetal susceptibility. Maternal 

(tubular dilation and regeneration in the 

kidneys, increased gestational period, 

and decreased relative kidney weights) 

and developmental (decreased pup 

weight, increased cumulative mortality/ 

litter, increased incidence of 

hydrocephaly, decreased relative kidney 

weights, decreased absolute brain 

weights, and increased incidences of 

hydrocephaly; defects in ribs, 

sternebrae, and vertebrae) were 

observed at the same dose (1,250 mg/kg/ 

day). There was no evidence of 

increased fetal susceptibility in another 

developmental study in rats, maternal 

(pre-implantation loss) and 

developmental (poorly ossified and 

unossified vertebral centra) effects were 

observed at the same dose (1,000 mg/kg/ 

day). However, there was a well 

established NOAEL in these two 

developmental toxicity studies in rats 

protecting fetuses. In addition, these 

fetal effects were generally seen at 

relatively high doses. In a reproduction 

study in mice, increased fetal 

susceptibility was observed but again it 

occurred above the limit dose. 

Developmental toxicity manifested as 

decrease number of live pups/litter, and 

mean live pup weight was observed in 

the absence of maternal toxicity at 1,640 

mg/kg/day. 

In another reproduction study in 

mice, maternal (kidney lesions and 

oxalate crystals) and developmental 

toxicity (decrease in pup weight 

adjusted for litter size) were observed at 

897 mg/kg/day. 

However, the concern for this 

increased susceptibility was low based 

on the following rationale: 

a. There is a well established NOAEL 

in these studies protecting fetuses/ 

offspring from the aforementioned 

effects; 

b. Although increased susceptibility 

was observed, this occurred at doses 

close to the limit dose of 1,000 mg/kg/ 

day; 

c. The effects seen in the 

developmental study were not 

reproduced in the reproduction studies; 

and 

d. The established chronic reference 

dose of 1.5 mg/kg/day will be protective 

of these effects. Therefore, based on the 

weight of evidence the concern for 

increased fetal susceptibility is low. 

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 

water and surface water modeling used 

to assess exposure to ethylene glycol in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by ethylene glycol. 

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 aPAD and 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. Using the exposure assumptions 

described in this unit for acute 

exposure, EPA has concluded that acute 

exposure to ethylene glycol from food 

and water will utilize 26.5% of the 

aPAD for females 13–49, the only 

population group identified as 

potentially facing an acute risk from 

exposure to ethylene glycol. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to ethylene glycol 

from food and water will utilize 12.8% 

of the cPAD for the general population 

and 41.6% 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). 

Ethylene glycol 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 ethylene glycol. 

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 200 for both adult males and 

females, respectively. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

homeowner mixer/loader/applicators 

using a trigger sprayer with a high end 

post application dermal exposure from 

contact with treated lawns. EPA has 

concluded that the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

170 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

surfaces (dermal and hand-to-mouth 

exposures). Because EPA’s LOC for 

ethylene glycol 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). 

Ethylene glycol 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 ethylene glycol. 

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 580 for both adult 

males and females, respectively. Adult 

residential exposure combines high end 

dermal and inhalation handler exposure 

from homeowner mixer/loader/ 

applicators using a trigger sprayer with 

a high end post application dermal 

exposure from contact with treated 

lawns. EPA has concluded that the 

combined short-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 200 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated surfaces (dermal and handto-mouth exposures). Because EPA’s 

LOC for ethylene glycol is a MOE of 100 


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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 ethylene 

glycol. 

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 ethylene 

glycol 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 ethylene glycol. 

C. Response to Comments 

The two comments were received 

from private citizens who opposed the 

authorization to sell any pesticide that 

leaves a residue on food. The Agency 

understands the commentors’ 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 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 180.910 for ethylene 

glycol (107–21–1) when used as an inert 

ingredient (in encapsulating agents for 

pesticides being applied post-harvest as 

residual, and crack and crevice sprays 

in and around food and nonfood areas 

of residential and nonresidential 

structures, including food handling 

establishments) and 40 CFR 180.920 for 

ethylene glycol when used as an (inert 

ingredient as a solvent, stabilizer and/or 

antifreeze within pesticide 

formulations/products without 

limitation) 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 

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: May 18, 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 ingredient to read as follows: 


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Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations 31479 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Ethylene glycol (CAS Reg. No. 107–21–1) ........... Without limitation ............. Encapsulating agent for pesticides being applied post-harvest as 

residual, and crack and crevice sprays in and around food 

and nonfood areas of residential and nonresidential structures, including food handling establishments. 

* * * * * * * 

■ 3. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Ethylene glycol (CAS Reg. No. 107–21–1) .............. Without limitation ............ Pesticide inert ingredient as a solvent, stabilizer and/or antifreeze. 

*******

[FR Doc. 2011–13577 Filed 5–31–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0426; FRL–8873–5] 

Pyraflufen-ethyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraflufenethyl in or on multiple commodities 

which are identified and discussed later 

in this document. Nichino America, 

Inc., requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective June 

1, 2011. Objections and requests for 

hearings must be received on or before 

August 1, 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–2010–0426. 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: 

Kathryn V. Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; e-mail address: 

montague.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://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 


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