22234 Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations 

through 10:45 p.m. on May 29, 2010. 

The Captain of the Port, Sector Lake 

Michigan, or his or her on-scene 

representative may terminate this 

operation at any time. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23 of 

this part, entry into, transiting, or 

anchoring within this safety zone is 

prohibited unless authorized by the 

Captain of the Port, Sector Lake 

Michigan, or his or her on-scene 

representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port, 

Sector Lake Michigan, or his or her onscene representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port, Sector Lake 

Michigan, is any Coast Guard 

commissioned, warrant or petty officer 

who has been designated by the Captain 

of the Port, Sector Lake Michigan, to act 

on his or her behalf. The on-scene 

representative of the Captain of the Port, 

Sector Lake Michigan, will be aboard 

either a Coast Guard or Coast Guard 

Auxiliary vessel. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port, Sector 

Lake Michigan, or his or her on-scene 

representative to obtain permission to 

do so. The Captain of the Port, Sector 

Lake Michigan, or his or her on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the Captain 

of the Port, Sector Lake Michigan, or his 

or her on-scene representative. 

Dated: April 8, 2010. 

L. Barndt, 

Captain, U.S. Coast Guard, Captain of the 

Port, Sector Lake Michigan. 

[FR Doc. 2010–9797 Filed 4–27–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[USCG–2010–0251] 

RIN 1625–AA00 

Safety Zone; Milwaukee Harbor, 

Milwaukee, WI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the safety zone for annual fireworks 

events in the Captain of the Port, Sector 

Lake Michigan, during four separate 

periods between 9:15 p.m. on June 12, 

2010 and 10:30 p.m. on June 24, 2010. 

This action is necessary and intended to 

ensure safety of life on the navigable 

waters of the United States immediately 

prior to, during, and immediately after 

fireworks events. This action will 

establish restrictions upon, and control 

movement of, vessels in a specified area 

immediately prior to, during, and 

immediately after fireworks events. 

During the enforcement period, no 

person or vessel may enter the safety 

zones without permission of the Captain 

of the Port, Sector Lake Michigan. 

DATES: The regulations in 33 CFR 

165.935 will be enforced during four 

separate periods between 9:15 p.m. on 

June 12, 2010 and 10:30 p.m. on June 

24, 2010. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or e-mail BM1 Adam Kraft, Prevention 

Department, Coast Guard Sector Lake 

Michigan, Milwaukee, WI at 414–747– 

7154, e-mail Adam.D.Kraft@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone listed 

in 33 CFR 165.935, Safety Zones, 

Milwaukee Harbor, Milwaukee, WI, for 

the following events: 

(1) Pridefest fireworks display on June 

12, 2010 from 9:15 p.m. through 10 p.m. 

(2) Polish Festival fireworks display 

on June 18, 2010 from 9:15 p.m. through 

10 p.m.; on June 19, 2010 from 9:15 p.m. 

through 10 p.m. 

(3) Summerfest fireworks display on 

June 24, 2010 from 9:15 p.m. through 

10:30 p.m. 

All vessels must obtain permission 

from the Captain of the Port, Sector Lake 

Michigan, or his or her on-scene 

representative to enter, move within, or 

exit the safety zone. Vessels and persons 

granted permission to enter the safety 

zone shall obey all lawful orders or 

directions of the Captain of the Port, 

Sector Lake Michigan, or his or her onscene representative. While within a 

safety zone, all vessels shall operate at 

the minimum speed necessary to 

maintain a safe course. 

This notice is issued under authority 

of 33 CFR 165.935 Safety Zone, 

Milwaukee Harbor, Milwaukee, WI and 

5 U.S.C. 552(a). In addition to this 

notice in the Federal Register, the Coast 

Guard will provide the maritime 

community with advance notification of 

these enforcement periods via broadcast 

Notice to Mariners or Local Notice to 

Mariners. The Captain of the Port, 

Sector Lake Michigan, will issue a 

Broadcast Notice to Mariners notifying 

the public when enforcement of the 

safety zone established by this section is 

suspended. If the Captain of the Port, 

Sector Lake Michigan, determines that 

the safety zone need not be enforced for 

the full duration stated in this notice, he 

or she may use a Broadcast Notice to 

Mariners to grant general permission to 

enter the safety zone. The Captain of the 

Port, Sector Lake Michigan, or his or her 

on-scene representative may be 

contacted via VHF Channel 16. 

Dated: April 8, 2010. 

L. Barndt, 

Captain, U.S. Coast Guard, Captain of the 

Port, Sector Lake Michigan. 

[FR Doc. 2010–9799 Filed 4–27–10; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0165; FRL–8816–4] 

Phosphate Ester, Tallowamine, 

Ethoxylated; 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 phosphate 

ester, tallowamine, ethoxylated (CAS 

Reg. No. 68308–48–5), herein referred to 

in this document as PETAE when used 

as an inert ingredient at a maximum of 

20% by weight in pesticide 

formulations applied in or on growing 

crops. Huntsman Corporation submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of PETAE. 

DATES: This regulation is effective April 

28, 2010. Objections and requests for 

hearings must be received on or before 

June 28, 2010, 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–2009–0165. 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, 


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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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; e-mail address: 

debesai.alganesh@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 cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2009–0165 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 June 28, 2010. 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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0165, 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 April 8, 

2009 (74 FR 15975) (FRL–8407–4), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

8E7477) by Huntsman Corporation, 

8600 Gosling Road, Woodlands, TX 

77381. The petition requested that 40 

CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of tallowamine, ethoxylated, mixture of 

dihydrogen phosphate and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

potassium, and sodium salts of the 

phosphate esters, where the 

poly(oxyethylene) content averages 2– 

20 moles, (CAS Reg. No. 68308–48–5) 

when used as an inert ingredient as 

surfactants, related adjuvants of 

surfactants in pesticide formulations 

applied to growing crops at a maximum 

of 20% by weight in pesticide 

formulations. That notice referenced a 

summary of the petition prepared by 

Huntsman Corporation, the petitioner, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 


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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 PETAE including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with PETAE 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 PETAE as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

The following provides a brief 

summary of the risk assessment and 

conclusions for the Agency’s review of 

PETAE. The Agency’s full decision 

document for this action is available in 

the Agency’s electronic docket 

(regulations.gov) under the docket 

number EPA–HQ–OPP–2009–0165. The 

database on PETAE is limited, however, 

the Agency has determined that studies 

on alkyl amine polyalkoxylates (AAPs) 

can be used to asses the toxicity of the 

PETAE because PETAE is a phosphate 

ester form of AAPs. The Agency has 

recently evaluated AAPs in docket ID 

number EPA–HQ–OPP–2008–0738. 

PETAE is not acutely toxic via oral, 

dermal, and inhalation routes of 

exposure. It is extremely irritating to the 

eyes and slightly irritating to the skin. 

It is not a dermal sensitizer. In a 

Combined Repeated Dose Toxicity 

Study with the Reproduction/ 

Developmental Toxicity Screening Test, 

clinical signs of toxicity (abnormal 

respiratory sounds, dyspnea, 

piloerection, and emaciation), mortality 

and decreased food consumptions and 

decreased in body weights were 

observed in parental animals at 200 

milligrams/kilogram/day (mg/kg/day). 

The clinical signs observed in this study 

are indicative of local irritation. No 

effects on functional observation battery 

(FOB) parameters were observed. The 

gestation index was decreased primarily 

due to mortality of females. Decreased 

in corpora lutea and implantation sites 

were observed at the highest dose tested 

(200 mg/kg/day). Decrease in pups’ 

body weight gain was observed on day 

4 at the high dose only. No mutagenicity 

studies are available in the database; 

however, there was no evidence that 

AAPs are mutagenic or clastogenic. 

There are no chronic toxicity or 

carcinogenicity studies available in the 

database. There is no evidence that the 

AAPs are carcinogenic. The Agency 

used a qualitative structure activity 

relationship (QSAR) database, 

DEREK11, to determine if there were 

structural alerts for a representative 

large molecule, as well as a smaller 

molecule that had been extensively 

dealkylated, with the amine group 

intact. No structural alerts were 

identified. Therefore, there are no 

triggers for carcinogenicity of PETAE in 

the database. 

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 PETAE used for human 

risk assessment is shown in the 

following table: 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PETAE FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(General population including infants and children) 

No appropriate endpoints were identified for acute dietary risk assessment. 


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SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PETAE 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 

Chronic dietary 

(All populations) 

NOAEL = 100 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Chronic RfD = 1 mg/kg/day 

cPAD = 0.33 mg/kg/day 

OECD 422 Reproduction/Developmental Screen in rats (MRID 

47600707) 

LOAEL = 200 mg/kg/day based 

on mortalities, clinical signs, 

decreased body weight and/or 

body weight gain and decreased food consumption in 

both sexes 

CAS 7664–38–2 

Incidental Oral Short-Term and Intermediate-Term Dermal and Inhalation NOAEL= 100 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

(10% Dermal absorption; 100% 

inhalation and oral toxicity assumed equivalent) 

Residential/Occupational LOC for 

MOE = 300 

OECD 422 Reproduction/Developmental Screen in rats (MRID 

47600707) 

LOAEL = 200 mg/kg/day based 

on mortalities, clinical signs, 

decreased body weight and/or 

body weight gain and decreased food consumption in 

both sexes 

CAS 7664–38–2 

Cancer 

(Oral, dermal, inhalation) 

Classification: No animal toxicity data available for an assessment. Based on SAR analysis, PETAE is not 

expected to be carcinogenic. 

UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation in sensitivity among members of the human population (intraspecies). 

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 PETAE, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

PETAE in food as follows: 

i. Acute exposure. No adverse effect 

attributable to a single exposure of the 

PETAE was seen in the toxicity 

databases; therefore, an acute dietary 

exposure assessment for the PETAE was 

not conducted. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, 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 PETAE. 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 concentrations 

of active ingredient in agricultural 

products are generally at least 50% of 

the product and often can be much 

higher. Further, pesticide products 

rarely have a single inert ingredient; 

rather there is generally a combination 

of different inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. In the case of the 

PETAE, EPA made a specific adjustment 

to the dietary exposure assessment to 

account for the use limitations of the 

amount of PETAE that may be in 

formulations (no more than 20% by 

weight in pesticide formulations) and 

assumed that the PETAE are present at 

the maximum limitation rather than at 

equal quantities with the active 

ingredient. This remains a very 

conservative assumption because 

surfactants are generally used at levels 

far below this percentage. 

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 


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single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100% of all foods 

are treated with the inert ingredient at 

the rate and manner necessary to 

produce the highest residue legally 

possible for an active ingredient. In 

summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, and 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. 

iii. Cancer. The Agency used a QSAR 

database, DEREK11, to determine if 

there were structural alerts suggestive of 

carcinogenicity. No structural alerts for 

carcinogenicity were identified. 

Therefore, a quantitative dietary 

exposure assessment was not conducted 

for the purpose of evaluating cancer 

risk. 

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 PETAE, 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., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). PETAE 

may be used in inert ingredients in 

pesticide products that are registered for 

specific uses that may result in both 

indoor and outdoor residential 

exposures. 

A screening level residential exposure 

and risk assessment was conducted for 

products containing the PETAE as inert 

ingredients. In this assessment, the 

Agency selected representative 

scenarios, based on end-use product 

application methods and labeled 

application rates. The residential 

products are typically formulated as 

liquids in concentrates or as wettable 

powders. PETAE has no pesticidal 

properties, and is added to pesticide 

formulations for its adjuvant property. 

PETAE is not generally added to any 

pesticides intended for indoor use (i.e., 

where the Agency would typically 

assess crack and crevice/pet uses). 

Therefore, EPA assumed no indoor uses 

exist. Similarly, residential post 

application dermal and oral exposure 

assessments were also performed 

utilizing high end indoor and outdoor 

exposure scenarios. Further details of 

this residential exposure and risk 

analysis can be found at http:// 

www.regulations.gov in the 

memorandum entitled ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations’’ (D364751, 5/7/09, Lloyd/ 

LaMay) in docket ID number EPA–HQ– 

OPP–2008–0710. 

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 PETAE to share a 

common mechanism of toxicity with 

any other substances, and PETAE does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that PETAE 

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 website 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. 

In the case of PETAE, there was no 

increased susceptibility to the offspring 

of rats following prenatal and postnatal 

exposure in the OPPTS Harmonized 

Test Guideline 870.3650 reproductive/ 

developmental screening study. 

Decreased litter size and body weight 

gain in pups was observed at 200 mg/ 

kg/day where maternal/paternal toxicity 

was manifested based on mortalities, 

clinical signs, decreased body weight 

and/or body weight gain and decreased 

food consumption in male and female 

rats at 200 mg/kg/day. There is no 

concern for residual uncertainties 

because clear NOAELs were established 

for parental and offspring toxicities. 

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 3X. That decision is 

based on the following findings: 

i. The toxicity data available on the 

PETAE consists of one OPPTS 

Harmonized Test Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/development 

toxicity screening test (rat); acute oral, 

dermal, inhalation skin irritation and 

sensitization, and eye toxicity data. The 

other studies were bridged from AAPs 

since PETAE is a phosphate ester form 

of AAPs which have been recently 

assessed by the Agency in docket ID 

number EPA–HQ–OPP–2008–0738. 

There was no evidence of 

immunotoxicity in the database. 

Furthermore, these compounds do not 

belong to a class of chemicals that 

would be expected to be immunotoxic 

and, there was no evidence that the 

AAPs are mutagenic or clastogenic. 

ii. No quantitative or qualitative 

increased susceptibility was 

demonstrated in the offspring in the 

OPPTS Harmonized Test Guideline 


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870.3650 combined repeated dose 

toxicity study with the reproduction/ 

developmental toxicity screening test in 

rats following prenatal and postnatal 

exposure. 

iii. There are no chronic studies or 

carcinogenicity studies are available in 

the database. EPA has considerable 

information on the general toxicity of 

surfactants. These compounds are 

shown to cause local irritation and 

corrosive effects on membrane. EPA 

recently assessed the toxicity of AAPs. 

PETAE is a phosphate ester form of 

AAPs. The database on AAPs indicates 

that the effects do not increase in 

severity over time (4 weeks to 13 

weeks). Based on the lack of progression 

of severity of effects with time along 

with the considerable similarities of 

effects across the species tested and the 

observation that the vast majority of the 

effects observed were related to local 

irritation and corrosive effects, EPA 

concludes that chronic data are unlikely 

to show significant differences from 

existing studies. In addition, the 

concern for chronic effects for PETAE is 

low based on SAR, DEREK11 analysis 

and available data on AAPs. Based on 

the above evidence, EPA concluded that 

the FQPA factor of 3X for the lack of 

chronic studies would be adequate and 

protective. 

iv. No treatment-related effects on 

FOB parameters were observed in the 

OPPTS Harmonized Test Guideline 

870.3650. In addition, no evidence of 

treatment-related clinical signs of 

neurotoxicity were observed in the 

available toxicological studies. EPA 

concluded that there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The food and drinking water assessment 

is not likely to underestimate exposure 

to any subpopulation, including infants 

and children. The food exposure 

assessments are considered to be highly 

conservative as they are based on the 

use of the highest tolerance level from 

the surrogate pesticides for every food, 

and 100% crop treated is assumed for 

all crops. EPA also made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to PETAE in drinking 

water. These assessments will not 

underestimate the exposure and risks 

posed by PETAE. Based on the above 

considerations, EPA has reduced the 

FQPA factor to 3X. 

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-term, 

intermediate-term, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified, 

and no acute dietary endpoint was 

selected. Therefore, PETAE is not 

expected to pose an acute risk. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure and the use limitations of not 

more than 20% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to PETAE 

is 23.2% of the cPAD for the U.S. 

population and 75.6% of the cPAD for 

children 1 to 2 years old, the most 

highly exposed population subgroup. 

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). 

PETAE 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 

PETAE. 

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 1,040 and 1,147 for adult males 

and females, respectively. Adult 

residential exposure combines high end 

dermal and inhalation handler exposure 

from indoor hand wiping with a high 

end post-application dermal exposure 

from contact with treated lawns. EPA 

has concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

600 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 PETAE is a MOE of 300 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). 

PETAE 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 PETAE. 

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 1,040 and 1,147 

for adult males and females, 

respectively. Adult residential exposure 

includes 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 680 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). Because EPA’s LOC for 

PETAE is a MOE of 300 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 PETAE. 

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 PETAE 

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 

The Agency is not aware of any 

country requiring a tolerance for PETAE 


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22240 Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations 

nor have any CODEX Maximum Residue 

Levels (MRLs) been established for any 

food crops at this time. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for PETAE (CAS 

Reg. No. 68308–48–5) when used as an 

inert ingredient (as surfactants, related 

adjuvants of surfactants) in pesticide 

formulations applied to growing crops 

at a maximum of 20% by weight in 

pesticide formulations. 

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) (Public Law 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: April 15, 2010. 

G. Jeffrey Herndon, 

Acting 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 ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Tallowamine, ethoxylated, mixture of dihydrogen phosphate and monohydrogen phosphate 

esters and the corresponding ammonium, calcium, potassium, and sodium salts of the phosphate esters, where the poly(oxyethylene) content averages 2–20 moles (CAS Reg. No. 

68308–48–5) 

Not to exceed 20% of 

pesticide formulation 

Surfactants, related 

adjuvants of 

surfactants 

* * * * * 

[FR Doc. 2010–9834 Filed 4–27–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0551; FRL–8818–8] 

Cyprodinil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of cyprodinil in or 

on canola, seed. Syngenta Crop 

Protection, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

28, 2010. Objections and requests for 

hearings must be received on or before 

June 28, 2010, and must be filed in 

accordance with the instructions 


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