42318 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 

MRA member at the time of the test. For 

firewalled conformity assessment 

bodies, the firewalled conformity 

assessment body must be one that the 

Commission accredited by order at or 

before the time the product was tested, 

even though the order will not have 

included the test methods in the 

regulations specified in this notice. If 

the third party conformity assessment 

body has not been accredited by a 

Commission order as a firewalled 

conformity assessment body, the 

Commission will not accept a certificate 

of compliance based on testing 

performed by the third party conformity 

assessment body before it is accredited, 

by Commission order, as a firewalled 

conformity assessment body; 

• The third party conformity 

assessment body’s application for 

testing using the test methods in the 

regulations identified in this notice is 

accepted by the CPSC on or before 

September 20, 2010; 

• The product was tested on or after 

July 21, 2010 with respect to the 

regulations identified in this notice; 

• The accreditation scope in effect for 

the third party conformity assessment 

body at the time of testing expressly 

included testing to the regulations 

identified earlier in part I of this 

document; 

• The test results show compliance 

with the applicable current standards 

and/or regulations; and 

• The third party conformity 

assessment body’s accreditation, 

including inclusion in its scope the 

standards described in part I of this 

notice, remains in effect through the 

effective date for mandatory third party 

testing and manufacturer/private labeler 

certification for conformity with 16 CFR 

parts 1630 and/or 1631. 

Dated: July 15, 2010. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2010–17724 Filed 7–20–10; 8:45 am] 

BILLING CODE 6355–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0692; FRL–8830–6] 

Poly(oxy-1,2-ethanediyl), α-isotridecylw-methoxy; 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 poly(oxy-1,2- 

ethanediyl), a-isotridecyl-w-methoxy 

(CAS Reg. No. 345642–79–7) when used 

as an inert ingredient (surfactant) at a 

maximum concentration of 10% in 

pesticide formulations under 40 CFR 

180.920 on growing crops only. Bayer 

CropScience 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 poly(oxy-1,2-ethanediyl), 

a-isotridecyl-w-methoxy. 

DATES: This regulation is effective July 

21, 2010. Objections and requests for 

hearings must be received on or before 

September 20, 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–2009–0692. 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: 

Deirdre Sunderland, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0851; e-mail address: 

sunderland.deirdre@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–2009–0692 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 September 20, 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 


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Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 42319 

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–2009–0692, 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 January 6, 

2010 (75 FR 864) (FRL–8801–5), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

9E7580) by Bayer CropScience, 2 T.X. 

Alexander Dr., P.O. Box 12014, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of poly(oxy-1,2- 

ethanediyl), a-isotridecyl-w-methoxy 

(CAS No. 345642–79–7) when used as 

an inert ingredient (surfactant) in 

pesticide formulations applied preharvest to all crops without limitation. 

That notice referenced a summary of the 

petition prepared by Bayer CropScience, 

the petitioner, which is available in the 

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

There were no comments received in 

response to the notice of filing. Based 

upon review of the data supporting the 

petition, EPA has limited the amount in 

formulation to 10%. This limitation is 

based on the Agency’s risk assessment 

which can be found at http:// 

www.regulations.gov in document 

‘‘Decision Document for Petition 

Number 9E7580; Poly(oxy-1,2- 

ethanediyl), a-isotridecyl-w-methoxy 

(CAS Reg. No. 345642–79–7)’’ in docket 

ID number EPA–HQ–OPP–2009–0692. 

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 poly(oxy-1,2- 

ethanediyl), a-isotridecyl-w-methoxy 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with poly(oxy-1,2- 

ethanediyl), a-isotridecyl-w-methoxy 

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 poly(oxy-1,2-ethanediyl), aisotridecyl-w-methoxy 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. 

The available toxicity data include an 

acute toxicity battery, a combined 

repeated dose toxicity study with the 

reproduction/developmental toxicity 

screening test (OPPTS Harmonized Test 

Guideline 870.3650), and two 

mutagenicity studies (OPPTS 

Harmonized Test Guideline 870.5100). 

In addition, sufficient toxicity data are 

available on the metabolite. Acute 

studies (OPPTS Harmonized Test 

Guidelines 870.1100 and 870.1200 

(acute inhalation study not provided)) 

showed low acute toxicity (Toxicity 

Category III) with an oral LD50 >2000 

milligrams/kilogram (mg/kg) and acute 

dermal LD50 >2000 mg/kg. Irritation 

studies (OPPTS Harmonized Test 

Guidelines 870.2400 and 870.2500) on 

rabbits revealed slight skin irritation 

(Toxicity Category IV) and severe eye 

irritation (Toxicity Category II). In 

addition, a skin sensitization study 

(OPPTS Harmonized Test Guidelines 


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870.2600) in guinea pigs showed skin 

sensitization when exposed to poly(oxy1,2-ethanediyl), a-isotridecyl-wmethoxy. 

In an OPPTS Harmonized Test 

Guideline 870.3650 poly(oxy-1,2- 

ethanediyl), a-isotridecyl-w -methoxy 

was administered by gavage prior to 

mating through postnatal day 4 (~6–7 

weeks). Clinical signs of toxicity 

included increased incidences of oral 

and urine staining (≥150 milligrams/ 

kilogram/day (mg/kg/day)) and a slight 

decrease in body weight and body 

weight gain (300 mg/kg/day male rats, 

pre-mating period); however, no 

treatment-related effects were observed 

during the remainder of the study. 

Additionally female rats (≥150 mg/kg/ 

day) exhibited a decrease in hind-limb 

strength and rearing in open-field. 

At necropsy females in the high dose 

(300 mg/kg/day) group showed a 

statistically significant increase in 

absolute and relative adrenal weight, 

relative kidney weight, and absolute 

liver weight. Females in the mid and 

high dose group (≥150 mg/kg/day) 

showed a statistically significant 

increase in relative liver weight. In the 

absence of any collaborative blood or 

histopathologic findings the effect seen 

in the liver is considered as an adaptive 

response. An increased incidence of 

minimal to moderate epithelial cell 

hyperplasia was noted in the nonglandular epithelium of the stomach of 

high-dose male and female rats 

indicating local irritation which is likely 

due to the irritation induced by gavage 

treatment of chemicals with irritative 

properties. 

A LOAEL was not established for 

poly(oxy-1,2-ethanediyl), a-isotridecylw-methoxy in male Wistar rats. The 

NOAEL for male rats is the highest dose 

tested, 300 mg/kg/day. The NOAEL for 

female rats is 45 mg/kg/day based on the 

functional observational battery 

observations (i.e. decrease in rearing in 

open field and hind limb grip strength) 

seen at the LOAEL of 150 mg/kg/day. 

The OPPTS 870.3650 study on 

poly(oxy-1,2-ethanediyl), a-isotridecylw-methoxy was also used to evaluate 

reproductive and developmental 

toxicity. No test material-related effects 

were observed on reproductive (e.g., 

mating, fertility, or gestation indices, 

days to insemination, gestation length, 

or number of implants) or 

developmental (e.g., mean litter size, 

viability, clinical signs of toxicity, or 

body weight of the pups) parameters at 

any dose tested; therefore, the NOAEL 

for poly(oxy-1,2-ethanediyl), aisotridecyl-w -methoxy for reproductive 

and developmental parameters is 300 

mg/kg/day (highest dose tested). 

Evidence of neurotoxicity was 

observed in the OPPTS 870.3650 study 

which showed a decrease in rearing in 

open field and hind limb grip strength 

for mid- and high-dose female rats (≥ 

150 mg/kg/day). No evidence of 

immunotoxicity was observed in the 

database. 

There are no carcinogenicity studies 

available in the database; however, 

poly(oxy-1,2-ethanediyl), a-isotridecylw-methoxy tested negative in two 

mutagenicity assays (OPPTS 

Harmonized Test Guideline 870.5100) 

and no evidence of specific target organ 

toxicity was observed in the OPPTS 

870.3650 study. In addition, no 

evidence of carcinogenicity was 

observed in studies on the metabolite aisotridecyl-w-hydroxy-poly(oxy-1 ,2- 

ethanediyl) (CAS Reg. No. 9043–30–5) 

(Federal Register, August 5, 2009 (74 FR 

38935, FRL–8430–1)). The Agency does 

not anticipate poly(oxy–1,2–ethanediyl), 

a–isotridecyl–w–methoxy to be 

carcinogenic. 

Based on available information the 

Agency has concluded that poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy has a higher toxicity than its 

metabolite; therefore, conducting the 

risk assessment on the parent would be 

protective of the metabolite. 

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. 

The POD for the risk assessment for 

all durations and routes of exposure was 

from the OPPTS Harmonized Test 

Guideline 870.3650 toxicity study in 

rats. The NOAEL was 45 mg/kg/day and 

the LOAEL was 150 mg/kg/day based on 

rearing in the open field and hind limb 

grip strength. A 300 fold uncertainty 

factor was used for the chronic exposure 

(10X interspecies extrapolation, 10X for 

intraspecies variability and 3X FQPA 

factor). 

The residential, occupational, and 

aggregate level of concern (LOC) is for 

MOEs that are less than 300 and is 

based on 10X interspecies extrapolation, 

10X for intraspecies variability and 3X 

FQPA factor. Dermal absorption was 

estimated to be 10% based on the large 

molecular weight of the chemical and 

the lack of water solubility. A 100% 

inhalation was assumed. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to poly(oxy–1,2–ethanediyl), 

a–isotridecyl–w–methoxy, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy was seen in the 

toxicity databases. Therefore, acute 

dietary risk assessments for poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy is not required. 

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 poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy. 

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 


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Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 42321 

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 is generally at least 50% of the 

product and often can be much higher. 

Further, pesticide products rarely have 

a single inert ingredient; rather there is 

generally a combination of different 

inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. In the case of 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy, EPA made a 

specific adjustment to the dietary 

exposure assessment to account for the 

use limitations of the amount of 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy that may be in 

formulations (no more than 10% by 

weight in pesticide formulations) and 

assumed that the poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

are present at the maximum limitations 

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 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100% of all foods 

are treated with the inert ingredient at 

the rate and manner necessary to 

produce the highest residue legally 

possible for an active ingredient. In 

summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity and specific 

organ toxicity in available studies, along 

with the lack of carcinogenicity in 

metabolite studies, poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

is not expected to pose a cancer risk to 

humans. Therefore, a cancer dietary 

exposure assessment is not necessary to 

assess cancer risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy. Tolerance level 

residues and/or 100% 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 poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy, 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 non– 

occupational, non–dietary exposure 

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

carpets, swimming pools, and hard 

surface disinfection on walls, floors, and 

tables). 

There are no known or anticipated 

residential uses and therefore, a 

residential risk assessment was not 

conducted. 

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 poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

to share a common mechanism of 

toxicity with any other substances, and 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that poly(oxy–1,2–ethanediyl), 

a–isotridecyl–w–methoxy 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. 

The OPPTS Harmonized Test Guideline 

870.3650 study on poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

was also used to evaluate reproductive 

and developmental toxicity. There was 


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no evidence of increased susceptibility 

of infants and children in the available 

database. No test material–related 

effects were observed on reproductive or 

developmental parameters at any dose 

tested; therefore, the NOAEL for 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w –methoxy for 

reproductive and developmental 

parameters is 300 mg/kg/day (highest 

dose tested). The parental systemic 

toxicity NOAEL is 45 mg/kg/day and the 

LOAEL of 150 mg/kg/day is based on 

clinical signs of neurotoxicity. 

3. Conclusion. Although there is no 

evidence of increased susceptibility in 

infants and children, in order to be 

protective in the absence of a 

developmental neurotoxicity study and 

the extrapolation from subchronic to 

chronic, a 3X FQPA safety factor has 

been retained. 

EPA has determined that reliable data 

show the safety of infants and children 

would be adequately protected if the 

FQPA SF was reduced to 3X. That 

decision is based on the following 

findings: 

i. There is no evidence that poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy results in increased 

susceptibility in in utero rats in an 

OPPTS Harmonized Test Guideline 

870.3650 study, a combined repeated 

dose toxicity study with reproduction/ 

developmental toxicity test parameters. 

ii. Evidence of neurotoxicity was 

observed in the OPPTS 870.3650 

Harmonized Test Guideline study 

which showed a decrease in rearing in 

open field and hind limb grip strength 

in females in the mid- and high-dose 

groups (≥ 150 mg/kg/day). EPA 

concluded that the 3X FQPA database 

uncertainty factor is adequate because 

the evidence of neurotoxicity was 

observed only in females while males 

had no effects at doses up to and 

including 300 mg/kg/day and a lack of 

a significant dose response in females. 

No chronic toxicity or carcinogenicity 

studies are available in the database; 

however, the Agency notes that 

surfactants are surface–active materials 

that can damage the structural integrity 

of cellular membranes at high dose 

levels. Thus, surfactants are often 

corrosive and irritating in concentrated 

solutions. The observed toxicity seen in 

the repeated dose studies, such as 

microscopic lesions or decreased body 

weight gain, are attributed to the 

corrosive and irritating nature of these 

surfactants. The Agency has 

considerable toxicity information on 

surfactants, which indicates that the 

effects do not progressively increase in 

severity over time. In addition, use of 

the full 10X interspecies factor will 

actually provide an additional margin of 

safety because it is not expected that 

humans’ response to local irritation/ 

corrosiveness effects would be markedly 

different from animals. No evidence of 

immunotoxicity was observed in the 

database. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 10% in 

formulation and a default 100 ppb 

concentration in drinking water. The I 

DEEM models uses highly conservative 

assumption and assumes that all crop/ 

crop groups are treated with all 

pesticide classifications (e.g., 

fungicides, insecticides, herbicides). 

There are no currently approved uses of 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy in pesticide 

products; therefore, this is a highly 

conservative estimate. In addition, it is 

unlikely that poly(oxy–1,2–ethanediyl), 

a–isotridecyl–w–methoxy will appear in 

drinking water. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy. 

iv. Sufficient data exist on the 

metabolite a–isotridecyl–w–hydroxy– 

poly(oxy–1 ,2–ethanediyl) (CAS Reg. 

No. 9043–30–5) and it has recently been 

assessed by the Agency (Federal 

Register, August 5, 2009 (74 FR 38935, 

FRL–8430–1)). Based on available 

information it has been concluded that 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy has a higher 

toxicity than its metabolite and 

therefore, conducting the risk 

assessment on the parent would be 

protective of the metabolite. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short–, 

intermediate–, and chronic–term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. 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, poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

is not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

from food and water will utilize 84.9% 

of the cPAD for children 1–2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy. 

3. Short–term risk. Short–term 

aggregate exposure takes into account 

short–term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

A short–term adverse effect was 

identified; however, poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

is not currently used as an inert 

ingredient in pesticide products that are 

registered for any use patterns that 

would result in short–term residential 

exposure. Short–term risk is assessed 

based on short–term residential 

exposure plus chronic dietary exposure. 

Because there is no short–term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short–term risk), 

no further assessment of short–term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short–term risk for poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy. 

4. Intermediate–term risk. 

Intermediate–term aggregate exposure 

takes into account intermediate–term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate–term adverse effect 

was identified; however, poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

is not currently used as an inert 

ingredient in pesticide products that are 

registered for any use patterns that 

would result in intermediate–term 

residential exposure. Intermediate–term 

risk is assessed based on intermediate– 

term residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate–term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate–term risk), no 

further assessment of intermediate–term 


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risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate–term risk for 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy. Therefore, an aggregate cancer 

risk was not conducted. 

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 poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

in or on any food commodities. EPA is 

establishing a limitation on the amount 

of poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy that may be 

used in pesticide formulations. That 

limitation will be enforced through the 

pesticide registration process under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), 7 U.S.C. 136 

et seq. EPA will not register any 

pesticide for sale or distribution that 

contains greater than 10% of poly(oxy– 

1,2–ethanediyl), a–isotridecyl–w– 

methoxy by weight in the pesticide 

formulation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for 

poly(oxy–1,2–ethanediyl), a– 

isotridecyl–w–methoxy 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 poly(oxy–1,2– 

ethanediyl), a–isotridecyl–w–methoxy 

(CAS Reg. No. 345642–79–7) when used 

as an inert ingredient (surfactant) in 

pesticide formulations applied to 

growing crops at a maximum of 10% 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: July 8, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In §180.920, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 


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42324 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 

Inert ingredients Limits Uses 

*******

Poly(oxy-1,2-ethanediyl), a-isotridecyl-w-methoxy (CAS Reg. 

No. 345642-79-7) 

At a maximum of 10% in formulation Surfactant 

* * * * * * * 

[FR Doc. 2010–17402 Filed 7–21–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0528; FRL–8834–8] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclostrobin 

in or on alfalfa and poultry, and 

increases tolerances for residues in or 

on soybean. BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

21, 2010. Objections and requests for 

hearings must be received on or before 

September 20, 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–2010–0528. 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: 

Shaunta Hill, Registration Division 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8961; e-mail address: 

hill.shaunta@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 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0528 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 September 20, 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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0528, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 4, 

2010 (75 FR 5792) (FRL–9110–5) and 

June 8, 2010 (75 FR 32465) (FRL–8827– 

5), EPA issued notices pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions PP 9F7590 and PP 

9F7528, respectively, by BASF 

Corporation, P.O. Box 13528, Research 


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