74628 Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

Tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on Tribal governments or preempt 

Tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by January 31, 2011. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

dioxide, Particulate matter, Ozone, 

Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: November 10, 2010. 

A. Stanley Meiburg, 

Acting Regional Administrator, Region 4. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart L—Georgia 

■ 2. Section 52.570(c) is amended by 

revising the entry for ‘‘391–3–1– 

.02(2)(zz)’’ to read as follows: 

§ 52.570 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED GEORGIA REGULATIONS

State citation Title/Subject 

State 

effective 

date 

EPA approval date Explanation 

*******

391–3–1–.02(2)(zz) .... Gasoline Dispensing Facility—Stage II.1/9/05 12/1/10 [Insert citation of 

publication].

Exemption for initial fueling of vehicles equipped 

with ORVR from Stage II requirements; allowing 

mixing of Stage II components when supported 

by third party certification and prior written approval of GA EPD. 

*******

* * * * * 

[FR Doc. 2010–30119 Filed 11–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0095; FRL–8851–6] 

Tristyrylphenol Ethoxylates; 

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-[tris(1- 

phenylethyl)phenyl]-w-hydroxy-, (CAS 

Reg. No. 99734–09–5), here in referred 

to as tristyrylphenol ethoxylate, when 

used as an inert ingredient post-harvest 

as a surfactant under 40 CFR 180.910 

with a maximum of 15 percent by 

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Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 74629 

weight in pesticide formulations. AgChem Consulting, on behalf of LG Life 

Science, submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting the 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of tristyrylphenol 

ethoxylate. 

DATES: This regulation is effective 

December 1, 2010. Objections and 

requests for hearings must be received 

on or before January 31, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0095. 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: 

Karen Samek, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8825; e-mail address: 

samek.karen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0095 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 January 31, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2008–0095, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Exemption 

In the Federal Register of June 23, 

2010 (75 FR 35801) (FRL–8831–3), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

0E7701) by Ag-Chem Consulting, 12208 

Quinque Lane, Clifton, VA 21024, on 

behalf of LG Life Science, 910 Sylvan 

Ave., Englewood Cliffs, NJ 07632. The 

petition requested that 40 CFR 180.910 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of tristyrylphenol 

ethoxylate (CAS Reg. No. 99734–09–5) 

when used as an inert ingredient as a 

surfactant with a maximum of 10 

percent by weight in pesticide 

formulations applied to food areas and 

food contact surfaces in food service 

and food handling establishments. That 

notice referenced a summary of the 

petition prepared by Ag-Chem 

Consulting, 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 

modified the exemption requested by 

limiting tristyrylphenol ethoxylate (CAS 

Reg. No. 99734–09–5) to a maximum of 

15 percent by weight in pesticide 

formulations. This limitation is based 

on the Agency’s risk assessment which 

can be found at http:// 

www.regulations.gov in document ‘‘PC 

Code: 800900; Decision Document for 

Pesticide Petition 0E7701; poly(oxy-1,2- 

ethanediyl), a-[tris(1- 

phenylethyl)phenyl]-w-hydroxy-, (CAS 

Reg. No. 99734–09–5) for use postharvest under 40 CFR 180.910 as an 

inert ingredient as a surfactant with a 

maximum of 15 percent by weight in 

pesticide formulations’’ in docket ID 

number EPA–HQ–OPP–2008–0095. 

It should be noted that there are other 

tolerance exemptions under 40 CFR 

180.920 and 40 CFR 180.1288 that apply 

to this tristyrylphenol ethoxylate 

compound (CAS Reg. No. 99734–09–5), 

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as well as, other closely related 

tristyrylphenol ethoxylate chemicals. 

The Agency believes that these existing 

exemptions could be consolidated at a 

later date by establishing a pre- and 

post-harvest exemption under 40 CFR 

180.910 for these tristyrylphenol 

ethoxylate compounds since these 

chemicals share a common chemical 

structure and are members of the same 

chemical class. 

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 tristyrylphenol 

ethoxylate including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with 

tristyrylphenol ethoxylate 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 the tristyrylphenol ethoxylates as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in the 

final rule published in the Federal 

Register of March 25, 2009 (74 FR 

12621) (FRL–8404–7). As stated in that 

document, the available toxicity 

database for the tristyrylphenol 

ethoxylates consists of studies on some 

of the tristyrylphenol ethoxylate 

chemicals, such as CAS Reg. Nos. 

90093–37–1 and 119432–41–6), and 

guideline studies on an analog chemical 

(CAS Reg. No. 105362–40–1). The 

studies on the tristyrylphenol ethoxylate 

chemicals and analog chemicals were 

considered appropriate to evaluate the 

toxicity of the tristyrylphenol 

ethoxylates because these chemicals 

share a common chemical structure and 

are members of the same chemical class. 

The tristyrylphenol ethoxylates and 

analog chemicals share a close 

structural similarity and same 

functional groups with the only 

difference being in the associated 

counterions. Therefore, the toxicity of 

these chemicals is expected to be 

similar. The Agency has determined 

that these data are appropriate and 

adequate to characterize the toxicity of 

the tristyrylphenol ethoxylates. 

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 used for human risk 

assessment is discussed in Unit IV of 

the final rule published in the Federal 

Register of March 25, 2009 (74 FR 

12621) (FRL–8404–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tristyrylphenol ethoxylate, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance as well as the 

other existing exemptions from 

tolerance for other closely related 

tristyrylphenol ethoxylate chemicals. 

EPA assessed dietary exposures from 

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Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 74631 

tristyrylphenol ethoxylate in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

tristyrylphenol ethoxylate were seen in 

the toxicity databases. Therefore, an 

acute dietary risk assessment for 

tristyrylphenol ethoxylate is not 

necessary. 

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 tristyrylphenol 

ethoxylate. In the absence of specific 

residue data, EPA has developed an 

approach which uses surrogate 

information to derive upper bound 

exposure estimates for the subject inert 

ingredient. Upper bound exposure 

estimates are based on the highest 

tolerance for a given commodity from a 

list of high-use insecticides, herbicides, 

and fungicides. A complete description 

of the general approach taken to assess 

inert ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts.’’ (D361707, 

S. Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentration of 

active ingredient in agricultural 

products is generally at least 50 percent 

of the product and often can be much 

higher. Further, pesticide products 

rarely have a single inert ingredient; 

rather there is generally a combination 

of different inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. In the case of 

tristyrylphenol ethoxylate, EPA made a 

specific adjustment to the dietary 

exposure assessment to account for the 

use limitations of the amount of 

tristyrylphenol ethoxylate that may be 

in formulations (no more than 15 

percent by weight in pesticide) and 

assumed that tristyrylphenol ethoxylate 

is present at the maximum limitations 

rather than at equal quantities with the 

active ingredient. In addition, in a 

previous risk assessment (2009) which 

can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2009–0095, the 

Agency concluded that residues 

following post harvest application to 

citrus crops would not be likely to 

exceed three times the residue attained 

following pre-harvest application. 

Therefore, the Agency applied a 

correction factor of 3x to the citrus crop 

group to account for the potentially 

higher residues from post-harvest 

treatment of this use. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

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. Considering the lack of 

mutagenicity, the lack of target organ 

toxicity in subchronic studies and 

known mode of action for the target 

organ toxicity, and the SAR predictions, 

the Agency concluded that 

carcinogenicity concerns are unlikely 

for the tristyrylphenol ethoxylate. 

Therefore, a cancer dietary exposure 

assessment was not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for tristyrylphenol ethoxylate. Tolerance 

level residues and/or 100 percent CT 

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 

tristyrylphenol ethoxylate, a 

conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for the chronic dietary risk 

assessments for parent compound. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Tristyrylphenol ethoxylate may be 

used as an inert ingredient in pesticide 

products that are registered for specific 

uses that may result in both outdoor and 

indoor residential exposures. In 

addition, tristyrylphenol ethoxylate may 

be used as an inert ingredient in 

pesticide formulations that are used in 

and around the home. Although dermal 

and inhalation exposures are possible 

from residential use of pesticide 

products containing this inert 

ingredient, negligible inhalation and 

dermal absorption is expected based on 

the molecular weight and the 

physicochemical properties of the 

compound. A screening level residential 

exposure and risk assessment was 

completed for products containing 

tristyrylphenol ethoxylate as an inert 

ingredient. The Agency conducted an 

assessment to represent worst-case 

residential exposure by assessing post 

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application exposures and risks from 

tristyrylphenol ethoxylate in pesticide 

formulations (Outdoor Scenarios) and 

tristyrylphenol ethoxylate in 

disinfectant-type uses (Indoor 

Scenarios). Further details of this 

residential exposure and risk analysis 

can be found in the document 

(D364751) 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 tristyrylphenol 

ethoxylate to share a common 

mechanism of toxicity with any other 

substances, and tristyrylphenol 

ethoxylate does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that tristyrylphenol ethoxylate 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. EPA has 

determined that reliable data show the 

safety of infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

2. EPA has sufficient data to assess 

the toxicity of the tristyrylphenol 

ethoxylates. The data presented in the 

assessment on the tristyrylphenol 

ethoxylates are adequate to characterize 

the expected behavior of the subject 

chemical. The primary toxicity appears 

to be to the kidney and thyroid in rats 

and liver in dogs. Because the kidney 

effects are the most sensitive endpoint, 

protective measures for kidney toxicity 

will be protective of any other long term 

effects. Further, EPA concluded that 

there is no need for the additional FQPA 

safety factor for use of subchronic 

toxicity for long term exposure 

assessment. The critical effect seen in 

the subchronic study (intratubular 

mineralization in the kidney) is believed 

to occur as a result of precipitation of 

a chemical based on its 

physicochemical properties. 

Precipitation of a chemical based on its 

physiochemical properties is a function 

primarily of dose level rather than 

duration of dosing. Thus, once the 

threshold for precipitation of the 

chemical is established (as it was in the 

subchronic dog study), this threshold 

level would be considered protective of 

any short or long term exposure. 

Therefore, the additional safety factor 

for the lack of long term studies is not 

warranted. 

3. EPA concluded that there is no 

evidence of increased susceptibility to 

infants and children. The 

developmental toxicity study in which 

rats were administered (CAS Reg. No. 

119432–41–6) resulted in a NOAEL of 

300 mg/kg/day for maternal toxicity 

(based on reduced body weights and 

increase in liver weights and loose feces 

seen at the LOAEL of 1,000 mg/kg/day) 

and a NOAEL of 300 mg/kg/day for 

developmental toxicity based on 

increased skeletal variations (increased 

incidence of all unossified proximal 

phalanges of the hind limb seen at the 

LOAEL of 1,000 mg/kg/day). Fetal 

effects were seen only at the limit dose 

and in the presence of maternal toxicity. 

4. No rabbit developmental study or 

reproductive toxicity studies are 

available for these chemicals, however, 

the developmental toxicity study in rats 

indicates no robust developmental 

toxicity at the limit dose and none of the 

reproductive parameters were affected 

in the rat developmental study at the 

limit dose of 1,000 mg/kg/day. This 

endpoint in the developmental study is 

considered conservative since the 

incidence of skeletal variations seen at 

1,000 mg/kg/day was marginal. 

5. There is no indication in the 

database that the tristyrylphenol 

ethoxylates are neurotoxic chemicals 

and there is no evidence of increased 

susceptibility. Therefore, there is no 

need for a developmental neurotoxicity 

study or the acute neurotoxicity and 90- 

day neurotoxicity studies. 

6. No treatment related effects were 

observed on the thymus or spleen at 

very high doses, indicating a lack of 

immunotoxic effects. Therefore, a 

functional immunotoxicity test is not 

required at this time and no additional 

uncertainty factor is required because of 

the lack of a immunotoxicity study. 

7. There are no residual uncertainties 

identified in the exposure databases. In 

the absence of actual exposure data on 

tristyrylphenol ethoxylates, a highly 

conservative dietary exposure 

assessment would not underestimate the 

risk to infants and children. EPA used 

similarly conservative assumptions to 

assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by the tristyrylphenol 

ethoxylates. Based on overall weight of 

evidence, the FQPA factor of 10X was 

reduced to 1X. 

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, tristyrylphenol 

ethoxylate 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 15 percent by weight in 

pesticide formulations, the chronic 

dietary exposure from food and water to 

tristyrylphenol ethoxylate is 13.5 

percent of the cPAD for the U.S. 

population and 43.6 percent 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 

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short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Tristyrylphenol 

ethoxylate is used as an inert ingredient 

in pesticide products that are currently 

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 

tristyrylphenol ethoxylate. Using the 

exposure assumptions described in this 

document, EPA has concluded that the 

combined short-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 91 for both 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. The 

models assume high end application 

rates, and high end exposures 

representing worst case scenarios, as 

well as, assuming that the inert 

ingredients are used on all commodities 

and that 100 percent of crops are treated 

and that residues will be present for 

every consumed commodity (including 

meat, milk, poultry, and eggs) that is 

included in the Dietary Exposure 

Evaluation Model (DEEMTM). 

Considering the extremely conservative 

nature of this screening level model the 

Agency concluded that this MOE is not 

of a concern. EPA has concluded that 

the combined short-term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 207 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, 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). 

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). 

Tristyrylphenol ethoxylate is currently 

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 tristyrylphenol ethoxylate. Using the 

exposure assumptions described in this 

document, EPA has concluded that the 

combined intermediate-term aggregated 

food, water, and residential exposures 

result in aggregate MOE of 869 for adult 

males and a MOE of 898 for adult 

females. 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 218 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, this MOE 

is not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to the 

tristyrylphenol ethoxylate. 

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 

tristyrylphenol ethoxylate 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 residue of tristyrylphenol 

ethoxylate in or on any food 

commodities. EPA is establishing a 

limitation on the amount of 

tristyrylphenol ethoxylate 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 15 percent of 

tristyrylphenol ethoxylate by weight in 

food use pesticide formulations. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for tristyrylphenol ethoxylate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for poly(oxy-1,2- 

ethanediyl), a-[tris(1- 

phenylethyl)phenyl]-w-hydroxy-, (CAS 

Reg. No. 99734–09–5), when used postharvest as an inert ingredient as a 

surfactant with a maximum of 15 

percent by weight in pesticide 

formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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 exemption 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, 

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74634 Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 18, 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 § 180.910, add alphabetically the 

following inert ingredient to the table to 

read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Poly(oxy-1,2-ethanediyl), a-[tris(1-phenylethyl)phenyl]-w-hydroxy-, (CAS Reg. No. 99734–09–5).For use in post-harvest applications; Not to exceed 15% by 

weight in pesticide formulations.

Surfactants. 

* * * * * * * 

[FR Doc. 2010–29992 Filed 11–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0136; FRL–8850–9] 

Spiroxamine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spiroxamine, 

[(8-(1,1-dimethylethyl)-N-ethyl-Npropyl-1, 4-dioxaspiro[4,5]decane-2- 

methanamine)], including its 

metabolites and degradates in or on 

artichoke, globe, import at 0.7 parts per 

million (ppm) asparagus, import at 0.05 

ppm; and vegetables, fruiting, crop 

group 8, import at 1.2 ppm. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 1, 2010. Objections and 

requests for hearings must be received 

on or before January 31, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0136. 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; e-mail address: 

gibson.tamue@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 

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