Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12621 

[FR Doc. E9–6263 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0095; FRL–8404–7] 

Tristyrylphenol Ethoxylates (CAS Reg. 

No. 70559-25-0) and (CAS Reg. No. 

99734-09-5); 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-[2,4,6-tris(1- 

phenylethyl)phenyl]-w-hydroxy- (CAS 

Reg. No. 70559–25–0) and poly(oxy-1,2- 

ethanediyl), a-[tris(1- 

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

Reg. No. 99734–09–5), herein referred to 

in this document as tristyrylphenol 

ethoxylates when used as inert 

ingredients in post-harvest applications 

to citrus crops, group 10, under 40 CFR 

180.1288 at a maximum of 10.0% in 

pesticide formulations with 

azoxystrobin and fludioxonil. Syngenta 

Crop Protection, Inc. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of the tristyrylphenol 

ethoxylates. 

DATES: This regulation is effective 

March 25, 2009. Objections and requests 

for hearings must be received on or 

before May 26, 2009, 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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the Federal Register listings at 

http://www.epa.gov/fedrgstr. You may 

also 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. 

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–2008–0095 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before May 26, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–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. Background and Statutory Findings 

In the Federal Register of March 12, 

2008 (73 FR 13225) (FRL–8354–6), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, as amended 

by FQPA (Public Law 104–170), 

announcing the filing of a pesticide 

petition (PP 7E7305) by Syngenta Crop 

Protection, Inc., P.O. Box 18300, 

Greensboro, NC 27409. The petition 

requested that 40 CFR 180.910 be 

amended by establishing an exemption 


sroberts on PROD1PC70 with RULES
12622 Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 

from the requirement of a tolerance for 

residues of the tristyrylphenol 

ethoxylates when used as inert 

ingredients in post-harvest applications 

at a maximum of 10.0% in pesticide 

formulations. That notice included a 

summary of the petition prepared by the 

petitioner. This request is specific for 

the post-harvest uses of these 

tristyrylphenol ethoxylates and does not 

impact the existing pre-harvest 

tolerance exemptions under 40 CFR 

180.920 granted by the Agency for these 

tristyrylphenol ethoxylates with a limit 

of not more than 15% in pesticide 

formulations. There were no comments 

received in response to the notice of 

filing. 

Section 408(b)(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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

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 ploymers 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. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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. The 

nature of the toxic effects caused by the 

tristyrylphenol ethoxylates are 

discussed in this unit. 

In 2006, EPA reassessed the inert 

ingredient tolerance exemptions under 

40 CFR 180.920 for the tristyrylphenol 

ethoxylates when used as inert 

ingredients at not more than 15% in 

pesticide formulations applied to 

growing crops. This tolerance 

reassessment document can be found at 

http://www.epa.gov/opprd001/inerts/ 

decisiondoc_a2k.html. As stated in that 

document, the tristyrylphenol 

ethoxylates have similar use patterns, 

restrictions/limitations, and potential 

exposures. A Structure Activity 

Relationship (SAR) assessment for the 

tristyrylphenol ethoxylates was 

performed by the Agency’s Office of 

Pollution Prevention and Toxics (OPPT) 

Structure Activity Team (SAT). In the 

2006 document, the SAT determined 

that the data presented on the analog 

compounds within the tristyrylphenol 

ethoxalates are adequate to characterize 

the expected toxicity of subject 

chemicals (CAS Reg. Nos. 70559–25–0 

and 99734–09–5) for the reasons set 

forth in Unit VII below. The available 

toxicity database for the tristyrylphenol 

ethoxylates consists of studies on some 

of the tristyrylphenol ethoxylate 

chemicals, such as CAS Reg. No. 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 are expected 

to be similar. 

An acute toxicity battery conducted 

on the tristyrylphenol ethoxylates 

resulted in low acute oral toxicity, slight 

skin irritation, and slight eye irritation. 

In subchronic toxicity studies, the 

primary toxicity appears to be to the 

kidney and thyroid in rats and the liver 

in dogs. The kidney effects in rats 

appear to be the most sensitive 

endpoint. In this study, there were 

minimal effects observed at 100 

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

but these effects were not considered 

adverse effects. Therefore, the no 

observed effect level (NOEL) for the 

study was 30 mg/kg/day and the no 

observed adverse effect level (NOAEL) 

was 100 mg/kg/day. No neurotoxicity 

studies are available; however, no signs 

of neurotoxicity were observed in any of 

the available studies. 

Based on the results of submitted 

mutagenicity studies, the 

tristyrylphenol ethoxylates are not 

likely to be mutagenic. There are no 

carcinogenicity studies available on the 

tristyrylphenol ethoxylates; however, 

the primary toxicity appears to be to the 

kidney and thyroid in rats and liver in 

dogs. The kidney effects in rats appear 

to be the most sensitive endpoint. The 

Agency has considerable knowledge of 

the intratubular mineralization toxic 

effect to the kidneys and has determined 

that by preventing the intratubular 

mineralization in the kidney, tumor 

formation is unlikely to occur. Since 

these kidney effects are the most 

sensitive endpoint, protective measures 

for kidney toxicity will be protective of 

any other long term effects. The thyroid 

toxicity in rats was observed at 1,500 

mg/kg/day and the NOAEL was 500 mg/ 

kg/day. The Agency has determined the 

mode of action of the compound 

causing thyroid toxicity and concluded 

that a dose preventing thyroid toxicity 

would be protective of both cancer and 

non cancer effects on the thyroid. In 

addition, the Agency also recognizes 

that the rats are more sensitive to 

thyroid effects than humans. The 

NOAEL used as the point of departure 

in calculating the chronic reference dose 

(cRfD) selected for this risk assessment 

is protective of any thyroid effects and 

is approximately 10 fold lower than the 

NOAEL established for the thyroid 

effects. There is not a concern for the 

liver toxicity seen in the dog study 

because the liver effects at dosages of 

500 mg/kg/day were marginal and seen 

in only one dog out of six. The SAR 

models predicted low concern for the 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12623 

carcinogenicity of the compounds. 

Considering the lack of mutagenicity, 

the lack of target organ toxicity in 

subchronic studies and known mode of 

action for the target organ toxicity seen, 

and the SAR prediction, the Agency 

concluded that carcinogenicity concerns 

are unlikely for the tristyrylphenol 

ethoxylates. 

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 lowest observed adverse 

effect level (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). 

The cRfD of 0.5 mg/kg/day was 

established based on the 90–day 

subchronic toxicity study in dogs, with 

a NOAEL of 50 mg/kg/day and a safety 

factor of 100 (10x for interspecies and 

10x for intraspecies variations). Since 

the Food Quality Protection Act (FQPA) 

safety factor is reduced from 10x to 1x, 

the chronic population adjusted dose 

(cPAD) is equal to the cRfD. In the dog 

study, the NOAEL of 50 mg/kg/day was 

based on equivocal liver toxicity seen at 

the LOAEL of 500 mg/kg/day. Therefore, 

in this dog study, the NOAEL would be 

between 50–500 mg/kg/day. Since the 

NOAEL for the subchronic rat studies is 

100 mg/kg/day based on kidney and 

thyroid toxicity, choosing the NOAEL of 

50 mg/kg/day would be protective of 

both the liver effects seen in the dog and 

the kidney and thyroid effects seen in 

the rat. 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

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. 

The primary route of exposure to 

these chemicals from their use as inert 

ingredients in pesticide products would 

most likely be through consumption of 

food to which pesticide products 

containing them have been applied, and 

possibly through drinking water (from 

runoff). Dermal and inhalation 

exposures are also possible from 

residential use of pesticide products 

containing these inert ingredients. 

However, the quantitative exposure 

assessment via inhalation and dermal 

routes of exposure was not performed 

because negligible inhalation and 

dermal absorption is expected based on 

the physicochemical properties of the 

compounds. 

There are no data available on 

tristyrylphenol ethoxylates residues in 

food or on non-occupational exposures 

to tristyrylphenol ethoxylates. In the 

absence of actual residue data for 

tristyrylphenol ethoxylates, the Agency 

performed a dietary (food and drinking 

water) exposure assessment for 

tristyrylphenol ethoxylates that 

included both the existing pre-harvest 

uses and the proposed post-harvest use 

on citrus crops in formulations of 

azoxystrobin and fludioxonil using 

worst-case assumptions as detailed 

below. The dietary exposure was 

calculated as a percentage of the cRfD. 

The chronic dietary estimate for the U.S. 

Population was 12.2% (non-nursing 

infants were the most highly exposed 

population with a chronic exposure 

estimate occupying 35.6% of the cPAD). 

In addition, this exposure assessment 

assumed that: 

• Tristyrylphenol ethoxylates would 

be used as an inert ingredient in all food 

use pesticide formulations applied to all 

crops. 

• One hundred percent of all food 

crops would be treated with pesticides 

containing tristyrylphenol ethoxylates. 

• Tristyrylphenol ethoxylates residues 

would be present in all crops at levels 

equal to or exceeding the highest 

established tolerance levels for any 

pesticide active ingredient for both the 

existing preharvest uses and the 

proposed postharvest use, and 

• A conservative default value of 

1,000 parts per billion (ppb) for the 

concentration of an inert ingredient in 

all sources of drinking water was used. 

This approach is highly conservative as 

it is extremely unlikely that 

tristyrylphenol ethoxylates would have 

such use as pesticide product inert 

ingredients and be present in food 

commodities and drinking water at such 

high levels. In addition, this highly 

conservative exposure assessment is 

protective of any possible nonoccupational exposures to 

tristyrylphenol ethoxylates as it results 

in exposure estimates orders of 

magnitude greater than the high-end 

exposure estimates for residential uses 

of pesticides routinely used by the 

Office of Pesticide Programs. 

VI. Cumulative Effects 

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.’’ Unlike other 

pesticide ingredients for which EPA has 

followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

tristyrylphenol ethoxylates and any 

other substances and tristyrylphenol 

ethoxylates do not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has not 

assumed that tristyrylphenol 

ethoxylates 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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

VII. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408 of the FFDCA provides 

that EPA shall apply an additional 

tenfold 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 that a different 

margin of safety will be safe for infants 


sroberts on PROD1PC70 with RULES
12624 Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 

and children. EPA concluded that the 

FQPA safety factor could be removed for 

tristyrylphenol ethoxylates for the 

following reasons: 

1. EPA has sufficient data to assess 

the toxicity of tristyrylphenol 

ethoxylates. The data presented in the 

assessment on the tristyrylphenol 

ethoxylates are adequate to characterize 

the expected behavior of the subject 

chemicals. There are no carcinogenicity 

studies available on the tristyrylphenol 

ethoxylates; however, the primary 

toxicity appears to be to the kidney and 

thyroid in rats and liver in dogs. The 

kidney effects in rats appear to be the 

most sensitive endpoint. The Agency 

has considerable knowledge of the 

intratubular mineralization toxic effect 

to the kidneys and has determined that 

by preventing the intratubular 

mineralization in the kidney, tumor 

formation is unlikely to occur. Since 

these 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. 

2. 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. 

3. 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. 

4. 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. 

5. 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. Based on 

overall weight of evidence, the FQPA 

factor of 10X was reduced to 1X. 

VIII. Determination of Safety for U.S. 

Population 

Residues of concern are not 

anticipated for dietary exposure (food 

and drinking water) or for residential 

exposure (inhalation and dermal). EPA 

determines whether pesticide chemical 

exposures are safe by comparing 

aggregate exposure estimates to the dose 

at which no adverse effects were seen in 

the most sensitive animal studies. In the 

case of tristyrylphenol ethoxylates, the 

estimated exposures are compared to a 

dose level equal to the chronic RfD of 

0.5 mg/kg/day (based on the subchronic 

dog study). Utilizing a highly 

conservative aggregate exposure 

assessment, the resulting chronic 

exposure estimates do not exceed the 

Agency’s level of concern (non-nursing 

infants were the most highly exposed 

population with the chronic exposure 

estimates occupying 35.6% of the 

cPAD). In addition, this highly 

conservative exposure assessment is 

protective of any possible nonoccupational exposures to the 

tristyrylphenol ethoxylates as it results 

in exposure estimates orders of 

magnitude greater than the high-end 

exposure estimates for residential uses 

of pesticides routinely used by the 

Office of Pesticides Programs. 

Taking into consideration all available 

information on the tristyrylphenol 

ethoxylates, it has been determined that 

there is a reasonable certainty that no 

harm to any population subgroup, 

including infants and children, will 

result from aggregate exposure to these 

chemicals when used as inert 

ingredients in post-harvest applications 

to citrus crops, group 10, at a maximum 

of 10.0% in pesticide formulations with 

azoxystrobin and fludioxonil, when 

considering dietary exposure and all 

other non-occupational sources of 

pesticide exposure for which there is 

reliable information. Therefore, the 

exemption from the requirement of a 

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

ethanediyl), a-[2,4,6-tris(1- 

phenylethyl)phenyl]-w-hydroxy- (CAS 

Reg. No. 70559–25–0) and poly(oxy-1,2- 

ethanediyl), a-[tris(1- 

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

Reg. No. 99734–09–5), when used as 

inert ingredients in post-harvest 

applications to citrus crops, group 10, 

under 40 CFR 180.1288 at a maximum 

of 10.0% in pesticide formulations with 

azoxystrobin and fludioxonil can be 

considered safe under section 408 of the 

FFDCA. 

IX. Other Considerations 

A. Analytical Method 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. Existing Exemptions 

The tristyrylphenol ethoxylates (CAS 

Reg. No. 70559–25–0 and CAS Reg. No. 

99734–09–5) are exempted from the 

requirement of a tolerance under 40 CFR 

180.920 when used as inert ingredients 

at not more than 15% in pesticide 

formulations applied to growing crops 

only. 

C. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for the 

tristyrylphenol ethoxylates nor have any 

CODEX Maximum Residue Levels 

(MRLs) been established for any food 

crops at this time. 

X. Conclusions 

Accordingly, an exemption from the 

requirement for a tolerance is 

established for poly(oxy-1,2-ethanediyl), 

a-[2,4,6-tris(1-phenylethyl)phenyl]-whydroxy- (CAS Reg. No. 70559–25–0) 

and poly(oxy-1,2-ethanediyl), a-[tris(1- 

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

Reg. No. 99734–09–5), when used as 

inert ingredients in post-harvest 

applications to citrus crops, group 10, 

under 40 CFR 180.1288 at a maximum 

of 10.0% in pesticide formulations with 

azoxystrobin and fludioxonil. 

XI. 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 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12625 

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). 

XII. 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: March 4, 2009. 

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. Section 180.1288 is added to read 

as follows: 

§ 180.1288 Tristyrylphenol ethoxylates; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of poly(oxy-1,2-ethanediyl), a-[2,4,6- 

tris(1-phenylethyl)phenyl]-w-hydroxy-, 

(CAS Reg. No. 70559–25–0) and 

poly(oxy-1,2-ethanediyl), a-[tris(1- 

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

Reg. No. 99734–09–5) on citrus crops, 

group 10, when used as inert 

ingredients under the following 

conditions: 

(a) They are applied post-harvest; 

(b) They are used as inert ingredients 

in pesticide formulations with 

azoxystrobin and fludioxonil; and 

(c) They constitute no more than 

10.0% of the formulated pesticide 

product. 

[FR Doc. E9–6259 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R06–RCRA–2008–0756–; FRL–8784– 

9] 

New Mexico: Final Authorization of 

State Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Immediate final rule. 

SUMMARY: The State of New Mexico has 

applied to the EPA for final 

authorization to administer the 

provisions of the Used Oil program 

under the Resource Conservation and 

Recovery Act (RCRA). The EPA has 

determined that the statutes and 

regulations of the State of New Mexico 

Used Oil program satisfy all 

requirements needed to qualify for final 

authorization, and is authorizing the 

State’s changes through this immediate 

final action. The EPA is publishing this 

rule to authorize the changes without a 

prior proposal because we believe this 

action is not controversial and do not 

expect comments that oppose it. Unless 

we receive written comments which 

oppose this authorization during the 

comment period, the decision to 

authorize New Mexico’s changes to its 

hazardous waste program will take 

effect. If we receive comments that 

oppose this action, we will publish a 

document in the Federal Register 

withdrawing this rule before it takes 

effect, and a separate document in the 

proposed rules section of this Federal 

Register will serve as a proposal to 

authorize the changes. 

DATES: This final authorization will 

become effective on May 26, 2009 

unless the EPA receives adverse written 

comment by April 24, 2009. If the EPA 

receives such comment, it will publish 

a timely withdrawal of this immediate 

final rule in the Federal Register and 

inform the public that this authorization 

will not take effect. 

ADDRESSES: Submit your comments by 

one of the following methods: 

1. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

2. E-mail: patterson.alima@epa.gov. 

3. Mail: Alima Patterson, Region 6, 

Regional Authorization Coordinator, 

State/Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733. 

4. Hand Delivery or Courier. Deliver 

your comments to Alima Patterson, 


sroberts on PROD1PC70 with RULES