Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 27443 

Inert Ingredients Limits Uses 

* * * * * 

a-(p-nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters 

and the corresponding ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts of the phosphate 

esters; the nonyl group is a propylene trimer isomer and 

the poly(oxyethylene) content averages 4-14 or 30 moles 

(CAS Reg. Nos. 51811-79-1, 59139-23-0, 67922-57-0, 

68412-53-3, 68553-97-9, 68954-84-7, 99821-14-4, 

152143-22-1, 51609-41-7, 37340-60-6, 106151-63-7, 

68584-47-4, 52503-15-8, 68458-49-1).

Not to exceed 7% of pesticide formulation. Expires May 17, 2012.Surfactants, related adjuvants of 

surfactants 

* * * * * 

a-(p-nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and 

zinc salts the nonyl group is propylene trimer isomer and 

the poly(oxyethylene) content averages 4 moles (CAS 

Reg Nos. 9014-90-8, 9051-57-4, 9081-17-8, 68649-55-8, 

68891-33-8).

Not to exceed 7% of pesticide formulation. Expires May 17, 2012.Surfactants, related adjuvants of 

surfactants 

* * * * * 

* * * * * 

■ 3. Section 180.930 is amended by 

adding alphabetically the following 

entries in the table of inert ingredients 

to read as follows: 

§180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

a-(p-nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters 

and the corresponding ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts of the phosphate 

esters; the nonyl group is a propylene trimer isomer and 

the poly(oxyethylene) content averages 4-14 or 30 moles 

(CAS Reg. Nos. 51811-79-1, 59139-23-0, 67922-57-0, 

68412-53-3, 68553-97-9, 68954-84-7, 99821-14-4, 

152143-22-1, 51609-41-7, 37340-60-6, 106151-63-7, 

68584-47-4, 52503-15-8, 68458-49-1).

Not to exceed 7% of pesticide formulation. Expires May 17, 2012.Surfactants, related adjuvants of 

surfactants 

* * * * * 

a-(p-nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and 

zinc salts the nonyl group is propylene trimer isomer and 

the poly(oxyethylene) content averages 4 moles (CAS 

Reg Nos. 9014-90-8, 9051-57-4, 9081-17-8, 68649-55-8, 

68891-33-8).

Not to exceed 7% of pesticide formulation. Expires May 17, 2012.Surfactants, related adjuvants of 

surfactants 

* * * * * 

[FR Doc. 2010–11687 Filed 5–14–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0890; FRL–8824–3] 

α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]- 

w-hydroxypoly(oxyethylene); TimeLimited Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited exemption from the 

requirement of a tolerance for residues 

of a-[p-(1,1,3,3- 

tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) when used as 

an inert ingredient at levels not to 

exceed 7% in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest. 

The Joint Inerts Task Force, Cluster 

Support Team Number 5 requested an 

exemption for the requirement of a 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). The 

exemption from the requirement of a 

tolerance expires on May 17, 2012. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of a-[p-(1,1,3,3- 

tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene). 

DATES: This regulation is effective May 

17, 2010. Objections and requests for 

hearings must be received on or before 

July 16, 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–2008–0890. 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 


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27444 Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 

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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@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 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp 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–2008–0890 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 July 16, 2010. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0890, 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 

In the Federal Register of March 25, 

2009 (74 FR 12856) (FRL–8399–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E7466) by the 

Joint Inerts Task Force, Cluster Support 

Team 5, c/o CropLife America, 1156 

15th Street, NW., Suite 400, 

Washington, DC 20005. The petition 

requested that 40 CFR 180.910 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of a-[p-(1,1,3,3- 

tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) produced by 

the condensation of 1 mole of p-(1,1,3,3- 

tetramethylbutyl)phenol with a range of 

1–14 or 30–70 moles of ethylene oxide: 

if a blend of products is used, the 

average range number of moles of 

ethylene oxide reacted to produce any 

product that is a component of the 

blend shall be in the range of 1–14 or 

30–70 (herein referred to in this 

document as octylphenol ethoxylate or 

OPE) when used as an inert ingredient 

in pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest. That notice 

referenced a summary of the petition 

prepared by the Joint Inerts Task Force, 

Cluster Support Teams 5, the petitioner, 

which is available to the public in the 

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

There were no comments received in 

response to the notice of filing. These 

tolerances expire on May 17, 2012. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the 40 CFR 180.910 

exemption from the requirement of a 

tolerance for octylphenol ethoxylate 

should be time-limited for a period of 

two years and include a use limitation 

of not to exceed 7% by weight of the 

pesticide formulation. This limitation is 

discussed further in Units IV.C. and 

V.C. and is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in the 

document ‘‘Alkylphenol Ethoxylates 

(APEs - JITF CST 5 Inert Ingredients). 

Revised Human Health Risk Assessment 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations’’ in docket ID number 

EPA–HQ–OPP–2008–0890. 

This petition was submitted in 

response to a final rule that was 

published in the Federal Register of 

August 9, 2006 (71 FR 45415) (FRL– 

8084–1) in which the Agency revoked, 

under section 408(e)(1) of FFDCA, the 

existing exemptions from the 

requirement of a tolerance for residues 

of certain inert ingredients because of 

insufficient data to make the 

determination of safety required by 

section 408(b)(2) of FFDCA. The 

expiration date for the tolerance 

exemptions subject to revocation was 

August 9, 2008, which was later 

extended to August 9, 2009, in the 

Federal Register of August 4, 2008 (73 


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Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 27445 

FR 45317) (FRL–8373–6) to allow for 

data to be submitted to support the 

establishment of tolerance exemptions 

for those inert ingredients prior to the 

effective date of the tolerance exemption 

revocation. The effective date of the 

revocation for a-[p-(1,1,3,3- 

tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) was 

subsequently extended on August 7, 

2009 (74 FR 39543) (FRL–8431–8), 

October 9, 2009 (74 FR 52148) (FRL– 

8794–1), and February 9, 2010 (75 FR 

6314) (FRL–8812–3). The current 

effective date of the revocation is May 

9, 2010. 

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(b)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement of 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....’’ 

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

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 octylphenol 

ethoxylate including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with octkylphenol 

ethoxylate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its 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. 

Octylphenol ethoxylate has low to 

moderate acute oral and dermal toxicity, 

is a mild to moderate skin irritant, and 

an eye irritant. Based on the analysis of 

the studies in the open literature, there 

is both positive and negative evidence 

that octylphenol ethoxylate is 

mutagenic in bacteria (Salmonella 

typhimurium) and mammalian (Chinese 

hamster ovary, mouse lymphoma) cells. 

In the Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats with 

octylphenol ethoxylate, there was no 

evidence of increased susceptibility. 

Additionally, there was no evidence of 

neurotoxicity, developmental toxicity, 

or reproductive toxicity in that same 

study. The Agency has identified 

octylphenol as a potential metabolite/ 

degradate of concern. The Agency 

considered available toxicity data on 

octylphenol as well as toxicity data on 

the structurally related nonylphenol 

when assessing the hazard for this 

potential metabolite/degradate. The 

major effects seen in the octylphenol/ 

nonylphenol databases are consistent 

with potential disturbances in 

estrogenic activity, but a complete mode 

of action analysis has not been 

conducted. These effects are the most 

sensitive endpoints for both substances 

and were considered the key findings 

for regulatory purposes. The Agency has 

used available data on the nonylphenol 

and octylphenol, which specifically 

look at these effects, to establish toxicity 

endpoints for both octylphenol 

ethoxylate and degradates of concern. 

The Agency considers the toxicity 

database to be sufficient to address 

potential hazards, and the Agency is 

regulating on the most sensitive 

endpoints seen in the database; effects 

which are well characterized with clear 

no-observed-adverse-effect levels 

(NOAEL). 

Specific information on the studies 

received and the nature of the toxic 

effects caused by octylphenol ethoxylate 

as well as the NOAEL and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document ‘‘Alkylphenol Ethoxylates 

(APEs - JITF CST 5 Inert Ingredients). 

Revised Human Health Risk Assessment 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations,’’ pp. 9–20 in docket ID 

number EPA–HQ–OPP–2008–0890. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors (UF/SF) are used in 

conjunction with the POD to calculate a 

safe exposure level – generally referred 

to as a population-adjusted dose (PAD (a 

= acute, c = chronic)) or a reference dose 

(RfD), and a safe margin of exposure 

(MOE) or level of concern. For nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for octylphenol ethoxylate 

used for human risk assessment is 

shown in the Table of this unit. 


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TABLE — SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR OCTYLPHENOL ETHOXYLATES AND ITS METABOLITES

(INCLUDING OCTYLPHENOL) FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

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

Acute dietary 

(Females 13–50 years of age) 

NOAEL = 15.6 milligrams/kilograms/ 

day (mg/kg/day) UFA = 10x 

UFH = 10x 

Food Quality Protection Act Safety 

Factor (FQPA SF) = 1x 

Acute RfD = 0.156 mg/kg/day 

aPAD = 0.156 mg/kg/day 

Initiation and maintenance of pregnancy in rats (octylphenol) 

LOAEL = 31.3 mg/kg/day based on 

on increased % post-implantation 

loss following exposure of dams 

during gestation days 0–8. 

Acute dietary 

(General population including 

infants and children) 

An endpoint attributable to a single exposure was not seen in the database; therefore a point of departure 

was not selected. 

Chronic dietary 

(All populations) 

NOAEL= 10 mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.1 mg/kg/day 

cPAD = 0.1 mg/kg/day 

2–Generation reproduction study in 

rats (octylphenol) 

LOAEL = 50 mg/kg/day based on 

significant increases in pituitary 

weight (↑12%, males), decreases 

in ovary weight (↓18%) in F0 animals; timing of vaginal opening 

significantly accelerated in F1 females; decreases in the numbers 

of implants and live F2 pups born 

Incidental oral and inhalation 

(short-term (1 to 30 days) 

and intermediate-term (1 to 

6 months) 

NOAEL= 150 mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

Residential LOC for MOE = 

1,000.

Occupational LOC for MOE = 

100 

Harmonized Guideline 870.3650 

combined repeated dose toxicity 

study with the reproduction/developmental toxicity screening test in 

rats (octylphenol ethoxylate) 

LOAEL = 300 mg/kg/day based on 

clinical signs (pushing head 

through bedding after dosing), decreased body-weight gain in both 

sexes during the premating period, 

decreased thymus weight in females, increased liver weight in 

males, and increased incidence of 

centrilobular hepatocyte hypertrophy in males. 

Dermal short-term 

(1 to 30 days) and intermediate-term (1 to 6 

months) 

Oral study NOAEL = 150 mg/kg/day 

(dermal absorption rate = 

1%Dermal equivalent dose = 

10,000 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x = UFDB

Residential LOC for MOE = 

1,000 

Occupational LOC for MOE = 

100 

Harmonized Guideline 870.3650 

combined repeated dose toxicity 

study with the reproduction/developmental toxicity screening test in 

rats (octylphenol ethoxylate) 

LOAEL = 300 mg/kg/day based on 

clinical signs (pushing head 

through bedding after dosing), decreased body-weight gain in both 

sexes during the premating period, 

decreased thymus weight in females, increased liver weight in 

males, and increased incidence of 

centrilobular hepatocyte hypertrophy in males 

Cancer 

(Oral, dermal, inhalation) 

Classification: Not classified; no alerts identified in structure-activity database (DEREK Version 11) with respect to carcinogenicity; potential mutagenicity concern identified in open literature for octylphenol ethoxylate 

and metabolite. Based on a weight of the evidence consideration of the available data, the Agency believes 

that cancer risks would be negligible. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFDB = to account for the absence of data or other data deficiency. 

C. Exposure Assessment 

Very limited information is available 

for octylphenol ethoxylate with respect 

to plant and animal metabolism/ 

degradation. There is extensive 

information in the literature on 

environmental degradation, and some 

information on bacterial and 

mammalian metabolism, all of which 

indicate similar degradation of the 

octylphenol ethoxylate compounds. The 

ethoxylate moiety is degraded by 

sequential removal of the ethoxylate 

groups, eventually degrading to 

octylphenol. There are studies in the 

literature that suggest that plants have 

the ability to take up octylphenol 

ethoxylate residues from treated soil. 


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Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 27447 

While the Agency does not expect that 

the use of octylphenol ethoxylate as an 

inert ingredient in pesticide 

formulations would result solely in 

exposure to octylphenol, there are no 

available data on the exact nature of 

octylphenol ethoxylate residues in food 

and drinking water resulting from the 

use of octylphenol ethoxylate as an inert 

ingredient. Therefore, the Agency has 

concluded that the residues of concern 

in food and drinking water are the 

octylphenol ethoxylate compounds, 

their partially de-ethoxylated 

degradation products, as well as the 

degradation product octylphenol, and 

has conservatively assumed that in the 

case of food and drinking water 

exposures all exposure will be in the 

form of exposure to octylphenol, the 

potential metabolite/degradate of 

greatest toxicological concern. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to octylphenol ethoxylate, 

EPA considered exposure from the 

petitioned-for exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

octylphenol ethoxylate in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. Such effects were identified 

for octylphenol ethoxylate. A hazard 

endpoint for acute exposure to 

octylphenol ethoxylate was identified 

only for females ages 13–49; no hazard 

endpoints for acute exposure were 

identified for any other population 

group. In estimating acute dietary 

exposure, 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). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. 

As to residue levels in food, in the 

absence of specific residue data, both 

the acute and chronic dietary exposure 

assessments are conducted using 

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 can be found 

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

document ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts’’ in docket ID 

number EPA–HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50% of 

the product and often can be much 

higher. Further, pesticide products 

rarely have a single inert ingredient; 

rather there is generally a combination 

of different inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product relative to that of the 

active ingredient. EPA made a specific 

adjustment to the dietary exposure 

assessment to account for the use 

limitations of the amount of the 

surfactant octylphenol ethoxylate that 

may be in formulations (no more than 

7%) and assumed that octylphenol 

ethoxylate is at the maximum limitation 

rather than at equal quantities with the 

active ingredient. This remains a very 

conservative assumption because 

surfactants are generally used at levels 

far below these percentages. For 

example, EPA examined several of the 

pesticide products associated with the 

tolerance/commodity combination 

which are the driver of the risk 

assessment and found that these 

products did not contain surfactants at 

levels greater than 2.25% and that none 

of the surfactants was octylphenol 

ethoxylate. 

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 ingredient residue 

could be on food, and then used this 

methodology to choose the highest 

possible residue that could be found on 

food and assumed that all food 

contained this residue. No consideration 

was given to potential degradation 

between harvest and consumption even 

though monitoring data shows that 

tolerance level residues are typically 

one to two orders of magnitude higher 

than actual residues in food when 

distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. Based on a weight of the 

evidence consideration of the available 

data, the Agency believes that cancer 

risks would be negligible. 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 octylphenol ethoxylate. Tolerance 

level residues and/or 100 PCT were 

assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for octylphenol ethoxylate. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of octylphenol 

ethoxylate. Further information 


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regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

A screening level drinking water 

analysis, based on the Pesticide Root 

Zone Model / Exposure Analysis 

Modeling System (PRZM/EXAMS) was 

performed to calculate the estimated 

drinking water concentrations (EDWCs) 

of octylphenol ethoxylate. Modeling 

runs on four surrogate inert ingredients 

using a range of physical chemical 

properties that would bracket those of 

octylphenol ethoxylate were conducted. 

Modeled acute drinking water values 

ranged from 0.001 parts per billion 

(ppb) to 41 ppb. Modeled chronic 

drinking water values ranged from 

0.0002 ppb to 19 ppb. Further details of 

this drinking water analysis can be 

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

the document ‘‘Alkylphenol Ethoxylates 

(APEs - JITF CST 5 Inert Ingredients). 

Revised Human Health Risk Assessment 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations,’’ p. 22 and Appendix C in 

docket ID number EPA–HQ–OPP–2008– 

0890. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for 

octylphenol 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 acute 

and chronic dietary risk assessments for 

the parent compounds and for the 

metabolites of concern. These values, 

which are 10 to 1,000 times greater than 

the highest levels of these substance 

seen in numerous surface and ground 

water monitoring studies, were directly 

entered into the acute and chronic 

dietary exposure models. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Octylphenol ethoxylate may be used as 

an inert ingredient in pesticide products 

that are registered for specific uses that 

may result in residential exposures. A 

screening level residential exposure and 

risk assessment was completed for 

pesticide products containing 

octylphenol ethoxylate as an inert 

ingredient. In this assessment, 

representative scenarios, based on enduse product application methods and 

labeled application rates, were selected. 

For each of the use scenarios, the 

Agency assessed residential handler 

(applicator) inhalation and dermal 

exposure for use scenarios with high 

exposure potential (i.e., exposure 

scenarios with high-end unit exposure 

values) to serve as a screening 

assessment for all potential residential 

pesticides containing octylphenol 

ethoxylate. Similarly, residential 

postapplication dermal and oral 

exposure assessments were also 

performed utilizing high-end exposure 

scenarios. In the case of octylphenol 

ethoxylate, non-dietary exposures are to 

octylphenol ethoxylate only as there is 

no appreciable metabolism or 

degradation of octylphenol ethoxylate in 

any of the representative residential use 

scenarios. Further details of this 

residential exposure and risk analysis 

can be found at http:// 

www.regulations.gov in the document 

‘‘JITF Inert Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations’’ in docket ID number 

EPA–HQ–OPP–2008–0710. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

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 octylphenol 

ethoxylate to share a common 

mechanism of toxicity with any other 

substances, and octylphenol 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 octylphenol 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 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 

pre-natal and post-natal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Pre-natal and post-natal sensitivity. 

In the case of octylphenol ethoxylate, 

there was no increased susceptibility to 

the offspring of rats following pre-natal 

and post-natal exposure in the 

Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test. The offspring 

effects (decreased body weight in male 

and female offspring) occurred at 300 

mg/kg/day in the presence of maternal 

toxicity, which was manifested as 

clinical signs, decreased body-weight 

gain, increased liver weight and liver 

hypertrophy in males, and decreased 

thymus weight in females at 300 mg/kg/ 

day. However, a study referenced in the 

petition (Hazelden and Wilson, 1986) 

suggests more severe developmental 

effects (supernumerary rib) following 

gestational exposure via the diet during 

gestation days 6–17. The Harmonized 

Guideline 870.3650 study did not 

include a skeletal examination of the 

offspring. Since the Harmonized 

Guideline 870.3650 study with 

octylphenol ethoxylate did not assess its 

impact on the estrogen system, it cannot 

be used alone to properly assess the 

most sensitive endpoint. However, 

selecting the POD from the Harmonized 

Guideline 870.3650 study, which is 

based on a NOAEL of 150 mg/kg/day 

and decreased body-weight gain in both 

sexes during the premating period, 

decreased thymus weight in females, 

and increased liver weight and liver 

hypertrophy in males at the LOAEL of 

300 mg/kg/day, and retaining the FQPA 

SF of 10X is comparable to using the 

POD from the reproduction studies on 

the most toxicologically potent 

compound (nonylphenol) that assessed 

estrogenic activity (endpoint: 

Accelerated vaginal opening; POD: 10 

mg/kg/day). The endpoint (accelerated 

vaginal opening) and point of departure 

(10 mg/kg/day) are considered health 

protective of effects not assessed in the 

Harmonized Guideline 870.3650 studies 

on the octylphenol ethoxylate. 


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For the octylphenol metabolite, the 2– 

generation reproduction study in rats 

showed a delay in the acquisition of 

preputial separation in both the F1 and 

F2 pups, and the timing of vaginal 

opening was accelerated in a study in 

prepubertal female rats. For the related 

nonylphenol, two of the multigeneration 

reproduction studies in rats and two 

studies in prepubertal female rats 

showed acceleration in the acquisition 

of vaginal patency. A delay in preputial 

separation was observed in male rats in 

a pubertal onset assay. The combined 

toxicology databases currently available 

on octylphenol and nonylphenol 

identify accelerated vaginal opening as 

the most consistent and sensitive 

endpoint, and a clear NOAEL of 10 mg/ 

kg/day has been demonstrated. 

In a developmental toxicity study 

with octylphenol ethoxylate, 

developmental toxicity was 

demonstrated, as evidenced by the 

increased incidence of supernumerary 

ribs following exposure to the dams 

during gestation days 6–17. However, 

the low pregnancy rate among all groups 

(56%–70%) in this study makes 

interpretation of the results difficult. 

Additionally, the Harmonized Guideline 

870.3650 study did not include a 

skeletal examination of the offspring. A 

developmental toxicity study was 

identified in the octylphenol database, 

and a clear NOAEL of 15.6 mg/kg/day 

(post-implantation loss) was 

established. The POD for octylphenol 

was selected from this study for the 

acute dietary (females 13+) exposure. 

This study is considered appropriate 

and health protective of effects observed 

in the developmental toxicity study 

with octylphenol ethoxylate. 

Since the rat reproduction studies on 

the most toxicologically potent 

compound (nonylphenol) identified a 

clear NOAEL of 10 mg/kg/day for the 

most sensitive endpoint (accelerated 

vaginal opening), and the selected POD 

of 10 mg/kg/day (NOAEL for accelerated 

vaginal opening) for the dietary risk 

assessment is protective of offspring 

effects, there are no residual concerns. 

3. Conclusion. EPA has determined 

that the FQPA SF can be reduced to 1X 

for the octylphenol metabolite upon 

which the dietary assessment is based. 

This decision is based on the following 

findings: 

i. The most sensitive endpoint from 

the most toxicologically potent 

compound (nonylphenol) was selected 

for risk assessment and is considered 

health protective. The database for 

nonylphenol is protective of 

octylphenol, which has a limited 

database. There are several studies on 

nonylphenol (two multigeneration 

reproduction studies, pubertal onset 

assays, uterotrophic assays), which 

demonstrate acceleration of vaginal 

opening in the rat. Accelerated vaginal 

opening is the most consistent and 

sensitive endpoint identified. Clear 

NOAELs for this endpoint have been 

identified following exposure to 

nonylphenol. 

ii. While endpoints were not selected 

from the Harmonized Guideline 

870.3650 study in rats following prenatal and post-natal exposure to 

octylphenol ethoxylate based on 

concerns that the study did not look for 

impacts on the estrogen system, the 

Agency does note that no increased 

susceptibility was demonstrated in the 

offspring in the Harmonized Guideline 

870.3650 study in rats following prenatal and post-natal exposure to 

octylphenol ethoxylate. 

iii. Although a developmental toxicity 

study was identified in the open 

literature for octylphenol ethoxylate 

with a developmental NOAEL of 70/mg/ 

kg/day, a developmental study on 

octylphenol demonstrated an increase 

in post-implantation loss following 

exposure to the dams from gestation day 

0–8. A clear NOAEL of 15.6 mg/kg/day 

was established for the offspring effects. 

Since the POD selected from that study 

for acute dietary exposure to the 

octylphenol metabolite is 15.6 mg/kg/ 

day, this value is considered health 

protective of offspring effects that might 

be found following octylphenol 

ethoxylate exposure. 

iv. There is a 2–generation 

reproduction study in rats on 

octylphenol that demonstrates no 

adverse effects on reproductive 

function. 

v. Although the available mammalian 

toxicity database does not include any 

chronic toxicity data, there is one 2– 

generation reproduction study on 

octylphenol and several multigeneration 

reproduction studies on the most 

toxicologically potent compound in the 

risk assessment, nonylphenol, in which 

test animals were dosed for extended 

periods of time and across generations. 

vi. No evidence of neurotoxicity was 

demonstrated in the database for 

octylphenol ethoxylate, octylphenol, or 

nonylphenol and thus there is no need 

for a developmental neurotoxicity study 

or additional UFs to account for 

neurotoxicity. 

vii. The exposure assessments used in 

this risk assessment are considered to be 

highly conservative. In the absence of 

substantial information on 

environmental degradation, the Agency 

has conducted an assessment which 

assumes that 100% of octylphenol 

ethoxylate is degradated to the more 

toxic degradate, octylphenol. Further, 

the assessment assumed residues of 

octylphenol will be present in all foods 

consumed at levels consistent with the 

highest established pesticide tolerance, 

and in drinking water at a high-end 

estimated level of 100 ppb. The Agency 

anticipates that this assessment will 

signifcantly overestimate risk. 

EPA has determined that the FQPA 

safety factor should be retained (10X) 

for octylphenol ethoxylate, the 

compound upon which the residential 

assessment is based. This decision is 

based on the following findings: 

a. Although endpoints from the 

Harmonized Guideline 870.3650 study 

in rats following pre-natal and postnatal exposure to the octylphenol 

ethoxylate were selected for the 

residential and occupational exposure 

risk assessments, there are concerns that 

the study did not look for the most 

sensitive endpoints for the estrogen 

system. 

b. The Agency does note that no 

increased susceptibility was 

demonstrated in the offspring in the 

Harmonized Guideline 870.3650 study 

in rats following pre-natal and postnatal exposure to octylphenol 

ethoxylate. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

appropriate PODs to ensure that an 

adequate MOE exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, including the limitation 

of use of octylphenol ethoxylate to not 

more than 7% of the pesticide product, 

the acute dietary exposure from food 

and water to octylphenol ethoxylate 

willl occupy 37% of the aPAD for 

females 13 to 49 years old, the only 

population group for which an acute 

toxicity endpoint was established. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, including the 

limitation of use of octylphenol 

ethoxylate to not more than 7% of the 

pesticide product, EPA has concluded 

that chronic exposure to octylphenol 

ethoxylate from food and water will 

utilize 90% of the cPAD for children 1– 

2 years old the population group 


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receiving the greatest exposure. Based 

on the explanation in Unit IV.C.3., 

regarding residential use patterns, 

chronic residential exposure to residues 

of octylphenol is not expected. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Short-term and intermediate-term 

aggregate risk assessments for 

octylphenol ethoxylate combine high 

end residential short-term or 

intermediate-term exposures with 

average food and drinking water 

exposures, and compare this total to a 

short-term or intermediate-term POD. 

The POD for the dietary risk 

assessment is 10 mg/kg/day and the 

LOC when examining the MOE is 100 

for octylphenol ethoxylate. The POD for 

the residential risk assessment is 150 

mg/kg/day and the LOC is 1,000 for 

octylphenol ethoxylate. For the purpose 

of aggregating risks from dietary and 

residential exposure, the Agency is 

using the Aggregate Risk Index (ARI) 

approach for aggregate risk assessment. 

This approach allows for combining 

exposures which must be compared to 

different NOAELs and different LOCs. 

Potential risks of concerns are identified 

by an ARI of less than 1. Short-term and 

intermediate-term aggregate risks for 

octylphenol ethoxylate are not of 

concern (values ranging from 1.0 to 4.3 

for children and adults, respectively). 

4. Aggregate cancer risk for U.S. 

population. The Agency has carefully 

considered the weight of the evidence 

with respect to carcinogenicity for both 

the parent compounds and for the 

degradate. There were no structral alerts 

for carcinogenicity amd there were 

equivocal mutagenicity findings in the 

literature studies. Based on a weight of 

the evidence consideration of the 

available data, the Agency believes that 

cancer risks would be negligible. 

However, due to the equivocal findings 

in the mutagenicity data base, the 

Agency is asking for confirmatory data. 

5. 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 octylphenol 

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 residues of octylphenol 

ethoxylate in or on any food 

commodities. EPA is establishing a 

limitation on the amount of octylphenol 

ethoxylate that may be used in pesticide 

formulations applied to growing crops 

and raw agricultural commodities. 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 such 

pesticide for sale or distribution that 

contains greater than 7% of octylphenol 

ethoxylate by weight in the pesticide 

formulation. 

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 octylphenol ethoxylate. 

C. Revisions to Petitioned-For 

Exemption from the Requirement of a 

Tolerance 

EPA is revising the petitioned-for 

octylphenol ethoxylate exemption from 

the requirement of a tolerance under 40 

CFR 180.910 by including a limitation 

of ‘‘not to exceed 7% of the pesticide 

formulation.’’ As discussed in Unit 

IV.C., this limitation will ensure that 

there are no aggregate risks of concern. 

Additionally, EPA is also revising the 

octylphenol ethoxylate exemption from 

the requirement of a tolerance under 40 

CFR 180.910 to include a 2-year time 

limitation. The exemption from the 

requirement of a tolerance for 

octylphenol ethoxylate will expire on 

May 17, 2012. This two-year time 

limitation is being established for two 

purposes: 

1. To provide time for the 

development and submission of 

confirmatory toxicity data to address the 

equivocal results in the available 

genotoxicity studies conducted on 

octylphenol ethoxylate; and 

2. To provide additional time, should 

the initial testing not confirm EPA’s 

conclusion regarding the lack of a 

cancer concern, for registrants to attain 

EPA approval of registration 

amendments for reformulation of their 

pesticide products to remove 

octylphenol ethoxylate and to replace 

existing products with reformulated 

products. 

EPA believes that its cancer 

conclusion can be confirmed by 

negative results in either in vitro or in 

vivo mutagenicity studies. EPA is 

recommending that supporters of the 

octylphenol ethoxylate tolerance 

exemption perform the following 

studies for confirmatory purposes: 

A new Ames assay (Harmonized 

Guideline 870.5100 — Bacterial reverse 

mutation test) and a mouse lymphoma 

assay (Harmonized Guideline 870.5300 

— In vitro mammalian cell gene 

mutation test). 

A bone marrow assay (Harmonized 

Guideline 870.5395 — Mammalian 

erythrocyte micronucleus test). 

Since in vivo mutagenicity studies 

such as the bone marrow assay are 

generally regarded as more definitive 

than in vitro studies, and a negative 

result in the bone marrow test may 

outweigh whatever results are found in 

the Ames test and mouse lymphoma 

assay, supporters of the octylphenol 

ethoxylate tolerance exemption may opt 

to conduct the mammalian erythrocyte 

micronucleus test in lieu of the two in 

vitro mutagenicity studies. If these data 

do not confirm EPA’s cancer 

conclusion, then EPA will need twoyear cancer bioassays in the mouse and 

rat (Harmonized Guideline 870.4200 — 

Carcinogenicity (mouse) and 

Harmonized Guideline 870.4300 — 

combined Chronic Toxicity/ 

Carcinogenicity (rat)) to make a safety 

finding in support of this tolerance 

exemption. 

In conducting confirmatory testing, 

supporters of the octylphenol ethoxylate 

tolerance exemption should keep the 

following information in mind. EPA 

believes that the minimum time period 

for registrants to obtain approval of 

reformulated products and to replace 

existing products is 15 months. Thus, 

EPA plans to alert the registrant 

community no later than February 17, 

2011 whether confirmatory data has 

been received and demonstrates that 

EPA’s cancer conclusion was correct. If 

submitted data do confirm EPA’s 

conclusion, EPA will notify registrants 

that it intends to remove the expiration 

date from the tolerance exemption prior 

to expiration of the exemption. If the 


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submitted data do not confirm the 

conclusion, EPA will inform registrants 

that they should assume that the 

tolerance exemption will expire on May 

17, 2012 and that they should take all 

appropriate steps to insure that they do 

not release for shipment product that 

may result in food containing residues 

inconsistent with the dictates of the 

FFDCA. EPA does not intend to extend 

the expiration date for the exemption if 

it is determined that two-year cancer 

bioassays are needed to evaluate 

potential cancer risk. Additionally, if no 

confirmatory data are submitted by 

November 17, 2010. EPA will not have 

time to make a decision on any 

confirmatory data by February 17, 2011 

and thus, at that time, EPA will inform 

registrants that they should assume that 

the tolerance exemption will expire on 

May 17, 2012 and that they should take 

all appropriate steps as indicated above. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance for residues 

of a-[p-(1,1,3,3- 

tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) when used as 

an inert ingredient at levels not to 

exceed 7% in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest 

under 40 CFR 180.910 is established 

with an expiration date of May 17, 2012. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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: May 10, 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. Section 180.910 is amended by 

adding alphabetically the following 

entry in the table of inert ingredients to 

read as follows: 

§ 180.910 Inert ingredients used pre and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

a-[p-(1,1,3,3-tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) produced by the condensation 

of 1 mole of p-(1,1,3,3-tetramethylbutyl)phenol with a 

range of 1–14 or 30–70 moles of ethylene oxide: If a 

blend of products is used, the average range number of 

moles of ethylene oxide reacted to produce any product 

that is a component of the blend shall be in the range of 

1–14 or 30–70 (CAS Reg. Nos. 9036–19–5, 9002–93–1).

Not to exceed 7% of pesticide formulation. Expires May 17, 2012.Surfactants, related adjuvants of 

surfactants 

* * * * * 


srobinson on DSKHWCL6B1PROD with RULES
27452 Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 

* * * * * 

[FR Doc. 2010–11686 Filed 5–14–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

43 CFR Part 8360 

[LLWO25000—L12200000.PM000—241A.00] 

RIN 1004–AD96 

Visitor Services 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Final rule. 

SUMMARY: The Bureau of Land 

Management (BLM) is amending its 

regulations to remove the Land and 

Water Conservation Fund Act as one of 

the authorities of its recreation 

regulations, in accordance with the 

Federal Lands Recreation Enhancement 

Act of 2004 (REA). The final rule 

amends and reorders the prohibitions to 

separate those that apply specifically to 

campgrounds and picnic areas from 

those with more general application. 

The reordering is necessary to broaden 

the scope to include all areas where 

standard amenity, expanded amenity, 

and special recreation permit fees are 

charged under REA. The final rule also 

removes regulations that have been 

interpreted by the BLM Field Offices to 

require the BLM to publish 

supplementary rules for each area for 

failure to pay recreation fees, thus 

relieving the BLM from publishing 

separate rules for each area. Finally, this 

rule makes technical changes to 

maintain consistency with other BLM 

regulations. 

DATES: This rule is effective on June 16, 

2010. 

ADDRESSES: Inquiries or suggestions 

should be delivered to U.S. Department 

of the Interior, Director (630), Bureau of 

Land Management, Mail Stop 401 LS, 

1849 C St., NW., Attention: RIN: 1004– 

AD96, Washington, DC 20240. 

FOR FURTHER INFORMATION CONTACT: For 

information on the substance of the rule, 

please contact Hal Hallett at (202) 912– 

7252 or Anthony Bobo Jr. at (202) 912– 

7248. For information on procedural 

matters, please contact Chandra Little at 

(202) 912–7403. Persons who use a 

telecommunications device for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

to contact the above individuals during 

normal business hours. FIRS is available 

twenty-four hours a day, seven days a 

week, to leave a message or question 

with these individuals. You will receive 

a reply during normal business hours. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Final Rule as Adopted and Response to 

Comments 

III. Procedural Matters 

I. Background 

The BLM is revising its fee 

management regulations, policies, and 

procedures in accordance with the REA, 

16 U.S.C. 6801 et seq., 43 CFR part 2930 

currently includes all recreation fee 

management regulations, including the 

requirement that visitors pay fees before 

occupying a campground or picnic area. 

The BLM is now amending 43 CFR part 

8360 to add regulatory changes made 

necessary by the REA, including the 

removal of any language pertaining to 

recreation fees. In addition, the section 

addressing the collection of fossils is 

modified to include common plant 

fossils, reflecting long established BLM 

policies. The Omnibus Public Land 

Management Act (OPLMA) became law 

on March 30, 2009, after the publication 

of the proposed rule and includes 

provisions on Paleontological Resources 

Preservation (PRP) (Title VI, Subtitle D 

(Pub. L. 111–11, 123 Stat. 1172, 16 

U.S.C. 470aaa et seq.)) The law requires 

that the Secretary of the Interior develop 

regulations to implement this subtitle. 

The OPLMA–PRP defines ‘‘casual 

collecting’’ as ‘‘* * * the collecting of a 

reasonable amount of common 

invertebrate and plant paleontological 

resources for non-commercial personal 

use, either by surface collection or the 

use of non-powered hand tools resulting 

in only negligible disturbance to the 

Earth’s surface and other resources.’’ 

These regulations define terms as used 

in this definition. However, the 

OPLMA–PRP does not change the 

BLM’s basic policy for allowing casual 

collecting of reasonable amounts of 

common invertebrate and common 

plant fossils from public lands for 

personal use without a permit, and 

therefore, the regulations at 43 CFR part 

8360 do not conflict with the OPLMA– 

PRP. 

Other changes were made that group 

related regulations in the same section 

to simplify language and clarify the 

intent, and to resolve inconsistencies 

between the existing provisions. 

II. Final Rule as Adopted and Response 

to Comments 

On October 3, 2008, the BLM 

published a proposed rule (73 FR 

57564) to implement REA with a 60-day 

public comment period that ended on 

December 2, 2008. The BLM received 

four comments on the proposed rule. 

These comments supported the 

proposed rule and suggested a few 

minor revisions to make the regulations 

consistent with other BLM regulations. 

The comments specifically addressed 

activities relating to the recreational 

collection of rocks and paleontological 

resources on BLM lands. 

Section 8360.0–3 Authority 

The final rule removes the Land and 

Water Conservation Fund Act (LWCFA) 

(16 U.S.C. 4601–6a) as an authority for 

the regulations. The enactment of the 

REA changed the BLM’s authority to 

collect recreation fees. Recreation fees 

that were previously authorized under 

the LWCFA are now authorized under 

REA. The BLM’s policies and 

procedures have also been revised to 

reflect this new and revised authority. 

We received no comment on this section 

and therefore the final rule remains as 

proposed. 

Section 8360.0–5 Definitions 

In paragraph (c), the proposed rule 

added the word ‘‘recreation’’ as a 

modifier to the term ‘‘developed sites 

and areas’’ in order to clarify that the 

definition is specific to developed 

recreation sites and areas. The same 

language is inserted elsewhere in this 

rule to distinguish developed recreation 

sites and areas from other developed 

sites and areas used for non-recreation 

purposes. We received no comment on 

this section, thus the final rule remains 

as proposed. 

Section 8365.1–5 Property and 

Resources 

We received three comments on this 

section that stated that removing the 

term ‘‘rocks’’ from the current 43 CFR 

8365.1–5(b)(2), as proposed, would lead 

to uncertainty about the collecting of 

rocks as a hobby without a permit on 

public lands. The commenters suggested 

that we retain the term ‘‘rocks’’ 

consistent with the current regulations 

and with the BLM’s policy of allowing 

recreational collection of rocks and 

minerals on public lands. The BLM 

stated in the preamble to the proposed 

rule that the term ‘‘rocks’’ should be 

removed because it was already covered 

in regulations at 43 CFR 8365.1–5(b)(4) 

which by reference to 43 CFR subpart 

3604 allows the recreational collection 

of ‘‘common’’ rocks without a permit. 

However, the regulations at 43 CFR part 

3600 do not address the recreational 

collection of rocks on public lands 

without a permit. The Materials Act 

does not allow recreational collection of 

rocks and payment is required. Section 

8365.1–5(b) makes an exception for the 


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