27434 Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions which do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves the establishment of security 

zones. 

An environmental analysis checklist 

and a categorical exclusion 

determination are available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add new temporary § 165.T11–308 

to read as follows: 

§ 165.T11–308 Security Zone; Golden 

Guardian 2010 Regional Exercise; San 

Francisco Bay, San Francisco, CA. 

(a) Location. All navigable waters 

within 100 yards of the exercise vessels 

while at positions: 37°47′33′′ N and 

122°18′00′′ W; 37°49′12.30′′ N and 

122°18′49.23′′ W; 37°46′39.37′′ N and 

122°23′12.64′′ W (NAD 83). 

(b) Enforcement Period. This section 

will be enforced from 8:50 a.m. through 

2:10 p.m. on May 18, 2010. If the 

operation concludes prior to the 

scheduled termination time, the Captain 

of the Port San Francisco will cease 

enforcement of the security zones and 

will make the announcement via 

Broadcast Notice to Mariners. 

(c) Definitions. The following 

definition applies to these sections: 

designated representative means any 

commissioned, warrant, and petty 

officers of the Coast Guard on board 

Coast Guard, Coast Guard Auxiliary, 

and local, state, and federal law 

enforcement vessels who have been 

authorized to act on the behalf of the 

Captain of the Port San Francisco. 

(c) Regulations. (1) Entry into, transit 

through or anchoring within this 

security zone is prohibited unless 

authorized by the Captain of the Port 

San Francisco or designated 

representative. 

(2) Mariners requesting permission to 

transit through the security zones may 

request authorization to do so from the 

Patrol Commander (PATCOM). The 

PATCOM may be contacted on VHF–FM 

Channel 16. 

(3) All persons and vessels shall 

comply with the instructions of the 

Coast Guard Captain of the Port San 

Francisco or designated representative. 

(4) Upon being hailed by U.S. Coast 

Guard patrol personnel by siren, radio, 

flashing light, or other means, the 

operator of a vessel shall proceed as 

directed. 

(5) The Coast Guard may be assisted 

by other federal, state, or local agencies. 

Dated: May 5, 2010. 

P.M. Gugg, 

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

Port San Francisco. 

[FR Doc. 2010–11883 Filed 5–13–10; 4:15 pm] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0892; FRL–8826–3] 

α-(p-Nonylphenol)-whydroxypoly(oxyethylene) Sulfate and 

Phosphate Esters; Time-Limited 

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-nonylphenol)-whydroxypoly(oxyethylene) mixture of 

dihydrogen phosphate and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

magnesium, potassium, sodium, and 

zinc salts of the phosphate esters and a- 

(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, 

ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts when 

used as inert ingredients at levels not to 

exceed 7% in pesticide formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and animals. The Joint Inerts Task 

Force, Cluster Support Team Number 9 

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-nonylphenol)-whydroxypoly(oxyethylene) mixture of 

dihydrogen phosphate and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

magnesium, potassium, sodium, and 

zinc salts of the phosphate esters and a- 

(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, 

ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts). 

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–2008–0892. All documents in the 

docket are listed in the docket index 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 27435 

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: 

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 

OPPTS harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0892 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–2008–0892, 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 8E7478) by the 

Joint Inerts Task Force, Cluster Support 

Team 9, c/o CropLife America, 1156 

15th Street, NW., Suite 400, 

Washington, DC 20005. The petition 

requested that 40 CFR 180.910 and 40 

CFR 180.930 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of of a-(p-nonylphenol)-whydroxypoly(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 for 

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 and 

a-(p-nonylphenol)-whydroxypoly(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 for CAS Reg Nos. 

9014-90-8, 9051-57-4, 9081-17-8, 68649- 

55-8, 68891-33-8 (herein referred to in 

this document as nonylphenol 

ethoxylate phosphate and sulfate 

derivatives or NPEPSDs) when used as 

inert ingredients 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 

Team 9, 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 and 

40 CFR 180.930 exemptions from the 

requirement of a tolerance for NPEPSDs 

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 ‘‘Nonylphenol Ethoxylates 


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27436 Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 

and Their Phosphate and Sulfate 

Derivatives (NPEs - JITF CST 9 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– 

2008–0892. 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 

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-nonylphenol)-whydroxypoly(oxyethylene) mixture of 

dihydrogen phosphate and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

magnesium, potassium, sodium, and 

zinc salts of the phosphate esters and a- 

(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate, 

ammonium, calcium, magnesium, 

potassium, sodium, and zinc salts 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 

andhydrocarbons; 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 NPEPDs 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with NPEPDs 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. 

NPEPSDs have low to moderate acute 

oral and dermal toxicity, are mild to 

moderate skin irritants, and eye 

irritants. Based on the analysis of the 

studies in the open literature, there is 

both positive and negative evidence that 

NPEPSDs are mutagenic in bacteria 

(Salmonella typhimurium). In 

Harmonized Guideline 870.3650 

combined repeated dose toxicity studies 

with the reproduction/developmental 

toxicity screening test in rats with 

NPEPSDs, there was no evidence of 

increased susceptibility. Additionally, 

there was no evidence of neurotoxicity, 

developmental toxicity, or reproductive 

toxicity in those same studies. The 

Agency has identified nonylphenol as a 

potential metabolite/degradate of 

concern. The Agency considered 

available toxicity data on nonylphenol 

as well as toxicity data on the 

structurally related octylphenol 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 

NPEPSDs 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 NPEPSDs as well as 

the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Nonylphenol Ethoxylates and Their 

Phosphate and Sulfate Derivatives 

(NPEs — JITF CST 9 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. 11–22 in docket ID 

number EPA–HQ–OPP–2008–0892. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 


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Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 27437 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level – generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD) – and a safe margin 

of exposure (MOE) or level of concern 

(LOC). For non-threshold risks, the 

Agency assumes that any amount of 

exposure will lead to some degree of 

risk. Thus, the Agency estimates risk in 

terms of the probability of an occurrence 

of the adverse effect expected in a 

lifetime. For more information on the 

general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for NPEPSDs used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE — SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NPEPSDS AND ITS METABOLITES (INCLUDING

NONYLPHENOL) 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 

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 

3–Generation reproduction study in 

rats (nonylphenol) LOAEL=30 mg/ 

kg/day based on acceleration of 

vaginal opening by by ≈2 days 

and ≈6 days in F1, F2, and F3 generations following dietary exposure 

at 30 and 100 mg/kg/day respectively (NOAEL ≈9 mg/kg/day) 

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 (NPEPSD) 

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. 


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27438 Federal Register / Vol. 75, No. 94 / Monday, May 17, 2010 / Rules and Regulations 

TABLE — SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NPEPSDS AND ITS METABOLITES (INCLUDING

NONYLPHENOL) FOR USE IN HUMAN RISK ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

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

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 (NPEPSD) 

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 NPEPSDs and metabolite. Based on a weight 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). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term assessment. UFDB = to account for 

the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, 

c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

Very limited information is available 

for NPEPSDs 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 

NPEPSD compounds. The ethoxylate 

moiety is degraded by sequential 

removal of the ethoxylate groups, 

eventually degrading to nonylphenol. 

There are studies in the literature that 

suggest that plants have the ability to 

take up nonylphenol ethoxylate 

residues from treated soil. While the 

Agency does not expect that the use of 

NPEPSDs as inert ingredients 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 NPEPSDs as inert ingredients. 

Therefore, the Agency has concluded 

that the residues of concern in food and 

drinking water are the NPEPSD 

compounds, their partially deethoxylated degradation products, as 

well as the degradation product 

nonylphenol, and has conservatively 

assumed that in the case of food and 

drinking water exposures all exposure 

will be in the form of exposure to 

nonylphenol, the potential metabolite/ 

degradate of greatest toxicological 

concern. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to NPEPSDs, EPA considered 

exposure from the petitioned-for 

exemption from the requirement of a 

tolerance. EPA assessed dietary 

exposures from NPEPSDs 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 NPEPSDs. A hazard endpoint for 

acute exposure to NPEPSDs 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 

percent of the product and often can be 

much higher. Further, pesticide 


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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 NPEPSD that may be in 

formulations (no more than 7%) and 

assumed that NPEPSDs are 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 were NPEPSDs. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert 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 to NPEPSDs 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 for NPEPSDs. 

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% CT 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 

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 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 

‘‘Nonylphenol Ethoxylates and Their 

Phosphate and Sulfate Derivatives 

(NPEs — JITF CST 9 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.’’ at pp. 23–25 and 

Appendix C in docket ID number EPA– 

HQ–OPP–2008–0892. 

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 1000 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). NPEPSDs 

may be used as inert ingredients 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 NPEPSDs as inert 

ingredients. 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 NPEPSDs. 

Similarly, residential postapplication 

dermal and oral exposure assessments 

were also performed utilizing high-end 

exposure scenarios. In the case of 

NPEPSDs, non-dietary exposures are to 

NPEPSDs only as there is no appreciable 

metabolism or degradation of NPEPSDs 

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. 


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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 NPEPSDs to share 

a common mechanism of toxicity with 

any other substances, and NPEPSDs 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that NPEPSDs do not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the case of NPEPSDs, there was no 

increased susceptibility to the offspring 

of rats following pre-natal and postnatal exposure in either Harmonized 

Guideline 870.3650 combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening test. In the Harmonized 

Guideline 870.3650 study with the 

nonylphenol ethoxylate phosphate 

ester, decrease in pup viability was 

observed at the limit dose, whereas 

parental toxicity was observed at a 

lower dose, as evidenced by the 

decrease in body-weight gain and food 

consumption during premating and 

signs of discomfort (pushing head 

through bedding) at 300 mg/kg/day. In 

the Harmonized Guideline 870.3650 

study on the nonylphenol ethoxylate 

sulfate, decreased pup viability 

(decreased number of live pups/litter at 

birth, increased number of dead pups 

and litters with dead pups), and 

decreased pup body weight/bodyweight gain were observed at the limit 

dose where parental toxicity manifested 

as mortality, clinical signs (soft feces, 

signs of discomfort), decreased body 

weight gain, liver toxicity, and lesions 

in the forestomach (both sexes) and 

decreased body temperature and 

locomotor activity, hematologic effects, 

and kidney lesions in females. Since the 

Harmonized Guideline 870.3650 studies 

with NPEPSDs did not assess their 

impact on the estrogen system, they 

cannot be used alone to properly assess 

the most sensitive endpoint. However, 

selecting the POD from the Harmonized 

Guideline 870.3650 study on 

nonylphenol ethoxylate phosphate 

which is based on a NOAEL of 100 mg/ 

kg/day and decreased body-weight gain 

in both sexes during the premating 

period 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 

NPEPSDs For the nonylphenol 

metabolite, two of the multigeneration 

reproduction studies in rats and two 

studies in prepubertal female rats 

showed accereration in the acquisition 

of vaginal patency. A delay in preputial 

separation was observed in male rats in 

a pubertal onset assay. 

Although no developmental toxicity 

studies were identified in the toxicology 

database for nonylphenol,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 nonylphenol 

was selected from this study for the 

acute dietary (females 13+) exposure. 

This study is considered appropriate 

and health protective in light of the fact 

that octylphenol and nonylphenol differ 

by only one methylene unit. 

3. Conclusion. EPA has determined 

that the FQPA safety factor can be 

reduced to 1X for the nonylphenol 

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. 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. Although no developmental 

toxicity studies were identified in the 

open literature for nonylphenol, a 

developmental study on the 

structurally-related substance, 

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 nonylphenol 

exposure. 

iii. There are several multigeneration 

reproduction studies in rats on 

nonylphenol that demonstrates no 

adverse effects on reproductive 

function. 

iv. Although the available mammalian 

toxicity database does not include any 

chronic toxicity data, there are 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. 

v. No evidence of neurotoxicity was 

demonstrated in the database for 

NPEPSDs, octylphenol, or nonylphenol 

and thus there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

vi. 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 NPEPSDs is 

degradated to the more toxic degradate, 

nonylphenol. Further, the assessment 

assumed residues of nonylphenol 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 

significantly overestimate risk. 

EPA has determined that the FQPA 

safety factor should be retained (10X) 


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for NPEPSDs, 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- endpost-natal exposure to 

NPEPSDs were selected for the 

residential and occupational risk 

assessments, there are concerns that the 

study did not look for the most sensitive 

endpoints for the estrogen system; and 

(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- and post-natal 

exposure to NPEPSDs. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, including the limitation 

of use of NPEPSDs to not more than 7% 

of the pesticide product, the acute 

dietary exposure from food and water to 

NPEPSDs 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 NPEPSDs to not 

more than 7% of the pesticide product, 

EPA has concluded that chronic 

exposure to NPEPSDs from food and 

water will utilize 90% of the cPAD for 

children 1–2 years old the population 

group 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 NPEPSDs 

combine high end residential short- or 

intermediate-term exposures with 

average food and drinking water 

exposures, and compare this total to a 

short- or intermediate-term PoD. 

The point of departure for the dietary 

risk assessment is 10 mg/kg/day and the 

the Level of Concern (LOC) when 

examining the margin of exposure is 100 

for NPEPSDs. The point of departure for 

the residential risk assessment is 150 

mg/kg/day and the LOC is 1000 for 

NPEPSDs. For the purpose of 

aggregating risks from dietary and 

residential exposure, the Agency is 

using the Aggregate Risk Index 

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- and 

intermediate-term aggregate risks for 

NPEPSDs are not of concern (values 

ranging from 1.0 to 4.3 for children and 

adults, respectively). 

4. The Agency has carefully 

considered the weight of the evidence 

with respect to carcinogenicity for both 

NPEPSDs and for nonylphenol. 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 

The Agency is not aware of any 

country requiring a tolerance for 

octylphenol ethoxylate nor have any 

CODEX Maximum Residue Levels been 

established for any food crops at this 

time. 

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 two-year time 

limitation. The exemption from the 

requirement of a tolerance for NPEPSDs 

will expire on May 17, 2012. This twoyear 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 

NPEPSDs; 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 NPEPSDs 

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 

NPEPSDs tolerance exemption perform 

the following studies for confirmatory 

purposes: 

A new Ames assay (Harmonized Test 

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 NPEPSDs 

tolerance exemption may opt to conduct 

the mammalian erythrocyte 

micronucleus test in lieu of the two in 


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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 NPEPSD 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 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 in this 

Unit. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance for residues 

of a-(p-nonylphenol)-whydroxypoly(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 and 

a-(p-nonylphenol)-whydroxypoly(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 when used as inert 

ingredients at levels not to exceed 7% 

in pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest under 40 CFR 

180.910 and to applied to animals under 

40 CFR 180.930 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 

entries 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. 

* * * * * 


srobinson on DSKHWCL6B1PROD with RULES
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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