28616 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 

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

of Homeland Security Delegation No. 0170.1 

■ 2. Add temporary § 165.T08–0310 to 

read as follows: 

165.T08–0310 Safety Zone; Ohio River, 

Miles 460.0 to 470.5, Cincinnati, OH. 

(a) Location. The following area is a 

safety zone: All waters of the Ohio 

River, from surface to bottom, beginning 

at mile marker 460.0 and ending at mile 

marker 470.5. 

(b) Effective Period. This section is 

effective from 8 a.m. to 12:30 p.m. on 

June 27, 2009. 

(d) Regulations. (1) In accordance 

with the general regulations in § 165.23 

of this part, entry into this zone is 

prohibited unless authorized by the 

Captain of the Port Ohio Valley or a 

designated representative. 

(2) Persons or vessels requiring entry 

into or passage through the zone must 

request permission from the Captain of 

the Port Ohio Valley or a designated 

representative. U.S. Coast Guard Sector 

Ohio Valley may be contacted on VHF 

Channel 13 or 16. 

(3) All persons and vessels shall 

comply with the instructions of the 

Captain of the Port Ohio Valley and 

designated U.S. Coast Guard patrol 

personnel. On-scene U.S. Coast Guard 

patrol personnel include commissioned, 

warrant, and Petty Officers of the U.S. 

Coast Guard. 

Dated: May 5, 2009. 

A.E. Tucci, 

Commander, U.S. Coast Guard, Captain of 

the Port Ohio Valley, Acting. 

[FR Doc. E9–14166 Filed 6–16–09; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[R05–OAR–2008–0031; FRL–8919–7] 

Approval and Promulgation of Air 

Quality Implementation Plans; Indiana; 

Withdrawal of Direct Final Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Withdrawal of direct final rule. 

SUMMARY: Due to the receipt of an 

adverse comment, the EPA is 

withdrawing the May 5, 2009 (74 FR 

20599), direct final rule approving a rule 

revision to extend Federally Enforceable 

State Operating Permit renewal terms 

from five years to ten years. The State 

of Indiana submitted this revision as a 

modification to the State 

Implementation Plan on December 19, 

2007. In the direct final rule, EPA stated 

that if adverse comments were 

submitted by June 4, 2009, the rule 

would be withdrawn and not take effect. 

On May 19, 2009, EPA received a 

comment. EPA believes this comment is 

adverse and, therefore, EPA is 

withdrawing the direct final rule. EPA 

will address the comment in a 

subsequent final action based upon the 

proposed action also published on May 

5, 2009 (74 FR 20665). EPA will not 

institute a second comment period on 

this action. 

DATES: The direct final rule published at 

74 FR 20599 on May 5, 2009, is 

withdrawn as of June 17, 2009. 

FOR FURTHER INFORMATION CONTACT: Sam 

Portanova, Environmental Engineer, Air 

Permits Section, Air Programs Branch 

(AR–18J), USEPA, Region 5, 77 West 

Jackson Boulevard, Chicago, Illinois 

60604, (312) 886–3189, 

portanova.sam@epa.gov. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

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

Dated: June 4, 2009. 

Walter W. Kovalick Jr., 

Acting Regional Administrator, Region 5. 

PART 52—[AMENDED] 

■ Accordingly, the amendment to 40 

CFR 52.770 published in the Federal 

Register on May 5, 2009 (74 FR 20599) 

on page 20601 is withdrawn as of June 

17, 2009. 

[FR Doc. E9–14240 Filed 6–16–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0738; FRL–8418–6] 

Alkyl Amine Polyalkoxylates; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of alkyl amine 

polyalkoxylates when used as inert 

ingredients in pesticide formulations 

applied to growing crops and animals. 

The Joint Inerts Task Force (JITF), 

Cluster Support Team Number 4 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of alkyl amine 

polyalkoxylates. 

DATES: This regulation is effective June 

17, 2009. Objections and requests for 

hearings must be received on or before 

August 17, 2009, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0738. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

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 those engaged in the 

following activities: 

• Crop production (NAICS code 111). 


dwashington3 on PROD1PC60 with RULES
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 28617 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. 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–2008–0738 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before August 17, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0738, 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 December 3, 

2008 (73 FR 73644) (FRL–8386–9), 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 8E7382) by The 

Joint Inerts Task Force (JITF), Cluster 

Support Team Number 4 (CST 4), c/o 

CropLife America, 1156 15th Street, 

NW., Suite 400, Washington, DC 20005, 

The petition requested that 40 CFR 

180.920 and 40 CFR 180.930 be 

amended by establishing exemptions 

from the requirement of a tolerance for 

residues of the inert ingredient N,N-Bisa-ethyl-w-hydroxypoly(oxy-1,2- 

ethanediyl) C8-C18 saturated and 

unsaturated alkylamines; the poly(oxy1,2-ethanediyl) content is 2–60 moles 

and N,N-Bis-a-ethyl-whydroxypoly(oxy-1,2-ethanediyl/ 

oxy(methyl-1,2-ethanediyl) C8-C18

saturated and unsaturated alkylamines; 

the poly(oxy-1,2-ethanediyl/oxy(methyl1,2-ethanediyl) content is 2-60 moles 

(these substances are referred to 

throughout this document as alkyl 

amine polyalkoxylates). That notice 

referenced a summary of the petition 

prepared by JITF, CST 4, 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. 

This petition was submitted in 

response to a final rule of August 9, 

2006, (71 FR 45415) 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 

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

date for the tolerance exemptions 

subject to revocation was August 9, 

2008, which was later extended to 

August 9, 2009 (73 FR 45312 ) to allow 

for data to be submitted to support the 

establishment of tolerance exemptions 

for these inert ingredients prior to the 

effective date of the tolerance exemption 

revocation. 

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....’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 


dwashington3 on PROD1PC60 with RULES
28618 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 

exposures that occur as a result of 

pesticide use in residential settings. 

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 the petitioned-for 

exemption from the requirement of a 

tolerance for residues of alkyl amine 

polyalkoxylates when used as inert 

ingredients in pesticide formulations 

applied to growing crops or foodproducing animals. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances 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. 

Alkyl amine polyalkoxylates are not 

acutely toxic by the oral and dermal 

routes of exposure, or via inhalation 

under normal use conditions. 

Concentrated materials are generally 

corrosive, eye and skin irritants and 

may be dermal sensitizers. There is no 

evidence that alkyl amine 

polyalkoxylates are neurotoxic, 

mutagenic, or clastogenic. 

Following subchronic exposure to 

rats, some gastrointestinal irritation was 

observed, but no specific target organ 

toxicity or neurotoxicity was seen. In 

subchronic studies in rats and/or dogs, 

the most sensitive effects noted were 

increased mortality, clinical signs 

(salivation, wheezing, emesis, and/or 

soft feces), cataracts, cellular changes in 

the stomach, and liver effects 

characterized by enzyme induction, and 

pigment accumulation in Kupffer cells 

and bile canaliculi. There was no 

increased susceptibility to the offspring 

of rats following in utero exposure in 

two prenatal developmental toxicity 

studies. However, there is evidence of 

increased susceptibility in a 

reproductive screening study in rats. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by alkyl amine 

polyalkoxylates as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document Alkyl 

Amine Polyalkoxylates (JITF CST 4 Inert 

Ingredients), Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations, at 

pp 10-17 in docket ID number EPA– 

HQ–OPP–2008–0738. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the 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 greater than that 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 alkyl amine 

polyalkoxylates used for human risk 

assessment is shown in the following 

Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ALKYL AMINE POLYALKOXYLATES 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 (all populations) NOAEL = 72 milligrams/kilograms/day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.72 mg/kg/day 

aPAD = 0.72 mg/kg/day 

90-Day Oral Toxicity Study in Rats LOAEL = 

216 mg/kg/day based on mortality (2 deaths 

after 2 exposures; gestation day (GD) 2), with 

a total of 6/25 deaths during GD 6-15. 

Chronic dietary (all populations) NOAEL 15 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.15 mg/kg/ 

day 

cPAD = 0.15 mg/kg/day 

90-Day Oral (Gavage) Toxicity Study in Rats 

LOAEL = 30 mg/kg/day based on increased 

mortality (2 deaths (days 36, 78)), salivation, 

and posterior subcapsular cataracts in males 

as well as wheezing, and macro- and microscopic changes in the nonglandular stomach 

of both sexes. 


dwashington3 on PROD1PC60 with RULES
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 28619 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ALKYL AMINE POLYALKOXYLATES 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 

Incidental oral short-term (1 

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

months) 

NOAEL= 15 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral (Gavage) Toxicity Study in Rats 

LOAEL = 30 mg/kg/day based on increased 

mortality (2 deaths (days 36, 78)), salivation, 

and posterior subcapsular cataracts in males 

as well as wheezing, and macro- and microscopic changes in the nonglandular stomach 

of both sexes. 

Dermal and Inhalation (all 

durations) 

Oral study NOAEL = 15 mg/ 

kg/day (dermal absorption 

rate = 5% (inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral (Gavage) Toxicity Study in Rats 

LOAEL = 30 mg/kg/day based on increased 

mortality (2 deaths (days 36, 78)), salivation, 

and posterior subcapsular cataracts in males 

as well as wheezing, and macro- and microscopic changes in the nonglandular stomach 

of both sexes. 

Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment; Based on SAR analysis, alkyl amine 

polyalkoxylates are not expected to be carcinogenic. 

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

(intraspecies). RfD = reference dose. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to alkyl amine 

polyalkoxylates, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from alkyl amine 

polyalkoxylates in food as follows: 

i. Acute and chronic exposure. In 

conducting the acute and chronic 

dietary exposure assessments, EPA used 

food consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, no residue data 

were submitted for the alkyl amine 

polyalkoxylates. In the absence of 

specific residue data, EPA has 

developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredients. 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 dietary exposure and 

risk assessment can be found at http:// 

www.regulations.gov in 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 assessment, the Agency 

assumed that the residue level of the 

inert ingredient would be no higher 

than the highest tolerance for a given 

commodity. Implicit in this assumption 

is that there would be similar rates of 

degradation (if any) between the active 

and inert ingredient and that the 

concentration of inert ingredient in the 

scenarios leading to these highest of 

tolerances would be no higher than the 

concentration of the active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products is generally at least 50 percent 

of the product and often can be much 

higher. Further, pesticide products 

rarely have a single inert ingredient; 

rather, there is generally a combination 

of different inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product relative to that of the 

active ingredient. In the case of alkyl 

amine polyalkoxylates, EPA made a 

specific adjustment to the dietary 

exposure assessment to account for the 

use limitations of the amount of alkyl 

amine polyalkoxylates that may be in 

formulations (no more than 25 percent 

in herbicides and no more than 10 

percent in fungicides and insecticides) 

and assumed the alkyl amine 

polyalkoxylates to be present at the 

maximum limitations rather than at 

equal quantities with the active 

ingredient. This remains a very 

conservative assumption because 

surfactants are generally used at levels 

far below 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 percent and that 

none of the surfactants were alkyl amine 

polyalkoxylates. 

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 sum, EPA chose a very conservative 

method for estimating what level of 

inert residue could be on food, then 

used this methodology to choose the 

highest possible residue that could be 

found on food and assumed that all food 

contained this residue. No consideration 


dwashington3 on PROD1PC60 with RULES
28620 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 

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. 

ii. Cancer. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts for potential carcinogenicity of 

both a representative alkyl amine 

polyalkoxylate, as well as a possible 

metabolite/degradate of alkyl amine 

polyalkoxylate that had been 

extensively dealkylated, with the amine 

group intact. No structural alerts for 

carcinogenicity were identified in either 

case. Alkyl amine polyalkoxylates are 

not expected to be carcinogenic. 

Therefore a cancer dietary exposure 

assessment is not necessary to assess 

cancer risk. 

iii. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for alkyl amine polyalkoxylates. 

Tolerance level residues and/or 100 

percent 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 alkyl amine polyalkoxylates in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of alkyl amine 

polyalkoxylates. 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 alkyl amine polyalkoxylates. 

Modeling runs on four surrogate inert 

ingredients using a range of physical 

chemical properties that would bracket 

those of the alkyl amine polyalkoxylates 

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 document Alkyl 

Amine Polyalkoxylates (JITF CST 4 Inert 

Ingredients), Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations, at 

pp 18 and 70–72 in docket ID number 

EPA–HQ–OPP–2008–0738. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for alkyl 

amine polyalkoxylates, a conservative 

drinking water concentration value of 

100 ppb based on screening level 

modeling was used to assess the 

contribution to drinking water for both 

the acute and chronic dietary risk 

assessments. These values were directly 

entered into the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). Alkyl 

amine polyalkoxylates are not used as 

inert ingredients in pesticide products 

that are registered for specific uses that 

could result in indoor residential 

exposures but may have uses as inert 

ingredients in pesticide products that 

may result in outdoor residential 

exposures. 

A screening level residential exposure 

and risk assessment was completed for 

products containing alkyl amine 

polyalkoxylates as inert ingredients. In 

this assessment, representative 

scenarios, based on end-use 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 

outdoor 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 alkyl amine polyalkoxylates. 

Similarly, residential postapplication 

dermal and oral exposure assessments 

were also performed utilizing high end 

outdoor exposure scenarios. Further 

details of this residential exposure and 

risk analysis can be found at http:// 

www.regulations.gov in document Alkyl 

Amine Polyalkoxylates (JITF CST 4 Inert 

Ingredients), Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations, at 

pp 22–26 and 74–80 in docket ID 

number EPA–HQ–OPP–2008–0738. 

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 alkyl amine 

polyalkoxylates to share a common 

mechanism of toxicity with any other 

substances, and alkyl amine 

polyalkoxylates do not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that alkyl amine 

polyalkoxylates 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. 

The toxicity database consists of a rat 

developmental toxicity study on an 

alkyl amine polyalkoxylate and a rat 

reproduction study on two different 

alkyl amine polyalkoxylates which 

covers the range of carbon chain lengths 

and polyalkoxylation within the group. 

No quantitative or qualitative increased 

susceptibility was demonstrated in the 

fetuses in the prenatal developmental 

toxicity study in rats following in utero 

exposure. There was some evidence of 

increased susceptibility in the rat 

reproductive toxicity study (where the 

offspring NOAEL of 300 ppm (12–14 


dwashington3 on PROD1PC60 with RULES
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 28621 

mg/kg/day) was lower than the parental 

NOAEL of 1,000 ppm (41–48.6 mg/kg/ 

day). There are no neurotoxicity studies 

available for the alkyl amine 

polyalkoxylates; however, there is no 

indication of neurotoxicity in the 

available toxicity studies. 

Based on the evidence of increased 

susceptibility in the offspring relative to 

the parents in the rat reproduction study 

a Degree of Concern analysis was 

performed. The purpose of the Degree of 

Concern analysis was (1) to determine 

the level of concern for the effects 

observed when considered in the 

context of all available toxicity data; and 

(2) identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment. 

There was no increased susceptibility 

to the offspring of rats following in utero 

exposure to alkyl amine polyalkoxylates 

in the prenatal development toxicity 

study. However, there was evidence of 

increased susceptibility in the 

reproduction toxicity studies in rats. 

Offspring effects include litter loss, 

increased mean number of 

unaccounted–for implantation sites and 

decreased mean number of pups born, 

live litter size and postnatal survival 

from birth to LD 4 (F1) at 1,000 ppm for 

one alkyl amine polyalkoxylate 

homologue (41–48.6 mg/kg/day) and at 

2,000 ppm (134–148 mg/kg/day) for a 

second homologue. However, the rat 

reproduction study identified a NOAEL 

of 300 ppm for both homologues (12–14 

mg/kg/day and 23–26 mg/kg/day, 

respectively) for offspring effects, and 

the selected point of departure for the 

dietary, dermal and inhalation risk 

assessments is protective of these 

offspring effects, thus there are no 

residual concerns. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for alkyl 

amine polyalkoxylates is considered 

adequate for assessing the risks to 

infants and children (the available 

studies are described in Unit IV.4.D.2. 

above). 

ii. There is no indication that alkyl 

amine polyalkoxylates are neurotoxic 

chemicals and thus there is no need for 

a developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that alkyl 

amine polyalkoxylates result in 

increased susceptibility in in utero rats 

in prenatal developmental studies. 

Increased susceptibility of young rats in 

the 2–generation reproduction study 

was seen, however the selected point of 

departure for the dietary, dermal and 

inhalation risk assessments is protective 

of these offspring effects, thus there are 

no residual concerns. 

iv. No chronic studies on alkyl amine 

polyalkoxylates are available, however, 

there is no need to add additional UFs 

to account for an incomplete toxicity 

database because the adverse effects 

observed in the available toxicity 

studies do not seem to increase in 

severity over time (4 weeks to 13 

weeks). Based on the lack of progression 

of severity of effects with time along 

with the considerable similarities of 

effects across the species tested and the 

observation that the vast majority of the 

effects observed are related to local 

irritation and corrosive effects, EPA 

concludes that an additional UF for 

extrapolation from subchronic toxicity 

study to a chronic exposure scenario is 

not needed. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The food and drinking water assessment 

is not likely to underestimate exposure 

to any subpopulation, including those 

comprised of infants and children. The 

food exposure assessments are 

considered to be highly conservative as 

they are based on the use of the highest 

tolerance level from the surrogate 

pesticides for every food and 100 

percent crop treated is assumed for all 

crops. EPA also made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to alkyl amine 

polyalkoxylates in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by alkyl amine 

polyalkoxylates. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

In conducting this aggregate risk 

assessment, the Agency has 

incorporated the petitioner’s requested 

use limitations of alkyl amine 

polyalkoxylates as inert ingredients in 

pesticide product formulations into its 

exposure assessment. Specifically the 

petition includes a use limitation of 

alkyl amine polyalkoxylates at not more 

than 10 percent by weight in fungicide 

and insecticide formulations and at no 

more than 25 percent in herbicide 

formulations. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, and the use limitations of not 

more than 10 percent by weight in 

fungicide and insecticide formulations 

and at no more than 25 percent in 

herbicide formulations, the acute 

dietary exposure from food and water to 

alkyl amine polyalkoxylates at the 95th 

percentile for food and drinking water is 

16 percent of the aPAD for the U.S. 

population and 44 percent of the aPAD 

for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking water 

Using the exposure assumptions 

discussed in this unit for chronic 

exposure, and the use limitations of not 

more than 10 percent by weight in 

fungicide and insecticide formulations 

and at no more than 25 percent in 

herbicide formulations, the chronic 

dietary exposure from food and water to 

alkyl amine polyalkoxylates is 27 

percent of the cPAD for the U.S. 

population and 85 percent of the cPAD 

for children 1 to 2 years old, the most 

highly exposed population subgroup. 

3. Short–term risk. Short–term 

aggregate exposure takes into account 

short–term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Alkyl amine polyalkoxylates are used 

as inert ingredients in pesticide 

products that are currently registered for 

uses that could result in short–term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short–term residential 

exposures to alkyl amine 

polyalkoxylates. 

Using the exposure assumptions 

described in this unit for short–term 


dwashington3 on PROD1PC60 with RULES
28622 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 

exposures, EPA has concluded the 

combined short–term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 156 and 172, for 

adult males and females respectively, 

for a combined high end dermal and 

inhalation handler exposure with a high 

end post application dermal exposure 

and an aggregate MOE of 90 for children 

for a combined turf dermal exposure 

with hand-to-mouth exposure. While 

the MOE for short-term aggregate 

exposure for children is slightly below 

100, EPA does not consider this MOE to 

represent a risk of concern for the 

following reasons. 

• The hazard assessment for the alkyl 

amine polyalkoxylates is conservative. 

The PODs used to calculate aggregate 

risks for alkyl amine polyalkoxylates 

were based on the most toxic surrogate 

chemical. The alkyl amine 

polyalkoxylates are actually a mixture of 

compounds, so it is likely that the POD 

is a conservative assessment of toxicity. 

• The Agency traditionally considers 

a level of concern (LOC) for these risk 

assessments to be for an MOE of 100 

based on the standard 10x inter- and 

10x intraspecies extrapolation safety 

factors. However, for alkyl amine 

polyalkoxylates, the primary toxic effect 

seen is related to the surfactants’ 

inherent function to disrupt cell 

membranes resulting in irritating 

properties to tissues. Given that a 

significant difference between species 

for this type of effect is not expected, an 

LOC lower than an MOE of 100 may be 

appropriate for the non-dietary risk 

assessments. 

• The dietary (food and water) portion 

of the aggregate risk assessment is a 

driver in this aggregate assessment and 

is considered to be highly conservative. 

• The highest tolerance level from the 

surrogate pesticides for every food is 

used adjusted by the limitation in 

formulation for alkyl amine 

polyalkoxylates specified in the 

exemption. Estimating alkyl amine 

polyalkoxylates exposure based on the 

assumption that alkyl amine 

polyalkoxylates will be present at the 

maximum permitted amount in the 

pesticide products producing the 

highest possible residue in food is very 

conservative. 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 contained between 1 and 2.25 

percent surfactant, none of which was 

alkyl amine polyalkoxylates. 

•100 percent crop treated is assumed 

for all crops (every food eaten by a 

person each day has tolerance-level 

residues). 

•Many of these high tolerances are 

based on very short pre-harvest intervals 

where there is little time for 

degradation. 

•No consideration was given to 

potential degradation between harvest 

and consumption (use of tolerance level 

residues which are typically one to two 

orders of magnitude higher than actual 

residues found in monitoring data). 

•No consideration was given to 

potential reduction in residues from 

washing or cooking. 

• The residential portion of the 

assessment is based on high-end 

application rates and assumes a dermal 

absorption of 5 percent which is a 

conservative, health protective value. 

• Finally, the aggregate assessment 

assumes that a child would receive a 

high-end dietary exposure with highend dermal and hand-to-mouth 

exposures concurrently. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Alkyl amine polyalkoxylates are used 

as inert ingredients in pesticide 

products that are currently registered for 

uses that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to alkyl amine polyalkoxylates. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 156 and 172, for 

adult males and females respectively, 

for a combined high end dermal and 

inhalation handler exposure with a high 

end post application dermal exposure 

and an MOE of 102 for children for a 

combined high end dermal exposure 

with hand-to-mouth exposure. 

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 residues of 

alkyl amine polyalkoxylates. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for alkyl 

amine polyalkoxylates nor have any 

CODEX Maximum Residue Levels been 

established for any food crops at this 

time. 

V. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of alkyl amine 

polyalkoxylates when used as an inert 

ingredient in pesticide formulations 

applied to growing crops or to animals. 

VI. 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 


dwashington3 on PROD1PC60 with RULES
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 28623 

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). 

VII. 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: June 2, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.920, the table is amended 

by adding alphabetically the new inert 

ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

*******

N,N-Bis-a-ethyl-w-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the poly(oxy-1,2- 

ethanediyl) content is 2–60 moles (CAS Reg. Nos. 10213– 

78–2, 25307–17–9, 26635–92–7, 26635–93–8, 288259–52– 

9, 58253–49–9, 61790–82–7, 61791–14–8, 61791–24–0, 

61791–26–2, 61791–31–9, 61791–44–4, 68155–33–9, 

68155–39–5, 68155–40–8,70955–14–5, 73246–96–5) 

Not to exceed 25% in herbicide formulations and 10% in insecticide and 

fungicide formulations 

Surfactants, related adjuvants of 

surfactants 

*******

N,N–Bis-a-ethyl-w-hydroxypoly(oxy-1,2-ethanediyl/oxy(methyl1,2-ethanediyl) C8-C18 saturated and unsaturated 

alkylamines; the poly(oxy-1,2-ethanediyl/oxy(methyl-1,2- 

ethanediyl) content is 2–60 moles (CAS Reg. Nos. 68213– 

26–3, 68153–97–9, 75601–76–2) 

Not to exceed 25% in herbicide formulations and 10% in insecticide and 

fungicide formulations 

Surfactants, related adjuvants of 

surfactants 

*******

■ 3. In § 180.930, the table is amended 

by adding alphabetically new entries 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 

*******

N,N-Bis-a-ethyl-w-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the poly(oxy-1,2- 

ethanediyl) content is 2–60 moles (CAS Reg. Nos. 10213– 

78–2, 25307–17–9, 26635–92–7, 26635–93–8, 288259–52– 

9, 58253–49–9, 61790–82–7, 61791–14–8, 61791–24–0, 

61791–26–2, 61791–31–9, 61791–44–4, 68155–33–9, 

68155–39–5, 68155–40–8,70955–14–5, 73246–96–5) 

Not to exceed 25% in herbicide formulations and 10% in insecticide and 

fungicide formulations 

Surfactants, related adjuvants of 

surfactants 

*******

N,N-Bis-a-ethyl-w-hydroxypoly(oxy-1,2-ethanediyl/oxy(methyl1,2-ethanediyl) C8-C18 saturated and unsaturated 

alkylamines; the poly(oxy-1,2-ethanediyl/oxy(methyl-1,2- 

ethanediyl) content is 2–60 moles (CAS Reg. Nos. 68213– 

26–3, 68153–97–9, 75601–76–2) 

Not to exceed 25% in herbicide formulations and 10% in insecticide and 

fungicide formulations 

Surfactants, related adjuvants of 

surfactants 

*******


dwashington3 on PROD1PC60 with RULES
28624 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Rules and Regulations 

[FR Doc. E9–14113 Filed 6–16–09; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2008–0020; Internal 

Agency Docket No. FEMA–8079] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP), that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Mitigation Directorate, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

flood insurance which is generally not 

otherwise available. In return, 

communities agree to adopt and 

administer local floodplain management 

aimed at protecting lives and new 

construction from future flooding. 

Section 1315 of the National Flood 

Insurance Act of 1968, as amended, 42 

U.S.C. 4022, prohibits flood insurance 

coverage as authorized under the NFIP, 

42 U.S.C. 4001 et seq.; unless an 

appropriate public body adopts 

adequate floodplain management 

measures with effective enforcement 

measures. The communities listed in 

this document no longer meet that 

statutory requirement for compliance 

with program regulations, 44 CFR part 

59. Accordingly, the communities will 

be suspended on the effective date in 

the third column. As of that date, flood 

insurance will no longer be available in 

the community. However, some of these 

communities may adopt and submit the 

required documentation of legally 

enforceable floodplain management 

measures after this rule is published but 

prior to the actual suspension date. 

These communities will not be 

suspended and will continue their 

eligibility for the sale of insurance. A 

notice withdrawing the suspension of 

the communities will be published in 

the Federal Register. 

In addition, FEMA has identified the 

Special Flood Hazard Areas (SFHAs) in 

these communities by publishing a 

Flood Insurance Rate Map (FIRM). The 

date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may legally be provided for 

construction or acquisition of buildings 

in identified SFHAs for communities 

not participating in the NFIP and 

identified for more than a year, on 

FEMA’s initial flood insurance map of 

the community as having flood-prone 

areas (section 202(a) of the Flood 

Disaster Protection Act of 1973, 42 

U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment under 5 U.S.C. 553(b) 

are impracticable and unnecessary 

because communities listed in this final 

rule have been adequately notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

stating that the community will be 

suspended unless the required 

floodplain management measures are 

met prior to the effective suspension 

date. Since these notifications were 

made, this final rule may take effect 

within less than 30 days. 

National Environmental Policy Act. 

This rule is categorically excluded from 

the requirements of 44 CFR part 10, 

Environmental Considerations. No 

environmental impact assessment has 

been prepared. 

Regulatory Flexibility Act. The 

Administrator has determined that this 

rule is exempt from the requirements of 

the Regulatory Flexibility Act because 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits flood insurance coverage 

unless an appropriate public body 

adopts adequate floodplain management 

measures with effective enforcement 

measures. The communities listed no 

longer comply with the statutory 

requirements, and after the effective 

date, flood insurance will no longer be 

available in the communities unless 

remedial action takes place. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 

1993, Regulatory Planning and Review, 

58 FR 51735. 

Executive Order 13132, Federalism. 

This rule involves no policies that have 

federalism implications under Executive 

Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This rule meets the applicable 

standards of Executive Order 12988. 

Paperwork Reduction Act. This rule 

does not involve any collection of 

information for purposes of the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. 

List of Subjects in 44 CFR Part 64 

Flood insurance, Floodplains. 

■ Accordingly, 44 CFR part 64 is 

amended as follows: 

PART 64—[AMENDED] 

■ 1. The authority citation for part 64 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp.; p. 376. 

§ 64.6 [Amended] 

■ 2. The tables published under the 

authority of § 64.6 are amended as 

follows: 


dwashington3 on PROD1PC60 with RULES