Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50891 

* * * * * 

[FR Doc. 2010–20299 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0046; FRL–8836–4] 

N-alkyl (C8-C18) Primary Amines and 

Acetate Salts; 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 N-alkyl (C8- 

C18) primary amines and acetate salts 

where the alkyl group is linear and may 

be saturated and/or unsaturated, herein 

referred to in this document as 

NAPAAS, when used as a surfactant 

and related adjuvants of surfactants for 

pre-harvest and post-harvest uses under 

40 CFR 180.910 and application to 

animals under 40 CFR 180.930 at a 

maximum concentration in formulated 

end-use products of 10% by weight in 

herbicide products, 4% by weight in 

insecticide products, and 4% by weight 

in fungicide products. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 25 submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of NAPAAS. 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 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–2009–0046. 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

Harmonized Test Guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/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–2009–0046 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 October 18, 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–2009–0046, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Exemption 

In the Federal Register of February 4, 

2010, (75 FR 5793) (FRL–8807–5), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

9E7627) by The JITF, Cluster Support 

Team 25 (CST 25), c/o CropLife 


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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 an exemption from the 

requirement of a tolerance for residues 

of NAPAAS when used as at surfactant 

and related adjuvants of surfactants in 

pesticide formulations applied to preharvest and post-harvest crops and 

animals. These uses are considered inert 

ingredients in pesticide products. The 

concentration in formulated end-use 

products not to exceed 10% by weight 

in herbicide products, 4% by weight in 

other pesticidal products. That notice 

referenced a summary of the petition 

prepared by the JITF, Cluster Support 

Team Number 25 (CST 25), the 

petitioner, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for NAPAAS 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with NAPAAS follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by NAPAAS as well as the NOAEL and 

the LOAEL from the toxicity studies are 

discussed in this unit. 

The available mammalian toxicology 

database for NAPAAS consists of one 

Harmonized Test Guideline 870.3650 

(combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats); acute 

oral, dermal, and eye toxicity data; and 

in vitro mutagenicity data. 

The NAPAAS are not acutely toxic by 

the oral route of exposure but are 

corrosive to the skin and are severe eye 

irritants. There is no clear target organ 

identified for the NAPAAS. In the 

Harmonized Test Guideline 870.3650 

study on the representative surfactant, 

treatment-related microscopic lesions 

were observed in both sexes, which 

included histomorphologic changes in 

the stomach (hyperplasia and 

hyperkeratosis of the squamous mucosa 

of the forestomach), and erosions, 

ulcers, inflammatory cell infiltrations, 

and/or edema in the submucosa of the 

forestomach and glandular areas of the 

mucosa. The accumulation of 

macrophages was most prevalent in the 

mesenteric lymph nodes and small 

intestine where they were large with an 

abundant amount of pale foamy 

cytoplasm. In the mesenteric lymph 

node and liver, coalescence of the large 

macrophages occurred forming 

microgranulomas. Thymic atrophy was 

observed in both sexes. Histologically, 

the thymus was smaller due to a 

decrease in the amount of cortical 

lymphocytes, which may be an indirect 

or secondary phenomenon, as thymic 

atrophy often occurs in animals under 

stress. No evidence of potential 

neurotoxicity was observed in females, 

and the reduced motor activity observed 

in the high-dose males was considered 

to be secondary to the gastrointestinal 

irritation and general malaise and not a 

neurotoxic effect. 

There was no evidence of increased 

susceptibility to the offspring following 

prenatal and postnatal (four days) 

exposure and reproductive toxicity was 

not observed. There is no evidence of 

mutagenicity or carcinogenicity. 

Primary amines and primary amine 

acetates are biologically equivalent and 

follow the same metabolic pathways of 

oxidation by monoamine oxidases to 

generate the C8–C10 fatty acid and 

ammonia. The fatty acid would be 

degraded by well-known pathways (boxidation) to successive releases of 

acetic acid, which enters into 

intermediary metabolism or is 

metabolized ultimately to carbon 

dioxide and water. The CST 25 

NAPAAS primary amines and primary 

amine acetate salt may also be 

conjugated, whether by glucuronidation 

or sulfonation, and excreted directly. 

There are no chronic toxicity studies 

available for this series of surfactants. 

The Agency used a qualitative structure 

activity relationship (SAR) database, 

DEREK 11, to determine if there were 

structural alerts suggestive of 


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carcinogenicity. No structural alerts 

were identified. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by the NAPAAS, as well 

as, the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘N-Alkyl (C8–C18) Primary Amines and 

Acetate Salts (NAPAAS - JITF CST 25 

Inert Ingredients). Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,’’ 

pp. 8-12 and 19-22 in docket ID number 

EPA–HQ–OPP–2009–0046. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level – generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD); and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for NAPAAS used for human 

risk assessment is discussed in Unit 

IV.A of the final rule published in the 

Federal Register of July 29, 2009, (74 FR 

37578) (FRL–8428–9). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to NAPAAS, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

NAPAAS in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of the 

NAPAAS inerts were seen in the 

toxicity databases; therefore, an acute 

exposure assessment for the NAPAAS is 

not necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, no residue data 

were submitted for the NAPAAS. In the 

absence of specific residue data, EPA 

has developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts.’’ 

(D361707, S. Piper, 2/25/09) and can be 

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

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentration of 

active ingredient in agricultural 

products is generally at least 50% of the 

product and often can be much higher. 

Further, pesticide products rarely have 

a single inert ingredient; rather there is 

generally a combination of different 

inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. In the case of 

NAPAAS, EPA made a specific 

adjustment to the dietary exposure 

assessment to account for the use 

limitations of the amount of NAPAAS 

that may be in formulations (to no more 

than 10% by weight in herbicide 

products, 4% by weight in insecticide 

products, and 4% by weight in 

fungicide products) and assumed that 

the NAPAAS are present 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 this percentage. 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 

NAPAAS. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100% of all foods 

are treated with the inert ingredient at 

the rate and manner necessary to 

produce the highest residue legally 

possible for an active ingredient. In 

summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 


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assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK 11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. The Agency has not 

identified any concerns for 

carcinogenicity relating to the inerts 

NAPAAS. 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 NAPAAS. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for NAPAAS, 

a conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for the chronic dietary risk 

assessments for parent compound. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

The Agency has reviewed the 

submitted petition as well as all 

available data on the use of these inert 

ingredients in pesticide formulations, 

and concludes that the NAPAAS inerts 

are not used in formulations that would 

be applied in and around the home or 

in a way that would result in residential 

exposures; therefore, a residential 

exposure risk assessment is not required 

for the NAPAAS inerts. 

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 NAPAAS to share 

a common mechanism of toxicity with 

any other substances, and NAPAAS 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that NAPAAS does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

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 the NAPAAS, there was 

no increased susceptibility to the 

offspring of rats following prenatal and 

postnatal exposure in the Harmonized 

Test Guideline 870.3650 reproductive/ 

developmental screening study. 

Decreased pup body weight was 

observed at 40 and 80 milligrams/ 

kilogram/day (mg/kg/day) where 

maternal/paternal toxicity was 

manifested as microscopic lesions in the 

stomach, jejunum, thymus, and lymph 

nodes at 20, 40, and 80 mg/kg/day. 

Since the rat reproduction/ 

developmental study identified a clear 

NOAEL of 20 mg/kg/day for offspring 

effects, and the selected point of 

departure of 5 mg/kg/day (parental 

NOAEL for stomach/jejunum/thymus/ 

lymph node lesions) for the dietary risk 

assessment is protective of the offspring 

effects, 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 the 

NAPAAS inerts is considered adequate 

for assessing the risks to infants and 

children. The toxicity data available on 

the NAPAAS consists of one 

Harmonized Test Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/development 

toxicity screening test (rat); acute oral, 

dermal, and eye toxicity data; and in 

vitro mutagenicity data. The Agency 

noted changes in thymus weight and 

thymus atrophy. However, these were 

determined to be non-specific changes 

not indicative of immunotoxicity. In 

addition, no blood parameters were 

affected. Furthermore, these compounds 

do not belong to a class of chemicals 

that would be expected to be 

immunotoxic. Therefore, these 

identified effects do not raise a concern 

necessitating an additional uncertainty. 

ii. There is no indication that 

NAPAAS is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

NAPAAS results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

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 PCT 

is assumed for all crops. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

NAPAAS 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 NAPAAS. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. 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-term, 

intermediate-term, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 


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a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, NAPAAS is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to NAPAAS from 

food and water will utilize 106% of the 

cPAD for children 1-2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for NAPAAS. 

3. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to NAPAAS. 

4. Determination of safety. EPA notes 

that the risk for children is slightly 

above a cPAD of 100%. The dietary 

exposure estimates overstate dietary risk 

because it assumes that the NAPAAS 

are present at the maximum limitation 

(10% by weight in herbicide products, 

4% by weight in insecticide products, 

and 4% by weight in fungicide 

products) because surfactants are 

generally used at levels far below these 

percentages. EPA examined several of 

the pesticide products associated with 

the tolerance/commodity combinations 

which are the drivers 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 NAPAAS. 

Therefore, given the exceptionally 

conservative nature of the exposure 

assessment, EPA believes that actual 

risks are significantly lower and are not 

of concern. Based on this risk 

assessment, 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 NAPAAS residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

EPA is establishing a limitation on the 

amount of NAPAAS that may be used in 

end-use pesticide formulations. That 

limitation will be enforced through the 

pesticide registration process under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), 7 U.S.C. 136 

et seq. EPA will not register any 

pesticide for sale or distribution that 

contains a maximum concentration in 

formulated end-use products of 

NAPAAS greater than 10% by weight in 

herbicide products, 4% by weight in 

insecticide products, and 4% by weight 

in fungicide products. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for 

NAPAAS nor have any CODEX 

Maximum Residue Levels (MRLs) been 

established for any food crops at this 

time. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and 40 CFR 

180.930 for N-alkyl (C8-C18) primary 

amines and acetate salts where the alkyl 

group is linear and may be saturated 

and/or unsaturated when used as an 

inert ingredient (surfactant and related 

adjuvants of surfactants) in pesticide 

formulations applied to pre-harvest and 

post-harvest crops and animals at a 

maximum concentration in formulated 

end-use products of 10% by weight in 

herbicide products, 4% by weight in 

insecticide products, and 4% by weight 

in fungicide products. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

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: August 9, 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: 


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50896 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

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

■ 2. In §180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 N-alkyl (C8-C18) primary amines 

and accetate salts; Exemption from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

N-alkyl (C8-C18) primary amines and their acetate salts 

where the alkyl group is linear and may be saturated 

and/or unsaturated (CAS Reg. Nos. 61790-57-6, 

61790-58-7, 61790-59-8, 61790-60-1, 61788-46-3, 

61790-33-8, 68155-38-4) 

Concentration in formulated enduse products not to exceed 10% 

by weight in herbicide products, 

4% by weight in insecticide 

products, and 4% by weight in 

fungicide products. 

Surfactants, related adjuvants of surfactants 

*******

■ 3. In §180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 N-alkyl (C8-C18) primary amines 

and accetate salts; Exemption from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

N-alkyl (C8-C18) primary amines and their acetate salts 

where the alkyl group is linear and may be saturated 

and/or unsaturated (CAS Reg. Nos. 61790-57-6, 

61790-58-7, 61790-59-8, 61790-60-1, 61788-46-3, 

61790-33-8, 68155-38-4) 

Concentration in formulated enduse products not to exceed 10% 

by weight in herbicide products, 

4% by weight in insecticide 

products, and 4% by weight in 

fungicide products. 

Surfactants, related adjuvants of surfactants 

*******

[FR Doc. 2010–20300 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0474; FRL–8838–9] 

Diethylene Glycol (DEG); 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 diethylene 

glycol (DEG) (CAS No. 111–46–6) when 

used as an inert ingredient as a solvent, 

stabilizer and/or antifreeze within 

pesticide formulations without 

limitation, under 40 CFR 180.920, for 

use on growing crops and raw 

agricultural commodities pre-harvest 

Huntsman, Dow AgroSciences L.L.C., 

Nufarm Americas Inc., BASF, Stepan 

Company, Loveland Products Inc., and 

Rhodia Inc. submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of DEG. 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 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–2008–0474. 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@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 


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