37578 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

Inert ingredients Limits Uses 

* * * * * 

a-Alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-whydroxypolyoxyethylene polymer with or without polyoxypropylene, mixture of di- and 

monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; 

minimum oxyethylene content is 2 moles; minimum oxypropylene content is 0 moles 

(CAS Reg. Nos. 9046–01–9, 37280–82–3, 39464–66–9, 42612–52–2, 50643–20–4, 

52019–36–0, 58318–92–6, 60267–55–2, 61837–79–4, 67711–84–6, 68070–99–5, 

68071–35–2, 68071–17–0, 68130–47–2, 68186–37–8, 68186–36–7, 68311–02–4, 

68425–73–0, 68458–48–0, 68511–37–5, 68610–65–1, 68585–36–4, 68649–29–6, 

68815–11–2, 68908–64–5, 68891–13–4, 73038–25–2, 78330–24–2, 108818–88–8, 

154518–39–5, 317833–96–8, 873662–29–4, 936100–29–7, 936100–30–0).

Not to exceed 30% of 

pesticide formulation.

Surfactants, related adjuvants of surfactants 

* * * * * 

■ 4. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

a-Alkyl(C6-C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4 

moles (CAS Reg. Nos. 3088–31–1, 9004–82–4, 9004–84–6, 13150–00–0, 25446– 

78–0, 26183–44–8, 32612–48–9, 50602–06–7, 62755–21–9, 68424–50–0, 68511– 

39–7, 68585–34–2, 68611–55–2, 68891–38–3, 73665–22–2).

Not to exceed 30% of 

pesticide formulation.

Surfactants, related adjuvants of surfactants 

* * * * * 

[FR Doc. E9–18033 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0046; FRL–8428–9] 

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 inert 

ingredients for pre-harvest uses under 

40 CFR 180.920 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 (CST 25), 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 NAPAAS. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–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: 

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). 

• 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 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37579 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the Federal Register listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gov/ 

opptsfrs/home/guidelin.htm. 

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–2009–0046 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 September 28, 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–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. Background 

In the Federal Register of March 4, 

2009 (74 FR 9397) (FRL–8401–8), 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 9E7519) by The 

Joint Inerts Task Force (JITF), Cluster 

Support Team 25 (CST 25), c/o CropLife 

America, 1156 15th Street, N.W., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.920 

be amended by establishing exemptions 

from the requirement of a tolerance for 

residues of the inert ingredients N-alkyl 

(C8-C18) primary amines and acetate 

salts where the alkyl group is linear and 

may be saturated and/or unsaturated 

(NAPAAS). Concentration in formulated 

end-use products not to exceed 8% by 

weight in herbicide products, 5% by 

weight in insecticide products, and 30% 

by weight in fungicide products. That 

notice referenced a summary of the 

petition prepared by JITF, CST 25, 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. 

Based upon review of the data 

supporting the petition, EPA has 

modified the exemption requested by 

changing the use limitations in pesticide 

products as follows: 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. These limitations 

are based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov, in 

document N-alkyl (C8-C18) Primary 

Amines and Acetate Salts (NAPAAS - 

JITF CST 25 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations, in docket ID number 

EPA–HQ–OPP–2009–0046. 

This petition was submitted in 

response to a final rule of August 9, 

2006 (71 FR 45415) (FRL–8084–1) in 

which the Agency revoked, under 

section 408(e)(1) of the 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 45311) (FRL– 

8372–7) 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....’’ 


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EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

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 NAPAAS 

provided that the concentration of the 

NAPAAS inerts are limited in 

formulated end-use product to no more 

than 10% by weight in herbicide 

products, 4% by weight in insecticide 

products, and 4% by weight in 

fungicide products. 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. 

The available mammalian toxicology 

database for NAPAAS consists of one 

OPPTS Harmonized 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. 

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 NAPAAS inert compounds. In the 

OPPTS Harmonized 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 the 

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-C18 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 

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 no observed adverse effect level 

(NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document Nalkyl (C8-C18) Primary Amines and 

Acetate Salts (NAPAAS - JITF CST 25 

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. 8–12 and pp. 19–22 in docket ID 

number EPA–HQ–OPP–2009–0046. 

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 the NAPAAS used for 

human health risk assessment is shown 

in Table 1. below: 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THE NAPAAS FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and uncertainty/safety factors1

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (all populations) No appropriate endpoint was identified for acute dietary assessment 

Chronic dietary (all populations) NOAEL= 5 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 mg/kg/ 

day 

cPAD = 0.05 mg/kg/day 

OPPTS harmonized guideline 870.3650 reproduction/developmental screen in rats 

LOAEL = 20 mg/kg/day, based on microscopic 

lesions in the stomach, jejunum, thymus, and 

lymph nodes in both sexes 

Incidental oral short- (1–30 

days) and intermediate term 

(1–6 months) 

Oral NOAEL= 5 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 5% dermal 

and 100% inhalation absorption assumed 

Residential LOC for MOE = 

100 

OPPTS harmonized guideline 870.3650 reproduction/developmental screen in rats 

LOAEL = 20 mg/kg/day, based on microscopic 

lesions in the stomach, jejunum, thymus, and 

lymph nodes in both sexes 

Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment. Based on SAR analysis, the NAPAAS 

are not expected to be carcinogenic 

1Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a = acute, c = chronic). FQPA SF = FQPA safety factor. RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the NAPAAS, EPA 

considered exposure under the 

petitioned-for 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 concentrations 

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 (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. The Agency does not expect 

that allowing a maximum of 10% in the 

final formulation for herbicides only 

will have a significant impact on the 

dietary exposure. Across the board it 

appears that selecting the highest 

fungicide tolerance and correcting for its 

limitation to 4% by weight as a 

maximum in the final formulation, 

results in a higher residue input into the 

dietary risk assessment than selecting 

the highest herbicide tolerance and 

correcting for 10% by weight as a 

maximum in the final formulation. 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 


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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 

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 SAR database, DEREK11, 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% crop treated 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 NAPAAS in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of NAPAAS. 

Further information regarding EPA 

drinking water models used in the 

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 NAPAAS. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of the NAPAAS 

were conducted. Modeled acute 

drinking water values ranged from 0.001 

parts per billion (ppb) to 41 ppb. 

Modeled chronic drinking water values 

ranged from 0.0002 ppb to 19 ppb. 

Further details of this drinking water 

analysis can be found at http:// 

www.regulations.gov in the document 

N-alkyl (C8-C18) Primary Amines and 

Acetate Salts (NAPAAS - JITF CST 25 

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. 13 and 25–27 in docket ID number 

EPA–HQ–OPP–2009–0046. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for the 

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 compounds and 

for the metabolites of concern. 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). 

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 

necessary 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 do 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

NAPAAS do not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the case of the NAPAAS, there was 

no increased susceptibility to the 

offspring of rats following prenatal and 

post-natal exposure in the OPPTS 

Harmonized Guideline 870.3650 

reproductive/developmental screening 

study. Decreased pup body weight was 

observed at 40 and 80 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 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37583 

the NAPAAS consists of one OPPTS 

Harmonized 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. No quantitative or qualitative 

increased susceptibility was 

demonstrated in the offspring in the 

OPPTS Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats following 

prenatal and postnatal exposure. 

iii. Although the available 

mammalian toxicity database does not 

include any chronic toxicity data, the 

effects observed in the parental animals 

following gavage dosing are mainly 

portal-of-entry effects (stomach 

irritation), and gavage dosing is not a 

relevant exposure condition in humans. 

The effects observed would not be 

expected to occur at a lower dose with 

increased duration of exposure under 

relevant exposure conditions. Also, 

based on the very conservative exposure 

assessment, the 10X interspecies and 

10X intraspecies uncertainty factor 

would be adequately protective, and no 

additional uncertainty factor is needed 

for extrapolating from subchronic to 

chronic exposure. 

iv. No neurotoxicity was 

demonstrated in the OPPTS 

Harmonized Guideline 870.3650 study. 

Thus, there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

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% 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 NAPAAS in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by NAPASS. 

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. No residential aggregate 

exposure assessment was conducted 

because no residential uses for NAPAAS 

are anticipated. Therefore, the aggregate 

risk for these inerts includes exposures 

through food and drinking water only. 

1. Acute risk. There was no hazard 

attributable to a single exposure seen in 

the toxicity database for NAPAAS. 

Therefore, the NAPAAS are not 

expected to pose an acute risk. 

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 to no 

more than 4% in fungicide and 

insecticide formulations and 10% in 

herbicide formulations, the chronic 

dietary exposure from food and water to 

NAPAAS is 36% of the cPAD for the 

U.S. population and 106% of the cPAD 

for children 1–2 yrs old, the most highly 

exposed population subgroup. While 

the Agency notes that the risk for 

children is slightly above a cPAD of 

100%, given the exceptionally 

conservative nature of the exposure 

assessment detailed above, the Agency 

believes that actual risks are 

significantly lower and are not of 

concern. 

3. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to NAPAAS. 

4. 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 

NAPAAS. 

V. 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 

NAPAAS nor have any CODEX 

maximum residue levels been 

established for any food crops at this 

time. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

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 when used as inert 

ingredients for pre-harvest uses under 

40 CFR 180.920 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 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, 


sroberts on DSKD5P82C1PROD with RULES
37584 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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: July 21, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR part 180 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 following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions 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. E9–18076 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0098; FRL–8425–5] 

Sodium Salts of N-alkyl (C8-C18)-betaiminodipropionic acid; 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 sodium salts of 

N-alkyl (C8-C18)-beta-iminodipropionic 

acid where the C8-C18 is linear and may 

be saturated and/or unsaturated, herein 

referred to in this document as SSNAs 

when used as an inert ingredient for 

pre-harvest uses under 40 CFR 180.920 

at a maximum of 30% by weight in 

pesticide formulations. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 14, 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 SSNAs. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–2009–0098. 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. 


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