Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6335 

(2) Section IV.B.2, Application for a 

Construction Permit, and Section 

IV.H.8, Application for a Final Permit, 

regarding operating and maintenance 

plans and recordkeeping formats. 

[FR Doc. 2011–2508 Filed 2–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0098; FRL–8861–9] 

Sodium and Potassium Salts of N-alkyl 

(C8–C18)-beta-iminodipropionic 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 and 

potassium salts of N-alkyl (C8–C18)-betaiminodipropionic acid where the C8–C18

is linear and may be saturated and/or 

unsaturated, (CAS Reg. Nos. 110676– 

19–2, 3655–00–3, 61791–56–8, 14960– 

06–6, 26256–79–1, 90170–43–7, 91696– 

17–2, and 97862–48–1), herein referred 

to in this document as SSNAs, when 

used as inert ingredients for pre- and 

post-harvest uses and for application to 

animals 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 the establishment of 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 

February 4, 2011. Objections and 

requests for hearings must be received 

on or before April 5, 2011, 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: 

Karen Samek, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8825; e-mail address: 

samek.karen@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 site at http:// 

www.gpoaccess.gov/ecfr. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2009–0098 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 April 5, 2011. 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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0098, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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 March 19, 

2010 (75 FR 132771) (FRL–8813–2), 

EPA issued a notice pursuant to section 

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

announcing the filing of a pesticide 

petition (PP 9E7631) by The Joint Inerts 

Task Force, Cluster Support Team 14 

(CST 14), c/o CropLife America, 1156 

15th Street, NW., Suite 400, 

Washington, DC 20005. The petition 

requested that 40 CFR 180.910 and 40 


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6336 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

CFR 180.930 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of the SSNAs (CAS Reg. Nos. 110676– 

19–2, 3655–00–3, 61791–56–8, 14960– 

06–6, 26256–79–1, 90170–43–7, 91696– 

17–2, and 97862–48–1) when used as 

inert ingredients as a surfactant in 

pesticide formulations applied to crops 

pre- and post-harvest, as well as to 

animals at a maximum of 30% by 

weight in pesticide formulations. That 

notice referenced a summary of the 

petition prepared by the Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 14 (CST 14), the petitioner, 

which is available in the docket, 

http://www.regulations.gov. Two 

comments were received in response to 

the Notice of Filing. One of the 

comments was received from a private 

citizen who opposed the authorization 

to sell any pesticide that leaves a 

residue on food. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that no residue of pesticides 

should be allowed. However, under the 

existing legal framework provided by 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA) EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. A second comment was 

received regarding endocrine effects 

from soybeans. Since the subject of this 

tolerance exemption request is not 

soybeans, this comment is not relevant 

to this action. 

EPA previously published a final rule 

to establish a tolerance exemption for 

sodium salts of SSNA (CAS Reg. Nos. 

3655–00–3, 61791–56–8, 14960–06–6, 

26256–79–1, 90170–43–7, 91696–17–2, 

and 97862–48–1) under 40 CFR 180.920 

in the Federal Register of July 29, 2009 

(74 FR 37584) (FRL–8425–5). That final 

rule established a tolerance exemption 

for sodium salts of SSNA when used as 

inert ingredients in pesticide 

formulations applied to growing crops 

only. 

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 the SSNAs 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with the SSNAs 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 the SSNAs, as well as, 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Sodium Salts of N-Alkyl (C8–C18)-biminodipropionic Acid (SSNAs—JITF 

CST 14 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations,’’ pages 8–13 and pages 

46–49 in docket ID number EPA–HQ– 

OPP–2009–0098. In this human health 

risk assessment an exemption from the 

requirement of a tolerance was assessed 

for an exemption under 40 CFR 180.920 

for pre-harvest use of sodium salts of 

SSNA where the C8-C18 is linear and 

may be saturated and/or unsaturated 

provided that the concentration of the 

SSNA inert is limited to no more than 

30% by weight in pesticide 

formulations. It was noted in the 

document that this risk assessment also 

supports the use of the SSNA inert 

ingredients in pesticide formulations 

intended for use post-harvest as well. 

Because it is likely that the sodium or 

potassium salts of SSNA readily 

disassociate in the body to the salt and 

the active moiety and that the toxicity 

of the chemical is associated with the 

active moiety, the Agency concludes 

that its risk assessment is sufficient to 

support both the sodium and potassium 

salts of SSNA. The Agency also 

concludes that the risk assessment 

supports the application of these 

chemicals to animals under 40 CFR 

180.930 with the limitation of no more 

than 30% in pesticide formulations. 

The available toxicity data indicate 

that the SSNAs have low acute oral and 

dermal toxicity, are potentially 


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Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6337 

corrosive to the skin, but are also mild 

to moderate eye irritants. In the OPPTS 

Harmonized Guideline 870.3650 study 

with sodium coco b-iminodipropionate 

in rats, decreased food consumption and 

body weight gain in males and females 

at 160 and 600 mg/kg bw/day were 

observed. Mean liver and kidney 

weights were increased at the high dose, 

while testis and epididymides were 

unaffected. Hypertrophy was found in 

the livers of males and/or females at the 

mid- and high-doses as well as renal 

histopathology in males, acanthosis of 

the non-glandular stomach in males and 

females, and inflammation of the 

glandular and non-glandular stomach in 

females. In the absence of any evidence 

of hepatic toxicity, liver hypertrophy 

was considered an adaptive effect and 

non-adverse. 

No reproduction or developmental 

effects were noted in the database and 

there was no evidence of neurotoxicity. 

In general, surfactants are surfaceactive materials that can damage the 

structural integrity of cellular 

membranes at high dose levels. Thus, 

surfactants are often corrosive and 

irritating in concentrated solutions. It is 

possible that some of the observed 

toxicity seen in the repeated studies, 

such as inflammation of the glandular 

stomach, can be attributed to the 

corrosive and irritating nature of these 

surfactants. 

There are no published metabolism 

studies for this series of surfactants. The 

SSNA mammalian metabolism pathway 

is based on analogy to well-described 

pathways for tertiary amines and fatty 

acids. Overall it is anticipated that the 

various metabolites are not systemically 

toxic and would be rapidly conjugated 

and excreted. 

The SSNA surfactants (mono and disodium propionates) may be conjugated 

and excreted directly. Alternatively, the 

tertiary amine dipropionate may be 

oxidized in the liver by monoamine 

oxidases to generate the intact tertiary 

amine dipropionate N-oxide which may 

either be conjugated and excreted or 

metabolically cleaved to a dipropionate 

oxime type metabolite that is conjugated 

and excreted. The linear fatty acid is 

metabolized via successive betaoxidation cycles to release acetic acid 

and eventually carbon dioxide and 

water. 

There are no chronic toxicity studies 

available for this series of nonionic 

surfactants. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK 

Version 11, to determine if there were 

structural alerts suggestive of 

carcinogenicity. No structural alerts 

were identified. 

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 the SSNAs used for 

human health risk assessment is shown 

in Table 1 of this unit. 

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

ASSESSMENT

Exposure/ 

scenario 

Point of departure and 

uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary .................. An effect attributable to a single exposure was not identified. 

Chronic dietary ...............

(All populations) 

NOAEL= 43 mg/kg/ 

day UFA = 10x.

UFH = 10x ..................

FQPA SF = 1x 

Chronic RfD = 0.43 

mg/kg/day.

cPAD = 0.43 mg/kg/ 

day.

Combined Repeated Dose Toxicity Study with the Reproduction/ 

Developmental Toxicity Screening Test-Rat OPPTS Harmonized 

Guideline 870.3650 (CAS Reg. No. 3655–00–3). 

Parental LOAEL = 160 mg/kg/day based on decreased body weight 

gain in males and females during the pre-mating period, and an 

increased incidence of microscopic lesions in the kidneys of 

males and acanthosis of the glandular + non-glandular stomachs 

of females. 

Reporductive/Developmental LOAEL was not observed. 

Incidental Oral, Dermal 

and Inhalation (Short-, 

and Intermediate-, and 

Long-Term).

NOAEL= 43 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

5% dermal and 100% 

inhalation absorption assumed.

LOC for MOE = 100 .. Combined Repeated Dose Toxicity Study with the Reproduction/ 

Developmental Toxicity screening Test-Rat OPPTS Harmonized 

Guideline 870.3650 (Cas Reg. No. 3655–00–3). 

Parental LOAEL = 160 mg/kg/day based on decreased body weight 

gain in males and females during the pre-mating period and an 

increased incidence of microscopic lesions in the kidneys of 

males and acanthosis of the glandular + non-glandular stomachs 

of females. 

Reproductive/Developmental LOAEL was not observed. 

Cancer (oral, dermal, inhalation).Classification: No animal toxicity data available for an assessment. Based on SAR analysis, the SSNAs are not expected to be carcinogenic. 

Point 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). 


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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 SSNAs, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

the SSNAs in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of the 

SSNAs were seen in the toxicity 

databases; therefore, an acute exposure 

assessment for the SSNAs 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 SSNAs. 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 are 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 

in relation to that of the active 

ingredient. In the case of the SSNAs, 

EPA made a specific adjustment to this 

dietary exposure assessment to account 

for the use limitations of the amount of 

SSNAs that may be in formulations (no 

more than 30% by weight in pesticide 

formulations) and assumed that the 

SSNAs 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. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert 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 structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. SSNAs are not expected to be 

carcinogenic. 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 SSNAs. Tolerance level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for SSNAs in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of SSNAs. 

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 SSNAs. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of the SSNAs were 

conducted. Modeled acute drinking 

water values ranged from 0.001 ppb to 

41 ppb. Modeled chronic drinking water 

values ranged from 0.0002 ppb to 19 

ppb. Further details of this drinking 

water analysis can be found at http:// 

www.regulations.gov in the document 

‘‘Sodium Salts of N-Alkyl (C8–C18)-biminodipropionic Acid (SSNAs—JITF 

CST 14 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations,’’ pages 13–14 and pages 

51–53 in docket ID number EPA–HQ– 

OPP–2009–0098. 


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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 

SSNAs, 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., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). SSNAs may be used as inert 

ingredients in pesticide products that 

are registered for specific uses that may 

result in both indoor and outdoor 

residential exposures. A screening level 

residential exposure and risk 

assessment was completed for products 

containing the SSNAs as inert 

ingredients. In this assessment, 

representative scenarios, based on enduse product application methods and 

labeled application rates, were selected. 

For each of the use scenarios, the 

Agency assessed residential handler 

(applicator) inhalation and dermal 

exposure for indoor and 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 

SSNAs. Similarly, residential post 

application dermal and oral exposure 

assessments were also performed 

utilizing high end indoor and outdoor 

exposure scenarios. Further details of 

this residential exposure and risk 

analysis can be found at http:// 

www.regulations.gov in the 

memorandum entitled ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations’’ (D364751, 5/7/09, Lloyd/ 

LaMay) in docket ID number EPA–HQ– 

OPP–2008–0710. 

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 the SSNAs to 

share a common mechanism of toxicity 

with any other substances, and the 

SSNAs do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that the SSNAs 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 Web site 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 toxicology database is adequate to 

assess risk for the SSNAs when used as 

inert ingredients in pesticide 

formulations. The toxicity data available 

on the SSNAs consists of one OPPTS 

Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/development 

toxicity screening test (rat) for the 

representative surfactant, sodium coco 

beta-iminodipropionate (CAS Reg. No. 

3655–00–3). There was no evidence of 

increased sensitivity in young animals 

because no developmental or 

reproductive toxicity was observed in 

the OPPTS Harmonized Guideline 

870.3650 combined repeated dose 

toxicity study. No treatment related 

effects were observed on litter sizes or 

on the early development of pups. 

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 SSNAs is 

considered adequate for assessing the 

risks to infants and children (the 

available studies are described in unit 

IV.D.2.). The Agency has determined 

that the OPPTS Harmonized Guideline 

870.3650, Combined Repeated Dose 

Toxicity Study with the Reproduction/ 

Developmental Toxicity Screening Test 

in rats is adequate to assess the toxicity 

of this chemical because the study 

provides information on systemic 

toxicity, neurotoxicity and 

immunotoxicity following repeated 

exposure, as well as assessing possible 

developmental and reproductive effects. 

The study measures various 

toxicological parameters such as 

hematology, clinical biochemistry, gross 

pathology and histopathology. In this 

study, no treatment related adverse 

effects were observed in any of the 

observed or measured parameters at 

dose levels below the high dose level of 

600 mg/kg/day except for decreased 

body weight gain during the pre-mating 

period, and increased incidence of 

microscopic renal lesions in males and 

congestion and inflammation of the 

glandular and non-glandular stomachs 

of females at the mid level dose level of 

160 mg/kg/day. Stomach epithelial cell 

congestion/inflammation is an effect 

attributable to local irritation rather than 

systemic activity. The Agency notes that 

surfactants are surface-active materials 

that can damage the structural integrity 

of cellular membranes at high dose 

levels. Thus, surfactants are often 

corrosive and irritating in concentrated 

solutions. The observed toxicity seen in 

the repeated dose studies are 

attributable to the corrosive and 

irritating nature of these surfactants. 

The Agency has considerable toxicity 

information on surfactants which 

indicates that their effects do not 

progressively increase in severity over 

time. In addition, use of the full 10X 

interspecies factor will actually provide 

an additional margin of safety because 

it is not expected that humans’ response 

to local irritation/corrosiveness effects 

would be markedly different from 

animals. The database on the SSNAs 

indicates that the target organ toxicity is 

occurring at relatively high doses. Based 

on the above considerations, the Agency 

concluded that there is no need for 

additional data and an additional FQPA 

safety factor is not necessary. 

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 

in utero and post-natal exposure. 

iii. There are no neurotoxicity studies 

available for this series of nonionic 


jdjones on DSK8KYBLC1PROD with RULES
6340 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

surfactants. However a Functional 

Observation Battery (FOB) to evaluate 

neurotoxicity was performed in the 

Combined Repeated Dose/ 

Developmental Screening study and 

only a minor decrease in temperature 

was observed in males at the mid and 

high doses. The effect was likely due to 

normal biological variation and; 

therefore, was not considered treatmentrelated. Thus, there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iv. 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 SSNAs in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by the SSNAs. 

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-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, the SSNAs 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 of not 

more than 30% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to SSNAs 

is 27% of the cPAD for the U.S. 

population and 87% of the cPAD for 

children 1–2 yrs 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). SSNAs 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 SSNAs. Using the exposure 

assumptions described in this unit, EPA 

has concluded that the combined shortterm aggregated food, water, and 

residential exposures result in aggregate 

MOEs of 160 for both adult males and 

females respectively. EPA has 

concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

100 for children. As the level of concern 

is for MOEs that are lower than 100, 

these MOEs are not of concern. 

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). 

SSNAs are currently registered for uses 

that could result in intermediate-term 

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 SSNAs. Using 

the exposure assumptions described in 

this unit, EPA has concluded that the 

combined intermediate-term aggregated 

food, water, and residential exposures 

result in aggregate MOEs of 430 and 450 

for adult males and females, 

respectively. EPA has concluded the 

combined intermediate-term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 110 for 

children. As the level of concern is for 

MOEs that are lower than 100, this MOE 

is not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to SSNAs. 

6. 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 

SSNAs. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of the SSNAs in 

or on any food commodities. EPA is 

establishing a limitation on the amount 

of the SSNAs that may be used in 

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 greater than 

30% of the SSNAs by weight in food use 

pesticide formulations. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The codex has not established a MRL 

for the SSNAs. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180. 910 and 40 CFR 

180.930 for sodium and potassium salts 

of N-alkyl (C8–C18)-betaiminodipropionic acid where the C8–C18

is linear and may be saturated and/or 

unsaturated (CAS Reg. Nos. 110676–19– 

2, 3655–00–3, 61791–56–8, 14960–06–6, 

26256–79–1, 90170–43–7, 91696–17–2, 

and 97862–48–1) when used as inert 

ingredients in pesticide formulations for 

pre-harvest and post-harvest uses, as 

well as, for application to animals at a 

maximum of 30% by weight in pesticide 

formulations. 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6341 

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) (Pub. L. 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: January 24, 2011. 

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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

Sodium and potassium salts of N-alkyl (C8–C18)-beta-iminodipropionic acid where 

the C8–C18 is linear and may be saturated and/or unsaturated (CAS Reg. Nos. 

110676–19–2, 3655–00–3, 61791–56–8, 14960–06–6, 26256–79–1, 90170–43–7, 

91696–17–2, 97862–48–1).

Concentration in formulated 

end-use products not to 

exceed 30% by weight in 

pesticide formulations.

Surfactants, related adjuvants of surfactants. 

* * * * * ■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

Sodium and potassium salts of N-alkyl (C8–C18)-beta-iminodipropionic acid where 

the C8–C18 is linear and may be saturated and/or unsaturated (CAS Reg. Nos. 

110676–19–2, 3655–00–3, 61791–56–8, 14960–06–6, 26256–79–1, 90170–43–7, 

91696–17–2, 97862–48–1).

Concentration in formulated 

end-use products not to 

exceed 30% by weight in 

pesticide formulations.

Surfactants, related adjuvants of surfactants. 


jdjones on DSK8KYBLC1PROD with RULES
6342 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

* * * * * 

[FR Doc. 2011–2408 Filed 2–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0181; FRL–8860–7] 

n-Octyl Alcohol and n-Decyl Alcohol; 

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-octyl alcohol 

(CAS Reg. No. 111–87–5); and n-decyl 

alcohol (CAS Reg. No. 112–30–1) when 

used as an inert ingredient (solvent or 

co-solvent) in pesticide formulations 

applied to growing crops or to raw 

agricultural commodities after harvest 

under EPA regulations. Technology 

Sciences Group Inc., on behalf of 

AMVAC, Chemical Corporation, 

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 n-octyl 

alcohol and n-decyl alcohol. 

DATES: This regulation is effective 

February 4, 2011. Objections and 

requests for hearings must be received 

on or before April 5, 2011, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION section). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0181. 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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; e-mail address: 

debesai.alganesh@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 site at http:// 

www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2010–0181 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 April 5, 2011. 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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0181, 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 March 24, 

2010 (75 FR 14154) (FRL–8815–6), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

9E7671) by AMVAC Chemical 

Corporation, 4695 MacArthur Court, 

Suit 1250, Newport Beach, CA 90660. 

The petition requested that 40 CFR 

180.910 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of n-octyl alcohol 

(CAS Reg. No. 111–87–5); and n-decyl 

alcohol (CAS Reg. No. 112–30–1) when 

used as inert ingredients (solvent or cosolvent) in pesticide formulations 

applied to growing crops or to raw 

agricultural commodities after harvest. 

That notice referenced a summary of the 

petition prepared by AMVAC Chemical 

Corporation, the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 


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