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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Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6343 

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 n-octyl alcohol 

and n-decyl alcohol including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with n-octyl alcohol and ndecyl alcohol 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 n-octyl alcohol and n-decyl alcohol 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in this unit. 

The following provides a brief 

summary for the risk assessment and 

conclusions for the Agency’s review for 

the aliphatic alcohols, which include noctyl alcohol and n-decyl alcohol. The 

Agency’s full decision document for this 

action is available in the Agency’s 

electronic docket (regulations.gov) 

under the docket number EPA–HQ– 

OPP–2010–0181. Details regarding the 

Agency’s findings with regards to 

human health and environmental fate 

and effects, are found in: ‘‘Aliphatic 

Alcohols: Human Health Chapter of the 

Reregistration Eligibility Decision (RED) 

Document Reregistration Case Number 

4004 (June 30, 2006). DP Barcode: 

325712; PC Codes: 079029, 079038, 

079059’’ (June 30, 2006), and ‘‘Ecological 

Risk Assessment Aliphatic Alcohols 

Considered in Registration Case 4004’’. 

These documents are available on the 

Agency’s Web site in the EPA Docket at: 

http://www.regulations.gov (Docket ID 

EPA–HQ–2007–0134). Additional 

information on the use, physical/ 

chemical properties, toxicological 

effects, and exposure profile of n-octyl 

and n-decyl alcohols can be found on 

the 2006 Agency’s reassessment 

decision document for tolerance 

exemption at http://www.epa.gov/ 

opprd001/inerts/octyldecyl.pdf. 

Briefly, the available acute toxicity 

studies indicate the aliphatic alcohols 

are of low acute toxicity. Acute oral 

toxicity for n-octyl alcohol was 4,135 

milligrams/kilogram (mg/kg) and for ndecyl alcohol was 9,800 mg/kg. Acute 

inhalation studies with the rat resulted 

in LC50 estimates above the limit 

concentration of 2 milligrams per Liter 

(mg/L). Eye irritation studies with 

undiluted test compound resulted in 

severe and sometimes non-reversible 

eye damage. Dermal irritation studies 

revealed slight to moderate irritation in 

rabbits. The aliphatic alcohols generally 

did not produce sensitization in guinea 

pigs. 

A 90-day dermal toxicity study in rats 

with fatty alcohol blend (56.7% 

decanol, 42.7% octanol) at dose levels 

of 0, 100, 300, or 1,000 mg/kg resulted 

in severe irritation at the application 

site. Severe irritation including fissuring 

of the skin occurred in 40% of the 

animals at 100 mg/kg/day and 80% of 

the animals at the limit dose. Slight 

changes in hematology, clinical 

chemistry, and organ weights were 

noted at the limit dose of 1,000 mg/kg/ 

day. The systemic toxicity NOAEL in 

the 90-day dermal study was 300 mg/kg/ 

day based on changes in clinical 

chemistry and hematological 

parameters, and organ weight changes 

seen at the LOAEL of 1,000 mg/kg/day. 

No systemic or developmental toxicity 

was observed in the developmental 

toxicity studies in rats via the inhalation 

with n-decyl alcohol at the maximum 

attainable vapor concentration (100 mg/ 

cubic meter (m3)) approximately 

equivalent to 30 mg/kg/day. Similarly, 

no maternal or developmental toxicity 

was seen in an oral (gavage) 

developmental toxicity study in rats 

with fatty alcohol blend at doses up to 

1,000 mg/kg/day. Aliphatic alcohols 

gave a negative response for 

mutagenicity in the available studies. 

No long term studies or carcinogenicity 

studies are available in the database via 

oral routes of exposure. However, as a 

class, the straight chain aliphatic 

alcohols are not considered 

carcinogenic. In addition, the Agency 

used a qualitative structure activity 

relationship (QSAR) database, 

DEREK11, to determine if there were 

structural alerts suggestive of 

carcinogenicity. No structural alerts for 

carcinogenicity were identified. 


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6344 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

No neurotoxicity studies are available 

in the database. The clinical signs 

suggestive of neurotoxicity were 

observed following a single high bolus 

dose and/or repeated high bolus doses. 

These signs were transient and 

considered due to bolus dosing. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to n-octyl and n-decyl alcohol, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from n-octy 

and n-decyl alcohol in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of noctyl alcohol and n-dectyl alcohol were 

seen in the available toxicity studies. 

Therefore, an acute dietary risk 

assessment for n-octyl and n-decyl 

alcohol was not conducted. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the U.S. 

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 n-octyl and n-decyl alcohol. In the 

absence of specific residue data, EPA 

has developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredients. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts.’’ 

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

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

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentration of 

active ingredient in agricultural 

products is generally at least 50 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. 

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, and then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically 1 to 2 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 (QSAR) database, 

DEREK11, to determine if there were 

structural alerts suggestive of 

carcinogenicity. No structural alerts for 

carcinogenicity were identified. 

Therefore, a quantitative dietary 

exposure assessment was not conducted 

for the purpose of evaluating cancer 

risk. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and or PCT 

information in the dietary assessment 

for n-octyl and n-decyl alcohol. 

Tolerance level residues and/or 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for, a 

conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). Due to the low hazard profile 

and lack of endpoint selection for the 

dermal route of exposure, no post 

application dermal risk was assessed. 

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 n-octyl and ndecyl alcohols to share a common 

mechanism of toxicity with any other 

substances, and does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that n-octyl and n-decyl 

alcohol 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. 


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Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6345 

C. Safety Factor for Infants and Children 

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 

Food Quality Protection Act Safety 

Factor (FQPA 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. EPA has determind 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. The decision is 

based on the following findings: 

1. The database on n-octyl alcohol 

and n-decyl alcohol is considered 

adequate for FQPA assessment. The 

database includes two developmental 

toxicity studies in rats via oral route of 

exposure, one developmental toxicity 

study in rats via inhalation routes and 

one Organization of Economic 

Development (OECD) 422 study 

(reproductive and developmental 

screening study) in rats. In addition, 

there are a 90-day dermal toxicity study 

in rats and several mutagenicity studies. 

2. There is no evidence of increased 

susceptibility of infants and children 

from exposure to low chain aliphatic 

alcohols. In developmental toxicity 

studies in rats via the oral route, no 

developmental toxicity was seen at 

doses 1,000 mg/kg/day and above. No 

developmental or systemic toxicity was 

seen in the developmental toxicity 

study in rats via the inhalation route of 

exposure. No evidence of fetal or 

systemic toxicity was seen at doses up 

to 2,000 mg/kg/day in the OECD 422 

study in rats. 

3. There is no indication in the 

database that n-octyl and n-decyl 

alcohols are neurotoxic chemicals 

except when administered in high bolus 

doses. Therefore, there is no need for a 

developmental neurotoxicity study. 

There is no indication of 

immunotoxicity in the available 

database; therefore, an immunotoxicity 

study is not required. 

4. There are no long-term studies in 

the database but there are no concerns 

for the lack of such data because the 

available studies indicate that no 

systemic toxicity was seen at the limit 

dose or above except in one 

developmental gavage study in rats in 

which the salivation was seen at the 

high dose of 1,000 mg/kg/day. This 

effect is considered to be due to bolus 

gavage dosing. This study and endpoint 

was used for the chronic reference dose 

(RfD), therefore, providing conservative 

estimates. 

5. 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 

dietary 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 n-octyl alcohol and n-decyl alcohol in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by both alcohols. Based on 

the above considerations; EPA has 

reduced the FQPA factor to 1X. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (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 

point of departures (PODs) to ensure 

that an adequate margin of exposure 

(MOE) exists. 

1. Acute aggregate (food and drinking 

water) risk. No adverse effect resulting 

from a single oral exposure was 

identified and no acute dietary endpoint 

was selected. Therefore, n-octyl alcohol 

and n-decyl alcohol are not expected to 

pose an acute risk. 

2. Chronic aggregate (food and 

drinking water) 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, the chronic dietary exposure 

from food and water to n-octyl alcohol 

and n-decyl alcohol is 5.1% of the cPAD 

for the U.S. population and 16.6% of the 

cPAD for children 1–2 years old, the 

most highly exposed population 

subgroup. The chronic dietary exposure 

estimates for food and drinking water 

are below the Agency’s level of concern 

(<100% cPAD) for the U.S. population 

and all population subgroups. 

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). Short- term quantitative 

aggregate risk assessment was not 

conducted because there is low hazard 

via the oral, dermal and inhalation 

routes of exposure. The endpoint of 

concern for the chronic RfD was based 

on the conservative NOAEL of 375 mg/ 

kg/day. This NOAEL was based on 

salivation seen at the LOAEL of 1,000 

mg/kg/day in a developmental toxicity 

study in rats. The dietary exposure from 

food and water is estimated to be 5.1% 

of the cPAD. The short-term residential 

exposure is not expected to be 95% of 

the cPAD because dermal and 

inhalation exposures are not likely to be 

significant since the alcohols will be 

readily volatized and dissipated in the 

environment. Therefore, aggregate shortterm exposure does not pose a risk 

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). 

Intermediate-term quantitative aggregate 

risk assessment was not conducted 

because there is low hazard via the oral, 

dermal and inhalation routes of 

exposure. The endpoint of concern for 

the chronic RfD was based on the 

conservative NOAEL of 375 mg/kg/day. 

This NOAEL was based on salivation 

seen at the LOAEL of 1,000 mg/kg/day 

in a developmental toxicity study in 

rats. The dietary exposure from food 

and water is estimated to be 5.1% of the 

cPAD. The intermediate-term residential 

exposure is not expected to be 95% of 

the cPAD because dermal and 

inhalation exposure are not likely to be 

significant since the alcohols will be 

readily volatized and dissipated in the 

environment. Therefore quantitative 

short-term residential exposure 

assessment was not conducted. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to n-octyl 

alcohol and n-decyl alcohol. 

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 n-octyl 

alcohol and n-decyl alcohol residues. 


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6346 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

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 residue of n-octyl alcohol 

and n-decyl alcohol in or any food 

commodities. 

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 n-octyl and n-decyl alcohol. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for 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 40 CFR 180.910. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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 exemptions 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 two new inert 

ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

n-Decyl alcohol (CAS Reg. No. 112–30–1) .......................................................................................... ..................... Solvent or co-solvent. 

*******

n-Octyl alcohol (CAS Reg. No. 111–87–5) ........................................................................................... ..................... Solvent or co-solvent. 

*******


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6347 

* * * * * 

§ 180.920 [Amended] 

■ 3. Section 180.920 is amended by 

removing from the table the entries for 

‘‘n-Decyl alcohol’’ and ‘‘n-Octyl alcohol’’. 

[FR Doc. 2011–2398 Filed 2–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0733; FRL–8860–6] 

(S,S)-Ethylenediamine Disuccinic Acid 

Trisodium Salt; 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 (S,S)- 

ethylenediamine disuccinic acid 

trisodium salt (CAS Reg. No. 178949– 

82–1) when used as an inert ingredient 

(sequestrant or chelating agent) in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest under EPA 

regulations. Innospec Limited 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 (S,S)- 

ethylenediamine disuccinic acid 

trisodium salt. 

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–2010–0733. 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–2010–0733 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–2010–0733, 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 September 

23, 2010 (75 FR 57942) (FRL–8845–4), 

EPA issued a notice pursuant to section 

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

announcing the filing of a pesticide 

petition (PP 0E7753) by Innospec 

Limited, c/o Walter G. Talarek, PC, 1008 

Riva Ridge Drive, Great Falls, VA 

22066–1620. The petition requested that 

40 CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of (S,S)-ethylenediamine disuccinic acid 

trisodium salt (CAS Reg. No. 178949– 

82–1) when used as an inert ingredient 

as sequestrant or chelating agent in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest. That notice 

referenced a summary of the petition 


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