Document ID: EPA-HQ-OPP-2010-0181-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: n-Octyl Alcohol and n-Decyl Alcohol
Posted Date: 2011-02-04T05:00Z

[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Rules and Regulations]
[Pages 6342-6347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2398]

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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.

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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 co-solvent) 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.

[[Page 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 n-decyl 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-adverse-effect-level (NOAEL) and the lowest-
observed-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 n-octyl 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 n-decyl 
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 (m\3\)) 
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.

[[Page 6344]]

    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 n-octyl 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 non-occupational, 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 n-decyl 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.

[[Page 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 short-term 
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.

[[Page 6346]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.910, the table is amended by adding alphabetically two 
new inert ingredients to read as follows:

Sec.  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.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[[Page 6347]]

* * * * *

Sec.  180.920  [Amended]

0
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