[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2398]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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)
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:
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
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.
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
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.
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
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
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
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
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
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.
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
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: January 24, 2011.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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.
* * * * * * *
* * * * *
Sec. 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