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[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Rules and Regulations]               
[Page 50884-50891]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au10-21]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0601 and EPA-HQ-OPP-2008-0602; FRL-8836-3]

 
2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and 
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl; 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 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) 
benzotriazole (CAS Reg. No. 25973-55-1) and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS Reg. No. 23328-53-2) when 
used as a ultraviolet (UV)

[[Page 50885]]

stabilizer at a maximum concentration of 0.6% in insecticide 
formulations applied pre-harvest to adzuki beans, canola, chickpeas, 
cotton, faba beans, field peas, lentils, linola, linseed, lucerne, 
lupins, mung beans, navy beans, pigeon peas, safflower, sunflower, and 
vetch under 40 CFR 180.920. Ag-Chem Consulting on behalf of Caltex Inc. 
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 2-(2'-hydroxy-3', 
5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl.

DATES: This regulation is effective August 18, 2010. Objections and 
requests for hearings must be received on or before October 18, 2010, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0601 and EPA-HQ-OPP-2008-
0602. 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: Deirdre Sunderland, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0851; e-mail address: 
sunderland.deirdre@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 cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2008-0601 and EPA-HQ-OPP-2008-0602 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 October 18, 2010. 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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
numbers EPA- EPA-HQ-OPP-2008-0601 and EPA-HQ-OPP-2008-0602, 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 December 3, 2008 (73 FR 73648) (FRL-
8391-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP 8E7362 
and PP 8E7363) by, Ag-Chem Consulting, 12208 Quinque Lane, Clifton, VA 
21024 on behalf of Caltex Inc., 2 Market Street, Sydney, Australia. The 
petition requested that 40 CFR 180.920 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 2-(2'-
hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole (CAS Reg. No. 25973-
55-1) and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS 
Reg. No. 23328-53-2) when used as an inert ingredient as an ultraviolet 
(UV) stabilizers at a maximum concentration of 0.6% in insecticide 
formulations applied to adzuki beans, canola, chickpeas, cotton, faba 
beans, field peas, lentils, linola, linseed, lucerne, lupins, mung 
beans, navy beans, pigeon peas, safflower, sunflower, and vetch. That 
notice referenced a summary of the petition prepared by Ag-Chem 
Consulting on behalf of Caltex Inc., 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 50886]]

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 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole 
and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl 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 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl 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 petition provided evidence that Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl is structurally and toxicologically similar to 
2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole. The Agency 
agrees that data on 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) 
benzotriazole would represent a worst case scenario for Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl and has, therefore, been used 
when determining risk associated with the use of both of these 
chemicals.
    Acute studies with 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) 
benzotriazole revealed low acute toxicity with an oral LD50 
>2325 mg/kg. Acute inhalation and dermal studies resulted in 
LC50 >1,420 mg/m3 and LD50 >2,000 mg/
kg, respectively for analog chemicals. Skin irritation studies with 2-
(2'-hydroxy-5'-methylphenyl) benzotriazole (CAS Reg. No. 2440-22-4), an 
analog chemical, on rats and mice showed no local irritation and no 
systemic toxicity. 2-(2'-hydroxy-5'-methylphenyl) benzotriazole was 
found to be slightly irritating to rabbit eyes. Skin sensitization 
studies with 2-(2'-hydroxy-5'-methylphenyl) benzotriazole in guinea 
pigs showed skin sensitization; however, studies conducted on humans 
showed no sensitization.
    A 90-day toxicity study in Wistar rats administered 2-(2'-hydroxy-
3', 5'-di-tert-amylphenyl) benzotriazole through the diet. Thyroid, 
liver, kidney, spleen, and testes weights were increased in higher 
exposure groups. The primary target organ was the liver which showed 
microscopic changes and a greenish-drab discoloration at higher dose 
levels. Reproductive organs were not evaluated microscopically. 
Pigmentation was also seen in the proximal tubular cells of females. No 
mortality was observed. The no-observed-adverse-effect-level (NOAEL) of 
20 mg/kg/day is based on liver and kidney effects seen at the lowest-
observed-adverse-effect-level (LOAEL) of 40 mg/kg/day.
    In a 90-day dog study, Beagles were administered 2-(2'-hydroxy-3', 
5'-di-tert-amylphenyl) benzotriazole via the diet. Animals in the high-
dose group showed decreases in body weight and food consumption, and 
changes in blood chemistry. Males showed decreases in testes, prostate, 
and epididymal weights (>=120 mg/kg/day) and females showed deceases in 
uterus weight (>=60 mg/kg/day). One male dog in the highest dose group 
died. Histopathologic effects were noted in the liver (the primary 
target organ), kidney, and testes (>=60 mg/kg/day) groups along with 
atrophy of uterus, abnormal spermiogenesis, and atrophy of the 
prostate. Liver damage was observed in a few dogs. The NOAEL was 30 mg/
kg/day based on body weight, liver, and kidney effects seen at the 
LOAEL of 60 mg/kg/day.
    Developmental studies have been conducted on two structurally 
similar chemicals. Rats and mice received the test substance containing 
2-(2'-hydroxy-5'-methylphenyl) benzotriazole (CAS Reg. No. 2440-22-4) 
on days 6-15 of gestation. No maternal toxicity was evident and the 
rates of implantation and embryotoxicity were not affected by 
treatment. No teratogenic effects were observed. The NOAEL for maternal 
and developmental toxicity was 1,000 mg/kg/day (highest dose tested) in 
mice and rats. A second developmental rat study showed no maternal 
toxicity at any dose tested for 2-(2H- Benzotriazol-2-yl)-4,6-

[[Page 50887]]

bis(1-methyl-1-phenylethyl) phenol (CAS Reg. No. 70321-86-7). A 
significant reduction in fetal body weight and an increased delay of 
skeletal maturation was observed in the 1,000 mg/kg/day dose group. 
However, there were no similar effects in the high dose group 
indicating that these effects may be ``incidental''. An omphalocele was 
seen in one fetus in the high dose group. The maternal toxicity NOAEL 
was 3,000 mg/kg/day (highest dose tested). A developmental toxicity 
NOAEL of 1,000 mg/kg/day was chosen based on the omphalocele seen at 
the LOAEL of 3,000 mg/kg/day.
    All genetic toxicity tests (in vitro and in vivo) conducted 
indicated that this group of chemicals are not mutagenic and will not 
undergo chromosomal aberrations. No evidence of carcinogenicity was 
observed in rats when 142 mg/kg/day of 2-(2'-hydroxy-5'-methylphenyl) 
benzotriazole (CAS Reg. No. 2440-22-4) was administered in the diet for 
104 weeks. Negative finding were also seen in rats and mice given up to 
62 mg/kg/day for 24 months. No clinical signs of neurotoxicity were 
seen in any of the repeat dose studies. Therefore, 2-(2'-hydroxy-3', 
5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl are not expected to be neurotoxic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level -- generally referred to as 
a population-adjusted dose (PAD) or a reference dose (RfD) -- and a 
safe margin of exposure (MOE). For non-threshold risks, the Agency 
assumes that any amount of exposure will lead to some degree of risk. 
Thus, the Agency estimates risk in terms of the probability of an 
occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
     The point of departure for risk assessment for all durations and 
routes of exposure was from the 90-day toxicity study in rats. The 
NOAEL was 20 mg/kg/day and the LOAEL was 40 mg/kg/day based on 
increases in liver, kidney, spleen, and testes weights. Although the 
chronic point of departure was selected from a subchronic study, 
longer-term studies are available that shows the lack of toxicity even 
at higher doses (NOAEL higher than 60 mg/kg/day in carcinogenicity 
studies on a structurally similar chemical). No additional uncertainty 
factor is needed for extrapolating from subchronic to chronic exposure. 
A 1,000 fold uncertainty factor was used for the chronic exposure (10X 
interspecies extrapolation, 10X for intraspecies variability and 10X 
FQPA factor for the lack of reproduction studies). The NOAEL of 20 mg/
kg/day was used for all exposure duration via dermal and inhalation 
routes of exposure. The residential, occupational and aggregate level 
of concern (LOC) is for MOEs that are less than 1,000 and is based on 
10X interspecies extrapolation, 10X for intraspecies variability and 
10X FQPA factor for the lack of reproduction studies. Dermal absorption 
is estimated to be 10% based on SAR analysis. A 100% inhalation is 
assumed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and 
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance. EPA assessed dietary exposures from 2-(2'-hydroxy-3', 5'-di-
tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl in food as follows:
    In conducting the chronic dietary exposure assessment, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). In the absence of specific residue 
data, EPA has developed an approach which uses surrogate information to 
derive upper bound exposure estimates for the subject inert ingredient. 
Upper bound exposure estimates are based on the highest tolerance for a 
given commodity from a list of high-use insecticides, herbicides, and 
fungicides. The Agency believes the assumptions used to estimate 
dietary exposures lead to an extremely conservative assessment of 
dietary risk. 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 case of 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) 
benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl, 
EPA made a specific adjustment to the dietary exposure assessment to 
account for the use limitations of the amount of 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl that may be in formulations (no more than 0.6% 
by weight in pesticide products applied to adzuki beans, canola, 
chickpeas, cotton, faba beans, field peas, lentils, linola, linseed, 
lucerne, lupins, mung beans, navy beans, pigeon peas, safflower, 
sunflower, and vetch) and assumed that the 2-(2'-hydroxy-3', 5'-di-
tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl are present at the maximum limitation rather than at 
equal quantities with the active ingredient.
    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 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl, a conservative drinking water concentration 
value of 100 ppb based on screening level modeling was used to assess 
the contribution to drinking water for the chronic dietary risk 
assessments for parent 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).
     Residential uses of these chemicals are extremely limited. 
However, in order to account for all of the current and unanticipated 
potential residential uses of these chemicals various exposure models 
were employed. The

[[Page 50888]]

Agency believes that the scenarios assessed represent highly 
conservative worse-case short and intermediate term exposures and risks 
to residential handlers and those experiencing post-application 
exposure resulting from the use of indoor and outdoor pesticide product 
containing these inert ingredients in residential environments. Based 
on the use pattern the chronic exposure is not anticipated. Therefore, 
the risk from the chronic residential exposure was not assessed.
     Further details of this residential exposure and risk analysis can 
be found at http://www.regulations.gov in the memorandum entitled 
``JITF Inert Ingredients. Residential and Occupational Exposure 
Assessment Algorithms and Assumptions Appendix for the Human Health 
Risk Assessments to Support Proposed Exemption from the Requirement of 
a Tolerance When Used as Inert Ingredients in Pesticide Formulations'' 
(D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
     EPA has not found 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) 
benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl 
share a common mechanism of toxicity with any other substances, and 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl do not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Developmental studies have 
been conducted on two structurally similar chemicals. In one study, no 
maternal toxicity was evident and the rates of implantation and 
embryotoxicity were not affected by treatment. No teratogenic effects 
were observed; however, the study does not specify what developmental 
endpoints were examined. The NOAEL for maternal and developmental 
toxicity was 1,000 mg/kg/day (highest dose tested). There was no 
evidence of increased susceptibility in this developmental toxicity 
study in rats and mice.
    In a second study, no maternal toxicity was observed at any dose 
tested. The maternal toxicity NOAEL was 3,000 mg/kg/day. The 
developmental NOAEL was 1,000 mg/kg/day based on omphalocele seen in 
the one fetus in the high dose group (LOAEL 3,000 mg/kg/day). The data 
suggest evidence of increased susceptibility in this developmental 
toxicity study in rats. However, there is a low concern for this 
susceptibility because this effect (omphalocele) was seen at a very 
high dose of 3,000 mg/kg/day and only in one fetus. In addition, the 
study did not provide historical controls that would assist in making 
determination whether this effect is treatment related or not.
    The dietary assessment includes estimates using highly conservative 
model assumptions. In addition, the drinking water assessment was 
conducted using the highly conservative value of 100 ppb. These model 
estimates are highly conservative so as to not under estimate the risk.
    3. Conclusion. EPA has determined that it does not have reliable 
data to vary from the default FQPA safety factor of 10X. EPA considered 
the following factors:
    i. The database for 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) 
benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl 
is incomplete. EPA lacks a 2-generation reproductive study or any study 
measuring reproductive performance parameters in male and female rats. 
EPA also does not have an immunotoxicity study. In a 90-day toxicity 
study in rats, slight increases in spleen weights without 
histopathological findings was observed at the highest dose tested (80 
mg/kg/day). There was no other evidence of immunotoxicity in the 
database.
    ii. No clinical signs of neurotoxicity were seen in any of the 
repeat dose studies. Therefore, 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl are not expected to be neurotoxic.
    iii. As discussed above, there is low concern for increased 
sensitivity in the young from exposure to 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl.
    iv. The dietary assessment includes estimates using highly 
conservative model assumptions. In addition, the drinking water 
assessment was conducted using the highly conservative value of 100 
ppb. Finally, the model estimates for residential exposure are highly 
conservative so as to not under estimate the risk. Of principal concern 
to EPA is the lack of a 2-generation reproductive study or any other 
study measuring reproductive performance parameters in male and female 
rats.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. EPA determines whether acute and 
chronic dietary pesticide exposures are safe by comparing aggregate 
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure. Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-
(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl are not expected to pose an 
acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure and the use limitation described previously 
in Unit C, the EPA has concluded that chronic exposure to 2-(2'-
hydroxy-3', 5'-di-tert-amylphenyl)

[[Page 50889]]

benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl 
from food and water will be 0.3% of the cPAD for US populations and 2.8 
% for non-nursing infants, the population group receiving the greatest 
exposure. Based on its use pattern, chronic residential exposure is not 
anticipated. Therefore, chronic residential exposure to residues of 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl were not assessed.
    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).
    2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 
2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl could potentially be used 
as an inert ingredient in pesticide products that may be registered for 
uses that could result in short-term residential exposure, and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short-term residential exposures 
to 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 
2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl.
    Using the exposure assumptions described in this unit for short-
term exposures and the use limitation described previously in Unit C, 
EPA has concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 7,100 for adult males and 
females. Adult residential exposure combines high end dermal and 
inhalation handler exposure from liquids/trigger sprayer in home 
gardens with a high end post application dermal exposure from contact 
with treated lawns. EPA has concluded the combined short-term 
aggregated food, water, and residential exposures result in an 
aggregate MOE of 10,000 for children. Children's residential exposure 
includes total exposures associated with contact with treated lawns 
(dermal and hand-to mouth exposures). The EPA's level of concern for 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl is for MOEs that are lower than 
1,000; therefore, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 
2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl could potentially be used 
as inert ingredients in pesticide products that may be registered for 
uses that could result in intermediate-term residential exposure, and 
the Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with intermediate-term residential 
exposures to 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and 
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 55,000 for adult males and 54,000 for adult females. 
Adult residential exposure includes high end post application dermal 
exposure from contact with treated lawns. EPA has concluded the 
combined intermediate term aggregated food, water, and residential 
exposures result in an aggregate MOE of 16,000 for children. Children's 
residential exposure includes total exposures associated with contact 
with treated lawns (dermal and hand-to-mouth exposures). The level of 
concern is for MOEs that are lower than 1,000; therefore, this MOE is 
not of concern.
    5. Aggregate cancer risk for U.S. population. 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl are not expected to be carcinogenic since there 
was no evidence of carcinogenicity in the available studies.
    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 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and 
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl 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 residues 
of 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole or Phenol, 2-
(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl in or on any food 
commodities. EPA is establishing a limitation on the amount of 2-(2'-
hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl that may be used in pesticide 
formulations. That limitation will be enforced through the pesticide 
registration process under the Federal Insecticide, Fungicide, and 
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register 
any pesticide for sale or distribution that contains greater than 0.6% 
of 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole or Phenol, 2-
(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl by weight in the pesticide 
formulation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole or Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl nor have any CODEX Maximum 
Residue Levels (MRLs) been established for any food crops at this time.

VI. Conclusions

     Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole (CAS Reg. No. 25973-55-1) and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS Reg. No. 23328-53-2) when 
used as an inert ingredient [as an ultraviolet (UV) stabilizers at a 
maximum concentration of 0.6%] in insecticide formulations applied to 
adzuki beans, canola, chickpeas, cotton, faba beans, field peas, 
lentils, linola, linseed, lucerne, lupins, mung beans, navy beans, 
pigeon peas, safflower, sunflower, and vetch.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special

[[Page 50890]]

considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 9, 2010.
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. 180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
2-(2'-hydroxy-3',5'-di-tert-      maximum             Ultraviolet (UV)
 amylphenyl) benzotriazole (CAS    concentration of    stabilizer
 Reg. No. 25973-55-1)              0.6% in
                                   insecticide
                                   formulations
                                   applied to adzuki
                                   beans, canola,
                                   chickpeas,
                                   cotton, faba
                                   beans, field
                                   peas, lentils,
                                   linola, linseed,
                                   lucerne, lupins,
                                   mung beans, navy
                                   beans, pigeon
                                   peas, safflower,
                                   sunflower, and
                                   vetch
Phenol, 2-(2H-benzotriazole-2-    maximum             Ultraviolet (UV)
 yl)-6-dodecyl-4-methyl; (CAS      concentration of    stabilizer
 Reg. No. 23328-53-2)              0.6% in
                                   insecticide
                                   formulations
                                   applied to adzuki
                                   beans, canola,
                                   chickpeas,
                                   cotton, faba
                                   beans, field
                                   peas, lentils,
                                   linola, linseed,
                                   lucerne, lupins,
                                   mung beans, navy
                                   beans, pigeon
                                   peas, safflower,
                                   sunflower, and
                                   vetch
------------------------------------------------------------------------

[[Page 50891]]

* * * * *

[FR Doc. 2010-20299 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S
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