Phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-; Exemption From the Requirement of a Tolerance, 23730-23735 [2015-09740]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Rules and Regulations]
[Pages 23730-23735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09740]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0418; FRL-9925-78]


Phenol, 2-(2H-benzotriazol-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 amends an exemption from the requirement of a 
tolerance for residues of phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-
methyl- (CAS Reg. No. 23328-53-2) to allow its use on all growing crops 
as an inert ingredient (ultraviolet (UV) stabilizer) at a maximum 
concentration of 10% in pesticide formulations, Loveland Products Inc., 
submitted a petition to EPA under the Federal Food, Drug and Cosmetic 
Act (FFDCA). This regulation eliminates the need to establish a maximum 
permissible level for residues of phenol, 2-(2H-benzotriazol-2-yl)-6-
dodecyl-4-methyl-.

DATES: This regulation is effective April 29, 2015. Objections and 
requests for hearings must be received on or before June 29, 2015, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0418, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Director, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under Federal Food, Drug, and Cosmetic Act (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-
2014-0418 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 June 29, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0418, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online

[[Page 23731]]

instructions for submitting comments. Do not submit electronically any 
information you consider to be CBI or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
IN-10704) by Loveland Products, Inc., 3005 Rocky Mountain Avenue, 
Loveland, CO 80538. The petition requested that the exemption from the 
requirement of a tolerance in 40 CFR 180.920 for residues of phenol, 2-
(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl be amended to allow for use 
on all growing agricultural crops when used as an inert ingredient (UV 
stabilizer) at a maximum concentration of 10% weight/weight in 
pesticide formulations. That document referenced a summary of the 
petition prepared by the petitioner Loveland Products, Inc., which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    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 exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which 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 performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

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 FFDCA section 408(c)(2)(A), 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 phenol, 2-(2H-benzotriazol-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 phenol, 2-(2H-benzotriazol-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 phenol, 2-(2H-benzotriazol-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.
    In the Federal Register of August 18, 2010 (75 FR 50884) (FRL-8836-
3), EPA published a final rule establishing an exemption from the 
requirement of tolerances for residues of phenol, 2-(2H-benzotriazol-2-
yl)-6-dodecyl-4-methyl- when used as an inert ingredient (UV

[[Page 23732]]

stabilizer) at a maximum concentration of 0.6% in insecticide 
formulations applied to adzuki beans, canola, chickpeas, cotton, fava 
beans, field peas, lentils, linola, linseed, lucerne, lupins, mung 
beans, navy beans, pigeon peas, safflower, sunflower, and vetch. 
Specific information on the studies received and the nature of the 
adverse effects caused by phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-
methyl- as well as the NOAEL and the LOAEL from the toxicity studies 
are discussed in that rulemaking which can be found in the docket under 
docket ID numbers EPA-HQ-OPP-2008-0602.
    Since that rulemaking, as part of the data submitted in support of 
the current petition, an additional study has been submitted. In this 
study, a one-generation oral reproduction study (OECD Test Guideline 
443) with the rat, the NOAEL for phenol, 2-(2H-benzotriazol-2-yl)-6-
dodecyl-4-methyl- for parental and reproductive toxicity was 10,000 
parts per million (ppm) (equal to 618 milligram/kilogram/day (mg/kg/
day), the highest dose tested (HDT)). The NOAEL for offspring toxicity 
was 5,000 ppm (equal to 311 mg/kg/day) based on decreased body weight, 
body weight gain, increased absolute spleen weights in males and 
increased incidence of splenic extra medullary hematopoiesis in males 
at the LOAEL of 10,000 ppm (equal to 618 mg/kg/day). Specific 
information on the study received and the nature of the adverse effects 
caused by phenol-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, as well as 
the NOAEL and LOAEL can found at https://www.regulations.gov in the 
document ``Phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-; Human 
Health Risk Assessment and Ecological Effects Assessment to Support 
Proposed Amendment to the Exemption from the Requirement of a Tolerance 
When Used as an Inert Ingredient in Preharvest Pesticide Products'' at 
pp. 16-19 in docket ID number EPA-HQ-OPP-2014-0418. Based on the 
results of this study, the NOAEL for parental and reproductive toxicity 
was 10,000 ppm (equal to 618 mg/kg/day, the HDT). The NOAEL for 
offspring toxicity was 5,000 ppm (equal to 311 mg/kg/day) based on the 
decreased body weight, body weight gain, increased absolute spleen 
weights in males and increased incidence of splenic extra medullary 
hematopoiesis in males at 10,000 ppm (equal to 618 mg/kg/day).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide chemical'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 the NOAEL and the LOAEL are identified. 
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No acute effects were observed from a single dose so no acute POD 
was selected. The POD for risk assessment for all remaining 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, no 
additional uncertainty factor is necessary for use of subchronic study 
for chronic exposure assessment since available longer-term studies 
shows the lack of toxicity even at higher doses. A 100-fold uncertainty 
factor was used for the chronic exposure (10X interspecies 
extrapolation, 10X for intraspecies variability and 1X Food Quality 
Protection Act (FQPA) factor. 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 100 and is based on 10X interspecies 
extrapolation, 10X for intraspecies variability and 1X FQPA factor. 
Dermal absorption is estimated to be 10% based on SAR analysis. A 100% 
inhalation absorption is assumed.
    In the Federal Register of August 18, 2010 (75 FR 50884) (FRL-8836-
3), EPA applied 10X FQPA factor for the lack of a reproduction study; 
however, the recently submitted Extended One-Generation Reproduction 
Toxicity Study of Tinuvin 571 in Wistar Rats provides a reliable basis 
for reducing the FQPA factor used in the previous risk assessment to 
1X.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, EPA 
considered exposure under the proposed exemption from the requirement 
of a tolerance. EPA assessed dietary exposures from phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl- in food as follows: Because no 
acute endpoint was identified, no acute dietary exposure assessment was 
conducted.
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-
FCID)\TM\, Version 3.16, EPA used food consumption information from the 
U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008. As to residue levels in 
food, no residue data were submitted for phenol, 2-(2H-benzotriazol-2-
yl)-6-dodecyl-4-methyl-. In the absence of specific residue data, EPA 
has developed an approach that uses surrogate information to derive 
upper bound exposure estimates for the subject inert ingredient. Upper 
bound exposure estimates are based on the highest tolerance for a given 
commodity from a list of high-use insecticides, herbicides, and 
fungicides. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessments for the Inerts'' (D361707, S. 
Piper, 2/25/09) and can be found at https://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    In the case of phenol, 2-(2H-benzotriazol-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 phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl- that may be in formulations (no 
more than 10% by weight in pesticide products applied to growing crops) 
and assumed that phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl- 
is present at the maximum limitation in all pesticide product 
formulations used on growing crops.

[[Page 23733]]

    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 phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl-, 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).
    Residential uses of pesticides containing phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl- are extremely limited. However, 
in order to account for all of the current and unanticipated potential 
residential uses of pesticide products containing phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl- various exposure models were 
employed. The Agency believes that the scenarios assessed represent 
highly conservative worst-case short-term and intermediate-term 
exposures and risks to residential handlers and those experiencing 
post-application exposure resulting from the use of indoor and outdoor 
pesticide products containing this inert ingredient in residential 
environments. Based on the use pattern, 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 https://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, Lloyd/LaMay, 5/7/09) 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 phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-
methyl-, to share a common mechanism of toxicity with any other 
substances, and phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, 
does 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 https://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 embryo 
toxicity were not affected by treatment in rats. 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 (HDT). In a separate study, there was no 
evidence of increased susceptibility in this developmental toxicity 
study in rats and mice at 1,000 mg/kg/day. In a second study in rats, 
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 the adverse 
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 a determination as to 
whether this effect is treatment related.
    No adverse reproductive effects were observed in a one-generation 
reproductive toxicity study in rats at dose levels up to 10,000 ppm; 
equal to 618 mg/kg/day, the HDT. There is a quantitative evidence of 
increased susceptibility in the one-generation reproduction study in 
rats. In this study, the NOAEL for offspring toxicity was 5,000 ppm 
(equal to 311 mg/kg/day) based on decreased body weight, body weight 
gain, increased absolute spleen weights in males and increased 
incidence of splenic extra medullary hematopoiesis in males at the 
LOAEL of 10,000 ppm (equal to 618 mg/kg/day), while no systemic 
toxicity was observed in parental animals at doses up to 10,000 ppm 
(equal to 618 mg/kg/day). However, the concern for this susceptibility 
is low since there is a well characterized NOAEL for protecting the 
offspring and the NOAEL selected for chronic RfD is more than 12 fold 
lower. Therefore, there is no need for additional uncertainty factor.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for phenol, 2-(2H-benzotriazol-2-yl)-6-
dodecyl-4-methyl-, is complete. Previously (2010), EPA identified study 
measuring reproductive parameters and lack of Immunotoxicity study as 
the data gaps. Since the last assessment, EPA received the one 
generation reproduction study. EPA concluded that the Immunotoxicity 
study is not required because the newly submitted study and previously 
reviewed studies do not show any indication of Immunotoxicity except 
one 90-day toxicity study in rats showing slight increases in spleen 
weights without histopathological findings and without changes in the 
blood parameters was observed at the HDT (80 mg/kg/day). Since this is 
an isolated finding, EPA concluded that the Immunotoxicity study is not 
required.
    ii. There is no indication that phenol, 2-(2H-benzotriazol-2-yl)-6-
dodecyl-4-methyl-, is a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional uncertainty factors 
(UFs) to account for neurotoxicity. No clinical signs of neurotoxicity 
were seen in any of the

[[Page 23734]]

repeat dose studies with phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-
methyl-.
    iii. No evidence of Immunotoxicity was seen in the available 
database except in one 90-day toxicity study in rats showing slight 
increases in spleen weights without histopathological findings and 
without changes in the blood parameters was observed at the HDT (80 mg/
kg/day). Since this is isolated findings, EPA concluded that the 
Immunotoxicity study is not required.
    iv. There is qualitative evidence of post natal susceptibility in 
1-generation reproduction study in rats, however, EPA concluded that 
there is no need for additional uncertainty factor since there is well 
characterized NOAEL protecting the offspring and the NOAEL selected for 
chronic RfD is more than 12 fold lower.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed using 
highly conservative model assumptions including 100 percent crop 
treated (PCT) and residue levels in crops equivalent to the highest 
established active ingredient tolerance. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-
methyl- in drinking water. EPA used similarly conservative assumptions 
to assess post-application exposure of children as well as incidental 
oral exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-
4-methyl-.

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, 
phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, is not expected 
to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl- from food and 
water will utilize 70.6% of the cPAD for children 1-2 years old, the 
population group receiving the greatest exposure: Based on the 
explanation in this unit, regarding residential use patterns, chronic 
residential exposure to residues of phenol, 2-(2H-benzotriazol-2-yl)-6-
dodecyl-4-methyl -, is not expected.
    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).
    Phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, is currently 
used as an inert ingredient in pesticide products that are 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 phenol, 2-(2H-benzotriazol-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 170 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 140 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 phenol, 2-(2H-benzotriazol-
2-yl)-6-dodecyl-4-methyl- is for MOEs that are lower than 100; 
therefore, these MOEs are not of concern.
    4. Intermediate-term risk. Phenol, 2-(2H-benzotriazol-2-yl)-6-
dodecyl-4-methyl-, is currently used as an inert ingredient in 
pesticide products that are 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 phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl-.
    Intermediate-term aggregate risk assessment was not conducted 
because short-term aggregate risk assessment is protective of 
intermediate-term aggregate risk since the same endpoint of concern has 
been identified for both exposure durations.
    5. Aggregate cancer risk for U.S. population. Phenol, 2-(2H-
benzotriazol-2-yl)-6-dodecyl-4-methyl- is not expected to pose a cancer 
risk to humans 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 phenol, 2-(2H-benzotriazol-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 
phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl- in or on any food 
commodities. EPA is establishing a limitation on the amount of phenol, 
2-(2H-benzotriazol-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 10% of phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-
methyl-, by weight in the pesticide formulation.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for phenol, 2-(2H-benzotriazol-2-yl)-
6-dodecyl-4-methyl- (CAS Reg. No. 23328-53-2) when used as an inert 
ingredient (UV stabilizer) at a maximum concentration of 10% in 
pesticide formulations applied to growing crops.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) 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,

[[Page 23735]]

October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the exemption 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: April 16, 2015.
Susan Lewis,
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 revise the inert ingredient, phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl- (CAS Reg. No. 23328-53-2) in 
the table to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Phenol, 2-(2H-benzotriazol-2-yl)- Not more than 10%   UV stabilizer.
 6-dodecyl-4-methyl-, (CAS Reg.    by weight of
 No. 23328-53-2).                  pesticide
                                   formulations.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-09740 Filed 4-28-15; 8:45 am]
BILLING CODE 6560-50-P