[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Rules and Regulations]
[Pages 50884-50891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20299]
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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:
[email protected].
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