[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Rules and Regulations]
[Pages 23730-23735]
[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 http://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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 http://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: http://www.regulations.gov.
Follow the online

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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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, http://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

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 http://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 http://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 http://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.

    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 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, 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 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 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

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,

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


[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49673-49674]
[FR Doc No: 2016-17804]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1502]

Blood Donor Deferral Policy for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket for comment on the Agency's blood donor
deferral recommendations for reducing the risk of human
immunodeficiency virus (HIV) transmission as described in the document
entitled ``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated December 2015. Interested persons are
invited to submit comments, supported by scientific evidence such as
data from research, regarding potential blood donor deferral policy
options to reduce the risk of HIV transmission, including the
feasibility of moving from the existing time-based deferrals related to
risk behaviors to alternate deferral options, such as the use of
individual risk assessments. Additionally, comments are invited
regarding the design of potential studies to evaluate the feasibility
and effectiveness of such alternative deferral options. FDA will take
the comments received into account as it continues to reevaluate and
update blood donor deferral policies as new scientific information
becomes available.

DATES: Submit either electronic or written comments by November 25,
2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-1502 for ``Blood Donor Deferral Policy for Reducing the Risk
of Human Immunodeficiency Virus Transmission by Blood and Blood
Products; Establishment of Public Docket; Request for Comments.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 23, 2015
(80 FR 79913), FDA announced the availability of the guidance entitled
``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated December 2015 (December 2015 guidance)
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf.
    The December 2015 guidance updates blood donor deferral
recommendations to reflect the most current scientific evidence. The
recommendations also help ensure continued safety of the blood supply
by reducing the risk of HIV transmission by blood and blood products.
As part of the updated blood donor deferral recommendations in the
December 2015 guidance, FDA changed the recommendation for an
indefinite deferral period for men who have sex with men (MSM) to a
deferral period of 12 months since the last sexual contact with another
man. The updated recommendations better align the deferral period for
MSM with the

deferral period for other men and women at increased risk for HIV
infection, such as those who had a recent blood transfusion or who have
been accidentally exposed to the blood of another individual through a
needle stick. In reviewing the Agency's recommendations to reduce the
risk of HIV transmission through blood and blood products, FDA
rigorously examined several alternative options, including individual
risk assessment. Ultimately, FDA concluded that the 12-month deferral
period is supported by the best available scientific evidence, at this
point in time, relevant to the U.S. population.
    As described in the December 2015 guidance, throughout the process
of comprehensively updating blood donor deferral policies, FDA has
worked with other government Agencies, considered input from external
advisory committees, reviewed comments from stakeholders to the draft
guidance of the same title (80 FR 27973, May 15, 2015), and carefully
examined the most recent available scientific evidence. FDA also has
implemented a nationally representative transfusion-transmissible
infections monitoring system for the U.S. blood supply with assistance
from the National Heart, Lung, and Blood Institute at the National
Institutes of Health. This system provides critical information to help
inform future actions that FDA may take on blood donor policies.
    When FDA issued the December 2015 guidance, it noted that while the
December 2015 guidance represents FDA's current thinking on the
subject, FDA was committed to continuing to reevaluate and update blood
donor deferral policies as new scientific information becomes
available. FDA also noted that, because the process must be data-
driven, FDA could not specify a time for when future policy changes
might occur.
    As part of the effort to continue to assess its donor deferral
policies, FDA is opening this docket to provide a mechanism for the
public to submit additional information regarding potential blood donor
deferral policy options. Specifically, we invite interested persons to
submit to the docket comments supported by scientific evidence
regarding possible revisions to FDA's blood donor deferral policies to
reduce the risk of HIV transmission by blood and blood products. FDA
requests that commenters provide scientific evidence, such as data from
research, to support any suggestions. Additionally, comments are
invited regarding the design of potential studies to evaluate the
feasibility or effectiveness of such alternative deferral policy
options.
    FDA recognizes that many stakeholders have expressed the desire to
move from a time-based deferral period to a deferral policy based on
individual risk assessment. An individual risk assessment would involve
asking potential donors a series of questions designed to defer donors
with high risk behaviors. In particular, we invite commenters to
address the following and provide supporting scientific evidence such
as data from research:

1. What questions would most effectively identify individuals at
risk of transmitting HIV through blood donation?
2. Are there specific questions that could be asked that might best
capture the recent risk of a donor acquiring HIV infection, such as
within the 2 to 4 weeks immediately preceding blood donation?
3. How specific can the questions be regarding sexual practices
while remaining understandable and acceptable to all blood donors?
For example, could questions about specific sexual behaviors be
asked if they helped to identify which donors should be at least
temporarily deferred because of risk factors? To the extent the
questions are explicit about sexual practices, how willing will
donors be to answer such questions accurately?
4. Under what circumstances would a short deferral period for high
risk behavior be appropriate? For each short deferral period
identified, please specify the duration of the deferral and provide
the scientific rationale.
5. What changes might be necessary within blood collection
establishments to assure that accurate, individual HIV risk
assessments are performed?
6. How best to design a potential study to evaluate the feasibility
and effectiveness of alternative deferral options such as individual
risk assessment?

    FDA will consider comments and supporting scientific data received
as it continues to reevaluate and update blood donor deferral policies
as new scientific information becomes available.

    Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17804 Filed 7-26-16; 11:15 am]
 BILLING CODE 4164-01-P


[Federal Register: October 7, 2010 (Volume 75, Number 194)]
[Notices]
[Page 62136]
[DOCID:fr07oc10-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Notice of Maximum Amount of Assistance Under the Individuals and
Households Program

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: FEMA gives notice of the maximum amount for assistance under
the Individuals and Households Program for emergencies and major
disasters declared on or after October 1, 2010.

DATES: Effective Date: October 1, 2010, and applies to emergencies and
major disasters declared on or after October 1, 2010.

FOR FURTHER INFORMATION CONTACT: Mark Misczak, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Section 408 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (the Stafford Act), 42
U.S.C. 5174, prescribes that FEMA must annually adjust the maximum
amounts for assistance provided under the Individuals and Households
(IHP) Program. FEMA gives notice that the maximum amount of IHP
financial assistance provided to an individual or household under
section 408 of the Stafford Act with respect to any single emergency or
major disaster is $30,200. The increase in award amount as stated above
is for any single emergency or major disaster declared on or after
October 1, 2010. In addition, in accordance with 44 CFR 61.17(c), this
adjustment includes the maximum amount of available coverage under any
Group Flood Insurance Policy (GFIP) issued for those disasters.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.1 percent for the 12-month period
ended in August 2010. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 17, 2010.

    Catalog of Federal Domestic Assistance No. 97.048, Individuals
and Households--Housing; 97.049 Individuals and Households--Disaster
Housing Operations; 97.050, Individuals and Households--Other Needs.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-25328 Filed 10-6-10; 8:45 am]
BILLING CODE 9111-23-P