Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate); Exemption From the Requirement of a Tolerance, 42543-42548 [2016-15613]
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Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Rules and Regulations
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[FR Doc. 2016–15707 Filed 6–29–16; 8:45 am]
BILLING CODE 1505–01–D
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0183; FRL–9947–45]
Pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate);
Exemption From the Requirement of a
Tolerance
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
exemptions from the requirement of a
tolerance for residues of pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) (CAS Reg.
No. 6683–19–8) under 40 CFR 180.910
and 180.930 when used as an inert
ingredient (antioxidant/stabilizer) in
pesticide formulations applied to
growing crops and raw agricultural
commodities after harvest at a
maximum concentration of 5% by
weight in the formulation and applied
to animals at a maximum concentration
of 3% by weight in the formulation,
respectively. BASF Corporation
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of
these exemptions from the requirement
of a tolerance. These regulations
eliminate the need to establish a
maximum permissible level for residues
of pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) for
these uses.
DATES: This regulation is effective June
30, 2016. Objections and requests for
hearings must be received on or before
August 29, 2016, 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–2016–0183, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
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SUMMARY:
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is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2016–0183 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 August 29, 2016. Addresses for
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42543
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–
2016–0183, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of April 25,
2016 (81 FR 24044) (FRL–9944–86),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–10829) by BASF
Corporation, 100 Park Avenue, Florham
Park, NJ 07932. The petition requested
that 40 CFR 180.910 and 180.930 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of pentaerythritol tetrakis (3(3,5-di-tert-butyl-4hydroxyphenyl)propionate) (CAS Reg.
No. 6683–19–8) when used as an inert
ingredient antioxidant/stabilizer in
pesticide formulations applied to
growing crops and raw agricultural
commodities after harvest under 40 CFR
180.910 at a maximum concentration of
5% by weight in the formulation; and
applied to animals under 40 CFR
180.930 at a maximum concentration of
3% by weight in the formulation. That
document referenced a summary of the
petition prepared by Lewis & Harrison
LLC on behalf of BASF Corporation, the
petitioner, which is available in the
docket, https://www.regulations.gov.
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There were no comments received in
response to the notice of filing.
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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
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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 pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with pentaerythritol tetrakis
(3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) 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. Pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) has low
acute toxicity via the oral, dermal, and
inhalation routes of exposure.
Pentaerythritol tetrakis 3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) is
not irritating to the eyes and the skin.
It is not a dermal sensitizer. In a
subchronic study in dogs and a
subchronic study in rats, effects were
limited to decreases in body weight
gain, food consumption, and thyroid
weights in rats. No fetal toxicity was
reported in developmental toxicity
study in the rat. In a developmental
toxicity study with mice, incompletely
ossified sternebrae in the high-dose
group was observed in the absence of
maternal toxicity. In a rat 2-generation
reproduction study, no adverse effects
were observed at doses up to 1,000
milligrams/kilogram/day (mg/kg/day).
There was no evidence of carcinogenic
potential in a rat chronic toxicity/
carcinogenicity study. Specific
information on the studies received and
the nature of the adverse effects caused
by pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) as
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well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
‘‘Pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl) propionate)
(CAS Reg. No. 6683–19–8).
Human Health Risk Assessment and
Ecological Effects Assessment to
Support
A Proposed Exemption from the
Requirement of a Tolerance When Used
as an Inert Ingredient’’ at pages 10–15 in
docket ID number EPA–HQ–OPP–2016–
018.
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
Based on the results of the available
safety studies for pentaerythritol tetrakis
(3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate, the
reference dose (RfD) for repeated oral,
dermal, and inhalation exposures to
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate is
1.35 mg/kg/day. The key study for
deriving the RfD is the chronic toxicity
study in rats. The NOAEL for in this
study is 135 mg/kg/day based on
decreases in body weight gain, food
consumption, and thyroid weights in
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males at the LOAEL of 446 mg/kg/day.
Applying an uncertainty factor of 100
for extrapolation from animal to human
(interspecies variation) and potential
variation in sensitivity among members
of the human population (intraspecies
sensitivity) results in the RfD of 1.35
mg/kg/day. The Food Quality Protection
Act (FQPA) (Pub. L. 104–170) safety
factor for pentaerythritol tetrakis (3-(3,5di-tert-butyl-4hydroxyphenyl)propionate is 1X. The
resultant population adjusted dose
(PAD) is 1.35 mg/kg/day. The margin of
exposure (MOE) for residential exposure
is 100 or greater and is based upon the
NOAEL derived from the chronic oral
toxicity study in rats (135 mg/kg/day)
with an assumption of 10% dermal
absorption (based on molecular weight
and octanol-water partition coefficient)
and inhalation toxicity being equivalent
oral toxicity.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pentaerythritol tetrakis (3(3,5-di-tert-butyl-4hydroxyphenyl)propionate), EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) in
food as follows:
An acute dietary risk assessment was
not conducted because no endpoint of
concern following a single exposure was
identified in the available studies. A
chronic dietary exposure assessment
was completed and performed using the
Dietary Exposure Evaluation Model
DEEM–FCIDTM, 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
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate). In
the absence of actual residue data, EPA
has developed an approach which uses
surrogate information to derive upper
bound exposure estimates for the
subject inert ingredient. In the absence
of actual residue data, the inert
ingredient evaluation is based on a
highly conservative model which
assumes that the residue level of the
inert ingredient would be no higher
than the highest established tolerance
for an active ingredient on a given
commodity. Implicit in this assumption
is that there would be similar rates of
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degradation between the active and
inert ingredient (if any) and that the
concentration of inert ingredient in the
scenarios leading to these highest of
tolerances would be no higher than the
concentration of the active ingredient.
The model assumes 100 percent crop
treated (PCT) for all crops and that every
food eaten by a person each day has
tolerance-level residues. A complete
description of the general approach
taken to assess inert ingredient risks in
the absence of residue data is contained
in the memorandum entitled ‘‘Alkyl
Amines Polyalkoxylates (Cluster 4):
Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and
Risk Assessments for the Inerts.’’
(D361707, S. Piper, 2/25/09) and can be
found at https://www.regulations.gov in
docket ID number EPA–HQ–OPP–2008–
0738.
In the case of pentaerythritol tetrakis
(3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) EPA made
specific adjustments to the dietary
exposure assessment to account for the
use limitations of pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) as an inert
ingredient in pesticide formulations
applied to growing crops and raw
agricultural commodities after harvest at
a maximum concentration of % by
weight in the pesticide formulation and
as an inert ingredient in pesticide
formulations applied to animals at a
maximum concentration of 3% by
weight in the pesticide formulation.
Preharvest uses.
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
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate), 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). Based on
the requested use of pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate), the Agency
does not expect non-occupational, nondietary exposures. However, once
approved, there is a potential for
residential exposure from use as an inert
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ingredient in pesticide formulations
used in residential settings. These
residential exposures could occur by
ingestion of materials to which
pesticides containing of pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate have been
applied as well as dermal and
inhalation exposures through the use of
such products. These residential
pesticide exposures are considered
short-term and intermediate-term in
nature.
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 pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) to share a
common mechanism of toxicity with
any other substances, and
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate)
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that pentaerythritol tetrakis
(3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
Fetal susceptibility was not observed in
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the developmental toxicity study in
mice. In a developmental toxicity study
with rats, fetal effects (decreased
ossification of the sternebrae) were
observed without accompanying
maternal toxicity at the high dose group
of 500 mg/kg/day. There are no
concerns for reproductive toxicity (no
effects at up to the limit dose of 1,000
mg/kg/day were observed in a 2generation reproductive toxicity study
in rats).
3. Conclusion. EPA has determined
that reliable data show the safety of
infant 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
pentaerythritol tetrakis(3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate)
includes a subchronic toxicity study,
two developmental toxicity studies, a
reproductive toxicity study, chronic/
carcinogenicity studies, and several
mutagenicity studies. No parental or
offspring effects were observed in a 2generation reproductive toxicity study
in rats at dose levels up to 500 mg/kg/
day, the highest dose tested. In a
developmental study in mice, no fetal or
maternal effects were observed at doses
up to 1,000 mg/kg/day. In a
developmental toxicity study in rats no
maternal effects were observed at 500
mg/kg/day, the highest dose tested,
however, fetal effects were observed,
albeit only in the high dose test group
of 500 mg/kg/day. Since a clear NOAEL
(150 mg/kg/day) for fetal effects was
established in this study, no effects are
observed in the mice developmental and
rat reproductive toxicity study, and the
selected point of departure for risk
assessment purposes is based on dose
levels below which effects are seen in
the rat developmental toxicity study,
there is no need for an additional UF to
account for fetal susceptibility.
ii. There is no indication that
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) is a
neurotoxic chemical. Although no
neurotoxicity studies were available in
the database, no clinical signs of
neurotoxicity were observed in the
available subchronic and chronic
studies. Therefore, there is no need for
a developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no indication that
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) is
an immunotoxic chemical. Although no
immunotoxicity studies were available
in the database, no signs of
immunotoxicity were observed in the
available studies. Therefore, there is no
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need for an immunotoxicity study or
additional UFs to account for
immunotoxicity.
iv. The dietary food exposure
assessment utilizes 100% crop treated
information for all commodities. By
using these screening-level assessments,
chronic exposures/risks will not be
underestimated. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) in drinking
water. EPA used similarly conservative
assumptions to assess postapplication
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by pentaerythritol tetrakis (3-(3,5di-tert-butyl-4hydroxyphenyl)propionate).
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute 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, pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) 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 pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) from food
and water will utilize 26% 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 pentaerythritol tetrakis (3(3,5-di-tert-butyl-4hydroxyphenyl)propionate) is not
expected.
3. Short-term aggregate risk. A shortterm aggregate risk assessment takes
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into account exposure estimates from
chronic dietary consumption of food
and drinking water; and short-term
residential exposure. Pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) may be
used as an inert ingredient in pesticide
products that would result in short-term
residential exposure. Short-term risk is
assessed based on short-term residential
exposure plus chronic dietary exposure.
The Agency has concluded that the
aggregate short-term MOEs for adult and
children are above 100. Therefore there
is no concern for short-term aggregate
risk.
4. Intermediate-term aggregate risk.
An intermediate-term aggregate risk
assessment takes into account exposure
estimates from chronic dietary
consumption of food and drinking
water; and intermediate- term
residential exposure. Pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) may be
used as an inert ingredient in pesticide
products that would result in
intermediate-term residential exposure.
Intermediate-term risk is assessed based
on intermediate-term residential
exposure plus chronic dietary exposure.
The Agency has concluded that the
aggregate intermediate-term MOEs for
adult and children are above 100.
Therefore there is no concern for
intermediate term aggregate risk.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in an
adequate rodent carcinogenicity studies,
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) is
not expected to pose a cancer risk to
humans.
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
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate)
residues.
V. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
tolerance for residues of pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4hydroxyphenyl)propionate) in or on any
food commodities. EPA is establishing a
limitation on the amount of
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate) that
may be used in pesticide formulations
applied to growing crops, raw
agricultural commodities after harvest,
and animals. Those limitations will be
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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 product
applied to growing crops and raw
agricultural commodities after harvest
that contains pentaerythritol tetrakis (3(3,5-di-tert-butyl-4hydroxyphenyl)propionate) a
concentration of more 5% by weight in
the formulation; or any pesticide
product applied applied to animals that
contains pentaerythritol tetrakis (3-(3,5di-tert-butyl-4hydroxyphenyl)propionate) a
concentration of more than 3% by
weight in the formulation.
VI. Conclusions
Therefore, exemptions from the
requirement of a tolerance are
established for residues of
pentaerythritol tetrakis (3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate)
(CAS Reg. No. 6683–19–8) when used as
an inert ingredient (antioxidant,
stabilizer) in pesticide products as
follows: under 40 CFR 180.910, at a
concentration not to exceed 5% by
weight of the formulation in pesticide
formulations applied to growing crops
and raw agricultural commodities and
under 40 CFR 180.930 at a
concentration not to exceed 3% by
weight of the formulation in pesticide
formulations applied to animals.
VII. Statutory and Executive Order
Reviews
This action establishes exemptions
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 exemptions in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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
Inert ingredients
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: June 13, 2016.
Daniel J. Rosenblatt,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
inert ingredient to the table to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
Limits
Uses
*
*
*
*
*
*
Pentaerythritol
tetrakis
(3-(3,5-di-tert-butyl-4- Not to exceed 5% by weight of the pesticide formulahydroxyphenyl)propionate) (CAS Reg. No. 6683–19–8).
tion.
srobinson on DSK5SPTVN1PROD with RULES
*
*
*
3. In § 180.930, add alphabetically the
inert ingredient to the table to read as
follows:
■
VerDate Sep<11>2014
20:00 Jun 29, 2016
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*
*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
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*
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*
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Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Rules and Regulations
Inert ingredients
Limits
Uses
*
*
*
*
*
*
Pentaerythritol
tetrakis
(3-(3,5-di-tert-butyl-4- Not to exceed 3% by weight of the pesticide formulahydroxyphenyl)propionate) (CAS Reg. No. 6683–19–8).
tion.
*
*
*
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 416, 482, and 483
[CMS–3277–CN]
RIN 0938–AR72
Medicare and Medicaid Programs; Fire
Safety Requirements for Certain Health
Care Facilities; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
AGENCY:
This document corrects
technical errors that appeared in the
final rule published in the Federal
Register on May 4, 2016, entitled
‘‘Medicare and Medicaid Programs; Fire
Safety Requirements for Certain Health
Care Facilities.’’
DATES: This correction is effective July
5, 2016.
FOR FURTHER INFORMATION CONTACT:
Kristin Shifflett, (410) 786–4133.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In FR Doc. 2016–10043 of May 4,
2016 (81 FR 26871), there were
technical errors that are identified and
corrected in the Correction of Errors
section below. The provisions in this
correction document are effective as if
they had been included in the document
published May 4, 2016. Accordingly,
the corrections are effective July 5, 2016.
srobinson on DSK5SPTVN1PROD with RULES
II. Summary of Errors in Regulations
Text
On page 26897, at § 416.44(b)(1), we
inadvertently omitted a portion of the
sentence. We are correcting this
sentence to read, ‘‘. . . the ASC must
meet the provisions applicable to
Ambulatory Health Care Occupancies,
regardless of the number of patients
served[.]’’.
On page 26899, at § 482.41(b)(1)(i), we
inadvertently omitted a sentence. We
20:00 Jun 29, 2016
Jkt 238001
*
are correcting this error by adding a
sentence to clarify that outpatient
surgical departments must meet the
provisions applicable to Ambulatory
Health Care Occupancies, regardless of
the number of patients served.
On page 26900, at § 483.70(a)(8), we
inadvertently specified an incorrect
facility type. We are correcting this error
to specify the requirements an LTC
facility must meet when a sprinkler
system is shut down for more than 10
hours.
[FR Doc. 2016–15613 Filed 6–29–16; 8:45 am]
VerDate Sep<11>2014
*
III. Waiver of Proposed Rulemaking
and the 30-Day Delay in Effective Date
*
§ 416.44
IV. Correction of Errors
In FR Doc. 2016–10043 of May 4,
2016 (81 FR 26871), make the following
corrections:
PO 00000
Frm 00096
Fmt 4700
Sfmt 4700
*
[Corrected]
1. On page 26897, in the first column,
line 1 (§ 416.44(b)(1)), after the word
‘‘Occupancies’’ insert ‘‘, regardless of
the number of patients served,’’.
■
§ 482.41
[Corrected]
2. On page 26899, in the first column;
in § 482.41(b)(1)(i), add a new sentence
at the end of the paragraph to read,
‘‘Outpatient surgical departments must
meet the provisions applicable to
Ambulatory Health Care Occupancies,
regardless of the number of patients
served.’’
■
§ 483.70
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). However,
we can waive this notice and comment
procedure if the Secretary finds, for
good cause, that the notice and
comment process is impracticable,
unnecessary, or contrary to the public
interest, and incorporates a statement of
the finding and the reasons therefore in
the notice.
Section 553(d) of the APA ordinarily
requires a 30-day delay in effective date
of final rules after the date of their
publication in the Federal Register.
This 30-day delay in effective date can
be waived; however, if an agency finds
for good cause that the delay is
impracticable, unnecessary, or contrary
to the public interest, and the agency
incorporates a statement of the findings
and its reasons in the rule issued. In this
case, we find that a period for comment
and a delay in the effective date of
publication are both unnecessary,
because this correction notice merely
corrects technical and typographical
errors in the regulations text and makes
no changes in CMS policy. For this
reason, we believe we have good cause
to waive the APA notice and comment
period and delayed effective date.
*
Antioxidant, stabilizer.
[Corrected]
3. On page 26900, in the first column;
in § 483.70(a)(8) introductory text, in
line 2, the word ‘‘ASC’’ is corrected to
read ‘‘LTC facility’’.
■
Dated: June 22, 2016.
Madhura Valverde,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2016–15460 Filed 6–29–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF TRANSPORTATION
Maritime Administration
46 CFR Parts 221, 307, 340, and 356
RIN 2133–AB89
Civil Penalties
Maritime Administration
(MARAD), Department of
Transportation (DOT).
ACTION: Interim final rule.
AGENCY:
This interim final rule
updates the maximum civil penalty
amounts for violations of statutes and
regulations administered by MARAD
pursuant to the Federal Civil Penalties
Inflation Adjustment Act Improvement
Act of 2015. This interim final rule
amends our regulations to reflect the
new, adjusted civil penalty amounts
MARAD may assess pursuant for
violations of procedures related to the
American Fisheries Act, certain
regulated transactions involving
documented vessels, the Automated
Mutual Assistance Vessel Rescue
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Rules and Regulations]
[Pages 42543-42548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15613]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0183; FRL-9947-45]
Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate); Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of pentaerythritol tetrakis (3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionate) (CAS Reg. No. 6683-19-8) under 40 CFR
180.910 and 180.930 when used as an inert ingredient (antioxidant/
stabilizer) in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest at a maximum concentration of 5%
by weight in the formulation and applied to animals at a maximum
concentration of 3% by weight in the formulation, respectively. BASF
Corporation submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting establishment of these exemptions
from the requirement of a tolerance. These regulations eliminate the
need to establish a maximum permissible level for residues of
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) for these uses.
DATES: This regulation is effective June 30, 2016. Objections and
requests for hearings must be received on or before August 29, 2016,
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-2016-0183, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under 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-2016-0183 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
August 29, 2016. 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-2016-0183, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-
86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10829) by
BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932. The petition
requested that 40 CFR 180.910 and 180.930 be amended by establishing an
exemption from the requirement of a tolerance for residues of
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) (CAS Reg. No. 6683-19-8) when used as an
inert ingredient antioxidant/stabilizer in pesticide formulations
applied to growing crops and raw agricultural commodities after harvest
under 40 CFR 180.910 at a maximum concentration of 5% by weight in the
formulation; and applied to animals under 40 CFR 180.930 at a maximum
concentration of 3% by weight in the formulation. That document
referenced a summary of the petition prepared by Lewis & Harrison LLC
on behalf of BASF Corporation, the petitioner, which is available in
the docket, https://www.regulations.gov.
[[Page 42544]]
There were no comments received in response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
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 pentaerythritol tetrakis (3-
(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) 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. Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) has low acute toxicity via the oral, dermal,
and inhalation routes of exposure. Pentaerythritol tetrakis 3-(3,5-di-
tert-butyl-4-hydroxyphenyl)propionate) is not irritating to the eyes
and the skin. It is not a dermal sensitizer. In a subchronic study in
dogs and a subchronic study in rats, effects were limited to decreases
in body weight gain, food consumption, and thyroid weights in rats. No
fetal toxicity was reported in developmental toxicity study in the rat.
In a developmental toxicity study with mice, incompletely ossified
sternebrae in the high-dose group was observed in the absence of
maternal toxicity. In a rat 2-generation reproduction study, no adverse
effects were observed at doses up to 1,000 milligrams/kilogram/day (mg/
kg/day). There was no evidence of carcinogenic potential in a rat
chronic toxicity/carcinogenicity study. Specific information on the
studies received and the nature of the adverse effects caused by
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from
the toxicity studies can be found at https://www.regulations.gov in the
document ``Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl) propionate) (CAS Reg. No. 6683-19-8).
Human Health Risk Assessment and Ecological Effects Assessment to
Support
A Proposed Exemption from the Requirement of a Tolerance When Used
as an Inert Ingredient'' at pages 10-15 in docket ID number EPA-HQ-OPP-
2016-018.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
Based on the results of the available safety studies for
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate, the reference dose (RfD) for repeated oral,
dermal, and inhalation exposures to pentaerythritol tetrakis (3-(3,5-
di-tert-butyl-4-hydroxyphenyl)propionate is 1.35 mg/kg/day. The key
study for deriving the RfD is the chronic toxicity study in rats. The
NOAEL for in this study is 135 mg/kg/day based on decreases in body
weight gain, food consumption, and thyroid weights in
[[Page 42545]]
males at the LOAEL of 446 mg/kg/day. Applying an uncertainty factor of
100 for extrapolation from animal to human (interspecies variation) and
potential variation in sensitivity among members of the human
population (intraspecies sensitivity) results in the RfD of 1.35 mg/kg/
day. The Food Quality Protection Act (FQPA) (Pub. L. 104-170) safety
factor for pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate is 1X. The resultant population adjusted dose
(PAD) is 1.35 mg/kg/day. The margin of exposure (MOE) for residential
exposure is 100 or greater and is based upon the NOAEL derived from the
chronic oral toxicity study in rats (135 mg/kg/day) with an assumption
of 10% dermal absorption (based on molecular weight and octanol-water
partition coefficient) and inhalation toxicity being equivalent oral
toxicity.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate), EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) in food as follows:
An acute dietary risk assessment was not conducted because no
endpoint of concern following a single exposure was identified in the
available studies. A chronic dietary exposure assessment was completed
and performed using the Dietary Exposure Evaluation Model 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 pentaerythritol tetrakis (3-
(3,5-di-tert-butyl-4-hydroxyphenyl)propionate). In the absence of
actual residue data, EPA has developed an approach which uses surrogate
information to derive upper bound exposure estimates for the subject
inert ingredient. In the absence of actual residue data, the inert
ingredient evaluation is based on a highly conservative model which
assumes that the residue level of the inert ingredient would be no
higher than the highest established tolerance for an active ingredient
on a given commodity. Implicit in this assumption is that there would
be similar rates of degradation between the active and inert ingredient
(if any) and that the concentration of inert ingredient in the
scenarios leading to these highest of tolerances would be no higher
than the concentration of the active ingredient. The model assumes 100
percent crop treated (PCT) for all crops and that every food eaten by a
person each day has tolerance-level residues. A complete description of
the general approach taken to assess inert ingredient risks in the
absence of residue data is contained in the memorandum entitled ``Alkyl
Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food
and Drinking Water) Dietary Exposure and Risk Assessments for the
Inerts.'' (D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
In the case of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) EPA made specific adjustments to the dietary
exposure assessment to account for the use limitations of
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) as an inert ingredient in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest at a maximum concentration of % by weight in the
pesticide formulation and as an inert ingredient in pesticide
formulations applied to animals at a maximum concentration of 3% by
weight in the pesticide formulation. Preharvest uses.
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 pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate), 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., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Based on the
requested use of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate), the Agency does not expect non-occupational,
non-dietary exposures. However, once approved, there is a potential for
residential exposure from use as an inert ingredient in pesticide
formulations used in residential settings. These residential exposures
could occur by ingestion of materials to which pesticides containing of
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate have been applied as well as dermal and
inhalation exposures through the use of such products. These
residential pesticide exposures are considered short-term and
intermediate-term in nature.
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 pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) to share a common mechanism of toxicity with
any other substances, and pentaerythritol tetrakis (3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionate) does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that pentaerythritol
tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Fetal susceptibility was not
observed in
[[Page 42546]]
the developmental toxicity study in mice. In a developmental toxicity
study with rats, fetal effects (decreased ossification of the
sternebrae) were observed without accompanying maternal toxicity at the
high dose group of 500 mg/kg/day. There are no concerns for
reproductive toxicity (no effects at up to the limit dose of 1,000 mg/
kg/day were observed in a 2-generation reproductive toxicity study in
rats).
3. Conclusion. EPA has determined that reliable data show the
safety of infant 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 pentaerythritol tetrakis(3-(3,5-di-
tert-butyl-4-hydroxyphenyl)propionate) includes a subchronic toxicity
study, two developmental toxicity studies, a reproductive toxicity
study, chronic/carcinogenicity studies, and several mutagenicity
studies. No parental or offspring effects were observed in a 2-
generation reproductive toxicity study in rats at dose levels up to 500
mg/kg/day, the highest dose tested. In a developmental study in mice,
no fetal or maternal effects were observed at doses up to 1,000 mg/kg/
day. In a developmental toxicity study in rats no maternal effects were
observed at 500 mg/kg/day, the highest dose tested, however, fetal
effects were observed, albeit only in the high dose test group of 500
mg/kg/day. Since a clear NOAEL (150 mg/kg/day) for fetal effects was
established in this study, no effects are observed in the mice
developmental and rat reproductive toxicity study, and the selected
point of departure for risk assessment purposes is based on dose levels
below which effects are seen in the rat developmental toxicity study,
there is no need for an additional UF to account for fetal
susceptibility.
ii. There is no indication that pentaerythritol tetrakis (3-(3,5-
di-tert-butyl-4-hydroxyphenyl)propionate) is a neurotoxic chemical.
Although no neurotoxicity studies were available in the database, no
clinical signs of neurotoxicity were observed in the available
subchronic and chronic studies. Therefore, there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. There is no indication that pentaerythritol tetrakis (3-(3,5-
di-tert-butyl-4-hydroxyphenyl)propionate) is an immunotoxic chemical.
Although no immunotoxicity studies were available in the database, no
signs of immunotoxicity were observed in the available studies.
Therefore, there is no need for an immunotoxicity study or additional
UFs to account for immunotoxicity.
iv. The dietary food exposure assessment utilizes 100% crop treated
information for all commodities. By using these screening-level
assessments, chronic exposures/risks will not be underestimated. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to pentaerythritol tetrakis (3-
(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) in drinking water. EPA
used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate).
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute 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,
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) 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
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) from food and water will utilize 26% 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
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) is not expected.
3. Short-term aggregate risk. A short-term aggregate risk
assessment takes into account exposure estimates from chronic dietary
consumption of food and drinking water; and short-term residential
exposure. Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) may be used as an inert ingredient in
pesticide products that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. The Agency has concluded that
the aggregate short-term MOEs for adult and children are above 100.
Therefore there is no concern for short-term aggregate risk.
4. Intermediate-term aggregate risk. An intermediate-term aggregate
risk assessment takes into account exposure estimates from chronic
dietary consumption of food and drinking water; and intermediate- term
residential exposure. Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) may be used as an inert ingredient in
pesticide products that would result in intermediate-term residential
exposure. Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. The Agency has
concluded that the aggregate intermediate-term MOEs for adult and
children are above 100. Therefore there is no concern for intermediate
term aggregate risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in an adequate rodent carcinogenicity
studies, pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) is not expected to pose a cancer risk to
humans.
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 pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) in or on any food commodities. EPA is
establishing a limitation on the amount of pentaerythritol tetrakis (3-
(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) that may be used in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals. Those limitations will be
[[Page 42547]]
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 product applied to growing
crops and raw agricultural commodities after harvest that contains
pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) a concentration of more 5% by weight in the
formulation; or any pesticide product applied applied to animals that
contains pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate) a concentration of more than 3% by weight in
the formulation.
VI. Conclusions
Therefore, exemptions from the requirement of a tolerance are
established for residues of pentaerythritol tetrakis (3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionate) (CAS Reg. No. 6683-19-8) when used as
an inert ingredient (antioxidant, stabilizer) in pesticide products as
follows: under 40 CFR 180.910, at a concentration not to exceed 5% by
weight of the formulation in pesticide formulations applied to growing
crops and raw agricultural commodities and under 40 CFR 180.930 at a
concentration not to exceed 3% by weight of the formulation in
pesticide formulations applied to animals.
VII. Statutory and Executive Order Reviews
This action establishes exemptions 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 exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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: June 13, 2016.
Daniel J. Rosenblatt,
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. 180.910, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Pentaerythritol tetrakis (3- Not to exceed 5% by Antioxidant,
(3,5-di-tert-butyl-4- weight of the stabilizer.
hydroxyphenyl)propionate) pesticide formulation.
(CAS Reg. No. 6683-19-8).
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
[[Page 42548]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Pentaerythritol tetrakis (3- Not to exceed 3% by Antioxidant,
(3,5-di-tert-butyl-4- weight of the stabilizer.
hydroxyphenyl)propionate) pesticide formulation.
(CAS Reg. No. 6683-19-8).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2016-15613 Filed 6-29-16; 8:45 am]
BILLING CODE 6560-50-P
