[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Rules and Regulations]
[Pages 42543-42548]
[FR Doc No: 2016-15613]

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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.

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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 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, 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 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: 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. 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, http://www.regulations.gov.

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 http://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 http://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

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 http://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 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. Fetal susceptibility was not
observed in

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

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.

* * * * *

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