Poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-; Exemption From the Requirement of a Tolerance, 52778-52783 [2019-20524]
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Federal Register / Vol. 84, No. 192 / Thursday, October 3, 2019 / Rules and Regulations
‘‘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); Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997); or
Executive Order 13771, entitled
‘‘Reducing Regulations and Controlling
Regulatory Costs’’ (82 FR 9339, February
3, 2017). This action does not contain
any information collections subject to
OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: September 11, 2019.
Michael Goodis,
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 § 180.920, revise the inert
ingredient ‘‘Nicotinamide (CAS Reg. No.
98–92–0)’’ in the table to read as
follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
Inert ingredients
Limits
*
*
Nicotinamide (CAS Reg. No. 98–
92–0).
*
*
*
Not to exceed 0.5% by weight of pesticide formulation as synergist;
not to exceed 5% by weight of pesticide formulation as corrosion inhibitor.
*
*
*
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0138; FRL–9999–72]
Poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy-;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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This regulation establishes an
exemption from the requirement of a
tolerance for residues of poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- (CAS Reg. No.
67674–67–3) when used as an inert
ingredient (surfactant) applied to
animals. Exponent, on behalf of
LNouvel, Inc., submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of poly(oxy-1,2-ethanediyl),
a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
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*
*
Uses
*
*
Synergist, Corrosion Inhibitor
*
SUMMARY:
[FR Doc. 2019–20528 Filed 10–2–19; 8:45 am]
AGENCY:
*
*
*
*
propyl)-w-hydroxy- when used in
accordance with the terms of the
exemption in EPA regulations.
DATES: This regulation is effective
October 3, 2019. Objections and
requests for hearings must be received
on or before December 2, 2019, 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–2019–0138, 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
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Federal Register / Vol. 84, No. 192 / Thursday, October 3, 2019 / Rules and Regulations
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:
Michael Goodis, 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 Publishing
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–2019–0138 in the subject line on
the first page of your submission. All
objections and requests for a hearing
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must be in writing and must be received
by the Hearing Clerk on or before
December 2, 2019. 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–
2019–0138, 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 May 13,
2019 (84 FR 20843) (FRL–9991–91),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–11248) by Exponent, on
behalf of LNouvel, Inc., 4657 Courtyard
Trail, Plano, TX 75024–2114. The
petition requested that 40 CFR 180.930
be amended by establishing an
exemption from the requirement of a
tolerance for residues of poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl)
oxy)disiloxanyl)propyl)-w-hydroxy(CAS Reg. No. 67674–67–3) when used
as an inert ingredient in pesticide
formulations applied to animals. That
document referenced a summary of the
petition prepared by Exponent, on
behalf of LNouvel, Inc., the petitioner,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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52779
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(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(c)(2)(B) requires EPA to take into
account the considerations set forth in
section 408(b)(2)(C) and (D), when
making this safety determination.
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
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A. Toxicological Profile
Repeat dose studies on poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- are limited. In a
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test in rats, effects
seen at 1,000 mg/kg/day, the highest
dose tested (i.e., 800 mg/kg/day to
poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy-)
included decreased body weight, body
weight gain, and food consumption and
reduced body temperature in males. No
developmental/reproductive adverse
effect attributed to the test substance
were observed in the study.
There is no evidence that exposure to
poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxysuppresses or otherwise harms immune
function in humans. No signs of
neurotoxicity were reported in acute or
repeat-dose oral studies. There were
also no signs of carcinogenicity in the
database. Similarly, all tests were
negative for genotoxicity and
mutagenicity. The available data
suggests that poly(oxy-1,2-ethanediyl),
a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- is not carcinogenic.
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by poly(oxy-1,2-ethanediyl), a-(3(1,3,3,3-tetramethyl-1-((trimethylsilyl)
oxy) disiloxanyl) propyl)-w-hydroxy- as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
Poly(oxy-1,2-ethanediyl), a-(3(1,3,3,3-tetramethyl-1-((trimethylsilyl)
oxy) disiloxanyl) propyl)-w-hydroxy
exhibits low levels of acute toxicity.
Acute studies in rats showed oral LD50
of >1,600 mg/kg. The dermal LD50 in
rats was >3,200 mg/kg. No acute
inhalation studies were available.
Poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy- is
considered to be an eye irritant and a
mild skin irritant. However, it was not
found to be a dermal sensitizer.
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
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 poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- follows.
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assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for poly(oxy-1,2-ethanediyl),
a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- used for human risk
assessment are described in this unit.
The Point of Departure (POD) for all
durations of oral, dermal, and inhalation
exposure is based on the NOAEL of 300
mg/kg/day and the LOAEL of 1,000 mg/
kg/day based on decreased body weight,
body weight gain, and food
consumption and reduced body
temperature in males from the
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test. Once corrected
for the percent inert ingredient in the
test formulation, the NOAEL was 240
mg/kg/day and the LOAEL was 800 mg/
kg/day poly(oxy-1,2-ethanediyl), a-(3(1,3,3,3-tetramethyl-1-((trimethylsilyl)
oxy) disiloxanyl) propyl)-w-hydroxy-.
A 100-fold uncertainty factor was
used (10X interspecies extrapolation,
10X for intraspecies variability, and 1X
FQPA safety factor (SF)). The FQPA SF
is reduced to 1X because the
reproductive and developmental
toxicity database is complete and there
is no evidence of increased risk to
infants and children.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), a(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy-, EPA considered
exposure under the proposed exemption
from the requirement of a tolerance as
well as the existing tolerance exemption
for this chemical. Poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- is currently
approved as a food use inert ingredient
under 40 CFR 180.910. EPA assessed
dietary exposures from poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- in food as follows:
Because no acute endpoint of concern
was identified, a quantitative acute
dietary exposure assessment is
unnecessary. In conducting the chronic
dietary exposure assessment 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
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to 2008. The Inert Dietary Exposure
Evaluation Model (I–DEEM) is a highly
conservative model with the assumption
that the residue level of the inert
ingredient would be no higher than the
highest tolerance for 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. This model
incorporates all current and proposed
pesticidal food uses for this inert
ingredient.
2. Dietary exposure from drinking
water. For the purpose of the screening
level dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for poly(oxy1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy-, 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., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables). A review of residential products
containing this inert ingredient revealed
that it is currently used in fungicides,
herbicides, and insecticides applied to
residential settings, mainly on lawns
and turf. In an effort to assess exposure,
the EPA has conducted a conservative
screening-level assessment using highend exposure scenarios for pesticidal
use on lawns/turf. For each residential
scenario, short-term exposure for both
the handler (adult) and post-application
exposure (adult and child) is expected.
Based on the use pattern (e.g., pre- and
post-harvest uses, use on lawns),
intermediate-term and long-term
pesticidal exposures from residential
uses are not expected.
In addition to the proposed and
current pesticidal uses of poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy-, poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
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propyl)-w-hydroxy- is also used in
various non-pesticidal products;
however, quantifiable exposure data are
not available for these exposure
scenarios.
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 poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- to share a common
mechanism of toxicity with any other
substances, and poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that poly(oxy-1,2-ethanediyl),
a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- 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 website 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.
A combined repeated dose toxicity
study with a reproduction/
developmental toxicity screening test
showed no effect on reproductive
parameters of fertility in the absence of
maternal toxicity.
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52781
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for poly(oxy1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy- is
complete.
ii. There is no indication that
poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy- is a
neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional UFs to account for
neurotoxicity.
iii. There is no evidence that
poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy- results
in increased susceptibility in in utero
rats in a combined repeated dose
toxicity study with the reproduction/
developmental toxicity screening test in
rats.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- in drinking water.
EPA used similarly conservative
assumptions to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by poly(oxy-1,2-ethanediyl), a-(3(1,3,3,3-tetramethyl-1-((trimethylsilyl)
oxy) disiloxanyl) propyl)-w-hydroxy-.
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
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water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- 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 poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- from food and water
will utilize 29.4% of the cPAD for
children 1 to 2 years old, the population
group receiving the greatest exposure.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- is currently used as
an inert ingredient in pesticide products
that are registered for uses that could
result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to poly(oxy-1,2-ethanediyl),
a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy-.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 390 for adults and 175 for
children 1 to 2 years old. Because EPA’s
level of concern for poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- is a MOE of 100 or
below, these MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). A
potential intermediate-term adverse
effect was identified; however,
poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy- is not
currently used as an inert ingredient in
pesticide products that are registered for
any use patterns that would result in
intermediate-term residential exposure.
Intermediate-term risk is assessed based
on intermediate-term residential
exposure plus chronic dietary exposure.
Because there is no intermediate-term
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residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for poly(oxy-1,2-ethanediyl),
a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy-.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity, poly(oxy1,2-ethanediyl), a-(3-(1,3,3,3tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-w-hydroxy- 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 poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy-residues.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.930 for poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- (CAS Reg. No.
67674–67–3) when used as an inert
ingredient (surfactant) in pesticide
formulations applied to animals.
VII. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
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), nor is it considered a
regulatory action for purposes of
Executive Order 13771, entitled
‘‘reducing Regulations and Controlling
Regulatory Costs (82 FR 9339, February
3, 2017). This action does not contain
any information collections subject to
OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.). This action does not
involve any technical standards that
would require Agency consideration of
voluntary consensus standards pursuant
to section 12(d) of the National
Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
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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).
and pests, Reporting and recordkeeping
requirements.
Dated: September 13, 2019.
Donna Davis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.930, add alphabetically the
inert ingredient ‘‘Poly(oxy-1,2ethanediyl), a-(3-(1,3,3,3-tetramethyl-1((trimethylsilyl) oxy) disiloxanyl)
propyl)-w-hydroxy- (CAS Reg. No.
67674–67–3)’’ to the table to read as
follows:
■
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
*
*
*
*
*
Inert ingredients
Limits
*
*
*
*
*
Poly(oxy-1,2-ethanediyl), a-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-w-hydroxy(CAS Reg. No. 67674–67–3).
*
....................................
*
*
*
[FR Doc. 2019–20524 Filed 10–2–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 282
[EPA–R01–UST–2019–0420; FRL–10000–
57–Region 1]
Maine: Final Approval of State
Underground Storage Tank Program
Revisions, Codification, and
Incorporation by Reference
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
Pursuant to the Resource
Conservation and Recovery Act (RCRA
or Act), the Environmental Protection
Agency (EPA) is taking direct final
action to approve revisions to the State
of Maine’s Underground Storage Tank
(UST) program submitted by the Maine
Department of Environmental Protection
(ME DEP). This action also codifies
EPA’s approval of Maine’s State
program and incorporates by reference
those provisions of the State regulations
that we have determined meet the
requirements for approval. The
provisions will be subject to EPA’s
inspection and enforcement authorities
under sections 9005 and 9006 of RCRA
Subtitle I and other applicable statutory
and regulatory provisions.
DATES: This rule is effective December 2,
2019, unless EPA receives adverse
comment by November 4, 2019. If EPA
receives adverse comments, it will
publish a timely withdrawal in the
Federal Register informing the public
SUMMARY:
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*
*
that the rule will not take effect. The
incorporation by reference of certain
publications listed in the regulations is
approved by the Director of the Federal
Register, as of December 2, 2019, in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51.
ADDRESSES: Submit your comments by
one of the following methods:
1. Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
2. Email: hanamoto.susan@epa.gov.
3. Mail: Susan Hanamoto, RCRA
Waste Management, UST, and
Pesticides Section; Land, Chemicals,
and Redevelopment Division; EPA
Region 1, 5 Post Office Square, Suite
100, (Mail Code 07–1), Boston, MA
02109–3912.
4. Hand Delivery or Courier: Deliver
your comments to Susan Hanamoto,
RCRA Waste Management, UST, and
Pesticides Section; Land, Chemicals,
and Redevelopment Division; EPA
Region 1, 5 Post Office Square, Suite
100, (Mail Code 07–1), Boston, MA
02109–3912. Such deliveries are only
accepted during the Regional Office’s
normal hours of operation.
Instructions: Direct your comments to
Docket ID No. EPA–R01–UST–2019–
0420. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
PO 00000
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*
Uses
*
Surfactant.
*
www.regulations.gov, or email. The
Federal website, https://
www.regulations.gov, is an ‘‘anonymous
access’’ system, which means the EPA
will not know your identity or contact
information unless you provide it in the
body of your comment. If you send an
email comment directly to the EPA
without going through https://
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and also with
any disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties, and cannot
contact you for clarification, EPA may
not be able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information
might not be publicly available, e.g., CBI
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
might be publicly available only in hard
copy form. Publicly available docket
materials are available either
electronically through
www.regulations.gov or in hard copy.
IBR and supporting material: You can
view and copy the documents that form
the basis for this codification and
associated publicly available materials
from 8:30 a.m. to 4:00 p.m. Monday
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]]>Agencies
[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Rules and Regulations]
[Pages 52778-52783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20524]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0138; FRL-9999-72]
Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-; Exemption
From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert
ingredient (surfactant) applied to animals. Exponent, on behalf of
LNouvel, Inc., submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- when
used in accordance with the terms of the exemption in EPA regulations.
DATES: This regulation is effective October 3, 2019. Objections and
requests for hearings must be received on or before December 2, 2019,
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-2019-0138, 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
[[Page 52779]]
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: Michael Goodis, 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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 Publishing 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-2019-0138 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
December 2, 2019. 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-2019-0138, 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 May 13, 2019 (84 FR 20843) (FRL-9991-
91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11248) by
Exponent, on behalf of LNouvel, Inc., 4657 Courtyard Trail, Plano, TX
75024-2114. The petition requested that 40 CFR 180.930 be amended by
establishing an exemption from the requirement of a tolerance for
residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy)disiloxanyl)propyl)-[omega]-hydroxy- (CAS Reg.
No. 67674-67-3) when used as an inert ingredient in pesticide
formulations applied to animals. That document referenced a summary of
the petition prepared by Exponent, on behalf of LNouvel, Inc., the
petitioner, which is available in the docket, https://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(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(c)(2)(B) requires EPA to take into
account the considerations set forth in section 408(b)(2)(C) and (D),
when making this safety determination. 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
[[Page 52780]]
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 poly(oxy-1,2-ethanediyl),
[alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl)
propyl)-[omega]-hydroxy- including exposure resulting from the
exemption established by this action. EPA's assessment of exposures and
risks associated with poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies are discussed in this unit.
Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy exhibits
low levels of acute toxicity. Acute studies in rats showed oral
LD50 of >1,600 mg/kg. The dermal LD50 in rats was
>3,200 mg/kg. No acute inhalation studies were available. Poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- is considered to be an eye
irritant and a mild skin irritant. However, it was not found to be a
dermal sensitizer.
Repeat dose studies on poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- are limited. In a combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test in
rats, effects seen at 1,000 mg/kg/day, the highest dose tested (i.e.,
800 mg/kg/day to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy-) included decreased body weight, body weight gain, and food
consumption and reduced body temperature in males. No developmental/
reproductive adverse effect attributed to the test substance were
observed in the study.
There is no evidence that exposure to poly(oxy-1,2-ethanediyl),
[alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl)
propyl)-[omega]-hydroxy- suppresses or otherwise harms immune function
in humans. No signs of neurotoxicity were reported in acute or repeat-
dose oral studies. There were also no signs of carcinogenicity in the
database. Similarly, all tests were negative for genotoxicity and
mutagenicity. The available data suggests that poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- is not carcinogenic.
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.
A summary of the toxicological endpoints for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- used for human risk assessment
are described in this unit. The Point of Departure (POD) for all
durations of oral, dermal, and inhalation exposure is based on the
NOAEL of 300 mg/kg/day and the LOAEL of 1,000 mg/kg/day based on
decreased body weight, body weight gain, and food consumption and
reduced body temperature in males from the combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test. Once corrected for the percent inert ingredient in the test
formulation, the NOAEL was 240 mg/kg/day and the LOAEL was 800 mg/kg/
day poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-.
A 100-fold uncertainty factor was used (10X interspecies
extrapolation, 10X for intraspecies variability, and 1X FQPA safety
factor (SF)). The FQPA SF is reduced to 1X because the reproductive and
developmental toxicity database is complete and there is no evidence of
increased risk to infants and children.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance as well as the existing tolerance exemption for this
chemical. Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is
currently approved as a food use inert ingredient under 40 CFR 180.910.
EPA assessed dietary exposures from poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- in food as follows:
Because no acute endpoint of concern was identified, a quantitative
acute dietary exposure assessment is unnecessary. In conducting the
chronic dietary exposure assessment 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
[[Page 52781]]
to 2008. The Inert Dietary Exposure Evaluation Model (I-DEEM) is a
highly conservative model with the assumption that the residue level of
the inert ingredient would be no higher than the highest tolerance for
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. This model incorporates
all current and proposed pesticidal food uses for this inert
ingredient.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy-, a conservative drinking water
concentration value of 100 ppb based on screening level modeling was
used to assess the contribution to drinking water for the chronic
dietary risk assessments for parent compound. These values were
directly entered into the dietary exposure model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). A
review of residential products containing this inert ingredient
revealed that it is currently used in fungicides, herbicides, and
insecticides applied to residential settings, mainly on lawns and turf.
In an effort to assess exposure, the EPA has conducted a conservative
screening-level assessment using high-end exposure scenarios for
pesticidal use on lawns/turf. For each residential scenario, short-term
exposure for both the handler (adult) and post-application exposure
(adult and child) is expected. Based on the use pattern (e.g., pre- and
post-harvest uses, use on lawns), intermediate-term and long-term
pesticidal exposures from residential uses are not expected.
In addition to the proposed and current pesticidal uses of
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-, poly(oxy-
1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl)
oxy) disiloxanyl) propyl)-[omega]-hydroxy- is also used in various non-
pesticidal products; however, quantifiable exposure data are not
available for these exposure scenarios.
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 poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- to share a common mechanism of toxicity with any other
substances, and poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- 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 website 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. A combined repeated dose
toxicity study with a reproduction/developmental toxicity screening
test showed no effect on reproductive parameters of fertility in the
absence of maternal toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is complete.
ii. There is no indication that poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- is a neurotoxic chemical and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. There is no evidence that poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- results in increased susceptibility in in utero rats
in a combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-
tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-
hydroxy- in drinking water. EPA used similarly conservative assumptions
to assess post-application exposure of children as well as incidental
oral exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy-.
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
[[Page 52782]]
water. No adverse effect resulting from a single oral exposure was
identified and no acute dietary endpoint was selected. Therefore,
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- 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
poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- from food
and water will utilize 29.4% of the cPAD for children 1 to 2 years old,
the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- is currently used as an inert
ingredient in pesticide products that are registered for uses that
could result in short-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy-.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 390 for adults
and 175 for children 1 to 2 years old. Because EPA's level of concern
for poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is a MOE
of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). A potential intermediate-term adverse effect was identified;
however, poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- is not
currently used as an inert ingredient in pesticide products that are
registered for any use patterns that would result in intermediate-term
residential exposure. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for poly(oxy-1,2-
ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy-.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity, poly(oxy-1,2-ethanediyl), [alpha]-(3-
(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- 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 poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-
1-((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy-residues.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.930 for poly(oxy-1,2-ethanediyl), [alpha]-
(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-
[omega]-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert
ingredient (surfactant) in pesticide formulations applied to animals.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action for
purposes of Executive Order 13771, entitled ``reducing Regulations and
Controlling Regulatory Costs (82 FR 9339, February 3, 2017). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and
[[Page 52783]]
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: September 13, 2019.
Donna Davis,
Acting 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. 180.930, add alphabetically the inert ingredient
``Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3-tetramethyl-1-
((trimethylsilyl) oxy) disiloxanyl) propyl)-[omega]-hydroxy- (CAS Reg.
No. 67674-67-3)'' 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
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-(3-(1,3,3,3- .................................. Surfactant.
tetramethyl-1-((trimethylsilyl) oxy)
disiloxanyl) propyl)-[omega]-hydroxy- (CAS Reg.
No. 67674-67-3).
* * * * * * *
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[FR Doc. 2019-20524 Filed 10-2-19; 8:45 am]
BILLING CODE 6560-50-P
