Tetraethyl Orthosilicate; Exemption From the Requirement of a Tolerance, 41411-41416 [2020-13012]
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Rules and Regulations
(mm) Redesignation. Approval—On
February 11, 2020, Wisconsin submitted
a request to redesignate the Shoreline
Sheboygan County area to attainment of
the 2008 8-hour ozone standard. As part
of the redesignation request, the State
submitted a maintenance plan as
required by section 175A of the Clean
Air Act. Elements of the section 175
maintenance plan include a contingency
plan and an obligation to submit a
subsequent maintenance plan revision
in eight years as required by the Clean
Air Act. The ozone maintenance plan
also establishes 2025 and 2032 Motor
Vehicle Emission Budgets (MVEBs) for
the area. The 2025 MVEBs for the Inland
Sheboygan County area are 0.50 tons per
hot summer day for VOC and 1.00 tons
per hot summer day for NOX. The 2032
MVEBs for the Inland Sheboygan
County area are 0.36 tons per hot
summer day for VOC and 0.77 tons per
hot summer day for NOX.
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Authority: 42 U.S.C. 7401, et seq.
5. In § 81.350, the table entitled
‘‘Wisconsin—2008 8-Hour Ozone
NAAQS [Primary and Secondary]’’ is
amended by revising the entry for
‘‘Shoreline Sheboygan County, WI’’ to
read as follows:
■
§ 81.350
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PART 81—DESIGNATION OF AREAS
FOR AIR QUALITY PLANNING
PURPOSES
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Wisconsin.
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4. The authority citation for part 81
continues to read as follows:
■
WISCONSIN—2008 8-HOUR OZONE NAAQS
[Primary and secondary]
Designation
Classification
Designated area
Date 1
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Shoreline Sheboygan County, WI 2 5 .............................................................
Sheboygan County (part):
Inclusive and east of the following roadways going from the
northern county boundary to the southern county boundary:
Highway 43, Wilson Lima Road, Minderhaud Road, County
Road KK/Town Line Road, N 10th Street, County Road A S/
Center Avenue, Gibbons Road, Hoftiezer Road, Highway 32,
Palmer Road/Smies Road/Palmer Road, Amsterdam Road/
County Road RR, Termaat Road.
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1 This
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7/10/2020
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Date 1
Type
Type
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Attainment.
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date is July 20, 2012, unless otherwise noted.
Indian country located in each area, unless otherwise noted.
date is extended to July 20, 2019 for both Inland Sheboygan County, WI, and Shoreline Sheboygan County, WI, nonattainment
2 Excludes
5 Attainment
areas.
‘‘D d. By redesignating paragraphs
(h)(102) through (113) as paragraphs
(h)(104) through (115), respectively;’’.
National Emission Standards for
Hazardous Air Pollutants: Organic
Liquids Distribution (Non-Gasoline)
Residual Risk and Technology Review
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
tolerance for residues of tetraethyl
orthosilicate when used as an inert
ingredient (binder) in pesticides applied
to growing crops and raw agricultural
commodities after harvest and
pesticides 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
tetraethyl orthosilicate when used in
accordance with the terms of this
exemption.
Correction
[EPA–HQ–OPP–2019–0098; FRL–10007–73]
DATES:
63.14
Tetraethyl Orthosilicate; Exemption
From the Requirement of a Tolerance
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[FR Doc. 2020–14691 Filed 7–9–20; 8:45 am]
BILLING CODE 6560–50–P
§ 63.14 Incorporations by reference.
[Corrected]
ENVIRONMENTAL PROTECTION
AGENCY
2. On the same page, in the same
column, the section heading for 63.14
should read as set forth above.
■
40 CFR Part 63
[EPA–HQ–OAR–2018–0074; FRL–10006–88–
OAR]
[FR Doc. C1–2020–05900 Filed 7–9–20; 8:45 am]
BILLING CODE 1301–00–D
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RIN 2060–AT86
[Corrected]
In rule document 2020–05900,
appearing on pages 40740 through
40791 in the issue of Tuesday, July 7,
2020, make the following corrections.
■ 1. On page 40760, in the second
column, amendatory instruction 2 d. for
§ 63.14 should read as follows:
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
SUMMARY:
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This regulation is effective July
10, 2020. Objections and requests for
hearings must be received on or before
September 8, 2020, 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)
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Rules and Regulations
number EPA–HQ–OPP–2019–0098, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Please note that due to the public
health emergency, the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit 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).
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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.
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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–2019–0098 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 September 8, 2020. 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–
2019–0098, 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–11247) by Exponent on
behalf of LNouvel, Inc. 4657 Courtyard
Trail, Plano, TX 75024. The petition
requested that 40 CFR 180.910 and 40
CFR 180.930 be amended by
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establishing exemptions from the
requirement of a tolerance for residues
of tetraethyl orthosilicate (CAS Reg. No.
78–10–4) when used as an inert
ingredient (binder) in pesticide
formulations applied to growing crops
or to raw agricultural commodities after
harvest and applied to animals with a
limitation of 5% by weight in pesticide
formulations. 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.
Based upon review of the data
supporting the petition, EPA has
decreased the limitation from 5% to 2%
by weight in pesticide formulations due
to risk concerns from aggregate exposure
to tetraethyl orthosilicate at the
requested 5% limitation. This limitation
is based on the Agency’s risk assessment
which can be found at https://
www.regulations.gov in document
‘‘Tetraethyl Orthosilicate; Human
Health Risk Assessment and Ecological
Effects Assessment to Support Proposed
Exemption from the Requirement of a
Tolerance When Used as an Inert
Ingredient in Pesticide Formulations’’ in
docket ID number EPA–HQ–OPP–2019–
0098.
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
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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 tetraethyl
orthosilicate including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with tetraethyl orthosilicate
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
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infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by tetraethyl orthosilicate as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies unit can be found at
https://www.regulations.gov in the
document Tetraethyl Orthosilicate;
Human Health Risk Assessment and
Ecological Effects Assessment to
Support Proposed Exemption from the
Requirement of a Tolerance When Used
as an Inert Ingredient in Pesticide
Formulations at page 8 in docket ID
number EPA–HQ–OPP–2019–0098.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
Based on the effects in the combined
repeated dose and reproductive and
developmental screening study, the
POD for chronic effects is the NOAEL of
10 mg/kg/day (based on kidney effects
in male rats at a LOAEL of 50 mg/kg/
day). The standard uncertainty factors
are applied to account for interspecies
(10X) and intraspecies (10X) variations.
The FQPA safety factor for the
protection of infants and children is
reduced to 1X. This results in a level of
concern (LOC) for the margin of
exposure (MOE) of 100. The chronic
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population adjusted dose (cPAD) is 0.1
mg/kg/day and this value is used for all
exposure scenarios. A default value of
100% absorption was used for the
dermal and inhalation exposure
scenario absorption factor.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tetraethyl orthosilicate, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
tetraethyl orthosilicate in food as
follows:
In conducting the chronic dietary
exposure assessment, EPA used food
consumption information from the U.S.
Department of Agriculture’s (USDA’s)
2003–2008 National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). As
to residue levels in food, no residue data
were submitted for tetraethyl
orthosilicate. In the absence of specific
residue data, EPA has developed an
approach which uses surrogate
information to derive upper bound
exposure estimates for the subject inert
ingredient. Upper bound exposure
estimates are based on the highest
tolerance for a given commodity from a
list of high use insecticides, herbicides,
and fungicides. A complete description
of the general approach taken to assess
inert ingredient risks in the absence of
residue data is contained in the
memorandum entitled ‘‘Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and
Chronic Aggregate (Food and Drinking
Water) Dietary Exposure and Risk
Assessments for the Inerts,’’ (D361707,
S. Piper, 2/25/09) and can be found at
https://www.regulations.gov in docket ID
number EPA–HQ–OPP–2008–0738 and
can be found at https://
www.regulations.gov in the document
Tetraethyl Orthosilicate; Human Health
Risk Assessment and Ecological Effects
Assessment to Support Proposed
Exemption from the Requirement of a
Tolerance When Used as an Inert
Ingredient in Pesticide Formulations at
page 14 in docket ID number EPA–HQ–
OPP–2019–0098
Accordingly, although sufficient
information to quantify actual residue
levels in food is not available, the
compounding of these conservative
assumptions will lead to a significant
exaggeration of actual exposures. EPA
does not believe that this approach
underestimates exposure in the absence
of residue data.
2. Dietary exposure from drinking
water. For the purpose of the screening
level dietary risk assessment to support
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this request for an exemption from the
requirement of a tolerance for tetraethyl
orthosilicate, 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).
Tetraethyl orthosilicate may be used
as an inert ingredient in products that
are registered for specific uses that may
result in residential exposure. A
screening level residential exposure and
risk assessment was completed for
products containing tetraethyl
orthosilicate as an inert ingredient. The
Agency selected representative
scenarios, based on end-use product
application methods and labeled
application rates. The Agency
conducted an assessment to represent
worst-case residential exposure by
assessing tetraethyl orthosilicate in
pesticide formulations (outdoor
scenarios) and tetraethyl orthosilicate in
disinfectant-type uses (indoor
scenarios). The Agency assessed the
disinfectant-type products containing
tetraethyl orthosilicate using exposure
scenarios used by OPP’s Antimicrobials
Division to represent worst-case indoor
residential handler exposure. Further
details of the residential exposure and
risk analysis can be found at https://
www.regulations.gov in the
memorandum entitled: ‘‘JITF Inert
Ingredients. Residential and
Occupational Exposure Assessment
Algorithms and Assumptions Appendix
for the Human Health Risk Assessments
to Support Proposed Exemption from
the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide
Formulations,’’ (D364751, 5/7/09,
Lloyd/LaMay in docket ID number
EPA–HQ–OPP–2008–0710.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ EPA has not
found tetraethyl orthosilicate to share a
common mechanism of toxicity with
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any other substances, and tetraethyl
orthosilicate does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that tetraethyl orthosilicate
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.
The Agency has concluded that there is
reliable data to determine the infants
and children will be safe if the FQPA SF
of 10X is reduced to 1X for the
assessment of all exposure scenarios.
The toxicity database for tetraethyl
orthosilicate contains subchronic,
developmental, reproduction and
mutagenicity studies. There is no
indication of immunotoxicity or
neurotoxicity in the available studies;
therefore, there is no need to require an
immunotoxicity or neurotoxicity study.
No fetal susceptibility is observed in
developmental toxicity studies in the rat
and rabbit or the 2-generation
reproduction toxicity study. Neither
maternal, offspring nor reproduction
toxicity is observed in any of the
studies.
3. Conclusion. Based on the adequacy
of the toxicity database, the conservative
nature of the exposure assessment and
the lack of concern for prenatal and
postnatal sensitivity, the Agency has
concluded that there is reliable data to
determine that infants and children will
be safe if the FQPA SF of 10X is reduced
to 1X for all exposure scenarios.
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E. Aggregate Risks and Determination of
Safety
Taking into consideration all available
information on tetraethyl orthosilicate
with an additional limit of 2% is
pesticide formulations, EPA has
determined that there is a reasonable
certainty that no harm to any population
subgroup will result from aggregate
exposure to tetraethyl orthosilicate
under reasonably foreseeable
circumstances. Therefore, the
establishment of an exemption from
tolerance under 40 CFR 180.910 and
180.930 for residues of tetraethyl
orthosilicate when used as an inert
ingredient in pesticide formulations
applied as a binder and not to exceed
2% of the formulation is safe under
FFDCA section 408.
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, tetraethyl
orthosilicate 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 tetraethyl
orthosilicate from food and water will
utilize 28.2% of the cPAD for children
1 to 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 tetraethyl orthosilicate is not
expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Tetraethyl orthosilicate 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 tetraethyl orthosilicate.
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 145 for both adult males and
females and 125 for children. Because
EPA’s level of concern for tetraethyl
orthosilicate is a MOE of 100 or below,
these MOEs are not of concern.
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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).
Tetraethyl orthosilicate is currently
used as an inert ingredient in pesticide
products that are registered for uses that
could result in intermediate-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with intermediate-term
residential exposures to tetraethyl
orthosilicate.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures result
in aggregate MOEs of 595 for adult
males and females and 163 for children.
Because EPA’s level of concern for
tetraethyl orthosilicate is a MOE of 100
or below, these MOEs are not of
concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
structural alerts in the Derek expertbased knowledge analysis regarding
carcinogenicity, tetraethyl orthosilicate
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 tetraethyl
orthosilicate residues.
V. Other Considerations
jbell on DSKJLSW7X2PROD with RULES
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(capillary gas chromotography using
electron capture detection) is available
to enforce the tolerance exemption
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; email address:
residuemethods@epa.gov.
B. Revisions to Petitioned-for Tolerances
The petition requested exemptions
with a limitation of 50,000 ppm of
tetraethyl orthosilicate in pesticide
formulations. This is equivalent to 5%
of the formulation. At that level, EPA’s
assessment indicated risks of concern
from aggregate exposures to tetraethyl
orthosilicate. EPA proposed a 2%
limitation to the petitioner, to which the
petitioner agreed. At that level, EPA’s
assessment indicates that risks are
below the Agency’s level of concern.
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16:12 Jul 09, 2020
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VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 and 180.930 for
tetraethyl orthosilicate (CAS Reg. No.
78–10–4) when used as an inert
ingredient (binder) in pesticide
formulations applied to growing crops
or to raw agricultural commodities after
harvest and applied to animals with a
limitation of 2% by weight in the
pesticide formulation.
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), nor is it considered a
regulatory action under 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 tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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
PO 00000
Frm 00095
Fmt 4700
Sfmt 4700
41415
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 2, 2020.
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 § 180.910 amend Table 1 by
adding alphabetically under ‘‘Inert
ingredients’’ the term ‘‘Tetraethyl
orthosilicate (CAS Reg. No. 78–10–4)’’
to read as follows:
■
E:\FR\FM\10JYR1.SGM
10JYR1
41416
Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Rules and Regulations
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
*
*
Tetraethyl
orthosilicate
(CAS Reg.
No. 78–10–4).
*
*
Not to exceed
2% by weight
of pesticide
formulations.
*
*
*
Uses
*
Binder.
*
*
3. In § 180.930, amend the table by
adding alphabetically under ‘‘Inert
Ingredients’’ the term ‘‘Tetraethyl
orthosilicate (CAS Reg. No. 78–10–4)’’
to read as follows:
■
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
*
*
Tetraethyl
orthosilicate
(CAS Reg.
No. 78–10–4).
*
*
Not to exceed
2% by weight
of pesticide
formulations.
*
*
*
Uses
*
Binder.
*
*
[FR Doc. 2020–13012 Filed 7–9–20; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 90
[WP Docket No. 15–32, RM–11572; FCC 20–
62; FRS 16797]
Creation of Interstitial 12.5 Kilohertz
Channels in the 800 MHz Band
Between 809–817/854–862 MHz
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this document, the
Commission grants in part and denies in
part a petition for reconsideration
seeking modification and clarification of
certain technical rules adopted in a
2018 Report and Order for coordinating
interstitial channels in the 809–817/
854–862 MHz band (800 MHz MidBand). In particular, the document
allows some applicants for interstitial
applications to streamline their
applications, clarifies standards for
calculating interference contours that
define the distances that must be
jbell on DSKJLSW7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:12 Jul 09, 2020
Jkt 250001
maintained between interstitial and
incumbent stations and refines certain
technical elements of the interstitial
channel rules.
DATES: Effective August 10, 2020.
FOR FURTHER INFORMATION CONTACT:
Brian Marenco, Policy and Licensing
Division, Public Safety and Homeland
Security Bureau, (202) 418–0838.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Order on
Reconsideration, FCC 20–62, adopted
on May 11, 2020 and released on May
12, 2020. The complete text of this
document is available for inspection
and copying during normal business
hours in the FCC Reference Information
Center, Portals II, 445 12th Street SW,
Room CY–A257, Washington, DC 20554.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to
FCC504@fcc.gov or call the Consumer &
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY). The complete text of the order
also is available on the Commission’s
website at https://www.fcc.gov.
Synopsis
1. On October 22, 2018 (83 FR 61072
(Nov. 27, 2018)), the Commission
released a Report and Order which
created 318 new ‘‘interstitial’’ channels
in the 800 MHz Mid-Band to alleviate
increased demand for spectrum capacity
from public safety and other Private
Land Mobile Radio (PLMR) users.
Following adoption of the Report and
Order, the Land Mobile
Communications Council (LMCC) filed
a petition for reconsideration on
December 27, 2018 seeking modification
and clarification of some of the
technical rules for coordinating
interstitial channel applications.
2. In its petition, LMCC asks the
Commission to clarify or reconsider four
aspects of the contour overlap analysis
required by the PLMR Report and Order.
First, LMCC asks the Commission to
clarify in its rules that applicants need
not perform contour overlap analysis if
the spacing between stations meets or
exceeds co-channel distance separation
criteria specified in the rules. Second,
LMCC asks the Commission to permit
interstitial applicants to use the
proposed station’s coverage contour
rather than its interference contour to
predict the area in which the station is
likely to cause interference. Although
the Commission rejected this proposal
in the Report and Order, LMCC asks the
Commission to revisit that
determination. Third, LMCC urges the
Commission to reconsider its decision
PO 00000
Frm 00096
Fmt 4700
Sfmt 4700
in the Report and Order not to allow
interstitial applicants to calculate
contour values based on a matrix chart
that LMCC proposes to maintain and
update on its website. Finally, LMCC
asks the Commission to modify a
footnote in a short-spacing separation
table added to the Commission’s rules
by the Report and Order.
3. In its Order on Reconsideration, the
Commission modifies its rules to specify
that applications for interstitial
channels do not need to conduct a
contour analysis if the distances in the
Commission’s co-channel spacing rules
are met or exceeded. It also updates its
rules to include a revised matrix that
uses contour values based on
interference and not coverage to predict
interference. The Commission once
again rejects LMCC’s request to allow
applicants to use a matrix posted on the
LMCC website rather than one codified
in the Commission’s rules. Further, the
Commission clarifies that applicants for
interstitial channels should assume that
incumbent stations are operating at the
maximum permitted effective radiated
power associated with the station’s
licensed antenna height when
calculating the potential of the new
station to cause interference to the
incumbent. Finally, the Commission
corrects a few clerical errors and
omissions in its rules.
Procedural Matters
A. Final Regulatory Flexibility Analysis
4. The Regulatory Flexibility Act of
1980, as amended (RFA), requires that
an agency prepare a regulatory
flexibility analysis for notice and
comment rulemakings, unless the
agency certifies that ‘‘the rule will not,
if promulgated, have a significant
economic impact on a substantial
number of small entities.’’ A Final
Regulatory Flexibility Certification on
the economic impact of the rule changes
adopted in the order is set forth in
Appendix A of the Order on
Reconsideration.
B. Paperwork Reduction Act of 1995
Analysis
5. The Order on Reconsideration
contains no new information collection
requirements subject to the Paperwork
Reduction Act of 1995 (PRA), Public
Law 104–13. The Commission’s
Consumer and Governmental Affairs
Bureau, Reference Information Center,
will send a copy of the Order on
Reconsideration to the Chief Counsel for
Advocacy of the Small Business
Administration.
E:\FR\FM\10JYR1.SGM
10JYR1
]]>Agencies
[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Rules and Regulations]
[Pages 41411-41416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13012]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0098; FRL-10007-73]
Tetraethyl Orthosilicate; 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 tetraethyl orthosilicate when used as an
inert ingredient (binder) in pesticides applied to growing crops and
raw agricultural commodities after harvest and pesticides 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 tetraethyl orthosilicate when used in accordance with
the terms of this exemption.
DATES: This regulation is effective July 10, 2020. Objections and
requests for hearings must be received on or before September 8, 2020,
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)
[[Page 41412]]
number EPA-HQ-OPP-2019-0098, is available at https://www.regulations.gov
or at the Office of Pesticide Programs Regulatory Public Docket (OPP
Docket) in the Environmental Protection Agency Docket Center (EPA/DC),
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave.
NW, Washington, DC 20460-0001. The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805.
Please note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit 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-2019-0098 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
September 8, 2020. 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-2019-0098, 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-11247) by
Exponent on behalf of LNouvel, Inc. 4657 Courtyard Trail, Plano, TX
75024. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be
amended by establishing exemptions from the requirement of a tolerance
for residues of tetraethyl orthosilicate (CAS Reg. No. 78-10-4) when
used as an inert ingredient (binder) in pesticide formulations applied
to growing crops or to raw agricultural commodities after harvest and
applied to animals with a limitation of 5% by weight in pesticide
formulations. 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.
Based upon review of the data supporting the petition, EPA has
decreased the limitation from 5% to 2% by weight in pesticide
formulations due to risk concerns from aggregate exposure to tetraethyl
orthosilicate at the requested 5% limitation. This limitation is based
on the Agency's risk assessment which can be found at https://www.regulations.gov in document ``Tetraethyl Orthosilicate; Human
Health Risk Assessment and Ecological Effects Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as an
Inert Ingredient in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2019-0098.
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
[[Page 41413]]
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 tetraethyl orthosilicate
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
tetraethyl orthosilicate 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 tetraethyl orthosilicate as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies unit can be
found at https://www.regulations.gov in the document Tetraethyl
Orthosilicate; Human Health Risk Assessment and Ecological Effects
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as an Inert Ingredient in Pesticide Formulations at
page 8 in docket ID number EPA-HQ-OPP-2019-0098.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
Based on the effects in the combined repeated dose and reproductive
and developmental screening study, the POD for chronic effects is the
NOAEL of 10 mg/kg/day (based on kidney effects in male rats at a LOAEL
of 50 mg/kg/day). The standard uncertainty factors are applied to
account for interspecies (10X) and intraspecies (10X) variations. The
FQPA safety factor for the protection of infants and children is
reduced to 1X. This results in a level of concern (LOC) for the margin
of exposure (MOE) of 100. The chronic population adjusted dose (cPAD)
is 0.1 mg/kg/day and this value is used for all exposure scenarios. A
default value of 100% absorption was used for the dermal and inhalation
exposure scenario absorption factor.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tetraethyl orthosilicate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from tetraethyl orthosilicate in food as follows:
In conducting the chronic dietary exposure assessment, EPA used
food consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no
residue data were submitted for tetraethyl orthosilicate. In the
absence of specific residue data, EPA has developed an approach which
uses surrogate information to derive upper bound exposure estimates for
the subject inert ingredient. Upper bound exposure estimates are based
on the highest tolerance for a given commodity from a list of high use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,''
(D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738 and can be
found at https://www.regulations.gov in the document Tetraethyl
Orthosilicate; Human Health Risk Assessment and Ecological Effects
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as an Inert Ingredient in Pesticide Formulations at
page 14 in docket ID number EPA-HQ-OPP-2019-0098
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support
[[Page 41414]]
this request for an exemption from the requirement of a tolerance for
tetraethyl orthosilicate, 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).
Tetraethyl orthosilicate may be used as an inert ingredient in
products that are registered for specific uses that may result in
residential exposure. A screening level residential exposure and risk
assessment was completed for products containing tetraethyl
orthosilicate as an inert ingredient. The Agency selected
representative scenarios, based on end-use product application methods
and labeled application rates. The Agency conducted an assessment to
represent worst-case residential exposure by assessing tetraethyl
orthosilicate in pesticide formulations (outdoor scenarios) and
tetraethyl orthosilicate in disinfectant-type uses (indoor scenarios).
The Agency assessed the disinfectant-type products containing
tetraethyl orthosilicate using exposure scenarios used by OPP's
Antimicrobials Division to represent worst-case indoor residential
handler exposure. Further details of the residential exposure and risk
analysis can be found at https://www.regulations.gov in the memorandum
entitled: ``JITF Inert Ingredients. Residential and Occupational
Exposure Assessment Algorithms and Assumptions Appendix for the Human
Health Risk Assessments to Support Proposed Exemption from the
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide
Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-
HQ-OPP-2008-0710.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
tetraethyl orthosilicate to share a common mechanism of toxicity with
any other substances, and tetraethyl orthosilicate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tetraethyl orthosilicate 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. The Agency has concluded
that there is reliable data to determine the infants and children will
be safe if the FQPA SF of 10X is reduced to 1X for the assessment of
all exposure scenarios. The toxicity database for tetraethyl
orthosilicate contains subchronic, developmental, reproduction and
mutagenicity studies. There is no indication of immunotoxicity or
neurotoxicity in the available studies; therefore, there is no need to
require an immunotoxicity or neurotoxicity study. No fetal
susceptibility is observed in developmental toxicity studies in the rat
and rabbit or the 2-generation reproduction toxicity study. Neither
maternal, offspring nor reproduction toxicity is observed in any of the
studies.
3. Conclusion. Based on the adequacy of the toxicity database, the
conservative nature of the exposure assessment and the lack of concern
for prenatal and postnatal sensitivity, the Agency has concluded that
there is reliable data to determine that infants and children will be
safe if the FQPA SF of 10X is reduced to 1X for all exposure scenarios.
E. Aggregate Risks and Determination of Safety
Taking into consideration all available information on tetraethyl
orthosilicate with an additional limit of 2% is pesticide formulations,
EPA has determined that there is a reasonable certainty that no harm to
any population subgroup will result from aggregate exposure to
tetraethyl orthosilicate under reasonably foreseeable circumstances.
Therefore, the establishment of an exemption from tolerance under 40
CFR 180.910 and 180.930 for residues of tetraethyl orthosilicate when
used as an inert ingredient in pesticide formulations applied as a
binder and not to exceed 2% of the formulation is safe under FFDCA
section 408.
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,
tetraethyl orthosilicate 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
tetraethyl orthosilicate from food and water will utilize 28.2% of the
cPAD for children 1 to 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
tetraethyl orthosilicate is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Tetraethyl orthosilicate 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 tetraethyl orthosilicate.
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 145 for both
adult males and females and 125 for children. Because EPA's level of
concern for tetraethyl orthosilicate is a MOE of 100 or below, these
MOEs are not of concern.
[[Page 41415]]
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).
Tetraethyl orthosilicate is currently used as an inert ingredient
in pesticide products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to tetraethyl
orthosilicate.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 595 for adult males and females and 163 for children.
Because EPA's level of concern for tetraethyl orthosilicate is a MOE of
100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts in the Derek expert-based knowledge analysis
regarding carcinogenicity, tetraethyl orthosilicate 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 tetraethyl orthosilicate residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (capillary gas chromotography
using electron capture detection) is available to enforce the tolerance
exemption expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email
address: [email protected].
B. Revisions to Petitioned-for Tolerances
The petition requested exemptions with a limitation of 50,000 ppm
of tetraethyl orthosilicate in pesticide formulations. This is
equivalent to 5% of the formulation. At that level, EPA's assessment
indicated risks of concern from aggregate exposures to tetraethyl
orthosilicate. EPA proposed a 2% limitation to the petitioner, to which
the petitioner agreed. At that level, EPA's assessment indicates that
risks are below the Agency's level of concern.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 and 180.930 for tetraethyl
orthosilicate (CAS Reg. No. 78-10-4) when used as an inert ingredient
(binder) in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest and applied to animals with a
limitation of 2% by weight in the pesticide formulation.
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), nor is it considered a regulatory action under
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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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 2, 2020.
Michael Goodis,
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 amend Table 1 by adding alphabetically under
``Inert ingredients'' the term ``Tetraethyl orthosilicate (CAS Reg. No.
78-10-4)'' to read as follows:
[[Page 41416]]
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
Tetraethyl orthosilicate (CAS Not to exceed 2% Binder.
Reg. No. 78-10-4). by weight of
pesticide
formulations.
* * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, amend the table by adding alphabetically under
``Inert Ingredients'' the term ``Tetraethyl orthosilicate (CAS Reg. No.
78-10-4)'' to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
Tetraethyl orthosilicate (CAS Not to exceed 2% Binder.
Reg. No. 78-10-4). by weight of
pesticide
formulations.
* * * * *
------------------------------------------------------------------------
[FR Doc. 2020-13012 Filed 7-9-20; 8:45 am]
BILLING CODE 6560-50-P
