Alcohols, C10-16, Ethoxylated, Sulfates, Mono(hydroxyethyl)ammonium Salts (CAS No. 157627-92-4); Tolerance Exemption, 5703-5708 [2022-01486]
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0656; FRL–9326–01–
OCSPP]
Alcohols, C10–16, Ethoxylated,
Sulfates,
Mono(hydroxyethyl)ammonium Salts
(CAS No. 157627–92–4); Tolerance
Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of alcohols, C10–
16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
(CAS No. 157627–92–4); when used as
an inert ingredient in pesticide
formulations used pre- and post-harvest
as well as in formulations applied to
livestock. Spring Regulatory Sciences,
on behalf of BASF Corporation,
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
the requirement of a tolerance for
specific uses. This regulation eliminates
the need to establish a maximum
permissible level for residues of
alcohols, C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
(CAS No. 157627–92–4) on food or feed
commodities or when applied to
livestock.
SUMMARY:
This regulation is effective
February 2, 2022. Objections and
requests for hearings must be received
on or before April 4, 2022, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0656, 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.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
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ADDRESSES:
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closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, 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 Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title40.
C. 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–2021–0656 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 April 4, 2022. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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5703
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–
2021–0656, 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 October 21,
2021 (86 FR 58239) (FRL–8792–04),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11530) filed by Spring
Regulatory Sciences (6620 Cypresswood
Dr. Suite 250, Spring, TX 77379), on
behalf of BASF Corporation (100 Park
Avenue, Florham Park, New Jersey
07932). The petition requested that 40
CFR 180.910 and 180.930 be amended
by establishing an exemption from the
requirement of a tolerance for residues
of alcohols, C10–16, ethoxylated,
sulfates,
mono(hydroxyethyl)ammonium salts
(CAS No. 157627–92–4) for use as an
inert ingredient at no more than 30% by
weight of the final pesticide
formulation. That document included a
summary of the petition prepared by the
petitioner and solicited comments on
the petitioner’s request. The Agency did
not receive any public comments.
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
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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.
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IV. Risk Assessment and Determination
of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue.’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown 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
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exemption from the requirement of a
tolerance may be established.
Consistent with FFDCA section
408(b)(2)(D), 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 and considered its
validity, completeness and reliability
and the relationship of this information
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. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure to alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections that
repeat what has been previously
published for tolerance rulemakings of
the same pesticide chemical. Where
scientific information concerning a
particular chemical remains unchanged,
the content of those sections would not
vary between tolerance rulemakings,
and republishing the same sections is
unnecessary. EPA considers referral
back to those sections as sufficient to
provide an explanation of the
information EPA considered in making
its safety determination for the new
rulemaking.
EPA has previously published
tolerance rulemakings for alkyl alcohol
alkoxylate phosphate derivatives
(AAAPDs) and alkyl alcohol alkoxylate
sulfate derivatives (AAASDs), in which
EPA concluded, based on the available
information, that there is a reasonable
certainty that no harm would result
from aggregate exposure to AAAPDs and
AAASDs, and established tolerances for
residues of those chemicals. EPA is
incorporating previously published
sections from that rulemaking as
described further in this rulemaking, as
they remain unchanged. The past rule
EPA cites here covers AAAPDs and
AAASDs, which are collectively
referred to as alkyl alcohol alkoxylate
phosphate and sulfate derivatives
(AAAPSDs). Alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
(CAS No. 157627–92–4) is an AAASD
that is synthesized as a mixture. Based
on the structural and physicochemical
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similarities between Alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
(CAS No. 157627–92–4) and other
AAAPSDs previously assessed by EPA,
the data used in the 2009 risk
assessment for AAAPSDs is considered
appropriate to assess alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts.
A. Toxicological Profile
The Toxicological Profile of alcohols,
C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
remain unchanged from the
Toxicological Profile in Unit IV.A. of the
July 29, 2009 rulemaking (74 FR 37571)
(FRL–8424–6). Refer to that section for
a discussion of the Toxicological Profile
of AAAPSDs.
B. Toxicological Points of Departure/
Levels of Concern
The Toxicological Points of
Departure/Levels of Concern of
alcohols, C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
remain unchanged from the
Toxicological Profile in Unit IV.B. of the
July 29, 2009 rulemaking (74 FR 37571)
(FRL–8424–6). Refer to that section for
a discussion of the Toxicological Points
of Departure/Levels of Concern of
AAAPSDs.
C. Exposure Assessment
The exposure assessment for alcohols,
C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
remain unchanged from the July 29,
2009 rulemaking and supporting human
health risk assessment (D365210, June 8,
2009). Provided that the AAAPSDs are
limited to no more than 30% by weight
in the final formulation, there were no
dietary, residential or aggregate risks of
concern for the U.S. population and all
subpopulations. No occupational risks
of concern were identified when
assuming that mixer/loader/applicators
will wear chemical-resistant gloves.
Based on this human health risk
assessment, an exemption from the
requirement of a tolerance was
established under 40 CFR 180.920 for
pre-harvest use of AAAPDs to no more
than 30% by weight in pesticide enduse products. This risk assessment also
supported the use of the AAASD inert
ingredients in pesticide formulations
intended for use pre- and post-harvest
(40 CFR 180.910) as well as for use on
livestock (40 CFR 180.930). Therefore,
provided alcohols, C10–16, ethoxylated,
sulfates,
mono(hydroxyethyl)ammonium salts
are limited to no more than 30% by
weight in the final formulation, there
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are no dietary, residential or aggregate
risks of concern for the U.S. population
and all subpopulations. As a result, the
Agency has determined that a tolerance
is not necessary to protect public health.
D. 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 determined that alcohols,
C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
share a common mechanism of toxicity
with any other substances, and alcohols,
C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts do
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
alcohols, C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts do
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.
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E. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold 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 data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. EPA continues to conclude
that there is reliable data showing that
the safety of infants and children would
be adequately protected if the Food
Quality Protection Act (FQPA) safety
factor were reduced from 10x to 1x. The
reasons for that decision are articulated
in Unit IV.D. of the July 29, 2009
rulemaking.
F. Determination of Safety
Therefore, based on the risk
assessments and information described
above, EPA concludes there is a
reasonable certainty that no harm will
result to the general population, or to
infants and children, from aggregate
exposure to alcohols, C10–16,
ethoxylated, sulfates,
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mono(hydroxyethyl)ammonium salts.
More detailed information about the
Agency’s analysis can be found at
https://www.regulations.gov in the
documents titled ‘‘Alkyl Alcohol
Alkoxylate Phosphate and Sulfate
Derivatives (AAAPDs and AAASDs—
JITF CST 2 Inert Ingredients). Human
Health Risk Assessment to Support
Proposed Exemption from the
Requirement of a Tolerance When Used
as Inert Ingredients in Pesticide
Formulations’’ and ‘‘IN–11530; Petition
to Add Alcohols, C10–16, Ethoxylated,
Sulfates,
Mono(hydroxyethyl)ammonium Salts
(CAS No. 157627–92–4) to the Current
Tolerance Exemption for Alkyl Alcohol
Alkoxylate Phosphate and Sulfate
Derivatives (AAAPSDs)’’ These
documents can be found in docket ID
numbers EPA–HQ–OPP–2009–0131 and
EPA–HQ–OPP–2021–0656.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
tolerance for residues of alcohols, C10–
16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts in
or on any food commodities. EPA is
establishing a limitation on the amount
of alcohols, C10–16, ethoxylated,
sulfates,
mono(hydroxyethyl)ammonium salts
that may be used in pesticide
formulations. This limitations will be
enforced through the pesticide
registration process under the Federal
Insecticide, Fungicide, and Rodenticide
Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA
will not register any pesticide
formulation for food use that exceeds
30% by weight of alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts in
the final pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
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which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for alcohols, C10–16, ethoxylated,
sulfates,
mono(hydroxyethyl)ammonium salts.
VI. Conclusion
EPA finds that exempting residues of
alcohols, C10–16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
from the requirement of a tolerance will
be safe. Therefore, an exemption from
the requirement of a tolerance is
established under 40 CFR 180.910 and
180.930 for alcohols, C10–16,
ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts
when used as an inert ingredient at no
more than 30% by weight in pesticide
formulations.
VII. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the 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
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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
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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
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and pests, Reporting and recordkeeping
requirements.
Dated: January 20, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, the EPA amends 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
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, revise the inert
ingredient(s) in the table to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
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*
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TABLE 1 TO 180.910
Inert ingredients
Limits
Uses
*
*
*
*
*
a-alkyl(C6-C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4 moles (CAS Reg. Nos.:
3088–31–1, 3694–74–4, 9004–82–4, 9004–84–6, 9021–91–4, 9086–52–6, 13150–00–0, 15826–
16–1, 25446–78–0, 26183–44–8, 27140–00–7, 27731–62–0, 32612–48–9, 34431–25–9, 35015–
74–8, 50602–06–7, 52286–18–7, 52286–19–8, 54116–08–4, 55901–67–2, 61702–79–2, 61894–
66–4, 62755–21–9, 63428–85–3, 63428–86–4, 63428–87–5, 65086–57–9, 65086–79–5, 65104–
74–7, 65122–38–5, 67674–66–2, 67762–19–0, 67762–21–4, 67845–82–3, 67845–83–4, 67923–
90–4, 68037–05–8, 68037–06–9, 68171–41–5, 68424–50–0, 68511–39–7, 68585–34–2, 68610–
66–2, 68611–29–0, 68611–55–2, 68649–53–6, 68890–88–0, 68891–29–2, 68891–30–5, 68891–
38–3, 69011–37–6, 73665–22–2, 75422–21–8, 78330–16–2, 78330–17–3, 78330–25–3, 78330–
26–4, 78330–27–5, 78330–28–6, 78330–29–7, 78330–30–0, 96130–61–9, 106597–03–9,
110392–50–2, 119432–41–6, 125301–88–4, 125301–89–5, 125301–92–0, 125736–54–1,
157627–92–4, 157707–85–2, 160104–51–8, 160901–27–9, 160901–28–0, 160901–29–1,
160901–30–4, 161025–28–1, 161074–79–9, 162063–19–6, 219756–63–5).
a-alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-w-hydroxypolyoxyethylene
polymer with or without polyoxypropylene, mixture of di- and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and
zinc salts of the phosphate esters; minimum oxyethylene content is 2 moles; minimum
oxypropylene content is 0 moles (CAS Reg. Nos.: 9004–80–2, 9046–01–9, 26982–05–8, 31800–
89–2, 37280–82–3, 37281–86–0, 39341–09–8, 39341–65–6, 39464–66–9, 39464–69–2, 42612–
52–2, 50643–20–4, 50668–50–3, 51325–10–1, 51884–64–1, 52019–36–0, 57486–09–6, 58206–
38–5, 58318–92–6, 58857–49–1, 59112–71–9, 60267–55–2, 61837–79–4, 62362–49–6, 62482–
61–5, 63747–86–4, 63887–54–7, 63887–55–8, 66020–37–9, 66272–25–1, 66281–20–7, 67711–
84–6, 67786–06–5, 67989–06–4, 68070–99–5, 68071–17–0, 68071–35–2, 68071–37–4, 68130–
44–9, 68130–45–0, 68130–46–1, 68130–47–2, 68186–29–8, 68186–34–5, 68186–36–7, 68186–
37–8, 68238–84–6, 68311–02–4, 68311–04–6, 68332–75–2, 68389–72–0, 68400–75–9, 68413–
78–5, 68425–73–0, 68425–75–2, 68439–39–4, 68458–48–0, 68511–15–9, 68511–36–4, 68511–
37–5, 68551–05–3, 68585–15–9, 68585–16–0, 68585–17–1, 68585–36–4, 68585–39–7, 68603–
24–7, 68607–14–7, 68610–64–0, 68610–65–1, 68649–29–6, 68649–30–9, 68650–84–0, 68815–
11–2, 68855–46–9, 68856–03–1, 68890–90–4, 68890–91–5, 68891–12–3, 68891–13–4, 68891–
26–9, 68908–64–5, 68909–65–9, 68909–67–1, 68909–69–3, 68921–24–4, 68921–60–8, 68954–
87–0, 68954–88–1, 68954–92–7, 68987–35–9, 69029–43–2, 69980–69–4, 70247–99–3, 70248–
14–5, 70844–96–1, 70903–63–8, 71965–23–6, 71965–24–7, 72480–27–4, 72623–67–7, 72623–
68–8, 72828–56–9, 72828–57–0, 73018–34–5, 73038–25–2, 73050–08–5, 73050–09–6, 73361–
29–2, 73378–71–9, 73378–72–0, 73559–42–9, 73559–43–0, 73559–44–1, 73559–45–2, 74499–
76–6, 76930–25–1, 78041–18–6, 78330–22–0, 78330–24–2, 82465–25–6, 84843–37–8, 91254–
26–1, 93925–54–3, 95014–34–9, 96416–89–6, 99924–51–3, 103170–31–6, 103170–32–7,
106233–09–4, 106233–10–7, 108818–88–8, 110392–49–9, 111798–26–6, 111905–50–1,
116671–23–9, 117584–36–8, 119415–05–3, 120913–45–3, 121158–61–0, 121158–63–2,
123339–53–7, 125139–13–1, 125301–86–2, 125301–87–3, 126646–03–5, 129208–04–4,
129870–77–5, 129870–80–0, 130354–37–9, 136504–88–6, 143372–50–3, 143372–51–4,
144336–75–4, 146815–57–8, 151688–56–1, 154518–39–5, 154518–40–8, 155240–11–2,
157627–92–4, 159704–69–5, 160498–49–7, 160611–24–5, 171543–66–1, 172027–16–6,
172274–69–0, 176707–42–9, 181963–82–6, 188741–55–1, 191940–53–1, 210493–60–0,
210993–53–6, 246159–55–7, 251298–11–0, 261627–68–3, 290348–69–5, 290348–70–8,
317833–96–8, 340681–28–9 , 422563–19–7, 422563–26–6, 522613–09–8, 717140–06–2,
717140–09–5, 717827–29–7, 762245–80–7, 762245–81–8, 866538–89–8, 866538–90–1,
873662–29–4, 913068–96–9, 936100–29–7, 936100–30–0, 1072943–56–6, 1087209–87–7,
1174313–54–2, 1187742–89–7, 1187743–35–6, 1205632–03–6, 1233235–49–8, 1451002–50–8,
1456802–88–2, 1456802–89–3, 1456803–12–5).
*
Not to exceed 30%
of formulation.
*
Surfactants, related
adjuvants of
surfactants.
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations
3. In § 180.930, revise the inert
ingredient(s) in the table to read as
follows:
■
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
*
*
a-alkyl(C6-C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4 moles (CAS Reg. Nos.:
3088–31–1, 3694–74–4, 9004–82–4, 9004–84–6, 9021–91–4, 9086–52–6, 13150–00–0, 15826–
16–1, 25446–78–0, 26183–44–8, 27140–00–7, 27731–61–9, 27731–61–9, 27731–62–0, 32612–
48–9, 34431–25–9, 35015–74–8, 50602–06–7, 52286–18–7, 52286–19–8, 54116–08–4, 55901–
67–2, 61702–79–2, 61894–66–4, 62755–21–9, 63428–85–3, 63428–86–4, 63428–87–5, 65086–
57–9, 65086–79–5, 65104–74–7, 65122–38–5, 67674–66–2, 67762–19–0, 67762–21–4, 67845–
82–3, 67845–83–4, 67923–90–4, 68037–05–8, 68037–06–9, 68171–41–5, 68424–50–0, 68511–
39–7, 68585–34–2, 68610–66–2, 68611–29–0, 68611–55–2, 68649–53–6, 68890–88–0, 68891–
29–2, 68891–30–5, 68891–38–3, 69011–37–6, 73665–22–2, 75422–21–8, 78330–16–2, 78330–
17–3, 78330–25–3, 78330–26–4, 78330–27–5, 78330–28–6, 78330–29–7, 78330–30–0, 96130–
61–9, 106597–03–9, 110392–50–2, 119432–41–6, 125301–88–4, 125301–89–5, 125301–92–0,
125736–54–1, 157627–92–4, 157707–85–2, 160104–51–8, 160901–27–9, 160901–28–0,
160901–29–1, 160901–30–4, 161025–28–1, 161074–79–9, 162063–19–6, 219756–63–5).
a-alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-w-hydroxypolyoxyethylene
polymer with or without polyoxypropylene, mixture of di- and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and
zinc salts of the phosphate esters; minimum oxyethylene content is 2 moles; minimum
oxypropylene content is 0 moles (CAS Reg. Nos.: 9004–80–2, 9046–01–9, 26982–05–8, 31800–
89–2, 37280–82–3, 37281–86–0, 39341–09–8, 39341–65–6, 39464–66–9, 39464–69–2, 42612–
52–2, 50643–20–4, 50668–50–3, 51325–10–1, 51884–64–1, 52019–36–0, 57486–09–6, 58206–
38–5, 58318–92–6, 58857–49–1, 59112–71–9, 60267–55–2, 61837–79–4, 62362–49–6, 62482–
61–5, 63747–86–4, 63887–54–7, 63887–55–8, 66020–37–9, 66272–25–1, 66281–20–7, 67711–
84–6, 67786–06–5, 67989–06–4, 68070–99–5, 68071–17–0, 68071–35–2, 68071–37–4, 68130–
44–9, 68130–45–0, 68130–46–1, 68130–47–2, 68186–29–8, 68186–34–5, 68186–36–7, 68186–
37–8, 68238–84–6, 68311–02–4, 68311–04–6, 68332–75–2, 68389–72–0, 68400–75–9, 68413–
78–5, 68425–73–0, 68425–75–2, 68439–39–4, 68458–48–0, 68511–15–9, 68511–36–4, 68511–
37–5, 68551–05–3, 68585–15–9, 68585–16–0, 68585–17–1, 68585–36–4, 68585–39–7, 68603–
24–7, 68607–14–7, 68610–64–0, 68610–65–1, 68649–29–6, 68649–30–9, 68650–84–0, 68815–
11–2, 68855–46–9, 68856–03–1, 68890–90–4, 68890–91–5, 68891–12–3, 68891–13–4, 68891–
26–9, 68908–64–5, 68909–65–9, 68909–67–1, 68909–69–3, 68921–24–4, 68921–60–8, 68954–
87–0, 68954–88–1, 68954–92–7, 68987–35–9, 69029–43–2, 69980–69–4, 70247–99–3, 70248–
14–5, 70844–96–1, 70903–63–8, 71965–23–6, 71965–24–7, 72480–27–4, 72623–67–7, 72623–
68–8, 72828–56–9, 72828–57–0, 73018–34–5, 73038–25–2, 73050–08–5, 73050–09–6, 73361–
29–2, 73378–71–9, 73378–72–0, 73559–42–9, 73559–43–0, 73559–44–1, 73559–45–2, 74499–
76–6, 76930–25–1, 78041–18–6, 78330–22–0, 78330–24–2, 82465–25–6, 84843–37–8, 91254–
26–1, 93925–54–3, 95014–34–9, 96416–89–6, 99924–51–3, 103170–31–6, 103170–32–7,
106233–09–4, 106233–10–7, 108818–88–8, 110392–49–9, 111798–26–6, 111905–50–1,
116671–23–9, 117584–36–8, 119415–05–3, 120913–45–3, 121158–61–0, 121158–63–2,
123339–53–7, 125139–13–1, 125301–86–2, 125301–87–3, 126646–03–5, 129208–04–4,
129870–77–5, 129870–80–0, 130354–37–9, 136504–88–6, 143372–50–3, 143372–51–4,
144336–75–4, 146815–57–8, 151688–56–1, 154518–39–5, 154518–40–8, 155240–11–2,
157627–92–4, 159704–69–5, 160498–49–7, 160611–24–5, 171543–66–1, 172027–16–6,
172274–69–0, 176707–42–9, 181963–82–6, 188741–55–1, 191940–53–1, 210493–60–0,
210993–53–6, 246159–55–7, 251298–11–0, 261627–68–3, 290348–69–5, 290348–70–8,
317833–96–8, 340681–28–9 , 422563–19–7, 422563–26–6, 522613–09–8, 717140–06–2,
717140–09–5, 717827–29–7, 762245–80–7, 762245–81–8, 866538–89–8, 866538–90–1,
873662–29–4, 913068–96–9, 936100–29–7, 936100–30–0, 1072943–56–6, 1087209–87–7,
1174313–54–2, 1187742–89–7, 1187743–35–6, 1205632–03–6, 1233235–49–8, 1451002–50–8,
1456802–88–2, 1456802–89–3, 1456803–12–5).
*
Not to exceed 30%
of formulation.
*
*
*
*
*
*
[FR Doc. 2022–01486 Filed 2–1–22; 8:45 am]
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02FER1
Uses
Surfactants, related
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Agencies
[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Rules and Regulations]
[Pages 5703-5708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01486]
[[Page 5703]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0656; FRL-9326-01-OCSPP]
Alcohols, C10-16, Ethoxylated, Sulfates,
Mono(hydroxyethyl)ammonium Salts (CAS No. 157627-92-4); Tolerance
Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of alcohols, C10-16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts (CAS No. 157627-92-4); when used as an
inert ingredient in pesticide formulations used pre- and post-harvest
as well as in formulations applied to livestock. Spring Regulatory
Sciences, on behalf of BASF Corporation, submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance for specific uses. This
regulation eliminates the need to establish a maximum permissible level
for residues of alcohols, C10-16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts (CAS No. 157627-92-4) on food or feed
commodities or when applied to livestock.
DATES: This regulation is effective February 2, 2022. Objections and
requests for hearings must be received on or before April 4, 2022, 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-2021-0656, 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.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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 Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title40.
C. 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-2021-0656 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
April 4, 2022. 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-2021-0656, 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 October 21, 2021 (86 FR 58239) (FRL-
8792-04), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11530) filed by Spring Regulatory Sciences (6620 Cypresswood Dr. Suite
250, Spring, TX 77379), on behalf of BASF Corporation (100 Park Avenue,
Florham Park, New Jersey 07932). The petition requested that 40 CFR
180.910 and 180.930 be amended by establishing an exemption from the
requirement of a tolerance for residues of alcohols, C10-16,
ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts (CAS No.
157627-92-4) for use as an inert ingredient at no more than 30% by
weight of the final pesticide formulation. That document included a
summary of the petition prepared by the petitioner and solicited
comments on the petitioner's request. The Agency did not receive any
public comments.
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
[[Page 5704]]
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. Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown 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(b)(2)(D), 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 and considered its validity, completeness and reliability and
the relationship of this information 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. EPA has sufficient data to assess the hazards of
and to make a determination on aggregate exposure to alcohols, C10-16,
ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with alcohols, C10-16,
ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and republishing the same sections is
unnecessary. EPA considers referral back to those sections as
sufficient to provide an explanation of the information EPA considered
in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for alkyl
alcohol alkoxylate phosphate derivatives (AAAPDs) and alkyl alcohol
alkoxylate sulfate derivatives (AAASDs), in which EPA concluded, based
on the available information, that there is a reasonable certainty that
no harm would result from aggregate exposure to AAAPDs and AAASDs, and
established tolerances for residues of those chemicals. EPA is
incorporating previously published sections from that rulemaking as
described further in this rulemaking, as they remain unchanged. The
past rule EPA cites here covers AAAPDs and AAASDs, which are
collectively referred to as alkyl alcohol alkoxylate phosphate and
sulfate derivatives (AAAPSDs). Alcohols, C10-16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts (CAS No. 157627-92-4) is an AAASD that
is synthesized as a mixture. Based on the structural and
physicochemical similarities between Alcohols, C10-16, ethoxylated,
sulfates, mono(hydroxyethyl)ammonium salts (CAS No. 157627-92-4) and
other AAAPSDs previously assessed by EPA, the data used in the 2009
risk assessment for AAAPSDs is considered appropriate to assess
alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium
salts.
A. Toxicological Profile
The Toxicological Profile of alcohols, C10-16, ethoxylated,
sulfates, mono(hydroxyethyl)ammonium salts remain unchanged from the
Toxicological Profile in Unit IV.A. of the July 29, 2009 rulemaking (74
FR 37571) (FRL-8424-6). Refer to that section for a discussion of the
Toxicological Profile of AAAPSDs.
B. Toxicological Points of Departure/Levels of Concern
The Toxicological Points of Departure/Levels of Concern of
alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium
salts remain unchanged from the Toxicological Profile in Unit IV.B. of
the July 29, 2009 rulemaking (74 FR 37571) (FRL-8424-6). Refer to that
section for a discussion of the Toxicological Points of Departure/
Levels of Concern of AAAPSDs.
C. Exposure Assessment
The exposure assessment for alcohols, C10-16, ethoxylated,
sulfates, mono(hydroxyethyl)ammonium salts remain unchanged from the
July 29, 2009 rulemaking and supporting human health risk assessment
(D365210, June 8, 2009). Provided that the AAAPSDs are limited to no
more than 30% by weight in the final formulation, there were no
dietary, residential or aggregate risks of concern for the U.S.
population and all subpopulations. No occupational risks of concern
were identified when assuming that mixer/loader/applicators will wear
chemical-resistant gloves. Based on this human health risk assessment,
an exemption from the requirement of a tolerance was established under
40 CFR 180.920 for pre-harvest use of AAAPDs to no more than 30% by
weight in pesticide end-use products. This risk assessment also
supported the use of the AAASD inert ingredients in pesticide
formulations intended for use pre- and post-harvest (40 CFR 180.910) as
well as for use on livestock (40 CFR 180.930). Therefore, provided
alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium
salts are limited to no more than 30% by weight in the final
formulation, there
[[Page 5705]]
are no dietary, residential or aggregate risks of concern for the U.S.
population and all subpopulations. As a result, the Agency has
determined that a tolerance is not necessary to protect public health.
D. 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 determined that alcohols, C10-16, ethoxylated,
sulfates, mono(hydroxyethyl)ammonium salts share a common mechanism of
toxicity with any other substances, and alcohols, C10-16, ethoxylated,
sulfates, mono(hydroxyethyl)ammonium salts do not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that alcohols, C10-16,
ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts do 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.
E. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold 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 data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. EPA continues to conclude that there is reliable data showing
that the safety of infants and children would be adequately protected
if the Food Quality Protection Act (FQPA) safety factor were reduced
from 10x to 1x. The reasons for that decision are articulated in Unit
IV.D. of the July 29, 2009 rulemaking.
F. Determination of Safety
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to alcohols, C10-16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts. More detailed information about the
Agency's analysis can be found at https://www.regulations.gov in the
documents titled ``Alkyl Alcohol Alkoxylate Phosphate and Sulfate
Derivatives (AAAPDs and AAASDs--JITF CST 2 Inert Ingredients). Human
Health Risk Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide
Formulations'' and ``IN-11530; Petition to Add Alcohols, C10-16,
Ethoxylated, Sulfates, Mono(hydroxyethyl)ammonium Salts (CAS No.
157627-92-4) to the Current Tolerance Exemption for Alkyl Alcohol
Alkoxylate Phosphate and Sulfate Derivatives (AAAPSDs)'' These
documents can be found in docket ID numbers EPA-HQ-OPP-2009-0131 and
EPA-HQ-OPP-2021-0656.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium
salts in or on any food commodities. EPA is establishing a limitation
on the amount of alcohols, C10-16, ethoxylated, sulfates,
mono(hydroxyethyl)ammonium salts that may be used in pesticide
formulations. This limitations will be enforced through the pesticide
registration process under the Federal Insecticide, Fungicide, and
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register
any pesticide formulation for food use that exceeds 30% by weight of
alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium
salts in the final pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for alcohols, C10-16,
ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts.
VI. Conclusion
EPA finds that exempting residues of alcohols, C10-16, ethoxylated,
sulfates, mono(hydroxyethyl)ammonium salts from the requirement of a
tolerance will be safe. Therefore, an exemption from the requirement of
a tolerance is established under 40 CFR 180.910 and 180.930 for
alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium
salts when used as an inert ingredient at no more than 30% by weight in
pesticide formulations.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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
[[Page 5706]]
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: January 20, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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, revise the inert ingredient(s) in the table to
read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest;
exemptions from the requirement of a tolerance.
* * * * *
[[Page 5707]]
Table 1 to 180.910
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-alkyl(C6-C15)-[omega]- Not to exceed 30% Surfactants,
hydroxypoly(oxyethylene)sulfate of formulation. related adjuvants
, and its ammonium, calcium, of surfactants.
magnesium, potassium, sodium,
and zinc salts,
poly(oxyethylene) content
averages 2-4 moles (CAS Reg.
Nos.: 3088-31-1, 3694-74-4,
9004-82-4, 9004-84-6, 9021-91-
4, 9086-52-6, 13150-00-0, 15826-
16-1, 25446-78-0, 26183-44-8,
27140-00-7, 27731-62-0, 32612-
48-9, 34431-25-9, 35015-74-8,
50602-06-7, 52286-18-7, 52286-
19-8, 54116-08-4, 55901-67-2,
61702-79-2, 61894-66-4, 62755-
21-9, 63428-85-3, 63428-86-4,
63428-87-5, 65086-57-9, 65086-
79-5, 65104-74-7, 65122-38-5,
67674-66-2, 67762-19-0, 67762-
21-4, 67845-82-3, 67845-83-4,
67923-90-4, 68037-05-8, 68037-
06-9, 68171-41-5, 68424-50-0,
68511-39-7, 68585-34-2, 68610-
66-2, 68611-29-0, 68611-55-2,
68649-53-6, 68890-88-0, 68891-
29-2, 68891-30-5, 68891-38-3,
69011-37-6, 73665-22-2, 75422-
21-8, 78330-16-2, 78330-17-3,
78330-25-3, 78330-26-4, 78330-
27-5, 78330-28-6, 78330-29-7,
78330-30-0, 96130-61-9, 106597-
03-9, 110392-50-2, 119432-41-6,
125301-88-4, 125301-89-5,
125301-92-0, 125736-54-1,
157627-92-4, 157707-85-2,
160104-51-8, 160901-27-9,
160901-28-0, 160901-29-1,
160901-30-4, 161025-28-1,
161074-79-9, 162063-19-6,
219756-63-5).
[alpha]-alkyl (minimum C6
linear, branched, saturated and/
or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer
with or without
polyoxypropylene, mixture of di-
and monohydrogen phosphate
esters and the corresponding
ammonium, calcium, magnesium,
monoethanolamine, potassium,
sodium, and zinc salts of the
phosphate esters; minimum
oxyethylene content is 2 moles;
minimum oxypropylene content is
0 moles (CAS Reg. Nos.: 9004-80-
2, 9046-01-9, 26982-05-8, 31800-
89-2, 37280-82-3, 37281-86-0,
39341-09-8, 39341-65-6, 39464-
66-9, 39464-69-2, 42612-52-2,
50643-20-4, 50668-50-3, 51325-
10-1, 51884-64-1, 52019-36-0,
57486-09-6, 58206-38-5, 58318-
92-6, 58857-49-1, 59112-71-9,
60267-55-2, 61837-79-4, 62362-
49-6, 62482-61-5, 63747-86-4,
63887-54-7, 63887-55-8, 66020-
37-9, 66272-25-1, 66281-20-7,
67711-84-6, 67786-06-5, 67989-
06-4, 68070-99-5, 68071-17-0,
68071-35-2, 68071-37-4, 68130-
44-9, 68130-45-0, 68130-46-1,
68130-47-2, 68186-29-8, 68186-
34-5, 68186-36-7, 68186-37-8,
68238-84-6, 68311-02-4, 68311-
04-6, 68332-75-2, 68389-72-0,
68400-75-9, 68413-78-5, 68425-
73-0, 68425-75-2, 68439-39-4,
68458-48-0, 68511-15-9, 68511-
36-4, 68511-37-5, 68551-05-3,
68585-15-9, 68585-16-0, 68585-
17-1, 68585-36-4, 68585-39-7,
68603-24-7, 68607-14-7, 68610-
64-0, 68610-65-1, 68649-29-6,
68649-30-9, 68650-84-0, 68815-
11-2, 68855-46-9, 68856-03-1,
68890-90-4, 68890-91-5, 68891-
12-3, 68891-13-4, 68891-26-9,
68908-64-5, 68909-65-9, 68909-
67-1, 68909-69-3, 68921-24-4,
68921-60-8, 68954-87-0, 68954-
88-1, 68954-92-7, 68987-35-9,
69029-43-2, 69980-69-4, 70247-
99-3, 70248-14-5, 70844-96-1,
70903-63-8, 71965-23-6, 71965-
24-7, 72480-27-4, 72623-67-7,
72623-68-8, 72828-56-9, 72828-
57-0, 73018-34-5, 73038-25-2,
73050-08-5, 73050-09-6, 73361-
29-2, 73378-71-9, 73378-72-0,
73559-42-9, 73559-43-0, 73559-
44-1, 73559-45-2, 74499-76-6,
76930-25-1, 78041-18-6, 78330-
22-0, 78330-24-2, 82465-25-6,
84843-37-8, 91254-26-1, 93925-
54-3, 95014-34-9, 96416-89-6,
99924-51-3, 103170-31-6, 103170-
32-7, 106233-09-4, 106233-10-7,
108818-88-8, 110392-49-9,
111798-26-6, 111905-50-1,
116671-23-9, 117584-36-8,
119415-05-3, 120913-45-3,
121158-61-0, 121158-63-2,
123339-53-7, 125139-13-1,
125301-86-2, 125301-87-3,
126646-03-5, 129208-04-4,
129870-77-5, 129870-80-0,
130354-37-9, 136504-88-6,
143372-50-3, 143372-51-4,
144336-75-4, 146815-57-8,
151688-56-1, 154518-39-5,
154518-40-8, 155240-11-2,
157627-92-4, 159704-69-5,
160498-49-7, 160611-24-5,
171543-66-1, 172027-16-6,
172274-69-0, 176707-42-9,
181963-82-6, 188741-55-1,
191940-53-1, 210493-60-0,
210993-53-6, 246159-55-7,
251298-11-0, 261627-68-3,
290348-69-5, 290348-70-8,
317833-96-8, 340681-28-9 ,
422563-19-7, 422563-26-6,
522613-09-8, 717140-06-2,
717140-09-5, 717827-29-7,
762245-80-7, 762245-81-8,
866538-89-8, 866538-90-1,
873662-29-4, 913068-96-9,
936100-29-7, 936100-30-0,
1072943-56-6, 1087209-87-7,
1174313-54-2, 1187742-89-7,
1187743-35-6, 1205632-03-6,
1233235-49-8, 1451002-50-8,
1456802-88-2, 1456802-89-3,
1456803-12-5).
* * * * * * *
------------------------------------------------------------------------
[[Page 5708]]
0
3. In Sec. 180.930, revise the inert ingredient(s) in the table to
read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
Table 1 to 180.910
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * *
[alpha]-alkyl(C6-C15)-[omega]- Not to exceed 30% Surfactants,
hydroxypoly(oxyethylene)sulfate of formulation. related adjuvants
, and its ammonium, calcium, of surfactants.
magnesium, potassium, sodium,
and zinc salts,
poly(oxyethylene) content
averages 2-4 moles (CAS Reg.
Nos.: 3088-31-1, 3694-74-4,
9004-82-4, 9004-84-6, 9021-91-
4, 9086-52-6, 13150-00-0, 15826-
16-1, 25446-78-0, 26183-44-8,
27140-00-7, 27731-61-9, 27731-
61-9, 27731-62-0, 32612-48-9,
34431-25-9, 35015-74-8, 50602-
06-7, 52286-18-7, 52286-19-8,
54116-08-4, 55901-67-2, 61702-
79-2, 61894-66-4, 62755-21-9,
63428-85-3, 63428-86-4, 63428-
87-5, 65086-57-9, 65086-79-5,
65104-74-7, 65122-38-5, 67674-
66-2, 67762-19-0, 67762-21-4,
67845-82-3, 67845-83-4, 67923-
90-4, 68037-05-8, 68037-06-9,
68171-41-5, 68424-50-0, 68511-
39-7, 68585-34-2, 68610-66-2,
68611-29-0, 68611-55-2, 68649-
53-6, 68890-88-0, 68891-29-2,
68891-30-5, 68891-38-3, 69011-
37-6, 73665-22-2, 75422-21-8,
78330-16-2, 78330-17-3, 78330-
25-3, 78330-26-4, 78330-27-5,
78330-28-6, 78330-29-7, 78330-
30-0, 96130-61-9, 106597-03-9,
110392-50-2, 119432-41-6,
125301-88-4, 125301-89-5,
125301-92-0, 125736-54-1,
157627-92-4, 157707-85-2,
160104-51-8, 160901-27-9,
160901-28-0, 160901-29-1,
160901-30-4, 161025-28-1,
161074-79-9, 162063-19-6,
219756-63-5).
[alpha]-alkyl (minimum C6
linear, branched, saturated and/
or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer
with or without
polyoxypropylene, mixture of di-
and monohydrogen phosphate
esters and the corresponding
ammonium, calcium, magnesium,
monoethanolamine, potassium,
sodium, and zinc salts of the
phosphate esters; minimum
oxyethylene content is 2 moles;
minimum oxypropylene content is
0 moles (CAS Reg. Nos.: 9004-80-
2, 9046-01-9, 26982-05-8, 31800-
89-2, 37280-82-3, 37281-86-0,
39341-09-8, 39341-65-6, 39464-
66-9, 39464-69-2, 42612-52-2,
50643-20-4, 50668-50-3, 51325-
10-1, 51884-64-1, 52019-36-0,
57486-09-6, 58206-38-5, 58318-
92-6, 58857-49-1, 59112-71-9,
60267-55-2, 61837-79-4, 62362-
49-6, 62482-61-5, 63747-86-4,
63887-54-7, 63887-55-8, 66020-
37-9, 66272-25-1, 66281-20-7,
67711-84-6, 67786-06-5, 67989-
06-4, 68070-99-5, 68071-17-0,
68071-35-2, 68071-37-4, 68130-
44-9, 68130-45-0, 68130-46-1,
68130-47-2, 68186-29-8, 68186-
34-5, 68186-36-7, 68186-37-8,
68238-84-6, 68311-02-4, 68311-
04-6, 68332-75-2, 68389-72-0,
68400-75-9, 68413-78-5, 68425-
73-0, 68425-75-2, 68439-39-4,
68458-48-0, 68511-15-9, 68511-
36-4, 68511-37-5, 68551-05-3,
68585-15-9, 68585-16-0, 68585-
17-1, 68585-36-4, 68585-39-7,
68603-24-7, 68607-14-7, 68610-
64-0, 68610-65-1, 68649-29-6,
68649-30-9, 68650-84-0, 68815-
11-2, 68855-46-9, 68856-03-1,
68890-90-4, 68890-91-5, 68891-
12-3, 68891-13-4, 68891-26-9,
68908-64-5, 68909-65-9, 68909-
67-1, 68909-69-3, 68921-24-4,
68921-60-8, 68954-87-0, 68954-
88-1, 68954-92-7, 68987-35-9,
69029-43-2, 69980-69-4, 70247-
99-3, 70248-14-5, 70844-96-1,
70903-63-8, 71965-23-6, 71965-
24-7, 72480-27-4, 72623-67-7,
72623-68-8, 72828-56-9, 72828-
57-0, 73018-34-5, 73038-25-2,
73050-08-5, 73050-09-6, 73361-
29-2, 73378-71-9, 73378-72-0,
73559-42-9, 73559-43-0, 73559-
44-1, 73559-45-2, 74499-76-6,
76930-25-1, 78041-18-6, 78330-
22-0, 78330-24-2, 82465-25-6,
84843-37-8, 91254-26-1, 93925-
54-3, 95014-34-9, 96416-89-6,
99924-51-3, 103170-31-6, 103170-
32-7, 106233-09-4, 106233-10-7,
108818-88-8, 110392-49-9,
111798-26-6, 111905-50-1,
116671-23-9, 117584-36-8,
119415-05-3, 120913-45-3,
121158-61-0, 121158-63-2,
123339-53-7, 125139-13-1,
125301-86-2, 125301-87-3,
126646-03-5, 129208-04-4,
129870-77-5, 129870-80-0,
130354-37-9, 136504-88-6,
143372-50-3, 143372-51-4,
144336-75-4, 146815-57-8,
151688-56-1, 154518-39-5,
154518-40-8, 155240-11-2,
157627-92-4, 159704-69-5,
160498-49-7, 160611-24-5,
171543-66-1, 172027-16-6,
172274-69-0, 176707-42-9,
181963-82-6, 188741-55-1,
191940-53-1, 210493-60-0,
210993-53-6, 246159-55-7,
251298-11-0, 261627-68-3,
290348-69-5, 290348-70-8,
317833-96-8, 340681-28-9 ,
422563-19-7, 422563-26-6,
522613-09-8, 717140-06-2,
717140-09-5, 717827-29-7,
762245-80-7, 762245-81-8,
866538-89-8, 866538-90-1,
873662-29-4, 913068-96-9,
936100-29-7, 936100-30-0,
1072943-56-6, 1087209-87-7,
1174313-54-2, 1187742-89-7,
1187743-35-6, 1205632-03-6,
1233235-49-8, 1451002-50-8,
1456802-88-2, 1456802-89-3,
1456803-12-5).
* * * * * *
------------------------------------------------------------------------
[FR Doc. 2022-01486 Filed 2-1-22; 8:45 am]
BILLING CODE 6560-50-P