Rule2021-17450
C10-C18-Alkyl Dimethyl Amine Oxides (ADAOs); Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 17, 2021
Effective
August 17, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of C10-C18-Alkyl dimethyl amine oxides herein referred to as ADAOs when used as inert ingredients (surfactants/foaming agents) in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy- processing equipment, food-processing equipment and utensils, limited to not more than 1,350 parts per million (ppm) at the end-use concentration in pesticide formulations. Technology Sciences Group Inc. on behalf of Mason Chemical Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ADAOs when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 86 Issue 156 (Tuesday, August 17, 2021)</title>
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[Federal Register Volume 86, Number 156 (Tuesday, August 17, 2021)]
[Rules and Regulations]
[Pages 45888-45892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17450]
[[Page 45888]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0164; FRL-8678-01-OCSPP]
C10-C18-Alkyl Dimethyl Amine Oxides (ADAOs); Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of C10-C18-Alkyl dimethyl amine oxides
herein referred to as ADAOs when used as inert ingredients
(surfactants/foaming agents) in antimicrobial pesticide formulations
applied to food-contact surfaces in public eating places, dairy-
processing equipment, food-processing equipment and utensils, limited
to not more than 1,350 parts per million (ppm) at the end-use
concentration in pesticide formulations. Technology Sciences Group Inc.
on behalf of Mason Chemical Company submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
amendment to an existing requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of ADAOs when used in accordance with this exemption.
DATES: This regulation is effective August 17, 2021. Objections and
requests for hearings must be received on or before October 18, 2021,
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-2021-0164, is available at <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#1f4d5b594d51706b767c7a6c5f7a6f7e31787069"><span class="__cf_email__" data-cfemail="4a180e0c1804253e23292f390a2f3a2b642d253c">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl">http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0164 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
October 18, 2021. 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-2021-0164, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11435) by
Technology Sciences Group Inc., 1150 18th Street NW, Suite 1000,
Washington, DC 20036, on behalf of Mason Chemical Company, 9075 Centre
Point Dr., Suite 400, West Chester, OH 45069. The petition requested
that 40 CFR 180.940(a) be amended by establishing an exemption from the
requirement of a tolerance for residues of ADAOs when used as inert
ingredients used as surfactants and foaming agents in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, food-processing equipment
and utensils. That document referenced a summary of the petition
prepared by Technology Sciences Group Inc. on behalf of the Mason
Chemical Company, the petitioner, which is available in the docket at
<a href="http://www.regulations.gov">http://www.regulations.gov</a>.
[[Page 45889]]
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
limited the maximum concentration of ADAOs to not more than 1,350 ppm
at the end-use concentration in pesticide formulations. This limitation
is based on the Agency's risk assessment, which can be found at <a href="http://www.regulations.gov">http://www.regulations.gov</a> in document ``C10-C18-Alkyldimethylamine oxides;
Human Health Risk Assessment and Ecological Effects Assessment to
Support Proposed Exemption from the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide Formulations'' in docket ID
number EPA-HQ-OPP-2021-0164.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm 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 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 ADAOs, including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with ADAOs follows.
On October 7, 2009, EPA published in the Federal Register a final
rule establishing an exemption from the requirement of a tolerance for
residues of ADAOs when used as an inert ingredient in pesticide
formulations applied to raw agricultural commodities pre- and post-
harvest. See 74 FR 51474 (FRL-8437-3). That document contains a summary
of the toxicological profile, toxicological points of departure/levels
of concern, certain assumptions for exposure assessment, and the
Agency's determination regarding the children's safety factor, which
have not changed except as described below.
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 ADAOs as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in Unit IV.A of
the final rule published in the Federal Register of October 7, 2009 (74
FR 51474) (FRL-8437-3).
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 <a href="http://www.epa.gov/pesticides/factsheets/riskassess.htm">http://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ADAOs, EPA considered exposure under the proposed exemption
from the requirement of a tolerance. To assess dietary exposures from
ADAOs in food, the Agency calculated the Daily Dietary Dose (DDD) and
the Estimated Daily Intake (EDI) using U.S. Food and Drug
Administration (FDA) Food Contact Surface Sanitizing Solution Dietary
Exposure Assessment Model. EPA's assessment used FDA's default
assumptions for the amount of residual solution or quantity of solution
remaining on the treated surface without rinsing with potable water (1
mg/cm\2\); surface area of the treated surface which comes into contact
with food (4,000 cm\2\); and the pesticide
[[Page 45890]]
migration fraction (100%). EPA used an application rate of ADAOs of
1,350 ppm, which was provided by the petitioner. EPA also derived
exposure amounts for population subgroups by accounting for body
weights and adjusting for relative food consumption using data from the
National Health and Nutrition Examination Survey (NHANES) (specifically
the 2003-2008 survey data).
ADAOs are currently exempt from the requirements of a tolerance
under 40 CFR 180.910 for use as inert ingredients in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest limited to 15% by weight in pesticide
formulations and use as a surfactant. One of the ADAO chemicals in the
group, alkyl (C10-16) dimethyl amine oxide, is also approved as an
antibacterial agent in dishwashing detergent for residential use.
Potential dietary exposures from these uses were included in the
overall dietary exposure.
2. Dietary exposure from drinking water. The proposed use of ADAOs
will not result in measurable levels in surface water or ground water
and therefore will not contribute to dietary exposure.
As stated above, ADAOs are approved for pre- and post-harvest uses
and for use in dishwashing detergent. Dietary exposures from drinking
water due to these uses are included in the overall dietary exposure.
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).
Indoor residential exposure may occur from use of ADAOs as inert
ingredients in antimicrobial pesticide products applied to food contact
surfaces. Indoor and outdoor residential exposure may also occur as a
result of current approved uses of ADAOs in pesticide formulations for
pre- and post-harvest application and in dishwashing detergent. ADAOs
are also used in soap and hair products. The Agency's assessment of
residential exposure combines exposure from all of the aforementioned
uses. A summary of certain other assumptions for exposure assessment of
ADAOs is discussed in Unit IV.C. of the final rule published in the
Federal Register of October 7, 2009 (74 FR 51474) (FRL-8437-3).
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) and (c)(2)(B) of FFDCA requires that,
when considering whether to establish, modify, or revoke a tolerance or
exemption, 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 ADAOs to share a common mechanism of toxicity
with any other substances, and ADAOs do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
action, therefore, EPA has assumed that ADAOs 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 <a href="http://www.epa.gov/pesticides/cumulative">http://www.epa.gov/pesticides/cumulative</a>.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) and (c)(2)(B) 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. EPA has
determined that reliable data show the safety of infants and children
would be adequately protected if the FQPA SF were reduced to 1X. The
rationale for the Agency's determination regarding the children's
safety factor is discussed in unit IV.D of the final rule published in
the Federal Register of October 7, 2009 (74 FR 51474) (FRL-8437-3).
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
ADAOs are not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described for
chronic exposure, EPA has concluded that chronic exposure to ADAOs from
food and water will utilize 91% of the cPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
ADAOs are 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 ADAOs.
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 171 and 101 for
the U.S. population and children 1 to 2 years old, respectively.
Because EPA's level of concern for ADAOs is MOEs of 100 or below, these
MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
ADAOs are currently used as inert ingredients 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 ADAOs.
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 322 and 104 for the U.S. population and children 1 to
2 years old, respectively. Because EPA's level of concern for ADAOs are
MOEs
[[Page 45891]]
of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to ADAOs.
6. Determination of safety. Taking into consideration all available
information on ADAOs, EPA has determined that there is a reasonable
certainty that no harm to the general population or any population
subgroup, including infants and children, will result from aggregate
exposure to residues of ADAOs. Therefore, the establishment of an
exemption from the requirement of a tolerance under 40 CFR 180.940(a)
for residues of ADAOs when used as inert ingredients in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, food-processing equipment,
and utensils limited to not more than 1,350 ppm at the end-use
concentration in pesticide formulations, is safe under FFDCA section
408.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
ADAOs in or on any food commodities. EPA is establishing limitations on
the amount of ADAOs that may be used in pesticide formulations applied
to food-contact surfaces in public eating places, dairy-processing
equipment, food-processing equipment, and utensils. These 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 1350 ppm of ADAOs in the end-use concentration in
pesticide formulations.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for C10-C18-Alkyl dimethyl amine
oxides (CAS Reg. Nos. 1643-20-5, 2571-88-2, 2605-79-0, 3332-27-2,
61788-90-7, 68955-55-5, 70592-80-2, 7128-91-8, 85408-48-6, and 85408-
49-7) when used as inert ingredients (surfactants/foaming agents) in
antimicrobial pesticide formulations applied to food-contact surfaces
in public eating places, dairy-processing equipment, food-processing
equipment and utensils limited to not more than 1,350 ppm at the end-
use concentration in pesticide formulations.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 10, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
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. 180.940, in paragraph (a), amend table 180.940(a) by adding
in alphabetical order an entry for the inert ingredient ``C10-C18-Alkyl
dimethyl amine oxides'' to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
[[Page 45892]]
Table 180.940(a)
------------------------------------------------------------------------
Inert ingredients CAS reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
C10-C18-Alkyl dimethyl amine 1643-20-5, 2571-88-2, When ready for
oxides. 2605-79-0, 3332-27-2, use, the end-
61788-90-7, 68955-55- use
5, 70592-80-2, 7128- concentration
91-8, 85408-48-6, and is not to
85408-49-7. exceed 1,350
ppm.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2021-17450 Filed 8-16-21; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.