Document ID: EPA-HQ-OPP-2021-0164-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: C10-C18-Alkyl dimethyl amine oxides
Posted Date: 2021-08-17T04:00Z

[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 [www.gpo.gov]
[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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (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: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of 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 
http://www.regulations.gov.

[[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 http://www.regulations.gov 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.

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 http://www.epa.gov/pesticides/cumulative.

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