Document ID: EPA-HQ-OPP-2017-0372-0012
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: 1-Octanamine, N, N-dimethyl-, N-oxide
Posted Date: 2020-09-16T04:00Z

[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Rules and Regulations]
[Pages 57750-57754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19347]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0312; FRL-10003-75]

1-Octanamine, N, N-dimethyl-, N-oxide; 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 1-octanamine, N,N-dimethyl-, N-oxide 
(CAS Reg. No. 2605-78-9) when used as an inert ingredient (surfactant) 
in pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest, at a concentration of not more than 15% by 
weight in pesticide formulations. The Spring Trading Company, on behalf 
of Oxiteno USA, LLC, submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of 1-octanamine, N,N-dimethyl-, N-oxide when used in 
accordance with the terms of the exemption.

DATES: This regulation is effective September 16, 2020. Objections and 
requests for hearings must be received on or before November 16, 2020 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0312, 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. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.
    Please note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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, 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-2017-0312 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 
November 16, 2020. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0312, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11046) by the Spring Trading Company on behalf of Oxiteno USA, LLC, 
9801 Bay Area Blvd., Pasadena, TX 77507. The petition requested that 40 
CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of 1-octanamine, N,N-dimethyl-, 
N-oxide (CAS Reg. No. 2605-78-9) when used as an inert ingredient 
(surfactant) in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest. That document referenced a 
summary of the petition prepared by the Spring Trading Company on 
behalf of Oxiteno USA, LLC, the petitioner, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's

[[Page 57751]]

response to these comments is discussed in Unit V.C.
    Based upon review of the data supporting the petition, EPA is 
establishing the requested exemption but with a limitation that the 
end-use product not contain 1-octanamine, N,N- dimethyl-, N-oxide in a 
concentration that exceeds 15% by weight. The reasons for this 
limitation are explained in the Agency's risk assessment which can be 
found at http://www.regulations.gov in document ``IN-11046; 1-
Octanamine, N,N-dimethyl-, N-oxide--Human Health Risk and Ecological 
Effects Assessment of Request for Food Use Inert Ingredient in docket 
ID number EPA-HQ-OPP-2017-0312.''

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 appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 1-octanamine, N,N-dimethyl-, N-
oxide including exposure resulting from the exemption established by 
this action. EPA's assessment of exposures and risks associated with 1-
octanamine, N,N-dimethyl-, N-oxide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Specific information on the studies received and the nature of the 
adverse effects caused by 1-octanamine, N,N-dimethyl-, N-oxide as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at http://www.regulations.gov in the document entitled ``IN-
11046; 1-Octanamine, N,N-dimethyl-, N-oxide--Human Health Risk and 
Ecological Effects Assessment of Request for Food Use Inert 
Ingredient'' at pages 3-5 in docket ID number EPA-HQ-OPP-2017-0312.

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.
    The toxicity endpoint selected for use in risk assessment is taken 
from the 28-day, repeat-dose toxicity study of 1-octanamine, N,N-
dimethyl-, N-oxide in which a NOAEL was established at 150 mg/kg/day 
based on decreases in body weight, food consumption, mortality, 
clinical signs of toxicity, decreased motor activity, histopathology of 
the kidney and spleen, and effects on hematology and clinical chemistry 
parameters seen at 750 mg/kg/day. The uncertainty factors include 10X 
for interspecies extrapolation, 10X for intraspecies variation, and a 
1X for the FQPA Safety Factor, bringing the combined uncertainty factor 
to 100. The resultant chronic Population Adjusted Dose (cPAD) is 1.5 
mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 1-octanamine, N,N-dimethyl-, N-oxide, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance. EPA assessed dietary exposures from 1-

[[Page 57752]]

octanamine, N,N-dimethyl-, N-oxide in food as follows:
    Because no acute endpoint of concern was identified, a quantitative 
acute dietary exposure assessment is unnecessary. In conducting the 
chronic dietary exposure assessment using the Dietary Exposure 
Evaluation Model (DEEM)--FCID\TM\, Version 3.16, EPA used food 
consumption information from the U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 
2008. Dietary exposure is estimated using the Agency's Dietary Exposure 
Estimate Model (DEEM). The Inert Dietary Exposure Evaluation Model (I-
DEEM) is a highly conservative model with the assumption that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation between the active and 
inert ingredient (if any) and that the concentration of inert 
ingredient in the scenarios leading to these highest of tolerances 
would be no higher than the concentration of the active ingredient. The 
model assumes 100 percent crop treated (PCT) for all crops and that 
every food eaten by a person each day has tolerance-level residues. In 
the case of1-octanamine, N,N-dimethyl-, N-oxide, a 15% by weight 
limitation in formulation was incorporated into the model.
    A complete description of the general approach taken to assess 
inert ingredient risks in the absence of residue data is contained in 
the memorandum entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): 
Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure 
and Risk Assessments for the Inerts,'' (D361707, S. Piper, 2/25/09) and 
can be found at http://www.regulations.gov in docket ID number EPA-HQ-
OPP-2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the 
screening-level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for 1-octanamine, N,N-
dimethyl-, N-oxide, a conservative drinking water concentration value 
of 100 ppb based on screening-level modeling was used to assess the 
contribution to drinking water for the chronic dietary risk assessments 
for parent compound. These values were directly entered into the 
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    1-Octanamine, N,N-dimethyl-, N-oxide may be used as an inert 
ingredient in pesticide products that are registered for specific uses 
that may result in residential exposure, such as pesticides used in and 
around the home, and in non-pesticide products such as household 
products, personal care products and cosmetics. In a conservative 
effort to assess residential exposure, EPA has conducted a screening-
level assessment using high-end residential exposure scenarios, such as 
pesticides used on lawns/turn, as antimicrobial cleaning products and 
in pet spot on applications.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found 1-octanamine, N,N-dimethyl-, N-oxide to share a 
common mechanism of toxicity with any other substances, and 1-
octanamine, N,N-dimethyl-, N-oxide does do not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that 1-octanamine, N,N-
dimethyl-, N-oxide does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. FFDCA Section 408(b)(2)(c) provides that EPA shall 
apply an additional tenfold (10X) margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor 
(SF). In applying this provision, EPA either retains the default value 
of 10X, or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
quantitative or qualitative susceptibility was seen in developmental 
toxicity studies in rats and rabbits with 1-octanamine, N,N-dimethyl-, 
N-oxide. No adverse effects on reproductive parameters were observed in 
a 2-generation rat reproductive study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The database for 1-octanamine, N,N-dimethyl-, N-oxide is 
considered adequate for FQPA assessment.
    ii. A combined repeated dose toxicity study with a reproduction/
developmental toxicity screening test showed no effect on reproductive 
parameters of fertility in the absence of maternal toxicity.
    iii. Although no neurotoxicity studies are available, no clinical 
signs of neurotoxicity were observed. Therefore, there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iv. Immunotoxicity studies were not available. However, there were 
no test-item related signs of immunotoxicity noted in the repeat-dose 
study.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and incorporated a limitation of 15% by weight in pesticide 
formulation. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 1-
octanamine, N,N-dimethyl-, N-oxide in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children. These assessments will not underestimate the exposure and 
risks posed by 1-octanamine, N,N-dimethyl-, N-oxide.

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

[[Page 57753]]

PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, no adverse effects were attributed to a single 
exposure of the acute dietary exposure from food and water to -
octanamine, N,N-dimethyl-, N-oxide. Therefore, 1-octanamine, N,N-
dimethyl-, N-oxide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
1-octanamine, N,N-dimethyl-, N-oxide, from food and water will utilize 
14.1% of the cPAD for all infants less than 1 year old, the population 
group receiving the greatest exposure. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of 1-octanamine, N,N-dimethyl-, N-oxide is not 
expected.
    3. Short-term risk. Short-term aggregate exposure considers short-
term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). 1-Octanamine, N,N-
dimethyl-, N-oxide is currently 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 1-octanamine, N,N-dimethyl-, 
N-oxide.
    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 1978 for adults 
and 589 for children. Because EPA's level of concern for 1-octanamine, 
N,N-dimethyl-, N-oxide is an MOE of 100 or below, these MOEs are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 1-
octanamine, N,N-dimethyl-, N-oxide.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in a rodent carcinogenicity study, 1-
octanamine, N,N-dimethyl-, N-oxide is not expected to pose a cancer 
risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to 1-octanamine, N,N-dimethyl-, N-oxide residues.

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 1-
octanamine, N,N-dimethyl-, N-oxide in or on any food commodities. EPA 
is establishing limitations on the amount of 1-octanamine, N,N-
dimethyl-, N-oxide that may be used in pesticide formulations applied 
pre- and post- harvest. 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 
15% by weight of 1-octanamine, N,N-dimethyl-, N-oxide in the final 
pesticide formulation.

B. Response to Comments

    Two comments were received concerning the safety and impact of 
pesticides on food and human health. Although the Agency recognizes 
that some individuals believe that no residue of pesticides should be 
allowed in or on food, the existing legal framework provided by section 
408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes the 
establishment of pesticide tolerances or exemptions where the Agency 
determines that tolerance or exemption meets the safety standard 
imposed by the statute. EPA has sufficient data to support a safety 
determination for the exemption from the requirement of a tolerance for 
1-octanamine, N,N-dimethyl-, N-oxide. The commenters have provided no 
additional information supporting a determination that the exemption is 
not safe.

C. Revisions to Petitioned-For Tolerances

    Based upon an evaluation of the data included in the petition, EPA 
is establishing an exemption from the requirement of a tolerance for 
residues of 1-octanamine, N,N-dimethyl-, N-oxide when used in pesticide 
formulations as an inert ingredient (surfactant), not to exceed 15% by 
weight of the formulation, instead of the unlimited use requested. 
Because unlimited use of 1-Octanamine, N,N-dimethyl-, N-oxide resulted 
in aggregate risks of concern, EPA is establishing a 15% limitation in 
formulation to support the safety finding of these tolerance 
exemptions. The concern for unlimited use of theses inert ingredients 
is documented on page 4 of the Agency's risk assessment documents ``IN-
11046; 1-Octanamine, N,N-dimethyl-, N-oxide--Human Health Risk and 
Ecological Effects Assessment of Request for Food Use Inert 
Ingredient'' which can be found at http://www.regulations.gov in docket 
ID number EPA-HQ-OPP-2017-0312.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for 1-octanamine, N,N-dimethyl-, N-
oxide when used as an inert ingredient (surfactant) limited to 15% by 
weight in pesticide formulations applied to growing crops or raw 
agricultural commodities after harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 
require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

[[Page 57754]]

    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act (CRA)

    Pursuant to the CRA (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 26, 2020.
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, add alphabetically the inert ingredient ``1-
Octanamine, N,N-dimethyl-,N-oxide (CAS Reg. No. 2605-78-9)'' to the 
table to read as follows:

Sec.  180.910   Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
1-Octanamine, N,N-dimethyl-, N- Not to exceed 15% of    Surfactant.
 oxide (CAS Reg. No. 2605-78-    pesticide formulation.
 9).
 
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[FR Doc. 2020-19347 Filed 9-15-20; 8:45 am]
BILLING CODE 6560-50-P