Rule2022-10878
Cocamidopropylamine Oxide; 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
May 20, 2022
Effective
May 20, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of cocamidopropylamine oxide (CAS Reg. No. 68155-09-9) when used as an inert ingredient (surfactant) at a concentration not to exceed 6% by weight in glyphosate formulations. SciReg, Inc., on behalf of Albaugh, LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of cocamidopropylamine oxide when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 98 (Friday, May 20, 2022)</title>
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[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Rules and Regulations]
[Pages 30832-30836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10878]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0582; FRL-8959-01-OCSPP]
Cocamidopropylamine 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 cocamidopropylamine oxide (CAS Reg. No.
68155-09-9) when used as an inert ingredient (surfactant) at a
concentration not to exceed 6% by weight in glyphosate formulations.
SciReg, Inc., on behalf of Albaugh, LLC submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of cocamidopropylamine oxide when used in accordance with
this exemption.
DATES: This regulation is effective May 20, 2022. Objections and
requests for hearings must be received on or before July 19, 2022, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0582, 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 and OPP Docket is (202) 566-1744.
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 (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#d1839597839fbea5b8b2b4a291b4a1b0ffb6bea7"><span class="__cf_email__" data-cfemail="9cced8daced2f3e8f5fff9efdcf9ecfdb2fbf3ea">[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, 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-2021-0582 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
July 19, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0582, 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 September 22, 2021 (86 FR 52624)
(FRL8792-03), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11268) by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on
behalf of Albaugh, LLC. The petition requested that 40 CFR 180.920 be
amended by establishing an exemption from the requirement of a
tolerance for residues of cocamidopropylamine oxide when used as an
inert ingredient (surfactant) at a concentration not to exceed 6% by
weight in glyphosate formulations. That document referenced a summary
of the petition prepared by SciReg, Inc on behalf of Albaugh, LLC, the
petitioner, which is available in the docket, <a href="http://www.regulations.gov">http://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
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
[[Page 30833]]
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 cocamidopropylamine oxide
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
cocamidopropylamine 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 cocamidopropylamine oxide 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
this unit.
Available acute toxicity studies on cocamidopropylamine oxide show
low oral, dermal, and inhalation toxicity. Cocamidopropylamine oxide
was determined to be a severe eye irritant and moderate dermal
irritant. Dermal sensitization studies showed cocamidopropylamine oxide
was a non-sensitizer to a mild sensitizer. No mutagenic effects were
noted in mutagenicity studies with cocamidopropylamine oxide. In a 28-
day repeat-dose oral toxicity study in rats, hematological changes,
statistically significant increase in spleen weight, and treatment-
related changes in liver, spleen, kidneys, urinary bladder, and stomach
were observed at the 150 mg/kg/day dose level. No adverse effects of
treatment were seen in reproduction/developmental toxicity study at the
highest dose tested (100 mg/kg/day). Therefore, the NOAEL for the 28-
day repeat-dose oral toxicity study is 15 mg/kg/day and the parental,
reproductive, and developmental NOAELs are 100 mg/kg/day.
There was no evidence of carcinogenicity or neuropathological
changes or effects reported in any of the studies. The agency does not
believe cocamidopropylamine oxide will be carcinogenic or neurotoxic.
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>.
The toxicity endpoint selected for use in risk assessment is taken
from the 28-day repeat-dose toxicity study of cocamidopropylamine oxide
in which a NOAEL was established at 15 mg/kg/day based on hematological
changes, a statistically significant increase in spleen weight, and
treatment-related changes in liver, spleen, kidneys, urinary bladder,
and stomach seen at 150 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 0.15
mg/kg/day.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cocamidopropylamine oxide, EPA considered exposure under
the proposed exemption from the requirement of a tolerance. Dietary
exposure to cocamidopropylamine oxide may occur from eating foods
treated with pesticide formulations containing this inert ingredient
and drinking water containing runoff from
[[Page 30834]]
soils containing the treated crops. 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)--FCIDTM,
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 of cocamidopropylamine oxide a 6% by weight
limitation in glyphosate formulations 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 cocamidopropylamine
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).
Cocamidopropylamine 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 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/turf
and as antimicrobial cleaning products. Cocoamidopropylamine oxide is
also used in some cosmetics, however the primary cosmetic use of
cocoamidopropylamine oxide is in rinse-off hair care products in which
dermal absorption would be unlikely given its highly polarized
molecular structure and short contact time. As a result, such uses
would result in negligible residential exposure to cocamidopropylamine
oxide.
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 cocamidopropylamine oxide to share a common
mechanism of toxicity with any other substances, and
cocamidopropylamine oxide does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that cocamidopropylamine 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 <a href="http://www.epa.gov/pesticides/cumulative">http://www.epa.gov/pesticides/cumulative</a>.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The Agency has concluded
that there is reliable data to determine that infants and children will
be safe if the FQPA SF of 10X is reduced to 1X for the assessment of
all exposure for the following reasons. The toxicity database for
cocamidopropylamine oxide contains subchronic, developmental,
reproduction, and mutagenicity studies. There is no indication of
immunotoxicity or neurotoxicity in the available studies; therefore,
there is no need to require an immunotoxicity or neurotoxicity study.
No fetal susceptibility is observed in developmental/reproductive
toxicity studies in the rat. Neither maternal, offspring nor
reproduction toxicity is observed in any of the studies. Therefore,
based on the adequacy of the toxicity database, the conservative nature
of the exposure assessment and the lack of concern for prenatal and
postnatal sensitivity, the Agency has concluded that there is reliable
data to determine that infants and children will be safe if the FQPA SF
of 10x is reduced to 1x all exposure scenarios.
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,
cocamidopropylamine 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
cocamidopropylamine oxide from food
[[Page 30835]]
and water will utilize 82% 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).
Cocamidopropylamine oxide may be 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 cocamidopropylamine 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 195 for both
adult males and females and 105 for children. Because EPA's level of
concern for cocamidopropylamine oxide is a 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).
Cocamidopropylamine oxide may be used as an inert ingredient in
pesticide products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to
cocamidopropylamine oxide.
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 195 for adult males and females and 105 for children.
Because EPA's level of concern for cocamidopropylamine oxide is a MOE
of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts in the DEREK expert-based knowledge analysis
regarding carcinogenicity, cocamidopropylamine 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 cocamidopropylamine oxide residues.
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
cocamidopropylamine oxide ADAOs in or on any food commodities. EPA is
establishing limitations on the amount of cocamidopropylamine oxide
that may be used in glyphosate formulations. 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 glyphosate formulation for food use
that contains cocoamidopropylamine oxide at concentations that exceed
6% by weight of the glyphosate formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 910 for cocamidopropylamine oxide (CAS
Reg. No. 68155-09-9) when used as inert ingredient (surfactant) in
glyphosate formulations at a concentration not to exceed 6% by weight
in the formulation.
VII. Statutory and Executive Order Reviews
This action establishes tolerance exemptions 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.
[[Page 30836]]
Dated: April 28, 2022.
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. 180.910 amend table 1 by adding in alphabetical order the
Inert ingredient ``Cocoamidopropylamine oxide (CAS Reg. No. 68155-09-
9)'' 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
------------------------------------------------------------------------
* * * * * * *
Ccocamidopropylamine oxide Not to exceed 6% Surfactant.
(CAS Reg. No. 68155-09-9). by weight in the
formulated
product; only
for use with
glyphosate.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2022-10878 Filed 5-19-22; 8:45 am]
BILLING CODE 6560-50-P
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