2,6-Pyridinedicarboxylic Acid; Exemption From the Requirement of a Tolerance, 71523-71527 [2022-25582]
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Ruth Stevenson,
Chief Counsel, Ethics and Legal Compliance.
[FR Doc. 2022–25482 Filed 11–22–22; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
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VerDate Sep<11>2014
40 CFR Part 180
[EPA–HQ–OPP–2019–0601; FRL–10400–01–
OCSPP]
2,6-Pyridinedicarboxylic Acid;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
exemptions from the requirement of a
tolerance for residues of 2,6pyridinedicarboxylic acid, also known
as DPA (CAS Reg. No. 499–83–2), when
used as an inert ingredient in
antimicrobial pesticide formulations for
use on food contact surfaces in public
eating places, dairy processing
equipment, and food processing
equipment and utensils and when used
in pesticide formulations applied preand post-harvest to crops with an enduse concentration not to exceed 2 parts
per million (ppm). EcoLab Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the establishment
of such exemptions from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of DPA.
DATES: This regulation is effective
November 23, 2022. Objections and
requests for hearings must be received
on or before January 23, 2023 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
SUMMARY:
Observations
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0601, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, 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:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
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Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
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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–2019–0601 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
January 23, 2023. 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–
2019–0601, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov//send-comments-epadockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets/epa-dockets.
II. Petition for Exemption
In the Federal Register of February
11, 2020 (85 FR 7708) (FRL–10005–02),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–11307) by EcoLab Inc.,
1 Ecolab Place, St. Paul, MN 55102. The
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petition requested to amend an
exemption from the requirement of a
tolerance for residues of 2,6pyridinedicarboxylic acid, also known
as DPA, (CAS Reg. No. 499–83–2) by
consolidating and expanding the current
exemptions to 40 CFR 180.940(a) and
increasing the limit to 2 parts per
million (ppm) when used as a pesticide
inert ingredient in pesticide
formulations applied to hard, nonporous food-contact surfaces in public
eating places, dairy processing
equipment, and food-processing
equipment and utensils. The petition
also requested EPA establish an
exemption from the requirement of a
tolerance at 40 CFR 180.910, limited to
2 ppm when used in pesticide
formulations applied to growing crops.
That document referenced a summary of
the petition prepared by EcoLab Inc,
which is available in the docket, https://
www.regulations.gov. 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
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
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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 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 DPA including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with DPA 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 DPA as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in this unit.
The Agency assessed DPA via the
Threshold of Toxicological Concern
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(TTC) approach as outlined by the
European Food Safety Authority (EFSA)
in their 2019 guidance document on the
use of TTC in food safety assessment.
This approach relies on the most recent
evaluation of the literature on TTC as
reviewed by EFSA and the World
Health Organization (WHO) in 2016.
Information regarding the database of
studies and chemicals used to derive
TTCs are reviewed therein. The TTC
approach has been used by the Joint
Expert Committee on Food Additives of
the U.N.’s Food and Agriculture
Organization and the World Health
Organization, the former Scientific
Committee on Food of the European
Commission, the European Medicines
Agency, and EFSA.
TTC are derived from a conservative
and rigorous approach developed by
Munro and Kroes to establish generic
threshold values for human exposure at
which a very low probability of adverse
effects is likely. There are three Cramer
Classes that are organized by structural
classes using the Cramer (1978) decision
scheme. By comparing a range of
compounds by Cramer Class (classes I,
II, and III) and no-observed-effect-level
(NOEL), fifth percentile NOELs were
established for each Cramer Class as
‘‘Human Exposure Thresholds’’
assuming a 60 kg human. These values
were 3, 0.91 and 0.15 mg/kg/day for
classes I, II and III, respectively.
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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.
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 nonthreshold 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 https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-pesticide-program.
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The human exposure threshold value
for threshold (i.e., non-cancer) risks for
DPA is based upon Cramer structural
class. DPA is categorized as Cramer
class III based on the OECD QSAR
toolbox analysis of the Cramer decision
scheme; therefore, this assessment uses
the NOEL of 0.15 mg/kg/day as the
point of departure for all exposure
scenarios assessed (chronic dietary,
incidental oral, dermal and inhalation
exposures).
C. Exposure Assessment
1. Dietary exposure. In evaluating
dietary exposure to DPA, EPA
considered exposure under the
proposed tolerance exemptions at a
concentration not to exceed 2 ppm of
DPA in an end-use pesticide
formulation, as well as any other
sources of dietary exposure. For the
purpose of the screening level dietary
risk assessment to support this request
for an exemption from the requirement
of a tolerance for DPA, 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.
Dietary exposure (food and drinking
water) may occur from the existing and
proposed uses of DPA (e.g., eating foods
treated with pesticide formulations
containing DPA, and drinking water
exposures). An acute dietary assessment
was not performed due to the lack of
adverse effects attributed to a single
dietary exposure.
2. Residential exposure. The term
‘‘residential exposure’’ is used in this
document to refer to non-occupational,
non-dietary exposure (e.g., from hard
surface disinfection on walls, floors, and
tables).
DPA may be used as an inert
ingredient in products that are
registered for specific uses that may
result in short-term and intermediateterm residential exposure, such as
pesticides used in and around the home.
The Agency conducted a conservative
assessment of potential residential
exposure by assessing DPA in pesticides
in outdoor and indoor scenarios. The
Agency’s assessment of adult residential
exposure combines high-end dermal
and inhalation handler exposure from
outdoor and indoor uses. The Agency’s
assessment of children’s residential
exposure includes total post-application
exposures associated with total
exposures to contact with both treated
outdoor or indoor scenarios.
3. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
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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 made a common
mechanism of toxicity finding as to DPA
and any other substances, and DPA does
not appear to produce toxic metabolites
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
DPA has a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
FFDCA Section 408(b)(2)(C) provides
that EPA shall retain 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 Food
Quality Protection Act (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. The FQPA SF has been reduced
to 1X for DPA because clear NOELs and
LOELs were established in the studies
analyzed by Munro et al 1996 (which
included developmental and
reproductive toxicity studies), maternal
and developmental-specific 5th
percentile NOELs calculated by van
Ravenzwaay et al 2011 indicate low
potential for offspring susceptibility,
there is no known precedent for
developmental or reproductive toxicity
potential for DPA using the QSAR
Toolbox DART Scheme, and the
conservative assumptions made in the
exposure assessment are unlikely
underestimate to risk.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
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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 aggregate risk. An acute
aggregate risk assessment takes into
account acute exposure estimates from
dietary consumption of food and
drinking water. No adverse effects
resulting from a single oral exposure
were identified and no acute dietary
endpoint were selected for DPA.
Therefore, DPA is not expected to pose
an acute risk.
2. Short-term aggregate risk. Shortterm aggregate exposure takes into
account short-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
DPA is 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.
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 1400 for both adult males and
females. EPA has concluded the
combined short-term aggregated food,
water, and residential pesticide
exposures result in an aggregate MOE of
530 for children. Because EPA’s level of
concern for DPA is a MOE of 100 or
below, these MOEs are not of concern.
3. Intermediate-term aggregate 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). An
intermediate-term adverse effect was
identified; however, DPA exposure
values for intermediate term risks are all
lower than the short-term risk.
Intermediate-term risk is assessed based
on intermediate-term residential
exposure plus chronic dietary 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 intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
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EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for DPA.
4. Chronic aggregate risk. A chronic
aggregate risk assessment takes into
account exposure estimates from
chronic dietary consumption of food
and drinking water. Using the exposure
assumptions described in unit IV for
chronic exposure, EPA has concluded
that chronic exposure to DPA from food
and water will utilize 18.1% of the
cPAD for children 1 to 2 years old, the
highest exposed subgroup. Therefore,
chronic dietary risks are below the
Agency’s level of concern of 100% of
the cPAD. The chronic aggregate risk is
equal to the chronic dietary risk and is
not of concern for DPA.
5. Cancer aggregate risk. No structural
alerts for cancer were identified for
DPA. Therefore, there is low concern for
genotoxicity/carcinogenicity in humans
and the assessment under the TTC value
for non-cancer risks is protective for all
risks, including carcinogenicity.
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 residues of
DPA.
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 DPA in or on any food
commodities. EPA is establishing a
limitation on the amount of DPA that
may be used in pesticide formulations.
This limitation 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 2 ppm of 2,6pyridinedicarboxylic acid in the final
pesticide formulation.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.940(a) for 2,6pyridinedicarboxylic acid, also known
as DPA, (CAS Reg. No. 499–83–2) when
used as an inert ingredient in
antimicrobial pesticide formulations
applied to food contact surfaces in
public eating places, dairy processing
equipment, and food processing
equipment and utensils at an end-use
concentration not to exceed 2 ppm, and
under 40 CFR 180.910 when used as an
inert ingredient (stabilizer) in pesticide
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formulations applied to growing crops
or to raw agricultural commodities after
harvest at a concentration not to exceed
2 ppm.
VII. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
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
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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).
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
List of Subjects in 40 CFR Part 180
Authority: 21 U.S.C. 321(q), 346a and 371.
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 17, 2022.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR part
180 as follows:
2. In § 180.910, amend Table 1 to
180.910, by adding in alphabetical
order, an entry for ‘‘2,6pyridinedicarboxylic acid (CAS Reg. No.
449–83–2)’’ to the table to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
*
2,6-pyridinedicarboxylic acid (CAS Reg. No. 449–83–2) .......................................
*
*
Not to exceed 2 ppm .............................
*
*
*
3. Amend § 180.940, by:
a. Adding in alphabetical order an
entry for the pesticide chemical ‘‘2,6Pyridinedicarboxylic acid’’ in table 1 to
paragraph (a);
■
■
*
Uses
*
*
Stabilizer.
*
*
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
b. Removing the entry for ‘‘2,6Pyridinedicarboxylic acid’’ from the
table in paragraph (b); and
■ c. Removing the entry for ‘‘2,6Pyridinedicarboxylic acid’’ from the
table in paragraph (c).
The addition reads as follows:
■
*
*
*
(a) * * *
*
*
TABLE 1 TO PARAGRAPH (a)
Pesticide chemical
CAS Reg. No.
*
*
2,6-Pyridinedicarboxylic acid .....................
*
*
*
*
*
*
*
499–83–2
Limits
*
*
*
*
When ready for use, the end-use concentration is not to exceed 2 ppm.
*
*
*
*
*
*
Final rule.
DEPARTMENT OF COMMERCE
ACTION:
National Oceanic and Atmospheric
Administration
SUMMARY:
[FR Doc. 2022–25582 Filed 11–22–22; 8:45 am]
BILLING CODE 6560–50–P
50 CFR Part 648
[Docket No. 221116–0244]
lotter on DSK11XQN23PROD with RULES1
RIN 0648–BI18
Fisheries of the Northeastern United
States; Amendment 20 to the Atlantic
Surfclam and Ocean Quahog Fishery
Management Plan
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
AGENCY:
VerDate Sep<11>2014
15:59 Nov 22, 2022
Jkt 259001
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
This final rule announces
approval of, and implements
management measures contained in,
Amendment 20 to the Atlantic Surfclam
and Ocean Quahog Fishery Management
Plan. The Mid-Atlantic Fishery
Management Council developed these
measures to limit the amount of
surfclam or ocean quahog individual
transferable quota share or annual
allocation in the form of cage tags that
an individual or their family members
are permitted to hold. These changes are
intended to ensure the management
plan is consistent with requirements of
the Magnuson-Stevens Fishery
E:\FR\FM\23NOR1.SGM
23NOR1
Agencies
[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Rules and Regulations]
[Pages 71523-71527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25582]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0601; FRL-10400-01-OCSPP]
2,6-Pyridinedicarboxylic Acid; Exemption From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of 2,6-pyridinedicarboxylic acid, also known
as DPA (CAS Reg. No. 499-83-2), when used as an inert ingredient in
antimicrobial pesticide formulations for use on food contact surfaces
in public eating places, dairy processing equipment, and food
processing equipment and utensils and when used in pesticide
formulations applied pre- and post-harvest to crops with an end-use
concentration not to exceed 2 parts per million (ppm). EcoLab Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting the establishment of such exemptions from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of DPA.
DATES: This regulation is effective November 23, 2022. Objections and
requests for hearings must be received on or before January 23, 2023
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-2019-0601, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, 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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal
[[Page 71524]]
Register's e-CFR site at https://www.ecfr.gov/current/title-40.
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-2019-0601 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
January 23, 2023. 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-2019-0601, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov//send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/epa-dockets.
II. Petition for Exemption
In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11307) by EcoLab Inc., 1 Ecolab Place, St. Paul, MN 55102. The petition
requested to amend an exemption from the requirement of a tolerance for
residues of 2,6-pyridinedicarboxylic acid, also known as DPA, (CAS Reg.
No. 499-83-2) by consolidating and expanding the current exemptions to
40 CFR 180.940(a) and increasing the limit to 2 parts per million (ppm)
when used as a pesticide inert ingredient in pesticide formulations
applied to hard, non-porous food-contact surfaces in public eating
places, dairy processing equipment, and food-processing equipment and
utensils. The petition also requested EPA establish an exemption from
the requirement of a tolerance at 40 CFR 180.910, limited to 2 ppm when
used in pesticide formulations applied to growing crops. That document
referenced a summary of the petition prepared by EcoLab Inc, which is
available in the docket, https://www.regulations.gov. 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 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 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 DPA including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with DPA 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 DPA 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.
The Agency assessed DPA via the Threshold of Toxicological Concern
[[Page 71525]]
(TTC) approach as outlined by the European Food Safety Authority (EFSA)
in their 2019 guidance document on the use of TTC in food safety
assessment. This approach relies on the most recent evaluation of the
literature on TTC as reviewed by EFSA and the World Health Organization
(WHO) in 2016. Information regarding the database of studies and
chemicals used to derive TTCs are reviewed therein. The TTC approach
has been used by the Joint Expert Committee on Food Additives of the
U.N.'s Food and Agriculture Organization and the World Health
Organization, the former Scientific Committee on Food of the European
Commission, the European Medicines Agency, and EFSA.
TTC are derived from a conservative and rigorous approach developed
by Munro and Kroes to establish generic threshold values for human
exposure at which a very low probability of adverse effects is likely.
There are three Cramer Classes that are organized by structural classes
using the Cramer (1978) decision scheme. By comparing a range of
compounds by Cramer Class (classes I, II, and III) and no-observed-
effect-level (NOEL), fifth percentile NOELs were established for each
Cramer Class as ``Human Exposure Thresholds'' assuming a 60 kg human.
These values were 3, 0.91 and 0.15 mg/kg/day for classes I, II and III,
respectively.
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. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
The human exposure threshold value for threshold (i.e., non-cancer)
risks for DPA is based upon Cramer structural class. DPA is categorized
as Cramer class III based on the OECD QSAR toolbox analysis of the
Cramer decision scheme; therefore, this assessment uses the NOEL of
0.15 mg/kg/day as the point of departure for all exposure scenarios
assessed (chronic dietary, incidental oral, dermal and inhalation
exposures).
C. Exposure Assessment
1. Dietary exposure. In evaluating dietary exposure to DPA, EPA
considered exposure under the proposed tolerance exemptions at a
concentration not to exceed 2 ppm of DPA in an end-use pesticide
formulation, as well as any other sources of dietary exposure. For the
purpose of the screening level dietary risk assessment to support this
request for an exemption from the requirement of a tolerance for DPA, 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.
Dietary exposure (food and drinking water) may occur from the
existing and proposed uses of DPA (e.g., eating foods treated with
pesticide formulations containing DPA, and drinking water exposures).
An acute dietary assessment was not performed due to the lack of
adverse effects attributed to a single dietary exposure.
2. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., from hard surface disinfection on walls, floors, and tables).
DPA may be used as an inert ingredient in products that are
registered for specific uses that may result in short-term and
intermediate-term residential exposure, such as pesticides used in and
around the home. The Agency conducted a conservative assessment of
potential residential exposure by assessing DPA in pesticides in
outdoor and indoor scenarios. The Agency's assessment of adult
residential exposure combines high-end dermal and inhalation handler
exposure from outdoor and indoor uses. The Agency's assessment of
children's residential exposure includes total post-application
exposures associated with total exposures to contact with both treated
outdoor or indoor scenarios.
3. 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 made a common mechanism of toxicity finding as to DPA
and any other substances, and DPA does not appear to produce toxic
metabolites produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that DPA has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain 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 Food Quality Protection Act
(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. The FQPA SF has been reduced to 1X for DPA because
clear NOELs and LOELs were established in the studies analyzed by Munro
et al 1996 (which included developmental and reproductive toxicity
studies), maternal and developmental-specific 5th percentile NOELs
calculated by van Ravenzwaay et al 2011 indicate low potential for
offspring susceptibility, there is no known precedent for developmental
or reproductive toxicity potential for DPA using the QSAR Toolbox DART
Scheme, and the conservative assumptions made in the exposure
assessment are unlikely underestimate to risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure
[[Page 71526]]
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 aggregate risk. An acute aggregate risk assessment takes
into account acute exposure estimates from dietary consumption of food
and drinking water. No adverse effects resulting from a single oral
exposure were identified and no acute dietary endpoint were selected
for DPA. Therefore, DPA is not expected to pose an acute risk.
2. Short-term aggregate 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).
DPA is 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.
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 1400 for both
adult males and females. EPA has concluded the combined short-term
aggregated food, water, and residential pesticide exposures result in
an aggregate MOE of 530 for children. Because EPA's level of concern
for DPA is a MOE of 100 or below, these MOEs are not of concern.
3. Intermediate-term aggregate 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). An intermediate-term adverse effect was identified;
however, DPA exposure values for intermediate term risks are all lower
than the short-term risk. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary 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 DPA.
4. Chronic aggregate risk. A chronic aggregate risk assessment
takes into account exposure estimates from chronic dietary consumption
of food and drinking water. Using the exposure assumptions described in
unit IV for chronic exposure, EPA has concluded that chronic exposure
to DPA from food and water will utilize 18.1% of the cPAD for children
1 to 2 years old, the highest exposed subgroup. Therefore, chronic
dietary risks are below the Agency's level of concern of 100% of the
cPAD. The chronic aggregate risk is equal to the chronic dietary risk
and is not of concern for DPA.
5. Cancer aggregate risk. No structural alerts for cancer were
identified for DPA. Therefore, there is low concern for genotoxicity/
carcinogenicity in humans and the assessment under the TTC value for
non-cancer risks is protective for all risks, including
carcinogenicity.
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 residues of DPA.
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 DPA in or on
any food commodities. EPA is establishing a limitation on the amount of
DPA that may be used in pesticide formulations. This limitation 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 2 ppm of 2,6-pyridinedicarboxylic acid in the final
pesticide formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for 2,6-pyridinedicarboxylic acid,
also known as DPA, (CAS Reg. No. 499-83-2) when used as an inert
ingredient in antimicrobial pesticide formulations applied to food
contact surfaces in public eating places, dairy processing equipment,
and food processing equipment and utensils at an end-use concentration
not to exceed 2 ppm, and under 40 CFR 180.910 when used as an inert
ingredient (stabilizer) in pesticide formulations applied to growing
crops or to raw agricultural commodities after harvest at a
concentration not to exceed 2 ppm.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food 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
[[Page 71527]]
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: November 17, 2022.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR part 180 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 to 180.910, by adding in
alphabetical order, an entry for ``2,6-pyridinedicarboxylic acid (CAS
Reg. No. 449-83-2)'' 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
------------------------------------------------------------------------
* * * * * * *
2,6-pyridinedicarboxylic acid Not to exceed 2 Stabilizer.
(CAS Reg. No. 449-83-2). ppm.
* * * * * * *
------------------------------------------------------------------------
0
3. Amend Sec. 180.940, by:
0
a. Adding in alphabetical order an entry for the pesticide chemical
``2,6-Pyridinedicarboxylic acid'' in table 1 to paragraph (a);
0
b. Removing the entry for ``2,6-Pyridinedicarboxylic acid'' from the
table in paragraph (b); and
0
c. Removing the entry for ``2,6-Pyridinedicarboxylic acid'' from the
table in paragraph (c).
The addition reads as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
2,6-Pyridinedicarboxylic acid.. 499-83-2 When ready for use, the
end-use concentration
is not to exceed 2
ppm.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-25582 Filed 11-22-22; 8:45 am]
BILLING CODE 6560-50-P