Calcium Pantothenate; Exemption From the Requirement of a Tolerance, 70497-70500 [2020-23109]
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70497
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations
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.).
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: October 9, 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, amend the table by
adding ‘‘thiamine mononitrate’’ in
alphabetical order to read as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
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Inert ingredients
Limits
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Thiamine Mononitrate (CAS Reg. No. 532–43–4) ............
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0.1% by weight in pesticide formulations .......................
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[FR Doc. 2020–23041 Filed 11–4–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0117; FRL–10015–71]
Calcium Pantothenate; Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of calcium
pantothenate (CAS Reg. No. 137–08–6)
when used as an inert ingredient
(enzyme cofactor) in pesticide products
applied to/on all growing crops preharvest, limited to 0.1% (by weight) in
pesticide formulations. SciReg, Inc on
behalf of Valagro, S.p.A submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting an establishment of an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of certain
SUMMARY:
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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).
VerDate Sep<11>2014
18:31 Nov 04, 2020
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Uses
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calcium pantothenate when used in
accordance with this exemption.
DATES: This regulation is effective
November 5, 2020. Objections and
requests for hearings must be received
on or before January 4, 2021, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0117, 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 is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
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Enzyme cofactor.
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email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
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Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations
• Pesticide manufacturing (NAICS
code 32532).
II. Petition for Exemption
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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 Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&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–2020–0117 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 4, 2021. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2020–0117, 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/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
VerDate Sep<11>2014
18:31 Nov 04, 2020
Jkt 253001
In the Federal Register of May 8, 2020
(85 FR 27346) (FRL–10008–38), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (IN–
11371) by SciReg, Inc (12733 Director’s
Loop, Woodbridge, VA 22192) on behalf
of Valagro S.p.A. (Zona Industriale, Via
Cagliari, 1, 66041 Atessa (CH), Italy).
The petition requested that 40 CFR be
amended by establishing an exemption
from the requirement of a tolerance for
residues of vitamin B5 (CAS Reg. No.
137–08–6) when used as an inert
ingredient (enzyme cofactor) in
pesticide products applied to/on all
growing crops pre-harvest under 40 CFR
180.920, limited to 0.1% (by weight) in
pesticide formulations. That document
referenced a summary of the petition
prepared by SciReg, Inc on behalf of
Valagro, S.p.A, the petitioner, 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 exemption is ‘‘safe.’’
Section 408(c)(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
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reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Under FFDCA
section 408(c)(2)(B), EPA must take into
account, among other considerations,
the factors in subparagraphs (C) and (D)
of subsection (b)(2). 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 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 certain calcium
pantothenate including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with calcium pantothenate
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
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the nature of the adverse effects caused
by calcium pantothenate as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document,
Calcium Pantothenate, Vitamin B5—
Human Health Risk and Ecological
Effects Assessment of Request to Amend
an Existing Exemption from the
Requirements of a Pesticide Tolerance
Under 40 CFR 180.920 for Food Use
Inert Ingredient, in docket ID number
EPA–HQ–OPP–2020–0117.
Vitamin B5 is also known as calcium
pantothenate. EPA is using the term
‘‘calcium pantothenate’’ in this
document and the tolerance exemption
to refer to vitamin B5 to be consistent
with standard agency nomenclature for
the identification of this substance.
The acute oral and inhalation
toxicities are low in rats and mice
treated with calcium pantothenate. It is
not irritating to the rabbit eye or skin.
No toxicity is observed in repeated
dose studies conducted with calcium
pantothenate administered to rats. Fetal
susceptibility is not observed in the
reproduction and developmental
toxicity studies in rats. No adverse
effects are observed in parents, offspring
or reproduction in rats treated with
calcium pantothenate at doses up to
2,000 mg/kg/day.
Mutagenicity is not expected with
calcium pantothenate based on available
mutagenicity studies. Calcium
pantothenate is not expected to be
carcinogenic based the lack of toxicity.
Neurotoxicity and immunotoxicity
studies are not available for review.
However, no evidence of neurotoxicity
or immunotoxicity is observed in any of
the available studies on calcium
pantothenate.
B. Toxicological Points of Departure/
Levels of Concern
The available toxicity studies indicate
that calcium pantothenate is not acutely
toxic. The acute oral lethal dose (LD)50
for mice and rats is > 10,000 milligrams/
kilograms (mg/kg). No effects are
observed in repeated dose studies at
doses up to 2,000 mg/kg/day of calcium
pantothenate in rats. Since no signs of
toxicity are observed, an endpoint of
concern for risk assessment purposes
was not identified. EPA assessed dietary
and other non-occupational exposures
qualitatively.
C. Exposure Assessment
1. Dietary exposure from drinking
water, food and feed uses. In evaluating
dietary exposure to calcium
pantothenate, EPA considered exposure
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under the proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from calcium
pantothenate in food as follows:
Dietary exposure (food and drinking
water) to calcium pantothenate may
occur following ingestion of foods with
residues from their use in accordance
with this exemption. Dietary exposure
may also occur from its use as a dietary
supplement and as a direct food
additive under the Food and Drug
Administration Code of Federal
Regulations Title 21. However, a
quantitative dietary exposure
assessment was not conducted since a
toxicological endpoint for risk
assessment was not identified.
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Calcium pantothenate may be used in
pesticide products and non-pesticide
products that may be used in and
around the home. Calcium pantothenate
may also be found in cosmetics and
personal care products. Based on the
discussion above regarding the toxicity
of the calcium pantothenate, a
quantitative residential exposure
assessment for calcium pantothenate
was not conducted.
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.’’
Based on the available data, calcium
pantothenate does not have a toxic
mechanism; therefore, section
408(b)(2)(D)(v) does not apply.
D. Safety Factor for Infants and
Children
Based on the lack of threshold effects,
EPA has not identified any toxicological
endpoints of concern and is conducting
a qualitative assessment of calcium
pantothenate. The qualitative
assessment does not use safety factors
for assessing risk, and no additional
safety factor is needed for assessing risk
to infants and children. Based on an
assessment of calcium pantothenate,
EPA has concluded that there are no
toxicological endpoints of concern for
the U.S. population, including infants
and children.
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70499
E. Aggregate Risks and Determination of
Safety
Because no toxicological endpoints of
concern were identified, 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 calcium
pantothenate 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 calcium
pantothenate in or on any food
commodities. EPA is establishing
limitations on the amount of calcium
pantothenate that may be used in
pesticide formulations applied preharvest. 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
0.1% by weight of calcium pantothenate
in the final pesticide formulation.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
for residues of calcium pantothenate
(CAS Reg. No. 137–08–6) when used as
inert ingredients (enzyme cofactor) in
pesticide products applied to/on all
growing crops pre-harvest under 40 CFR
180.920, limited to 0.1% (by weight) in
pesticide formulations.
VII. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption under FFDCA section 408(d)
in response to a petition submitted to
the Agency. The Office of Management
and Budget (OMB) has exempted these
types of actions from review under
Executive Order 12866, entitled
‘‘Regulatory Planning and Review’’ (58
FR 51735, October 4, 1993). Because
this action has been exempted from
review under Executive Order 12866,
this action is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997),
nor is it considered a regulatory action
under Executive Order 13771, entitled
‘‘Reducing Regulations and Controlling
Regulatory Costs’’ (82 FR 9339, February
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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).
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
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: October 14, 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, amend the table by
adding ‘‘calcium pantothenate’’ in
alphabetical order to read as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
Inert ingredients
Limits
*
*
*
Calcium Pantothenate (CAS Reg. No. 137–08–6) ...........
*
*
*
0.1% by weight in pesticide formulations .......................
*
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BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 9
[PS Docket No. 07–114; FRS 17212]
DATES:
Wireless E911 Location Accuracy
Requirements
Jkt 253001
John
Evanoff, john.evanoff@fcc.gov, of the
Public Safety and Homeland Security
Bureau, Policy and Licensing Division,
(202) 418–0848.
FOR FURTHER INFORMATION CONTACT:
The Federal Communications
Commission (Commission) is correcting
the dates announced in a document that
appeared in the Federal Register on
August 28, 2020. That document
announced that compliance with
specific sections of the Commission
rules will not be required until the
Commission publishes a document in
18:31 Nov 04, 2020
November 5, 2020.
Federal Communications
Commission, 45 L Street NE,
Washington, DC 20554.
Federal Communications
Commission.
ACTION: Final rule; correction.
VerDate Sep<11>2014
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ADDRESSES:
AGENCY:
SUMMARY:
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SUPPLEMENTARY INFORMATION:
Correction
In FR Doc. 2020–18795 appearing on
page 53234 in the Federal Register on
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Uses
the Federal Register announcing the
compliance date. This document
corrects the list of rule provisions
subject to this compliance date. In
addition, this document revises a
section of the Commission’s rules to
advise that compliance is not required
until after OMB approval of the
information collection and
recordkeeping requirements.
[FR Doc. 2020–23109 Filed 11–4–20; 8:45 am]
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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).
*
*
Enzyme cofactor.
*
Friday, August 28, 2020, the following
corrections are made:
1. On page 53234, in the first column,
the Compliance date is corrected to
read:
Compliance date: Compliance will
not be required for § 9.10(i)(2)(ii)(J)(4),
(i)(4)(iv) and (v), (j)(4), and (k) until the
Commission publishes a document in
the Federal Register announcing the
compliance date.
2. On page 53245, in the first column,
paragraph 74 is corrected to read:
74. Paperwork Reduction Act
Analysis. The requirements in sections
9.10(i)(2)(ii)(J)(4), 9.10(i)(4)(iv),
9.10(i)(4)(v), 9.10(j)(4) and 9.10(k),
constitute modified information
collections. They will be submitted to
the Office of Management and Budget
(OMB) for review under section 3507(d)
of the Paperwork Reduction Act of 1995
(PRA). OMB, the general public, and
other Federal agencies will be invited to
comment on the new or modified
information collection requirements
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[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Rules and Regulations]
[Pages 70497-70500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23109]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0117; FRL-10015-71]
Calcium Pantothenate; 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 calcium pantothenate (CAS Reg. No. 137-
08-6) when used as an inert ingredient (enzyme cofactor) in pesticide
products applied to/on all growing crops pre-harvest, limited to 0.1%
(by weight) in pesticide formulations. SciReg, Inc on behalf of
Valagro, S.p.A submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of certain calcium pantothenate when used in accordance with
this exemption.
DATES: This regulation is effective November 5, 2020. Objections and
requests for hearings must be received on or before January 4, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0117, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[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).
[[Page 70498]]
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 Printing Office's e-CFR site at https://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-2020-0117 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 4, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0117, 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/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of May 8, 2020 (85 FR 27346) (FRL-10008-
38), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (IN-11371) by
SciReg, Inc (12733 Director's Loop, Woodbridge, VA 22192) on behalf of
Valagro S.p.A. (Zona Industriale, Via Cagliari, 1, 66041 Atessa (CH),
Italy). The petition requested that 40 CFR be amended by establishing
an exemption from the requirement of a tolerance for residues of
vitamin B5 (CAS Reg. No. 137-08-6) when used as an inert ingredient
(enzyme cofactor) in pesticide products applied to/on all growing crops
pre-harvest under 40 CFR 180.920, limited to 0.1% (by weight) in
pesticide formulations. That document referenced a summary of the
petition prepared by SciReg, Inc on behalf of Valagro, S.p.A, the
petitioner, 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 exemption is ``safe.'' Section 408(c)(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. Under FFDCA section 408(c)(2)(B), EPA must take
into account, among other considerations, the factors in subparagraphs
(C) and (D) of subsection (b)(2). 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 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 certain calcium pantothenate
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with calcium
pantothenate 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
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the nature of the adverse effects caused by calcium pantothenate 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 https://www.regulations.gov in the document, Calcium
Pantothenate, Vitamin B5--Human Health Risk and Ecological Effects
Assessment of Request to Amend an Existing Exemption from the
Requirements of a Pesticide Tolerance Under 40 CFR 180.920 for Food Use
Inert Ingredient, in docket ID number EPA-HQ-OPP-2020-0117.
Vitamin B5 is also known as calcium pantothenate. EPA is using the
term ``calcium pantothenate'' in this document and the tolerance
exemption to refer to vitamin B5 to be consistent with standard agency
nomenclature for the identification of this substance.
The acute oral and inhalation toxicities are low in rats and mice
treated with calcium pantothenate. It is not irritating to the rabbit
eye or skin.
No toxicity is observed in repeated dose studies conducted with
calcium pantothenate administered to rats. Fetal susceptibility is not
observed in the reproduction and developmental toxicity studies in
rats. No adverse effects are observed in parents, offspring or
reproduction in rats treated with calcium pantothenate at doses up to
2,000 mg/kg/day.
Mutagenicity is not expected with calcium pantothenate based on
available mutagenicity studies. Calcium pantothenate is not expected to
be carcinogenic based the lack of toxicity.
Neurotoxicity and immunotoxicity studies are not available for
review. However, no evidence of neurotoxicity or immunotoxicity is
observed in any of the available studies on calcium pantothenate.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that calcium pantothenate
is not acutely toxic. The acute oral lethal dose (LD)50 for
mice and rats is > 10,000 milligrams/kilograms (mg/kg). No effects are
observed in repeated dose studies at doses up to 2,000 mg/kg/day of
calcium pantothenate in rats. Since no signs of toxicity are observed,
an endpoint of concern for risk assessment purposes was not identified.
EPA assessed dietary and other non-occupational exposures
qualitatively.
C. Exposure Assessment
1. Dietary exposure from drinking water, food and feed uses. In
evaluating dietary exposure to calcium pantothenate, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from calcium pantothenate in
food as follows:
Dietary exposure (food and drinking water) to calcium pantothenate
may occur following ingestion of foods with residues from their use in
accordance with this exemption. Dietary exposure may also occur from
its use as a dietary supplement and as a direct food additive under the
Food and Drug Administration Code of Federal Regulations Title 21.
However, a quantitative dietary exposure assessment was not conducted
since a toxicological endpoint for risk assessment was not identified.
2. 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).
Calcium pantothenate may be used in pesticide products and non-
pesticide products that may be used in and around the home. Calcium
pantothenate may also be found in cosmetics and personal care products.
Based on the discussion above regarding the toxicity of the calcium
pantothenate, a quantitative residential exposure assessment for
calcium pantothenate was not conducted.
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.''
Based on the available data, calcium pantothenate does not have a
toxic mechanism; therefore, section 408(b)(2)(D)(v) does not apply.
D. Safety Factor for Infants and Children
Based on the lack of threshold effects, EPA has not identified any
toxicological endpoints of concern and is conducting a qualitative
assessment of calcium pantothenate. The qualitative assessment does not
use safety factors for assessing risk, and no additional safety factor
is needed for assessing risk to infants and children. Based on an
assessment of calcium pantothenate, EPA has concluded that there are no
toxicological endpoints of concern for the U.S. population, including
infants and children.
E. Aggregate Risks and Determination of Safety
Because no toxicological endpoints of concern were identified, 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 calcium pantothenate 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
calcium pantothenate in or on any food commodities. EPA is establishing
limitations on the amount of calcium pantothenate that may be used in
pesticide formulations applied pre-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 0.1% by weight of calcium pantothenate in the final
pesticide formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of calcium pantothenate (CAS Reg. No. 137-08-
6) when used as inert ingredients (enzyme cofactor) in pesticide
products applied to/on all growing crops pre-harvest under 40 CFR
180.920, limited to 0.1% (by weight) in pesticide formulations.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February
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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).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 14, 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. 180.920, amend the table by adding ``calcium pantothenate''
in alphabetical order to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
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Inert ingredients Limits Uses
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Calcium Pantothenate (CAS Reg. 0.1% by weight in Enzyme cofactor.
No. 137-08-6). pesticide
formulations.
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[FR Doc. 2020-23109 Filed 11-4-20; 8:45 am]
BILLING CODE 6560-50-P
