[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Rules and Regulations]
[Pages 70494-70497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23041]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0112; FRL-10015-69]
Thiamine Mononitrate; 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 thiamine mononitrate (CAS Reg. No. 532-
43-4) 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 thiamine mononitrate when used in accordance with this
exemption. Vitamin B1 is also known as thiamine mononitrate. Throughout
this document and for purposes of issuing the tolerance, EPA is using
the name ``thiamine mononitrate'' to be consistent with standard agency
nomenclature for the identification of this substance.
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-2020-0112, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr50/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-2020-0112 in the subject line on the first
page of your submission. All objections and requests for a hearing
[[Page 70495]]
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-2020-0112, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of 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-11370) 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 B1 (thiamine mononitrate, CAS Reg. No. 532-43-4) 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, http://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 thiamine mononitrate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with thiamine mononitrate
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 thiamine mononitrate as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov in the document Thiamine Mononitrate,
Vitamin B1--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-2020-0112.
The acute oral toxicity is low in mice treated with thiamine
mononitrate. It is mildly to irritating to the rabbit eye and not
irritating to rabbit skin. Thiamine mononitrate is a sensitizer.
No toxicity is observed in repeated dose studies conducted with
thiamine mononitrate administered via diet and gavage to rats and mice.
Fetal susceptibility is not observed in the reproduction and
developmental toxicity studies in rats. No adverse effects are observed
in parents, offspring
[[Page 70496]]
or reproduction in rats treated with thiamine mononitrate at doses up
to 100 mg/kg/day. There is no concern for reproduction or developmental
toxicity since metabolism studies indicate that thiamine mononitrate
absorption declines for an intake higher than 5 mg/day and absorbed
thiamine mononitrate is actively excreted in the urine.
Mutagenicity is not expected with thiamine mononitrate based on
available mutagenicity studies. Thiamine mononitrate is not expected to
be carcinogenic based on studies in mice.
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 thiamine mononitrate.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that thiamine mononitrate
has very low oral toxicity. An acute oral toxicity study shows the
lethal dose (LD)50 above 5,000 mg/kg in mice. Repeated dose
studies show no toxicity at doses up to 1,500 mg/kg/day. Since no
toxicity is 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 thiamine mononitrate, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from thiamine mononitrate in
food as follows:
Dietary exposure (food and drinking water) to thiamine mononitrate
may occur following ingestion of foods with residues from their use in
accordance with this exemption. Dietary exposure may also occur from
its presence naturally in food, its use as a dietary supplement, and as
a direct food additive. 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).
Thiamine mononitrate may be used in pesticide products and non-
pesticide products that may be used in and around the home. Thiamine
mononitrate may also be found in cosmetics and personal care products.
Based on the discussion above regarding the toxicity of the thiamine
mononitrate, a quantitative residential exposure assessment for
thiamine mononitrate 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, thiamine mononitrate 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 thiamine mononitrate. 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 thiamine mononitrate, 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 thiamine mononitrate 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
thiamine mononitrate in or on any food commodities. EPA is establishing
limitations on the amount of thiamine mononitrate 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 thiamine mononitrate in the final
pesticide formulation.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of thiamine mononitrate (CAS Reg. No. 532-43-
4) 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 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
[[Page 70497]]
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 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
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 ``thiamine mononitrate''
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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* * * * * * *
Thiamine Mononitrate (CAS Reg. 0.1% by weight in Enzyme cofactor.
No. 532-43-4). pesticide
formulations.
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[FR Doc. 2020-23041 Filed 11-4-20; 8:45 am]
BILLING CODE 6560-50-P