Rule2021-24268
Calcium Bisulfate; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 9, 2021
Effective
November 9, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of calcium bisulfate when used as an inert ingredient (acidifying/buffering agent) in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy- processing equipment, and food-processing equipment and utensils, limited to 2,000 parts per million (ppm). Burdock Group on behalf of SCG Solutions, LLC., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of calcium bisulfate.
Full Text
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<title>Federal Register, Volume 86 Issue 214 (Tuesday, November 9, 2021)</title>
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[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Rules and Regulations]
[Pages 62101-62104]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24268]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0326; FRL-9180-01-OCSPP]
Calcium Bisulfate; 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 bisulfate when used as an inert
ingredient (acidifying/buffering agent) in antimicrobial formulations
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils,
limited to 2,000 parts per million (ppm). Burdock Group on behalf of
SCG Solutions, LLC., submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of calcium bisulfate.
DATES: This regulation is effective November 9, 2021. Objections and
requests for hearings must be received on or before January 10, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0326, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#cf9d8b899d81a0bba6acaabc8faabfaee1a8a0b9"><span class="__cf_email__" data-cfemail="f2a0b6b4a0bc9d869b919781b2978293dc959d84">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0326 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 10, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0326, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of June 28, 2021 (86 FR 33890) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11436) by
the Burdock Group (859 Outer Road, Orlando, FL 32814) on behalf of SCG
Solutions, LLC (1358 South 9th St., DePere, WI 54115). The petition
requested that 40 CFR 180.940(a) be amended by establishing an
exemption from the requirement of a tolerance for residues of calcium
bisulfate when used as an inert ingredient (acidifying/buffering agent)
in antimicrobial formulations applied to food-contact surfaces in
public eating places, dairy-processing equipment, and food-processing
equipment and utensils, limited to 2,000 parts per million (ppm) in the
final formulation. That document referenced a summary of the petition
prepared by the Burdock Group on behalf of SCG Solutions, LLC, the
petitioner, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and
[[Page 62102]]
diatomaceous earth; thickeners such as carrageenan and modified
cellulose; wetting, spreading, and dispersing agents; propellants in
aerosol dispensers; microencapsulating agents; and emulsifiers. The
term ``inert'' is not intended to imply nontoxicity; the ingredient may
or may not be chemically active. Generally, EPA has exempted inert
ingredients from the requirement of a tolerance based on the low
toxicity of the individual inert ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for calcium bisulfate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with calcium bisulfate
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 calcium bisulfate 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document ``Calcium Bisulfate; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2021-0326.
Calcium bisulfate readily dissociates to the bisulfate anion and
the respective calcium cation. Similarly, sodium bisulfate readily
dissociates to the bisulfate anion and the sodium cation. Since the
bisulfate anion is converted to sulfate in aqueous solution, toxicology
studies for sodium sulfate are generally considered relevant for sodium
bisulfate and calcium bisulfate. Therefore, toxicity data on sodium
sulfate are used as surrogate data for calcium bisulfate.
The acute oral and dermal toxicity of calcium bisulfate is low in
rats. It is slightly irritating to the rabbit skin. It is expected to
be mildly irritating to the eyes.
Based on the toxicity database for sodium sulfate, no toxicity is
observed in a 30-day oral toxicity study and developmental study in
rats at >2,000 mg/kg/day. No toxicity and no tumors are seen in a 27
and 44-week oral toxicity study in rats up to 400 mg/kg/day, the
highest dose tested. No mutagenicity is seen in the Ames test.
Neurotoxicity and immunotoxicity toxicity studies are not available
for review. However, no evidence of neurotoxicity or immunotoxicity is
seen in the available studies.
Calcium bisulfate is expected to readily undergo hydrolysis and
dissociate to calcium ions and sulfate ions in the body. Sulfate anions
are excreted mainly in the urine.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that calcium bisulfate has
a very low overall toxicity. No toxicity was observed in any of the
available studies. In the 30-day oral and the developmental toxicity
studies with the calcium bisulfate surrogate (sodium sulfate), no
toxicity is seen at >2,000 mg/kg/day which is well above the limit dose
of 1,000 mg/kg/day. In addition, calcium bisulfate readily dissociates
to the bisulfate anion and the calcium cation. Bisulfate/sulfate anion
is a naturally occurring constituent in many food substances as well as
an essential component in a large number of mammalian (human) metabolic
processes. The sulfate anion is a normal constituent in the body,
predominantly resulting from the body's metabolism of sulfur-containing
food sources such as foods containing the essential amino acids
cysteine and methionine. Sulfate anions are vital components in a
number of human biosynthetic pathways such as cartilage production and
the formation of pancreatic digestive enzymes. Also, the sulfate anion
is an important conjugate in the Phase II conjugation/elimination of
oxidized (OH) aromatic ring metabolites and for hydroxyl steroid
hormones. The Agency did not identify an endpoint of concern for risk
assessment purposes because no signs of toxicity were observed, and
calcium and sulfate ions are present ubiquitously in the human body.
Since no endpoint of concern was identified for the acute and chronic
dietary exposure assessment and short and intermediate dermal and
inhalation exposure, a quantitative risk assessment for calcium
bisulfate is not necessary.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to calcium bisulfate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from calcium bisulfate in food as follows:
Dietary exposure (food and drinking water) to calcium bisulfate may
occur following ingestion of foods with residues from their use in
accordance with this exemption. However, a quantitative dietary
exposure
[[Page 62103]]
assessment was not conducted and is not necessary 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 bisulfate may be used in pesticide products and non-
pesticide products that may be used in and around the home. Based on
the discussion above regarding the low toxicity of the calcium
bisulfate, a quantitative residential exposure assessment was not
conducted and is not necessary.
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 lack of toxicity in the available data, calcium
bisulfate and its metabolites are not expected to share a common
mechanism of toxicity with other chemicals. For the purposes of this
action, therefore, EPA has assumed that calcium bisulfate do not have a
common mechanism of toxicity with other substances.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of the FFDCA requires EPA to retain an
additional tenfold margin of safety in the case of threshold effects 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. Based on the lack of threshold effects, EPA has not identified
any toxicological endpoints of concern and is conducting a qualitative
assessment of calcium bisulfate. 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.
E. Aggregate Risks and Determination of Safety
Taking into consideration all available information on calcium
bisulfate, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to calcium
bisulfate residues. Therefore, the establishment of exemptions from the
requirement of a tolerance under 40 CFR 180.940(a) for residues of
calcium bisulfate 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 a maximum end-use concentration of 2,000 ppm
is safe under FFDCA section 408.
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 bisulfate in or on any food commodities. EPA is establishing a
limitation on the amount of calcium bisulfate 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
2,000 ppm calcium bisulfate 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 calcium bisulfate when used as
an inert ingredient (acidifying/buffering agent) in antimicrobial
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils
under 40 CFR 180.940(a), limited to 2,000 ppm in the final formulation.
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). 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
[[Page 62104]]
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 1, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.940, in paragraph (a), amend table 180.940(a) by adding
in alphabetical order an entry for the inert ingredient ``Calcium
bisulfate'' to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
Table 180.940(a)
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Inert ingredients CAS Reg. No. Limits
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* * * * * * *
Calcium bisulfate............................................... .............. When ready for use, the end-
use concentration is not to
exceed 2,000 ppm.
* * * * * * *
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* * * * *
[FR Doc. 2021-24268 Filed 11-8-21; 8:45 am]
BILLING CODE 6560-50-P
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