Rule2022-05213
Calcium Sulfate; 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
March 11, 2022
Effective
March 11, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of calcium sulfate when used as an inert ingredient in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food- processing equipment and utensils, limited to 100 parts per million (ppm) in the final formulation. Exponent, Inc. on behalf of Tygrus, 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 sulfate when used in accordance with this exemption.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 48 (Friday, March 11, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Rules and Regulations]
[Pages 13945-13948]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05213]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0642; FRL-9536-01-OCSPP]
Calcium Sulfate; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of calcium sulfate when used as an inert
ingredient in antimicrobial formulations applied to food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils, limited to 100 parts per million
(ppm) in the final formulation. Exponent, Inc. on behalf of Tygrus,
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 sulfate
when used in accordance with this exemption.
DATES: This regulation is effective March 11, 2022. Objections and
requests for hearings must be received on or before May 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-2021-0642, 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 open to visitors by
appointment only. For the latest status information on EPA/DC services
and 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#faa8bebca8b4958e93999f89ba9f8a9bd49d958c"><span class="__cf_email__" data-cfemail="b7e5f3f1e5f9d8c3ded4d2c4f7d2c7d699d0d8c1">[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(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0642 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
May 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-2021-0642, 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 November 23, 2021 (86 FR 66512) (FRL-
8792-05), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11565) by Exponent, Inc., 1150 Connecticut Ave. NW, Suite 1100,
Washington, DC 20036 on behalf of Tygrus, LLC, 1132 E. Big Beaver Road,
Troy, MI 48083. 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 sulfate when used as an inert
ingredient in antimicrobial formulations applied to food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils, limited to 100 parts per million
(ppm) in the final formulation. That document referenced a summary of
the petition prepared by Exponent, Inc. on behalf of Tygrus, 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
[[Page 13946]]
polyoxyethylene polymers and fatty acids; carriers such as clay and
diatomaceous earth; thickeners such as carrageenan and modified
cellulose; wetting, spreading, and dispersing agents; propellants in
aerosol dispensers; microencapsulating agents; and emulsifiers. The
term ``inert'' is not intended to imply nontoxicity; the ingredient may
or may not be chemically active. Generally, EPA has exempted inert
ingredients from the requirement of a tolerance based on the low
toxicity of the individual inert ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(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. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a 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 sulfate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with calcium sulfate
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 sulfate 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 Sulfate; 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-
2021-0642.
Acute oral toxicity, primary dermal and eye irritation, acute
inhalation toxicity and dermal sensitization studies are available for
calcium sulfate. The acute oral toxicity of calcium sulfate is low. The
acute oral LD50 (lethal dose) in rats is greater than 2,000 milligrams/
kilogram (mg/kg). Acute inhalation toxicity is also low; the
LC<INF>50</INF> (lethal concentration) in rats is greater than 2.61
milligrams/liter (mg/L). A study conducted in rabbits indicates it is
not irritating to the skin or eye. A study conducted in the guinea pig
indicates it is not a dermal sensitizer.
Based on the toxicity database for calcium sulfate, no toxicity is
observed in a combined repeated dose toxicity study with the
reproduction/developmental screening test in rats at the limit dose of
1,000 mg/kg/day. No mutagenicity is seen in the Ames or in the
mammalian erythrocyte micronucleus tests.
Neurotoxicity and immunotoxicity toxicity studies for calcium
sulfate are not available for review. However, no evidence of
neurotoxicity or immunotoxicity is seen in the available studies.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that calcium sulfate has a
very low overall toxicity. No toxicity was observed in any of the
available studies. 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 sulfate is not necessary.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to calcium sulfate, EPA considered exposure under the proposed
exemption from the requirement of a tolerance and from existing uses.
EPA assessed dietary exposures from calcium sulfate in food as follows:
Dietary exposure (food and drinking water) to calcium sulfate may
occur following ingestion of foods with residues from use in accordance
with this exemption (e.g., ingesting foods that come in contact with
surfaces treated with pesticide formulations containing calcium
sulfate), as well as non-pesticidal uses in food (see 21 CFR 184.1230).
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 sulfate may be used in pesticide products and non-pesticide
products that may be used in and around the home (e.g., for lawn and
garden pest control, indoor pest control) and in personal care
products. A quantitative residential exposure assessment was not
conducted since a toxicological endpoint for risk assessment was not
identified.
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
sulfate and its
[[Page 13947]]
metabolites are not expected to share a common mechanism of toxicity
with other chemicals; therefore, section 408(b)(2)(D)(v) does not
apply.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database unless EPA concludes that
a different margin of safety will be safe 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 sulfate. 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 sulfate, 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
Taking into consideration all available information on calcium
sulfate, EPA has determined 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 sulfate residues.
Therefore, the establishment of an exemption from the requirement of a
tolerance under 40 CFR 180.940(a) for residues of calcium sulfate 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
limited to 100 ppm in the final formulation, 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 sulfate in or on any food commodities. EPA is establishing a
limitation on the amount of calcium sulfate that may be used in
antimicrobial pesticide formulations applied to food-contact surfaces
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. 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 such antimicrobial pesticide
formulation that exceeds 100 ppm of calcium sulfate when ready for use.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 940(a) for calcium sulfate when used as
an inert ingredient in antimicrobial formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment,
and food-processing equipment and utensils limited to 100 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 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: March 3, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.940, amend table 1 to paragraph (a) by adding in
alphabetical order an entry for ``Calcium Sulfate'' to read as follows:
[[Page 13948]]
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions)
* * * * *
(a) * * *
Table 1 to Paragraph (a)
----------------------------------------------------------------------------------------------------------------
Inert ingredients CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Calcium Sulfate..................... 7778-18-9............... When ready for use, the end-use concentration is
not to exceed 100 ppm.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-05213 Filed 3-10-22; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 11, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.